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URUGUAY ROUND AGREEMENT: TRIPS

Part I — General Provisions and Basic Principles

• PART I General Provisions and Basic Principles
• PART II Standards Concerning the Availability, Scope and Use of Intellectual Property Rights
• 1. Copyright and Related Rights
• 2. Trademarks
• 3. Geographical Indications
• 4. Industrial Designs
• 6. Layout-Designs (Topographies) of Integrated Circuits
• 7. Protection of Undisclosed Information
• 8. Control of Anti-Competitive Practices in Contractual Licences
• PART III Enforcement of Intellectual Property Rights
• 1. General Obligations
• 2. Civil and Administrative Procedures and Remedies
• 3. Provisional Measures
• 4. Special Requirements Related to Border Measures
• 5. Criminal Procedures
• PART IV Acquisition and Maintenance of Intellectual Property Rights and Related Inter-Partes Procedures
• PART V Dispute Prevention and Settlement
• PART VI Transitional Arrangements
• PART VII Institutional Arrangements; Final Provisions

Article 1 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”).

Article 2 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.

Article 3 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.

Article 4 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:

(a)  deriving from international agreements on judicial assistance or law enforcement of a general nature and not particularly confined to the protection of intellectual property;  

(b)  granted in accordance with the provisions of the Berne Convention (1971) or the Rome Convention authorizing that the treatment accorded be a function not of national treatment but of the treatment accorded in another country;  

(c)  in respect of the rights of performers, producers of phonograms and broadcasting organizations not provided under this Agreement;  

(d)  deriving from international agreements related to the protection of intellectual property which entered into force prior to the entry into force of the WTO Agreement, provided that such agreements are notified to the Council for TRIPS and do not constitute an arbitrary or unjustifiable discrimination against nationals of other Members.

Article 5 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.

Article 6 Exhaustion

  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.

Article 7 Objectives

  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.

Article 8 Principles

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.

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• 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 October 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

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Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)

Interpreting the Flexibilities Under the TRIPS Agreement

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• Open Access
• First Online: 28 October 2021
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• Carlos M. Correa 3  

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While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.

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1 introduction.

While the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘the TRIPS Agreement’) has had a major impact in framing national laws on intellectual property rights (IPRs)—notably in developing countries—and has led to some degree of harmonization of such laws, it is not a uniform law on IPRs.

One the one hand, the TRIPS Agreement provides for minimum standards, thereby allowing the members of the World Trade Organization (WTO) to adopt broader protections. Footnote 1 Many such ‘TRIPS-plus’ protections have been established through free trade agreements signed by the US and the European Union with developing country partners. Footnote 2 Examples of such TRIPS-plus protections include (in the area of patents) the extension of the patent term in order to compensate for delays in the grant of a patent or the marketing approval of a pharmaceutical product, Footnote 3 data exclusivity, Footnote 4 and what is known as ‘patent linkage’, Footnote 5 among others.

On the other hand, the TRIPS Agreement leaves some room for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations.

The possibility, and admissibility, of differences in the implementation of the provisions of the TRIPS Agreement are expressly recognized in Article 1.1 of the Agreement: “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” Competition law, which may be applied to control the acquisition or exercise of IPRs, is an example of the second situation in which the Agreement does not provide a binding standard. Footnote 6 The room for different interpretations may result from the absence of definitions. One example is the lack of a definition of the concept of ‘invention,’ which differs among countries and allows WTO members not to grant patents, for instance, on developments without a technical effect (such as under European law), or to grant or not grant patents on genetic materials. Footnote 7 In many cases, the space for different interpretations derives from general expressions or ambiguities in the text resulting from compromises reached in the negotiation of the Agreement. An outstanding example is the WTO members’ right to grant compulsory licenses due to lack of working of a patent, an issue indirectly referred to in Article 27.1 of said Agreement. Footnote 8 The task of the interpreter is particularly daunting when the text includes general terms such as “reasonably,” “unreasonably,” Footnote 9 “unjustifiable,” Footnote 10 or “unjustifiably.” Footnote 11

The actual policy space available under the TRIPS Agreement—beyond those areas not covered under the Agreement—depends, in the last instance, on the interpretation of the Agreement’s provisions. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. It discusses, first, the concept of ‘TRIPS flexibilities’ and the possible types of such flexibilities as found in the legislation of developing and developed countries. Second, the paper discusses the references to such flexibilities in WTO jurisprudence. Third, it briefly refers to some of the principles of interpretation that are relevant for the use of TRIPS flexibilities, including the value of dispute settlement rulings, the search for the ordinary meaning of the terms used, the context, and the object and purpose of the treaty. Fourth, it discusses the legal status of the Doha Declaration on the TRIPS Agreement and Public Health adopted at the 4th WTO Ministerial Conference in November 2001. Footnote 12 There is no attempt in this paper to analyze the specific content of the rulings in TRIPS-related disputes; however, the paper does draw some general conclusions for the implementation of such flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives (as specifically recognized by the Doha Declaration). Footnote 13

2 Defining the TRIPS Flexibilities

The terminology used to refer to the policy space available for the implementation of the TRIPS Agreement has evolved. Expressions such as “room to maneuver,” “margins of freedom,” “safeguards,” and “margin of discretion” were used in the early studies and reports that identified various aspects of such space. Footnote 14 Currently, the diversity of legislative options available under said Agreement is generally known as ‘TRIPS flexibilities.’

The term ‘flexibility’ appears in the Preamble (sixth paragraph) and in Article 66.1 of the TRIPS Agreement but it is used there with a broader meaning. It indicates that least-developed countries (LDCs) are not bound to comply with the TRIPS Agreement obligations (except Articles 3 through 5) during the transition period:

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 ... Footnote 15

The terminology ‘TRIPS flexibilities’ does include the exemption for LDCs, but it also encompasses possible variations in the manner in which the TRIPS Agreement’s provisions are interpreted and implemented as they are applied to countries actually subject to them. Such terminology was used for the first time with this latter meaning in the context of the WTO in paragraph 4 of the Doha Declaration. Footnote 16 Said paragraph states:

4. 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' right 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. Footnote 17

The Declaration confirmed the availability of a number of flexibilities. Its adoption was a response to the concerns of developing countries about the obstacles they faced when seeking to implement measures to promote access to affordable medicines, without limitation to certain diseases, in the interest of public health. Footnote 18

Since the adoption of the Doha Declaration, the concept of ‘TRIPS flexibilities’ has been referenced in a vast body of literature, especially (but not only) in relation to access to medicines, Footnote 19 and in numerous resolutions of UN agencies Footnote 20 and bodies, including the World Health Organization (WHO), the Human Right Council (HRC), Footnote 21 and the UN Assembly, as well as in reports of the UN Special Rapporteur on the Right to Health. Footnote 22 For instance, the World Health Assembly (WHA) urged member states “to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)”. Footnote 23 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Footnote 24 explicitly referred to the flexibilities reaffirmed by the Doha Declaration, including the research exception (Element 2.4e), the transitional period for least-developed countries (LDCs) (Element 6.1b), and the regulatory exception or “Bolar exception” (Element 6.3a). A 2011 resolution adopted by the HRC, and subsequent resolutions on the matter, also noted the governments’ right to use, to the fullest extent, the provisions of the TRIPS Agreement, the Doha Declaration, and the WTO General Council Decision of 30 August 2003 in the context of the HIV/AIDS epidemic. Footnote 25 Importantly, Goal 3. Target 3.b of the Sustainable Development Goals (SDGs), as adopted by the UN General Assembly, also refers to the TRIPS flexibilities:

Goal 3. Target 3.b: Support the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. Footnote 26

There is no agreed-upon definition of ‘TRIPS flexibilities.’ In accordance with a WIPO document, the term “flexibilities” means that there are “different options through which TRIPS obligations can be transposed into national law so that national interests are accommodated and yet TRIPS provisions and principles are complied with.” Footnote 27 That concept implies that the legislative options made are compatible with the TRIPS Agreement and, hence, fully legitimate . Although this remark may be deemed trite , it is important to make it in view of the reluctance of some developed countries to accept the use of such flexibilities, and even to exert pressures on or apply retaliatory trade sanctions against countries that do comply with the Agreement’s obligations. This position is well reflected in the continuous use by the US of the Special Section 301 of the US Trade Act 1974, Footnote 28 and in the European Commission Staff Working Document on the protection and enforcement of intellectual property rights in third countries. Footnote 29

There are different types of TRIPS flexibilities. Some refer to the scope and extent of the substantive rights to be recognized under the Agreement, Footnote 30 and others to the ways in which such rights can be enforced. One way of grouping flexibilities is also to take into account “the point in time at which Members may resort to them: (i) in the process of the acquisition of the right; (ii) defining the scope of the right; and (iii) when enforcing the right.” Footnote 31 As noted in one report, those flexibilities

…sometimes are made very explicit (as in the right of each WTO Member to choose its national regime of exhaustion of IP rights, hence allowing parallel imports), and in other instances follow from the use of general and open terms in TRIPS provisions (such as legitimate interests, justifiability, ordre public and morality) that WTO Member can – within the limits of accepted principles of treaty interpretation in public international law – interpret and implement in accordance with their public policy preferences. Footnote 32

Given the possible variations in national regimes in interpreting and implementing the TRIPS Agreement, it would be an impossible task to identify all flexibilities. They can be found in all the areas covered by the Agreement, and they can be identified as new circumstances arise. Thus, the exception to copyright protection, which is of particular importance to ensure access to knowledge and preserve a robust public domain, Footnote 33 needs to be considered in light of technological developments. Footnote 34 WIPO’s Database on Flexibilities in the Intellectual Property System Footnote 35 provides information on just fourteen TRIPS flexibilities as provided for in the national laws of some countries, but the list is certainly much longer and their use in national laws and regulations more extensive. As noted, the type and use of such flexibilities have been widely explored, most particularly in relation to public health policies and access to medicines, Footnote 36 in academic literature, numerous reports, and other sources of information. Footnote 37 Box 1 includes references to some of the flexibilities available in the field of public health.

Box 1 Public health-related TRIPS flexibilities

Flexibility in the choice of patentability criteria, including for chemical entities and biologics —WTO members have considerable policy space to define what an ‘invention’ is and to apply rigorous standards of patentability to avoid the grant of patents that, without making a genuine technical contribution, may distort market competition.

Compulsory license —Widely recognized in the legislation of developed and developing countries—and granted since the adoption of the TRIPS Agreement by administrations or courts in countries such as Thailand, Ecuador, Indonesia, India, USA, Italy, and Germany—compulsory licenses may be necessary to correct market distortions (abuses of market power, unfair pricing, refusal to license, etc.).

Government use —In many cases governments may decide, consistently with the TRIPS Agreement, to use patented inventions for non-commercial purposes, such as for ensuring the supply of essential medicines.

Compulsory licenses for the supply of medicines to countries with a lack of or insufficient manufacturing capacity —Compulsory licenses exclusively for the export of medicines can be granted under the amendment introduced to the TRIPS Agreement in 2017 and the waiver adopted by WTO in 2003.

Test data protection —The TRIPS Agreement (Article 39.3) requires WTO members to protect test data against unfair competition, which does not create exclusive rights. The Agreement is complied with if legislation on unfair competition is implemented to protect such data.

