U.S. push to waive vaccine patents will NOT increase the supply for poorer countries and could compromise the safety of the shots, Pfizer CEO says
- Biden administration Wednesday threw its support behind a World Trade Organization plan to waive patent protections for Covid vaccines
- The plan is intended to make it easier for poorer countries to manufacture the shots
- Pfizer's CEO has hit out at the plan, calling it 'so wrong' and saying he is 'not at all' in support of patent waivers
- The firm made an estimated $900 million in Covid vaccine sales last quarter
- Experts say that the waiver is unlikely to help countries in desperate need of vaccine doses get them any time soon
- The move could pressure firms into making deals with foreign manufacturers
- But experts warn waiving patents for the shots could stop ongoing development for additional vaccines, and even sap the U.S. of drug manufacturing jobs The Biden administration's move to loosen patent restrictions protecting Covid vaccine makers' secret formulas is unlikely to increase the global supply on its own, because it could take months or even years for nations like India and South Africa to build and outfit the necessary facilities and secure raw materials experts say.
And they suspect the controversial play may be an empty threat to pressure firms to take other steps toward getting shots to poorer countries.
Pfizer's CEO, Albert Bourla, warned on Friday that waiving patents could lead to a global race for the scarce raw materials required to make vaccines, potentially compromising the safety of the shots.
'It will unleash a scramble for the critical inputs we require in order to make a safe and effective vaccine,' he wrote in a letter posted to LinkedIn.
'Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk.'
U.S. support for waiving intellectual property rights on COVID-19 vaccines could be a tactic to convince drugmakers to back less drastic steps like sharing technology and expanding joint ventures to quickly boost global production, lawyers said on Thursday.
'I think the end result that most players are looking for here is not IP waiver in particular, it's expanded global access to the vaccines,' said Professor Lisa Ouellette of Stanford Law School.
President Joe Biden on Wednesday supported a proposal to waive World Trade Organization intellectual property (IP) rules, which would allow poorer countries to produce vaccine for themselves, but the decision is being starkly criticized by companies like Pfizer, and its utility is being questioned by experts around the world.
Experts worry that researchers making new additional Covid vaccines (of which there are about 60 in development) will lose funding for their work if they know they won't be able to license them to offset the cost, the waiver could cost the U.S. drug manufacturing jobs and generally de-incentivize future innovation.
Shares for Pfizer fell slightly (by about 0.08 percent) Friday morning after slipping nearly one percent on Thursday following the Biden administration's announcement.
Shares for competitor Moderna - which said in October it would not enforce its vaccine patents - plummeted 12 percent on Thursday before recovering. By Friday morning, shares for the firm were up by nearly two percent.
Experts warn that waiving patent protection for COVID-19 vaccines won't immediately increase the vaccine supply because poorer countries would need to train people to make them, outfit expensive factories and secure raw materials - which could take years
Pfizer CEO Albert Bourla said he does 'not at all' support the play to temporarily waive patent rights
Shares for Pfizer fell slightly (by about 0.08 percent) Friday morning after slipping nearly one percent on Thursday following the Biden administration's announcement
Shares for competitor Moderna - which said in October it would not enforce its vaccine patents - plummeted 12 percent on Thursday before recovering. By Friday morning, shares for the firm were up by nearly two percent
'I genuinely think it's pretty marginal,' in terms of the benefits, Rachel Silverman, a policy analyst with the Center for Global Development, told the Washington Post.
'I think it will not have disastrous effects. I don't think it will do much to speed production.'
While Pfizer's CEO Albert Bourla has hit out at the Biden administration's move, calling it 'wrong' and telling the AFP he is 'not at all' in support of waiving patents, Moderna's CEO has shrugged the issue off. Stephane Bancel said he 'didn’t lose a minute of sleep' over the patent waiver issue during a quarterly earnings call.
He acknowledged, however, that he's concerned the waiver could hamper motivation for future innovation from the biotech sector, according to the Boston Globe.
That's becoming the chorus from the biotech sphere as well as experts and attorneys who deal with the World Trade Organization (WTO), which is fielding the international negotiations over patent waivers.
