In a break from longstanding US policy, President Joe Biden’s administration has backed a proposal that would temporarily lift intellectual property (IP) rights for COVID-19 vaccines.
The “monumental” decision, as described by the World Health Organization’s (WHO) chief, raised hopes for developing nations struggling with vaccine supply but was met with anger from the pharmaceutical industry.
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If approved, the waiver would theoretically allow drugmakers around the world to produce coronavirus jabs without the risk of being sued for breaking IP rules. Lengthy negotiations are expected before a consensus can be reached at the World Trade Organization (WTO).
Here is all you need to know.
Who are the supporters and the opponents?
The proposal, which was put forward at the WTO in October by India and South Africa, has gained formal support from at least 61 countries in the face of pressing concerns about vaccine access. However, a handful of mostly rich nations that are home to pharmaceutical companies, including Japan, the United Kingdom, Switzerland, Australia, Brazil and European Union members, rejected the idea.
But following the US announcement, cracks swiftly appeared in the wall of opposition to any changes to IP rules. A few hours after US Trade Representative Kathrine Tai’s endorsing statement on Wednesday, New Zealand said it was supporting the waiver.
This was followed by European Commission chief Ursula von der Leyen saying the bloc was “ready to assess how the US proposal” could help ramp up global vaccine production. Without directly endorsing the IP waiver, von der Leyen said the EU was ready to discuss any “effective and pragmatic solution”.
Our priority is to ramp up production to achieve global vaccination.
At the same time we are open to discuss any other effective and pragmatic solution.
In this context we are ready to assess how the US proposal could help achieve that objective.
— Ursula von der Leyen (@vonderleyen) May 6, 2021
For its part, the UK said it is “working at the WTO to resolve this issue. We are in discussions with the US and others to facilitate the increased production and supply” of vaccines.
The German government on Thursday voiced opposition to the waiver, with a spokeswoman saying it has “significant implications for vaccine production as a whole,” and adding that “the protection of intellectual property is a source of innovation and must remain so in the future”.
What are the arguments?
The original proposal at the WTO sought a temporary exemption from certain obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights, with the waiver also covering “industrial designs, copyright and protection of undisclosed information” for a period “until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity”.
Those pushing against it say existing regulations allowing drugmakers to voluntarily engage in bilateral agreements with generic manufacturers are flexible enough when it comes to tackling a public health emergency.
They also argue that waiving patents would infer a heavy blow to scientific innovation by deterring private investment.
“Who will make the vaccine next time?” Brent Saunders, former chief executive of Allergan, now part of US drugmaker AbbVie, said after the US move.
Opponents also highlighted that waiving IP rights was not the answer to vaccine shortages as patent holders should also transfer technical know-how and personnel.
“Handing needy countries a recipe book without the ingredients, safeguards and sizeable workforce needed will not help people waiting for the vaccine,” said Michelle McMurry-Heath, president and chief executive of the Biotechnology Innovation Organization. “Handing them the blueprint to construct a kitchen that – in optimal conditions – can take a year to build will not help us stop the emergence of dangerous new COVID variants.”
However, proponents of relaxing IP rules argue that the waiver will finally encourage developing countries to invest in setting up a practical framework without fear of being sued, as well as enable prompt access to affordable medical products in times of need.
Supporters also disagree that a waiver would hamper scientific development, instead pointing out that developers received consistent sums in public and non-profit funding for their vaccine candidates.
“The US is traditionally a hardliner [on IP rights], no matter who sits at the White House, so this [Wednesday’s announcement] is a huge shift,” Ellen ‘t Hoen, director of Medicines Law & Policy, told Al Jazeera.
“But we also need to recognise that to produce vaccines we need more than waiving IP rights,” she said. “To produce a vaccine is a process for which you need to follow specific instructions and for that you need a mechanism to share know-how and technology transfer,” she added, referring to the COVID-19 Technology Access Pool (C-TAP) that was set up by the WHO last year but no company has so far signed up to it.
Before countries can hammer out a deal and actually amend the current regulation on IP rights, the proposal needs the unanimous backing of the 164 WTO members, all of whom have veto power.
Negotiations are expected to last months, considering that 10 meetings over the past seven months have failed to move discussions forward.
At the height of the HIV crisis in the 1990s, antiretroviral drugs revolutionised the treatment of AIDS. However, it was only in 2001 when WTO countries reached a landmark agreement that allowed member states to seek compulsory licensing when faced with extreme emergencies.
Looking ahead, ‘t Hoen said “there will be text-based negotiations so countries are entering a more formal phase where various proposals will be made.
“That is a tricky process that can lead to a diplomatic solution but not necessarily an effective one.”