Extension of COVID-19 vaccine waiver back on the table

The extension of the COVID-19 vaccine waiver to include diagnostics and treatments will once again be on the agenda at the World Trade Organisation (WTO) Council on Trade-related aspects of Intellectual Property Rights (TRIPS) on Monday and Tuesday (30-31 October).

The initial deadline for a decision on an extension was set in the WTO ministerial decision of 17 June 2022 (MC12 decision), which saw WTO members agree on a TRIPS waiver only for vaccines. The waiver was originally proposed by India and South Africa in October 2020 to break down barriers to global access to COVID-19 products.

After the TRIPS waiver deadline was extended indefinitely in December last year, the almost 500-page US International Trade Commission (USITC) report on COVID-19 diagnostics and therapeutics from last week will be the basis for renewed discussions on extending the TRIPS waiver although it does not draw any conclusions or make suggestions.

Despite the WTO hailing the June 2022 deal as a success, neither civil society organisations nor the pharmaceutical industry were satisfied: The former because they believed the waiver should be wider-reaching and include diagnostics and treatments, the latter because they believed an IP waiver could be downright harmful to pharmaceutical companies’ incentives to invest in the development of medical countermeasures.

These stances remain firmly the same, and the question is now whether time and a fresh report will advance next week’s discussions.

United States Trade Representative Katherine Tai’s only comment following the report’s release was that her office would “carefully review” the findings and that she hoped that they would “help inform a thoughtful and constructive policy discussion and deliberative process here at home, around the world, and at the World Trade Organization on matters so critically important to global public health and economic resilience.”

The EU’s position

According to a European Commission spokesperson, they are also reviewing the findings of the USITC report alongside continuing their “engagement and internal consultations”.

“It is clear from these consultations that the situation on access to and uptake of COVID-19 therapeutics and diagnostics globally is complex and the factors that drive it are very diverse and country-specific,” the spokesperson told Euractiv.

He highlighted that there is “no single factor that influences access to and distribution of vaccines or medicines” and mentioned factors including regulatory matters, distribution, funding, the role of global, regional and national initiatives to promote equitable access, forecasting and demand issues.

“The EU remains committed to finding a way to advance the discussions at the World Trade Organization (WTO) on the extension of the TRIPS decision to COVID-19 therapeutics and diagnostics,” he said, not touching upon whether the EU will be advocating for an extension or not.

EU member states are represented as a whole at the WTO by the European Commission through the Commissioner in charge of trade, Valdis Dombrovskis.

Voluntary vs compulsory licencing 

On voluntary and compulsory licensing, the USITC report does not make explicit recommendations.

Compulsory licensing (CL) is when a government allows an entity separate from the patent owner to produce an IP-protected product without the approval of the owner. This practice has been discouraged by research-based pharmaceutical companies, because they argue it would harm research and development. Instead, they argue for voluntary licensing.

According to the report, the only COVID-19 products that have been subject to compulsory licences have been therapeutics.

While the report does not make conclusions, it supports the civil society argument that CL can improve access and boost local production in some cases. However, it emphasises that these licences only cover patents and do not include know-how such as trade secrets, technical specifications and training, instructions, process controls, test data, and quality control procedures.

On CLs harming innovation, they note that there is insufficient research on the topic.

Few new elements

“Maybe we didn’t expect a revolutionary report, but we had higher hopes,” Piotr Kolczynski, advisor at anti-poverty NGO Oxfam and the People’s Vaccine Alliance, told Euractiv following the release of the report.

Kolczynski had hoped that the report would use the evidence to make some conclusions about whether to go forward with the extension.

“It is really hard to believe that this investigation was intended to be anything more than a stonewalling tactic and that it was meant by the US – maybe with other wealthy countries – to buy them more time. Basically just waiting for the pandemic to recede and for the urgency of the extension to decrease,” he added, saying that while the report covers a lot of ground, the issues were already well-known.

Nevertheless, he is still hoping for an extension of the waiver. So is Mihir Mankad, global health advocacy and policy senior advisor at Médecins Sans Frontières USA, despite not thinking the MC12 decision was good enough.

“It’s important for there to be a recognition at WTO level that IP is also obstructing access to therapeutics and diagnostics for COVID-19. There’s a danger that just having this focused on vaccines creates a kind of exception in a problematic way,” said Mankad.

He was not expecting any conclusions in the report, but said that it did confirm that “IP is a barrier to access on many occasions” and that “voluntary licences were not adequate in addressing the access shortfalls that we continue to see across the board”.

Regardless of an extension, Mankad mentions that the broader discussions about a pandemic treaty among World Health Organisation (WHO) members are “an opportunity to make up for the fact that they didn’t do what was necessary to ensure access to COVID-19 products” as well as preparing for the next pandemic.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) did not have time for an interview, however sent a statement that “compulsory licences are and should be used as a last resort”.

“During the COVID-19 pandemic, we have seen an unprecedented level of voluntary partnerships – over 450 – supporting the manufacturing scale-up. They are one of the different types of access models used by companies,” they wrote and added:

“While different in approach, the common thread amongst these partnerships was that they were enabled by IP and based on trust, prior experience and expertise. Flexibility allows for partners to efficiently adapt to the circumstances and to be able to cater to the unique needs of a country or surge demands.”

More will be known about countries’ positions after the TRIPS Council meeting next week (30-31 October).

[Edited by Giedrė Peseckytė/Nathalie Weatherald]


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