What could a vaccine patent waiver mean for pharma manufacturing?
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What could a vaccine patent waiver mean for pharma manufacturing?

By Darcy Jimenez 28 Jul 2021 (Last Updated July 29th, 2021 15:09)

Advocates of a patent waiver for Covid-19 vaccines say it would increase global vaccine production, while critics argue it could dampen pharmaceutical innovation.

What could a vaccine patent waiver mean for pharma manufacturing?
Credit: Shutterstock.com

In October 2020, India and South Africa submitted a proposal at the World Trade Organization (WTO) to temporarily waive drug companies’ intellectual property (IP) rights for Covid-19 vaccines and treatments under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) treaty.

The motivations behind the petition are clear: 85% of the Covid-19 vaccine shots administered worldwide have been given in high and upper-middle-income countries, low-income countries have received just 0.3% of all shots so far, and some nations are yet to administer a single vaccine dose.

If permitted, an IP waiver would allow vaccine makers in poorer countries to produce jabs without risking legal action from the companies that own the product patents.

While the proposal received US Government backing in May, it has been fiercely opposed by the pharmaceutical industry, which argues that doing away with IP rights will remove the incentive for drug companies to innovate.

In a piece for the Economist, Biotechnology Innovation Organization president and CEO Michelle McMurry-Heath wrote that the proposal “undermines the very system that produced the life-saving science in the first place”, and “destroys the incentive for companies to take risks to find solutions for the next health emergency”.

Proponents of the waiver, on the other hand, say big pharma shouldn’t have a monopoly over vaccine production, especially given that a number of Covid-19 vaccines have been publicly funded. Oxford University, Moderna, Janssen and BioNTech – the German company Pfizer partnered with for its vaccine – have all received hefty sums of public money to fund their research.

The IP waiver debate is a contentious one – but just how much would a patent waiver impact global vaccine production, and what else can be done to tackle the inequity?

What would a patent waiver mean?

So far, it’s unclear what a waiver of IP rights would actually mean for vaccine makers in low-income countries.

The US Government is supportive of a waiver for Covid-19 vaccines, but the proposal submitted to the WTO also covers patents for all health products and technologies related to the prevention and treatment of Covid-19, including “their materials or components, and their methods and means of manufacture”.

Duncan Matthews, a professor of Intellectual Property Law and director of the Queen Mary Intellectual Property Research Institute, says the overall picture is still “very complex”.

“We are still very much in a state of flux, so it’s very difficult to give a straight answer about what the impact of a waiver might have on scaling up production and supply chain issues in developing countries in middle and low-income countries,” he says. “Because as yet, we don’t know what the content of the waiver might be.”

“I think that the current focus on waivers is going to lead to new strategies by the vaccine manufacturers in terms of rethinking how they share not only the patented technologies but the tacit know-how and the trade secrets and the regulatory data, which, of course, will all be needed.”

Not only is it unclear what exactly the TRIPS waiver would involve, but negotiations at the WTO could take a considerably long time to complete. One expert told Reuters that an agreement may not be settled until December – meaning disadvantaged countries could go without the vaccines they need to tackle coronavirus for many more months.

Matthews says this “bureaucratic and long-winded procedure” raises questions about the efficacy of an IP waiver in boosting vaccine production. He points out that for the TRIPS waiver to be approved, it must be agreed upon by all 164 WTO members – including the EU, which has been vocal in its opposition to the proposal.

“It would need to be a consensus document,” Matthews says. “So again, that sort of limits the potential for a major impact in terms of scaling up and improving supply chains in low and middle-income countries.”

Manufacturing capabilities

Another argument made by those opposed to the waiver is that IP rights are not the problem; pharma companies and trade groups have argued that a lack of manufacturing capability is to blame for vaccine scarcity in poorer nations.

In a recent EU proposal to establish a multilateral trade response to the pandemic, executive vice-president and commissioner for trade Valdis Dombrovskis said: “In reality, the main problem at this moment relates to the lack of sufficient manufacturing capacity to rapidly produce the required quantities.”

Matthews disagrees with the view that scaling up local vaccine manufacturing in middle and low-income countries is unachievable.

“We know for a fact that there is spare manufacturing capacity in countries like Iran and Canada, and requests for voluntary licences have been denied by the vaccine manufacturers,” he says.

“So, while acknowledging that, of course, production of particularly the mRNA vaccines is complex and requires particular manufacturing conditions, we know for things like the Moderna and Pfizer vaccine that the practical manufacturing issues are not insurmountable.”

Another significant obstacle to vaccine production in low and middle-income countries is a lack of access to the necessary materials and equipment.

