Intellectual Property Law and Access to Medicines

TRIPS Agreement, Health, and Pharmaceuticals

Srividhya Ragavan, Amaka Vanni, Srividhya Ragavan, Amaka Vanni

• Publisher: Routledge
• Year: 2021
• ISBN:
  9781000398731
• Edition: 1
• Topic: Law
• Subtopic: Intellectual Property Law
• Index: Law

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought.

In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Part I

International Norm Setting and Patent Metamorphosis

First Generation

1World Trade Organization

A Barrier to Global Public Health?

Srividhya Ragavan

Introduction

“The World Health Organization Draws Flak for Coronavirus Response,” read the headline of the Wall Street Journal on February 12, 2020.¹ The global struggle with the coronavirus pandemic has highlighted two things: first, the importance of medication; second, the need to access health care and medication. With tens of thousands of individuals infected with COVID-19, and a death toll spreading into almost all countries, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared this virus a “public health emergency of international concern.” Disruptive global epidemics – such as the AIDS, ebola, and SARS – have time and again raised the issue of global response and preparedness to pandemics.² While the WHO continues to be at the center of the debate, the role of the World Trade Organization (WTO) remains crucial in proactively preventing or addressing epidemics and pandemics.³ The harmonized trading system of the WTO was built on an underlying assumption that egalitarian access to health is a barrier to trade and that disparate access to health was the solution to innovation. Considering that a public health crisis in one part of the world can affect global trade in unimaginable ways, protecting public health has become the threshold to protect global trade.

In the face of a global pandemic, access to health care and medication is the one paradigm that can alleviate many global concerns, including those involving and relating to trade such as employment, travel, and more. Lack of medications – either from lack of availability of medication or lack of access – can catapult a possible national public health issue into an international global health crisis. In turn, a global health crisis can affect several industries in ways otherwise unimaginable. Hence, there is a need for balance between innovation and access. The role of the WTO as the gatekeeper for eliminating trade barriers while preserving access to health-care remains important in taking a strategic leadership position for health-related matters. If global productivity is affected due to lack of access to available medication, global trade suffers as a consequence. Despite this reality, the WTO has remained normative and divorced from the real impact of local realities on larger health issues. Its stature as a global organization notwithstanding, the WTO has shown a remarkable tendency to succumb to unrealistic rhetoric and pressures from corporate interests and powerful countries that have shown susceptibility to pandering by powerful trade lobbies. Consequently, the WTO has been irrelevant in ensuring access to medication as a means to strengthen productivity and global trade.⁴

1 Jeremy Page & Betsy McKay, The World Health Organization Draws Flak for Coronavirus Response, Wall St. J. (Feb. 12, 2020), https://on.wsj.com/35e3V5x. 2 Brendan Murray, Slump in Global Goods Trade to Deepen with Coronavirus, WTO Says, Bloomberg (Feb. 17, 2020), https://bloom.bg/2Z8OAPK. 3 See generally Ana Swanson, Global Trade Sputters, Leaving Too Much Here, Too Little There, N.Y. Times (Apr. 10, 2020), https://www.nytimes.com/2020/04/10/business/economy/global-trade-shortages-coronavirus.html.

Indeed, the WTO's failure to balance innovation with access has caused, contributed to, and affected access to medications. The actions of the WTO have actively contributed to morphing access to lifesaving medications into a luxury by creating an elite global class of people with access to health care and medication or, mediclass. While the WTO's emphasis on patents on lifesaving medications played a role in innovation, it largely facilitated corporations from disengaging with issues that raise public policy, public health, and right to life concerns – both by commissions and omissions that denied access to lifesaving medications.

This chapter outlines seven specific ways in which the WTO has, through its actions, inactions, and/or prescriptions, detrimentally affected access to medicines. Hence, it outlines how the WTO's myopic actions resulted in trade becoming a barrier to public health, and in turn, to trade itself. The chapter emphasizes that minimizing barriers to access medications and health is the lifeline to minimizing barriers to trade. It is imperative to control the pandemic as the first step to rejuvenate trade. This pandemic has raised questions on preserving public health, and on innovation implicating the role of intellectual property (IP) in trade in this area. Despite the impact of the public health crisis on trade, the WTO largely remained silent during the COVID pandemic until a waiver was sought without addressing how Trade Related Aspects of Intellectual Property Rights (TRIPS) provisions on innovation is a barrier to health and thus, indirectly to trade. In highlighting the ways in which the WTO has been a barrier to the protection of public health, the hope is that the trade regime of the future will promote rather than prevent countries from instituting measures critical to improving global public health, which in turn is the lifeline to improving productivity and trade.

