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Mixed response to COVID-19 intellectual property waiver

2022; Elsevier BV; Volume: 399; Issue: 10332 Linguagem: Inglês

10.1016/s0140-6736(22)00610-9

1474-547X

John Zarocostas,

Pharmaceutical Economics and Policy

The global health community says the draft outcome—between the EU, the USA, India, and South Africa—falls short of expectations. John Zarocostas reports from Geneva. A tentative compromise deal brokered in trade talks between the EU, the USA, India, and South Africa (the Quad) on a World Trade Organization (WTO) intellectual property waiver for COVID-19 vaccines has drawn mixed responses. The agreement authorises eligible WTO members to use patented ingredients and processes for the production and supply of COVID-19 vaccines without the consent of the right holder. The draft text says that WTO members will decide on its extension to cover COVID-19 diagnostics and therapeutics no later than 6 months from the date of the decision on vaccines. The duration of the waiver is also still not agreed on and could be for a 3-year or 5-year period. Global leaders and health-access advocacy groups, while welcoming the politically important breakthrough after 18 months of gridlock in the WTO, say the proposal falls short and needs to be drastically improved to include upfront commitments on therapeutics and diagnostics. WHO says any waiver of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) would need to include all health products to be effective. However, the agency also supports all legitimate avenues to manage intellectual property in the context of this pandemic and beyond. “In a crisis, half measures are not acceptable. Every barrier to accessing these crucial vaccines and treatments must be cleared away. We urge member states [of the WTO] to return to the negotiating table and come back with a comprehensive waiver that will work to cut short this pandemic and guarantee everyone is protected”, said Max Lawson, head of inequality policy for Oxfam and co-chair of the People's Vaccine Alliance, in a statement. The initial proposal put forward by South Africa and India back in October, 2020, and backed by over 100 nations, called for a waiver of TRIPS protections for COVID-19 medical products, including vaccines, medicines, diagnostics, personal protective equipment, and ventilators. The current proposal is “embarrassingly late and misleading. Not an exceptional answer to an exceptional situation. Not what we were expecting”, Germán Velásquez, special adviser on policy and health at the South Centre think-tank, told The Lancet. The lesson here “is a failure in solidarity”, he said but added, “let's wait and see what will be the final deal and whether the rest of the WTO members will accept it”. Velásquez, a former senior WHO official, said the draft proposal does not cover copyrighted information and trade secrets to produce vaccines, treatments, and devices to treat COVID-19, and excludes many countries. The draft proposal stipulates that only developing countries in the WTO that exported less than 10% of world exports of COVID-19 vaccines in 2021 would be eligible, which excludes countries such as China. Winnie Byanyima, executive director of UNAIDS, told The Lancet, that the text “falls short of a meaningful waiver and in some areas, even takes us backwards”. “We have yet to see any official proposal and I hope that South Africa, India and all co-sponsors of the TRIPS waiver will stand together and demand much more…Africa has repeatedly been pushed to the back of the vaccine queue and we are tragically seeing avoidable deaths as a result. Accepting a weak proposal would be yet another cruel injustice that we cannot abide,” she noted. Ngozi Okonjo-Iweala, WTO director-general, however, welcomed the outcome with caveats. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO membership”, she said in a statement on March 16. Okonjo-Iweala, who helped facilitate the breakthrough, cautioned that although the quadrilateral agreement is an essential element to any final deal, not all the details of the compromise have been resolved, and emphasised that work must commence immediately to broaden the discussions to include all 164 members of the WTO. “In the WTO, we decide by consensus, and this has not yet been achieved.” Once the proposal is formally submitted to the WTO secretariat, members are expected to discuss its contents in the TRIPS Council, where further discussions are supposed to take place to try and make changes. Diplomatic sources, speaking on condition of anonymity, said that some delegations have already started informal talks on ways to improve the contents. “The parties to the negotiation proved that it is not impossible to meet virtually to work through a difficult negotiating challenge and bring about a positive outcome”, Alan Wolff, distinguished visiting fellow at the Peterson Institute for International Economics (Washington, DC, USA) and a former WTO deputy director-general, told The Lancet. “The issue was highly divisive, but with goodwill and substantial effort, with the WTO serving its central function as a place where deals are to be made, a reasonable result was achieved that can now be put to the full membership”, he added. However, WTO insiders and negotiators, speaking on the condition of non-attribution, warned that the deal “can come apart or be strengthened” and “it is still a delicate operation”. There is also concern, given