Inflection Point? TRIPS Waiver proposal

“…Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19….

“…As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there are significant concerns, how these will be made available promptly, in sufficient quantities and at affordable price to meet global demand. Critical shortages in medical products have also put at grave risk patients suffering from other communicable and non-communicable diseases…”

“The rapid scaling up of manufacturing globally is an obvious crucial solution to address the timely availability and affordability of medical products to all countries in need.”

Beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers. In addition, many countries especially developing countries may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A particular concern for countries with insufficient or no manufacturing capacity are the requirements of Article 31bis and consequently the cumbersome and lengthy process for the import and export of pharmaceutical products.

Sangeeta Shashikant, Legal Advisor to Third World Network told Geneva Health Files, “We are in a global pandemic, and yet there is no global sharing of knowledge, technology and related IP. Instead we see supply constraints and high prices due to IP. This waiver, if accepted, will be in force internationally and will give countries legal freedom to operate. This is a credible way to address IP barriers related to COVID-19 medical products.”

“The Doha Declaration has been a useful political instrument for signalling purposes. As a result many countries stepped up and issued compulsory licenses. But political pressures continue to operate on any country considering such measures. However, a waiver from certain provisions of the TRIPS Agreement, will give countries the moral authority. To an extent such pressures will reduce on countries looking to address the pandemic,” K M Gopakumar, Legal Advisor to Third World Network said.

“When countries lack immediate manufacturing capacity for any of the essential parts for a product, including raw materials, components or packaging materials, removing IP barriers on one product in one country alone will not be sufficient,” MSF said in its briefing on the proposal.

Members shall not challenge any measures taken in conformity with the provision of the waivers contained in this Decision under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994, or through the WTO’s Dispute Settlement Mechanism.”

The proposal by LDCs says, “Developing a viable technological base is a long-term process. LDCs need a continuing exemption from the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) in order to be able to grow economically viable industrial and technological sectors, to consolidate capacity, and to work their way up the technological value chain. To overcome the difficulties confronting LDCs, magnified manifold by the COVID-19 crisis, LDCs need maximum policy space inter alia to access various technologies, educational resources, and other tools necessary for development and to curb the spread of COVID-19 pandemic. Most intellectual property (IP)- protected commodities are simply priced beyond the purchasing power of least developed countries.”

Given the systemic nature of this pandemic, and the overwhelming lack of infrastructure to fight health emergency the world over, and toxic co-morbidities, overlain with global health security concerns and interests, could push countries in a common direction, the diplomatic source summed up.

Gavi’s COVAX Facility is limiting in its scope and ambition. “For the moment, COVAX aims at providing vaccines only over the next two years. What happens after that? Why not bring in more players? This waiver seeks to do that, breaking this notion of donor countries “giving” vaccines to poorer ones,” a source who did not wish to be identified said.

As representative of the European Union in the TRIPS Council, does the Commission intend to support the Waiver requested by India and South Africa?

How does the EU accommodate the proposed waiver in its global pandemic response, to ensure that global access and access in the EU to covid19 medical tools are complementary?

“This waiver can potentially change this dynamic of manufacturers calling the shots. It is not an ideological opposition to the TRIPS Agreement, but it is very defined and applies only to COVID-19. Low supply, and high prices of diagnostics, vaccines, and therapeutics will leave many countries without enough access to medical products during the pandemic. This waiver seeks to address this,” Shashikant of TWN said.



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