trips agreement and human rights

FrederickAbbott.com

Trips and human rights: preliminary reflections.

INTERNATIONAL TRADE AND HUMAN RIGHTS: FOUNDATIONS AND CONCEPTUAL ISSUES, p. 145, F. Abbott, C. Breining-Kaufmann & T. Cottier, eds., University of Michigan Press, 2006

Download here:   http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922823

We are considering the relationship between human rights and trade-related aspects of intellectual property rights (TRIPS). Intellectual property rights (IPRs) have always reflected a balancing of general public interests and private stakeholder interests, and in this sense IPRs take into account social welfare concerns as well as those of individual inventors and artists. While the balance struck in the TRIPS Agreement is flawed, it is capable of flexible interpretation and amendment. Human rights represent the values for establishing a global constitutional balance between the interests of the public and the private holders of IPRs. We are collectively at a somewhat early stage of analyzing from a legal standpoint the relationship between human rights and the TRIPS Agreement. The observations in this paper reflect the preliminary nature of this inquiry. From a legal perspective, the sources of human rights relating to TRIPS are customary international law, the Universal Declaration of Human Rights, and various other human rights instruments including the International Covenant on Civil and Political Rights (lCCPR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Report prepared by the Office of the High Commissioner for Human Rights, entitled "The impact of the Agreement on Trade-Related Aspects on Intellectual Property Rights on human rights", insightfully surveys the relevant human rights instruments and their potential application to TRIPS issues.  The idea or concept of human rights as it applies to the field of IPRs involves something beyond the specific norms we may identify in human rights instruments or customary law. Human rights involve the shared perceptions of individuals regarding basic questions of right and wrong, fairness and equity. When an overwhelming part of the world's public perceives a situation as unjust, and expresses its concern, that shared perception itself becomes a part of our human rights dialogue, and informs public policy makers in their actions. Human rights take on character, and become appropriately multidimensional in the context of specific cases, and reflect the spirit of the times. Lawyers may incline to be dismissive of public perception because the legal profession is by nature analytical, and the lawyer prides him or herself on objectivity and precision. Yet laws do not operate in clinical isolation from events, and events (particularly those of great moment) are rarely analytical and precise. One does not stop a war on a legal technicality. In the combating of social wrongs, it is the shared perception of the public, and the willingness of the public to take on the responsibility for setting things back in their proper order, that matters. Meetings in the TRIPS Council on access to medicines that ultimately resulted in the Doha Declaration on the TRIPS Agreement and Public Health flowed largely from efforts by developing WTO Members to deal with public health problems affecting their people. The TRIPS Council did not begin taking access to medicines issues seriously because the OECD governments became more enlightened about the consequences of TRIPS and patents. Rather, this took place because the worldwide public did not accept that the rights of pharmaceutical industry patent holders should take precedence over the rights to life and health of millions of individuals. The human rights dimension will play a substantial role in the response of the WTO and other multilateral organizations to public health issues. It is precisely because fundamental human rights are at stake, and that these rights are paramount in public consciousness, that the legal situation will adapt.

Copyright© 2010—2022 Frederick M. Abbott

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• legal texts
• agreement on trips as amended by the 2005 protocol

THE WTO AGREEMENTS: agreement on TRIPS as amended by the 2005 protocol

Agreement on Trade-Related Aspects of Intellectual Property Rights as Amended by the 2005 Protocol Amending the TRIPS Agreement

• Part I: General Provisions and Basic Principles
• Article 1: Nature and Scope of Obligations
• Article 2: Intellectual Property Conventions
• Article 3: National Treatment
• Article 4: Most-Favoured-Nation Treatment
• Article 5: Multilateral Agreements on Acquisition or Maintenance of Protection
• Article 6: Exhaustion
• Article 7: Objectives
• Article 8: Principles
• Part II: Standards Concerning the Availability, Scope and Use of Intellectual Property Rights

Section 1: Copyright and Related Rights

• Article 9: Relation to the Berne Convention
• Article 10: Computer Programs and Compilations of Data
• Article 11: Rental Rights
• Article 12: Term of Protection
• Article 13: Limitations and Exceptions
• Article 14: Protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations

Section 2: Trademarks

• Article 15: Protectable Subject Matter
• Article 16: Rights Conferred
• Article 17: Exceptions
• Article 18: Term of Protection
• Article 19: Requirement of Use
• Article 20: Other Requirements
• Article 21: Licensing and Assignment

Section 3: Geographical Indications

• Article 22: Protection of Geographical Indications
• Article 23: Additional Protection for Geographical Indications for Wines and Spirits
• Article 24: International Negotiations; Exceptions

Section 4: Industrial Designs

• Article 25: Requirements for Protection
• Article 26: Protection

Section 5: Patents

• Article 27: Patentable Subject Matter
• Article 28: Rights Conferred
• Article 29: Conditions on Patent Applicants
• Article 30: Exceptions to Rights Conferred
• Article 31: Other Use Without Authorization of the Right Holder

Article 31bis

• Article 32: Revocation/Forfeiture
• Article 33: Term of Protection
• Article 34: Process Patents: Burden of Proof

Section 6: Layout-Designs (Topographies) of Integrated Circuits

• Article 35: Relation to the IPIC Treaty
• Article 36: Scope of the Protection
• Article 37: Acts Not Requiring the Authorization of the Right Holder
• Article 38: Term of Protection

Section 7: Protection of Undisclosed Information

Section 8: control of anti-competitive practices in contractual licences.

• Part III: Enforcement of Intellectual Property Rights

Section 1: General Obligations

Section 2: civil and administrative procedures and remedies.

• Article 42: Fair and Equitable Procedures
• Article 43: Evidence
• Article 44: Injunctions
• Article 45: Damages
• Article 46: Other Remedies
• Article 47: Right of Information
• Article 48: Indemnification of the Defendant
• Article 49: Administrative Procedures

Section 3: Provisional Measures

• Section 4: Special Requirements Related to Border Measures
• Article 51: Suspension of Release by Customs Authorities
• Article 52: Application
• Article 53: Security or Equivalent Assurance
• Article 54: Notice of Suspension
• Article 55: Duration of Suspension
• Article 56: Indemnification of the Importer and of the Owner of the Goods
• Article 57: Right of Inspection and Information
• Article 58: Ex Officio Action
• Article 59: Remedies
• Article 60: De Minimis Imports

Section 5: Criminal Procedures

• Part IV: Acquisition and Maintenance of Intellectual Property Rights and Related Inter-Partes Procedures
• Part V: Dispute Prevention and Settlement
• Article 63: Transparency
• Article 64: Dispute Settlement
• Part VI: Transitional Arrangements
• Article 65: Transitional Arrangements
• Article 66: Least-Developed Country Members
• Article 67: Technical Cooperation
• Part VII: Institutional Arrangements: Final Provisions
• Article 68: Council for Trade-Related Aspects of Intellectual Property Rights
• Article 69: International Cooperation
• Article 70: Protection of Existing Subject Matter
• Article 71: Review and Amendment
• Article 72: Reservations
• Article 73: Security Exceptions
• Annex to the TRIPS Agreement
• Appendix to the Annex to the TRIPS Agreement

AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS AS AMENDED BY THE 2005 PROTOCOL AMENDING THE TRIPS AGREEMENT

      Desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade;

      Recognizing , to this end, the need for new rules and disciplines concerning:

      Recognizing the need for a multilateral framework of principles, rules and disciplines dealing with international trade in counterfeit goods;

      Recognizing that intellectual property rights are private rights;

      Recognizing the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives;

      Recognizing also the special needs of the least-developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base;

      Emphasizing the importance of reducing tensions by reaching strengthened commitments to resolve disputes on trade-related intellectual property issues through multilateral procedures;

      Desiring to establish a mutually supportive relationship between the WTO and the World Intellectual Property Organization (referred to in this Agreement as “WIPO”) as well as other relevant international organizations;

      Hereby agree as follows:

GENERAL PROVISIONS AND BASIC PRINCIPLES

Nature and Scope of Obligations

1.  Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

2.  For the purposes of this Agreement, the term “intellectual property” refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.

3.  Members shall accord the treatment provided for in this Agreement to the nationals of other Members.  (1) In respect of the relevant intellectual property right, the nationals of other Members shall be understood as those natural or legal persons that would meet the criteria for eligibility for protection provided for in the Paris Convention (1967), the Berne Convention (1971), the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, were all Members of the WTO members of those conventions.  (2) Any Member availing itself of the possibilities provided in paragraph 3 of Article 5 or paragraph 2 of Article 6 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for Trade-Related Aspects of Intellectual Property Rights (the “Council for TRIPS”).

Intellectual Property Conventions

1.  In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967).

2.  Nothing in Parts I to IV of this Agreement shall derogate from existing obligations that Members may have to each other under the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits.

National Treatment

1.  Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection  (3) of intellectual property, subject to the exceptions already provided in, respectively, the Paris Convention (1967), the Berne Convention (1971), the Rome Convention or the Treaty on Intellectual Property in Respect of Integrated Circuits. In respect of performers, producers of phonograms and broadcasting organizations, this obligation only applies in respect of the rights provided under this Agreement. Any Member availing itself of the possibilities provided in Article 6 of the Berne Convention (1971) or paragraph 1(b) of Article 16 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for TRIPS.

2.  Members may avail themselves of the exceptions permitted under paragraph 1 in relation to judicial and administrative procedures, including the designation of an address for service or the appointment of an agent within the jurisdiction of a Member, only where such exceptions are necessary to secure compliance with laws and regulations which are not inconsistent with the provisions of this Agreement and where such practices are not applied in a manner which would constitute a disguised restriction on trade.

Most-Favoured-Nation Treatment

      With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members. Exempted from this obligation are any advantage, favour, privilege or immunity accorded by a Member:

Multilateral Agreements on Acquisition or Maintenance of Protection

      The obligations under Articles 3 and 4 do not apply to procedures provided in multilateral agreements concluded under the auspices of WIPO relating to the acquisition or maintenance of intellectual property rights.

      For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.

      The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

1.  Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2.  Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

STANDARDS CONCERNING THE AVAILABILITY, SCOPE AND USE OF INTELLECTUAL PROPERTY RIGHTS

Relation to the Berne Convention

1.  Members shall comply with Articles 1 through 21 of the Berne Convention (1971) and the Appendix thereto. However, Members shall not have rights or obligations under this Agreement in respect of the rights conferred under Article 6 bis of that Convention or of the rights derived therefrom.

2.  Copyright protection shall extend to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such.

Computer Programs and Compilations of Data

1.  Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971).

2.  Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself.

Rental Rights

      In respect of at least computer programs and cinematographic works, a Member shall provide authors and their successors in title the right to authorize or to prohibit the commercial rental to the public of originals or copies of their copyright works. A Member shall be excepted from this obligation in respect of cinematographic works unless such rental has led to widespread copying of such works which is materially impairing the exclusive right of reproduction conferred in that Member on authors and their successors in title. In respect of computer programs, this obligation does not apply to rentals where the program itself is not the essential object of the rental.

Term of Protection

      Whenever the term of protection of a work, other than a photographic work or a work of applied art, is calculated on a basis other than the life of a natural person, such term shall be no less than 50 years from the end of the calendar year of authorized publication, or, failing such authorized publication within 50 years from the making of the work, 50 years from the end of the calendar year of making.

Limitations and Exceptions

      Members shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.

Protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations

1.  In respect of a fixation of their performance on a phonogram, performers shall have the possibility of preventing the following acts when undertaken without their authorization: the fixation of their unfixed performance and the reproduction of such fixation. Performers shall also have the possibility of preventing the following acts when undertaken without their authorization: the broadcasting by wireless means and the communication to the public of their live performance.

2.  Producers of phonograms shall enjoy the right to authorize or prohibit the direct or indirect reproduction of their phonograms.

3.  Broadcasting organizations shall have the right to prohibit the following acts when undertaken without their authorization: the fixation, the reproduction of fixations, and the rebroadcasting by wireless means of broadcasts, as well as the communication to the public of television broadcasts of the same. Where Members do not grant such rights to broadcasting organizations, they shall provide owners of copyright in the subject matter of broadcasts with the possibility of preventing the above acts, subject to the provisions of the Berne Convention (1971).

4.  The provisions of Article 11 in respect of computer programs shall apply mutatis mutandis to producers of phonograms and any other right holders in phonograms as determined in a Member’s law. If on 15 April 1994 a Member has in force a system of equitable remuneration of right holders in respect of the rental of phonograms, it may maintain such system provided that the commercial rental of phonograms is not giving rise to the material impairment of the exclusive rights of reproduction of right holders.

5.  The term of the protection available under this Agreement to performers and producers of phonograms shall last at least until the end of a period of 50 years computed from the end of the calendar year in which the fixation was made or the performance took place. The term of protection granted pursuant to paragraph 3 shall last for at least 20 years from the end of the calendar year in which the broadcast took place.

6.  Any Member may, in relation to the rights conferred under paragraphs 1, 2 and 3, provide for conditions, limitations, exceptions and reservations to the extent permitted by the Rome Convention. However, the provisions of Article 18 of the Berne Convention (1971) shall also apply, mutatis mutandis , to the rights of performers and producers of phonograms in phonograms.

Protectable Subject Matter

1.  Any sign, or any combination of signs, capable of distinguishing the goods or services of one undertaking from those of other undertakings, shall be capable of constituting a trademark. Such signs, in particular words including personal names, letters, numerals, figurative elements and combinations of colours as well as any combination of such signs, shall be eligible for registration as trademarks. Where signs are not inherently capable of distinguishing the relevant goods or services, Members may make registrability depend on distinctiveness acquired through use. Members may require, as a condition of registration, that signs be visually perceptible.

2.  Paragraph 1 shall not be understood to prevent a Member from denying registration of a trademark on other grounds, provided that they do not derogate from the provisions of the Paris Convention (1967).

3.  Members may make registrability depend on use. However, actual use of a trademark shall not be a condition for filing an application for registration. An application shall not be refused solely on the ground that intended use has not taken place before the expiry of a period of three years from the date of application.

4.  The nature of the goods or services to which a trademark is to be applied shall in no case form an obstacle to registration of the trademark.

5.  Members shall publish each trademark either before it is registered or promptly after it is registered and shall afford a reasonable opportunity for petitions to cancel the registration. In addition, Members may afford an opportunity for the registration of a trademark to be opposed.

Rights Conferred

1.  The owner of a registered trademark shall have the exclusive right to prevent all third parties not having the owner’s consent from using in the course of trade identical or similar signs for goods or services which are identical or similar to those in respect of which the trademark is registered where such use would result in a likelihood of confusion. In case of the use of an identical sign for identical goods or services, a likelihood of confusion shall be presumed. The rights described above shall not prejudice any existing prior rights, nor shall they affect the possibility of Members making rights available on the basis of use.

2.  Article 6 bis of the Paris Convention (1967) shall apply, mutatis mutandis , to services. In determining whether a trademark is well-known, Members shall take account of the knowledge of the trademark in the relevant sector of the public, including knowledge in the Member concerned which has been obtained as a result of the promotion of the trademark.

3.  Article 6 bis of the Paris Convention (1967) shall apply, mutatis mutandis , to goods or services which are not similar to those in respect of which a trademark is registered, provided that use of that trademark in relation to those goods or services would indicate a connection between those goods or services and the owner of the registered trademark and provided that the interests of the owner of the registered trademark are likely to be damaged by such use.

      Members may provide limited exceptions to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate interests of the owner of the trademark and of third parties.

      Initial registration, and each renewal of registration, of a trademark shall be for a term of no less than seven years. The registration of a trademark shall be renewable indefinitely.

Requirement of Use

1.  If use is required to maintain a registration, the registration may be cancelled only after an uninterrupted period of at least three years of non-use, unless valid reasons based on the existence of obstacles to such use are shown by the trademark owner. Circumstances arising independently of the will of the owner of the trademark which constitute an obstacle to the use of the trademark, such as import restrictions on or other government requirements for goods or services protected by the trademark, shall be recognized as valid reasons for non-use.

2.  When subject to the control of its owner, use of a trademark by another person shall be recognized as use of the trademark for the purpose of maintaining the registration.

Other Requirements

      The use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements, such as use with another trademark, use in a special form or use in a manner detrimental to its capability to distinguish the goods or services of one undertaking from those of other undertakings. This will not preclude a requirement prescribing the use of the trademark identifying the undertaking producing the goods or services along with, but without linking it to, the trademark distinguishing the specific goods or services in question of that undertaking.

Licensing and Assignment

      Members may determine conditions on the licensing and assignment of trademarks, it being understood that the compulsory licensing of trademarks shall not be permitted and that the owner of a registered trademark shall have the right to assign the trademark with or without the transfer of the business to which the trademark belongs.

Protection of Geographical Indications

1.  Geographical indications are, for the purposes of this Agreement, indications which identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin.

2.  In respect of geographical indications, Members shall provide the legal means for interested parties to prevent:

3.  A Member shall, ex officio if its legislation so permits or at the request of an interested party, refuse or invalidate the registration of a trademark which contains or consists of a geographical indication with respect to goods not originating in the territory indicated, if use of the indication in the trademark for such goods in that Member is of such a nature as to mislead the public as to the true place of origin.

4.  The protection under paragraphs 1, 2 and 3 shall be applicable against a geographical indication which, although literally true as to the territory, region or locality in which the goods originate, falsely represents to the public that the goods originate in another territory.

Additional Protection for Geographical Indications for Wines and Spirits

1.  Each Member shall provide the legal means for interested parties to prevent use of a geographical indication identifying wines for wines not originating in the place indicated by the geographical indication in question or identifying spirits for spirits not originating in the place indicated by the geographical indication in question, even where the true origin of the goods is indicated or the geographical indication is used in translation or accompanied by expressions such as “kind”, “type”, “style”, “imitation” or the like.  (4)

2.  The registration of a trademark for wines which contains or consists of a geographical indication identifying wines or for spirits which contains or consists of a geographical indication identifying spirits shall be refused or invalidated, ex officio if a Member’s legislation so permits or at the request of an interested party, with respect to such wines or spirits not having this origin.

3.  In the case of homonymous geographical indications for wines, protection shall be accorded to each indication, subject to the provisions of paragraph 4 of Article 22. Each Member shall determine the practical conditions under which the homonymous indications in question will be differentiated from each other, taking into account the need to ensure equitable treatment of the producers concerned and that consumers are not misled.

4.  In order to facilitate the protection of geographical indications for wines, negotiations shall be undertaken in the Council for TRIPS concerning the establishment of a multilateral system of notification and registration of geographical indications for wines eligible for protection in those Members participating in the system.

International Negotiations; Exceptions

1.  Members agree to enter into negotiations aimed at increasing the protection of individual geographical indications under Article 23. The provisions of paragraphs 4 through 8 below shall not be used by a Member to refuse to conduct negotiations or to conclude bilateral or multilateral agreements. In the context of such negotiations, Members shall be willing to consider the continued applicability of these provisions to individual geographical indications whose use was the subject of such negotiations.

2.  The Council for TRIPS shall keep under review the application of the provisions of this Section; the first such review shall take place within two years of the entry into force of the WTO Agreement. Any matter affecting the compliance with the obligations under these provisions may be drawn to the attention of the Council, which, at the request of a Member, shall consult with any Member or Members in respect of such matter in respect of which it has not been possible to find a satisfactory solution through bilateral or plurilateral consultations between the Members concerned. The Council shall take such action as may be agreed to facilitate the operation and further the objectives of this Section.

3.  In implementing this Section, a Member shall not diminish the protection of geographical indications that existed in that Member immediately prior to the date of entry into force of the WTO Agreement.

4.  Nothing in this Section shall require a Member to prevent continued and similar use of a particular geographical indication of another Member identifying wines or spirits in connection with goods or services by any of its nationals or domiciliaries who have used that geographical indication in a continuous manner with regard to the same or related goods or services in the territory of that Member either ( a ) for at least 10 years preceding 15 April 1994 or ( b ) in good faith preceding that date.

5.  Where a trademark has been applied for or registered in good faith, or where rights to a trademark have been acquired through use in good faith either:

measures adopted to implement this Section shall not prejudice eligibility for or the validity of the registration of a trademark, or the right to use a trademark, on the basis that such a trademark is identical with, or similar to, a geographical indication.

6.  Nothing in this Section shall require a Member to apply its provisions in respect of a geographical indication of any other Member with respect to goods or services for which the relevant indication is identical with the term customary in common language as the common name for such goods or services in the territory of that Member. Nothing in this Section shall require a Member to apply its provisions in respect of a geographical indication of any other Member with respect to products of the vine for which the relevant indication is identical with the customary name of a grape variety existing in the territory of that Member as of the date of entry into force of the WTO Agreement.

7.  A Member may provide that any request made under this Section in connection with the use or registration of a trademark must be presented within five years after the adverse use of the protected indication has become generally known in that Member or after the date of registration of the trademark in that Member provided that the trademark has been published by that date, if such date is earlier than the date on which the adverse use became generally known in that Member, provided that the geographical indication is not used or registered in bad faith.

8.  The provisions of this Section shall in no way prejudice the right of any person to use, in the course of trade, that person’s name or the name of that person’s predecessor in business, except where such name is used in such a manner as to mislead the public.

9.  There shall be no obligation under this Agreement to protect geographical indications which are not or cease to be protected in their country of origin, or which have fallen into disuse in that country.

Requirements for Protection

1.  Members shall provide for the protection of independently created industrial designs that are new or original. Members may provide that designs are not new or original if they do not significantly differ from known designs or combinations of known design features. Members may provide that such protection shall not extend to designs dictated essentially by technical or functional considerations.

2.  Each Member shall ensure that requirements for securing protection for textile designs, in particular in regard to any cost, examination or publication, do not unreasonably impair the opportunity to seek and obtain such protection. Members shall be free to meet this obligation through industrial design law or through copyright law.

1.  The owner of a protected industrial design shall have the right to prevent third parties not having the owner’s consent from making, selling or importing articles bearing or embodying a design which is a copy, or substantially a copy, of the protected design, when such acts are undertaken for commercial purposes.

2.  Members may provide limited exceptions to the protection of industrial designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of protected industrial designs and do not unreasonably prejudice the legitimate interests of the owner of the protected design, taking account of the legitimate interests of third parties.

3.  The duration of protection available shall amount to at least 10 years.

Patentable Subject Matter

1.  Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.  (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

2.  Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

3.  Members may also exclude from patentability:

1.  A patent shall confer on its owner the following exclusive rights:

2.  Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.

Conditions on Patent Applicants

1.  Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

2.  Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.

Exceptions to Rights Conferred

      Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Other Use Without Authorization of the Right Holder

      Where the law of a Member allows for other use  (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

1.  The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement.

2.  Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.

3.  With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question.

4.  Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994.

5.  This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).

Revocation/Forfeiture

      An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available.

      The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date  (8)

Process Patents: Burden of Proof

1.  For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process:

2.  Any Member shall be free to provide that the burden of proof indicated in paragraph 1 shall be on the alleged infringer only if the condition referred to in subparagraph (a) is fulfilled or only if the condition referred to in subparagraph (b) is fulfilled.

3.  In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their manufacturing and business secrets shall be taken into account.

Relation to the IPIC Treaty

      Members agree to provide protection to the layout-designs (topographies) of integrated circuits (referred to in this Agreement as “layout-designs”) in accordance with Articles 2 through 7 (other than paragraph 3 of Article 6), Article 12 and paragraph 3 of Article 16 of the Treaty on Intellectual Property in Respect of Integrated Circuits and, in addition, to comply with the following provisions.

Scope of the Protection

      Subject to the provisions of paragraph 1 of Article 37, Members shall consider unlawful the following acts if performed without the authorization of the right holder:  (9) importing, selling, or otherwise distributing for commercial purposes a protected layout-design, an integrated circuit in which a protected layout-design is incorporated, or an article incorporating such an integrated circuit only in so far as it continues to contain an unlawfully reproduced layout-design.

Acts Not Requiring the Authorization of the Right Holder

1.  Notwithstanding Article 36, no Member shall consider unlawful the performance of any of the acts referred to in that Article in respect of an integrated circuit incorporating an unlawfully reproduced layout-design or any article incorporating such an integrated circuit where the person performing or ordering such acts did not know and had no reasonable ground to know, when acquiring the integrated circuit or article incorporating such an integrated circuit, that it incorporated an unlawfully reproduced layout-design. Members shall provide that, after the time that such person has received sufficient notice that the layout-design was unlawfully reproduced, that person may perform any of the acts with respect to the stock on hand or ordered before such time, but shall be liable to pay to the right holder a sum equivalent to a reasonable royalty such as would be payable under a freely negotiated licence in respect of such a layout-design.

