By James Paton and Tim Loh
The US-backed effort to waive patent protection for Covid-19 vaccines, even if successful, is unlikely to narrow a yawning gap in access to life-saving shots any time soon.
The proposal faces weeks of difficult negotiations and intense pushback from the pharmaceutical industry. And if it were approved at the World Trade Organization, it could take a year or more to meaningfully increase supplies, vaccine specialists said.
“The short answer is no, it’s not going to make any big difference,” said Klaus Stohr, a former World Health Organization official who helped mobilize governments and drugmakers to prepare for pandemics. “Patents are not the real hurdle. It’s the understanding of complex technology.”
The Biden administration won plaudits from health advocacy groups for backing what they describe as an important step toward achieving equitable access to vaccines, which are still scarce in much of the world, and the European Union and China signaled willingness to take part in the debate. However, German Chancellor Angela Merkel appears opposed to the proposal.
“The limiting factor for the production of vaccines are manufacturing capacities and high quality standards, not the patents,” a German government spokeswoman said in an email.
Even if companies diverted resources and know-how in a “full-blown technology transfer,” it wouldn’t make a difference before the middle of 2022, said Stohr, also a former executive at drugmaker Novartis AG. In the meantime, the virus continues to rage in many regions, including India, an important producer nation. Countries with ample supplies could help more quickly by committing to increased exports and publishing when and how much they can share, he said.
Nurturing Innovation
To boost production, the priorities should be addressing a lack of key materials and components needed to make vaccines, adding manufacturing lines and, if possible, more sharing of expertise to support technology transfers, said Rajeev Venkayya, president of Takeda Pharmaceutical Co.’s vaccines business.
“It’s important for the world to be focused on the more complex issues of scaling up manufacturing rather than spending time on patents,” said Venkayya, who worked in the George W. Bush administration to develop a US pandemic flu plan.
Despite understandable concerns about how the use of intellectual property in the past has restricted access to important medicines, “we absolutely would not have the innovation that has resulted in vaccines being available to the entire American population” without the patent system, he said.
Touch of Hypocrisy
Relaxing IP restrictions would certainly help over the long term, but many nations need vaccines now, said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown. Countries should be given both immediate supplies and the ability to manufacture that the patent waiver would provide, he said.
“There’s more than a touch of hypocrisy in what the US is doing,” he said. “It’s been the world’s No. 1 hoarder of vaccines, and the country that’s most gotten in the way of equitable vaccine rollout globally.”
While the industry has excelled in getting safe and effective Covid vaccines approved swiftly, much of that achievement comes thanks to decades of public funding for basic science, such as messenger RNA technology, that made the vaccines possible, said Stefan Swartling Peterson, a professor at the Karolinska Institute in Sweden. Companies can still be richly rewarded for their products, but the crisis calls for measures such as sharing patents and helping countries make vaccines, he said.
Hard Pushback
“We have an emergency situation,” he said. “If not now, when?”
“I have a hard time accepting that countries like India, Brazil, and South Africa, and others should not be able to do this if they could get access,” he said, citing India’s Serum Institute as an example of the countries’ companies successfully making complex products.
Many low-income countries have only a tiny fraction of global supplies, while the US has secured enough doses to protect its entire population and still has hundreds of millions of surplus vaccines left over, according to Doctors Without Borders. The group supported the US decision, and said it expects the proposal to increase access to these life-saving medical tools..
Still, the industry has predictably pushed back hard.
The waiver would fail to increase global capacity to manufacture Covid-19 vaccines while discouraging companies from continuing research to tackle variants and coming up with novel treatments and vaccines to fight Covid, according to Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations trade group.
Misplaced Focus
Such a step increases the risk that materials and supplies will be diverted from established supply chains to less efficient manufacturing sites where productivity and quality could pose a problem, she wrote in a statement. Boosting capacity to deliver doses all over the world meanwhile requires the skill and technical know-how of vaccine developers, she said.
Just training the engineers at other companies would take three to six months, Pascal Soriot, the chief executive officer of AstraZeneca Plc, said at a shareholder event last week. Novartis, the Swiss pharmaceutical giant, is helping to produce vaccines for BioNTech SE and CureVac NV in a process that takes about seven or eight months from the start of discussions.
“I worry it’s going to create a tremendous disincentive in the future for small biotechs and startups to work on these technologies for the next pandemic,” Novartis CEO Vas Narasimhan said at an event Friday. “I don’t believe it will make a difference in this pandemic.”
The effort instead should shift to sharing excess doses, ensuring the free movement of vaccine ingredients and funding Covax, the global program set up to distribute shots equitably all over the planet, according to the U.K.’s pharmaceutical industry group.
The Coalition for Epidemic Preparedness Innovations, which has worked to accelerate development of Covid vaccines, backs the US commitment to increase production of raw materials and is pushing for all countries to share doses with Covax, Chief Executive Officer Richard Hatchett wrote in an email.
The development in the US is “significant,” he said. “But it will take some time to be fully formed and implemented.”
Such delays could set back the entire pandemic effort, said Krishna Udayakumar, the founding director of the Duke Global Health Innovation Center, in a briefing on Thursday.
Focusing on patents “risks actually making us complacent and moving more of our energy and time to negotiating this agreement,” he said, “which could be better spent making sure that we’re taking a comprehensive approach.”