Exemptions) for LDCs —LDCs need not grant patents for pharmaceuticals and test data protection at least until 2033 under the extended transition period provided for under Article 66.1 of the TRIPS Agreement.

Parallel importation —Importing protected medicines from any country where they can be purchased cheaper than locally is consistent with the TRIPS Agreement.

Pre and post patent grant opposition —Procedures before patent offices provide for the possibility for third parties to contribute to the examination process through ‘observations’ or ‘oppositions,’ whether before or after the grant of a patent, or both.

Use of competition law to address the misuse of IPRs —Competition law may be applied to correct market distortions created through the abuse of IPRs.

Bolar exception —‘Bolar exceptions’ are important to accelerate the entry of generic products and promote a dynamic market for medicines.

Research or experimentation exception —This exception allows research to be conducted by third parties on patented inventions, for instance, to improve on them or derive new inventions.

Disclosure requirement, particularly for biologics —The full and precise disclosure of an invention is crucial for the patent system to perform its informational function. This is particularly relevant for biologicals, which cannot be described in the same way as medicines produced by chemical synthesis

Flexibilities in enforcement of IP —Measures to enforce IPRs—such as reversal of the burden of proof, determination of infringement by equivalence and damages, and border measures—if overly broad, may distort competition by discouraging or preventing market entry and the availability of generic medicines. Provisional injunctions need to be cautiously granted so as not to distort the market dynamics, generally after giving the alleged infringer an opportunity to articulate his defense. Permanent injunctions may be denied for public health reasons under certain circumstances.

Security exception —Compliance with obligations under the TRIPS Agreement can be suspended, inter alia, in cases of emergency in international relations, such as in the case of a pandemic (Article 73 (b) of the Agreement).

Source: adapted from South Centre, “A Public Health Approach to Intellectual Property Rights: Public Health Related Flexibilities in the TRIPS Agreement,” available from: https://ipaccessmeds.southcentre.int/wp-content/uploads/2018/12/Public-Health-Related-Flexibilities-in-the-TRIPS-Agreement.pdf .

Any WTO member can make use of the TRIPS flexibilities, as applicable, in order to attain public health or other public objectives and, in fact, both developed and developing countries have done so. Thus, the flexibility in the TRIPS Agreement permitted the US to maintain a double-novelty standard depending on whether the disclosure of the invention had taken place within or outside the territory of the US (35 USC section 102 (a)). Footnote 38 In defending this flexibility, which has allowed for the misappropriation of genetic resources and traditional knowledge, Footnote 39 the US held that in the TRIPS Agreement there was “no prescription as to how WTO Members define what inventions are to be considered ‘new’ within their domestic systems” and, hence, that its legislation was “perfectly consistent with the provisions of the TRIPS Agreement.” Footnote 40 Another example in the US is the doctrine that allows US courts not to grant a permanent injunction despite the proven existence of an infringement of IPRs, in accordance with the precedent set by the US Supreme Court in the eBay vs. MercExchange case. Footnote 41 There are also many examples in Europe Footnote 42 where, for instance, the European Parliament’s Resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)) emphasized “that the European Patent Office (EPO) and the Member States should only grant patents on medicinal products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability, as enshrined in the European Patent Convention” (paragraph 48). Footnote 43 More recent examples are the amendments to the patent laws in Canada and Germany to address the COVID-19 emergency. Bill C 13 2020 of Canada, Footnote 44 for instance, added a new section to the Patent Act implementing a new type of compulsory license for patents:

19.4  (1)  The Commissioner shall, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.

In Germany, an amendment to the Patent Act provided that an invention relating to medicinal products, including narcotics; the active ingredients, starting materials, and auxiliary materials for these products; medical devices; laboratory diagnostics; aids; personal protective equipment; and products for disinfection of the products shall be used in the interest of public welfare (“öffentliche Wohlfahrt”) or in the interest of the security of the Federation. Footnote 45

3 TRIPS Flexibilities in WTO Jurisprudence

Despite the TRIPS Agreement being one of the most controversial components of the WTO system, and that it has given rise to a large number of proceedings under the Dispute Settlement Understanding, a relatively small number of cases has reached the phase of a panel or Appellate Body intervention.

Paradoxically, although the adoption of the TRIPS Agreement essentially was aimed at disciplining developing countries, who have been forced to make massive legislative changes to adapt to the Agreement’s high minimum standards, Footnote 46 most disputes leading to the establishment of a panel have been against developed countries (two against the US, Footnote 47 two against the European Communities and their Member States, Footnote 48 two against Canada, Footnote 49 and one against Australia Footnote 50 ). Only two developing countries were subject to such procedures: Footnote 51 India (two complaints concerning the implementation of Article 70.8, the so called “mailbox” provision) Footnote 52 and China (criminal sanctions for copyright infringement and other issues). Footnote 53 Only four developing countries (Indonesia, Cuba, Honduras, and the Dominican Republic) have been complaining parties (against Australia in the tobacco plain packaging case) in WTO disputes under the TRIPS Agreement that have reached such stage. Footnote 54

In other cases of disputes initiated against developing countries, no panel was established. One example was a complaint by the US against Argentina on patents and test data protection. Footnote 55 A mutually agreed-upon solution was communicated to the Dispute Settlement Body (DSB) on 20 June 2002. However, the parties did not reach a common understanding on the interpretation of Article 39.3 of the TRIPS Agreement, nor on the application of Article 70.7. Footnote 56 Argentina has not to date introduced the data exclusivity regime that the US claimed would remedy the (unproven) violation of Article 39.3. Another example, further discussed below, was the US challenge in January 2001 against Brazilian legislation that authorizes the granting of compulsory licenses and parallel imports in instances when patents are not worked. Footnote 57 The dispute ended several months later when the US complaint was withdrawn. Footnote 58

The panel and Appellate Body reports produced in relation to the disputes mentioned above have, in practice, addressed the policy space available under the TRIPS Agreement, but they have only occasionally referred to the concept of ‘flexibilities.’ In China—Intellectual Property Rights , for instance, third parties alluded to the ‘flexibility’ allowed by the TRIPS Agreement in relation to the definition of ‘commercial scale.’ Footnote 59 The US noted, with respect to Article 1.1 of the Agreement, that the provision “only offers flexibility in how a Member implements TRIPS obligations and does not exempt a Member from full compliance with TRIPS obligations.” Footnote 60 In this case the panel confirmed that the TRIPS Agreement does not mandate specific forms of legislation. Footnote 61 In relation to the US claim that China did not comply with Article 61 of the TRIPS Agreement, it stated:

The Panel may not simply assume that a Member must give its authorities wide discretion to determine what is on a commercial scale in any given case, and may not simply assume that thresholds, including numerical tests, are inconsistent with the relative benchmark in the first sentence of Article 61 of the TRIPS Agreement. As long as a Member in fact provides for criminal procedures and penalties to be applied in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale, it will comply with this obligation. If it is alleged that a Member's method of implementation does not so provide in such cases, that allegation must be proven with evidence…(para. 7.602).

A few references to the ‘flexibilities’ allowed by the prohibition contained in Article 20 of the TRIPS Agreement can be found in the panel report in Australia—Tobacco Plain Packaging . For instance, the panel stated:

On their face, the explicit prohibitions contained in Article 20 of the TRIPS Agreement and Article 2.2 of the TBT Agreement respectively must be read and, absent a conflict, applied together. The principle of harmonious reading dictates that the flexibilities implicitly left by those prohibitions also need to be viewed together, without a priori giving precedence to one over, and to the exclusion of, the other. Footnote 62

The panel in the same case also referred, as discussed below, to the Doha Declaration as a “re-affirmation by Members of the flexibilities provided in the TRIPS Agreement in relation to measures taken for the protection of public health”; Footnote 63 the concept of TRIPS flexibilities was also alluded to, for example, by Brazil and Thailand as third parties Footnote 64 and by the panel itself (para. 7.2407 and 7.2408). Interestingly, the Appellate Body in Australia—Tobacco Plain Packaging referred to the concept of Members’ ‘regulatory autonomy’ in encumbering the use of trademarks by special requirements under Article 20. Footnote 65

4 Interpretation of the TRIPS Agreement

This section is partially based on Carlos Correa, op. cit., 2005, which examines other aspects, such as the role of the negotiating history and the application of prior intellectual property conventions incorporated into the TRIPS Agreement;—,; see also Kennedy ( 2016 ).

This section considers some principles for and aspects of the interpretation of the TRIPS Agreement particularly relevant for the application of the TRIPS flexibilities.

4.1 Precedential Value of GATT/WTO Jurisprudence

Neither the GATT nor the WTO jurisprudence have precedential value; however, even if unrelated to intellectual property, such jurisprudence may influence and provide guidance for future rulings on the TRIPS Agreement. Footnote 66 One issue of particular relevance is whether jurisprudence on subjects other than those covered by this Agreement should be used to interpret it. The panel in India—Patent Protection for Pharmaceutical and Agricultural Chemical Products, for instance, held that although the TRIPS Agreement has a “relatively self-contained, sui generis status within the WTO,” it also was “an integral part of the WTO system, which itself builds upon the experience of over nearly half a century under the GATT 1947.” Footnote 67 In United States—Section 110(5) of the U.S. Copyright Act , while the panel noted that caution was required when interpreting the TRIPS Agreement provisions in the light of precedents developed in GATT dispute settlement practice, it stated that

given that the agreements covered by the WTO form a single, integrated legal system, we deem it appropriate to develop interpretations of the legal protection conferred on intellectual property right holders under the TRIPS Agreement which are not incompatible with the treatment conferred to products under the GATT, or in respect of services and service suppliers under the GATS, in the light of pertinent dispute settlement practice. Footnote 68

The application of general GATT and WTO jurisprudence to cases involving the TRIPS Agreement would ignore the specificity of intellectual property issues and one major difference between the TRIPS Agreement and other WTO covered agreements: the former provides for disciplines on intellectual property rights, which are private rights , Footnote 69 the exercise of which may restrain rather than facilitate international trade (as in the case of other WTO agreements). The private rights nature of intellectual property rights was highlighted in the panel report in China—Intellectual Property Rights :

Viewed in context, the phrase “shall have the authority” does not require Members to take any action in the absence of an application or request. Therefore, a condition that authority shall only be available upon application or request seems to be assumed in much of Sections 2, 3 and 4 of Part III. This is consistent with the nature of intellectual property rights as private rights, as recognized in the fourth recital of the preamble of the TRIPS Agreement. Acquisition procedures for substantive rights and civil enforcement procedures generally have to be initiated by the right holder and not ex officio . Footnote 70

One corollary of this, for instance, is that in contrast to the general GATT/WTO jurisprudence, the exceptions in the TRIPS Agreement need not to be read narrowly, but instead with the aim of achieving the objectives as defined in Article 7 (see below). Notably, intellectual property rights constitute exceptions in terms of Article XX(d) of GATT and, hence, their restrictive effects should not be augmented but mitigated through the interpretation of the scope and extent of the conferred exclusive rights. Footnote 71 The exceptions to exclusive rights are crucial to preserve market dynamics and achieve a diversity of public interests; they are a key component of the TRIPS flexibilities. Footnote 72