2.  The conditions set out in subparagraphs (a) through (k) of Article 31 shall apply mutatis mutandis in the event of any non-voluntary licensing of a layout-design or of its use by or for the government without the authorization of the right holder.

1.  In Members requiring registration as a condition of protection, the term of protection of layout-designs shall not end before the expiration of a period of 10 years counted from the date of filing an application for registration or from the first commercial exploitation wherever in the world it occurs.

2.  In Members not requiring registration as a condition for protection, layout-designs shall be protected for a term of no less than 10 years from the date of the first commercial exploitation wherever in the world it occurs.

3.  Notwithstanding paragraphs 1 and 2, a Member may provide that protection shall lapse 15 years after the creation of the layout-design.

1.  In the course of ensuring effective protection against unfair competition as provided in Article 10 bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.

2.  Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices  (10) so long as such information:

3.  Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

1.  Members agree that some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology.

2.  Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market. As provided above, a Member may adopt, consistently with the other provisions of this Agreement, appropriate measures to prevent or control such practices, which may include for example exclusive grantback conditions, conditions preventing challenges to validity and coercive package licensing, in the light of the relevant laws and regulations of that Member.

3.  Each Member shall enter, upon request, into consultations with any other Member which has cause to believe that an intellectual property right owner that is a national or domiciliary of the Member to which the request for consultations has been addressed is undertaking practices in violation of the requesting Member’s laws and regulations on the subject matter of this Section, and which wishes to secure compliance with such legislation, without prejudice to any action under the law and to the full freedom of an ultimate decision of either Member. The Member addressed shall accord full and sympathetic consideration to, and shall afford adequate opportunity for, consultations with the requesting Member, and shall cooperate through supply of publicly available non-confidential information of relevance to the matter in question and of other information available to the Member, subject to domestic law and to the conclusion of mutually satisfactory agreements concerning the safeguarding of its confidentiality by the requesting Member.

4.  A Member whose nationals or domiciliaries are subject to proceedings in another Member concerning alleged violation of that other Member’s laws and regulations on the subject matter of this Section shall, upon request, be granted an opportunity for consultations by the other Member under the same conditions as those foreseen in paragraph 3.

ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS

1.  Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.

2.  Procedures concerning the enforcement of intellectual property rights shall be fair and equitable. They shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.

3.  Decisions on the merits of a case shall preferably be in writing and reasoned. They shall be made available at least to the parties to the proceeding without undue delay. Decisions on the merits of a case shall be based only on evidence in respect of which parties were offered the opportunity to be heard.

4.  Parties to a proceeding shall have an opportunity for review by a judicial authority of final administrative decisions and, subject to jurisdictional provisions in a Member’s law concerning the importance of a case, of at least the legal aspects of initial judicial decisions on the merits of a case. However, there shall be no obligation to provide an opportunity for review of acquittals in criminal cases.

5.  It is understood that this Part does not create any obligation to put in place a judicial system for the enforcement of intellectual property rights distinct from that for the enforcement of law in general, nor does it affect the capacity of Members to enforce their law in general. Nothing in this Part creates any obligation with respect to the distribution of resources as between enforcement of intellectual property rights and the enforcement of law in general.

Fair and Equitable Procedures

      Members shall make available to right holders  (11) civil judicial procedures concerning the enforcement of any intellectual property right covered by this Agreement. Defendants shall have the right to written notice which is timely and contains sufficient detail, including the basis of the claims. Parties shall be allowed to be represented by independent legal counsel, and procedures shall not impose overly burdensome requirements concerning mandatory personal appearances. All parties to such procedures shall be duly entitled to substantiate their claims and to present all relevant evidence. The procedure shall provide a means to identify and protect confidential information, unless this would be contrary to existing constitutional requirements.

1.  The judicial authorities shall have the authority, where a party has presented reasonably available evidence sufficient to support its claims and has specified evidence relevant to substantiation of its claims which lies in the control of the opposing party, to order that this evidence be produced by the opposing party, subject in appropriate cases to conditions which ensure the protection of confidential information.

2.  In cases in which a party to a proceeding voluntarily and without good reason refuses access to, or otherwise does not provide necessary information within a reasonable period, or significantly impedes a procedure relating to an enforcement action, a Member may accord judicial authorities the authority to make preliminary and final determinations, affirmative or negative, on the basis of the information presented to them, including the complaint or the allegation presented by the party adversely affected by the denial of access to information, subject to providing the parties an opportunity to be heard on the allegations or evidence.

Injunctions

1.  The judicial authorities shall have the authority to order a party to desist from an infringement, inter alia to prevent the entry into the channels of commerce in their jurisdiction of imported goods that involve the infringement of an intellectual property right, immediately after customs clearance of such goods. Members are not obliged to accord such authority in respect of protected subject matter acquired or ordered by a person prior to knowing or having reasonable grounds to know that dealing in such subject matter would entail the infringement of an intellectual property right.

2.  Notwithstanding the other provisions of this Part and provided that the provisions of Part II specifically addressing use by governments, or by third parties authorized by a government, without the authorization of the right holder are complied with, Members may limit the remedies available against such use to payment of remuneration in accordance with subparagraph (h) of Article 31. In other cases, the remedies under this Part shall apply or, where these remedies are inconsistent with a Member’s law, declaratory judgments and adequate compensation shall be available.

1.  The judicial authorities shall have the authority to order the infringer to pay the right holder damages adequate to compensate for the injury the right holder has suffered because of an infringement of that person’s intellectual property right by an infringer who knowingly, or with reasonable grounds to know, engaged in infringing activity.

2.  The judicial authorities shall also have the authority to order the infringer to pay the right holder expenses, which may include appropriate attorney’s fees. In appropriate cases, Members may authorize the judicial authorities to order recovery of profits and/or payment of pre-established damages even where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity.

Other Remedies

      In order to create an effective deterrent to infringement, the judicial authorities shall have the authority to order that goods that they have found to be infringing be, without compensation of any sort, disposed of outside the channels of commerce in such a manner as to avoid any harm caused to the right holder, or, unless this would be contrary to existing constitutional requirements, destroyed. The judicial authorities shall also have the authority to order that materials and implements the predominant use of which has been in the creation of the infringing goods be, without compensation of any sort, disposed of outside the channels of commerce in such a manner as to minimize the risks of further infringements. In considering such requests, the need for proportionality between the seriousness of the infringement and the remedies ordered as well as the interests of third parties shall be taken into account. In regard to counterfeit trademark goods, the simple removal of the trademark unlawfully affixed shall not be sufficient, other than in exceptional cases, to permit release of the goods into the channels of commerce.

Right of Information

      Members may provide that the judicial authorities shall have the authority, unless this would be out of proportion to the seriousness of the infringement, to order the infringer to inform the right holder of the identity of third persons involved in the production and distribution of the infringing goods or services and of their channels of distribution.

Indemnification of the Defendant

1.  The judicial authorities shall have the authority to order a party at whose request measures were taken and who has abused enforcement procedures to provide to a party wrongfully enjoined or restrained adequate compensation for the injury suffered because of such abuse. The judicial authorities shall also have the authority to order the applicant to pay the defendant expenses, which may include appropriate attorney’s fees.

2.  In respect of the administration of any law pertaining to the protection or enforcement of intellectual property rights, Members shall only exempt both public authorities and officials from liability to appropriate remedial measures where actions are taken or intended in good faith in the course of the administration of that law.

Administrative Procedures

      To the extent that any civil remedy can be ordered as a result of administrative procedures on the merits of a case, such procedures shall conform to principles equivalent in substance to those set forth in this Section.

1.  The judicial authorities shall have the authority to order prompt and effective provisional measures:

2.  The judicial authorities shall have the authority to adopt provisional measures inaudita altera parte where appropriate, in particular where any delay is likely to cause irreparable harm to the right holder, or where there is a demonstrable risk of evidence being destroyed.

3.  The judicial authorities shall have the authority to require the applicant to provide any reasonably available evidence in order to satisfy themselves with a sufficient degree of certainty that the applicant is the right holder and that the applicant’s right is being infringed or that such infringement is imminent, and to order the applicant to provide a security or equivalent assurance sufficient to protect the defendant and to prevent abuse.

4.  Where provisional measures have been adopted inaudita altera parte , the parties affected shall be given notice, without delay after the execution of the measures at the latest. A review, including a right to be heard, shall take place upon request of the defendant with a view to deciding, within a reasonable period after the notification of the measures, whether these measures shall be modified, revoked or confirmed.

5.  The applicant may be required to supply other information necessary for the identification of the goods concerned by the authority that will execute the provisional measures.

6.  Without prejudice to paragraph 4, provisional measures taken on the basis of paragraphs 1 and 2 shall, upon request by the defendant, be revoked or otherwise cease to have effect, if proceedings leading to a decision on the merits of the case are not initiated within a reasonable period, to be determined by the judicial authority ordering the measures where a Member’s law so permits or, in the absence of such a determination, not to exceed 20 working days or 31 calendar days, whichever is the longer.

7.  Where the provisional measures are revoked or where they lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no infringement or threat of infringement of an intellectual property right, the judicial authorities shall have the authority to order the applicant, upon request of the defendant, to provide the defendant appropriate compensation for any injury caused by these measures.

8.  To the extent that any provisional measure can be ordered as a result of administrative procedures, such procedures shall conform to principles equivalent in substance to those set forth in this Section.

Section 4: Special Requirements Related to Border Measures (12)

Suspension of Release by Customs Authorities

      Members shall, in conformity with the provisions set out below, adopt procedures  (13) to enable a right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods  (14) may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. Members may enable such an application to be made in respect of goods which involve other infringements of intellectual property rights, provided that the requirements of this Section are met. Members may also provide for corresponding procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories.

Application

      Any right holder initiating the procedures under Article 51 shall be required to provide adequate evidence to satisfy the competent authorities that, under the laws of the country of importation, there is prima facie an infringement of the right holder’s intellectual property right and to supply a sufficiently detailed description of the goods to make them readily recognizable by the customs authorities. The competent authorities shall inform the applicant within a reasonable period whether they have accepted the application and, where determined by the competent authorities, the period for which the customs authorities will take action.

Security or Equivalent Assurance

1.  The competent authorities shall have the authority to require an applicant to provide a security or equivalent assurance sufficient to protect the defendant and the competent authorities and to prevent abuse. Such security or equivalent assurance shall not unreasonably deter recourse to these procedures.

2.  Where pursuant to an application under this Section the release of goods involving industrial designs, patents, layout-designs or undisclosed information into free circulation has been suspended by customs authorities on the basis of a decision other than by a judicial or other independent authority, and the period provided for in Article 55 has expired without the granting of provisional relief by the duly empowered authority, and provided that all other conditions for importation have been complied with, the owner, importer, or consignee of such goods shall be entitled to their release on the posting of a security in an amount sufficient to protect the right holder for any infringement. Payment of such security shall not prejudice any other remedy available to the right holder, it being understood that the security shall be released if the right holder fails to pursue the right of action within a reasonable period of time.

Notice of Suspension

      The importer and the applicant shall be promptly notified of the suspension of the release of goods according to Article 51.

Duration of Suspension

      If, within a period not exceeding 10 working days after the applicant has been served notice of the suspension, the customs authorities have not been informed that proceedings leading to a decision on the merits of the case have been initiated by a party other than the defendant, or that the duly empowered authority has taken provisional measures prolonging the suspension of the release of the goods, the goods shall be released, provided that all other conditions for importation or exportation have been complied with; in appropriate cases, this time-limit may be extended by another 10 working days. If proceedings leading to a decision on the merits of the case have been initiated, a review, including a right to be heard, shall take place upon request of the defendant with a view to deciding, within a reasonable period, whether these measures shall be modified, revoked or confirmed. Notwithstanding the above, where the suspension of the release of goods is carried out or continued in accordance with a provisional judicial measure, the provisions of paragraph 6 of Article 50 shall apply.

Indemnification of the Importer and of the Owner of the Goods

      Relevant authorities shall have the authority to order the applicant to pay the importer, the consignee and the owner of the goods appropriate compensation for any injury caused to them through the wrongful detention of goods or through the detention of goods released pursuant to Article 55.

Right of Inspection and Information

      Without prejudice to the protection of confidential information, Members shall provide the competent authorities the authority to give the right holder sufficient opportunity to have any goods detained by the customs authorities inspected in order to substantiate the right holder’s claims. The competent authorities shall also have authority to give the importer an equivalent opportunity to have any such goods inspected. Where a positive determination has been made on the merits of a case, Members may provide the competent authorities the authority to inform the right holder of the names and addresses of the consignor, the importer and the consignee and of the quantity of the goods in question.

Ex Officio Action

      Where Members require competent authorities to act upon their own initiative and to suspend the release of goods in respect of which they have acquired prima facie evidence that an intellectual property right is being infringed:

      Without prejudice to other rights of action open to the right holder and subject to the right of the defendant to seek review by a judicial authority, competent authorities shall have the authority to order the destruction or disposal of infringing goods in accordance with the principles set out in Article 46. In regard to counterfeit trademark goods, the authorities shall not allow the re-exportation of the infringing goods in an unaltered state or subject them to a different customs procedure, other than in exceptional circumstances.

De Minimis Imports

      Members may exclude from the application of the above provisions small quantities of goods of a non-commercial nature contained in travellers’ personal luggage or sent in small consignments.

      Members shall provide for criminal procedures and penalties to be applied at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale. Remedies available shall include imprisonment and/or monetary fines sufficient to provide a deterrent, consistently with the level of penalties applied for crimes of a corresponding gravity. In appropriate cases, remedies available shall also include the seizure, forfeiture and destruction of the infringing goods and of any materials and implements the predominant use of which has been in the commission of the offence. Members may provide for criminal procedures and penalties to be applied in other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale.

ACQUISITION AND MAINTENANCE OF INTELLECTUAL PROPERTY RIGHTS AND RELATED INTER-PARTES PROCEDURES

1.  Members may require, as a condition of the acquisition or maintenance of the intellectual property rights provided for under Sections 2 through 6 of Part II, compliance with reasonable procedures and formalities. Such procedures and formalities shall be consistent with the provisions of this Agreement.

2.  Where the acquisition of an intellectual property right is subject to the right being granted or registered, Members shall ensure that the procedures for grant or registration, subject to compliance with the substantive conditions for acquisition of the right, permit the granting or registration of the right within a reasonable period of time so as to avoid unwarranted curtailment of the period of protection.

3.  Article 4 of the Paris Convention (1967) shall apply mutatis mutandis to service marks.

4.  Procedures concerning the acquisition or maintenance of intellectual property rights and, where a Member’s law provides for such procedures, administrative revocation and inter partes procedures such as opposition, revocation and cancellation, shall be governed by the general principles set out in paragraphs 2 and 3 of Article 41.

5.  Final administrative decisions in any of the procedures referred to under paragraph 4 shall be subject to review by a judicial or quasi-judicial authority. However, there shall be no obligation to provide an opportunity for such review of decisions in cases of unsuccessful opposition or administrative revocation, provided that the grounds for such procedures can be the subject of invalidation procedures.

DISPUTE PREVENTION AND SETTLEMENT

Transparency

1.  Laws and regulations, and final judicial decisions and administrative rulings of general application, made effective by a Member pertaining to the subject matter of this Agreement (the availability, scope, acquisition, enforcement and prevention of the abuse of intellectual property rights) shall be published, or where such publication is not practicable made publicly available, in a national language, in such a manner as to enable governments and right holders to become acquainted with them. Agreements concerning the subject matter of this Agreement which are in force between the government or a governmental agency of a Member and the government or a governmental agency of another Member shall also be published.

2.  Members shall notify the laws and regulations referred to in paragraph 1 to the Council for TRIPS in order to assist that Council in its review of the operation of this Agreement. The Council shall attempt to minimize the burden on Members in carrying out this obligation and may decide to waive the obligation to notify such laws and regulations directly to the Council if consultations with WIPO on the establishment of a common register containing these laws and regulations are successful. The Council shall also consider in this connection any action required regarding notifications pursuant to the obligations under this Agreement stemming from the provisions of Article 6 ter of the Paris Convention (1967).

3.  Each Member shall be prepared to supply, in response to a written request from another Member, information of the sort referred to in paragraph 1. A Member, having reason to believe that a specific judicial decision or administrative ruling or bilateral agreement in the area of intellectual property rights affects its rights under this Agreement, may also request in writing to be given access to or be informed in sufficient detail of such specific judicial decisions or administrative rulings or bilateral agreements.

4.  Nothing in paragraphs 1, 2 and 3 shall require Members to disclose confidential information which would impede law enforcement or otherwise be contrary to the public interest or would prejudice the legitimate commercial interests of particular enterprises, public or private.

Dispute Settlement

1.  The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to consultations and the settlement of disputes under this Agreement except as otherwise specifically provided herein.

2.  Subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 shall not apply to the settlement of disputes under this Agreement for a period of five years from the date of entry into force of the WTO Agreement.

3.  During the time period referred to in paragraph 2, the Council for TRIPS shall examine the scope and modalities for complaints of the type provided for under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 made pursuant to this Agreement, and submit its recommendations to the Ministerial Conference for approval. Any decision of the Ministerial Conference to approve such recommendations or to extend the period in paragraph 2 shall be made only by consensus, and approved recommendations shall be effective for all Members without further formal acceptance process.

TRANSITIONAL ARRANGEMENTS

Transitional Arrangements

1.  Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date of entry into force of the WTO Agreement.

2.  A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5.

3.  Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2.

4.  To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years.

5.  A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement.

Least-Developed Country Members

1.  In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period.

2.  Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base.

Technical Cooperation

      In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel.

INSTITUTIONAL ARRANGEMENTS: FINAL PROVISIONS

Council for Trade-Related Aspects of Intellectual Property Rights

      The Council for TRIPS shall monitor the operation of this Agreement and, in particular, Members’ compliance with their obligations hereunder, and shall afford Members the opportunity of consulting on matters relating to the trade-related aspects of intellectual property rights. It shall carry out such other responsibilities as assigned to it by the Members, and it shall, in particular, provide any assistance requested by them in the context of dispute settlement procedures. In carrying out its functions, the Council for TRIPS may consult with and seek information from any source it deems appropriate. In consultation with WIPO, the Council shall seek to establish, within one year of its first meeting, appropriate arrangements for cooperation with bodies of that Organization.

International Cooperation

      Members agree to cooperate with each other with a view to eliminating international trade in goods infringing intellectual property rights. For this purpose, they shall establish and notify contact points in their administrations and be ready to exchange information on trade in infringing goods. They shall, in particular, promote the exchange of information and cooperation between customs authorities with regard to trade in counterfeit trademark goods and pirated copyright goods.

Protection of Existing Subject Matter

1.  This Agreement does not give rise to obligations in respect of acts which occurred before the date of application of the Agreement for the Member in question.

2.  Except as otherwise provided for in this Agreement, this Agreement gives rise to obligations in respect of all subject matter existing at the date of application of this Agreement for the Member in question, and which is protected in that Member on the said date, or which meets or comes subsequently to meet the criteria for protection under the terms of this Agreement. In respect of this paragraph and paragraphs 3 and 4, copyright obligations with respect to existing works shall be solely determined under Article 18 of the Berne Convention (1971), and obligations with respect to the rights of producers of phonograms and performers in existing phonograms shall be determined solely under Article 18 of the Berne Convention (1971) as made applicable under paragraph 6 of Article 14 of this Agreement.

3.  There shall be no obligation to restore protection to subject matter which on the date of application of this Agreement for the Member in question has fallen into the public domain.

4.  In respect of any acts in respect of specific objects embodying protected subject matter which become infringing under the terms of legislation in conformity with this Agreement, and which were commenced, or in respect of which a significant investment was made, before the date of acceptance of the WTO Agreement by that Member, any Member may provide for a limitation of the remedies available to the right holder as to the continued performance of such acts after the date of application of this Agreement for that Member. In such cases the Member shall, however, at least provide for the payment of equitable remuneration.

5.  A Member is not obliged to apply the provisions of Article 11 and of paragraph 4 of Article 14 with respect to originals or copies purchased prior to the date of application of this Agreement for that Member.

6.  Members shall not be required to apply Article 31, or the requirement in paragraph 1 of Article 27 that patent rights shall be enjoyable without discrimination as to the field of technology, to use without the authorization of the right holder where authorization for such use was granted by the government before the date this Agreement became known.

7.  In the case of intellectual property rights for which protection is conditional upon registration, applications for protection which are pending on the date of application of this Agreement for the Member in question shall be permitted to be amended to claim any enhanced protection provided under the provisions of this Agreement. Such amendments shall not include new matter.

8.  Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:

9.  Where a product is the subject of a patent application in a Member in accordance with paragraph 8(a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member.

Review and Amendment

1.  The Council for TRIPS shall review the implementation of this Agreement after the expiration of the transitional period referred to in paragraph 2 of Article 65. The Council shall, having regard to the experience gained in its implementation, review it two years after that date, and at identical intervals thereafter. The Council may also undertake reviews in the light of any relevant new developments which might warrant modification or amendment of this Agreement.

2.  Amendments merely serving the purpose of adjusting to higher levels of protection of intellectual property rights achieved, and in force, in other multilateral agreements and accepted under those agreements by all Members of the WTO may be referred to the Ministerial Conference for action in accordance with paragraph 6 of Article X of the WTO Agreement on the basis of a consensus proposal from the Council for TRIPS.

Reservations

      Reservations may not be entered in respect of any of the provisions of this Agreement without the consent of the other Members.

Security Exceptions

      Nothing in this Agreement shall be construed:

ANNEX TO THE TRIPS AGREEMENT

1.  For the purposes of Article 31 bis and this Annex:

2.  The terms referred to in paragraph 1 of Article 31 bis are that:

3.  In order to ensure that the products imported under the system are used for the public health purposes underlying their importation, eligible importing Members shall take reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of the products that have actually been imported into their territories under the system. In the event that an eligible importing Member that is a developing country Member or a least-developed country Member experiences difficulty in implementing this provision, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in order to facilitate its implementation.

4.  Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of products produced under the system and diverted to their markets inconsistently with its provisions, using the means already required to be available under this Agreement. If any Member considers that such measures are proving insufficient for this purpose, the matter may be reviewed in the Council for TRIPS at the request of that Member.

5.  With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products, it is recognized that the development of systems providing for the grant of regional patents to be applicable in the Members described in paragraph 3 of Article 31 bis should be promoted. To this end, developed country Members undertake to provide technical cooperation in accordance with Article 67 of this Agreement, including in conjunction with other relevant intergovernmental organizations.

6.  Members recognize the desirability of promoting the transfer of technology and capacity building in the pharmaceutical sector in order to overcome the problem faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. To this end, eligible importing Members and exporting Members are encouraged to use the system in a way which would promote this objective. Members undertake to cooperate in paying special attention to the transfer of technology and capacity building in the pharmaceutical sector in the work to be undertaken pursuant to Article 66.2 of this Agreement, paragraph 7 of the Declaration on the TRIPS Agreement and Public Health and any other relevant work of the Council for TRIPS.

7.  The Council for TRIPS shall review annually the functioning of the system with a view to ensuring its effective operation and shall annually report on its operation to the General Council.

APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT

      Assessment of Manufacturing Capacities in the Pharmaceutical Sector

      Least-developed country Members are deemed to have insufficient or no manufacturing capacities in the pharmaceutical sector.