that there was “not equal input” in the talks process, that the deal could still be derailed politically, although some negotiators believe the best way forward—despite its shortcomings—is to try and build on it. James Love, director of Knowledge Ecology International, a health-access advocacy group, told The Lancet that the proposal that Okonjo-Iweala “is asking countries to accept is based largely on the EU negotiation position, as a ‘take it or leave it’ text”, and said, “the greatest appeal is to people who don’t understand the WTO's TRIPS agreement, and who don’t appreciate how little are the benefits and how significant are the negatives, both in terms of its relevance to COVID 19, but also as a precedent for other diseases like cancer”. UN secretary-general António Guterres recently underscored the need for equity and urgency to secure access to vaccines. “Our world cannot afford a two-tiered COVID-19 recovery…Despite the many other crises we face today, we must meet our goal of vaccinating 70% of the population in all countries by mid-year”, he said. Guterres also noted that, although manufacturers produce 1·5 billion doses per month, nearly 3 billion people—mostly living in the least developed countries—are still waiting for their first injection. Governments, pharmaceutical companies, and regional and international organisations, he said, must work together to increase the number of countries able to produce tests, vaccines, and treatments, through the sharing of licences and intellectual property rights, and the provision of adequate technological and financial support. “After 2 years of inadequate access to testing in low and middle-income countries and ongoing hoarding of promising antivirals by rich countries, it is disappointing that the draft Quad agreement has kicked the can down the road on a waiver for treatments and diagnostics”, Rohit Malpani, a Unitaid board member and consultant, told The Lancet. The WTO member states should not wait 6 months, he said, to make a decision on a waiver for treatments and tests—it should be included now and should remove all barriers to low-cost generic competition. “The only way to ensure treatments and diagnostics are included in a final agreement is for low and middle-income countries to reject the proposed agreement. Charitable donations and voluntary licenses are not acceptable substitutes to a full waiver.” In May, 2021, US President Joe Biden's administration agreed to a WTO waiver only for COVID-19 vaccines. Extending coverage to include therapeutics and diagnostics, as favoured by WHO and health experts, would be “much more difficult”, top WTO diplomats told The Lancet. Lawrence O Gostin, a professor of global health law at Georgetown University, told The Lancet that any deal to add therapeutics and diagnostics would face “massive pushback” by US pharmaceutical companies and that there would be an enormous lobbying effort. He noted that Biden has been more resolute than his predecessor in trying to be a global citizen to ensure affordable access but added that it would be “an enormous uphill battle politically, and particularly Congress would have fierce opposition to it defending big pharma”. Gostin emphasised that medications against COVID-19 will become fundamentally important in the future in the fight against the disease: “At this stage of the pandemic, we are probably transitioning from supply shortages for vaccines to extreme scarcity of effective therapeutics, and that is likely to be even more amplified as we have higher vaccination rates and the objective of pandemic response will soon be shifting to preventing serious disease, hospitalisation, and death, and that's where you need treatments.” Global big pharma is also not pleased, however, with the Quad's proposal, as it goes against the industry's long-standing position that protection of intellectual property rights is sacrosanct. “The Quad proposal is an unnecessary and damaging proposal that undermines [intellectual property] and health innovation, which will be deeply disruptive for future innovation to tackle pandemics, with the potential to disrupt a vast range of companies involved in the supply, production, and distribution of vaccines and treatments”, Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations, told The Lancet. To date, he said, 13 billion doses of approved vaccines have been produced, and the industry is able to deliver over 1 billion doses per month. COVID-19 vaccine output has moved, within the space of 12 months, “from shortages to demand constraints”. Today, there are 371 collaborations on vaccine manufacturing and 155 on therapeutics. In addition, Cueni said, there have been multiple announcements of partnerships to improve the geographical diversity of vaccine production. Indeed, experts point out that transparent collaborative arrangements, like the one recently announced by the Medicines Patent Pool with 35 manufacturers in 12 countries to produce and supply the COVID-19 treatment nirmatrelvir–ritonavir, are positive initiatives in the absence of a global waiver deal. Experts and health diplomats say that if a deal emerges from the WTO, it would be a vital precedent of enormous symbolic value and would pave the way for securing a WTO waiver with fewer impediments and controversy in a future pandemic. Gostin noted, “the last thing you want to do is to repeat the unconscionable inequities, nationalism, and populism that we have seen” in this pandemic.