India-South Africa TRIPS Waiver Proposal Dies at WTO

The recently concluded 12th Ministerial Conference of the World Trade Organisation (WTO) (MC12) in Geneva was hailed as a great success by several developed countries. After all, a ‘consensus’ was reached on the ‘Geneva package’, which included multilateral negotiations on various contentious issues such as fisheries subsidies, WTO response to emergencies, food safety and agriculture and reforms in the 164-member body.

One of the crucial issues on the negotiation table was the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver proposal demanding doing away with certain requirements concerning COVID-19 vaccines, therapeutics and diagnostics.

The text that was finally adopted, however, is limited to vaccines and excludes therapeutics and diagnostics. It is also limited to patents and does not say anything about other restrictive elements such as copyrights, industrial designs or trade secrets. In addition, there are a number of stringent TRIPS-Plus provisions that remain.

“We wanted a waiver from the application of TRIPS agreement and not a compulsory license (CL) which was really the EU’s proposal,” Biswajit Dhar, faculty, Jawaharlal Nehru University, told Newsclick.

“The TRIPS provisions have been watered down to almost homeopathic levels from the original proposal … What has emerged isn’t really a waiver at all: it’s a clarification of existing flexibilities for overriding vaccine patents, in case, of a health emergency with some extra bureaucracy added,” Alan Beattie, world trade editor, Financial Times, wrote.

In fact, the June 14 statement by commerce minister Piyush Goyal at the negotiations rightly assessed the situation. “Vaccines have already lost relevance. Two years they [WTO] spent without giving a solution and it is too late—not even a situation where you can say better late than never. It is just too late,” he said.

It is another matter that Goyal did a volte-face at the end of MC12. Claiming to “secure a favourable outcome at the WTO”, he turned self-congratulatory and projected India as the messiah of “other developing countries, LDCs, poor and vulnerable”.

The outcome of the WTO negotiations has been squarely criticised and termed a failure by experts, activists and civil society—those who had been rooting for the original India-South Africa TRIPS waiver proposal and challenging the might of big pharma.

Originally mooted by India and South Africa in October 2020, during the early days of the pandemic, the TRIPS waiver proposal demanded a temporary waiver of certain intellectual property right 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.

The final text that was adopted at the WTO this month is nowhere near the original proposal.

“The October 2020 was a brilliant proposal; it was absolutely spot on given the needs. What we have got is not even a patch. In fact, it turns the whole thing around. We wanted a clean waiver so that anyone and everyone could get access to the technology without any encumbrances. With CL, there is also the issue of payment of royalties to the patent holder. Moreover, we had said waiver with respect to four forms of IP—patents, copyrights, industrial designs, undisclosed information. What we have got is only patents,” explained Dhar.

“This agreement fails overall to offer an effective and meaningful solution to help increase people’s access to needed medical tools during the pandemic; it does not adequately waive intellectual property on all essential COVID-19 medical tools and it does not apply to all countries,” Dhar added.

According to a statement issued by Médecins Sans Frontières (MSF) international president Christos Christou: “The measures outlined in the decision will not address pharmaceutical monopolies or ensure affordable access to lifesaving medical tools, and will set a negative precedent for future global health crises and pandemics.”

Already A Weakened and Pro-Pharma Text

The WTO director general had circulated a draft text in May which formed the basis of the intense negotiations at MC12 in June 12-17. This text had emerged from the informal discussions among the US trade representative, the European Union (EU), South Africa and India, led by the WTO Secretariat.

In fact, the original TRIPS waiver proposal was undermined the moment India and South Africa entered the Quad process, from where this text emerged. India and South Africa were the protagonists of the original proposal, which was supported by more than 100 developing and less developed countries and co-sponsored by around 65 member countries.

In the run-up to the MC12, there were numerous voices across the globe—civil society, academics, researchers and experts – who spoke against the draft Quad text. It was criticised on its limited applicability to vaccines and exclusion of therapeutics and diagnostics. It was also criticised for being limited to only patents and excluding the crucial restrictions due to trade secrets, copyrights and industrial designs from the purview. The experts also warned about the many TRIPS-Plus provisions that the draft insisted upon.

Renowned experts, including professors Joseph Stiglitz, Jayati Ghosh and Srinath Reddy, sent direct appeals to Indian and South African heads of state. The civil society and other subject experts sent a letter and appealed to Prime Minister Narendra Modi. Lok Sabha member from Thrissur, TN Prathapan, wrote to Modi requesting to reject the leaked compromise text of the TRIPS waiver.

Leading public health organisations such as the People’s Vaccine Alliance, MSF, Third World Network, People’s Health Movement, Oxfam International and several academics criticised it on numerous grounds and called for its rejection. However, these appeals did not affect the negotiations.