      For other eligible importing Members insufficient or no manufacturing capacities for the product(s) in question may be established in either of the following ways:

• 1 When “nationals” are referred to in this Agreement, they shall be deemed, in the case of a separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory. back to text
• 2 In this Agreement, “Paris Convention” refers to the Paris Convention for the Protection of Industrial Property; “Paris Convention (1967)” refers to the Stockholm Act of this Convention of 14 July 1967. “Berne Convention” refers to the Berne Convention for the Protection of Literary and Artistic Works; “Berne Convention (1971)” refers to the Paris Act of this Convention of 24 July 1971. “Rome Convention” refers to the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations, adopted at Rome on 26 Octobe 1961. “Treaty on Intellectual Property in Respect of Integrated Circuits” (IPIC Treaty) refers to the Treaty on Intellectual Property in Respect of Integrated Circuits, adopted at Washington on 26 May 1989. “WTO Agreement” refers to the Agreement Establishing the WTO. back to text
• 3 For the purposes of Articles 3 and 4, “protection” shall include matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as those matters affecting the use of intellectual property rights specifically addressed in this Agreement. back to text
• 4 Notwithstanding the first sentence of Article 42, Members may, with respect to these obligations, instead provide for enforcement by administrative action. back to text
• 5 For the purposes of this Article, the terms“inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively. back to text
• 6 This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6. back to text
• 7 “Other use” refers to use other than that allowed under Article 30. back to text
• 8 It is understood that those Members which do not have a system of original grant may provide that the term of protection shall be computed from the filing date in the system of original grant. back to text
• 9 The term “right holder” in this Section shall be understood as having the same meaning as the term “holder of the right” in the IPIC Treaty. back to text
• 10 For the purpose of this provision, “a manner contrary to honest commercial practices” shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition. back to text
• 11 For the purpose of this Part, the term “right holder” includes federations and associations having legal standing to assert such rights. back to text
• 12 Where a Member has dismantled substantially all controls over movement of goods across its border with another Member with which it forms part of a customs union, it shall not be required to apply the provisions of this Section at that border. back to text
• 13 It is understood that there shall be no obligation to apply such procedures to imports of goods put on the market in another country by or with the consent of the right holder, or to goods in transit. back to text
• 1 This subparagraph is without prejudice to subparagraph 1(b) back to text
• 2 It is understood that this notification does not need to be approved by a WTO body in order to use the system.
• 3 Australia, Canada, the European Communities with, for the purposes of Article 31 bis and this Annex, its member States, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States. back to text
• 4 Joint notifications providing the information required under this subparagraph may be made by the regional organizations referred to in paragraph 3 of Article 31 bis on behalf of eligible importing Members using the system that are parties to them, with the agreement of those parties. back to text
• 5 The notification will be made available publicly by the WTO Secretariat through a page on the WTO website dedicated to the system. back to text
• 6 This subparagraph is without prejudice to Article 66.1 of this Agreement. back to text
• 7 The licensee may use for this purpose its own website or, with the assistance of the WTO Secretariat, the page on the WTO website dedicated to the system. back to text
• 8 It is understood that this notification does not need to be approved by a WTO body in order to use the system. back to text
• 9 The notification will be made available publicly by the WTO Secretariat through a page on the WTO website dedicated to the system. back to text

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An International Law Perspective on the Protection of Human Rights in the TRIPS Agreement

An interpretation of the trips agreement in relation to the right to health, series:  international studies in human rights , volume: 108.

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Protection of public interests through a human rights framework in the TRIPS Agreement: realities and challenges

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Mohammad Towhidul Islam, Protection of public interests through a human rights framework in the TRIPS Agreement: realities and challenges, Journal of Intellectual Property Law & Practice , Volume 4, Issue 8, August 2009, Pages 573–582, https://doi.org/10.1093/jiplp/jpp089

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The protection of IP rights as a trade issue has long been the subject of human rights debate between IP rights owning developed countries and IP rights using developing countries. Proponents of the TRIPS Agreement hold that IP rights qualify as human rights since they have moral standing and developmental value to assist the enjoyment of other rights.

This author argues that IP rights take on protectionist trade implications and monopolistic ownership traits because of their inclusion in the developed country dominated-TRIPS Agreement. Such features lead IP rights to clash with the principle of free trade and comparative advantage. This conflict encourages monopolization and restricts comparative advantages of developing and least developed countries in reverse engineering of knowledge products. As a consequence, developing and least developed countries lag behind in fulfilling their developmental needs or protecting public interests in agriculture, health, biodiversity, economic developments, etc. Consequently, this raises concerns regarding a broad range of human rights including right to health and life, right to food, right to education, privacy and expression, indigenous people's rights, and so on.

For the protection of public interests, this article recommends the establishment of a human rights framework in the TRIPS Agreement by incorporating a human rights reference for IP protection.

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Does TRIPS (Agreement on Trade‐Related Aspects of Intellectual Property Rights) prevent COVID‐19 vaccines as a global public good?

Hans morten haugen.

1 Faculty of Theology, Diakonia and Leadership, VID Specialized University, Oslo Norway

Associated Data

The data that support the findings of this study are available from the corresponding author upon reasonable request.

The article analyses the global public goods approach to COVID‐19 technologies, embedded in 2020 affirmations by the World Health Assembly (WHA), the UN Human Rights Council and G20 on broad immunization against COVID‐19. After identifying the access to COVID‐19 tools (ACT) Accelerator members, the UN efforts are identified, focusing primarily on the UN human rights bodies, acknowledging how these and the WHA have mutually reinforced each others' efforts. The article finds that the global public goods terminology appeared in UN resolutions in 2020, while wording that included vaccines—on an equal footing as medicines—appeared in 2016, and recognition of generic medicines appeared in 2019. The so‐called Trilateral Cooperation on IP and public health between two UN specialized agencies and the World Trade Organization (WTO) has increased awareness of the flexibilities within WTO's TRIPS Agreement. These flexibilities are explained. With notable exceptions, like India, these flexibilities are not widely applied in domestic legislation. A different emphasis characterizes the millennium development goals era as compared to the sustainable development goals era, and this shift is explained by applying relevant theories. Among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, but their overall position has not changed.

1. A HUMAN RIGHTS AND GLOBAL PUBLIC GOODS APPROACH

The Leaders' Declaration from the G20 summit in Riyadh November 21–22, 2020 reads: “We recognize the role of extensive immunization against COVID‐19 as a global public good” (G20, 2020a , para. 3) and these terms are also found in the Statement from a G20 Joint Finance & Health Ministers Meeting September 17, 2020 (G20, 2020b ). The statement has three references to intellectual property (IP): on voluntary licensing, effective IP protection, as well as stating that IP has enabled medicines and vaccines and “not been an impediment to the common goal of ending this pandemic” (G20, 2020b ).

The same wording on global public goods is found in the Human Rights Council's resolution, adopted without a vote July 16, 2020, with the specification that the vaccines must be “safe, quality, efficacious, effective, accessible and affordable…” (UN Human Rights Council, 2020 , para. 7) and in a resolution by World Health Assembly of May 19, 2020 (World Health Organization [WHO], 2020a , para. 6, not including the terms effective and accessible). The two terms “safe and effective” are highlighted in the G20 Declaration and Statement (G20, 2020a , para. 3; 2020b ).

Two other differences are noteworthy. First, while the G20 Statement eight times mention medicines and vaccines together and twice applies the terms equitable and affordable together, the others apply the term “equitable access to and fair distribution of all … health technologies and products  …” (UN Human Rights Council, 2020 , para. 5; WHO, 2020a , para. 4; italics added). Second, while G20 said that IP “has not been an impediment” (G20, 2020b ), the two others, in the context of access and distribution, called for an “urgent removal of unjustified obstacles thereto, in accordance with … TRIPS … flexibilities …” (UN Human Rights Council, 2020 , para. 5; WHO, 2020a , para. 4).

Hence, we see that the IP, more specifically the TRIPS Agreement—Annex 1C to the World Trade Organization (WTO) Agreement—can allegedly serve as an obstacle or facilitator for promoting the such equitable access and fair distribution of vaccines and other health technology. The terms equity and equitable are in accordance with the Oxford Dictionary of Law Enforcement understood as synonymous to just, fair, and reasonable. The term global public good is in accordance with the Oxford Dictionary of Economics understood as a good that provides nonexcludable and nonrival benefits on a worldwide scale. Nonexcludable implies that the good is to be accessed by all, and nonrival implies that other's use of the good does reduce one's own possibilities to access the same good.

Immunization by providing vaccines has for decades been a responsibility of particularly the UN Children's Fund (Unicef) in those countries where the health authorities are not capable of providing vaccines. Since 2000, the Global Alliance for Vaccines and Immunization (Gavi) have strengthened domestic capacities for provding immunization. This author is not aware of any countries where individuals must pay for vaccines. Hence, it is reasonable to understand vaccines as standing out from other products produced by pharmaceutical corporations. The global market for vaccines can be characterized as an oligopsony whose core characteristic is few large buyers.

This article analyzes the context for the allegation that IP is among the crucial factors in promoting health innovation globally, and not preventing the universal and equitable access to vaccines, even if supply of medicines is held by developed countries to be “difficult” (WTO Secretariat, 2020a ). Biotechnology actors expressed criticism of the UN High‐level Panel on Access to Medicines ( 2016 ), arguing that IP tends to be overemphasized in debates over access to medicines, ignoring the wider context of what impedes such access (International Council of Biotech Associations [ICBA], 2016 ; Biotechnology Innovation Organization [BIO], 2016 ). Hence, developed countries and biotech associations concur in identifying weak funding of health care and lack of manufacturing capacity as constituting the core of the problem of access (WTO Secretariat, 2020a ; see also U.S. Department of State, 2016 ), as well as regulatory inefficiencies, trade policies and inadequate health insurance (ICBA, 2016 ).

While there are no international treaties that explicitly specify rights and obligations in the context of global public goods (Maskus & Reichman, 2005 ), the global dimensions of IP and access gained more prominence in the aftermath of TRIPS (Drahos & Mayne, 2002 ; Matthews, 2002 ). Moreover, antologies and monographies have analyzed the relationships between human rights and IP (Geiger, 2015 ; Grosheide, 2010 ; Grosse Ruse‐Khan, 2016 ; Helfer & Austin, 2011 ; Hestermeyer, 2007 ; Torremans, 2020 ). Human rights constitute primarily a proaccess and prodevelopment approach (Yu, 2020 ). Human rights in the context of medicines and vaccines are regulated in two provisions of the International Covenant on Economic, Social and Cultural Rights (ICESCR). First Article 12(2)(c) encompasses state measures for the “prevention, treatment and control of of epidemic … diseases.” Second, Article 15(1)(b) recognizes the right to “benefits of scientific progress and its applications.” As will be shown in Section 5.2 , there is also a provision on authors' rights in the ICESCR, Article 15(1)(c), whose expansive interpretation has been criticized (Koopman, 2008 , pp. 578–582). Moreover, the fact that the human right to property can justify IP claims has given rise to notions of “paradox” (Grosheide, 2010 ; Plomer, 2013 ).

It is important to acknowledge that the encounter between human rights and IP is an encounter between two regimes with different implementing institutions. The human rights regime has few specific prohibitions and more emphasis on taking the right measure, while the IP regime has more specific provisions and stronger mechanisms for enforcement. After identifying the core of the relevant human rights and TRIPS flexibilities, not elaborating on the corresponding obligations in great depth, the article will turn to soft‐law documents. While proposals for an access to knowledge (A2K; Shaver, 2009) treaty has not progressed further—with the exception of the 2013 Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled (Helfer et al., 2017 )—such access has been emphasized in the context of the sustainable development goals (SDG) and science and technology for innovation (STI).

The article will proceed as follows: Section 2 elaborates on the theoretical framework of power and space‐claiming, and principled pragmatism, which will be applied in explaining both opposing and reapproaching views over IP. Section 3 presents the institutional framwork for vaccine development, approval, and dissemination. Section 4 identifies the TRIPS flexibilities and how these are applied. Section 5 reviews the 20 years of efforts to enhance access to medicines and vaccines within a human rights framework. Section 6 identifies initiatives and proposals in the millennium development goals (MDG) era practices for enhanced access to medicines and vaccines, particularly for states with limited purchasing capacity. Section 7 has a similar discussion for the SDG era, termed Agenda 2030. Section 8 provides a critical assessment of the role of IP in the context of STI. Section 9 is a concluding discussion, linking up to the rationales for the global public goods as identified above.

India will be central in the analysis as a core country in term of its pharmaceutical manufacturing capacity—being a producer of 70% of all vaccines globally (Upadhyay, 2020 , referring to the Director‐General of International Vaccine Institute)—its extensive use of TRIPS flexibilities—as reflected in both laws and court rulings—and its proactive role in the Council for TRIPS.

The research question this article seeks to answer is: How has the UN framed its efforts to enhance accessibility to medicines and vaccines, and has the framing of the COVID‐19 medicines and vaccines in a global equity context—representing global public good and being crucial for human rights fulfillment—had any impact on the position of the most pro‐TRIPS WTO member states?

2. INSTITUTIONAL AND THEORETICAL EMBEDDING: POWER ASYMMETRIES AND SPACE‐CLAIMING, AND PRINCIPLED PRAGMATISM

Unequal control over both technology and decision‐making give rise to power asymmetries. Power that comes with controlling technologies, including patents and other IP, seems relatively obvious. The power dimensions inherent in the structure and functioning of the WTO, particularly TRIPS, as well as the theory of principles pragmatism must be explained. The section will introduce and embed the theories in the context of WTO, TRIPS, and the UN Guiding Principles on Business and Human Rights, and aspects of WTO decision‐making will also be included in Section 2.2 .

2.1. Decision‐making in the WTO

In the WTO, decision‐making is neither based on financial contribution—as in the World Bank—nor on one state, one vote—as in the UN. The decision‐making principle that applies in the WTO is that of consensus. There are examples of Ministerial Conferences that have not been able to come to agreement because of opposition expressed by merely one state, like India at the Cancun Ministerial Conference in 2003.

For some decisions, for instance determining on a waiver, applying to one—or a few—member state(s), there is a requirement of a three‐fourths majority, as specified in the WTO Agreement, Article IX.3. Note 4 to the Agreement Establishing the WTO (hereafter: WTO Agreement) specifies that if a member state requests extension of its transition period—with less obligations imposed—the decision must be taken by consensus.

The meeting in the Council for TRIPS October 15 and 16, 2020 had before it a proposal by India and South Africa to adopt a waiver on the enforcement of IP—patents, industrial designs, trade secrets and copyrights—in relation to prevention, containment or treatment of COVID‐19 (India and South Africa, 2020 , para. 12). The term containment must be understood as encompassing vaccines. The duration of the waiver was specified to last “until widespread vaccination is in place globally, and the majority of the world's population has developed immunity” (India and South Africa, 2020 , para. 13). Not surprisingly, the debate was fierce, and concerns were expressed that the waiver proposal risks to “undermine the collaborative efforts to fight the pandemic” (WTO Secretariat, 2020a ). A proposal for a “Trade And Health” Initiative was subsequently proposed (Australia et al., 2020 ). Three developing countries joined this proposal: Brazil, Chile, and Kenya.

The WTO requires all waiver requests to be considered within 90 days and then brought before the General Council; see WTO Agreement Article IX.3(b). The proposal by India and South Africa ( 2020 ) is specified as applying to all WTO member states. The WTO General Council instructed in December 2020 the Council for TRIPS to work further with the waiver proposal (WTO, 2020 ).

Hence, it is reasonable to state that the WTO system is characterized by certain asymmetries, but it must also be acknowledged that interests of economically poorer states might prevail over interests of economically more powerful states, at least in specific decisions.

2.2. Power theories

A comprehensive model that builds on Lukes' theory on forms of power, distinguishing between visible (influence others), hidden (influencing what is and what is not on the agenda) and invisible (influencing overall perceptions) (Lukes, 1974 ) is the power cube (Gaventa, 2009 ). The power cube adds two dimensions: levels (global, national, and local) and spaces (closed, invited, and claimed/created). The realm of WTO is obviously on a global level. Hence, there is no need for a further elaboration on the dimension of levels, except from reminding of the fact that there are various traditions and legal frameworks for openness and transparency as regard IP and trade policies at the domestic level. Moreover, asymmetrical power relations might be exercised more directly in bilateral relations as compared to multilateral relations where alliances can be built. A characterization of the degree of openness in the WTO will be given below.

As regards the forms of power, it is obvious that the WTO system has a relatively rigid monitoring and enforcement system, able to influence the conduct of the member states. Hence, visible power is obviously relevant. First, there are regular reviewing of each member state's legal framework in accordance with the Trade Policy Review Mechanism, Annex 3 to the WTO Agreement. Second, the Dispute Settlement Understanding (DSU), Annex 2 to the WTO Agreement. The DSU outlines procedures for how to solve any dispute arising under any of the WTO agreements, specifying in Article 22.1 that two forms of measures can be determined—by the Dispute Settlement Body—in cases of noncompliance with a given recommendation and ruling: compensation and suspension of concessions.

To what extent is there also hidden power at play in the WTO particularly in the context of TRIPS? TRIPS has established a minimum level of IP protection with certain flexibilities, as will be shown below. Several bilateral and trade and investment treaties have introduced higher levels of IP protection, with less flexibility, termed TRIPS+. The Council for TRIPS has not always served to uphold the TRIPS flexibilities in its oral and written communication, as will be shown when discussing TRIPS flexibilities below. Hence, there can be no doubt that agenda‐setting power is exercised by the WTO and the Council for TRIPS.

Are the WTO and TRIPS processes also characterized by invisible power, which is about influencing overall perceptions? The overall perception that high levels of IP protection are an absolute requirement for private investors' willingness to invest, might ignore the fact that there are several other elements that must be in place in a given country (BIO, 2016 ; ICBA, 2016 ). Nevertheless, IP is important for enhancing predictability, particularly in the important phase from invention to a marketable innovation. What about perceptions about TRIPS flexibilities, specified in both the 2001 Doha Declarations (WTO, 2001a , para 17; 2001b ) and in the Trilateral Cooperation on Public Health, IP and Trade (WHO, World Intellectual Property Organization [WIPO], and WTO, 2020a ; 2013 )? We will come back to these in Section 4.1 . The G20 Statement emphasizing “effective IP protection” (G20, 2020b ) might sum up these overall perceptions. TRIPS has introduced high overall protection levels and rigorous enforcement requirements globally.

As regards the spaces of power, particularly applying to TRIPS, it is reasonable to state that while the TRIPS negotiations in 1986–1994 can be characterized as closed, there has gradually been more space for civil society in the overall WTO system, and accreditation procedures allow civil society organizations to be “invited.” Many of the IP negotiations within regional and bilateral trade and investment treaties are still relatively closed and asymmetrical. Civil society actors have tried to influence by various campaigns, advocacy efforts, and demonstrations, claiming a space for influencing decisions.

Tensions regarding IP between developed and developing countries are also evidenced in other forums, most notably WIPO, a UN specialized agency. An organizational review of WIPO found “an acute polarization between various groups of delegations…” (UN Joint Inspection Unit, 2014 , p. 10). It is therefore reasonable to state that it is IP on a broader term, and not TRIPS specifically, that explains IP tensions globally.

2.3. Theory on public–private cooperation

Additionally, a theory that is believed to capture the enhanced cooperation between public and private for‐profit actors is the theory of principled pragmatism, being embedded in human rights and identifying “what works best in creating change where it matters most…” (UN Special Representative of the Secretary‐General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, 2006 , para. 81). The Special Representative 2005–2011 was John Ruggie, one of the world's leading social constructivist scholars within international relations studies. His efforts resulted in the UN Guiding Principles on Business and Human Rights (“UN Guiding Principles,” UN Special Representative of the Secretary‐General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, 2011 ; see also UN Human Rights Council, 2011a , para. 1). The UN Guiding Principles consist of three pillars for the promotion of human rights: state duties to protect, corporate responsibility to respect, and access to remedies.

3. THE GLOBAL INSTITUTIONAL FRAMEWORK FOR THE COVID‐19 RESPONSE

Unicef and Gavi are already mentioned above, and there are other actors in the global response to COVID‐19. According to its Constitution (WHO, 2006 [1946]), its objective is the “attainment by all peoples of the highest possible level of health.” While WHO has adopted various tools to fight epidemic and endemic diseases—most notably the International Health Regulations, first adopted in 1969 (WHO, 2005 )—WHO's overall inadequacies have been highligthed (France and Germany, 2020 ). Three distinct efforts by the WHO in 2020 are reviewed.

3.1. WHO's coordination of vaccines testing and aprovals

WHO keeps a record of vaccines developments globally, currently being updated twice a week. On November 3, 2020 WHO published an overview of the various COVID‐19 vaccines initiatives, identifying 10 to be in the Phase 3 (WHO, 2020b ), implying that the vaccine is tested for efficacy and safety among several thousand persons (Robinson, 2016 ).

Within 3 weeks, 3 of 10 reported to have developed vaccines with 90%, 94.5%, and up to 90% efficacy, respectively (Moderna, 2020 ; Pfizer and BioNTech, 2020; 90% achieved in the smallest sample). 1 The first has challenging storing requirements (−70°C). Moderna has cooperated with the National Institute of Allergy and Infectious Diseases (NIAID), one of 27 institutes under the National Institute for Health (NIH, 2020 ). AstraZeneca has cooperated with the Jenner Institute and Oxford Vaccine Group at the University of Oxford.

Efficacy is measured during the testing phase, being the “protective effects of vaccination by the reduction in the infection risk of a vaccinated individual relative to that of a susceptible, unvaccinated individual” (Shim & Galvani, 2012 , p. 6700). Effectiveness is measured in the context of the actual vaccination, being defined as “the reduction in the transmission rate for an average individual in a population with a vaccination program at a given level of coverage compared to an average individual in a comparable population with no vaccination program” (Shim & Galvani, 2012 , p. 6700).

Together, the three first corporations indicate that approximately five billion vaccines can be produced by 2021 (AstraZeneca, 2020 ; Moderna, 2020 ; Pfizer & BioNTech, 2020 ). AstraZeneca seeks an Emergency Use Listing from the WHO to make vaccines available in low‐income countries.

3.2. WHO promoting access to COVID‐19 tools in developing countries

WHO has launched the Solidarity Call to Action, highlighting three elements in the headings of the Call: public common good, equitable global access, and pooling of knowledge, IP and data (WHO, 2020c ). Moreover the term response used in the Call must be understood to encompass both diagnosis, treatment, and vaccines, as well as broader measures to strengthen health systems. To facilitate pledges of commitments to the Solidarity Call to Action, the COVID‐19 Technology Access Pool (C‐TAP) has been established (WHO, 2020d ). The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), having 12 corporations—including AstraZeneca—and 12 national associations as full members (IFPMA, 2020a ), criticizes C‐TAP:

By urging licenses or non‐enforcement declarations for COVID‐19 treatments and vaccines to be granted on a non‐exclusive global basis, the Solidarity Call to Action promotes a one‐size‐fits all model that disregards the specific circumstances of each situation, each product and each country (IFPMA, 2020b ).

This must be understood as a form of assertion by the biotech corporations that they know best when to engage in voluntary licensing and nonenforcement of patent.

Other pledges have been launched by other actors, most notably the Open COVID Pledge, whose call is to “organizations around the world to make their patents and copyrights freely available in the fight against the COVID‐19 pandemic” (Open COVID Pledge, 2020 ). Having support from main technology corporations, including Microsoft, IBM, and Facebook, as well as Amazon, the project is led and stewarded by Creative Commons.

3.3. WHO's overall promotion and facilitation of joint efforts in the context of COVID‐19

WHO has been instrumental in setting up the Access to COVID‐19 Tools Accelerator (ACT‐A), launched in April 2020 (WHO, 2020e ). ACT‐A coordinates efforts by nine global health organizations, as well as governments, scientists, businesses, civil society, and philanthropists. The highest body of the ACT‐A is the Facilitation Council.

An overview of the nine organizations which are behind ACT‐A—and how they interrelate to each other—is helpful in identifying the global landscape for COVID‐19 responses (year of founding in paranthesis). First, the Bill & Melinda Gates Foundation (BMGF, 2000) is the largest foundation in the world, and is a cofounder (with Norway, Germany, India, Japan and Wellcome Trust; see below) of the second organization, the Coalition for Epidemic Preparedness Innovations (CEPI, 2016). The third organization is Foundation for Innovative New Diagnostics (FIND, 2003), having six of the nine organizations in ACT‐A as donors (FIND, 2020 ), and the Memorandum of Understanding (MoU) entered between WHO and FIND February 10, 2020 refers to COVID‐19 (WHO, 2020f ). Fourth, Gavi, whose main funder continues to be BMGF. Fifth, The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund, 2002). Sixth, Unitaid (2006), established by France and Brazil to transfer innovative sources of financing—like air ticket levies—to innovative health projects, acknowledged as a partner by the WHO ( 2020g ), and BMGF is also listed among the main donors (Unitaid, 2020 ). Seventh, Wellcome Trust (1936), listing its cooperation with CEPI and Unitaid in the context of COVID‐19 efforts (Wellcome Trust, 2020 ). Eight, the WHO (1946), Ninth, the World Bank (1944).

