Amid controversy over global access to Covid-19 vaccines, Pope Francis lent his moral authority to the debate and urged drug makers to make their intellectual property available so that other companies can manufacture enough shots for low and middle-income countries.
In a video address to the World Meeting of Popular Movements, the Pope made a simple, straightforward plea: “I ask all the great pharmaceutical laboratories to release the patents. Make a gesture of humanity and allow every country, every people, every human being, to have access to the vaccines. There are countries where only 3% or 4% of the inhabitants have been vaccinated.”
His remarks came as the pharmaceutical industry continues to resist pressure at the World Trade Organization to agree to a temporary waiver of intellectual property for Covid-19 medical products. Despite support from the Biden administration, a proposal made a year ago has stalled amid objections from the European Union and some countries where several large drug makers are based.
The proposal, which was made by South Africa and India, would cover patents, industrial designs, copyrights, and protection of trade secrets. The move came because, at the outset of the pandemic, wealthy nations raced to sign deals with vaccine makers and now account for 43% of the 16.6 billion doses locked up in purchase agreements, according to the Duke Global Health Innovation Center.
In theory, a temporary waiver could make it easier for countries that permit compulsory licensing to allow a domestic manufacturer to export Covid-19 vaccines elsewhere around the globe. A WTO agreement reached in 2001 called TRIPS permits countries to issue compulsory licenses, but low- and middle-income countries argue the language is insufficient for the pandemic.
Existing exemptions in international trade law do not permit countries to quickly or easily reproduce vaccines or distribute them to other low-income countries that lack manufacturing capabilities. Officials in South Africa and India have pointed to intellectual property held by drug makers as a key barrier. But the pharmaceutical industry has argued that patents are not a hurdle to wider access.
For its part, the European Union offered an alternative proposal that, while appearing to embrace the use of compulsory licensing, was criticized as “mostly meaningless” in a blog post by Ellen ‘t Hoen, a former head of the Medicines Patent Pool and Pascale Boulet, a researcher at Medicine, Law & Policy, who also heads intellectual property access at the Drugs for Neglected Diseases Initiative.
So far, the manufacturers of the most widely sought vaccines – Pfizer (PFE) and Moderna (MRNA) – have refused to share patents and know how. Instead, they have emphasized agreements reached to supply their shots to COVAX, a program overseen by the World Health Organization, the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations to facilitate distribution of vaccines to dozens of low and middle-income countries.
The idea was to create a sort of insurance policy for wealthy nations, which would buy vaccines from multiple manufacturers to boost the odds that enough would work. For poorer ones, it would be a lifeline. But the effort has fallen short. So far, COVAX has contributed less than 5% of all the vaccines administered globally and recently announced it would miss its 2 billion distribution target for this year.
Meanwhile, Moderna has been criticized for shipping more of its vaccines to wealthy nations than other vaccine makers, according to Airfinity, a research firm that tracks vaccine shipments. At the same time, some middle-income countries have had to pay more for Moderna vaccines than such wealthy countries as the U.S., which provided financial and research backing for its shot.
Last week, David Kessler, the chief science officer at the White House for the Covid-19 response, sought to ratchet up pressure on Modern and told a webinar that the company needs “step up” to provide more of its vaccine to rest of the world. Several U.S. lawmakers also asked the Biden administration to review the U.S. government contract with Moderna and consider sharing manufacturing steps.
Last month, Modern was chastised for a plan to build a manufacturing plant in Africa that can produce up to 500 million doses each year for different diseases in a bid to combat the pandemic and other illnesses on a wider scale. But the company did not address ongoing calls by WHO officials to transfer its technology to a hub the global health agency plans to create in Africa.
Three months ago, Pfizer (PFE) and BioNTech (BNTX) struck a deal with The Biovac Institute, a vaccine maker backed in part by the South African government, to assemble the last stages of their vaccine. From there, more than 100 million finished doses will be supplied exclusively to all 55 African Union countries annually. But the companies avoided participating in the WHO technology transfer hub.
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