4.2 Ordinary Meaning

The GATT and WTO panels, as well as the WTO Appellate Body, have relied on the interpretive method codified by the Vienna Convention on the Law of the Treaties (VCLT). One of the basic steps for interpretation under Article 31 of the VCLT is the determination of the ‘ordinary meaning’ of the terms employed in the treaty, provided that “a special meaning shall be given to a term if it is established that the parties so intended” (Article 31.4). Many WTO panel and Appellate Body reports clearly indicate that such ordinary meaning is searched in the dictionary in order to clarify the scope and content of the relevant texts. Footnote 73 Thus, the Appellate Body in EC – Chicken Cuts states: "The Appellate Body observed that dictionaries

are a useful starting point” for the analysis of 'ordinary meaning' of a treaty term, but they are not necessarily dispositive. The ordinary meaning of a treaty term must be ascertained according to the particular circumstances of each case. Importantly, the ordinary meaning of a treaty term must be seen in the light of the intention of the parties “as expressed in the words used by them against the light of the surrounding circumstances.” Footnote 74

In China—Intellectual Property Rights , the panel observed that

the general rule of treaty interpretation in Article 31 of the Vienna Convention refers in paragraph 1 to the ordinary meaning of the terms of the treaty, read in context. Where the terms are a single term, or ordinarily used together, then the treaty interpreter should refer to the ordinary meaning of that single term, or of each term in the particular context of each other. This is a distinct exercise from that in paragraph 4 of Article 31 of the Vienna Convention which requires a “special meaning” to be given to a term if it is established that the parties so intended. No party to this dispute considers that a “special meaning” should be given to the phrase "on a commercial scale," and nor does the Panel. Footnote 75

While the rule regarding the ordinary meaning seems clear, an important question relates to the temporal aspect of the interpretation, that is, whether panels and Appellate Body should rely on the meaning of a term at the time of negotiation or adoption of an agreement, or whether they would be authorized to apply an evolutionary approach, that is, to rely on the meaning of a term at the time of its interpretation. Two approaches exist on this issue:

…the principle of contemporaneity , according to which the terms of a treaty are to be interpreted according to the meaning which they possessed, or which would have been attributed to them, and in the light of current linguistic usage, at the time when the treaty was originally concluded. Opposed to that is the dynamic approach , very often also labelled ‘evolutionary’ interpretation, which seeks to establish the meaning of a treaty at the time of its interpretation. Footnote 76

In Canada—Patent Protection for Pharmaceutical Products, the panel examined the status of the legislation at the time of the negotiation of the Agreement to determine the concept of “legitimate interest” as contained in Article 30:

Moreover, the Panel believed that it was significant that concerns about regulatory review exceptions in general, although well known at the time of the TRIPS negotiations, were apparently not clear enough, or compelling enough, to make their way explicitly into the recorded agenda of the TRIPS negotiation. The Panel believed that Article 30’s “legitimate interests” concept should not be used to decide, through adjudication, a normative policy issue that is still obviously a matter of unresolved political debate. Footnote 77

The WTO jurisprudence has adopted in some cases the evolutionary method of interpretation. Footnote 78 In United States—Section 110(5) of the US Copyright Act , reference was made to the WIPO Copyright Treaty (WCT) adopted in 1996, 2 years after the TRIPS Agreement. The panel stated that the WCT should be viewed as “relevant to seek contextual guidance ... when developing interpretations that avoid conflicts within the overall multilateral copyright framework …” Footnote 79 Although it noted that the statement concerning WCT’s Article 10 adopted by the signatory parties did not fall under the Vienna Convention rules on a subsequent agreement on the same matter or subsequent practice, the recourse to a post-TRIPS treaty to interpret a provision of the TRIPS Agreement constitutes a troubling precedent as long as it may lead to interpretations unduly expanding the Agreement’s obligations. This is particularly the case in the light of technological developments and the increase of the level of protection beyond the standards of the TRIPS Agreement resulting from free trade agreements. Footnote 80

It is also worth noting that article 71 of the TRIPS Agreement specifically provides for the TRIPS Council to review the Agreement “in the light of any relevant new developments, which might warrant modification or amendment of this Agreement,” thereby suggesting that any further ‘developments’ in intellectual property law need to be incorporated on the basis of WTO members’ consensus, rather than via interpretation.

4.3 Context

In accordance with Article 31 of the VCLT, the terms in a treaty need to be considered taking their context into account. The preambles of WTO agreements have often been considered as the relevant context for the interpretation of particular provisions. Footnote 81 In India–Patents (US) , the Appellate Body referred to the Preamble of the TRIPS Agreement for the interpretation of Article 70.8(a): “The Panel’s interpretation here is consistent with the object and purpose of the TRIPS Agreement.” According to the Appellate Body, the object and purpose of the Agreement is, inter alia , “the need to promote effective and adequate protection of intellectual property rights.” Footnote 82 References to the preamble were also made in China—Intellectual Property Rights . Footnote 83 The Preamble of the Agreement on Technical Barriers to Trade was largely invoked as well by the panel in Australia—Tobacco Plain Packaging . Footnote 84

The appropriate choice of treaty provisions that provide the context for interpreting other provisions is crucial. One example is the interpretation of Article 27.1 in fine . As noted above, the US initiated a case against Brazil arguing that Article 68 of the Brazilian patent law, which authorizes the government to grant a compulsory license if the patent owner fails to work the patent, was inconsistent with Article 27.1 in fine of the TRIPS Agreement. In accordance to this provisions, “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.” Key to addressing the US argument is identifying the context for the interpretation of this phrase in Article 27.1. In fact, this text incorporated a compromise reached, at the final stages of the negotiation of the Agreement, between developed and developing countries since the latter wanted to preserve the possibility of granting compulsory licenses for the lack or insufficient working of a patent. Footnote 85

Developing countries expressed the concern that Article 27.1 could be read in a way that restricts the use of compulsory licenses, for instance, on the grounds of lack of working, as specifically provided for under Article 5A of the Paris Convention for the Protection of Industrial Property. In fact, the “patent rights” referred to in Article 27.1 are defined in Article 28.1, which only requires the granting of negative rights with regard to the exploitation of the invention, that is, the right to prevent third parties from using (without authorization) the patented invention. Hence, a proper interpretation of Article 27.1 read in conjunction with Article 28.1, based on the rules of the Vienna Convention, indicates that the products mentioned in Article 27.1 are infringing products, not the products of the patent owner itself, since patents only confer exclusionary and not positive rights. In other words, Article 27.1—if read in the context of Article 28 of the Agreement—forbids discrimination between infringing imported and infringing locally-made products, but it does not prevent the establishment of differential obligations with regard to non-infringing imported and locally-made products (i.e., products made or imported by the patent owner or with his/her consent). Hence, it does not outlaw compulsory licenses for lack of working.

The principle of “effective interpretation” (or “l’effet utile”) requires that a treaty must be interpreted in such a way as to give meaning and effect to all the terms of the treaty. This is certainly possible with respect to Article 27.1 in fine . This non-discrimination clause may apply, for instance, to a case in which the rights enjoyed by patent owners differ depending on whether the alleged infringing goods have been locally produced or imported. For instance, Section 337 of the U.S. Tariff Act was found inconsistent with the GATT in United States—Section 337 of the Tariff Act of 1930 , since it accorded less favorable treatment to imported products challenged as infringing on US patents than the treatment accorded to similarly challenged products of United States origin. Footnote 86

Another example in which the correct identification of the context for a provision may have decisive effects relates to Article 39.3, which has been interpreted by the US and the European Commission as requiring the grant of exclusive rights (‘data exclusivity’) with respect to test data for pharmaceuticals and agrochemical products. This interpretation is clearly inviable in light of Article 39.1 which provides an essential contextual element and only requires protection against unfair commercial practices, which does not entail such exclusive rights. Footnote 87

In engaging in the difficult task of clarifying the meaning of ‘unjustifiably’ in Article 20 of the TRIPS Agreement, the panel in Australia—Tobacco Plain Packaging elaborated on the context of that provision. It specifically alluded to the Preamble and Articles 7 and 8 of the Agreement:

We first note that the first recital of the preamble to the TRIPS Agreement expresses a key objective of the TRIPS Agreement, namely to “reduce distortions and impediments to international trade” and takes into account the need, on one hand, “to promote effective and adequate protection of intellectual property rights” and, on the other, “to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade” (para. 7.2398).

We also consider that Article 7 entitled “Objectives” and Article 8 entitled “Principles” provide relevant context (para 7.2399).

Articles 7 and 8, together with the preamble of the TRIPS Agreement, set out general goals and principles underlying the TRIPS Agreement, which are to be borne in mind when specific provisions of the Agreement are being interpreted in their context and in light of the object and purpose of the Agreement. As the panel in Canada – Pharmaceutical Patents observed in interpreting the terms of Article 30 of the TRIPS Agreement, “[b]oth the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes” (para. 7.2402).

The panel further elaborated on the ‘balance’ suggested by Articles 7 and 8.1 of the TRIPS Agreement and, in particular, on the fact that the Agreement did not intend to prevent WTO members from adopting measures to protect public interests, such as public health. It stated:

Article 7 reflects the intention of establishing and maintaining a balance between the societal objectives mentioned therein. Article 8.1, for its part, makes clear that the provisions of the TRIPS Agreement are not intended to prevent the adoption, by Members, of laws and regulations pursuing certain legitimate objectives, specifically, measures “necessary to protect public health and nutrition” and “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 the Agreement (para. 7.2403).

Article 8 offers, in our view, useful contextual guidance for the interpretation of the term “unjustifiably” in Article 20. Specifically, the principles reflected in Article 8.1 express the intention of drafters of the TRIPS Agreement to preserve the ability for WTO Members to pursue certain legitimate societal interests, at the same time as it confirms their recognition that certain measures adopted by WTO Members for such purposes may have an impact on IP rights, and requires that such measures be “consistent with the provisions of the [TRIPS] Agreement” (para. 7.2404).

The specific objectives expressly identified in Article 8.1 do not, in our view, necessarily exhaust the scope of what may constitute a valid basis for the “justifiability” of encumbrances on the use of trademarks under Article 20. However, their identification in Article 8.1 may shed light on the types of recognized “societal interests” that may provide a basis for the justification of measures under the specific terms of Article 20, and unquestionably identify public health as such a recognized societal interest (para. 7.2406).

In summary, while the Preamble and Articles 7 and 8 of the TRIPS Agreement provide the context for the interpretation of all its provisions, as suggested by the examples above, the careful choice of other specific provisions to examine the scope and extent of particular obligations is key to preserving the flexibilities under that agreement.

