TRIPS Flexibilities

Research Paper 170, 17 November 2022

Left on Our Own: COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health  

By Melissa Omino and Joanna Kahumbu

The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter “the Declaration”) was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter “TRIPS”) Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus (“the TRIPS waiver”). These citizens are especially vulnerable because of their inability to access vaccines due to their prices and supply shortages caused by the refusal to share manufacturing technology. The Doha Declaration aimed at reaffirming the interpretation and implementation of the TRIPS Agreement to support WTO members’ right to protect public health and promote access to medicines. However, the operationalization of the Declaration via Article 31bis of TRIPS has been cumbersome and procedurally difficult to navigate. This paper argues that the current iteration of the Doha Declaration within TRIPS fails to meet the objectives of the Declaration as demonstrated by the need for a further waiver of the TRIPS agreement. It also attempts to “reimagine” Article 31 bis in light of the TRIPS waiver from the position of the Global South to make it more equitable and practicable and maintain the spirit of the Declaration.

(more…)

SouthViews No. 243, 15 November 2022

International Clean Technology Diffusion: Pathways and Prospects

By Wenting Cheng

International clean technology diffusion is essential to mitigate and adapt to climate change, while fast and optimal diffusion can be prevented by the paywall of patents. This article examines three pathways to foster international clean technology diffusion: through restriction of intellectual property, including imposing external restraints in environmental law; striking an internal balance in maximizing TRIPS flexibilities; and keeping the status quo. It finds that the first two treaty-based pathways may not work, and an operable pathway to promote clean technology diffusion is to maximize and consolidate TRIPS flexibilities in national laws. This option challenges the popular proposal of a “Doha-like” declaration on TRIPS and climate change due to the paralysed multilateral trade mechanism, asymmetrical negotiation power of developing countries, prolonged negotiation process, and categorization problem in treaty negotiations.

(more…)

Research Paper 169, 8 November 2022

The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?

By Carlos M. Correa and Nirmalya Syam

The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.

(more…)

Research Paper 168, 28 October 2022

TRIPS Flexibilities and Access to Medicines: An Evaluation of Barriers to Employing Compulsory Licenses for Patented Pharmaceuticals at the WTO

By Anna S.Y. Wong, Clarke B. Cole, Jillian C. Kohler

Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner’s authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel originator manufacturers to license their patents to generic manufacturers before patent expiry, increasing the supply and reducing the price of patented pharmaceuticals domestically.

This paper evaluates the three primary barriers to employing compulsory licenses for pharmaceuticals underscored by members during TRIPS waiver discussions at the WTO: (1) a lack of enabling domestic legislation, (2) a lack of domestic manufacturing capacity coupled with an unworkable Article 31bis importation system, and (3) consistent political pressure from other members to refrain from issuing compulsory licenses. A survey of members’ domestic compulsory license legislation finds that virtually all members have enacted enabling legislation under Article 31 for the issuance of compulsory licenses to supply their local markets. However, implementation of Article 31bis is limited by a lack of enabling compulsory license export legislation, streamlined administrative processes, or both across all members, preventing members lacking domestic manufacturing capacity from importing pharmaceuticals. An analysis of USTR Special 301 Reports from 1994-2021 further reveals that countries have consistently been placed on the Special 301 Report Priority Watch List for issuing pharmaceutical compulsory licenses, with instances as recent as 2020. As such, general reluctance by members to issue compulsory licenses due to overt political pressure through the Special 301 Report is likely warranted. These results highlight a range of barriers preventing the full use of compulsory licenses for pharmaceuticals under the current Article 31 and 31bis framework, with the effects disproportionately borne by member states lacking domestic manufacturing capacity.

(more…)

Research Paper 166, 6 October 2022

Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health

By Nanditta Batra

The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence, including patented AZT for HIV/AIDS treatment, showed that patents could make life saving drugs prohibitively expensive. Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions “in all fields of technology”. While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States’ rights to use them. It is in this background that the historic Doha Declaration on the TRIPS Agreement and Public Health assumed importance as it reaffirmed the rights of the Member States to take measures to protect public health, reconciled the interpretative tensions in the text of TRIPS Agreement and clarified the scope of some of the flexibilities and attempts to find solutions to the problems faced by countries that do not have sufficient manufacturing facilities. The Declaration which was initially dismissed by some scholars as “non-binding,” “soft law” has been held by WTO Dispute Settlement Body (DSB) to constitute a “subsequent agreement” which must be followed in interpreting the provisions of TRIPS Agreement (Australia-Tobacco Plain Packaging Case).