Their message is coalescing around the prediction that waivers probably won't do much harm or good in the immediate future, but could ease future access to Covid vaccines, or undermine innovation.
The Biden administration made good on a campaign progress by supporting the waivers, but the move has created a rift between Biden and European allies like Germany
So far COVID-19 vaccines have been distributed primarily to the wealthy countries that developed them, while the pandemic sweeps through poorer ones, like India.
The real goal, though, is expanded vaccine distribution.
'If it is possible to increase the rate of scaling up production, this potentially would give the manufacturers a greater incentive to come to an agreement to make that happen,' Ouellette said.
Vaccine makers like Moderna, Pfizer and BioNTEch have argued that patents have not been a limiting factor in supply.
New technology and global limits on supplies are frequently cited as challenges, and both Moderna and Pfizer nevertheless have steadily boosted supply forecasts.
'There is no mRNA in manufacturing capacity in the world,' Moderna Chief Executive Stephane Bancel said on a conference call with investors on Thursday, referring to the messenger RNA technology behind both the Moderna and Pfizer vaccine.
'This is a new technology. You cannot go hire people who know how to make the mRNA. Those people don't exist.
'And then even if all those things were available, whoever wants to do mRNA vaccines will have to buy the machine, invent the manufacturing process, invent verification processes and analytical processes.'
Unless, that is, the firms have to share the know-how to for the equipment and manufacturing they use too.
Even then, there's the danger that releasing all this information would make it easier for counterfeit or unsafe vaccines to be made.
'Already, there have been reports that with the Pfizer vaccine of counterfeits and fakes in other countries. When you release the IP, the shots might not be controlled to standard, [new facilities] might make bad vaccines,' warned Jamieson Greer, a partner at the intellectual property law firm King & Spalding who specialized in WTO disputes and trade policy in an interview with DailyMail.com.
That in turn could further compromise trust in the safety of vaccines, and discourage still more people from getting the shots.
To increase vaccine production capacity significantly within two years, the Biden administration would need to do much more than waive patents, including providing funding to find and build new manufacturing sites, and backing technology and expertise transfer to the new manufacturers, said drug supply chain expert Prashant Yadav.
Moreover, the U.S. government must guard against allowing foreign companies to use COVID-19 vaccine makers´ technology to compete in areas outside of COVID-19, which are likely to be more lucrative in the long term, said Thomas Kowalski, an attorney at Duane Morris who specializes in intellectual property.
Once a competitor has the technology, restrictions on use are difficult to enforce, he said.
'That know how would be used for other things,' added Greer.
'We've already lost pharmaceutical manufacturing jobs to China and India. Allowing them to take our IP with no consequence...Everyone had been saying for years, "let’s not give China our IP." Now going to facilitate it?'
The pharmaceutical and medicine manufacturing industry employs about 148,000 people in America, according to DataUSA.io.
Professor Sarah Rajec of William & Mary Law School said she did not think a waiver itself would do as much as the signal from the United States, a stronger supporter of corporate intellectual property, that patent rights take a backseat to the urgent needs of the world population during the pandemic.
Rajec said Biden's support for a waiver 'pushes the drug companies to be more open to partnerships, and other licensing on favorable terms, in a way that perhaps they otherwise wouldn't be.'
Drugmakers argue that they have already struck significant partnerships, sharing technology with competitors who they might not have linked up with if not for the pandemic.
'Our position is very clear: this decision will further complicate our efforts to get vaccines to people around the world, address emerging variants and save lives,' Brian Newell, spokesman for pharmaceutical industry group Pharmaceutical Research and Manufacturers of America said in a statement.
European patent attorney Micaela Modiano said that even if the waiver is adopted, vaccine makers are likely to negotiate for some payment, if less than what is generally paid in licensing arrangements. Her firm Modiano & Partners represents Pfizer but has not worked on any COVID-19 related matters.
'I would imagine that the pharmaceutical companies are already and will continue to lobby significantly to make sure that if this waiver proposal passes, that it just doesn't pass as such, but that they receive some sort of financial compensation,' she said.
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