4.4 Object and Purpose

As noted, the interpretative method codified by the VCLT—as spelled out in Articles 31 and 32 of the VCLT—relies on the textual interpretation of treaty provisions. The reference, however, to the ‘object and purpose’ of the treaty as one of the elements for interpretation has been understood by some courts as leaving room to consider the ‘intention’ of the negotiating parties or to apply a teleological approach. Footnote 88 It has been noted, for instance, that the European Court of Human Rights, “has developed its own version of these rules of interpretation—a version that tracks the three traditional approaches to treaty interpretation: the textual approach, the subjective approach, and the teleological approach. Footnote 89 However, as noted by two commentators,

The consideration of object and purpose finds its limits in the ordinary meaning of the text of the treaty. It may only be used to bring one of the possible ordinary meanings of the terms to prevail and cannot establish a reading that clearly cannot be expressed with the words used in the text. Footnote 90

The quoted authors note in this regard the opinion in the Iran-US Claims Tribunal which pointed out:

Even when one is dealing with the object and purpose of a treaty, which is the most important part of the treaty’s context, the object and purpose does not constitute an element independent of that context. The object and purpose is not to be considered in isolation from the terms of the treaty; it is intrinsic to its text. It follows that, under Article 31 of the Vienna Convention, a treaty’s object and purpose is to be used only to clarify the text, not to provide independent sources of meaning that contradict the clear text. Footnote 91

In the case of the WTO agreements, adherence to the treaty text and avoiding ‘activism’ in the interpretation of their provisions is of utmost importance—as shown by recent debates on the functioning of the Appellate Body Footnote 92 —so as not to expand the Members’ obligations or create new ones, and to provide certainty to their trade relations.

Notably, under Article 4.2 of the Dispute Settlement Understanding (“DSU”), panels and the Appellate Body are mandated to ‘clarify’ the various WTO agreements, and in doing so they cannot add to or diminish the rights and obligations provided in such agreements. Moreover, Article 4.9 provides that the DSU does not prejudice a government's right to seek an ‘authoritative interpretation’ of any of those agreements from the Ministerial Conference or General Council of the WTO. Hence, the WTO attempts to introduce a difficult distinction between ‘clarification’ and ‘interpretation.’ The panels and Appellate Body reports regularly note, however, that they ‘interpret’ the provisions invoked by the members in accordance to the VLCT rules. This has indeed been the case in those disputes referring to the TRIPS Agreement. Footnote 93

However, although the literal interpretation is the basic rule of interpretation under Article 31 (1) of the VCLT as recognized in the Convention itself, in some cases the textual reading of a provision or a term thereof in its context may still leave ambiguity as to the legal meaning of a text. At this point, the identification of the ‘object and purpose’ of the treaty, conceived as part of the literal interpretation and not as a separate step, acquires particular importance. It is difficult to think of judgments that are absolutely neutral in terms of the policy objectives enshrined in the treaty.

Identifying the object and purpose of the TRIPS Agreement is different from characterizing the purpose of intellectual property rights, as the objectives pursued by governments with these rights, as well as the way of implementing them, may differ significantly, even while they comply with the standards of the Agreement and other applicable international treaties). There is no global, uniform system of intellectual property protection.

In Canada—Patent Protection for Pharmaceutical Products , the panel elaborated on the policy objective of patent laws. It stated:

The normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity … Patent laws establish a carefully defined period of market exclusivity as an inducement to innovation, and the policy of those laws cannot be achieved unless patent owners are permitted to take effective advantage of that inducement once it has been defined. Footnote 94

This view seems to suggest that obtaining ‘economic returns’ as an ‘inducement to innovation’ is what underpins patent policies. It is not consistent with the purpose of the TRIPS Agreement as reflected in Articles 7 and 8. This approach overlooks that patents, as well as other intellectual property rights, can and should be designed and implemented to achieve public rather than private interests, including the diffusion of technical knowledge, technological progress, and access to the outcomes of innovation. Footnote 95 Thus, in 1917, the US Supreme Court noted that “the primary purpose of that [patent] law is not to create private fortunes, but is to promote the progress of science and the useful arts.” Footnote 96

Articles 7 (‘Objectives’) and 8 (‘Principles’) of the TRIPS Agreement are key for the determination of the object and purpose of the Agreement, in conjunction, as discussed below, with the Doha Declaration as a subsequent agreement among the parties. Importantly, those provisions are not just hortatory provisions Footnote 97 but have been incorporated—upon the demand of developing countries during the negotiations Footnote 98 —among the prescriptive provisions of the Agreement.

In Canada–Patent Term , the Appellate Body referred to the need to interpret Article 70.1 of the Agreement as having particular regard to the object and purpose of the treaty, but it eluded an interpretation and application of Articles 7 and 8:

[W]e note that our findings in this appeal do not in any way prejudge the applicability of Article 7 or Article 8 of the TRIPS Agreement in possible future cases with respect to measures to promote the policy objectives of the WTO Members that are set out in those Articles. Those Articles still await appropriate interpretation. Footnote 99

The Panel Report in Canada—Pharmaceutical Patents dealt more specifically with the question of the ‘object and purpose’ of the TRIPS Agreement. It relied to this end on Articles 7 and 8 for that determination, but in conjunction with other provisions of the Agreement. It stated:

Article 30’s very existence amounts to a recognition that the definition of patent rights contained in Article 28 would need certain adjustments. On the other hand, the three limiting conditions attached to Article 30 testify strongly that the negotiators of the Agreement did not intend Article 30 to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement. Obviously, the exact scope of Article 30’s authority will depend on the specific meaning given to its limiting conditions. The words of those conditions must be examined with particular care on this point. Both the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes. Footnote 100

It is unclear what “other provisions of the TRIPS Agreement which indicate its object and purposes” are suggested by the panel. While there might be different perceptions about the object and purpose of the TRIPS Agreement—as the debates between developed and developing countries have shown during the negotiation and after the adoption of the TRIPS Agreement Footnote 101 —the panels and Appellate Body need to be guided by the text of the Agreement and not by the individual views of the members of those bodies.

Paragraph 5(a) of the Doha Declaration confirmed the importance of Articles 7 and 8 for the interpretation of the TRIPS Agreement:

Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.

The wording of this paragraph (“in particular”) suggests that while Articles 7 and 8 are determinant in defining the object and purpose of the Agreement, other provisions of the Agreement, as well as the preambular provisions, can also contribute to the determination of its object and purpose. Such may be the case, for instance, of Article 41.2 which states: “Procedures concerning the enforcement of intellectual property rights shall be fair and equitable …” This provision makes it clear that one purpose of the Agreement is to ensure that the enforcement of intellectual property rights (as mandated in Part III of the Agreement) is ‘fair and equitable’ to all the parties concerned, and that it does not provide undue advantages to the right holders over third parties in judicial or administrative procedures, or vice versa.

An interesting elaboration on the object and purpose of the TRIPS Agreement based on Articles 7 and 8 was undertaken by the panel in Australia—Tobacco Plain Packaging . Footnote 102 The panel largely relied on the Doha Declaration to address this issue. It noted:

We note in this respect that the Doha Declaration, adopted by Ministers on 14 November 2001, provides that, “[i]n applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles” (para. 7.2407).

While this statement was made in the specific context of a re-affirmation by Members of the flexibilities provided in the TRIPS Agreement in relation to measures taken for the protection of public health, we note that paragraph 5 of the Doha Declaration is formulated in general terms, inviting the interpreter of the TRIPS Agreement to read “each provision of the TRIPS Agreement” in the light of the object and purpose of the Agreement, as expressed in particular in its objectives and principles. As described above, Articles 7 and 8 have central relevance in establishing the objectives and principles that, according to the Doha Declaration, express the object and purpose of the TRIPS Agreement relevant to its interpretation (7.2408).

The Appellate Body essentially followed the panel’s views on this matter. It clarified, however, that the conclusions reached regarding the purpose of the TRIPS Agreement are supported by Articles 7 and 8, and that the analysis of the Doha Declaration reconfirmed the panel’s findings. It held:

The Panel also remarked that the societal interests referred to in Article 8 may provide a basis of the justification of measures under Article 20. Thus, we agree with Australia that, in any event, the reliance on the Doha Declaration was not of decisive importance for the Panel's reasoning since the Panel had reached its conclusions about the contextual relevance of Articles 7 and 8 of the TRIPS Agreement to the interpretation of Article 20 before it turned to the Doha Declaration. The Panel relied on the Doha Declaration simply to reconfirm its previous conclusions regarding the contextual relevance of Articles 7 and 8 of the TRIPS Agreement (6.658).

This analysis and the observations above show that the WTO case law has considered Articles 7 and 8, both as part of the context for interpretation and as defining elements of the object and purpose of the TRIPS Agreement. It confirms the relevance of said provisions for the interpretation of other provisions in the Agreement.

4.4.1 Legal Weight of the Doha Declaration

In order to give authority to its argument regarding the relevance of Articles 7 and 8 for the interpretation of the TRIPS Agreement’s provisions, the panel in Australia—Tobacco Plain Packaging specifically elaborated on the legal weight of the Doha Declaration. This is one of the most distinct (and welcome) contributions of this panel’s report, as it is the first time in which the normative effects of that Declaration have been considered in WTO jurisprudence.

In some WTO disputes prior to the Australia tobacco case, the issue of subsequent practices as an element for interpretation of the TRIPS provisions was very cautiously considered. Thus, in Canada—Patent Protection for Pharmaceutical Products, the panel considered comparative law in order to determine whether the interest claimed as “legitimate” by the EC was a “widely recognized policy norm.” Footnote 103 In United States—Section 110(5) of the US Copyright Act , the panel confirmed its conclusion with reference to examples of “state practice” of members of the Berne Union and WTO, but it warned that it “did not wish to express a view on whether these are sufficient to constitute ‘subsequent practice’ within the meaning of Article 31(3)(b) of the Vienna Convention.” Footnote 104 In China—Intellectual Property Rights , the panel rejected certain material submitted by China to prove a “subsequent practice” in the application of the TRIPS Agreement within the meaning of Article 31(3) of the Vienna Convention. The panel considered that it lacked “the breadth to constitute a common, consistent, discernible pattern of acts or pronouncements” and that “the content of the material does not imply agreement on the interpretation of Article 61 of the TRIPS Agreement.” Footnote 105

A key panel assertion in the referenced case against Australia is that the Doha Declaration must be considered a ‘subsequent agreement’ as defined in the VCLT. Footnote 106 In accordance with Article 31.3(a) of the VCLT, “any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions” shall be taken into account, together with the context. Footnote 107 It is worth noting that the International Law Commission adopted in its 2018 report “Draft Conclusions on Subsequent Agreements and Subsequent Practice in Relation to the Interpretation of Treaties” Footnote 108 which, in accordance with one commentator, suggests a “subtle elevation of subsequent agreement and subsequent practice,” which would thereby become an integral part of the main rule of interpretation. Footnote 109

In making reference to the Appellate Body ruling in US – Clove Cigarettes (para. 262), the panel stated:

This paragraph of the Doha Declaration may, in our view, be considered to constitute a “subsequent agreement” of WTO Members within the meaning of Article 31(3)(a) of the Vienna Convention. As the Appellate Body has clarified: Based on the text of Article 31(3)(a) of the Vienna Convention, we consider that a decision adopted by Members may qualify as a “subsequent agreement between the parties” regarding the interpretation of a covered agreement or the application of its provisions if: (i) the decision is, in a temporal sense, adopted subsequent to the relevant covered agreement; and (ii) the terms and content of the decision express an agreement between Members on the interpretation or application of a provision of WTO law (para. 7.2409).