ACT‐A works within four pillars: diagnostics, treatments, vaccines, and health system strengthening. The Global Fund and FIND are the coconvenors of the Diagnostics Partnership. Unitaid and Wellcome are the coconvenors of the Therapeutics Partnership. The vaccines partnership is termed COVAX, with Gavi, CEPI and WHO as the coconvenors, operating through a mechanism called COVAX Facility (Berkley, 2020 ). The Global Fund and the World Bank are the coconvenors of the health system strengthening pillar. It is also relevant that Unicef has both facilities and experience in vaccine programmes—cooperating with WHO, CEPI and Gavi—and Unicef will be involved in the actual vaccination.

In addition to these organizations, the other categories: governments, scientists, businesses and civil society—supported by philanthropists—are working strenuously to provide vaccines and other medical technology, including tools for treatment and accurate diagnosis. Hence, the global institutional system for fighting COVID‐19 by all means is complex and committed to find a solution to the COVID‐19 pandemic as soon as possible.

4. TRIPS FLEXIBILITIES AND THEIR APPLICATION

A full review of all the TRIPS flexibilities is neither possible nor necessary. In addition to the possibilities to adopt waivers under Article IX.3 of the WTO Agreement, as shown above, at least five provisions of TRIPS must be mentioned: Articles 6, 30, 31, 32, and 39. It is also relevant to emphasize that TRIPS Article 40 regulates anticompetitive practices, as will be seen in Section 6.2 .

Moreover, TRIPS Article 7 (Objectives) and Article 8 (Principles) are important for “integrating and accommodating competing concerns within IP protection…” (Grosse Ruse‐Khan, 2020 ; p. 206; see also 2016 , pp. 439–481). While finding that these provisions were not frequently applied by the WTO dispute settlement system (Grosse Ruse‐Khan, 2011 ; Rochel, 2020 , p. 34), Grosse Ruse‐Khan ( 2020 ) endorses the Panel's report in Australia—Plain Packaging which emphasized that each provision of the TRIPS Agreement is to be interpreted in light of these two provisions (WTO, 2018 , para. 7.2410; see also WTO, 2001b , para. 5a). The panel emphasized that the 2001 Declaration on the TRIPS Agreement and public health is not an authoritative interpretation under Article IX:2 of the WTO Agreement, but a “subsequent agreement” in the words of the Vienna Convention on the Law of Treaties Article 31(3)(a), that is to be taken into account in the interpretation (WTO, 2018 , para.7.2409).

It is also relevant to emphasize each state is able to determine its own standards of what is eligible for patentability, in accordance with TRIPS Article 27, but this is not further elaborated upon.

4.1. Five flexibility provisions in TRIPS

TRIPS Article 6 establishes each country's freedom to establish its own regime of IP exhaustion. In 2001 it was specified that this must be done “without challenge…” (WTO, 2001b , para. 5d). Hence, provided that a country has chosen international exhaustion in its domestic legislation (WIPO Secretariat, 2010 , pp. 32–42), a product legally placed in the market of one state can be subject to parallel importation. This might reduce the potential for monopoly tendencies and inadequate supply in the importing countries. EEA states and Switzerland practice regional exhaustion; India practices international exhaustion (WIPO Secretariat, 2010 , p. 36).

TRIPS Article 30 applies the term “limited exceptions” provision, specifies that national legislation must comply with the TRIPS Agreement while “taking account of the legitimate interests of third parties.” This phrase can be read to permit states to enact “innocent infringer” provisions, but not to allow stockpiling of generic medicines (WTO, 2000 ). Generic medicines must be distinguished from what is in normal language referred to as counterfeit products, whose new term is “substandard and falsified (SF) medical products” (WHO, WIPO, and WTO, 2020a , p. 214).

TRIPS Article 31 specifies the conditions for compulsory licenses. This provision underwent a long process of formal amendment, ending in 2017 and incorporating a new Article 31 bis and Annex. This provision specifies that the general requirement that compulsory licenses shall be for the supply of the domestic market (TRIPS Article 31(f)) does not apply in certain situations. Such situations are specified in Article 31 bis and in the Annex, including that the country in question has “insufficient or no manufacturing capacities in the pharmaceutical sector …” (TRIPS, Annex, Article 2(a)(ii)). Moreover, it is relevant to note that TRIPS Article 31(b) permits compulsory licenses for public noncommercial use, specifying that in such situations, “the right holder shall be informed promptly.” WIPO has published an overview of compulsory license provisions—country by country—demonstrating that almost all countries include in their patent legislation provisions allowing for either compulsory licenses for public interest use or government use (WIPO Secretariat, 2010 , pp. 1–31). India has provisions for all six categories of compulsory licenses (WIPO Secretariat, 2010 , p. 11).

TRIPS Article 32 (“Revocation/Forfeiture”) is rarely understood as an exceptions provision, and its wording is simply “An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available.” Procedures for revocation are also specified in four other provisions of TRIPS: Articles 41.2, 41.3, 62.4, and Article 62.5. The Paris Convention for the Protection of Industrial Property regulates forfeiture and revocation of patents in even greater detail (Article 5A(3) and 5A(4)), and TRIPS Article 2.1 specifies that the Paris Agreement must be complied with. Because TRIPS Article 32 specifies no requirements for when revocation or forfeiture can be decided, specifying only the availability of judicial review, TRIPS does not prohibit states from authorizing patent revocation or forfeiture to protect prevailing public interests (Haugen, 2014 , p. 205). India's Patent Act, Act No. 39 of 1970, is an example of a national legislation that authorizes revocation, if the patent is exercised in a manner that is “mischievous to the State or generally prejudicial to the public…” (Article 66), or in cases of nonworking of the patent (Article 85). The WIPO Secretariat ( 2012 , pp. 52–56) lists other examples of domestic revocation provisions.

TRIPS Article 39 is on protection of undisclosed information; also termed trade secrets. Article 39.3 regulates protection of test data for pharmaceuticals or agricultural chemical products. It requires such test data to be protected if the domestic legislation requires such test data for approving marketing of products. India is among those countries which do not require this, even if there has been attempts of introducing this requirement (Haugen, 2021 ). On this background, it is unfortunate that the Council for TRIPS Chair did not challenge, but rather affirmed Switzerland's criticism of India's lack of test data protection (WTO Council for TRIPS, 2015, para 6.5; see also para 4.42).

Most of these flexibilities—but not Article 32—are analyzed in two publications from the so‐called Trilateral Cooperation, which include a correct understanding of TRIPS Article 39.3 (WHO, WIPO, and WTO, 2020a , p. 82; 2013 , p. 65). In summary, flexibilities in the TRIPS Agreement are applied to various degrees by the member states. India's legislation allows for most flexibility in the implementation of TRIPS (WIPO Secretariat, 2010 ).

4.2. More on licensing

TRIPS does not use the term voluntary licensing, unlike the G20 ( 2020a , para. 3; 2020b ). According to IFPMA, a voluntary license is “an authorization given by the patent holder to a generic company, allowing it to produce the patented article …” (IFPMA, 2010 ). The agreement might include conditions for such authorization (Médecins Sans Frontières [MSF], 2020 ; South Africa, 2020 ). Voluntary licenses are, however implicitly addressed in TRIPS Article 31(b), specifying the conditions for when compulsory licencing is permitted; there are three situations; the two first are identified above, namely in situations of public noncommercial use, specifying that in such situations, “the right holder shall be informed promptly” and in the situation of production for countries lacking manufacturing capacities (TRIPS Article 31 bis and Annex).

The third situation is specified as follows in TRIPS Article 31(b), stating that use without the right‐holder's authorization

may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.

TRIPS Article 31(h) specifies that the right holder shall be paid adequate remuneration in situations of compulsory licenses, and the general principles in TRIPS Article 41, as interpreted in light of Article 7 and 8, will apply.

In reality, therefore, there are four situations of licensing by a right‐holder: (i) voluntary licence, (ii) compulsory licence if negotiation efforts for a voluntary licence are not successful, (iii) compulsory licence for public noncommercial use, if the right‐holder is adequtely informed, and (iv) compulsory licence for export to countries lacking manufacturing capacities. In all situations, the right‐holder is to receive adequate remuneration for others' use of the patented technology, but this can be exempted in situations of voluntary licensing. The main purpose of voluntary licensing agreements is to enhance production and distribution (Raju, 2017 ).

According to the Trilateral Cooperation, the system established by TRIPS Article 31 bis and Annex, “does not apply to most procurement scenarios …” (WHO, WIPO, and WTO, 2020a , p. 242), listing three such situations: (i) the product is available from countries with no patent in force; (ii) product prices are sufficiently low; and (iii) voluntary licensing. I like to add: (iv) the product is legally placed in the market in countries practicing international exhaustion of patent rights, in accordance with TRIPS Article 6.

5. TWENTY YEARS WITH HUMAN RIGHTS‐EMBEDDED EXPLORATION OF IP—AND ITS RESULTS

A 1998 seminar convened by WIPO to celebrate the 50th anniversary of the Universal Declaration of Human Rights was the first comprehensive effort of specifying human rights in the context of IP (WIPO, 1999 ). Three human rights, to health, culture and scientific progress, recognized in Articles 12, 15(1)(a) and 15(1)(b) of the ICESCR, respectively, were highlighted. Three other presentations framed the IP‐human rights debate, addressed IP and traditional knowledge, and elaborated on links between IP and nationality embedded in nondiscrimation. Before 2000 the number of scholarly publications on human rights and IP were few. The attention of the civil society towards IP grew rapidly, with various campaigns, the first focusing on so‐called “biopiracy”—practices contrary to the Convention on Biological Diversity Articles 15 and 8(j)—and on medicines and pricing.

5.1. Initial clarifications

Starting in 2000, various human rights bodies became very active in analyzing IP‐human rights links. It started with the [then] Subcommission on the Protection and Promotion of Human Rights (UN Subcommission, 2000 ; 2001 ), inviting a broad range of actors—including the UN Secretary‐General and the UN High Commissioner for Human Rights—to clarify the IP‐human rights links, 2 highlighting the role of TRIPS specifically.

5.2. More elaborate clarifications

Another actor that was challenged by the Subcommission was the UN Committee on Economic, Social, and Cultural Rights (UN CESCR). It responded initially by a Day of General Discussion (2000a), followed by a Statement (2001), and then by a General comment (2006; adopted in 2005), all of which seek to clarify the content of the Article 15(1)(c) of the ICESCR, on human rights arising from the moral and material interests of authors of scientific, literary or artistic production. With the exception of a clear distinction between this human rights and IP in the initial paragraphs—a distinction that is not practiced consistently (Haugen, 2012 , pp. 37–53)—there are few explicit references to IP. One paragraph specifies, however (UN CESCR, 2006 , para. 35, extracts):

Ultimately, intellectual property is a social product and has a social function. States parties thus have a duty to prevent unreasonably high costs for access to essential medicines … undermining the rights of large segments of the population to health…

In addition to medicines, plant seeds and schoolbooks and learning materials are referred to in this paragraph, and affordability of facilities, goods and services is specified as one of the essential elements of the right to health (UN CESCR, 2000b , para. 12(b)(iii)).

The most recent General comment is on science and economic, social, and cultural rights (UN CESCR, 2020a ), 3 preceeded by a Day of General Discussion, with experts and written responses to an open call to respond to a Discussion Paper (UN CESCR, 2018 ). The core provision is ICESCR Article 15(1)(b) on the human right of everyone to enjoy the benefits of scientific progress and its applications, a provision that was analyzed in the Venice Statement (Haugen, 2012 , pp. 30–34; Müller, 2010 ; UNESCO, 2009 ). Three forms of benefits are identified by the UN CESCR: material results, like vaccines; knowledge and information; and “the role of science in forming critical and responsible citizens …” (UN CESCR, 2020a , para. 8). As regards science and IP, the UN CESCR acknowledges that IP enhances science and technology by providing economic incentives for innovation, but IP can also distort research funding, restrict information sharing and impede physical and affordable access (UN CESCR, 2020a , paras. 60–61). Generics are seen as a way to overcome the affordability problem (UN CESCR, 2020a , paras. 69–70; see also UN High Commissioner for Human Rights, 2001 ).

At the same session, the CESCR adopted a Statement on COVID‐19, emphasizing that if public measures adopted do limit the human rights recognized in the ICESCR, Article 4 on justified limitations should be applied. These Article 4 requirements were specified as “necessary to combat the public health crisis posed by COVID‐19, and be reasonable and proportionate” (UN CESCR, 2020b , para. 11). Such considerations also apply when securing national supply, calling upon states to take other countries' urgent needs into account (UN CESCR, 2020b , para. 20).

5.3. States' acknowledgment of access to medication in the context of human rights

The first resolution on access to medication was adopted by the [then] UN Commission on Human Rights ( 2001a ); from 2006 replaced by the UN Human Rights Council. These resolutions have operationalised ICESCR Article 12(2)(c). This first resolution was adopted with 52 votes to none with 1 abstention: the USA (UN Commission on Human Rights, 2001b , p. 410). Its scope was narrow, focusing on HIV/AIDS, and its wording addressed only states. The emphasis was on the pharmaceutical corporations in the 2000 Millennium Declaration: “To encourage the pharmaceutical industry to make essential drugs more widely available and affordable by all who need them in developing countries” (UN General Assembly, 2000 , para. 20 [extract]). The first UN General Assembly access to medication resolution extended the scope from HIV/AIDS to tuberculosis and malaria (UN General Assembly, 2004 ; adopted 2003), in line with MDG indicators 6.9 and 6.6, respectively (UN Statistics Division, 2008 ).

A full review of all resolutions is not possible, and in the final section I will return to how vaccines were initially ignored in the resolutions. The Trilateral Cooperation refers to 20 UN resolutions and seven reports by Special Rapporteurs on the right to health, specifying that the “list does not imply any evaluation of importance” (WHO, WIPO, and WTO, 2020a , p. 294), as well as 35 resolutions from the World Health Assembly (WHO, WIPO, and WTO, 2020a , pp. 300–301). Three aspects of the political declaration from the 2019 high‐level meeting on universal health coverage are interesting: (i) generics are explicitly acknowledged in a substantive paragraph on increased acccess, together with medicines, vaccines, diagnostics and health technologies (UN General Assembly, 2019a , para. 51); (ii) the 2001 Doha Declaration (WTO, 2001b ) is explicitly reaffirmed (UN General Assembly, 2019a , para. 51); and (iii) the resolution was adopted without a vote (UN General Assembly, 2019b ).

5.4. More on the right to enjoy the benefits of scientific progress and its applications

The mandate of the Special Rapporteur in the field of cultural rights was in 2012 extended to encompass the right to enjoy the benefits of scientific progress and its applications (UN Human Rights Council, 2012 , para. 9–11; adopted without a vote). This led—via experts seminars and broad consultations—to an initial report and two final reports, one on patents and one on copyrights for the human right to science and culture (UN Special Rapporteur in the Field of Cultural Rights, 2012 , 2014 ,  2015 ).

Most interesting is the assertion that “States have a human rights obligation not to support, adopt or accept … [TRIPS+, and] … reconciling patent protection with human rights” (UN Special Rapporteur in the field of cultural rights, 2015 , para. 104). The term “obligation” is most interesting, as well as the acknowledgment that it is only by using TRIPS exclusions, exceptions and flexibilities that IP and human rights can be reconciled. Moreover, she recommends that pharmaceutical companies “should disclose information about the costs for developing drugs, the items included in such costs and the sums they reinvest in research and development” (UN Special Rapporteur in the field of cultural rights, 2015 , para. 94); for an emphasis on transparency and accountability in the context of COVID‐19, see UN Human Rights Experts ( 2020 ).

Unlike the UN High‐level Panel on Access to Medicines ( 2016 ), which received strong criticism (BIO, 2016 ; ICBA, 2016 ), the 2015 report from the UN Special Rapporteur in the field of cultural rights did not receive much opposition. This might be because the report did not directly specify that IP are subordinate to human rights, as was done in another report (Commission on Intellectual Property, 2002 , p. 6). A more realistic explanation is that it went under the radar of the pharmaceutical and biotech associations.

5.5. What has been achieved?

In summary, an assessment of 20 years of human rights‐embedded exploration of IP is that there is more insight regarding the IP‐human rights interface in 2020 as compared to the situation in 2000, when the UN Subcommission identified “actual or potential conflicts exist between the implementation of the TRIPS Agreement and the realization of economic, social and cultural rights…” (UN Subcommission, 2000 , preambular para. 11; see also UN Subcommission, 2001 , preambular para. 11). Even if there have been mutual references between World Health Assembly resolutions and UN human rights resolutions, there is no evidence to indicate that the human rights resolutions have had a substantial impact on domestic legislative IP processes.

On the international level, Grosse Ruse‐Khan argues that there has been an “attempted regime capture …” of the IP system by human rights actors (Grosse Ruse‐Khan, 2016 , p. 265; see also 2020 ; p. 206). However, the strategy has shifted from a confrontational to a more accomodating approach (Grosse Ruse‐Khan, 2020 , p. 204; see also p. 486) by promoting the maximum use of flexibilities provided by TRIPS to also comply with human rights. His own approach is to apply TRIPS Article 7 and 8(1), particularly when faced with broad and open legal concepts, terming Article 7 “the single most important element in the process of interpretation…” (Grosse Ruse‐Khan, 2020 , p. 235; contra : Pires de Carvalho, 2014 ), arguing also for IP ceilings to enhance the enjoyment of global public goods (Grosse Ruse‐Khan, 2016 , p. 492; Grosse Ruse‐Khan, 2009 ).

The 2019 General Assembly Political declaration does, however, stand out from other UN resolutions, as noted above, inter alia by including generics (UN General Assembly, 2019a , para. 51). Neither this nor previous resolutions do, however, explicitly regard medicines and vaccines as a global public good, but this was emphasized one year later (UN Human Rights Council, 2020 , para. 7).

Expert seminars on the right to benefit from science have brought up concepts like public assets and public knowledge (UN High Commissioner for Human Rights, 2014 ). In her initial report, the UN Special Rapporteur in the field of cultural rights proposed “the adoption of a public good approach to knowledge innovation and diffusion, and … a minimalist approach to IP protection” (UN Special Rapporteur in the Field of Cultural Rights, 2012 , para. 65; see also 2015 , para. 12; 2014 , para 14). Hence, despite these references, it is fair to state that the global public good terminology has generally been absent from the UN human rights system.

6. HAVE 20 YEARS WITH MDGS AND SDGS IMPROVED OVERALL ACCESS TO MEDICINES? THE MDG ERA

To capture the MDG era, it is relavant to identify positive efforts and inadequate results of making medicines more accessible, and a particular focus on developing countries is warranted.

6.1. Positive efforts

Access to medicines was high on the international agenda in 2000–2001, and the Doha Declaration on TRIPS and Public Health (WTO, 2001b ) was the culmination. As seen above, the Millennium Declaration included a paragraph on affordability of essential drugs for persons in developing countries, using the term “encourage” (UN General Assembly, 2000 , para. 20). The ambitions, particularly for HIV/AIDS, were subsequently strengthened (UN General Assembly, 2005 , para. 57(d)), resulting in a new target: 6.B: “Achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it” (UN Statistics Division, 2008 ; also MDG targets 1.B, 5.B, and 7.B were added after 2005).

The 2010 deadline was not met. A Special Session of the UN General Assembly in 2011 specified that 15 million persons should receive antiretroviral treatment (ART) by 2015 (UN General Assembly, 2011 , para. 66). The 2015 MDG Report specified that this was on track, as 13.4 million had such access in June 2014 (UN, 2015 , p. 46).

In addition to MDG target 6.B on universal access to ART, there is one other MDG target that directly addresses IP in the context of medicines. This is 8.E, reading: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries,” and it is specified in the indicator that such affordable access is on a sustainable basis (UN Statistics Division, 2008 ). Sustainable is in the context of affordable access understood as enduring, implying that there are mechanisms in place to ensure predictable delivery at affordable prices. In the General comment on the rights to health this is specified to encompass equity (UN CESCR, 2000b , para. 12(b)(iii)). If equity is operationalized as implying that household incomes are not decisive for one's access, there is still a long way to go. This does not imply, however, that there have not been considerable efforts by a wide range of actors to foster such affordable access.

Hence, two of 22 MDG targets (6.B and 8.E) highlighted IP, at least implicitly, in the context of affordable access to medicines, and the efforts to enhance such access for at least some medicines must be acknowledged. Therefore, at least as regards some types of medicines there has been improved overall access to medicines, as well as higher awareness among relevant actors. This positive acknowledgment must, however, be nuanced.

6.2. Inadequate results

First, WHO's efforts of establishing a voluntary fund, proposed to be named Health Product Research and Development Fund, to finance neglected disease research, was not successful, due to lack of funding (WHO, WIPO, and WTO, 2020a , p. 161; WHO, 2017 , p. 49). The proposal came from WHO's Special Programme for Research and Training in Tropical Diseases (WHO, 2016 ). In 2020, the World Health Assembly (WHA) adopted a new road map for neglected tropical diseases for the period 2021–2030 (WHO, 2020h ; WHO, 2020i ). It is relevant to mention that WHO was a cofounder of the Drugs for Neglected Diseases initiative (DNDi) in 2003 (DNDi undated).

Second, the prices for certain newly introduced medicines are still very high. A decision at the 2020 WHA called for further discussions on “promoting and monitoring transparency of medicines prices and actions to prevent shortages” (WHO, 2020j , para. 3). To enhance affordability in situations of too high prices, TRIPS Article 40(2) is relevant (extract):

Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market.

What price level that constitutes “abuse” has not been clarified by the WTO's Dispute Settlement Body or any other WTO organ, as seen in the WTO's Analytical index (WTO Secretariat, 2020b ). Even powerful states might have to accept the price as determined by the pharmaceutical corporations. Depending on the specific priorities, states might nevertheless be able and willing to pay the excessive costs to enable affordable access, as few individuals are able to pay for particular treatment by their own. There are also examples of crowd‐funding or philanthropic efforts—but these efforts are not addressing the structural problem of affordability.

6.3. Diverse approaches for various countries

The date for least‐developed countries' implementation of the TRIPS Agreement has been extended several times, for pharmaceutical products the extension is until 2033 (WTO, 2015 ). Extension for other products—also untill 2033—has been proposed to the Council for TRIPS (Chad, 2020 ). Hence, there are limited TRIPS obligations for least‐developed countries, having a GNI/capita of $1018 or below, but there are no distinctions between other countries.

Beyond the actual diverse approach within the WTO, the most specific proposal for a diverse approach of IP protection was presented in the report from the UN Millennium Project ( 2005b ). This Task Force was one of 13 Task Forces under the UN Millennium Project. Those five Task Force reports that addressed IP did so in a critical manner (Haugen, 2021 ), as reflected in the overall report, that called for “revisiting … the rules to examine … any additional flexibility required” (UN Millennium Project, 2005a , p. 219). The UN Task Force on Science, Technology, and Innovation proposed a “three‐tier system,” based on the level of GDP/capita, with less onerous obligations for states with less than 5000 USD in per capita income, and even less onerous obligations for states with less than 1000 USD (UN Millennium Project, 2005b , pp. 112–113). This proposal has not proceeded further, and it is not likely that TRIPS will be amended.

The UN Millennium Project reports' assessments of the IP system can be characterized as overall highly critical (UN Millennium Project, 2005a , 2005b ) and the same applies to the Commission on Intellectual Property ( 2002 ).

More moderate proposals, not amending TRIPS, are proposed by the WHO‐mandated Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) under the four headings discovery, development, delivery, and promote innovation (2006, pp. 175–185). When mandating the CIPIH, the report by the WHO Secretariat emphasized voluntary licensing (WHO, 2003a )—unlike the resolution (WHO, 2003b )—and the importance of voluntary licensing is addressed in the final report (CIPIH, 2006 , pp. 121–123).

