Angela Merkel has expressed opposition to the Biden administration’s proposal to suspend intellectual property rights for Covid-19 vaccines, saying it would have “serious implications” for vaccine production worldwide.
The German chancellor said the limiting factors in vaccine supply were “production capacities and the high-quality standards, not the patents”.
“The protection of intellectual property is a source of innovation and it must remain so in the future,” she added.
Merkel was responding to the announcement by President Joe Biden’s top trade adviser, Katherine Tai, who said that while the US “believes strongly” in IP protections, it would support a waiver of those rules for Covid-19 vaccines.
A waiver would allow any pharmaceutical manufacturer in the world to make “copycat” vaccines without fear of being sued for infringing intellectual property rights.
“This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures,” Tai said on Wednesday.
The US would “actively participate” in negotiations at the World Trade Organization to hammer out the text of a waiver, she added, noting that those discussions would take time given the complexity of the issues involved.
Washington’s proposal has put the EU on the back foot. In recent months the bloc has resisted a push led by India and South Africa within the WTO for a vaccine patent waiver.
The US move received a cool response from Ursula von der Leyen, European Commission president. She said the EU was “ready to discuss” how the proposal could help address the current crisis “in an effective and pragmatic manner”.
But she also insisted the priority was for vaccine-producing countries to lift barriers to exports and address supply chain interruptions.
Von der Leyen contrasted the EU’s approach with that of some allies: “Europe is the only democratic region in the world that exports vaccines on a large scale.” The US, a large vaccine-producing country, has reserved most of its homegrown jabs for domestic use.
The US proposal received a more positive response from Vladimir Putin, who said Russia, which manufactures the Sputnik V vaccine, would support the move. “A pandemic is an emergency situation . . . No doubt, Russia would support such an approach,” the Russian president said.
China’s foreign ministry said it looked “forward to having active and constructive discussions with all parties under the WTO framework in order to reach an effective and equitable agreement”.
Emmanuel Macron, the French president, said he was open to the idea of a waiver of IP rights, but “the reality is that the bottlenecks today are not price or the patents”.
“You can transfer the intellectual property to pharma companies in Africa but they have no platform to make mRNA vaccines,” he said.
Spain indicated support for the US proposal but said more needed to be done to provide vaccines for developing countries.
“Intellectual property cannot be an obstacle to ending Covid-19,” said a document drawn up by the office of Pedro Sánchez, prime minister.
The “non-paper”, which Sánchez is due to take to an EU meeting on Friday, also called for pharmaceutical companies to step up voluntary licensing while a temporary IP waiver is negotiated at the WTO.
The foreign minister of Brazil, which has opposed the waiver proposal, said on Thursday he expected to speak to Tai about the plan.
“The biggest bottleneck today, for access to vaccines, is the material limits of production capacity,” Carlos Alberto de Franco França told a Senate committee. “According to experts, vaccines are almost impossible to copy, in the short or medium term, without the support of the laboratories that developed them — even with the aid of the patent.”
The idea of a waiver is also opposed by BioNTech, the German start-up whose joint venture with Pfizer brought the first messenger RNA-based vaccine to the market. The company said it would not ease current supply shortfalls and warned of the risks of opening up manufacturing to producers with no mRNA experience.
“Together with Pfizer, we are also working with various organisations to support the supply of vaccines to populations worldwide. And we will continue to provide low or lower middle-income countries with our vaccine at a not-for-profit price,” BioNTech said in a statement on Thursday.
“However, patents are not the limiting factor for the production or supply of our vaccine . . . The manufacturing process of mRNA is a complex process developed over more than a decade.”
Stéphane Bancel, Moderna’s chief executive, said the vaccine makers would have vastly expanded their capacity before any new players could make a real difference to supply.
“If you were to start today, you’re going to have to start by hiring people. Those vaccines don’t fall from the sky,” Bancel told the FT US Pharma and Biotech Summit on Thursday. “There is no mRNA industry . . . When we hire people that come from traditional pharma, we have to train them in the art of mRNA.”
Matthias Kromayer, a general partner at the venture capital firm MIG, one of BioNTech’s earliest investors, said a patent waiver would discourage future investments in the sector.
“If the US/EU/WHO suspend patent protection, they will lose a lot in the long run — namely the willingness of private investors to invest in such companies, many years before it is clear whether their technologies will succeed or not,” he said.
“This would mean the collapse of an entire industry that has just demonstrated it is the only one that can deliver a sustainable solution for this global medical, economic and social crisis.”
The chief executive of Bristol-Myers Squibb described the US government’s support for waiver as “very concerning” during an interview at the FT US Pharma and Biotech Summit on Thursday.
“Our industry depends on intellectual property protection in order to invest in R&D and make the investments needed to address crises like Covid,” Giovanni Caforio said. “The developments of the past 24 hours are very concerning and disappointing.”
As well as being important during the coronavirus crisis, Caforio said that IP protection is “critical for some of the areas of higher medical need where BMS invests like cancer care”.
Additional reporting by Leila Abboud in Paris, Daniel Dombey in Madrid and Michael Pooler in São Paulo