The panel’s view rebuts the United States Trade Representative' (USTR) opinion expressed upon the conclusion of the Doha Conference that the Doha Declaration merely was a “political declaration.” Footnote 110 As noted by a commentator, “[d]istinguishing legal claims from non-legal or political claims, such as access to essential medicines, can deprive them of their status as rights and thereby serve to legitimize an unjust status quo.” Footnote 111

The panel further explored the legal status of the Doha Declaration under WTO law, noting that although being a ‘declaration,’ it was adopted by a consensus decision at the WTO Conference. The panel argued as follows:

In this instance, the instrument at issue is a “declaration,” rather than a “decision.” However, the Doha Declaration was adopted by a consensus decision of WTO Members, at the highest level, on 14 November 2001 on the occasion of the Fourth Ministerial Conference of the WTO, subsequent to the adoption of the WTO Agreement, Annex 1C of which comprises the TRIPS Agreement. The terms and contents of the decision adopting the Doha Declaration express, in our view, an agreement between Members on the approach to be followed in interpreting the provisions of the TRIPS Agreement. This agreement, rather than reflecting a particular interpretation of a specific provision of the TRIPS Agreement, confirms the manner in which “each provision” of the Agreement must be interpreted, and thus “bears specifically” on the interpretation of each provision of the TRIPS Agreement (7.2410).

This paragraph reiterates the characterization of the Doha Declaration as a ‘subsequent agreement’ under the VCLT and adds two important elements: its adoption ‘at the highest level’ and an agreement ‘on the approach’ to be followed in interpreting each provision of the Agreement. This ‘approach’ is reflected in paragraph 5(a) of the Declaration quoted above but also in the rest of the Declaration, particularly as it makes a clear case for protecting public health, a key public interest and a matter of respect and realization of human rights, in implementing the TRIPS Agreement. Footnote 112

The panel’s analysis on the Doha Declaration does not aim, however, at asserting its legal value per se but its role as a confirmation that Articles 7 and 8 of the TRIPS Agreement provide both the context and define the object and purpose of the Agreement. The panel stated in this regard:

The guidance provided by the Doha Declaration is consistent, as the Declaration itself suggests, with the applicable rules of interpretation, which require a treaty interpreter to take account of the context and object and purpose of the treaty being interpreted, and confirms in our view that Articles 7 and 8 of the TRIPS Agreement provide important context for the interpretation of Article 20 (7.2411).

The analysis of the legal status of the Doha Declaration is one of the most significant contributions by the panel in Australia—Tobacco Plain Packaging . It supported the panel’s conclusion with respect to the justifiability of the plain packaging measures adopted by that country and, hence, their consistency with Article 20 of the TRIPS Agreement. Footnote 113

5 Conclusions

The notion that the TRIPS Agreement is not a uniform law and that it allows WTO members some room to maneuver in interpreting and implementing the Agreement’s obligations is well established in the literature and numerous resolutions by UN agencies and bodies. The adoption of the Doha Declaration, and several rulings by panels and the Appellate Body, point in the same direction. An evolution is perceptible in the WTO jurisprudence on the matter. In particular, the most recent panel report in Australia—Tobacco Plain Packaging shows the explicit acceptance of the concept of TRIPS flexibilities in WTO case law and their role in preserving the required policy space to pursue public policies such as public health. This is an important development that could provide the basis for a further step in that jurisprudence: the integration of human rights law, as a component of international law, in the analysis of the obligations imposed by that Agreement and of the leeway that states should preserve for the realization of such rights. Footnote 114

The extent to which the TRIPS flexibilities can be implemented at the national level without the risk of trade retaliations depends on the way the Agreement’s provisions are interpreted by panels and the Appellate Body. Several issues need to be addressed in considering how such provisions should be interpreted, consistently with the interpretive method codified by the VCLT. While the search for the ordinary meaning of the terms used is a well-established methodology, divergences may exist with regard to whether they should be deemed as ‘static’ or ‘evolutionary.’ An evolutionary approach creates the risk of unduly expanding the obligations under the Agreement, as actively promoted by some developed countries through free trade agreements. The adequate determination of the context—beyond the Preamble and Articles 7 and 8—for interpretation of a particular provision is also important, as it may decisively influence the determination of the scope and extent of the obligation under the Agreement. Similarly, the understanding on the object and purpose of the Agreement plays an important role. The WTO jurisprudence seems to have firmly admitted that such a determination is to be based on said Articles 7 and 8.

The impact of the TRIPS Agreement on public health and, particularly, access to medicines has been one of the most sensitive issues since its adoption. This issue has been key in promoting debates and analyses on the TRIPS flexibilities (although they are also important in relation to other public interests, such as access to knowledge or food security). In this regard, the panel ruling in the case against Australia on plain packaging has confirmed the legal status of the Doha Declaration—seen by some as a merely political instrument—as a ‘decision’ taken by consensus that constitutes a ‘subsequent agreement’ among the WTO members. This is also an important development as it suggests that a pro-public health interpretation is not only tenable but also mandated, and confirms the room that governments have to confidently adopt pro-public health measures without fearing the risk of costly and burdensome litigation under the DSU.

Article 1.1 of the TRIPS Agreement makes it clear, however, that no WTO member is obliged to grant such a broader protection. See, e.g., Correa ( 2020b ), p. 21.

See, e.g., Morin and Surbeck ( 2020 ).

See, e.g., The Law Library of Congress, Global Legal Research Center ( 2016 ). Available from: https://www.loc.gov/law/help/patent-terms/patent-term-extensions-adjustments.pdf .

Shaikh ( 2016 ).

Son et al. ( 2018 ). Available from: https://doi.org/10.1186/s12992-018-0423-0 .

UNDP ( 2015b ). Available from: https://www.undp.org/content/undp/en/home/librarypage/hiv-aids/using-competition-law-to-promote-access-to-medicine.html .

Minn ( 2016 ).

Article 27.1 in fine: “…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.” See, e.g., Correa ( 2005 ). See also below.

A large number of provisions in the TRIPS Agreement uses these terms, e.g., Articles 8.2, 13, 15.5, 25.5, 26.2, 30. 31(b), 31(l), 34.2, 37, 1, 39.2(c), 41, 43.

Article 4(d) of the TRIPS Agreement.

Article 20 of the TRIPS Agreement.

Available from: https://www.who.int/medicines/areas/policy/tripshealth.pdf?ua=1 . Hereinafter, “the Doha Declaration.”

See, e.g., Velásquez et al. ( 2020 ). https://www.southcentre.int/book-by-the-south-centre-2020/#more-14014 .

Germán Velásquez ( 2013 ), p. 5. https://www.southcentre.int/wp-content/uploads/2013/05/RP47_WTO-role-in-IP-and-access-to-medicines_EN.pdf .

Emphasis added.

Paragraph 17 of the general Doha Ministerial Declaration states: “We stress the importance we attach to implementation and interpretation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines and, in this connection, are adopting a separate Declaration.” https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm .

The Council for TRIPS convened special sessions (which were held in June, August, and September of 2001) to deal with the relationship between health and TRIPS. See, e.g., the submissions made by the European Communities and their Members States on the relationship between the provisions of the TRIPS Agreement and access to medicines, IP/C/W/280 (12 June 2001); and submissions by the African Group, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand, and Venezuela on TRIPS and public health, IP/C/W/296 (29 June 2001). See also Council for TRIPS Special Discussion on Intellectual Property and Access to Medicines, IP/C/M/31 (10 July 2001).

One of the first studies on TRIPS flexibilities was published by the UNCTAD ( 1996 ). https://unctad.org/en/docs/ite1_en.pdf .

On the relationship between the TRIPS Agreement and the human right to health, see, e.g., Sellin ( 2015 ). https://link.springer.com/article/10.1007/s40802-015-0047-5#Abs1 .

See, e.g., WHO, WIPO, and WTO ( 2012 ). https://www.wipo.int/edocs/pubdocs/en/global_challenges/628/wipo_pub_628.pdf .

WHA 56.27, “Intellectual property rights, innovation and public health” (28 May 2003). Available from: https://apps.who.int/gb/archive/pdf_files/WHA56/ea56r27.pdf?ua=1 . For a list of WHO resolutions referring to intellectual property, see Germán Velásquez, Carlos M. Correa, and Vitor Ido, op. cit., pp. 73–75.

Available from: https://www.who.int/phi/implementation/phi_globstat_action/en/ . See, Germán Velásquez ( 2019 ).

See, https://www.ohchr.org/EN/Issues/HIV/Pages/Documents.aspx .

Resolution adopted by the General Assembly on 25 September United Nations General Assembly ( 2015 ), A/RES/70/1. https://www.un.org/ga/search/view_doc.asp?symbol=A/RES/70/1&Lang=E .

WIPO ( 2010 ), p. 11. https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=142068 .

See, e.g., Correa ( 2020a ).

European Commission ( 2020 ). https://trade.ec.europa.eu/doclib/docs/2020/january/tradoc_158561.pdf .

The ‘scope’ of a right delimits the boundaries and defines its content; the ‘extent’ refers to the legal limitations on the exercise of the right.

WIPO ( 2010 ), op. cit., p. 12.

Ruse-Khan and Puutio ( 2017 ), p. 10. Available from: https://www.unescap.org/sites/default/files/IPR%20Handbook.pdf .

See, e.g., Geiger et al. ( 2013 ). https://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1041&context=research .

Eger and Scheufen ( 2012 ). https://www.researchgate.net/publication/280043122_The_past_and_the_future_of_copyright_law_technological_change_and_beyond .

Available from: https://www.wipo.int/ip-development/en/agenda/flexibilities/database.html .

See, e.g., Germán Velásquez, Carlos M. Correa, and Vitor Ido, op. cit.

See, e.g. , Medicines Law & Policy, The TRIPS Flexibilities Database. Available from: http://tripsflexibilities.medicineslawandpolicy.org/ . See also, The Graduate Institute Geneva, Knowledge Portal on Innovation and Access to Medicines. https://www.knowledgeportalia.org/ .

According to this section, “[a] person shall be entitled to a patent unless the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” This rule was amended by the Leahy-Smith America Invents Act (2011). http://www.wipo.int/edocs/lexdocs/laws/en/us/us219en.pdf .

Reid ( 2019 ). https://digitalcommons.law.ou.edu/cgi/viewcontent.cgi?article=1121&context=ailr .

See, Document IP/Q3/USA/1 (1 May 1998). As a result of the relative novelty requirement of the US, several patents were granted to researchers or firms relating to or consisting of genetic materials or traditional knowledge acquired in developing countries. See, e.g., Mgbeoji ( 2006 ). https://books.google.fr/books?id=q4MIoBKy88MC&pg=PA121&lpg=PA121&dq=biopiracy+us+patents&source=bl&ots=-ZBMOhXLLn&sig=ACfU3U0DslCI-lxiwQuSmN-jeuuC-fafLQ&hl=en&sa=X&ved=2ahUKEwitsrmu8N_pAhUSx4UKHe1_DHYQ6AEwEnoECAkQAQ#v=onepage&q=biopiracy%20us%20patents&f=false .

eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), https://www.supremecourt.gov/opinions/05pdf/05-130.pdf .

