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Big pharma unhappy as Joe Biden backs waiving patent protection on Covid-19 vaccines: 'It won't save lives'

'This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,' says PhRMA chief

The Biden-Harris administration released a statement on May 5 supporting the waiver on intellectual properties (IP) for Covid-19 vaccines. Released by US Trade Representative Katherine Tai, the statement could have major ramifications for big pharma, who clearly aren't happy. 

The announcement comes after the World Trade Organization (WTO) has been pushing for a waiver of IP on vaccines, led by India and South Africa. If agreed upon, it would allow countries and smaller pharmaceuticals to manufacture the vaccines that have already gained approval elsewhere, without having to go through all the research. Tai tweeted, "These extraordinary times and circumstances of call for extraordinary measures. The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in @WTO negotiations to make that happen."

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"The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines," Tai said. She then adds, "We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen." Trade ambassadors are scheduled for a two-day meeting on May 5 and 6 to discuss vaccines, but it may be hard for a consensus to emerge.

The importance of IP-free vaccines

On the campaign trail, candidate Biden promised to waive IP for vaccines. "Absolutely, positively. This is the only humane thing in the world to do," he said in a July interview on the matter. Vice President Harris went even further when she suggested the government use the power of 'eminent domain' to seize intellectual property related to medications critical to public health. Their statements, which could be disastrous for big pharma, are vital for the battle against Covid-19.

Doses have quickly been bought by developed nations like the US, Canada, Israel, and the European Union, leaving developing nations with little recourse but to wait for enough vaccines to be produced. In the meantime, the virus rampages on, as seen with the situation in India, South Africa, and other nations. Lifting IP would allow pharmaceuticals in these nations to quickly ramp up vaccines, without having to wait for Pfizer, AstraZeneca, or Johnson & Johnson to complete their obligations first. 

However, it's not without consequences. Stephen Ubl, president of Pharmaceutical Research and Manufacturers of America, told The Daily Beast, "The Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines." Ubl added, "This change in longstanding American policy will not save lives." 

Experts, civil rights groups disagree

Despite the pushback from big pharma, the administration seems convinced that waiving IP is a key step forward in the battle. It has found strong support with civil rights groups, who have written a public letter to President Biden urging him to waive IP for vaccines. Even WHO Director Tedros Adhanom Ghebreyesus tweeted in support of the US decision, saying, "This is a monumental moment in the fight against #COVID19. The commitment by @POTUS Joe Biden & @USTradeRep @AmbassadorTai to support the waiver of IP protections on vaccines is a powerful example of leadership to address global health challenges."

Any decision to waive IP for vaccines is likely to take time as Tai warned. Trade ambassadors are currently in the midst of a two-day meeting to discuss the issue, but as CNBC warned, "No consensus — which is required under WTO rules — was expected to emerge". There are also other vital challenges that need to be addressed, such as supply chains, which are equally complex. 

Back in November 2020, India and South Africa led the push for waivers, on certain provisions of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). However, it was pushed back against by the US and EU. Right now, the EU is still one of the biggest hold-outs. Even if they do agree, it could be months or even years before nations can start manufacturing vaccines, due to the complex nature of IP rights and the vaccines themselves.