The CIPIH report refers to public goods once (CIPIH, 2006 , p. 56), in the context of presenting the international agricultural research centers operating under the umbrella of the Consultative Group on International Agricultural Research (CGIAR), indentifying three previous studies promoting a CGIAR‐like model as highly relevant in mobilizing resources for under‐funded research (CIPIH, 2006 , p. 187). It is relevant, however, that several of the actors identified above, like Gavi, The Global Alliance and Unitaid, are relevant responses to this underfunded research.

7. HAVE 20 YEARS WITH MDGS AND SDGS IMPROVED OVERALL ACCESS TO MEDICINES? THE SDG ERA

Initially, it is relevant to observe that the processes for formulating the MDGs and the MDG targets—and indicators—differ substantively from the process for formulating the SDGs and SDG targets. The MDGs and MDG targets and indicators were formulated by the Interagency and Expert Group on the Millennium Development Goal Indicators (IAEG‐MDGs) after the adoption of the Millennium Declaration (UN General Assembly, 2000 ). The formulation of the 169 targets of the SDG were negotiated before the adoption (UN General Assembly, 2015a ), but the efforts to formulate SDG indicators were left to a process under the auspices of the UN Statistics Division. The first list of the SDG indicators were adopted in 2016 (UN General Assembly, 2016 ), and are subject to annual refinement (UN Statistics Division, 2020 ).

7.1. The SDGs targets

Among the 169 SDG targets, only two address IP in the context of medicines, one implicitly and one explicitly. Target 3.8 is on (extract) “access to safe, effective, quality and affordable essential medicines and vaccines for all.” Target 3.B reads (extracts):

Support the research and development of vaccines and medicines …, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration… [WTO, 2001b ] which affirms the right of developing countries to use to the full the … [TRIPS] flexibilities to … provide access to medicines for all.

We see that both provisions refer to medicines and vaccines, while the MDG targets merely referred to medicines. There are also three SDG targets on technology under SDG 17, but these are are not in themselves adding much to the problem complex of access to medicines. It must be noted, however, that the SDG Multistakeholder Forum on science, technology, and innovation for the Sustainable Development Goals (STI Forum; UN General Assembly, 2015a , target 17.6) is a forum for addressing IP–STI–SDG relationships, as will be further analyzed in Section 8.1 below.

It is relevant to ask whether the SDG era or Agenda 2030 can be characterized by terms from the theory of principled pragmatism. As an initial illustration, the UN High‐level Panel on Access to Medicines ( 2016 )—which was met with criticism (BIO, 2016 ; ICBA, 2016 )—was rather moderate at least if compared with the UN Millennium Project ( 2005a , 2005b ; Haugen, 2021 ), as seen above. The UN High‐level Panel on Access to Medicines called for utilizing TRIPS flexibilities provisions and interpreting TRIPS provisions in accordance with TRIPS Article 7 and 8(1) (The UN High‐level Panel on Access to Medicines, 2016 , p. 60; see also WTO, 2001b ).

7.2. Stronger emphasis on public–private cooperation

The UN Guiding Principles are inspired by principled pragmatism, and norms dissemination through distributed networks globally and domestically, being embedded in reflexive dynamics and process legitimacy (Ruggie, 2015 ). They imply greater acknowledgment of corporations' potential for doing good and their responsibilites to avoid doing harm. Doing harm can either happen by their own activities or because of their business relationships with corporations, where knowledge about harmful conduct is not acted upon. According to Jägers ( 2020 , p. 147), the MDGs were viewed as having too little attention to the private sector, while the SDGs “recognize business as a key partner…”

It is on this background that we can understand this statement:

The private sector and public‐private partnerships can promote innovations aimed at sustainable development, appropriately protecting intellectual property rights while increasing access of developing countries to essential goods and technologies (UN, 2019 , p. 37).

This is the most substantial statement on IP in the Global Sustainable Development Report , whose 2019 edition highlights science. This harmonious relationship between IP protection and increased access to essential goods is reflecting the SDG era, influenced by the UN Guiding Principles. Moreover, there have been several IP and access‐related initiatives over the last two decades, in addition to the processes within TRIPS and the Trilateral Cooperation.

Hence, new forms of cooperation and funding, often with specified conditions for how the resulting products are to be made available, are gaining ground.

7.3. IP acting as impediments in the fights against COVID‐19?

Full freedom to operate, implying that for instance developers of new vaccines can progress without having to consider existing patents, is illusory. One example is the mNeonGreen, which is a green fluorescent protein, patented by Allele Biotechnology, based in San Diego (U.S. Patent No. 10,221,221). On October 5, 2020 Allele brought two lawsuits, one against Pfizer and BioNTech for patent infringement, for using the technology for their COVID‐19 vaccine without a licence (Egbuonu, 2020 ). 4

In this context it is relevant that the Public Readiness and Emergency (“PREP”) Act, 42 U.S.C. §247d–6d, adopted in 2011 and applying if the Secretary for Health determines a “public health emergency” as specified in Section §247d–6d(b)(1) might constitute a legitimate defense to patent infringement (Alosh, 2020 ).

Moreover, it is relevant that the Pandemic Influenza Preparedness (PIP) Framework was adopted by the 2011 World Health Assembly (WHO, 2011 ). The PIP Framework specifies IP concerns in Article 6 of its Standard Material Transfer Agreement (“SMTA 1”). The SMTA 1 intends to enhance access to vaccines and other benefits between authorized laboratories and while Article 6.1 discourages IP, Article 6.3 emphasizes respect of IP (WHO, 2011 , p. 31). Even if the PIP Framework was adopted in the MDG era, it will be applied in the SDG era.

While IP can act as an impediment, as legal proceedings might not be finalized on time, no actor will like to be seen by the international community as an obstacle for an effective COVID‐19 response. Hence, it is likely that in this situation, solutions will be found.

7.4. Overall assessment of the MDG and SDG era

To sum up, the overall context for development‐related efforts over the last two decades have been the MDGs and more recently the SDGs, driven in large parts by the various UN specialized agencies, funds and programmes. Four trends can be identified within these two frameworks. First, the role of the business actors have been more acknowledged in the SDG era as compared to the MDG era. Second, while there has been shifting emphasis on the issue of voluntary licensing (CIPIH, 2006 , pp. 121–123), it is reasonble to state that voluntary licensing is more recognized and practiced today than at least at the start of the MDG era. Third, vaccines are explicitly included, in addition to medicines, in the context of identifying TRIPS flexibilities. Fourth, there are new institutional mecanisms for promoting STI globally, to which we will now turn.

8. THE ROLE OF IP IN PROMOTING STI FOR THE SDGS

The IP‐STI‐SDG relationships are complex, but I will highlight three distinct issues. These three issues are chosen because they are the most specific in the context of implementing an IP policy that seeks to promote enhanced access, and hence most interesting. First, if generic medicines and vaccines is acknowledged. Second, what role voluntary licensing can play for enhanced access. Third, why not more countries follow the example of India and make use of the flexibilities that TRIPS provides.

8.1. Acknowledgment of generic medicines and vaccines

Initially, as specified above, it is relevant that the 2015 General Assembly resolution adopting the 17 SDGs and the 169 SDG targets endorsed the multistakeholder Forum on science, technology, and innovation for the Sustainable Development Goals (UN STI Forum; UN General Assembly, 2015a , target 17.6). The STI Forum had already been established by the Third International Conference on Financing for Development (UN General Assembly, 2015b , para 123). It is the third component of the Technology Facilitation Mechanism (TFM); the others are UN interagency task team on STI for the SDGs (UN IATT) and the online platform on STI for the SDGs, titled 2030 Connect (UN Secretariat, 2020a ). 5

The two first meetings in the UN STI Forum addressed IP, summarized by the term “effective” protection (UN STI Forum, 2017 , paras. 21 and 68; see also G20, 2020b ), and seeing IP as an element of “robust legal environments…” (UN STI Forum, 2016 , para. 21). Similar terminology was not included in the summaries from the three subsequent forums. While these are merely summaries of the issues discussed at the STI Forums, these terms have a different emphasis than found in other UN documents, like “balanced” (UN Secretary‐General, 2014 , para. 11) and “access” (UN General Assembly, 2020 , para 7). Nothing on generics is specified in these reports.

The UN STI Forum reports to the annual UN High‐level Forum on Sustainable Development, which so far has not addressed IP in great detail. Specific advice on IP could have been foreseen in the 2020 UN Guidebook for the Preparation of STI for SDGs Roadmaps, developed under the auspices of the UN IATT. The most specific paragraph on IP merely refers to internal UN processes, expecting these to overcome the previous “political gridlock over [IP] and technology transfer issues” (UN IATT's Sub‐Working Group on STI Roadmaps coled by World Bank, DESA, UNCTAD and UNESCO, 2020, p. 68). While this escape from the “political gridlock” is positive, the new approaches, including potentials for generics, is not addressed.

Hence, during the 5 years since the adoption of the SDGs, the issue of generic medicines and vaccines has seemingly not proceeded, with the exception for the 2019 Political declaration (UN General Assembly, 2019a , para. 51).

8.2. Voluntary licensing

Voluntary licensing is addressed in two various ways in the UN MDG Gap Task Force report ( 2015 ), produced through an interagency coordination. The main part of the report reads (UN MDG Gap Task Force, 2015 , p. 62):

Full incorporation and use of TRIPS flexibilities will thus continue to be important to encourage pharmaceutical companies to license their products to increase access while not discouraging innovation.

In this context, the TRIPS flexibilities per se are seen as important to foster enhanced licensing by the corporations. Even if no specification of such licensing is given, the context implies that it is voluntary licensing. Voluntary licensing is not explicitly regulated in TRIPS, as seen in Section 4.2 above. Nevertheless, the wording in the UN MDG Gap Task Force report implies a link between using TRIPS flexibilities and promoting voluntary licensing.

In the summary part of the report, voluntary license agreements are specified as “other means,” in addition to public health flexibilities (UN MDG Gap Task Force, 2015 , p. xv). This seems to be more in line with the realities: The voluntary licensing is another means—beyond ultilizing TRIPS flexibilities—in enhancing access to medicines and vaccines. Extensive use of TRIPS flexibilities does not necessarily imply more licensing.

Hence, the summary is more precise as regards the “framing” of voluntary licensing, as compared to the main text. It is not certain that voluntary licensing will be the preferred option by pharmaceutical corporations in a situation where these corporations are pressed by the relevant legislation to enjoy less favorable IP protection, as is the situation in India.

Voluntary licensing has not been addressed within the STI Forum, but was emphasized in the 2020 study by the Trilateral Commission, sometimes together with voluntary pooling and generics (WHO, WIPO, and WTO, 2020a , pp. 20–21; WHO, 2020a , para. 8(2); on patent pools, see WIPO Secretariat, 2014 ). Moreover, the Trilateral Commission refers to Unitaid's Medicines Patent Pool (WHO, WIPO, and WTO, 2020a , p. 157).

8.3. India's strategies

Why not more countries apply flexibilities as done by India is a question that will have many answers. The obvious answer is that India has a considerable generic medicines industry, as well as other relevant bioech industries and wants to protect their interests.

This explanation has to be supplemented by other explanations, and the theories on forms of power—visible, hidden, invisible (Lukes, 1974 )—and spaces of power—closed, invited, claimed (Gaventa, 2009 )—is relevant.

As regards forms of power, there is no doubt that India is powerful enough in itself to make several actors change their conduct. While all states have laws and court systems to regulate the conduct of corporate actors, the Indian parliamentary, executive, and judicial systems together represent a strength that can influence both WTO negotiations globally and biotech corporations domestically. As regards the hidden form of power, this also applies, as India can at least domestically determine what is not placed on the political agenda. This applies as long as there are no rulings from the WTO dispute settlement system that India has to comply with.

The (no‐)agenda‐setting power on the global level is obviously more restricted. The invisible power, being about perceptions, is also more difficult to identify, at least on the global level. The positive role of generics in the Political declaration (UN, 2019 , para. 51) is, however, important to acknowledge. Moreover, WIPO' Standing Committee on Patents (SCP) has two on‐going agenda items: Agenda item 5 on Exceptions and limitations to patent rights and Agenda item 7 on Patents and Health. Countries like South Africa and particularly Brazil are more active in the SCP than India (Argentina Brazil Canada and Switzerland, 2018 , para. 1; acknowledging generics). It is noteworthy that Switzerland—being one of the strongest proponents of an IP system with high protection standards—is acknowledging generics. Brazil, together with Argentina, was also behind the proposal to establish the Development Agenda for WIPO ( 2004 ), leading to the establishment of the Committee on Development and Intellectual Property (CDIP). India, on the other hand, is one of the most proactive countries in the Council for TRIPS.

This brings us over to the spaces of power. India is obiously neither excluded from nor merely invited to the relevant global forums where IP is discussed. Rather India is able to claim a space for the broadening of issues which are relevant to discuss in an IP context. India is not alone in seeking to broaden the agenda, but India is a leading actor. When India justifies its IP policies (see also WIPO Secretariat, 2010 ), the former WIPO's Director‐General, Francis Gurry (2008–2020), is quoted twice when reminding of “how IP can not only be about protecting investment, but also social benefit” (Thomas, 2013 , p. 19; see also p. 4).

8.4. Promoting innovation and access in a global context

In summary, the complex issues of how to ensure the optimal balance between innovation and access for meeting the SDGs has not been brought much forward by the STI mechanisms under the TFM. The Trilateral Cooperation provides the richest source for measures that can overcome inadeaquate access, either because of quantity or because of too high prices. These measures include pricing agreements, based on negotiations, voluntary licensing, compulsory licensing, patent oppositions, and buyers' clubs (WHO, WIPO, and WTO, 2020a , pp. 224–225).

9. CONCLUDING DISCUSSION

The last two decades have seen a shift from the very high tensions over patenting and accessibility in 2000–2001 to a broader acknowledgment of the need to find a better balance between protection of innovations and access to such innovations. While the most important actor on the global scene is the WHO, the so‐called nonpaper by France and Germany ( 2020 ) identifies the need for changes in the WHO governance. The initial framing of wide‐spread immunization against COVID‐19 as a global public good was done by the World Health Assembly (WHO, 2020a , para. 6), with others repeating its core (UN Human Rights Council, 2020 , para. 7; G20, 2020a , para. 3; G20, 2020b ). The global public goods terminology has been most consistently applied in the three reports on science by the former UN Special Rapporteur in the Field of Cultural Rights ( 2012 , para. 65,  2014 , para 14,  2015 , para. 12). As seen above, her reports were not met with opposition and her involvement of recognized IP scholars in the preparation of her two last reports must be acknowledged.

How much acknowledgment for the changes in the perceptions among political leaders should be given to the various UN human rights bodies that have been engaged? Most notably, the 2019 Political declaration must be seen as a culmination for the enhanced access, by the explicit acknowledgment of generic medicines (UN General Assembly, 2019a , para. 51). In this context it is relevant to note that in the draft resolution for the 2018 UN Special Session on Tuberculosis, nothing was said about TRIPS flexibilities (UN Intergovernmental Consultations for the High‐level Meeting on the Fight Against Tuberculosis, 2018 ), but this came in the final resolution (UN General Assembly, 2018 , para. 19). The mutual influence takes place between the UN human rights bodies and the WHO through the World Health Assembly, which in turn influences the WHO–WIPO–WTO Trilateral Cooperation.

The new mechanisms on STI within the SDGs have so far not contributed to alternative perspectives. However, the UN Millennium Project ( 2005a , 2005b ; Haugen, 2021 ) and the UN MDG Gap Task Force ( 2015 ) did identify the need for changes in IP policies. Furthermore, SDG targets 3.8 and 3.B both refer to vaccines and medicines together, which was a progress as compared to the MDG era.

As regards the latter part of the research question formulated at the end of the first section on whether the global equity, global public goods and human rights framing has had any impact on the position of the most pro‐TRIPS WTO member states, this is also complex. It is a too strong assertion to claim that the position of these states have been substantively modified, but I have found that there is an increased openness to discuss alternative approaches—within an IP framework.

A relevant question is if it is only in the case of a pandemic—defined by the WHO as the widespread human infection of a new disease in at least three countries in at least two different WHO regions (WHO, 2009 )—that a global public goods approach to vaccines (and medicines) is relevant. In other words, if there is widespread human infection of a new disease in several countries in only one WHO region, this will not be declared a pandemic. As an example, Ebola was declared as a “public health emergency of international concern” (WHO, 2014 ).

Notwithstanding these distinctions, merely the risk of spread of infectious diseases to other WHO regions should allow the global public goods approach to vaccines and medicines to be applied also in situations which are not declared a pandemic.

The language of the UN resolutions on access to medicines has been strenghtened overall. The first UN resolution on access to medicines included neither of the terms equitable or fair (UN Commission on Human Rights, 2001a ). In the access to medication resolution adopted at the peak of the swine flu pandemic (H1N1), neither the terms equitable or fair nor the term vaccines is applied (UN Human Rights Council, 2009 ). Moreover, the first time the term vaccines appeared in the access to medication resolutions, it was in the context of recognizing innovative funding mechanisms (UN Human Rights Council, 2011b , para. 8). Only in 2016 was the term vaccines applied in a stricter manner, specified as to “ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need…” (UN Human Rights Council, 2016 , para. 5). It is reasonable that the SDGs, which referred to vaccines and medicines together (UN General Assembly, 2015a , targets 3.B and 3.8) is an important explanation for this shift.

The terms equitable and fair are applied in the 2020 resolutions on COVID‐19, which also calls for the “urgent removal of unjustified obstacles … in accorance with [TRIPS] … as confirmed by the Doha Declaration … [WTO, 2001b ]” (World Health Assembly [WHO, 2020a ], para. 4; UN Human Rights Council, 2020 , para. 5).

The biannual resolutions on STI for sustainable development, which are adopted without a vote are, however much softer, by “encouraging access” within an “efficient, adequate, balanced and effective [IP] framework…” (UN General Assembly, 2020 , para. 7). This is a resolution that is linked to UN's STI agenda for the SDGs, and hence not a “pure” human rights resolution.

Hence, the direct influence of the UN human rights resolutions on domestic legislative outcome is somewhat difficult to identify. As regards norms development globally, it seems reasonable that the elements identified by Ruggie as crucial in norms dissemination, taking place through distributed networks globally (Ruggie, 2015 ) explain the overall positive role that the UN human rights system has exercised in the context of medicines and vaccines. The debates within the WTO are of course also influenced by this development, as witnessed in the Trilateral Cooperation. The urgency of identifying the best possible responses to COVID‐19 within the IP framework has made the Trilateral Cooperation publish an extract of its 2020 report that applies particularly to COVID‐19 (WHO, WIPO, and WTO, 2020b ). It is reasonable to state that among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, some of which are identified by South Africa ( 2020 )—and of the social functions of an IP system—but their overall position on the IP system has not changed.

Hans Morten Haugen , Cand. Polit, Dr. Jur. is Professor of International Diakonia at VID Specialized University, Oslo, Norway. He has written extensively on the encounters between international economic law, particularly intellectual property law, and human rights law, ranging from the right to benefit from science, to indigenous peoples' rights. He has provided advice on these matters as an invited expert at UN meetings; see for instance A/HRC/26/19, see also A/70/279.

Haugen, H. M. (2021). Does TRIPS (Agreement on Trade‐Related Aspects of Intellectual Property Rights) prevent COVID‐19 vaccines as a global public good? J World Intellect Prop . 24 , 195–220. 10.1111/jwip.12187 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

1 Sinovac's efficacy is only 50.4%; see BBC ( 2021 ); on efficacy of vaccines developed by Johnson & Johnson and Novavax, see Clinical Trials Arena ( 2021 ); Sputnik V is in phase 2 (January 2021).

2 Two reports are compilations of responses by nongovernmental and international organizations, by the UN Secretary‐General (see Haugen, 2012 , p. 38 (no. 7)); one is a substantive analysis, by the UN High Commissioner for Human Rights ( 2001 ); identifying in para 43–49 measures like generic substitutes, differential pricing and price negotiations, and parallel importation.

3 Space does not allow a full review of General Comment 25, but it is surprising that it contains no references to the two comprehensive report by the UN Special Rapporteur in the Field of Cultural Rights ( 2015 , 2014 ), only to her initial report (UN Special Rapporteur in the Field of Cultural Rights, 2012 ). Between these two reports, there were three expert seminars, in Geneva in 2013 (UN High Commissioner for Human Rights, 2014 ) and in New York and Geneva in 2014 (UN Special Rapporteur in the Field of Cultural Rights, 2014 , para. 5 and Annex).

4 Allele's Licensing Director explains: “The purpose of these lawsuits is to maintain Allele's patent rights and to ensure that an agreement can be put in place to protect the rights of current and future licensees” (Egbuonu, 2020 ). Moverover, Allele's CEO asserts that “in no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology” (Egbuonu, 2020 ).

5 Three UN bodies were responsible for the first launch of the Connect 2030, on July 15, 2020: UNCTAD (UN Conference on Trade and Development), UN Department on Social and Economic Affairs, which has a Division for Sustainable Development Goals (DESA/DSDG), and UN Office of Information and Communications Technology (OICT) (UN Secretariat, 2020b ). It is specified: “Materials provided on this Site are provided 'as is'…”; and: “The United Nations in collaboration with the UN and non‐UN partners, periodically adds, changes, improves or updates the Materials on this Site without notice” (UN Secretariat, 2020c ). As there is a login function, it seems that anyone who is registering as user can place documents on the 2030 Connect. For one example of what was found by the search term “patents,” see Sehgal ( 2020 ).