For the use of TRIPS flexibilities in relation to plant patents, see, e.g., Correa ( 2014 ). https://www.southcentre.int/wp-content/uploads/2014/11/RP55_Patent-Protection-for-Plants_EN.pdf . See also, Prifti ( 2015 ).

Available from: https://www.europarl.europa.eu/doceo/document/TA-8-2017-0061_EN.html .

Available from: https://www.parl.ca/DocumentViewer/en/43-1/bill/C-13/royal-assent .

Fuchs ( 2020 ). https://www.twobirds.com/en/news/articles/2020/germany/covid-19-new-german-legislation-to-fight-pandemic-may-affect-granted-patents .

See, e.g., Correa ( 2011a ).

See, DS 160 Panel Report United States — Section 110(5) of US Copyright Act (2010); Appellate Body report DS 176 United States — Section 211 Omnibus Appropriations Act of 1998 (2002).

See, DS 174 Panel Report European Communities — Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs (2005); DS 290 Panel Report , European Communities — Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs (2005).

See, Report of the WTO Panel, Canada—Patent Protection for Pharmaceutical Products , WT/DS114/R; Report of the Appellate Body, Canada—Term of Patent Protection , WT/DS170/AB/R (2000).

See Panel Report in DS435, 441, 458, 467, Australia — Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging (2018) (hereinafter, “ Australia—Tobacco Plain Packaging ”). The panel report was appealed by Honduras and the Dominican Republic (see, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds441_e.htm ). The report of the Appellate Body was issued on June 9, 2020 (WT/DS435/AB/R WT/DS441/AB/R). On the situation of the Appellate Body as a result of the US blockade to the appointment of new members, see, e.g., Danish and Aileen Kwa ( 2019 ). Available from: https://www.southcentre.int/wp-content/uploads/2019/12/PB69_Crisis-at-the-WTO%E2%80%99s-Appellate-Body-AB-Why-the-AB-is-Important-for-Developing-Members_EN-1.pdf .

A violation to the TRIPS Agreement was incidentally invoked in the Indonesia-Autos case in relation to the protection of trademarks. The panel, however, found that the United States had not demonstrated that Indonesia was in breach of its TRIPS obligations (Report of the WTO Panel, Indonesia—Certain Measures Affecting The Automobile Industry, WT/DS 54/R, WT/DS 55/R, WT/DS 59/R, WT/DS 64/R (1998), para. 11.1–11.43).

See Report of the Appellate Body, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (1998) and Report of the WTO Panel, India—Patent Protection for Pharmaceutical and Agricultural Chemical Products , WT/DS79/R (1998) (hereinafter, “ India—Patents (US) ”).

See Panel Report in lDS362, China—Measures Affecting the Protection and Enforcement of Intellectual Property Rights (2009) (hereinafter, “ China—Intellectual Property Rights ”).

Brazil requested the US consultations with regard to provisions of US legislation that limits the right to use or sell any federally-owned invention only to a licensee that agrees that any products embodying the invention or produced through the use of the invention will be manufactured substantially in the United States. See, United States—US Patents Code , WT/DS224/1 (7 February 2001). In DS 408, India complained about border measures imposed on the transit of medicines. See, European Union and a Member State—Seizure of Generic Drugs in Transit ( 2010 ) . These cases were not ultimately pursued.

Argentina—Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemicals , WT/DS171 (6 May 1999) and Argentina-Certain Measures on the Protection of Patents and Test Data , WT/DS196 (30 May 2000).

See, Notification of Mutually Agreed Solution According to the Conditions Set Forth in the Agreement (IP/D/18/Add.1, IP/D/22/Add.1).

See, Brazil—Measures Affecting Patent Protection , Request for the Establishment of a Panel by the United States , WT/DS199/3 (9 January 2001).

Brazil—Measures Affecting Patent Protection, Notification of Mutually Agreed Solution , WT/DS199/4, G/L/454, IP/D/23/Add.1 (19 July 2001).

See, China—Intellectual Property Rights , para. 7.484, 7.493, 7.597, and 7.678.

Idem, para. 7.199.

Para 7.602.

Australia—Tobacco Plain Packaging , para. 7.100.

Idem, para. 7.2408.

Idem, para. 7.2391 and 2387.

Appellate Body Report, op. cit., para. 6.697.

See, e.g., Flowers ( 2019 ), pp. 90–104. See also, Howse ( 2000 ). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1747-1796.2000.tb00139.x .

Para. 7.19.

Para. 6.185.

See , the Preamble to the TRIPS Agreement, fourth paragraph.

Panel Report, lDS362, China—Measures Affecting the Protection and Enforcement of Intellectual Property Rights , op. cit., para 7.247. See also, para. 7.135. See also, para. 7.247, 7.135, 7.241, and 7.530; and Australia—Tobacco Plain Packaging , footnote 4472.

See, e.g., Okediji ( 2017 ).

Rodrigues Jr. ( 2012 ). https://www.researchgate.net/publication/288719106_The_general_exception_clauses_of_the_TRIPS_agreement_Promoting_sustainable_development .

See, e.g., the elaboration DS 160 Panel Report, United States — Section 110(5) of US Copyright Act (2010); Appellate Body report DS 176, United States — Section 211 Omnibus Appropriations Act of 1998 (2002).

Appellate Body Report in EC – Chicken Cuts , para. 175, quoting Appellate Body Report in US – Softwood Lumber IV , para. 59, and referring to Appellate Body Reports in US – Offset Act (Byrd Amendment) , para. 248, and US – Gambling , para. 166, and quoting McNair ( 1961 ), p. 365.

Para 7.558.

Dörr and Schmalenbach ( 2012 ). Available from: https://link.springer.com/chapter/10.1007%2F978-3-642-19291-3_34 , para. 58 (emphasis in the original), para. 23 (emphasis in the original). On the importance of the principle of “contemporaneity” in treaty interpretation, see also, Brownlie ( 1998 ), p. 627.

Canada—Patent Protection for Pharmaceutical Products , para. 7.82.

In United States – Import Prohibition of Certain Shrimp and Shrimp Products , WT/DS58/AB/R, para. 130 (1998), the Appellate Body held that certain terms in the WTO Agreements are not “static” but evolutionary, in relation to the term “exhaustible natural resources” as it appears in GATT Article XX(g) (para. 127, 130).

United States—Section 110(5) of the U.S. Copyright Act , para. 6.70.

See, e.g., Ruse-Khan ( 2017 ) (forthcoming, Netherlands Yearbook of International Law); Max Planck Institute for Innovation & Competition Research Paper, No. 18-02; University of Cambridge Faculty of Law Research Paper, No. 3/2018. https://ssrn.com/abstract=3082718 .

See, e.g. Carlos Correa, op. cit., 2020, Chapter 1.

See, https://www.wto.org/english/docs_e/legal_e/27-trips_02_e.htm .

See, para. 7.135.

See, e.g., para. 7.2398.

UNCTAD and ICTSD ( 2005 ), p. 467. https://unctad.org/en/PublicationsLibrary/ictsd2005d1_en.pdf .

See, e.g., Haedicke ( 2000 ), p. 1774.

See, e.g., Correa ( 2011b ).

Linderfalk ( 2007 ), p. 205. https://www.corteidh.or.cr/tablas/r32592.pdf .

See, e.g., Dothan ( 2019 ), p. 765; iCourts Working Paper Series, No. 141. https://ssrn.com/abstract=3241331 .

Oliver Dörr and Kirsten Schmalenbach, op. cit., para 58.

Iran-United States Claims Tribunal, Federal Reserve Bank of New York v. Bank Markazi (n 19) para 58.

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Motion Picture Patents Co. v. Universal Film Co. [1917] 243 U. S. 502 .

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See, Carlos Correa, op. cit., 2020, pp. 83–95.

Appellate Body Report, Canada – Term of Patent Protection , WT/DS170/AB/R (18 September 2000), para. 101. https://www.wto.org/english/tratop_e/dispu_e/170abr_e.pdf .

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Shadlen ( 2004 ). Available from: https://link.springer.com/article/10.1007%2FBF02686283 .

Romero ( 2020b ). Available from: https://www.southcentre.int/policy-brief-79-june-2020/ .

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Para. 7.581.

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Correa, C.M. (2022). Interpreting the Flexibilities Under the TRIPS Agreement. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-030-83114-1_1

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WTO ANALYTICAL INDEX TRIPS Agreement – Article 8 (Jurisprudence) 1 1 ARTICLE 8

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WTO ANALYTICAL INDEX TRIPS Agreement – Article 8 (Jurisprudence)

1 ARTICLE 8 ...... 1 1.1 Text of Article 8 ...... 1 1.2 General ...... 1 1.3 Article 8.1 ...... 2 1.4 Relationship with other provisions of the TRIPS Agreement ...... 2 1.4.1 Article 20 ...... 2 1.4.2 Article 30 ...... 2

1 ARTICLE 8

1.1 Text of Article 8

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.

1.2 General

1. The Panel in Australia – Tobacco Plain Packaging, in considering the types of reasons that may sufficiently support the application of special requirements not to be considered to "unjustifiably" encumber the use of a trademark in the course of trade within the meaning of Article 20, noted that:

"Articles 7 and 8, together with the preamble of the TRIPS Agreement, set out general goals and principles underlying the TRIPS Agreement, which are to be borne in mind when specific provisions of the Agreement are being interpreted in their context and in light of the object and purpose of the Agreement."1

2. As regards Article 8 specifically, the same Panel observed that:

"Article 8.1 … makes clear that the provisions of the TRIPS Agreement are not intended to prevent the adoption, by Members, of laws and regulations pursuing certain legitimate objectives, specifically, measures 'necessary to protect public health and nutrition' and '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 the Agreement.