(more…)

SC Statement to the WIPO Assemblies, 18 July 2022

Statement by the South Centre to the 2022 Assemblies of the Member States of WIPO

The South Centre is the intergovernmental organization of developing countries based in Geneva that supports developing countries’ efforts to build up a fair and inclusive multilateral system conducive to the achievement of the Sustainable Development Goals (SDGs). We are of the view that a central objective of World Intellectual Property Organization (WIPO) as part of the United Nations (UN) UN system should be to support the achievement of such goals through the promotion of a balanced international intellectual property (IP) system that reflects the interests of countries at different levels of economic and technological development, and in line with the WIPO Development Agenda.

(more…)

Research Paper 158, 15 June 2022

Twenty Years After Doha: An Analysis of the Use of the TRIPS Agreement’s Public Health Flexibilities in India

By Muhammad Zaheer Abbas, PhD  

The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to provide latitude to the Member States to tailor their national patent laws to fit their individual needs. In 2001, the Doha Declaration further clarified and reaffirmed the existing TRIPS flexibilities. This paper argues that India has taken the lead role in enacting the TRIPS Agreement’s substantive and procedural patent flexibilities by introducing unique legislative measures to deal with the problem of access to medicines. This article evaluates India’s use of section 3(d) as a subject matter exclusivity provision. It examines constitutional validity and TRIPS compliance of section 3(d). It also evaluates India’s use of the flexibility to define the term “inventive step”. Moreover, this article evaluates India’s use of compulsory licensing, the most notable exception to patent rights provided under the TRIPS Agreement. This empirical study is important in the context of the COVID-19 pandemic, which has once again highlighted the same public health issues that the Doha Declaration sought to address twenty years ago.

(more…)

Policy Brief 110, 5 May 2022

Analysis of the Outcome Text of the Informal Quadrilateral Discussions on the TRIPS COVID-19 Waiver

By Carlos M. Correa and Nirmalya Syam

Almost one  and a half years after the proposal for a waiver of certain provisions of the TRIPS Agreement regarding health technologies for COVID-19 was proposed by India and South Africa with the support of the majority of WTO Members, the TRIPS Council has been unable to reach consensus on the proposed waiver or engage in text negotiations. In this context, the TRIPS Council agreed to suspend the discussions to allow the possibility of some solution to emerge from informal high-level consultations between the European Union, the United States of America, India and South Africa. Recently, the WTO Director-General transmitted the outcome of the informal consultations along with a draft text to the TRIPS Council. In this context, this policy brief analyzes the elements of the draft text that has been transmitted to the TRIPS Council. The proposed solution, which offers clarifications and limited waivers on some of the provisions governing compulsory licenses on patents relating to vaccines, reflects developed countries’ strong opposition to the broader waiver sought by the proponents to rapidly expand manufacturing capacity and the supply of health products needed to address the pandemic.

(more…)

Research Paper 146, 16 February 2022

A Review of WTO Disputes on TRIPS: Implications for Use of Flexibilities for Public Health   

By Nirmalya Syam

The use of TRIPS flexibilities by WTO members involves interpretation of the obligations under TRIPS which can be challenged under the WTO dispute settlement system. Mutually agreed solutions, panel or Appellate Body decisions adopted in such disputes can thus impact the scope of TRIPS flexibilities to address, among others, public health objectives. This paper explores how the WTO dispute settlement system applies to disputes under TRIPS, and reviews the outcomes of the disputes relating to the implementation of TRIPS obligations in the context of pharmaceutical products. The paper points to both systemic and substantive concerns arising from the application of the dispute settlement system to disputes under TRIPS. It finds that the dispute settlement system is not aligned to the unique nature of the TRIPS Agreement in the WTO as an agreement that creates positive obligations, and consequently how jurisprudence arising under disputes concerning other covered agreements having negative obligations, have led panels and Appellate Bodies to adopt narrow interpretations of the scope of TRIPS flexibilities in some of the few disputes arising under the TRIPS Agreement. Moreover, mutually agreed settlements adopted in the context of some of the disputes arising under TRIPS have also led to the adoption of TRIPS plus standards, limiting the scope of TRIPS flexibilities. However, in a recent decision, the WTO panel has also relied on the Doha Declaration on TRIPS and Public Health as a subsequent agreement to guide the interpretation of its provisions. In this context, the paper advances some suggestions to address the systemic and substantive issues arising from the application of the dispute settlement system to the TRIPS Agreement.

