The process was looming long, and it is being so. Discussions on the intellectual property of COVID-19 vaccines will continue to rage at the World Trade Organization (WTO). The countries still cannot agree and have decided to ask for more time to continue discussing India and South Africa’s proposal for a temporary exemption of patents and other intellectual property rights for vaccines and other medical products, commercial sources have reported. They will also continue to debate the counterproposal presented by the European Union.
Vaccination soars: the world exceeds 3,000 million doses with great inequalities between countries
The delegations will meet again informally in early September. Although there is a possibility that it will go ahead, another formal meeting is scheduled for mid-October. At that time, it will be a year since India and South Africa first presented their proposal, which has been systematically opposed since then by rich countries such as the United Kingdom or the European Union bloc.
Dozens of countries with fewer resources have supported the measure, arguing that it could help improve global access, while the US has publicly supported an exemption only for vaccines.
The backdrop is the huge gap in global immunization, which remains unchanged: 75% of vaccines have been injected into the arms of just 10 nations. In low-income communities, only 1% of citizens have received at least one dose, compared with more than half of people in high-income ones, according to WHO figures.
Activists have criticized that no further progress has been made. “Sadly, there will be no talks in August on the exemption, as Europe goes on summer holidays with a rapid rate of vaccination, while the third wave continues to plague many countries in Africa, Asia and Latin America, where vaccination levels they are very low, “lamented on Twitter Shailly Gupta, head of communication for the access campaign of Doctors Without Borders, one of the civil organizations that have advocated for the measure.
The Vaccine Alliance for the People, which includes NGOs, experts and world leaders, said it was “devastated.” The inaction of countries is not just a frustrating bureaucracy. It is a death sentence for many people. “Similar was the reaction of the Spanish NGO Salud por Derecho:” Thousands of lives are at stake every day. It is unbearable. “” When you hear the EU authorities say that the TRIPS exemption will not lead to more vaccines this year, remember that they could have agreed a year ago, “said Steve Cockburn of Amnesty International.
At a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) held this Tuesday, members agreed to report next week on the decision to continue debating the General Council, the highest-level body of the organization, which will only have to ratify it.
To succeed, the measures in the WTO need consensus. One of the biggest unknowns to be resolved continues to be whether the countries will be able to agree on a common text, which is not clear, as well as the details of such text, that is, the demands that will be collected.
What is known so far is that the positions are still very far apart. They have remained so throughout the process of formal negotiations based on a text that could begin in June, after 11 meetings since last October.
Throughout this month, discussions have continued in small group consultations and six other meetings, where the European Union proposal has also been discussed. Delegations have exchanged views, asked questions, asked for and provided clarification but, according to sources in Geneva, they remain mired in what is most fundamental: disagreement over the most appropriate and effective way to address the unequal distribution of vaccines and other products.
On Tuesday, both texts were discussed separately in the TRIPS Council, a reflection of this division.
The trouble spots
During the negotiations, the countries have debated some conflictive points, such as the scope of the exemption proposal – both from the perspective of the products (vaccines, or beyond, such as treatments or tests) and the intellectual protection rights that would be suspended. (beyond patents) – duration, application and protection of undisclosed information.
In May, India, South Africa and the more than 60 states that co-sponsor the proposal reformulated it in an attempt to reconcile positions and established the duration of the measure, which was previously left open: at least three years from the date of adoption. As explained by South Africa in the meetings, this means that the exemption would not automatically expire after this period, but upon review by the General Council whether the exceptional circumstances that existed when the measure was initiated continue to exist at that particular time. But during the negotiation process, some countries have said they are concerned about the duration and completion, and its consistency with the Marrakesh Agreement, the founding of the WTO, including the US.
Delegations have also discussed issues such as transparency and provisions to limit the long-term impact of the disclosure of confidential data during the waiver period, commercial sources report, and have reflected on the measures that will be necessary at the national level. There has not been enough time to discuss the regulatory data issue in depth.
At the July 14 meeting, South Africa was optimistic about progress. The African power refused to limit the debate only to patents, saying that it is necessary to address other issues that go further and that are aimed, he argued, to increase the production and supply of vaccines, such as trade secrets. India, for its part, said there was little enthusiasm among some members to participate in discussions on the text, although it did not mention who it was referring to.
A group of members, including Singapore, Mexico, the United Kingdom, Chile and Norway, consider that there are still unanswered questions in relation to the proposal from India and South Africa, in particular about the legal certainty that it could create at the time national application, or questions such as what would be the commercial relationship between a member that applies the exemption and another that does not.
The EU remains against
The EU, for its part, has argued that its proposal should be treated on an equal footing with that of South Africa and India, and has defended it as the only quick and viable option to improve the international response to the pandemic and achieve the goal of provide equitable global access to vaccines and other medical products around the world. And it has reiterated that the current intellectual property system can facilitate the deployment of existing capacity or in the creation of new capacity to produce vaccines and drugs against COVID-19, maintaining, the European delegate said, the necessary incentives for innovation. .
In June, after the surprising turn of the US and amid mounting pressure, the EU presented an alternative proposal that does not support the exemption, but emphasizes the use of the so-called “flexibilities” already provided, including compulsory licenses, a A process that impoverished countries say is too cumbersome, one of the reasons they have advocated for the temporary suspension proposed by India and South Africa.
Experts, NGOs and activists in favor of the suspension of patents have criticized the measures proposed by the Union, arguing that they are not ambitious enough and do not contribute “anything significantly new”. These same voices warned that they can hinder the negotiations.
“The contrary proposal of the EU offers little news beyond the Doha Declaration of 2001. The EU has not offered a global package nor has it supported the one offered by India and South Africa”, Luke McDonagh, associate professor of Intellectual Property Law at the London School of Economics. McDonagh places particular emphasis on Germany’s opposition to the exemption. “Germany is putting the financial interests of BioNTech and Curevac above other concerns. Germany remains a major obstacle to a full waiver agreement.”
Throughout these weeks, the United States has asked countries to focus on proposals that are pragmatic and can quickly reach consensus. In her brief announcement on May 5 when she leaned toward an exemption, the United States trade representative, Katherine Tai, advanced that “negotiations will take time given the institution’s consensus-based nature and the complexity of the issues involved.” .
McDonagh stresses that although the US has endorsed a waiver, “it has not given strong support to the specific proposal of India and South Africa, and it has not offered its own waiver text.” “If the United States offered a consensus waiver text, the negotiations would accelerate. The United States has to intensify its leadership to help push the agreement forward,” he says.
In his view, the inability to reach an urgent agreement on a waiver text during a pandemic “reflects negatively on the WTO system.” “Low- and middle-income countries are right to criticize high-income states for hoarding vaccine doses and for allowing pharmaceutical companies to hoard crucial know-how for vaccine manufacturing,” he says. “Not a single pharmaceutical company has joined WHO’s voluntary C-TAP knowledge transfer center.”
Many voices in favor of the exemption say that, in order for it to achieve its goal, would have to form a larger package to boost manufacturing, and demand that it be accompanied by technology transfer and massive investment in production capacity.