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Relationship between TRIPS and International Human Rights Law in the Context of Access to Medicines

Chapter 6 Relationship between TRIPS and International Human Rights Law in the Context of Access to Medicines Introduction The relationship between TRIPS and human rights has often been conceived as conflicting. This chapter begins with a brief overview of the debate about TRIPS and human rights. In order to enhance conceptual clarity, a clarification is provided as to distinctive features of the entitlements under the existing intellectual property system, in comparison to the right to the protection of the moral and material interests of the author under Article 15.1(c) of the ICESCR. Also, the relationship between intellectual property rights on one hand, and the right to property recognised in international human rights instruments on the other is briefly discussed. This chapter then redirects its attention to TRIPS and human rights concerning the issue of access to medicines. It considers the definition of normative conflicts in international law, drawing upon recent relevant studies, and examines how norms in TRIPS and norms in international human rights law relate to each other in the context of access to medicines. Stress is placed on the importance of interpreting TRIPS in light of international human rights law. Inquiry is made as to whether the understanding of TRIPS has evolved or is able to evolve so as to be responsive to values and concerns intrinsic to international human rights law. While a harmonised interpretation of TRIPS and international human rights enables the State to utilise appropriate policy measures that promote access to medicines, this chapter also notes, it may be of limited benefit to the issue of health innovation and access to its outcome in developing countries, which requires the development of an alternative or complementary R&D system. The Early Interface between TRIPS and Human Rights UN Sub-Commission on Human Rights The adoption of TRIPS in 1994 and the following bilateral and regional ‘TRIPS-plus’ treaties has revealed that the way intellectual products are regulated through the grant of exclusive rights may have significant human rights implications. The first response to the issue, directly devoted to the relationship between human rights and intellectual property, came from the UN Sub-Commission on the Protection and Promotion of Human Rights (‘Sub-Commission’) in 2000. In its resolution 2000/7 ‘Intellectual property rights and human rights’ 1 with its focus on TRIPS, the Sub-Commission warned that ‘actual or potential conflicts exist between the implementation of TRIPS and the realization of economic, social and cultural rights’. 2 The Sub-Commission listed as areas of human rights concern: (a) impediments to the transfer of technology to developing countries; (b) the consequences for the enjoyment of the right to food of plant variety rights and the patenting of genetically modified organisms; (c) ‘bio-piracy’ and the protection of traditional knowledge; and (d) the implications for the right to health of restrictions on access to patented pharmaceuticals. 3 To resolve potential conflicts between intellectual property and human rights, the Sub-Commission urged all States to recognise ‘the primacy of human rights over economic policies’ when designing national law and policy concerning intellectual property. 4 Furthermore, the Sub-Commission requested the WTO to ‘take fully into account the existing State obligations under international human rights’. 5 The various UN bodies, including the Secretary-General, the High Commissioner for Human Rights, the Committee on Economic, Social and Cultural Rights (CESCR), and the World Intellectual Property Organization were recommended to analyse the human rights implications of TRIPS. 6 A significant number of reactions from other UN human rights bodies, various intergovernmental organisations, governments and NGOs followed. 7 WTO and WIPO The WTO drew an analogy between the intellectual property system and human rights in its reply to the Sub-Commission’s critique of TRIPS. It took special note of authors’ rights to the protection of moral and material interests resulting from their work under Article 27(2) of the UDHR and Article 15(1)(c) of the ICESCR. 8 The WTO stated that ‘it can be argued that TRIPS also seeks to give effect … to article 15(1)(c) [of the ICESCR]’. 9 It also considered that Article 7 setting out the objectives of TRIPS ‘corresponds with the objectives of article 15(1)(a) and (b) of the ICESCR’ recognising the right of everyone to take part in cultural life and to enjoy the benefits of scientific progress and its applications. 10 Article 7 of TRIPS (Objectives) states that ‘the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations’. 11 The WIPO, similarly, stated that intellectual property and human rights both require ‘resolving tensions and striking balances’ between ‘the rights of creators and those of users’, 12 referring to Article 15 of the ICESCR and Article 27.2 of the UDHR. 13 UN High Commissioner for Human Rights The UN High Commissioner for Human Rights also recognised that there exist links between TRIPS and human rights. However, the High Commissioner posed a question as to ‘whether TRIPS strikes a balance that is consistent with a human rights approach’. 14 On this question, the High Commissioner for Human Rights made several preliminary remarks, which can be summarised as follows: (1) ‘The promotion of public health, nutrition, environment and development’, which has close links with human rights, ‘are generally expressed in terms of exceptions to the rule’ in TRIPS, whereas ‘a human rights approach … would explicitly place the promotion and protection of human rights … at the heart of objectives of intellectual property protection’. 15 (2) TRIPS does not provide the content of the responsibilities of intellectual property holders, as opposed to the detailed rules of their rights, and thus the balance under TRIPS may not be consistent with a human rights approach. 16 (3) TRIPS might restrict States’ capacities to protect and promote human rights. 17 (4) The protection of traditional knowledge is not provided for in TRIPS. 18 Further, the report of the High Commissioner for Human Rights provided an analysis of the impact of TRIPS in the context of the right to health, substantiating the need to review TRIPS in light of human rights. Other UN Human Rights Bodies Besides the responses from the WTO, WIPO and the UN High Commissioner for Human Rights, a series of reports and resolutions of UN human rights bodies have addressed the issue of human rights and intellectual property since the adoption of the Sub-Commission’s resolution 2000/7. The CESCR released a ‘statement on Human Rights and Intellectual Property’ 19 in 2001 and provided a preliminary analysis of the relationship between human rights and intellectual property. From 2001 to 2003, the UN Commission on Human Rights adopted three annual resolutions on ‘Access to medication in the context of pandemics such as HIV/AIDS, tuberculosis and malaria’, and requested States and the relevant intergovernmental organisations to ensure access to essential medicines. 20 The UN Special Rapporteur on the Right to Food mentioned ‘concerns that patents on seeds limit the access of peasant farmers to seeds for replanting’ in his 2002 and 2003 reports. 21 The UN Special Rapporteur on the Right to Health recommended States make use of provisions in TRIPS, such as compulsory licensing, with a view to promote access to affordable drugs, and further cautioned the potential negative impact of ‘TRIPS-plus’ legislation on the right to health. 22 These early debates concerning the relationship between intellectual property and human rights, described so far, have given rise to the need for clarification as to how intellectual property relates to human rights, whether there is conflict between TRIPS and human rights, and if so, how it can be resolved. These questions are central to characterising and reshaping the relationship between intellectual property and human rights. The following sections of this chapter ask these questions, specifically in the context of access to medicines. Distinction between Intellectual Property Rights and Human Rights Intellectual Property Rights and the Right to Benefit from the Protection of the Moral and Material Interests of the Author (Art. 15.1(c) of the ICESCR) Different types of intellectual property It is necessary to clarify the distinctive features of intellectual property rights in comparison to human rights, before exploring the issue of normative conflicts. The mention of Article 15.1(c) of the ICESCR and Article 27 of the UDHR, in the responses from the WTO and WIPO to the Sub-Commission’s resolution 2000/7, indicates a tendency to equate intellectual property rights with the right to benefit from the protection of the moral and material interests of the author, recognised in international human rights instruments. 23 There are various types of intellectual property rights and each of them may have a different relationship with human rights. For instance, the moral rights of authors in Article 6 bis of the Berne Convention may share the characteristics of human rights, 24 although the provisions on copyrights in TRIPS have excluded the protection of the moral interests of authors from its scope. 25 On the other hand, corporate trademarks, one type of intellectual property right, may share few commonalities with the human right under Article 15.1(c) of the ICESCR, since they are not to protect intellectual creations of individuals but to facilitate competition by distinguishing different goods and services. 26 The scope of analysis here is restricted to patent rights among other types of intellectual property since patent rights are of particular relevance in the context of access to medicines. Differing foundational principles The fact that the human person is the central subject and primary beneficiary of human rights distinguishes human rights, including the right of authors to the moral and material interests in their works, from legal rights recognized in intellectual property systems. Human rights are fundamental, inalienable and universal entitlements belonging to individuals, and in some situations groups of individuals and communities. Human rights are fundamental as they derive from the human person as such, whereas intellectual property rights derived from intellectual property systems are instrumental, in that they are a means by which States seek to provide incentives for inventiveness and creativity from which society benefits. In contrast with human rights, intellectual property rights are generally of a temporary nature, and can be revoked, licensed or assigned to someone else. While intellectual property rights may be allocated, limited in time and scope, traded, amended and even forfeited, human rights are timeless expressions of fundamental entitlements of the human person. Whereas human rights are dedicated to assuring satisfactory standards of human welfare and well-being, intellectual property regimes, although they traditionally provide protection to individual authors and creators, are increasingly focused on protecting business and corporate interests and investments. Moreover, the scope of protection of the moral and material interests of the author provided for under article 15 of the Covenant does not necessarily coincide with what is termed intellectual property rights under national legislation or international agreements. 27 This statement by the UN CESCR succinctly describes differences between intellectual property and the right under Article 15.1(c) of the ICESCR. 28 What follows further elaborates these distinctive features of patent rights and the right under Article 15.1(c) of the ICESCR. Most significantly, patent rights and the right to the protection of moral and material interests are different from each other in terms of foundational principles. As the CESCR identified, a human right ‘derives from the inherent dignity and worth of all persons’, ‘whereas intellectual property rights are first and foremost means by which States seek to provide incentives for inventiveness and creativity, encourage the dissemination of creative and innovative productions, … for the benefit of society as a whole’. 29 The historical overview of intellectual property in Chapter 1 has shown that patent rights are created to serve a social function, and are not an end in themselves. This is illustrated by section 6 of the Statute of Monopolies of 1623 (England), 30 the foundation of the modern patent system, and section 8 of the US Constitution. 31 The analysis of different perspectives on patents in Chapter 2 has also indicated that the main ground for a patent is that it is a policy tool to stimulate knowledge creation, balancing with access to knowledge. Objectives set out in Article 7 of TRIPS reflect this perspective. 32 Patents as a policy instrument Distinctive features of patent rights follow from their instrumental nature. States, through legislative acts, grant the exclusive rights, adjust the scope and duration of those rights, permit exceptions to the exclusive rights, and may even make provisions for the revocation or forfeiture of the rights. 33 Not all inventions are patentable. 34 One important criterion for patentability is industrial applicability, which reflects the main purpose of patents, i.e. encouraging inventions useful to society. The life of a patent is limited, and after a certain period of time, the subject matter of the patent belongs to the public domain. 35 Determining the duration of the patent protection is a balancing exercise between private interests and public interests. An applicant for a patent is also required to disclose the details of the invention he or she is seeking a patent for, which is to facilitate further innovation. 36 A patent system provides exceptions and limitations to the exclusive rights, such as compulsory licensing. 37 Chapter 3 of this book has elaborated various exceptions and limitations to the exclusive rights, provided in Articles 27(2) and (3), 30 and 31 of the TRIPS Agreement. All these features illustrate that patent rights are granted, protected and limited, with a view to achieving social ends. While the human right under Article 15.1(c) is not without limitations, human rights require stringent rules regarding limitations. 38 Even among human rights, the scope of permissible limitations differs according to the moral importance of the right in question. The scope of limitations upon human rights is discussed in detail in Chapter 7 . Rights holder Who is entitled to a right is another major issue distinguishing patent rights from the right under Article 15.1(c). Under the patent system, a patent right is granted to the first to file an application, with the exception of the US where the first to invent is granted a patent. Neither the first-to-file nor the first-to-invent system provides a patent right to other independent inventors of the same or similar piece of invention. Such systems are justified by several reasons, e.g. promoting prompt disclosure of inventions, providing sufficient incentives to innovation, and easing the burden of administration. 39 However, in case several persons or groups independently come up with a same invention, all independent inventors, not only the first applicant of a patent, are within the scope of Article 15.1(c) of the ICESCR. 40 Whether assignees and corporations can be the right holder highlights a further difference between the patent rights and the human right under Article 15.1(c). According to the CESCR, the protection of Article 15.1(c) requires a personal link between the creators and the creations, and thus can be enjoyed only by ‘individuals and, under certain circumstances, groups of individuals and communities’, 41 as discussed under ‘Authors’ in Chapter 5 . On the other hand, patent rights are mostly held by corporations. 42 The corporations may hold the patent rights ‘by assignment from the actual, human creators’. 43 While patent rights can be assigned to someone else and traded, 44 the human right owed to the inventor is inalienable. 45 The CESCR has noted that ‘[u]nder the existing international treaty protection regimes, legal entities are included among the holders of intellectual property rights. However, … their entitlements, because of their different nature, are not protected at the level of human rights’. 46 Issue of traditional knowledge The issue of traditional knowledge also exposes a divergence between the human right under Article 15.1(c) and patent rights. While traditional knowledge is within the scope of Article 15.1(c), 47 it does not easily fit with the existing intellectual property system. Most traditional knowledge would be considered to belong to prior art, thus failing to meet the novelty criteria for the protection of intellectual property. 48 A sui generis intellectual property system, that is, ‘a legal regime “of its own kind” which is specifically adapted to the nature and characteristics of traditional knowledge’, 49 can be established in order to protect traditional knowledge holders. 50 However, for the most part, traditional and indigenous communities may not pursue private ownership over their knowledge. Instead, they may seek other measures to preserve and safeguard traditional knowledge, e.g. the identification, documentation, transmission, revitalization and promotion of traditional knowledge. 51 Therefore, the grant of exclusive rights, a typical form of the existing intellectual property system, may not be one of the essential features of the protection of the moral and material interests of traditional knowledge holders under Article 15.1(c). So far, it has been discussed that a patent right under the existing intellectual property system is different from the human right under Article 15.1(c) of ICESCR, in terms of the foundation and purpose of each right, and the manner in which each right is implemented. 52 To the extent that these differing features are recognised, a patent system can be used as a means to protect the human right of the inventor. Nonetheless, it is worth revisiting some of the points explained in Chapter 5 on material interests within the meaning of Article 15.1(c) of the ICESCR. 53 What is protected as a human right under Article 15.1(c) is adequate and just remuneration for intellectual labour so as to enable the author/inventor to enjoy an adequate standard of living. 54 These basic material interests of the author/inventor under Article 15.1(c) can be satisfied by other measures, such as one-time payments, as well as the grant of exclusive rights for a limited period of time. 55 When a patent system is used to protect the material interests of the inventor, States must make sure that it does not negatively affect other independent inventors. Patent Rights and the Human Right to Property There is a separate question of whether a patent falls within the right to property under international human rights law. If the answer to this question is positive, a discussion has to follow as to the scope of permissible limitations of a patent right. A similar question was raised when 39 global pharmaceutical companies brought a legal action against the South African government, claiming that the Medicines Act 1997, limiting a patent right with a view to increasing access to medicines, contravenes, inter alia , the right-to-property provision of South Africa’s Constitution (section 25). 56 The lawsuit was, however, dropped by the companies as a consequence of mounting pressure from civil society worldwide. What follows briefly discusses the relationship between a patent and the right to property in the context of international human rights law. The right to property in international human rights law Article 17 of the UDHR recognises everyone’s right to own property alone as well as in association with others, and prohibits arbitrary deprivation of property. 57 There is no provision on right to property, however, in either the ICESCR or the ICCPR. The drafting history indicates that although there was a consensus on the recognition of the right to property, disagreement over the formulation of the right and the scope of limitations upon the right was insurmountable. 58 The Annotations on the text of the draft International Covenants on Human Rights 59 are instructive in understanding differing views about the right to property that can be characterised as a human right. The Annotations report three different views about the formulation of the universal human right to property. One view proposes the formulation of the right in broad and general terms, modelling Article 17 of the UDHR, considering ‘the differences of views regarding property rights embodied in the social and political systems of various States’. 60 Another view was in favour of the formulation ‘drafted in precise legal terms and spel[t] out the necessary qualifications and limitations to which the right of property would be subject’, and proposed texts which ‘would not only provide that States parties should undertake to respect the right of property, but would indicate that the right was not absolute and would specify the conditions under which a person might be deprived of his property’. 61 A third view was that the article should delineate the scope of the right to property that is qualified as a human right. From this point of view, only to the extent that is ‘necessary for decent living and for maintaining the dignity of the individual and the home … could the right of property be regarded as fundamental and inviolable’. 62 What was generally agreed was that ‘the right to own property was not absolute’ 63 and ‘the right to own property was subject to some degree of control by the State’. 64 However, it was not possible to reach an agreement on the extent of not only the limitations of the right, but also the restrictions on State action. 65 In the absence of the right to property provision in the two Covenants, Eibe Riedel suggests that the right to property in the UDHR can ‘still serve, for instance, to legitimize the concept of “smaller ownership”, i.e. property rights limited to subsistence guarantees of individuals, but it could not be utilized as a justification for large-scale capital accumulation’. 66 While ‘it was not possible to reach a consensus on the permissible restrictions in the context of a universal convention’, the similar ‘legal and social traditions’ within geographical areas made it possible to include the right to property and relevant limitation clauses in regional human rights treaties. 67 Thus, the right to property is provided in Article 23 of the American Declaration 68 and Article 21 of the ACHR. 69 The right to property was included in Article 1 of Protocol 1 to the ECHR 70 and in Article 17 of the Charter of Fundamental Rights of the European Union. 71 Article 14 of the African Charter on Human and Peoples’ Rights 72 and Article 31 of the Arab Charter on Human Rights 73 also recognise the right to property. All the above provisions in regional human rights instruments include limitation clauses. This indicates that while the right to property is widely recognised since the security of individual possession is necessary for one’s autonomy and personal development, a property system is constantly adjusted according to the economic and social policies of States on e.g. land, tax, welfare and the environment. 74 For this reason, Catarina Krause observed that, in the context of international human rights law, ‘there will always be a certain amount of reluctance towards international supervision of these rights [property rights]’. 75 An expectation of obtaining a patent When examining a question of whether a patent right is within the scope of the human right to property, a distinction should be made between those who have an expectation of obtaining a patent on one hand, and those who have acquired a patent on the other. The human right to property does not apply to those who seek a patent over an invention, since there is no existing property. 76 The formulations of the right to property provisions in international human rights instruments are commonly understood to protect only ‘acquired property rights’ from arbitrary interference by the State. 77 This implies that the right to property in international human rights law does not give rise to a positive obligation upon States to provide a specific form of property to a person. The scope of the right to property may be extended so as to imply that everyone is entitled to a certain minimum of property necessary for a decent standard of living and a life with dignity. 78 Such a reading can be supported by how the right to property is phrased in Article 23 of the American Declaration. 79 With this universal right to have a minimum of personal property as a potential exception, the right to property provisions in international human rights conventions ‘emphasize the negative aspects of the right by spelling out the conditions for permissible interference with one’s property’. 80 It is doubtful that an expectation of acquiring a patent falls within the scope of a potentially justifiable positive right to property. Moreover, Article 17 of the UDHR suggests that the right to property is not predicated on a specific form of property, by containing the phrase ‘alone as well as in association with others’. The drafting history confirms this reading. 81 Peter K. Yu noted that this article can provide ‘an equally compelling basis for the creation of a rich public domain and for unrestricted access to protected materials [intellectual products]’. 82 The natural right to property argument, based on Locke’s theory, also does not favour private property in intellectual products over the common ownership, as discussed in Chapter 2 . Therefore, determining what kind of property rights in intellectual products should be prescribed by the relevant law is a matter of social agreement. In fact, a modern patent system does not grant all inventors the exclusive right in their invention. It combines time-limited exclusive rights and public domain, as explained earlier in chapters 1 , 2 and 3 . A set of criteria for patentability is set out by the relevant domestic law, subject to the TRIPS Agreement. 83 These criteria for patentability may change, reflecting relevant policy changes. Any patent claim over an invention is subject to an examination by the granting office as to whether it satisfies the criteria for patentability. Therefore, some inventions become part of the public domain from their inception, and other inventions, those that have met the conditions for patentability, are subject to the exclusive rights for a certain period of time and then belong to the public domain. This question of an expectation of holding a patent was examined by the European human rights system. In British-American Tobacco Company Ltd v. the Netherlands , the Commission was of the opinion that an application for a patent was not covered by the right to property provision in Article 1 of Protocol No. 1 to the ECHR. 84 This view was reiterated by the European Court of Human Rights in a case concerning a trade mark, stating that ‘the applicant company could not be sure of being the owner of the trade mark in question until after final registration and then only on condition that no third party raised an objection, as the applicable legislation permitted. … Prior to such registration, the applicant did, of course, have a hope of acquiring such a “possession”, but not a legally-protected legitimate expectation.’ 85 An acquired patent Does the human right to property apply to the person having acquired the patent after having met the conditions set out by relevant law? First of all, this question has to surmount a conceptual difficulty raised by the fact that patents are mostly held by corporations. As seen above in relation to the right to the protection of moral and material interests, the CESCR is of the view that human rights are ‘fundamental entitlements of the human person’ 86 and intellectual property rights, held by legal entities, ‘are not protected at the level of human rights’. 87 Article 1.2 of the ACHR clarifies that ‘2. For the purposes of this Convention, “person” means every human being’. However, Article 1 of the First Protocol to the ECHR is extended to claims by corporations. This is the only provision of the ECHR that expressly recognises the rights not only of natural persons, but also of legal persons. 88 Specifically regarding intellectual property, the European Commission and Court of Human Rights have been requested, very occasionally, to examine the applicability of Article 1 of the First Protocol to intellectual property. The resultant case law has ruled that patents, copyrights and trademarks are ‘possessions’ in the sense of Article 1 of Protocol 1 to the Convention, 89 often referring to Smith Kline and French Laboratories Ltd v. the Netherlands : 90 ‘The Commission notes that under Dutch law the holder of a patent is referred to as the proprietor of a patent and that patents are deemed, subject to the provisions of the Patent Act, to be personal property which is transferable and assignable. The Commission finds that a patent accordingly falls within the scope of the term “possessions” in Article 1 of Protocol No. 1.’ The Charter of Fundamental Rights of the European Union, adopted in 2000, specifically included intellectual property in the right to property provision. 91

Seeds & Intellectual Property Rights: Bad Faith and Undue Influence Undermine Food Security and Human Rights

• First Online: 23 June 2022

Cite this chapter

• Kim van der Borght 6 &
• Saurav Ghimire 6  

Part of the book series: Economic and Financial Law & Policy – Shifting Insights & Values ((EFLP,volume 6))

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The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) annexed to the Marrakesh Agreement establishing the World Trade Organization (WTO) contains some important flexibilities. In relation to plant variety protection (PVP), TRIPS indicates the necessity of devising a legal regime tailored to local realities. It is disappointing to witness that the International Convention for the Protection of New Varieties of Plants (UPOV Convention) has been advocated as the most appropriate regime and even least-developed countries are being brought under the UPOV framework (The acronym UPOV is based on the French title of the treaty: Union internationale pour la protection des obtentions végétales). The applicability ratione materiae of the UPOV Convention has expanded by encompassing a broad range of activities under ‘commercial breeders’ rights’. The applicability ratione loci has been widened by applying persuasive force on developing countries through bilateral and regional arrangements.

This chapter shows how national laws based on the UPOV Convention negatively affect smallholder farmers and over the long-run affects the realisation of many countries’ policy objectives such as poverty alleviation and human rights protection. Showing how the support of developed countries is making UPOV an undeniable force, and considering the fact that WTO members are obliged to provide for PVP, this chapter argues that countries should devise suitable laws in line with their national objectives before committing to any bilateral or regional obligation to accede to the UPOV Convention. Further, this chapter suggests that along with protecting farmers from the detrimental effect of PVP laws, national laws should be designed in such a way that farmers make use these laws and benefit from the PVP regime.

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Social Benefits, Development, and the Pertinence of Laws: The Case of Commercialization of Plant Genetic Resources in the Global Markets

From farmers’ rights to the rights of peasants: seeds and the biocultural turn

International Law on Plant Genetic Resources for Food and Agriculture: Towards a New Balance?

Kloppenburg ( 2008 ), p. 3.

WTO ( 2013 ).

Dutfield ( 2019 ), p. 277.

Narasimhan ( 2008 ), pp. 9–10.

Aoki ( 2009 ), Fowler ( 2000 ), Kloppenburg ( 1988 ) and Correa ( 2000 ).

Braunschweig et al. ( 2014 ), Christinck and Tvedt ( 2015 ), De Schutter ( 2011 ), Haugen ( 2007 ) and Narasimhan ( 2008 ).

Marrakesh Agreement establishing the World Trade Organization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994.

Antons and Kanniah ( 2012 ), p. 2.

Haugen et al. ( 2011 ), p. 120.

UNCTAD-ICTSD ( 2005 ), p. 394.

Some discussion on the interpretation of ‘effectiveness’ can be found in WTO ( 2014 ) e.g. section 5.2.6 of the Appellate Body Report in China—Measures Related to the Exportation of Rare Earths, Tungsten, and Molybdenum, WT/DS431/AB/R / WT/DS432/AB/R / WT/DS433/AB/R (adopted 29 August 2014).

Kanniah ( 2005 ), p. 283; Antons ( 2016 ), p. 393.

UPOV ( 2002 ).

Dutfield ( 2011 ), p. 11.

For instance, India, Zimbabwe, Kenya, etc. WTO ( 2006 ), para 50.

Representative of European Communities. WTO ( 1999a ), para 74.

WTO ( 1999b ), p. 4.

See Statement of representative of Thailand. WTO ( 1999b ), para 78.

Narasimhan ( 2008 ), p. 5. This working paper was prepared as part of the work programme of the UNDP Bureau for Development Policy, Poverty Group, Inclusive Globalization Cluster’s project on Intellectual Property, Trade and Biodiversity.

Ragavan and O’Shields ( 2007 ), pp. 101–102.

Narasimhan ( 2008 ), p. 6.

Statement of Representative of Switzerland. WTO ( 1999a ), para 82.

‘To maximize the chances of success,[in the first Conference] the French Government issued invitations to twelve countries only, all from Western Europe, which were known to share the same concerns and the same hopes (Austria, Belgium, Denmark, Finland, Federal Republic of Germany, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, the United Kingdom). All were to participate at one stage or another in the elaboration of the UPOV Convention.’ as quoted by Heitz ( 1990 ), p. 35. For the participants of the conference (states and organizations), see UPOV ( 1974 ), pp. 103–104.

Plant Variety and Farmers Right Act, 2001; Sanderson ( 2017 ), p. 108.

Protection of Plant Variety and Farmers Right Act, of India 2001 (PPVFR Act), Sec. 26(5).

Protection of Plant Variety and Farmers Right Act, of India 2001 (PPVFR Act), Sec. 45.

Correa ( 2015 ), p. 27.

The following organizations, which represented the interests of commercial breeders, were present in the Conference: Association internationale des sélectionneurs pour la protection des obtentions végétales (ASSINSEL), Association internationale pour la protection de la propriété industrielle (AIPPI), Communauté internationale des obtenteurs de plantes ornementales de reproductions asexuée (CIOPORA) and Fédération internationale du commerce des semences (FIS), see UPOV ( 1974 ), p. 104. For the history and role of these organizations, see Heitz ( 1987 ), pp. 80–83.

Sanderson ( 2017 ), p. 43.

Haugen ( 2020 ), p. 6.

Recommendation Relating to Article 15(2) added to UPOV Convention 1991.