Article 8 offers, in our view, useful contextual guidance for the interpretation of the term 'unjustifiably' in Article 20. Specifically, the principles reflected in Article 8.1 express the intention of drafters of the TRIPS Agreement to preserve the ability for WTO Members to pursue certain legitimate societal interests, at the same time as it confirms their recognition that certain measures adopted by WTO Members for such

1 Panel Reports, Australia – Tobacco Plain Packaging, para. 7.2402.

purposes may have an impact on IP rights, and requires that such measures be 'consistent with the provisions of the [TRIPS] Agreement'."2

3. The same Panel took the view that paragraph 5 of the Doha Declaration on the TRIPS Agreement and Public Health may be considered to constitute a "subsequent agreement" of WTO Members within the meaning of Article 31(3)(a) of the Vienna Convention. The Panel noted that:

"The guidance provided by the Doha Declaration is consistent, as the Declaration itself suggests, with the applicable rules of interpretation, which require a treaty interpreter to take account of the context and object and purpose of the treaty being interpreted, and confirms in our view that Articles 7 and 8 of the TRIPS Agreement provide important context for the interpretation of Article 20."3

1.3 Article 8.1

4. In EC – Trademarks and Geographical Indications, in the course of explaining why the TRIPS Agreement did not contain a general exceptions provision, the Panel referred to the principles of the Agreement set out in Article 8.1:

"These principles reflect the fact that the TRIPS Agreement does not generally provide for the grant of positive rights to exploit or use certain subject matter, but rather provides for the grant of negative rights to prevent certain acts. This fundamental feature of intellectual property protection inherently grants Members freedom to pursue legitimate public policy objectives since many measures to attain those public policy objectives lie outside the scope of intellectual property rights and do not require an exception under the TRIPS Agreement."4

1.4 Relationship with other provisions of the TRIPS Agreement

1.4.1 Article 20

5. The Panel in Australia – Tobacco Plain Packaging, in considering the types of reasons that may sufficiently support the application of special requirements not to be considered to "unjustifiably" encumber the use of a trademark in the course of trade within the meaning of Article 20, noted that:

"The specific objectives expressly identified in Article 8.1 do not, in our view, necessarily exhaust the scope of what may constitute a valid basis for the 'justifiability' of encumbrances on the use of trademarks under Article 20. However, their identification in Article 8.1 may shed light on the types of recognized 'societal interests' that may provide a basis for the justification of measures under the specific terms of Article 20, and unquestionably identify public health as such a recognized societal interest."5

1.4.2 Article 30

6. The Panel in Canada – Pharmaceutical Patents considered both the systemic importance of Article 30 within the TRIPS Agreement and the extent to which other provisions of the Agreement can impart meaning to Article 30:

"In the Panel's view, Article 30's very existence amounts to a recognition that the definition of patent rights contained in Article 28 would need certain adjustments. On the other hand, the three limiting conditions attached to Article 30 testify strongly that the negotiators of the Agreement did not intend Article 30 to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement. Obviously, the exact scope of Article 30's authority will depend on the specific meaning given to

2 Panel Reports, Australia – Tobacco Plain Packaging, paras. 7.2403 – 7.2404. 3 Panel Reports, Australia – Tobacco Plain Packaging, para. 7.2411. 4 Panel Reports, EC – Trademarks and Geographical Indications (US), para. 7.210, and (Australia), para. 7.246. 5 Panel Reports, Australia – Tobacco Plain Packaging, para. 7.2406. See also paras. 1 to 3 above.

its limiting conditions. The words of those conditions must be examined with particular care on this point. Both the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes."6

Current as of: June 2021

6 Panel Report, Canada – Pharmaceutical Patents, para. 7.26.

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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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Articles 7 and 8 as the basis for interpretation of the TRIPS Agreement

2020, South Centre Policy Brief 79

Articles 7 and 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) play a central role in assuring the members of the World Trade Organization (WTO) the right to implement public health measures. The Doha Declaration on the TRIPS Agreement and Public Health is also an important element for the interpretation of any provision of the TRIPS Agreement that may have public health implications. The most recent and prominent example of the use of articles 7 and 8 for interpretation in WTO law can be found in the WTO Panel decision of 2018 on the Australia Tobacco Plain Packaging dispute.

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The limited role the objectives and principles of the TRIPS Agreement (Articles 7 and 8) have played so far in the interpretation and implementation of its substantive provisions has often been criticised. The WTO Panel and Appellate Body Reports in the “Australia - Plain Packaging” dispute are likely to change this situation for the future, as for the first time the WTO dispute settlement bodies fully engage with Articles 7 and 8 of TRIPS to interpret Article 20 relative to the use of trademarks. It is indeed the reliance on these two provisions that allows the Panel and the Appellate Body to conclude that there are legitimate reasons for which Members may encumber trademark use. The awakening of these two provisions that have long remained dormant in the Agreement could have a fundamental impact in offering the possibility of a more flexible reading of TRIPS. It could indeed secure the adaptability of intellectual property rights to the evolution of economic, technological and social circumstances by guaranteeing a more balanced interpretation of the limitations and exceptions included in the Agreement, as advocated for example several years ago by a group of international IP scholars in the “Declaration on a balanced interpretation of the three-step test”. Furthermore, the use of these two provisions could serve as a gateway for the taking into account ethical imperatives supported by international human rights in the interpretation of the TRIPS norms. If such a reading has been advocated in the past, the “Plain Packaging”- Reports might lead in the future to a more frequent and welcomed raising of human rights arguments in the context of international trade law.

Andrew D Mitchell , Tania Voon

TRIPS raises an array of complex questions and its implications for development, trade, and competition are dij cult to identify in the abstract. On the one hand, it risks favouring IP owners, traditionally residing in developed countries, at the expense of vigorous competition and open trade. On the other hand, as the scope of IP expands (for example in the context of GIs), it offers potential beneC ts to at least some developing countries. In addition, it provides developing country Members with the possibility of cross-retaliation as an effective means of inducing compliance of other Members with their WTO obligations following adverse rulings in WTO dispute settlement. J e Members’ ultimate response to the public health problems of developing countries (especially those with limited pharmaceutical manufacturing capacity) is also a significant achievement, although this would be best consolidated through the passing of the formal amendment to TRIPS and the use of the available flexibilities in practice. Moving beyond the first decade of TRIPS, and even beyond Doha, WTO Members may need to reinvigorate discussions on areas of disagreement such as non-violation complaints, exhaustion, and anti-competitive practices. At the same time, they must recognize that TRIPS is not operating in a vacuum. Especially in the absence of progress under TRIPS from the perspective of all Members, IP laws including those relevant to international trade will continue to advance outside the WTO. This is already evident in the work of WIPO and several FTAs, most o[ en in the direction of strengthening IP rights, which may upset the balance achieved in TRIPS (if indeed it is regarded as having struck an appropriate balance to begin with). On the opposite side, UN calls for greater appreciation of human rights in TRIPS and its application should remind Members of the need to consider the wider ramifications of stronger IP protection in the longer term. While many debated the propriety of including TRIPS in the WTO to begin with, it need not be a one-sided document in future.

Information & Communications Technology Law

Jae Sundaram

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Plain packaging of cigarettes as a way of reducing tobacco consumption and its related health costs and effects raises a number of international trade law issues. The plain packaging measures adopted in Australia impose strict format requirements on word trademarks (such as Marlboro or Camel) and ban the use of figurative marks (colors, logos, etc.). As a result, questions have been raised as to plain packaging’s compatibility with the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). WTO members can validly take measures to protect and promote public health, but in doing so they must comply with the WTO agreements. In order to determine compliance, a proper method to interpret applicable WTO rules is indispensable for the stability and predictability of the world trading system. In this Article, the authors consider the proper interpretation of the TRIPS Agreement as it applies to plain packaging regulations using the Vienna Convention on the Law of Treaties (VCLT). The VCLT has been adopted several times in WTO disputes as a set of interpretive rules. The authors argue that the interpretation of the TRIPS Agreement in the cases filed in 2012 against Australia by a number of developing countries after Australia’s adoption of the plain packaging legislation is likely to impact future cases involving the TRIPS Agreement and specifically the method and approach to be used to interpret it. As such, the cases will likely impact other public health issues (beyond tobacco use) and the interpretation of the TRIPS Agreement in several other contexts. The two major issues discussed in this Article are (a) Article 20 of the TRIPS Agreement, which prohibits certain unjustified encumbrances on the use of trademarks, and (b) the debate about the nature of trademark owners’ rights in the TRIPS Agreement. The latter issue has been referred to as the “right to use” debate—namely, whether trademark owners have a right to use trademarks protected under the TRIPS Agreement. The authors contend that the issue is better seen as a debate over the nature and scope of trademark owners’ rights and interests that the TRIPS Agreement seeks to protect. Specifically, the Article argues that the fact that the principal rights of trademark owners under the TRIPS Agreement are rights to exclude others from using their mark (or “negative rights”) is not determinative of the issue but rather should inform the interpretation of Article 20 in light of the TRIPS Agreement’s object and purpose.

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Patent protection for pharmaceutical products as mandated in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) represents a potentially signicant obstacle to public health measures, particularly for developing countries seeking to import medicines to deal with serious public health concerns, such as the HIV/AIDS crisis. Since 2001, WTO members have acknowledged this tension while working slowly towards a formal amendment of WTO rules that would facilitate compulsory licensing of pharmaceuticals for the benefit of least-developed country (LDC) members, as well as other members lacking sufficient manufacturing capacity to use the existing flexibilities in the TRIPS Agreement in respect of public health. As the first shipment of drugs from Canada to Rwanda under the new arrangements has recently taken place (in September 2008), we take opportunity to reflect on the steps taken to date within the WTO to resolve the patent/public health tension. In section 2, we explain why WTO members needed to reform the TRIPS Agreement in order to improve access to medicines for public health reasons, before turning in section 3 to the temporary solution reached in the form of a waiver of certain TRIPS obligations. In section 4 we then consider the more permanent solution of a formal amendment that is envisaged for the future. This chapter then turns in section 5 to consider how the waiver remains underutilized, suggesting that members need to re-evaluate their commitment to affordable medicines and test the workability of the waiver before making it permanent. Finally, in section 6 we examine the additional limited exceptions to patent protection granted in the waiver for bilateral free trade agreements and regional patent systems. However, we conclude that the potential of this use of the waiver is also not being realized.

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8 Unique Things to Do in Toronto

Published : September 05, 2024

AAA Travel Editor, WA

Table of contents.

• St. Lawrence Market
• Hockey Hall of Fame
• Distillery Historic District
• Bata Shoe Museum
• Graffiti Alley
• Allan Gardens Conservatory
• The Monkey's Paw

Plan Your Trip to Toronto with AAA

Toronto is brimming with activities and culture, along with scenic natural beauty that can be explored in every season. From museums to boutique shops, cultural landmarks and exciting modern attractions, there are endless Toronto unique things to see and do on your vacation.

With so many different types of options, it can be difficult to find the best attractions that interest you. This guide will help you discover 8 unique things to do in Toronto to make your next vacation truly unforgettable.

1. St. Lawrence Market

• Address: 93 Front St E, Toronto, ON

• Best for: Food and crafts, historical sights

Located in Toronto’s historical city hall, the St. Lawrence Market has been operating since 1803 and continues to provide visitors with incredible food, crafts and much more.

On the first floor, you have access to over 50 food vendors serving a variety of local and international flavors. Be sure to bring some cash though, as some vendors don’t accept cards.

On the upper level, you’ll find a gallery devoted to local art, history and other unique artifacts. Plus, there’s a local farmer’s market early on Saturdays, along with an antiques market on Sundays, among other rotating events and seasonal attractions.

2. Hockey Hall of Fame

• Address: 30 Yonge St, Toronto, ON

• Best for: Historical, cultural

Hockey is the undisputed sport of Canada and the Hockey Hall of Fame is a great way to explore the nation's pride and culture during your Toronto vacation.

Located inside the historical Bank of Montreal building, this museum features artifacts like the original Stanley Cup plus important items from the NHL’s most famous players and games.

There’s also a gift shop along with interactive exhibits to help you understand the sport better. Whether you’re a huge fan of the game or are entirely new to it, this is an entirely Canadian experience that’s one of the best unique things to visit in Toronto today.

3. Distillery Historic District

• Address: 55 Mill St, Toronto, ON

• Best for: Outdoor, cultural, food, drinks and art events

Named after the historical distillery that once occupied the area's sprawling buildings, the Distillery Historic District is one of Toronto’s most exciting and chic places to stroll and experience the youthful culture of the city.

