LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
More than 35 countries and international bodies have signed up to support the COVID-19 Technology Access Pool (C-TAP), as a single repository for knowledge and IP, with the aim of accelerating discovery of treatments through open science research and fast tracking manufacturing by mobilizing capacity at a local level, around the world.
Setting up C-TAP is a response to concerns that national interests will get in the way of collaboration, and that, with limited supplies, bidding wars will drive up prices and leave many countries with no access to COVID-19 products.
Apart from Norway, the Netherlands, Portugal and Luxembourg, governments supporting the initiative are in low- and middle-income countries that expect to be at the end of the queue.
“Science is moving at incredible speed. But will all people benefit from those tools, or will they become another reason people are left behind?” asked Tedros Adhanom Ghebreyesus, director general of WHO, at the online launch of the initiative on May 29.
WHO is calling on companies that develop vaccines and therapies to contribute them to the United Nations’ Medicines Patents Pool, through which HIV and hepatitis treatments have been sublicensed to generics manufacturers, and the drugs made available at low cost and in tiered pricing arrangements that reflect ability to pay.
“WHO recognizes the role patents play in fueling innovation. But this is a time when people take priority,” Ghebreyesus said. “Science is giving us solutions; to make solutions work for everyone, we need solidarity.”
C-TAP was proposed by Carlos Alvarado, president of Costa Rica, who said, “No country can overcome the pandemic until we have all overcome it.” Pooling IP will “free up the power of science” he said. “There is no point in achieving these amazing technological developments if we cannot guarantee access.”
For Mia Amor Mottley, prime minister of Barbados, concerns about being left behind are based on the experience of the past few months, when it has been impossible to obtain basic medical equipment. “I fear when vaccines and therapies come we are not going to get access,” Mottley said. “Small island developing states cannot be dispensable in the face of this pandemic.”
One of the issues riling supporters of C-TAP is that much of the money flowing into COVID-19 research comes from public sources, but will emerge in the form of corporate IP. Even those who recognize industry know-how and willingness to take risks are essential in developing vaccines and therapies think the usual rules do not apply now.
“IP is a social construct designed to promote innovation, but in this particular case governments are taking a key role in financing research,” said Nobel prize-winning economist Joseph Stiglitz. It is important that knowledge is used quickly, for the benefit of all. “That’s why a pool of ideas is absolutely essential,” Stiglitz said.
One of the five demands of C-TAP is that governments and other agencies include clauses in funding agreements with pharma companies requiring them to ensure equitable distribution, and to make products affordable.
“Public investment in health innovation should come with strings attached,” said Mariana Mazzucato, professor in the economics of innovation and public good at University College London.
“I’m a big supporter of IP; however I’m very supportive of C-TAP,” said Gregg Alton, former chief patient officer of Gilead Sciences Inc., and architect of the company’s policy of expanding access to its drugs through broad licensing and technology transfer to multiple generics manufacturers.
“It would be fantastic to see the industry come forward and commit to work with the Medicines Patents Pool,” Alton said. “I expect and respect” that companies want to protect commercial interests. “It can be done,” he said.
Pharma makes its case
The industry has seen pressure building over IP and knew C-TAP was on the way. At last week’s WHO general assembly, the EU put forward a resolution backing the right of developing countries to override patents.
Pharma companies got their defense in first, at a briefing organized by the industry group, the International Federation of Pharmaceutical Manufacturers and Associations, on May 28.
The CEOS of Astrazeneca plc, Glaxosmithkline plc, Pfizer Inc. and Johnson & Johnson all said they support equitable distribution of COVID-19 vaccines and therapies they are developing, and promised a not-for-profit approach to pricing vaccines.
But they said, compulsory licensing will not solve the problem of access.
“There is no enormous evidence IP is a barrier to access,” said Emma Walmsley, CEO of Glaxosmithkline. The GAVI global vaccines initiative has been able to implement a tiered system of pricing of vaccines, whilst protecting IP principles, she said.
Albert Bourla, CEO of Pfizer was more caustic. “I think it is nonsense,” he said. People are putting billions into vaccine development. “Don’t say if you discover it we are going to take your IP – it’s dangerous,” Bourla said.