UPOV ( 2020 ).

Agreement between the World Intellectual Property Organization and the International Union for the Protection of New Varieties of Plants (WIPO/UPOV Agreement) signed on 26 November 1982 (UPOV/INF/8).

OAU ( 2000 ); Straba ( 2017 ), p. 192.

GRAIN ( 2001 ); Opoku Awuku ( 2008 ), p. 114.

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The Members of the Organisation Africaine de la Propriété Intellectuelle (OAPI) at the time were Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo, Ivory Coast, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal and Togo. The list of OAPI Members is available at http://www.oapi.int/index.php/en/aipo/presentation/member-countries (Last consulted on 20 April 2020). See Straba ( 2017 ), p. 193; Roseboom ( 2012 ), p. 453.

The Bangui Agreement established OAPI in 1977 and was revised in 1999: Accord portant révision de l’Accord de Bangui du 2 mars 1977 instituant une Organisation Africaine de la Propriété Intellectuelle (Bangui (République centrafricaine) (24 February 1999). See also Roseboom ( 2012 ), p. 453.

The current members of OAPI are Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros Congo, Ivory Coast, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal and Togo. Among them Benin, Burkina Faso, Central African Republic, Chad, Comoros Congo, Guinea, Guinea-Bissau, Mali, Mauritania and Senegal are least-developed countries. The UN list of Least-Developed Countries is available at https://unctad.org/en/Pages/ALDC/Least%20Developed%20Countries/UN-list-of-Least-Developed-Countries.aspx (Last consulted on 20 April 2020).

Haugen ( 2015 ), p. 197.

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Arusha Protocol for the Protection of New Varieties of Plants within the Framework of the African Regional Intellectual Property Organization (ARIPO), ARIPO Office, Arusha, Tanzania adopted on 06 July 2015 (Arusha Protocol) available at https://www.aripo.org/ip-services/plant-variety-protection-pvp/ (Last consulted on 20 April 2020).

See Haugen ( 2015 ), p. 206.

Elver ( 2016 ).

The members of the African Regional Intellectual Property Organization (ARIPO) are Botswana, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tomoe and Principe, Sierra Leone, Somalia, Sudan, Tanzania, Uganda, Zambia, and Zimbabwe available at https://www.aripo.org/member-states/ (Last consulted on 20 April 2020); Among them, Gambia, Lesotho, Liberia, Malawi, Mozambique, Rwanda, Sao Tomoe and Principe, Sierra Leone, Somalia, Sudan, Tanzania, Uganda, Zambia are least-developed countries. UN list of Least-Developed Countries is available at https://unctad.org/en/Pages/ALDC/Least%20Developed%20Countries/UN-list-of-Least-Developed-Countries.aspx (Last consulted on 20 April 2020).

UPOV ( 2019 ).

World Bank ( 2006 ), p. 46.

Dutfield ( 2019 ), p. 289.

GRAIN ( 2018 ).

Indonesia-Japan Economic Partnership Agreement (IJEPA), Art. 106 (3)(c).

The European Union’s (EU) proposal for a legal text on intellectual property in the EU-Indonesia FTA available at https://trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155281.pdf (Last consulted on 10 May 2020).

Action Fiche for IP Key South East Asia is available at https://ipkey.eu/sites/default/files/ipkey-docs/2019/ANNEX-10_IPKey-SouthEastAsia.pdf (Last consulted on 01 April 2020).

The details of IP Key project is available at https://ipkey.eu/en (Last consulted on 01 April 2020).

USTR ( 2020 ), pp. 62 and 80.

De Schutter ( 2015 ), p. 27.

The Japan Agricultural News ( 2018 ).

GRAIN ( 2019a ).

Further information on EAPVP Forum is available at http://eapvp.org/about/ (Last consulted on 01 April 2020).

EAPVP Forum ( 2019 ), p. 1.

EAPVP Forum ( 2018 , 2019 ).

UN list of Least-Developed Countries is available at https://unctad.org/en/Pages/ALDC/Least%20Developed%20Countries/UN-list-of-Least-Developed-Countries.aspx (Last consulted on 20 April 2020).

On February 1, 2019, the Ministry of Agriculture and Rural Affairs (MOA) issued an announcement to publicly solicit comments on the ‘Revised Draft Regulations on the Protection of New Varieties of Plants of the People’s Republic of China (Draft for Comment)’, for purpose of further stimulating original innovation and enhancing protection. See Xiang ( 2010 ).

CIOPORA ( 2019 ).

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China remained the top filing office in 2018, receiving 5760 applications. The China office now accounts for over a quarter of the plant varieties filed worldwide. WIPO ( 2019 ), p. 164.

WIPO ( 2019 ), p. 166.

See para 14 of the Opinion of General Office of Communist Party of China and the State Council is available [Chinese] at http://www.gov.cn/zhengce/2019-11/24/content_5455070.htm (Last consulted on 22 April 2020).

See para 12 of the Opinion of General Office of Communist Party of China and the State Council is available [Chinese] at http://www.gov.cn/zhengce/2019-11/24/content_5455070.htm (Last consulted on 22 April 2020).

GRAIN ( 2019b ).

Abbas ( 2018 ).

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World Bank ( 2020 ).

Braunschweig et al. ( 2014 ), p. 6.

Louwaars et al. ( 2005 ), p. 4.

UPOV Convention 1991, Art 14(1).

A field study was conducted in Indonesia by Saurav Ghimire. The study was carried with financial support from the Vlaamse Interuniversitaire Raad (VLIR-UOS) as a Global Minds Small Great Projects of Vrije Universiteit Brussels (SGP 018) in collaboration with Universitas Airlangga, Surabaya, Indonesia (October–December 2018) (VUB GM 2018).

Christinck and Tvedt ( 2015 ), p. 69.

CIPR ( 2002 ), p. 63.

Braunschweig et al. ( 2014 ), p. 7; Gene Campaign ( n.d. ).

Protection of Plant Variety and Farmers Right Act, of India 2001 (PPVFR Act), Sec. 39 (1)(iv).

Protection of Plant Variety and Farmers Right Act, of India 2001 (PPVFR Act), Sec. 42; Plant Breeder’s Rights Act 1994 of Australia, Sec. 57.

Ragavan and O’Shields ( 2007 ), p. 121.

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Wattnem ( 2014 ), pp. 14 and 17.

Consultation with local farmers and farmers’ right activists by Ghimire during a field research in Indonesia (as yet unpublished) (VUB GM 2018).

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Protection of Plant Variety and Farmers Right Act, of India 2001 (PPVFR Act), Sec. 42.

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Christinck and Tvedt ( 2015 ), p. 64.

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van der Borght, K., Ghimire, S. (2022). Seeds & Intellectual Property Rights: Bad Faith and Undue Influence Undermine Food Security and Human Rights. In: Byttebier, K., van der Borght, K. (eds) Law and Sustainability. Economic and Financial Law & Policy – Shifting Insights & Values, vol 6. Springer, Cham. https://doi.org/10.1007/978-3-030-92620-5_7

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VIEWPOINT Protecting Public Health through Technology Transfer: The Unfulfilled Promise of the TRIPS Agreement

Volume 24/2, December 2022, pp. 211-214 |  PDF

Ellen ‘t Hoen

The scrambling for access to COVID-19 vaccines by developing countries has reignited the debate on the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and its effects on public health and health-related rights.

In such debates, the TRIPS Agreement is often cast as “the big evil.” There is no denying that when the TRIPS Agreement was adopted in 1995, it ushered in intellectual property (IP) norms and standards derived from wealthy nations with robust industries. These norms and standards were suitable to expand the global protection of the IP assets of these industries. However, TRIPS was ill-suited to the needs of developing and least-developed nations, representing the majority of the WTO’s membership. In 2002, the World Bank estimated that the implementation of the TRIPS Agreement by developing countries would amount to more than US$20 billion in income transfers from developing countries to technology-creating nations—particularly the United States, Germany, and France. [1] The promised trade-off from the TRIPS Agreement was that the higher levels of IP protection would lead to technology transfers from high-income to lower-income countries and that the benefits of this technology transfer, creating research and industrial activities in lower-income countries, would outweigh the cost of expanded levels of IP protection. Article 66.2 of the TRIPS Agreement stipulates that high-income countries “shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base.”

Disputes around access to HIV medicines in the late nineties and early 2000 first called the TRIPS promise into question: medicines were accessible in wealthy countries, but IP protection meant that treatment prices were often several times the per capita income if they were available at all in the lower-income countries hardest hit by the disease. It was not until patent barriers were cleared away that low-cost generic medicines became widely available where they were needed most. More recently, the unsuccessful attempts by vaccine producers—most of them in developing countries—to access the intellectual property, manufacturing know-how, and technology needed to produce COVID-19 vaccines may have confirmed the view that the TRIPS Agreement primarily serves the rich to the detriment of the poor. [2]

The right to health, including access to medicines and vaccines, is firmly rooted in international human rights law and some domestic constitutional law. [3] However, this right is hard to realize and enforce when medicines and vaccines are predominantly available from private corporations that hold monopoly rights to those products. As a result, those companies determine when, where, and at what price the products are made available.

While this is the reality of today, the stated objective of the TRIPS Agreement in fact focuses on creating societal benefits for all and supporting the transfer of technologies. In particular, articles 7 and 8, which lay out the objectives and principles of the TRIPS Agreement, deserve more attention.

Article 7 acknowledges that the protection and enforcement of IP should benefit society as a whole, not only rights holders. It describes the IP system as a social policy tool rather than a means to gather and hold on to assets. It refers explicitly to technology transfer and dissemination of technology. Article 8 acknowledges countries’ rights to take measures to protect the public interest and specifically public health. It further states that measures may be needed to prevent abuse by IP holders and to prevent practices that restrain trade or adversely affect technology transfer.

The Doha Declaration on the TRIPS Agreement and Public Health, adopted by the WTO Ministerial Conference in 2001, confirmed this right and spotlighted compulsory licensing (the authorization to use patents without the consent of the patent holder against an adequate remuneration) to ensure access to medicines for all, further strengthening the hand of governments to intervene when patents are a barrier to accessing medical products. [4]

While TRIPS articles 7 and 8 and the Doha Declaration do not explicitly refer to human rights, they are crucial provisions for the realization of the right to health. [5] For example, the Doha Declaration states that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” This paragraph echoes article 12 of the International Covenant on Economic, Social and Cultural Rights, which requires that states take steps necessary for the full realization of the right to health. The importance of taking the Doha Declaration into account when interpreting the TRIPS Agreement was confirmed by a WTO panel in the Australia – Tobacco Plain Packaging case. [6] This ruling offered important encouragement for pro-public health interpretation and implementation of the TRIPS Agreement.

The TRIPS Agreement provides ample scope for WTO members to intervene in private IP rights on public interest grounds, to protect public health, or to respond to an emergency in international relations such as a pandemic. [7]

In the past, countries have resorted to compulsory licensing, including government use of patents, to allow the supply of generic antiretroviral medicines for the treatment of HIV. Since 2001, the TRIPS Flexibilities Database—a resource that tracks when TRIPS flexibilities are proposed or executed—has documented 80 instances of compulsory licensing for public health in 43 countries. [8] Thirty-four least-developed country (LDC) members of the WTO have used the special provision for LDCs that allows them not to grant or enforce pharmaceutical product patents. [9] The WTO has 35 LDC members.

In 2021, all of the 10 new instances of compulsory licenses concerned products to prevent or treat COVID-19. This underlines the value of being able to get around IP protection when public health is at risk. Of course, compulsory measures come into play only when voluntary measures are not sufficient, which was the case for COVID-19 vaccines. Collaboration with the World Health Organization’s COVID-19 Technology Access Pool, a voluntary mechanism for sharing IP related to pandemic countermeasures established in May 2020, was rejected by COVID-19 vaccine companies.

Compulsory licensing is also at the core of the WTO Ministerial Decision of June 17, 2022, on the TRIPS Agreement in the context of the COVID-19 pandemic, often referred to as “the TRIPS waiver.” [10] The decision reiterates members’ rights to authorize the use of the subject matter of patents needed for the production and supply of COVID-19 vaccines, without the consent of the patent holder. The decision further waives the TRIPS requirement that a compulsory license of vaccine technology be predominantly for the supply of the domestic market, so that equitable access can be achieved across countries. But since compulsory licensing extends only to patents and not to other forms of IP that are essential in vaccine production, such as manufacturing know-how, the utility of the decision for vaccines will likely be limited. Discussions are now ongoing at the WTO to extend the decision to COVID-19 therapeutics and diagnostics, which are more suitable technologies for compulsory licensing.

Tension between protecting IP and protecting the human right to health remains. The COVID-19 pandemic and the inability of developing-country manufacturers to obtain IP, know-how, and technology needed to produce COVID-19 vaccines through voluntary measures illustrates the need for a more forceful implementation of the measures the TRIPS Agreement offers to rebalance IP and human rights. If vaccine companies had agreed to collaborate with the COVID-19 Technology Access Pool to share IP, provide manufacturing know-how, regulatory information needed to obtain marketing authorization, and technical assistance, eligible producers in various countries would have been able to start producing and supplying COVID-19 vaccines. Instead, vaccines were first supplied within the wealthy nations that held the technology to produce them. The subsequent hoarding of vaccines by those nations might have cost a million lives. [11]

In 2015, the then United Nations Secretary-General Ban Ki-moon established the High-Level Panel on Innovation and Access to Health Technologies to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” [12] The eight recommendations of the panel regarding the protection of intellectual property center around the use of TRIPS flexibilities, which can be implemented within the current TRIPS framework. However, the panel also warned against the pursuit of stricter levels of IP protection in bilateral and regional trade talks. Specifically, the panel recommended that countries refrain from demanding that their trading partners implement IP obligations that go beyond TRIPS. The recently leaked draft IP chapter of the UK-India free trade agreement is evidence that high-income countries continue to seek to erode TRIPS flexibilities implemented in national law. [13] The lack of transparency around such trade negotiations means that democratically crafted national legislation is changed in closed-door trade negotiations. Considering the important role of the Indian pharmaceutical industry in the supply of low-cost medicines, applying stricter IP rules that are not required under WTO law will have consequences far beyond India alone.

The panel further recommended that public financing for research should require that the research results be shared and that IP be licensed, including through patent pools, to promote technology transfer and enable broad access to innovations.

The pandemic treaty that is currently being negotiated at the World Health Organization is an opportunity to remind the international community about the objectives and principles underlying the TRIPS Agreement and to see them put into practice for more equitable management and sharing of IP, know-how, and knowledge needed for pandemic preparedness and response. In October 2021, Medicines Law & Policy held an expert working group meeting that formulated seven recommendations for the pandemic treaty that are consistent with international human rights law. [14] One of the recommendations is to mandate technology transfer for government-funded research and to incentivize or mandate it for privately funded research on pandemic countermeasures.

The lack of equity in access to COVID-19 vaccines makes us wonder what would have happened if governments had taken measures to ensure the sharing of health innovations and the knowledge needed to make them. The World Health Organization’s pandemic treaty negotiations offer a new opportunity to put technology transfer and sharing of IP at the heart of global pandemic preparedness and response for more equitable and rights-based access to medicines for all.

Ellen ‘t Hoen, PhD, is a lawyer and public health advocate with a focus on pharmaceutical and intellectual property policies, and director of Medicines Law & Policy, Amsterdam, the Netherlands.

Please address correspondence to the author. Email: [email protected].

Competing interests: None declared.

Copyright © 2022 ‘t Hoen. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original authors and source are credited.

[1] World Bank, Global Economic Prospects and the Developing Countries (Washington, DC: World Bank, 2001) .

[2] G. Krikorian and E. Torreele, “We Cannot Win the Access to Medicines Struggle Using the Same Thinking That Causes the Chronic Access Crisis,” Health and Human Rights Journal 23/1 (2021).

[3] L. Forman, “‘Rights’ and Wrongs: What Utility for the Right to Health in Reforming Trade Rules on Medicines?,” Health and Human Rights Journal 10 (2008); K. Perehudoff, B. Toebes, and H. Hogerzeil, “Essential Medicines in National Constitutions: Progress since 2008,” Health and Human Rights Journal 18/1 (2016).

[4] Fourth WTO Ministerial Conference, Doha Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (2001); E. ‘t Hoen, “TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha,” Chicago Journal of International Law 3 (2002).

[5] C. Correa, “Interpreting the Flexibilities under the TRIPS Agreement,” South Centre Research Paper 132 (2021).

[6] T. Romero, “Public Health and Plain Packaging of Tobacco: An Intellectual Property Perspective,” South Centre Research Paper 108 (2020).

[7] Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1896 U.N.T.S. 299 (1994), arts. 27, 30, 31, 31bis, 44.2, 66, 73(b)iii; South Centre, “A Public Health Approach to Intellectual Property Rights: Public Health Related Flexibilities in the TRIPS Agreement,” https://ipaccessmeds.southcentre.int/wp-content/uploads/2018/12/Public-Health-Related-Flexibilities-in-the-TRIPS-Agreement.pdf; F. Abbott, “The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic,” South Centre Research Paper 116 (2020).

[8] Medicines Law & Policy, “The TRIPS Flexibilities Database, http://tripsflexibilities.medicineslawandpolicy.org; E. ‘t Hoen, J. Veraldi, B. Toebes, and H. Hogerzeil, “Medicine Procurement and the Use of Flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016,” Bulletin of the World Health Organization 96/3 (2018).

[9] Fourth WTO Ministerial Conference (see note 4), para. 7.

[10] World Trade Organization, Ministerial Decision on the TRIPS Agreement (June 17, 2022).

[11] H. Ledford, “Covid Vaccine Hoarding Might Have Cost More Than a Million Lives,” Nature (November 2, 2022).

[12] United Nations, Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies (New York: United Nations, 2016).

[13] Bilaterals.org, “UK-India FTA: Draft Intellectual Property Chapter” (April 2022), https://www.bilaterals.org/IMG/pdf/uk-india_fta_ip_chapter_dated_april_2022_68_.pdf.

[14] K. Perehudoff, E. ‘t Hoen, K. Mara, et al., “A Pandemic Treaty for Equitable Global Access to Medical Countermeasures: Seven Recommendations for Sharing Intellectual Property, Know-How and Technology,” BMJ Global Health 7/7 (2022).

Trips agreement and access to drugs in developing countries

Carlos m. correa.

The TRIPS Agreement brought about very important changes in international standards relating to intellectual property rights. Because of its far-reaching implications it is one of the most controversial components of the WTO system. On the initiative of developing countries, the concerns raised regarding the implications of the TRIPS Agreement on public health were reflected in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health, in 2001. The Declaration was followed by a Council for TRIPS Decision in 2003 on the implementation of its paragraph 6. In this article, the author states that as adopted, the implementation of paragraph 6 is unlikely to put strong pressure on patent owners to lower their prices or negotiate voluntary licenses. The author highlights that controversies are likely to continue, especially as developed countries seek TRIPS-plus protection via interpretation or negotiation of bilateral and regional agreements, and as patents over trivial developments are granted and used to block or delay generic competition.

Health | Trade | WTO | Intellectual property | Doha Declaration

The Doha Declaration on TRIPS and public health

The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) 1   brought about very important changes in international standards relating to intellectual property rights. Because of its far-reaching implications, particularly with respect to developing countries, the agreement has been one of the most controversial components of the WTO System. Strong disagreements on the scope and content of the Agreement emerged during the Uruguay Round negotiations, both between developed and developing countries and among developed countries themselves. Implementation of the Agreement and its review under the “built-in agenda” have also been contentious. 2

This has notably been the case in relation to pharmaceuticals. By their very essence, patents enable pharmaceutical manufacturers to charge prices above marginal costs, recover research and development expenditures and make a profit. The AIDS crisis in Africa, and growing evidence on the negative implications of patents for access to medicines by the poor, have brought the relationship between TRIPS and health to the forefront. With more than 30 million people living with HIV, most of them in the poorest regions of the world, the need to address the problem of access to patented medicines has emerged as a global priority. While it is true, as argued by the pharmaceutical industry, that other factors such as infrastructure and professional support play an important role in determining access to drugs, 3   it is also true that the prices resulting from the existence of patents ultimately determine how many will die from AIDS and other diseases in the years to come.

The concerns raised about the implications of the TRIPS Agreement on public health were reflected in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health 4   upon the initiative of developing countries, at the Fourth WTO Ministerial Conference (9-14 November 2001). The Doha Declaration recognizes the “gravity” of the public health problems afflicting many developing and least developed countries, especially – but not limited to – those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. However, the Declaration reflects the concerns of developing and least developed countries regarding the implications of the TRIPS Agreement on public health in general, without limitation to certain diseases.

While acknowledging the role of intellectual property protection “for the development of new medicines”, the Declaration specifically recognizes concerns about resulting effects on prices. The Declaration affirms (paragraph 4) that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health, and that it should be interpreted accordingly:

We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ rights to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

The Doha Declaration clarifies members’ rights to adopt an international principle of exhaustion of rights (under which parallel imports may be accepted). 5   It states that “the effect of the provisions in the TRIPS Agreement … is to leave each member free to establish its own regime for such exhaustion without challenge” (paragraph 5d). Similarly, the Declaration confirms the members’ rights to grant compulsory licenses on grounds determined by each member. It also allowed least developed countries to delay the introduction of pharmaceutical patents until 2016. The Declaration also makes clear that “public health crises” can represent “a national emergency or other circumstance of extreme urgency”. “Emergency” in this context may be either a short-term problem, or a long-lasting situation.

Confirmation that the TRIPS Agreement leaves room for flexibility at the national level has important political and legal implications. It indicates that the pressures to impede the use of available flexibilities run counter to the spirit and purpose of the TRIPS Agreement. In legal terms, it means that panels and the Appellate Body must interpret the TRIPS Agreement and laws and regulations adopted to implement it in light of the public health needs of the individual members.

In paragraph 6 the Doha Declaration instructed the Council for TRIPS to address this delicate issue: how can members lacking or having insufficient manufacturing capacities make effective use of compulsory licensing. 6   The basic problem underlying paragraph 6 is that many developing countries lack or have an insufficient capacity to manufacture medicines on their own. Manufacturing capacities of pharmaceuticals are distributed very unevenly in the world. Not many countries have the capacity to produce both active ingredients and formulations, and very few countries maintain significant research and development capabilities.

When the TRIPS Agreement becomes fully operative (after 2005), many countries may face difficulties in acquiring medicines at affordable prices. Today, for example, some countries, such as India, do not provide patent protections for pharmaceutical products, and produce generic versions at a fraction of the price of the patented products. A member country where the price of patented products is high has the option of issuing a compulsory license to permit import from such countries. The problem is that, as countries fully comply with the TRIPS Agreement by 2005 at the latest, they will no longer be able to produce and export cheap generic copies of patented medicines. Consequently, the sources of affordable new medicines will dry up and countries without sufficient manufacturing capacity and market demand will not be able to grant a compulsory license either for the local production or for the importation of such medicines: they will become entirely dependent upon expensive patented versions.

The Doha Declaration requested the Council for TRIPS “to find an expeditious solution to this problem and to report to the General Council before the end of 2002” by the end of 2002. An agreement was only reached on August 30, 2003, 7   after a diplomatic battle, when the United States finally accepted a text covering all diseases, as mandated by the Declaration. 8   The agreed “solution” is based on a compromise developed by the Chair of the TRIPS Council 9   and on a “Statement by the Chair” proposed by the US as a condition to accept the deal and satisfy the American pharmaceutical industry.

For the purposes of the Decision, “eligible importing member” means any least developed country member, as well as any other member that has made a notification to the Council for TRIPS of its intention, to use the system as an importer. Some countries have notified the Council that they will only use the system in cases of national emergencies or in other circumstances of extreme urgency or in cases of public non-commercial use, and in others that they will not use the system. The eligible importing country must make a notification to the Council for TRIPS, that:

• specifies the names and expected quantities of the product(s) needed;

• confirms that the eligible importing member in question, other than a least developed country member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question; and

• confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory license in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision.

In addition, the compulsory license issued by the exporting member shall contain the following conditions:

• Only the amount necessary to meet the needs of the eligible importing member(s) may be manufactured under the license and the entirety of this production shall be exported to the member(s) which has notified the Council for TRIPS of its needs.

