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US Comes out for Covid Vaccine Patent Waiver

07.05.2021 - The long simmering discussion over whether manufacturers of Covid-19 vaccines should waive their intellectual property (IP) rights in hope of giving more people access to a shot and whether this would indeed end the pandemic faster reached the boiling point on May 5 when the US unexpectedly joined a group of developing nations pushing for such a move.

Asserting that “extraordinary times and circumstances call for extraordinary measures,” US Trade Representative Katherine Tai said the administration of US president Joe Biden “supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in negotiations to make that happen.” However, implementing such a move could be a lengthy process as all 164 World Trade Organization member countries must approve, she conceded. A WTO panel on intellectual property will debate the matter before the end of May, and a formal meeting is scheduled for June 8-9.

The Biden administration's aim,” Tai said, “is to get as many safe and effective vaccines to as many people as fast as possible. As our vaccine supply for the American people is secured, the administration will continue to ramp up its efforts — including working with the private sector and all possible partners — to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.”

Last week, the president announced that the US would release supplies of vaccine raw materials from the US stockpile to India, without saying precisely what these would be. Major vaccine manufacturers in other countries have accused Washington of hoarding products it doesn’t need.

Biden’s decision – which initially sent shares of publicly traded Covid-19 vaccine makers tumbling – came as a surprise to many observers, as the new president previously had been seen as opposing the waiver of patent protection, despite pressure from the left wing of the Democratic Party.  When the IP discussion first arose last year the administration of then-US president Donald Trump, as well as the EU and the UK, opposed the plans advanced by South Africa and India with the backing of other poorer countries, the World Health Organization (WHO) and other NGOs.

US moves catches Europe off guard

The US forward thrust this week caught Europe off guard and split the EU, which was just beginning to recover from an internal squabble over vaccine procurement, into different camps. European Commission president Ursula von der Leyen, who had previously declared she was “no friend” of patent waivers, offered that the 27-member bloc was “ready to discuss any proposals that address the crisis in an effective and pragmatic manner.” French president Emmanuel Macron also reversed his earlier stance, saying he was for a waiver under the present circumstances. While Italy, too, signaled it was on board with US, the UK held its cards close to its chest, remarking only that it was "working with WTO members to resolve this issue.” 

Germany was vehemently opposed to the plans. In a statement, the Berlin government said the proposal would have "significant implications” for vaccine production as a whole. "The limiting factors in the production of vaccines are the production capacities and the high quality standards and not patents," it said, adding that vaccine makers are already working with partners to ramp up manufacturing. Switzerland, Canada, Norway, Japan and Brazil have also been counted among opponents of a waiver.

Most responses to the US announcement were along predictable lines. The WHO said a patent waiver would benefit India, which is in the grip of a deadly second infection wave. Its director-general, Tedros Adhanom Ghebreyesus, praised the US move as a "monumental moment in the fight against Covid-19.” Such waivers are within the powers of the WTO and now is the perfect time to use them, he said.

Samantha Power, administrator of the US Agency for International Development (USAID), called the government’s action “a bold move and the right move.” Waiving IP protections for Covid-19 vaccines will ensure we get them out to the world sooner and stop future outbreaks and new variants before they rise," she said. The medical NGO Médecins sans Frontières (MSF) commented that waiving patent protection "would increase sufficient and timely access to these lifesaving medical tools as Covid-19 continues to ravage countries across the globe."

Would technology transfer compromise quality and safety?

As could be expected, the pharmaceutical industry was not on the same page as the NGOs. While Moderna was the only vaccine maker to comment directly, several industry organizations expressed opposition to an IP waiver. Between applause and criticism of the US move, there was a discussion of what a technology transfer could achieve in terms of speeding up Covid vaccine production. Patents are not the only issue, was the general consensus. Commentators questioned how many companies would know how to make a generic copy of a complex vaccine, fearing that so that mana would struggle to reach the necessary quality standards.

The head of the International Pharmaceutical Manufacturers and Associations, Thomas Cueni, told British broadcaster BBC that “technology transfer should not be forced,” as handing knowhow to a company that has never used it could compromise quality and safety of the vaccines. A senior scholar at the Johns Hopkins Center for Health Security, Amesh Adalija, told Reuters that a waiver would amount to expropriating the property of pharmaceutical companies whose innovation and financial investments made the development of Covid-19 vaccines possible.

Former head of the US Food and Drug Administration, Scott Gottlieb, who now sits on Pfizer’s board, estimated that it could take a year after intellectual property transfer before a new company could make a vaccine. Others pointed out also that Oxford University’s vaccine knowhow, which went into the shot manufactured by AstraZeneca, has already been licensed to Serum Institute of India.

Moderna CEO Stephane Bancel told analysts he doubted that an IP waiver would help the situation, as his company’s technology has been open to anyone since October 2020. One of the most pressing problems is finding qualified personnel to make the vaccines, he added, reiterating remarks made at a recent pandemic summit. “This is a new technology. You cannot go hire people who know how to make mRNA. Those people don’t exist.”

Another issue mentioned by several industry players is the shortage of peripheral equipment needed to make vaccines, such as filters, tubes, bags and glass vials. Novavax complained last month that it would have difficulty filling the entire order of the EU Commission because it could not get the sterile bags in which to grow the virus cells for the vaccine. Germany’s CureVac has also complained that its planned vaccine rollout is also being complicated by the US refusal to export.

Brent Saunders, former CEO of US pharma player Actavis, who led the company’s 2015 merger with Allergan and now heads Vesper Healthcare Acquisition Corp., called the discussion over patent waivers “political theater.” Noting that it takes years to build new factories to produce vaccines, he suggested that “if the government wanted to be helpful, it would help expand the manufacturing capacity of existing companies” – a move the Biden administration actually has already initiated by nudging Merck & Co on board to help Johnson & Johnson.

Inside the administration, there seems to be uncertainty about whether the planned moves would speed vaccine production. “Intellectual property rights is part of the problem,” White House chief of staff, Ron Klain, told CBS News. “But manufacturing is the biggest problem,” he said, referencing the irregularities at CDMO Emergent BioSolutions in Baltimore, Maryland.  The company, whose plant was shut down after it allegedly mixed up doses of Johnson & Johnson and AstraZeneca’s vaccines, has full intellectual property rights, but can’t make any doses.

Author: Dede Williams, Freelance Journalist

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