In apparent opposition to U.S. Trade Representative Katherine Tai’s support for a proposed World Trade Organization (WTO) mandatory intellectual property (IP) waiver on COVID-19-related medical products, the Vice President American Kamala Harris signed on May 21 Rome Declaration which commits member countries to work to overcome the pandemic within the current flexibilities of the TRIPS Agreement by encouraging voluntary intellectual property licensing agreements, technology and knowledge transfer and patent pooling to mutually agreed terms.

The declaration, accepted by all members of the G20, rejects health nationalism and sets out several principles for a unified front against the current pandemic and future crises: share existing products, diversify production capacity, identify and resolve bottlenecks. production throttling, facilitate trade and transparency across the entire value chain, and “promote increased efficiency in capacity utilization and global distribution through cooperation and expansion of existing capacities, including working consistently within the framework of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the 2001 Doha Declaration ”.

While Harris apparently made no mention of the WTO waiver proposed last October by India and South America during his comments at the first G20 health summit, officials at the EU and WTO have done so. WTO Director-General Ngozi Okonjo-Iweala said she hoped WTO members could make progress on revisions to the text of the proposed waiver by July, and then agree, by December, of a pragmatic framework “which offers developing countries almost automatic access to health technologies.” , while preserving incentives for research and innovation. “

In line with the G20 statement, the European Commission (EC) said it would offer an alternative to the WTO proposal, which it opposed as being too broad in its waiver of TRIPS obligations with regard to copyrights, patents, industrial designs and undisclosed data, including clinical trial data and trade secrets, for the “prevention, containment and treatment” of COVID-19 until ‘that “a generalized vaccination is in place in the world and that the majority of the world population has developed immunity”.

Calling for the EC’s ‘third way’ alternative to ensuring global access to vaccines and other pandemic-related medical products, EC President Ursula von der Leyen said the EU proposal would focus on facilitating trade and limiting export restrictions, supporting the expansion of production, and clarifying and simplifying the use of compulsory licenses within the framework of the existing flexibilities of the TRIPS Agreement to deal with crises such as the COVID-19 pandemic.

“Voluntary licensing is the best way to ensure the necessary transfer of technology and know-how as well as intellectual property rights,” said von der Leyen after the summit. “The existing TRIPS Agreement and the 2001 Doha Declaration already provide for compulsory licensing today, as a perfectly legitimate tool that governments can use in times of crisis. . . . But I have listened carefully to developing countries who complain about the difficulty of using these flexibilities. This is something the global community must act on to ensure security and predictability. “

Von der Leyen also stressed that the EU is committed to investing in vaccine production in Africa, which imports 99% of its vaccines. This investment will be part of a € 1 billion (US $ 1.22 billion) European initiative to strengthen manufacturing capacity and access to vaccines, medicines and health technologies. health in Africa. In addition to covering infrastructure and production capacities in regional hubs, the initiative will invest in training and skills, supply chain management and regulatory frameworks in Africa.

In addition to the flexibilities of the TRIPS Agreement and access issues, G20 members agreed to put in place early warning information, surveillance and trigger systems to detect new viruses and variants. before they reach pandemic scale. “We learned our lessons from the early days of the pandemic and the slow flow of information at the time,” said von der Leyen. “It won’t happen again, because everyone will be setting up a system now. And our systems will be interoperable. They will cover new viruses, but also variants, so we will be able to detect them much faster and act. “

Industry Moves Toward Equity in Vaccines

Meanwhile, European, American and global biopharmaceutical industry organizations have developed their own five-step plan to tackle global vaccine inequalities. The organizations noted that by the end of the year, vaccine makers expect to have produced a total of 11 billion doses of COVID-19 vaccine – more than enough to immunize the global adult population.

“It is however crucial that COVID-19 vaccines do not currently reach all priority populations in the world,” according to a statement released last week by the Association of the British Pharmaceutical Industry, Biotechnology Innovation Organization, European Federation of Pharmaceutical Industries and Associations, International Council of Biotechnology Associations, International Federation of Pharmaceutical Manufacturers and Associations, Pharmaceutical Research and Manufacturers of America and Vaccines Europe.

The groups urged manufacturers, governments and non-governmental organizations to “work together to take urgent action to address this inequality”, with immediate action focused on responsible dose sharing and maximizing production without compromising production. quality or safety.

The other steps include:

• eliminate trade and regulatory barriers affecting the export of raw materials, essential manufacturing components and finished vaccines;
• support country preparedness to ensure low- and lower-middle-income countries are able to deploy available COVID-19 vaccine doses during their shelf life and mitigate risks to the production and deployment of ‘other vaccines vital to global public health;
• further drive innovation by prioritizing the development of new COVID-19 vaccines and urging governments to provide unhindered access to pathogens of COVID-19 variants to support the development of new vaccines and treatments.