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The sudden US support for a worldwide waiver of patent protection for COVID-19 vaccines offers hope to poor nations battling over doses – but the big pharmaceutical industry thinks the idea is wrong.
Some countries view the temporary waiver of intellectual property rights as a shortcut to end the coronavirus pandemic.
However, the pharmaceutical industry believes that an IP waiver this year won't help produce a single dose more and could actually stifle the vaccine rush by diverting scarce resources to newcomers.
There will undoubtedly be months of negotiations before a consensus can be found at the World Trade Organization in Geneva.
The big idea
The IP plan was submitted to the WTO by India and South Africa on October 2 last year and received support from a large number of developing countries who – rightly – expected to be left behind in the vaccination race.
The original text proposed a temporary exemption from certain obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) so that every country can manufacture vaccines without worrying about patents.
The exemption would also cover "industrial designs, copyright and undisclosed information protection" and "last until there is widespread vaccination around the world and the majority of the world's population has developed immunity".
The General Council of the WTO, its highest decision-making body, debated the issue on Wednesday before the dramatic change in Washington.
India and South Africa committed to come forward with an amended text, indicating that they could be open to compromise, the WTO said.
Spokesman Keith Rockwell said the debates had been "very constructive" – more than in previous sessions – even if the 164 member states remained divided.
WTO members are expected to meet before an official meeting of the TRIPS Council on June 8th and 9th to discuss the text revisions by the end of May.
All for it
More than 80 countries support the proposal, including Argentina, Bangladesh, DR Congo, Kenya, Nigeria and Venezuela.
Egypt, Indonesia, Morocco and Pakistan are among a variety of countries that have indicated they have manufacturing capabilities when patents are revoked.
A number of NGOs, including the medical charity Doctors Without Borders, support the waiver, saying it would facilitate timely access to affordable medical products for all countries in need.
The idea is also supported by the head of the World Health Organization, Tedros Adhanom Ghebreyesus, who hailed the US move as a "monumental moment" in the pandemic fight.
"Ultimately, the solution to the vaccine crisis is for the countries and companies that control global supply … to share technology, know-how and forego intellectual property rights," he said on Wednesday.
All who are against it
The International Federation of Pharmaceutical Manufacturers and Associations is decidedly against the proposal.
"A waiver is the simple but wrong answer to a complex problem," said the large IFPMA pharmaceutical lobby group, describing the US face as "disappointing".
"Waiving patents for COVID-19 vaccines will neither increase production nor provide practical solutions."
IFPMA believes the real challenge in increasing production is removing barriers to trade and removing the supply chain bottlenecks and raw material shortages – and anticipates that introducing new manufacturers will not help.
Big players also suggest that unrestrained production could undermine confidence in vaccines.
Wealthy nations, in which large pharmaceutical companies such as Switzerland and Great Britain are based, have long spoken out against the idea of IP waiver.
The European Union, also an important pharmaceutical hub, has so far been against it, but after the announcement by the USA, the President of the European Commission, Ursula von der Leyen, said on Thursday that Brussels was at least ready to discuss the idea.
Opponents of the exemption highlight the huge financial investments made by laboratories in developing vaccines in record time and believe they are best placed to manufacture them on the required global scale.
They fear that investments could dry up if companies fail to generate a return.
They also say that the existing WTO IP rules already contain provisions for so-called compulsory licenses, which are specifically designed for emergency situations.
Compulsory licenses give companies other than the patent owner permission to manufacture a product, provided certain procedures and conditions are followed.
Around 275 manufacturing deals, including technology transfer between strong competitors, have helped the industry reach its goal of 10 billion COVID-19 vaccine doses from zero this year.
Template for AIDS drugs
In the late 1990s, antiretroviral drugs revolutionized the treatment of HIV / AIDS. However, the cost of such treatments has been out of reach for most of those affected.
It wasn't until the early 2000s that several agreements were signed to facilitate the manufacture and sale of generic antiretroviral drugs at low prices for poor countries.
A temporary agreement in 2003, later confirmed in 2005, allowed an exemption from intellectual property rights that allowed poor countries affected by serious infectious diseases – malaria, tuberculosis and AIDS – to import generic medicines, if you couldn't make them yourself.
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