The cobblestone streets are pedestrian only, making this a wonderful place to simply relax and take in all the sights. Aside from the Victorian-era architecture, you’ll also find an eclectic mix of bars, cafés and pop-up museums and art installations by local creators.

You could spend an hour here or stay for the whole evening as there’s always something exciting and new happening. Plus, during Christmas and other holidays, the area is often complete with festive markets and lighting, making it a must-visit attraction in Toronto during your stay.

4. Bata Shoe Museum

• Address: 327 Bloom St W, Toronto, ON

• Best for: History enthusiasts, fashion enthusasts

As their tagline says, “for every shoe there is a story,” and the Bata Shoe Museum proves this spectacularly.

Here, you can view countless artfully designed and culturally significant shoes from around the world. With over 20,000 shoes, some dating back nearly a thousand years, you can see everything from:

• 16th century Italian high-heels

• Samurai shoes

• Iconic celebrity shoes worn by Elvis, Elton John and Queen Victoria

With a focus on both the art and design of the shoes, along with interesting stories about their cultural relevance, this is one of the top unique things to see in Toronto today.

5. Graffiti Alley

• Address: 513 Queen St W, Toronto, ON

• Best for: Outdoor, cultural, art

Located right near the iconic Fashion District in downtown Toronto, Graffiti Alley is an exciting side street featuring historical and modern graffiti by Canada’s most renowned artists.

Some of the murals are large and sprawling, while others are so tiny you could easily miss them. While some notable works have been maintained over the years, Graffiti Alley changes constantly making it a great place to take a truly unique photo.

Once you’re done exploring the art, you can walk into the Fashion District and enjoy some great cafés and boutique shops to complete your day.

6. Casa Loma

• Address: 1 Austin Terrace, Toronto, ON

Located in midtown, Casa Loma is one of the city’s most unique buildings with its towering Gothic design and fairy tale aesthetics.

This large castle was designed over a hundred years ago by a local financier and the project went so over budget that it eventually bankrupted him. Today, you can stop by to explore the interior museum or walk along the gorgeous gardens. Even without going inside, it’s worth stopping by for a quick photo and view of this gorgeous, yet slightly out of place, historical structure.

7. Allan Gardens Conservatory

• Address: 160 Gerrard St E, Toronto, ON

• Best for: Indoor and outdoor, historical, sightseeing

Designed in 1910, the Allan Gardens Conservatory is a Victorian garden featuring a gorgeous mix of plants and perfectly manicured gardens.

This is a great place to stroll and unwind away from the city life and find somewhere more serene. Here you can walk through the blooming gardens or relax on a bench and enjoy some local coffee while taking in the views.

With six greenhouses, ponds with turtles and large playgrounds for children, this is a great attraction for families, couples and anyone looking for unique attractions in Toronto.

8. The Monkey's Paw

• Address: 1067 Bloom St W, Toronto, ON M6h 1M5

• Best for: Cultural, shopping

The Monkey’s Paw is one of Toronto’s most eccentric and beloved bookstores and it features a number of rare and unique books for all tastes.

Come in to browse the unique collection and try your luck with the used book vending machine for a great souvenir. The collection is always changing and you’ll likely find something that’s perfect for you in this exciting vintage shop.

Join the over a million people who are AAA members and start planning your trip to Toronto today. Dream up the perfect trip and use your membership to get the best discounts on hotels , rental cars and entertainment tickets.

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Why Trump’s Arlington Debacle Is So Serious

The former president violated one of America’s most sacred places.

Produced by ElevenLabs and News Over Audio (NOA) using AI narration.

This article was featured in the One Story to Read Today newsletter. Sign up for it here .

The section of Arlington National Cemetery that Donald Trump visited on Monday is both the liveliest and the most achingly sad part of the grand military graveyard, set aside for veterans of the wars in Iraq and Afghanistan. In Section 60, young widows can be seen using clippers and scissors to groom the grass around their husbands’ tombstones as lots of children run about.

Karen Meredith knows the saddest acre in America only too well. The California resident’s son, First Lieutenant Kenneth Ballard, was the fourth generation of her family to serve as an Army officer. He was killed in Najaf, Iraq, in 2004, and laid to rest in Section 60. She puts flowers on his gravesite every Memorial Day. “It’s not a number, not a headstone,” she told me. “He was my only child.”

The sections of Arlington holding Civil War and World War I dead have a lonely and austere beauty. Not Section 60, where the atmosphere is sanctified but not somber—too many kids, Meredith recalled from her visits to her son’s burial site. “We laugh, we pop champagne. I have met men who served under him, and they speak of him with such respect. And to think that this man”—she was referring to Trump—“came here and put his thumb up—”

She fell silent for a moment on the telephone, taking a gulp of air. “I’m trying not to cry.”

For Trump, defiling what is sacred in our civic culture borders on a pastime. Peacefully transferring power to the next president, treating political adversaries with at least rudimentary grace, honoring those soldiers wounded and disfigured in service of our country—Trump long ago walked roughshod over all these norms. Before he tried to overturn a national election, he mocked his opponents in the crudest terms and demeaned dead soldiers as “suckers.”

Read: Trump calls Americans killed in war “suckers” and “losers”

But the former president outdid himself this week, when he attended a wreath-laying ceremony honoring 13 American soldiers killed in a suicide bombing in Kabul during the final havoc-marked hours of the American withdrawal. Trump laid three wreaths and put hand over heart; that is a time-honored privilege of presidents. Trump, as is his wont, went further. He walked to a burial site in Section 60 and posed with the family of a fallen soldier, grinning broadly and giving a thumbs-up for his campaign photographer and videographer.

Few spaces in the United States join the sacred and the secular to more moving effect than Arlington National Cemetery, 624 acres set on a bluff overlooking the Potomac River and our nation’s capital. More than 400,000 veterans and their dependents have been laid to rest here, among them nearly 400 Medal of Hono r recipients . Rows of matching white tombstones stretch to the end of sight.

A cemetery employee politely attempted to stop the campaign staff from filming in Section 60. Taking campaign photos and videos at gravesites is expressly forbidden under federal law. The Trump entourage, according to a subsequent statement by the U.S. Army, which oversees the cemetery, “abruptly pushed” her aside.

Trump’s campaign soon posted a video on TikTok , overlaid with Trump’s narration: “We didn’t lose one person in 18 months. And then they”—the Biden administration—“took over, that disaster of leaving Afghanistan.”

Trump was unsurprisingly not telling the truth; 11 soldiers were killed in Afghanistan in his last year in office, and his administration had itself negotiated the withdrawal. But such fabrications are incidental sins compared with what came next. A top Trump adviser, Chris LaCivita, and campaign spokesperson Steven Cheung talked to reporters and savaged the employee who had tried to stop the entourage. Cheung referred to her as “an unnamed individual, clearly suffering a mental-health episode.” LaCivita declared her a “despicable individual” who ought to be fired.

There was, of course, another way to handle this mistake. Governor Spencer Cox of Utah had accompanied Trump to the cemetery, and his campaign emailed out photos of the governor and the former president there. When challenged, Cox did what is foreign to Trump: He apologized . “You are correct,” Cox replied to a person criticizing the event on X, adding, “It did not go through the proper channels and should not have been sent. My campaign will be sending out an apology.”

Read: Trump dishonors fallen soldiers again

This was not a judgment call, or a minor violation of obscure bureaucratic boilerplate. In the regulations governing visitors and behavior at Arlington National Cemetery, many paragraphs lay out what behavior is acceptable and what is not. These read not as suggestions but as commandments. Memorial services are intended to honor the fallen, the regulations note, with a rough eloquence: “Partisan activities are inappropriate in Arlington National Cemetery, due to its role as a shrine to all the honored dead of the Armed Forces of the United States and out of respect for the men and women buried there and for their families.”

As the clamor of revulsion swelled this week, LaCivita did not back off. On Wednesday, the Trump adviser posted a photo of Trump at Arlington Cemetery on X and added these words : “The Photo that shook the world and reminded America who the real Commander in Chief is …August 26th 2024 ..Mark the day ⁦@KamalaHarris⁩ and weak ⁦@JoeBiden.”

The Army, which is historically loath to enter politics, issued a rare statement yesterday rebuking the Trump campaign, noting that ceremony participants “had been made aware” of relevant federal laws “prohibiting political activities” and that the employee “acted with professionalism.” The Army said it “considers this matter closed” because the cemetery employee had declined to press charges.

Meanwhile, an unrepentant Trump team kept stoking the controversy. Yesterday, LaCivita posted another photo of Trump at Arlington and added this: “Reposting this hoping to trigger the hacks at @SecArmy ”—the Army secretary’s office.

It had the quality of middle-school graffiti, suggesting that Trump viewed the controversy as yet another chance to mock his critics before moving on to the next outrage. For grieving families with loved ones buried in Section 60, moving on is not so easy.

How old, I asked Meredith, was your son at the time of his death? “He was 26,” she replied. “He did not have time to live. I didn’t get to dance at his wedding. I didn’t get to play with grandkids.”

This week, all she could do was call out a crude and self-regarding 78-year-old man for failing, in that most sacred of American places, to comport himself with even the roughest facsimile of dignity.

About the Author

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I plan every detail of our family trips. In exchange, my husband watches our kid when we fly — it's a win for us both.

• My husband and I split our parenting duties equally unless we're traveling.
• I plan our trips and pack our bags in exchange for my husband watching our kid during the flight.
• I'm more of a planner, and he's not as worried about what to do if our baby freaks out on a plane.

There were many stressful moments in my first year as a parent — but nothing filled me with more dread than our first time traveling as a family .

My daughter was just a few months old when we took our first flight with her, and I spent the weeks leading up to it filled with stress.

I felt like I was served countless videos of people complaining or venting about flying with babies and toddlers. Though I'd never been a massive fan of flying pre-parenthood, the idea of dealing with the disdain of other passengers while trying to calm a screaming child made me lose sleep at night.

Fast-forward two years later, and we've survived numerous hourslong flights with our daughter using one simple strategy.

We found a way to play to each of our strengths as parents

As we approached our first flight as a family of three, my husband and I were stressed about two completely different things.

I was worried about what we'd do if our baby started freaking out on the plane, but he was more concerned about what we needed to pack for the flight .

That's when we came up with the plan we've sworn by for every trip since.

For each trip, I'm in charge of packing everything for myself and my daughter. I put together everything she'll need for the flight and destination, taking it off her dad's plate completely.

In exchange, he's in charge once we get on the plane. If she needs a diaper change, entertainment, food, whatever — he handles it. And he does a great job helping her calm down from tantrums or fall asleep on longer, late-night flights.

Even with this division of labor, we're still equal partners — it's not as if he'd say no to helping me pack or plan something or that I wouldn't help him during the flight if he asked.

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We've found what works for us

This clear division of labor has saved us a lot of stress by taking what each of us considers the worst part of traveling off the plate of the other.

I still worry about the judgmental looks I might get for not being the primary caregiver of our kid during a flight. I still feel mom guilt and often wonder if I'm not doing enough.

But as a big-time planner married to someone who's very much not, I get to do what comes most naturally to me and avoid the part that doesn't.

And once we land, we're back to splitting the chaos of parenting 50/50.

Watch: Why one mother fled Texas to keep her child safe

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