(more…)

Book by the South Centre, 2006

THE USE OF FLEXIBILITIES IN TRIPS BY DEVELOPING COUNTRIES: Can they Promote Access to Medicines? 

This study was commissioned to: (1) examine the extent to which the flexibilities contained in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been incorporated into the legislation of developing countries and the extent of the actual use for public health purposes; (2) review the stated trade policies of major industrialized countries, particularly the United States and the European Union , vis-à-vis developing countries, to determine whether they take adequate account of the public health priorities of developing countries; and (3) examine the practical effect and implications of recently concluded bilateral and regional free trade agreements (FTAs) for public health protection in developing countries. The study has been compiled based on existing literature and other available evidence.

Overall, the study finds that the use of TRIPS flexibilities can promote access to medicines in developing countries. Most developing countries whose laws and practices we reviewed had incorporated one or more of the TRIPS flexibilities and there has been increasing usage of these flexibilities such as compulsory licensing for public health purposes. However, there remain important gaps both in terms of incorporation and usage of flexibilities, which will need to be addressed if the TRIPS flexibilities are to be used effectively across the developing world.

With respect to the stated trade policies of the United States and the EU relating to the protection of intellectual property in third countries, especially developing countries, we find that although some concern for the public health needs of developing countries is reflected, in general, the policies fail to adequately take into account the public health priorities of developing country trading partners.

Finally, with respect to FTAs, we find that a number of provisions in recently concluded FTAs between developed countries (essentially the United States) and developing countries, pose a real risk of undermining the effective use of TRIPS flexibilities in developing countries for public health purposes.

THE USE OF FLEXIBILITIES IN TRIPS BY DEVELOPING COUNTRIES: Can they Promote Access to Medicines? 

Book by the South Centre, 2004

UTILIZING TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PROTECTION THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS

Despite the significant scientific and technological developments of the 20th century, there continue to exist unacceptable inequalities in the health status of people as between developed and developing countries as well as within developing countries. It is in this context that efforts have been underway over the last several years to make medical technology work better for developing countries and for poor people. A major component of these efforts has focused on the impact of the expansion of patent protection to pharmaceutical products and processes under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The initial challenge related to the scope and interpretation of the policy flexibilities embodied in the Agreement that could be used to improve availability and access to essential patented medicines. This challenge was resolved by the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration), which affirmed that public health considerations can and should condition the extent to which patents on pharmaceuticals are enforced and that flexibilities in the TRIPS Agreement should be used to this end.

However, while developing countries have the right to exercise the flexibilities under the TRIPS Agreement, in reality it remains difficult for many of them to make effective use of these flexibilities as a public health policy tool. For example, paragraph six of the Doha Declaration on TRIPS and public health recognized that while developing countries can issue compulsory licences; they nevertheless faced difficulties in making effective use of this policy tool due to lack of or insufficient manufacturing capacity. This is, however, just one of the constraints that developing countries face at the national level in their efforts to use TRIPS flexibilities. Other constraints include: lack of technical expertise effectively to implement the TRIPS flexibilities; insufficient technical and infrastructural capacities for medicines regulations; bilateral and other pressures not to use the TRIPS flexibilities for public health purposes and/or to adopt TRIPS-plus standards; difficulties in regulating anti competitive practices and abuse of intellectual property rights; and difficulties in accessing pricing and patent status information. Many of these constraints can be addressed by adopting complimentary policy and legal measures at the regional level.

UTILIZING TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PROTECTION THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS

0

Your Cart