While the US has declared its support for the suspension of IP rights, it has blocked the export of much-needed raw materials under the Defense Production Act, which grants US manufacturers priority access to specialised materials and equipment for vaccines.

Transferring tricky tech

It’s not just vaccine recipes and manufacturing facilities that drug makers in poorer countries need to up their vaccine production.

Moderna and Pfizer’s Covid-19 vaccines, for example, are based on mRNA technology; even if a patent waiver is granted, vaccine makers without mRNA know-how won’t be able to produce these jabs. Moderna CEO Stéphane Bancel has said anyone trying to reproduce the company’s vaccine “will have to figure out how to make mRNA, which is not in our patents”.

Mei Mei Hu, CEO of Vaxxinity, also believes the focus on IP rights is misguided. She says that while her company is “dedicated to serving the underserved”, patents are not responsible for vaccine scarcity in low-income countries.

“Vaccines are complex biologics, they’re not something that you can just genericise,” Hu explained in an earlier interview with Pharmaceutical Technology. “First of all, a lot of developing countries don’t have facilities that are able to produce a lot of these vaccine technologies. Even if they did, tech transfer is very difficult; it’s not just like you have a formula and you can reproduce it – these things take months, if not years.

“In this case of the pandemic, I don’t think that waiving [IP] will alleviate what we’re trying to solve.”

It’s true that those hoping to reproduce certain vaccines will need to understand the technology behind them. For People’s Vaccine Alliance health policy expert Dr Mohga Kamal-Yanni, this means pharma companies should be sharing not just the recipes for vaccines, but the tech and know-how required to make them.

“For some of the vaccines, it’s possible to produce without a massive technology share, but many vaccines are not at that level,” she previously told Pharmaceutical Technology. “You wouldn’t get the many companies that you want producing unless you are sharing technology as well as waiving IP … You do need both.”

In May 2020, the World Health Organization and partners set up the Covid-19 Technology Access Pool, where vaccine and drug makers can voluntarily share intellectual property, knowledge, and data to help manufacturers with untapped capacity to boost the production of Covid-19 health products. So far, the pool is yet to see a single contribution from the pharmaceutical industry.

“We need pharmaceutical companies and research institutions to put their technology in the pool, so that the pool can licence and transfer technology to all other potential companies everywhere, including in developing countries,” Kamal-Yanni said.

TRIPS and transparency

Matthews says the IP waiver debate has prompted “renewed focus” on the possibility of sharing patents, technology and knowledge with poorer nations – but even if patents are waived and technology is transferred, he says, increased vaccine production requires further transparency.

“[A waiver] in itself wouldn’t give potential manufacturers all the information that they need about how to manufacture and store the vaccine,” Matthews explains. “You’d need information about cell lines and the types of tacit know-how that I was referring to earlier, particularly this sort of know-how about how you make small adjustments during the manufacturing process.

“This is probably information which is in people’s heads; it may not be written down anywhere,” he says. “So how do you actually access this type of tacit knowledge, which is covered by the TRIPS agreement? The trade secrets part of it might just be in somebody’s head – how do you enforce a waiver on that?

“This is why it might be difficult to achieve a waiver access all the types of relevant IP quickly, because of course, you might need to threaten the vaccine manufacturer with a lawsuit in order to force them to reveal tacit information. But it’s difficult to prove what that information is if it’s not written down anywhere.”

Lessons for the future

If, as many have argued, IP isn’t the sole obstacle to increased vaccine supply, should the waiver proposal be scrapped altogether? Or would waiving vaccine patents for manufacturers worldwide solve one part of a very complex challenge?

“I do think that the IP is part of the problem, despite repeated statements from the International Federation of Pharmaceutical Manufacturers & Associations and the European Union that it’s not,” Matthews says.

“Something like 100 member countries of the WTO from the developing world have said that the IP is a problem, so it’s very difficult to sustain an argument that it is not.

“I think, given the procedural issues of the WTO, that consensus is required of all WTO member countries, we’re likely either to see a watering down of current proposals from India and South Africa, or a substantial delay in actually achieving the waiver.”

For Matthews, the pandemic is an opportunity to properly address the drug access and manufacturing limitations that low and middle-income countries disproportionately face, and better prepare for any future public health crises.

“I think historically there has been an absence of planning and pandemic preparedness, so there’s an endemic lack of production capacity in middle and low-income countries, which is exacerbating the current problem.

“The attention is now focusing not only on the current pandemic response, but also what lessons we can learn to improve pandemic preparedness and pharmaceutical innovation in response to future global healthcare crises,” he says.

“By transferring technology and scaling up production in middle and low-income countries now, this will be part of the strategy of being prepared for the next pandemic, so we’re not in the same position again.”