TRIPS Waiver Proposal: Big Pharma Steering Discourse Away From Patent Monopoly

At various global fora, Big Pharma and rich countries have been steadfastly pushing the focus toward supply-side bottlenecks of vaccines and unequal distribution of doses in a bid to steer the discourse away from the more contentious issue of patents and the reluctance of corporates to share technical know-how with manufacturers in the developing countries.

Vaccine equity is desired but only till the point it preserves the patent monopoly of Big Pharma in manufacture. So seems to be the discourse at major global meetings held recently, such as the G20 Summit. A recent World Trade Organisation paper also argued that elimination or significant reduction of tariffs on vaccine inputs is important to reduce costs and to expand output from vaccine manufacturers meeting acute global needs.

All this comes ahead of the 12th WTO Ministerial to be held in Geneva from November end and appears to be a multi-pronged effort to scuttle the TRIPS waiver proposal mooted by India and South Africa in October 2020.

Waiver Proposal and WTO Negotiations

The India-South Africa proposal demands a temporary waiver of certain TRIPS (Trade Related Intellectual Property Rights) obligations on copyrights and related rights, industrial designs, patents, and the protection of undisclosed information in relation to the prevention, containment, or treatment of COVID-19. Such a waiver would provide countries with the policy space to collaborate in research and development and manufacturing, scaling up and supplying COVID tools, including drugs, vaccines, diagnostics, and other technologies, such as masks and ventilators.

This proposal has support from over 100 other countries now, including the United States, which announced its support on May 5, 2021. The US, however, only mentions vaccines for COVID-19 and omits mention of other technologies for treatment, prevention and containment.

During the continuing discussions at WTO, clarifications were sought and changes demanded, making India and South Africa submit a revised proposal on May 25, 2021. This revised draft tried to balance the commercial interests of IP (intellectual property) rights holders and public health at large and clarified that the waiver was intended to be time bound, mandating the WTO General Council to decide on the date of its termination once the exceptional circumstances end. (Medicines Sans Frontieres).

But, some developed countries continued to oppose the proposal. On June 4, the European Union submitted an alternate proposal to the TRIPS Council. This alluded to the use of TRIPS flexibilities under the Doha Declaration on the TRIPS Agreement and Public Health (2001). The alternate proposal emphasised the use of compulsory license with support to manufacturers and adequate remuneration to the IPR holder.

More recently, HuffPost obtained a leaked document, which is apparently a new text by EU on the table. It reported that EU is inviting some developing country negotiators to Brussels to discuss this new text that reaffirms existing exceptions to the TRIPS agreement, but does not waive monopoly control over patents, copyrights, trade secrets and other forms of intellectual property regarding where and how much vaccine is made.

A statement issued by MSF says “the new leaked EU document again focuses only on compulsory licensing on patents and does not address legal barriers related to regulatory data and trade secrets, which are critical to start rapid production by alternate manufactures”.

“This leaked document may create a false image of the EU being constructive and participating in text-based negotiations on the TRIPS waiver proposal, while in reality it diverts attention from the original TRIPS Waiver proposal. The EU is again putting forward a misleading idea that in no way provides the comprehensive removal of intellectual property barriers that is needed to open the door for broad global production of lifesaving COVID-19 medical tools” says Dimitri Eynikel, EU Policy Advisor for MSF's Access Campaign.

Big Pharma Prevails

At the recently concluded G20 Summit, the Communiqué from the Joint G20 Finance and Health Ministers meeting mentions taking “steps to help boost the supply of vaccines and essential medical products and inputs in developing countries and remove relevant supply and financing constraints.” However, there is no mention of the TRIPS waiver proposal.

These positions are in consonance with the position of Big Pharma. In a recent statement, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said: “Now all efforts should be focused on distributing and sharing doses. It would be our hope that the energy focused on undermining intellectual property could be channelled into collectively addressing vaccine equity”.

Meanwhile, World Health Organisation (WHO) Director General Tedros Ghebreyesus has once again appealed to rich countries and corporates, saying that “the G20 countries must fulfil their dose-sharing commitments immediately; manufacturers must prioritize and fulfil their contracts with COVAX and AVAT as a matter of urgency, and be far more transparent about what’s going where.” To end the pandemic and speed up global recovery, he appealed that “they must share know-how, technology and licences, also including the waiver of intellectual property rights.”

Basically, the stage is gradually being set ahead of WTO’s 12th Ministerial Conference (MC12) – the topmost decision-making body which meets every two years. There are apprehensions that the developed countries might be aiming at watering-down the TRIPS waiver proposal toeing the Big Pharma line and also use it to manoeuvre deals on other issues under WTO negotiations, such as trade reforms or fisheries subsidies. Commentators on global trade issues argue that it will be “imperative on the part of the co-sponsors to de-link the TRIPS waiver, from other issues that are being tossed up for MC12.”