Goyal’s statement had “a few disturbing things to share”. He expressed with a heavy heart that “the effort they [developed countries] are putting in is more to showcase to the world that ‘Oh! We found a wonderful solution; we agreed with 80 countries or more to give a TRIPS waiver’. Now, the common man does not understand that this is nothing near a TRIPS waiver. They do not understand that this is a little elevation from compulsory licensing.”

However, at the conclusion of MC12 on June 17, Goyal drastically changed his tone. “Shot in the arm for India’s Vaccine Maitri. Our TRIPS proposal is accepted at @WTO opening the window for production & exports of patented vaccines. Poor & vulnerable nations will benefit from India’s healing touch. #NewIndiaAtWTO,” he tweeted.

In a June 17 PIB release, the minister said, “The TRIPS decision will boost export, vaccine equity, accessibility and affordability. A country can authorise production of vaccines patented elsewhere and there would be no consent required as well as there would be no limit on exports.”

In his June 14 statement, Goyal had criticised the developed countries and said that “what we are getting is completely half baked and it will not allow us to make any vaccines. They have no intentions of allowing therapeutics and diagnostics”.

Experts say that it is a mere publicity gimmick for the domestic constituency. There is nothing new in this as the Doha Declaration on Public Health already had these provisions.

“Let us not call it a waiver; it is plain and simple authorisation of CL. It is already there in our Patents Act. In fact, we have a CL Plus which includes government authorisation. We did not need this decision. It sounds pretty strange to come back and say that we have got this authorisation,” said Dhar.

The only additions to the final adopted text is “a set of clarifications of the existing public health safeguards and a limited exception for the procedure of using compulsory licensing for export of COVID-19 vaccines by eligible countries for a duration of five years”, MSF clarified.

Detailed accounts of India’s poor diplomacy, lack of effective leadership, leaving diplomats at the negotiating table in lurch and inconsistent stands during the WTO negotiations are already in public domain.

Stringent TRIPS-Plus Provisions Intact

According to experts, the adopted text is not only limited to vaccines and patents but also most of the stringent TRIPS-Plus provisions remain intact.  

For instance, Paragraph 3 (c) stipulates that “eligible members shall undertake all reasonable efforts to prevent the re-exportation of products manufactured.…” Although a footnote has been added regarding exceptional circumstances for humanitarian and not-for-profit purposes, it remains a restrictive TRIPS-Plus provision.

Further, Paragraph 1 invokes the necessity test, i.e., “an eligible member may limit the rights provided for under Article 28.1 of the TRIPS Agreement … to the extent necessary to address the COVID-19 pandemic….” This is a restrictive condition as in this case the burden of proof that it is necessary for it to suspend a patent lies on the member.

Moreover, the text has contradictions. On the one hand, paragraph 3 (b) allows waiving of Article 31 (f) and allows for any proportion of the products manufactured under the authorisation to be exported to eligible members. On the other hand, footnote 1 says that “developing country members with existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this decision”. This effectively tries to put countries such as India out of this and limit the use of these clauses.

Has WTO lost its Legitimacy?

“India and South Africa had tabled an important issue which gave rise to a global debate on the impact IP has on patents, trade secrets and control over data and on the impact it has on the capacity of developing countries to produce what they need not just in emergencies but overall for public health and access to medicines,” Leena Menghaney, South Asia head, MSF Access Campaign, told Newsclick.

“The WTO negotiation process directly reflects the ability of the developed countries to block any issue that is related to development agenda. The countries that have traditionally backed the pharma corporations—US, EU, Swiss, Germany and UK—are home to big multinational corporations and they tend to back them. The manner in which they created the logjam is clear that WTO is not a fit forum for a solution to public health emergencies,” Menghaney argued.

“Perhaps, it is time to debate about taking pharmaceuticals and medical innovations outside the purview of the WTO and TRIPS agreement and let countries decide what level IP standards they want to follow,” Menghaney added.

Calling for governments to “act in good faith outside of the WTO’s structures”, a statement by more than 100 civil society organisations clearly stated, “Health needs cannot be subservient to pharmaceutical monopolies’ profits. A few wealthy countries promoting pharmaceutical corporation interests have been able to block the use of the WTO’s waiver mechanism to temporarily suspend such barriers despite more than 100 WTO member countries supporting a waiver.”

Given WTO’s consistent failure to act in people’s interest and its siding with the big pharma, the organisations called for a boycott of WTO’s and other trade and investment agreements’ dispute mechanisms, to defy its pharma monopoly rules and to fully use its existing flexibilities.

The outcome of the recent WTO negotiations casts doubts over its legitimacy and its capacity to take care of the interests of poor and developing countries. India, too, has seemingly failed to play its role in strengthening the voice of poorer countries.

The result is the growing power of Big Pharma in dictating terms and entrenching the IP regime further. Will another platform or forum emerge out of this, where developing and less developed countries can fight for more equitable terms of trade?