US backs IP rights waiver for Covid vaccines, EU says ready to discuss

In a move that could potentially help increase production of Covid-19 vaccines around the world, the United States on Wednesday announced its support for waiving intellectual property (IP) protections for these vaccines.

Subsequently, the European Union (EU) agreed to discuss such a waiver, after having opposed the proposal made by India and South Africa last year.

A waiver on IP protections would mean pharmaceutical firms and vaccine makers across the world can learn how to make these vaccines without fear of lawsuits from companies that originally developed them.

However, such a waiver can only be enforced if the final proposal, which will have to be reworked through discussions, is accepted by all members of the World Trade Organisation (WTO).

“Countries such as Canada, South Korea, and Bangladesh have all evinced interest in producing Covid vaccines if they have a patent waiver, so we should utilise whatever global capacity is there,” Public Health Foundation of India (PHFI) president Prof K Srinath Reddy told The Indian Express.

The discussion on the waiver stems from a broader proposal by India and South Africa on October 2, seeking a waiver on certain conditions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The two countries had originally asked the TRIPS Council to recommend, “as early as possible”, a waiver on the implementation, application, and enforcement of four sections of the agreement. However, these waivers had been sought on copyright-related rights, industrial designs, patents, and the protection of undisclosed information that could impede timely access not only to Covid-19 vaccines, but to affordable diagnostics, therapeutics, and other medical products that can be used to combat the virus as well.

The US and EU are among the major countries that have opposed this proposal during discussions at the WTO so far.

But with US President Joe Biden coming under increasing pressure to back India and South Africa’s move, especially with respect to a waiver for vaccines, United States Trade Representative (USTR) Katherine Tai on Wednesday announced that the country would “actively” participate in text-based negotiations at the WTO for this purpose.

“This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines,” Tai said in a statement.

However, the text-based negotiations “will take time”, given the consensus-based nature of the WTO and the “complexity of the issues involved”, she said.

Following the US announcement, European Commission president Ursula von der Leyen said on Thursday that Brussels was ready to “discuss” this proposal, AFP reported.

“The European Union is also ready to discuss any proposal that addressed the crisis in an effective and pragmatic manner,” she said in an online conference cited by the news agency. “And that’s why we are ready to discuss how the US proposal for waiver on intellectual property protection for covered vaccines could help achieve that objective.”

Minister for Commerce and Industry Piyush Goyal said on Thursday evening: “We welcome (the) US government supporting this initiative and joining 120 other countries working towards affordable Covid-19 vaccines.”

In a release, the Ministry said: “We are hopeful that with a consensus based approach, the waiver can be approved quickly at the WTO. The waiver is an important step for enabling rapid scaling up of manufacture and timely availability of affordable Covid-19 vaccines and essential medical products.”

Trade expert Prof Biswajit Dhar of JNU’s Centre for Economic Studies and Planning said the USTR’s decision was “significant”, since this is the first US Administration that has tacitly accepted the adverse implications of intellectual property rights on public health.

“However, assuming that the other countries opposing the waiver proposal also come on board, it will be important to watch the progress of the text-based negotiations since time is of the essence,” Prof Dhar said.

“Two issues will be extremely important for the waiver to work out as proposed. One, the duration of the waiver should be reasonable, and two, there should not be any limiting conditions attached on producers who seek to take advantage of the waiver.”

A WTO expert said the crux of the final text is likely to be discussed in an informal mode among developed countries like the US, EU, and Japan, along with some developing countries, including India.

“What is likely to happen in the coming few weeks, if not months, is intense negotiations on the actual legal text of the waiver, which is likely to focus on crucial issues such as the scope of the waiver in terms of what products are covered,” this person said, adding that “contentious” issues related to the types of intellectual property rights within the proposal will also need to be chalked out.

While public health activists, officials, and experts have said the latest developments could open up the production of these potentially life-saving jabs, some members of the industry have pointed out that the issue is much more complex.

World Health Organisation (WHO) Director General Tedros Adhanom Ghebreyesus described the USTR announcement as a “monumental moment” in the fight against Covid-19.

But the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) termed the move “disappointing”. A waiver is “the simple but the wrong answer to what is a complex problem,” the global pharma lobby group said. It was likely to distract from the “real challenges” in scaling up production and distribution of Covid-19 vaccines — trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chain, and an unwillingness by rich countries to share doses with poor ones — IFPMA said.