• Products produced under the license shall be clearly identified as being produced under the system set out in this Decision through specific labeling or marking. Suppliers should distinguish such products through special packaging and/or special coloring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price.

• Before shipment begins, the licensee shall post on a website the following: (1) the quantities being supplied to each destination; and (2) the distinguishing features of the product(s).

Further, the exporting member shall notify the Council for TRIPS of the granting of the license, including the conditions attached to it. Where a compulsory license is granted by an exporting member, adequate remuneration pursuant to Article 31.h of the TRIPS Agreement 10   shall be paid to that member taking into account the economic value to the importing member of the use that has been authorized by the exporting member. This means that, although the remuneration would be paid by the exporter, the “economic value” taken into account to determine the amount of remuneration is that of the importing country. Where a compulsory license is granted for the same products to the eligible importing member, the obligation of that member under Article 31.h shall be waived in respect of those products for which remuneration is paid by the exporting member.

One of the main concerns voiced by developed countries during the negotiation of the Decision, was the possible diversion of the exported products to rich countries. 11   The Decision establishes that eligible importing members shall take all reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of products that have actually been imported into their territories under the system. In the event that an eligible importing member that is also a developing country member or a least-developed country member experience difficulty in implementing this provision, developed country members shall provide, on request, and on mutually agreed terms and conditions, technical and financial cooperation in order to facilitate its implementation. Additionally, members shall ensure the availability of effective legal means to prevent the importation into, and sale of, within their territories, products produced under the system set out in this Decision and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement. If any member considers that such measures are proving insufficient for this purpose, the matter may be reviewed in the Council for TRIPS at the request of that member.

The Chair’s Statement added that the special conditions (as set out in paragraph 2b(ii) of the Decision) 12   apply not only to formulated pharmaceuticals but also to active ingredients produced and supplied under the system as well as to finished products that have been produced using such active ingredients. The Statement also adds (though there is no evidence to support this statement), that it “is the understanding of members that in general special packaging and/or special coloring or shaping should not have a significant impact on the price of pharmaceuticals”. In addition the Statement introduces a monitoring system, including verification of how the member in question has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector. 13

The Statement also indicates that members recognize that the system “should be used in good faith to protect public health and, without prejudice to paragraph 6 of the Decision, not be an instrument to pursue industrial or commercial policy objectives”. The only reasonable reading of this statement is that the importingcountry should use the system for public health reasons, but it certainly does not exclude the supply of the required medicines which have a profit objective by commercial entities. Without the possibility of making a profit, potential suppliers will lack the incentive to make the investments (including the covering of legal costs) necessary to satisfy the requirements of countries without manufacturing capacity.

Changing national laws

The Decision takes the form of an interim waiver, which allows countries producing patented products under compulsory licenses to export the products to eligible importing countries, provided that a compulsory license has also been granted in the importing country and that various other conditions, as discussed above, are met. The waiver would last until the TRIPS Agreement is amended. 14

It is important to note that the system under paragraph 6 of the Doha Declaration will operate in a scenario in which there is only one world supplier of a patented drug and, therefore, there will be no available source of generic products. The use of such a system will be necessary when the patent owner refuses to supply a patented drug in a country (with insufficient or no manufacturing capacity in pharmaceuticals) at a price or under other conditions acceptable to the interested country. The basic assumption for the application of the system is, therefore, a situation where (a) a drug is available andcouldbe sold to the country in need by the patent owner, and (b) the patent owner refuses to do so.

This means that whatever humanitarian reasons underlie the country’s demand for a given drug, nothing in the adopted system will compel the patent owner to supply the needed drugs. He may just passively watch how the country in need strives to fulfill the conditions imposed by the Decision, while people remain without treatment. He may also facilitate the process by conferring a voluntary license to a potential exporter. It may also occur that the patent owner exploits the intricacies and complexities of the system, and exercises his rights under the relevant national laws to block the unauthorized use of his patent. The system under paragraph 6 may, in fact, be applied in a context of conflict between the demanding country and the patent owner unwilling to supply.

A WTO waiver means that a member shall not initiate a complaint against another member if the latter acts under the terms of the adopted waiver. But to the extent that the national law is not aligned with the waiver, it will not prevent the patent owner from invoking provisions in the national laws to prevent the acquisition of the patented drug from other sources. Therefore the actual implementation of the Decision will depend on the extent to which national laws allow the waived acts.

Under the adopted system, for instance, is recognized the possibility (fully consistent with the TRIPS Agreement) of granting a compulsory license to import a patented drug. The problem, however, is that many developing countries provide for the granting of compulsory licenses for the manufacture of patented subject matter, and not for importation. Hence, in order to make operative any solution under paragraph 6, those developing countries would need to amend their national patent laws accordingly. This may be unnecessary if the national laws included provisions for non commercial government use of patented inventions, allowing for either local manufacturing or importation. 15

Similarly, amendments to national laws will be necessary in the potential exporting countries. Compulsory licenses are granted under grounds specified by national laws. The supply of export markets is not an accepted ground in most national laws. 16   Moreover, in implementing Article 31.f of the TRIPS Agreement, 17   WTO members have established compulsory licenses to supply “predominantly” the domestic market. If a company receives a request under paragraph 6 to supply a foreign country, it would not be able to obtain a compulsory license exclusively to export, unless the national law has been amended accordingly. The extent to which governments will be willing to start the complex process of amending the patent law – especially on the basis of an interim waiver – is open to question. Nothing in the Decision precludes developed countries from acting as exporters of generic drugs under the system, but it is uncertain how their governments would react if requested to amend their laws and grant compulsory licenses for supplying under paragraph 6. In fact, most observers expect the large generic producers in the developing world (such as India, China, Brazil, Thailand and South Africa) to undertake this production and export. 18

The effective use of a compulsory license in both the importing and exporting country will also depend on procedures. In some countries (e.g. Argentina) an appeal by the patent owner against the grant of a compulsory license does not suspend its immediate execution (e.g. Article 49, Argentine Patent Law n. 24481, as amended). In other countries, this may not be the case. The patent owner may file an appeal or obtain an injunction and thereby stop exports under a compulsory license until a final administrative or judicial decision is taken, perhaps a few years later. National patent laws, hence, will have to be amended, as necessary, in order to make the use of compulsory licenses for export an effective mechanism to address public health needs.

Conditions for use of the waiver

Numerous conditions are established in the text of the Decision, as interpreted by the Chair’s Statement, for allowing exports of patented medicines. In order to get the supply of drugs under this mechanism the following steps must be followed: 19

1. Unless the prior request of a voluntary license does not apply, 20   an entity in the importing country must seek a voluntary license from the patent owner. 21

2. Failing this, an application for a compulsory license must be submitted to the government of the importing country and the license be obtained there (unless there is no applicable patent in that country).

3. The importing country must assess the capacity of its generic industry to produce the required medicine locally.

4. If capacity is insufficient, it must notify the WTO of its decision to use the paragraph 6 system.

5. The interested importing party must identify a potential exporter.

6. That exporter must in turn seek a voluntary license from the patent owner on commercially reasonable terms for a commercially reasonable period of time.

7. If the voluntary license is refused, the potential exporter must seek a compulsory license (to be granted on a single-supply basis) from its own government.

8. The exporter will need to seek product registration and prove bio-equivalence and bioavailability, as required by national law.

9. If exclusive rights (as promoted by the US) are granted 22   in the importing country with regard to data submitted for registration of a medicine, the supplier will have to obtain authorization by the possessor of the data to use them, or to develop its own studies about toxicity and efficacy (unless the use of such data is authorized under the compulsory license).

10. Before shipment begins, the licensee shall post on website information about the quantities being supplied and the distinguishing features of the product.

11. The exporting member must notify the Council for TRIPS of the granting of the license, including the conditions attached to it.

This process must be fulfilled over and over, since only the amount necessary to meet the needs of one particular eligible importing member may be manufactured under the license, and the entirety of this production shall be exported to the member that has notified its needs to the Council for TRIPS.

Economic feasibility

As discussed elsewhere, 23   in order to be effective, a solution to the problem described in paragraph 6 should be economically viable, and not only diplomatically acceptable. Does the Decision provide the incentives to encourage potential suppliers to make the necessary investment and take the associated risks? In addition to complying with the legal procedures involved in the application of a compulsory license and the marketing approval of the product, the potential exporter will have to develop (when produced for the first time) the chemistry and formulate the drug, and then produce the active ingredients and/or formulations with shape, color, label and packaging different from of the patent owner’s product, and at a low price affordable to the acquiring party. Pharmaceutical firms are unlikely to make the required investment if there is no reasonable profit expectation.

The Decision recognizes that the viability of the “solution” largely depends on the existence of economies of scale that justify production. According to paragraph 6 of the Decision, however, the realization of economies of such scale is only envisaged in cases where the importing country is a party to a regional trade agreement with at least half of its current membership made up of least developed countries. In this case the obligation of that member under Article 31.f of the TRIPS Agreement shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory license in that member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. Given the requirement about participation of least developed countries, this exception will only apply to some regional agreements in Africa but not in other regions, 24   thereby limiting the effect on economies of scale that could have been obtained.

As noted by Maskus (2003, op. cit.), though overall needs in the poor nations are immense, “even if some poor countries in a trade agreement covered by this exception pooled their demands for a particular medicine, the scale may be still too low to become attractive for potential suppliers … because the eligible import markets in really small countries will not be large, generic producers may not be interested in producing such small volumes and foregoing chances for economies of scale”.

Conclusions

The implementation of the Decision on paragraph 6 of the Doha Declaration will require adaptations in national laws and entail, in particular cases, significant transaction costs. As adopted, it is unlikely to put strong pressure on patent owners to lower their prices or to negotiate voluntary licenses, nor is it likely to provide incentives to potential suppliers to make the investments necessary to develop and produce the needed drugs. Subventions from the international organizations and donor governments made be necessary to make this “solution” workable. 25

Despite the quite obvious limitations of and many constraints imposed by the examined Decision, countries in need of acquiring patented drugs should test the viability of the system. The Decision should be interpreted, in line with the Doha Declaration on the TRIPS Agreement and Public Health, in a manner that facilitates an increase in the supply of medicines to poor countries. It is also necessary to elaborate a permanentsolution to the problem affecting countries with limited or without manufacturing capacities in this field, based on an amendment to the TRIPS Agreement. Such an amendment should be based on a simpler and more straightforward approach, 26   which provides the economic incentives for the solution to be effective.

It is also important to note that the system under paragraph 6 seems to be built upon the assumption that a patent owner is legitimized to prevent access to products under his control, even in the presence of compelling humanitarian reasons. This is certainly not consistent with the Doha Declaration on the TRIPS Agreement and Public Health (particularly paragraph 4), nor with States’ commitments under the International Covenant on Economic, Social and Cultural Rights, especially its Article 12 (recognizing the human “right of everyone to the enjoyment of the highest attainable standard of physical and mental health” and obliging the taking of steps to fully realize this right, including “those necessary for … the prevention, treatment and control of epidemic, endemic, … and other diseases”). The adoption of the Decision, hence, cannot prevent the use of other means when the owner of the relevant patent or patents refuses to supply a needed drug. Countries should be encouraged to develop disciplines to deal with such refusals in the context of the “essential facilities” doctrine, 27   or other concepts under competition and public health law.

Finally, it should be recalled that paragraph 6 only describes one of the problems arising in the context of the TRIPS Agreement with regard to public health. The intellectual property protection of pharmaceuticals will continue to pose significant challenges to public health policies in developing countries, even if the agreed “solution” were proven to be viable and effective. The agreement on paragraph 6 does not mean an end to the controversies around intellectual property and public health. They are likely to continue, especially as developed countries seek TRIPS-plus protection via interpretation 28   or negotiation of bilateral and regional agreements, 29   and as patents on marginal or trivial developments (sometimes called “ever-greening” patents) are granted and used to block or delay generic competition. 30

* Published in Emory International Law Review, vol. 17, n. 2. Atlanta (Ga.), 2003.

1. The TRIPS Agreement provides for minimum standards for the protection of patents, trademarks, copyrights and other intellectual property rights. See the text of the agreement in www.wto.org .

2. See, e.g. various contributions in Brigitte Granville (ed.), The Economics of Essential Medicines(London: The Royal Institute of International Affairs, 2002); and Peter Drahos & Ruth Mayne (ed.),Global Intellectual Property Rights. Knowledge, Access and Development (New York: Palgrave Macmillan-Oxfam, 2002).

3. International Intellectual Property Institute, “Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa” (Washington DC, 2001), p. 23.

4. WT/MIN(01)/DEC/W/2, 14 November 2001, hereinafter the Doha Declaration.

5. According to the principle of international exhaustion of rights, a patent holder “exhausts” his rights after the first legitimate sale of patented products in a foreign country. Hence, he cannot prevent the subsequent transborder movement of such products.

6. A “compulsory license” is the authorization given by a judicial or administrative authority to a third party for the use of a patented invention, without the consent of the patentee, on various grounds of general interest (e.g., absence of working, public health, anticompetitive practices, emergency, national defense).

7. See IP/C/W/405, available at www.wto.org (hereinafter “the Decision”).

8. The US initial position aimed at limiting the possible solution to HIV/AIDS, malaria and tuberculosis.

9. See the text of the Chairman of the Council for TRIPS of 16 December 2002 (JOB(02)/217). Available at www.wto.org .

10. Article 31.h: “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”.

11. The risk of diversion has probably been overstated. Trade in medicines is subject to stringent national regulations that erect effective barriers to market access. The European Commission has noted that “the industry acknowledges that to date there is no re-importation of medicines from the poorest developing countries into the European Union, i.e. the problem of re-importation is still largely theoretical”, in European Commission (DGTrade, 2002). “Tiered Pricing for Medicines Exported to Developing Countries, Measures to Prevent their Re-Importation into the EC Market and Tariffs in Developing Countries” (Brussels: Working Document, 22 April), p. 10.

12. Article 2(b)(ii): “The products produced under the license shall be clearly identified as being produced under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special coloring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price”.

13. One of the noticeable ambiguities in the Decision is the concept of “manufacturing capacity”. It is unclear, in particular, whether such capacity should be determined on technical grounds only, or taken into account the economic feasibility of manufacturing. This latter interpretation seems the most reasonable on efficiency grounds, and given that economic feasibility may be as an important barrier for local manufacturing as the lack of technical capacity.

14. According to paragraph 11, “… This Decision, including the waivers granted in it, shall terminate for each member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that member. The TRIPS Council shall initiate by the end of 2003 work on the preparation of such an amendment with a view to its adoption within six months, on the understanding that the amendment will be based, where appropriate, on this Decision and on the further understanding that it will not be part of the negotiations referred to in paragraph 45 of the Doha Ministerial Declaration (WT/MIN(01)/DEC/1)”.

15. It is to be noted that the Decision only refers to “compulsory licenses” and not to government use for non-commercial purposes. However, the waiver is adopted with regard to Article 31, paragraphs (f) and (h) of the TRIPS Agreement, which equally covers both forms of uses without authorization of the patent holder. Any good faith interpretation of the Decision, therefore, should admit such government uses.

16. However, Article 168 of the Australian Patent Act and Article 55(2) of the Patent Act of New Zealand, permits exports under an agreement with a foreign country to supply products required for the defense of that country. Article 48B(d) and (i) of the UK Patent Act provides for a compulsory license in respect of a patent whose proprietor is not a WTO proprietor when the owner’s failure to license the patent on reasonable grounds means that a market for the export a patented product made in the UK is not being supplied. Article 45.g of the Argentine patent law permits the granting of a compulsory license not predominantly for the domestic markets when necessary to remedy anticompetitive practices or in cases of health emergencies or national security.

17. Article 31.f: “any such use shall be authorized predominantly for the supply of the domestic market of the member authorizing such use”.

18. K. Maskus, “TRIPS, Drug Patents and Access to Medicines-Balancing Incentives for R&D with Public Health Concerns”, in Knowledge Economy, Development Gateway (2003), at old.developmentgateway.org/download/206719/Maskus_on_TRIPS . Last access on 12 September 2005.

19. See Brook K. Baker, “Vows of Poverty, Shrunken Markets, Burdensome Manufacturing and other Nonsense at the WTO” (Health GAP, 27 August 2003). Available at IP-Health website: www.healthgap.org/press_releases/03/092703_HGAP_BP_WTO_Cancun.html . Last access on 7 September 2005.

20. This would generally be the case – depending, however, on national law – when an authorization is given on grounds of extreme urgency, anti-competitive practices or non-commercial public use (Article 31 (f) and (k) of the TRIPS Agreement).

21. In requesting a compulsory license both in the importing and the exporting country, it will be necessary to identify and include all the patents that may affect the supply of a drug, since normally there are patents covering the active ingredient, acceptable formulations, polymorphs, manufacturing processes etc. of the same drug. On patenting practices in pharmaceuticals, see Correa, Trends in Drug Patenting (Buenos Aires: Corregidor, 2001).

22. See Correa, “Protection of Data Submitted for the Registration of Pharmaceutical Products. Implementing the Standards of the Trips Agreement” (Geneva: South Centre, 2002).

23. See Correa, Implications of the Doha Declaration on the TRIPS Agreement and Public Health (Geneva: World Health Organization, 2002), p. 33. Available at www.who.int/medicines/library/par/who-edm-par-2002-3/doha-implications.doc . Last access on 7 September 2005. See also “Integrating Intellectual Property Rights and Development Policy” (London: Commission on Intellectual Property Rights, 2002). Available at www.iprcommission.org . Last access on 7 September 2005.

24. For instance, Mercosur and the Andean Community do not qualify under the Decision as a single market for the purposes of the Decision.

25. See K. Maskus, 2003, op. cit.

26. For instance, on 3 October 2002, the European Parliament adopted Amendment 196 to the European Medicines Directive, which provides that “manufacturing shall be allowed if the medicinal product is intended for export to a third country that has issued a compulsory license for that product, or where a patent is not in force and if there is a request to that effect of the competent public health authorities of that third country”.

27. See John Taladay & James Carlin Jr., “Compulsory Licensing of Intellectual Property under the Competition Laws of the United States and European Community” (George Mason Law Review 10, n. 3, Spring 2002), p. 443.

28. The United States Trade Representative (USTR), for instance, interprets that Article 39.3 of the Agreement requires the granting of an exclusive period of protection for data submitted for the marketing approval of pharmaceuticals and agrochemicals.

29. See, e.g, the recent US–Chile and US–Singapore bilateral agreements.

30. “Ever-greening” refers to the acquisition of patent rights over minor or trivial modifications or formulations of existing drugs, with the aim of delaying the entry of generic competition. See Correa, 2001, op. cit.

Lawyer and economist, professor at the University of Buenos Aires, Argentina.

Original in English.

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MONROVIA, Liberia—President Joseph Boakai has withdrawn his appointment of Liberian lawyer, Jonathan Massaquoi  to head the newly constituted Office of War and Economic Crimes Courts following nearly two months of public condemnation from almost all leading victims and human rights advocates and the umbrella body for lawyers in the country, the Bar Association .

By Anthony Stephens with New Narratives

Opponents had demanded a reset of the appointment process, saying it had not been conducted in a transparent and consultative manner that would give Liberia’s large number of victims a sense of inclusion and trust in the process. Cllr. Massaquoi had also drawn fire because of his representation of accused perpetrators, including Agnes Reeves Taylor of the National Patriotic Front for Liberia, against human rights advocates. To date, he has not recused himself from those cases.

The outcry against the appointment had also concerned major international donors, who will be called upon to fund the courts. They expressed their unhappiness with the lack of consultation to this paper. The failure of the president’s office to publicly announce it had sent a letter requesting support for the courts to the office of the UN Secretary General, was also seen as compounding the secrecy around the process.

The Mansion said it was now acting in response to the outcry.

“I want to state that this decision stems from our desire to ensure that the process leading to the establishment or the constitution of the actors in the Office for the War and Economic Crimes Courts is open, broad based and ensure public scrutiny. The government chose to have a listening ear,” Mr. Jerolinmek Piah, Liberia’s Information Minister, told the government’s weekly press conference .

The head of the office was tasked with creating a blueprint for the courts which would try those most responsible for international crimes and serious human rights violations during the country’s three decades of conflict starting in 1979. As many as 250,000 Liberians died and more than a million were displaced.

In a statement the Ministry of Information announced the president’s decision to create a committee to oversee appointment of a new head chaired by the Justice Ministry, comprising the Bar, the Economic Community of West African States (Ecowas), the African Union, the Inter-Religious Council of Liberia, and “eminent organizations to recruit and vet candidates that will lead the Office of War and Economic Crimes Courts.” 

The statement made no mention of Mr. Massaquoi. Cllr. Massaquoi did not respond to an FPA/NN request for comment on the president’s decision.

Minister Piah said the committee had a 21-day timeframe within which to suggest three names to the president to make a new appointment. Pressure will be on the committee, which apparently had no pre-warning of its new role. News of the Bar Association’s appointment was a surprise to Cllr. Sylvester Rennie, the Bar’s president. “We have not been spoken to. Nobody has called me on that. Let them call us first. Let’s know the Terms of Reference.”

Meanwhile, human rights advocates praised Mr. Boakai’s about-turn.

“It says that he is a leader who will listen to people; a leader who will respect that he can also be advised; a leader with humility,” said Madam Massa Washington, a commissioner of Liberia’s 2009 Truth and Reconciliation Commission, by WhatsApp. “Humility in some instances, is a huge quality of a good leader.”

Madam Washington also said the decision to have a consultative committee to appoint the new head is the right course.

“That is how best practices all around the world are done,” Madam Washington said. “The human rights community must be involved in vetting the head of the WECC. It has to be transparent and inclusive so that person when appointed, will have all of our support. The president is the first citizen. He sets the tone for the rest of the citizenry.”  

Madam Lovetta Tugbeh, founder of the Coalition for Justice in Liberia, which had called on President Boakai to rescind Cllr. Massaquoi’s appointment in an open letter, also commended the announcement. 

“This move reflects the need for individuals with impeccable character and unwavering dedication to justice in pivotal positions,” said Madam Tugbeh by WhatsApp. “Given the tragic loss of approximately 250,000 lives, including foreign nationals, during Liberia’s brutal civil war, ensuring trustworthy figures in key roles is essential for rebuilding the nation and honoring the victims’ memories. This decision is a crucial step towards setting Liberia on a path of justice and recovery.”

That path to recovery and justice is to be designed by the Office, which Mr. Boakai set up through an executive order in May. Whoever heads the Office will have to also ensure the drafting of bills for the establishment of the courts and solicit donors’ technical and financial support for the courts.

Advocates warned that donors would have been skeptical of funding the initial process for the courts because it lacked transparency.

“This was very clear,” said Mr. Hassan Bility, Director of the Liberian based Global Justice and Research Project, which together with its Swiss partner, Civitas Maxima has been behind the investigations and prosecutions in European and American courts of individuals accused of committing war related crimes during Liberia’s civil wars. “President Boakai would have hit the wall. It is good that the president has finally listened to his people, the Liberian people. This Office must not only be neutral and fair but must be seen as such by the victims in particular and the Liberian people in general. There was no other choice.”

Mr. Adama Dempster, another human rights advocate, agreed with Mr. Bility that there was little choice. 

“There would have been major roadblocks to the establishment of a war and economic crimes courts in Liberia with reference to international support,” said Mr. Dempster by WhatsApp. “The international community usually looks for a credible and transparent window to move its support towards a process taking into account their work with all stakeholders including civil society and human rights groups on the ground.”

Madam Washington agreed.

“Donors support would’ve been in short supply for the WECC because donors want to bet on a successful final outcome but if the process or pathway towards achieving that successful outcome is massively flawed already, it will be catastrophic for the final product,” Madam Washington said. “Processes do matter you know, because they are the patent for how your final product turns out. We are in touch with historically pro-transitional justice partners and donors who are prepare not to put a dime in that WECC Secretriat as was. At best, our traditional partners would’ve minimally made donations but so miniscule as to have zero meaningful impact on the project.”

The committee will be under pressure to act fast. The executive order establishing the Office runs for one year, in which it must come up with a plan for the courts, funding from donors and bills to establish the courts to go to the Legislature for its approval. Though the Legislature passed a resolution to establish the courts, there is still considerable opposition within the body, including from accused warlords who will likely be indicted by the courts. Three months have already passed.

This story is a collaboration with  New Narratives  as part of the West Africa Justice Reporting Project . 

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