4 Srividhya Ragavan & Brian Manning, The Dispute Settlement Process of the WTO: A Normative Structure to Achieve Utilitarian Objectives, 79 UMKC L. Rev. 1, 22 (2010).

It Began with the Original Draft

When the WTO was established, the TRIPS Agreement mandated that countries provide product patent protection as part of the required minimum standards.⁵ At that time, developing countries vociferously pointed to local realities to highlight that the TRIPS Agreement would be detrimental to accessing lifesaving medication in poorer members. Moreover, poorer countries criticized the TRIPS Agreement for not considering their resource restraints before enforcing the establishment of the patent regime. The main criticism against the TRIPS Agreement was that the harmonization effort did not provide for – nor did it factor in – issues of national import. Weaving adequate flexibility to allow countries at different stages of economic growth to balance between “incentives to create and the benefits of free competition” was an important aspect that the TRIPS agenda overlooked.⁶ The overwhelming reality was that the minimum standards set forth in the TRIPS Agreement represented a maximalist approach.⁷

Particularly, the TRIPS Agreement's approach to access to medication was criticized for not taking the objectives and principles of the Agreement into account. Article 7 of the TRIPS Agreement outlines objectives stating that the enforcement of intellectual property mechanisms should promote technological innovation and transfer of technology in a manner mutually advantageous to the social and economic welfare of the users.⁸ On a plain reading, Article 7 emphasizes the welfare paradigm by asserting that the international obligations of protection and enforcement of IP rights should contribute to the national, social, and economic welfare of members. The outlined objectives have been criticized for the primacy they lend to IP protection, and for not providing members with adequate flexibility to address national issues.⁹ The principles under which the objectives of Article 7 work are outlined in Article 8.¹⁰ Entitled Principles, Article 8 recognizes members' rights to adopt public interest or public health measures, provided they are consistent with the TRIPS provisions.¹¹ Thus, Article 8 recognizes limitations on private rights under some circumstances. This article can also be viewed as limiting the policy-making rights of member states in a public health or public interest exigency.¹² Operationally, the assertion of Article 7 to balance members' rights with obligations notwithstanding, the TRIPS Agreement was more effective in encouraging fulfillment of obligations than in enabling members to achieve public policy and national developmental goals. Consequently, the WTO faced considerable push-back, most significantly from health activists, patient groups, and nongovernmental organizations (NGOs), on the grounds that the innovation agenda did not address the question of providing global access to lifesaving drugs.¹³ Thus, the WTO draft did not give preference to access to medication.

5 TRIPS: Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement], art. 27. 6 TRIPS Agreement, supra note 5. 7 Jerome H. Reichman, Enforcing the Enforcement Procedures of the TRIPS Agreement, 37 Va. J. Int'l L. 335, 337–39 (1997). 8 TRIPS Agreement, art. 7, supra note 5. 9 Id. See, e.g., The Doha Round, http://www.wto.org/english/tratop_e/dda_e/dda_e.htm (last visited June 11, 2011). 10 Id. at art. 8. 11 Id.

WTO's Elitist Attitude Toward Epidemics

The establishment of minimum standards, with maximalist approach toward IP protection, characterized an inadequacy of the TRIPS Agreement in catering to issues such as balancing innovation with access to lifesaving medicines. For instance, during the early 1990s, the HIV/AIDS epidemic was ravaging the world at an unprecedented rate, particularly in developing countries. The patented medication, which cost $15,000–$20,000 per patient per year,¹⁴ remained inaccessible to many HIV/AIDS patien...

Table of contents

• Cover
• Half Title
• Series Page
• Title Page
• Copyright Page
• Dedication
• Contents
• Preface
• Acknowledgements
• Notes on Contributors
• Introduction Access to Medicines and TRIPS Agreement: A Mapping of the Tradescape
• PART I International Norm Setting and Patent Metamorphosis: First Generation
• PART II State Action and Access to Medicines Debate: Second Generation
• PART III Global Patterns and Emerging Issues: Third Generation
• PART IV COVID-19 and Access to Medicines
• Index