A BioNTech/Pfizer Covid-19 vaccine is administered at a Düsseldorf pharmacy earlier this month
A BioNTech/Pfizer Covid-19 vaccine is administered at a Düsseldorf pharmacy earlier this month © AFP/Getty

Pierre Delsaux faces a tricky task in trying to prepare the EU for future disease outbreaks, with the pharmaceutical industry and campaigners arguing over the lessons to be learned from the Covid-19 pandemic.

He has been appointed director-general of Europe’s new Health Emergency Preparedness and Response Agency, launched last September, to scan for new threats and identify potential solutions — with an annual “peacetime” budget of €1bn, which will increase during emergencies.

According to most in the pharma industry, the pandemic has shown innovation at its finest — and this work should be incentivised by investment and protected with intellectual property rights. But civil society advocates believe the West has failed to deliver equal access to vaccines to developing countries, and suggest that future funding should come with a commitment to waive patents.

Delsaux admits it will be “challenging” to bridge this gap. “I know it’s a very important issue,” he says. “Of course, I hear what the industry is saying, and I hear what civil society is saying. And we know we’ll have to face it and to find a way out.”

HERA’s formation has been further complicated by the EU’s plan to review all regulations related to the pharmaceutical industry by the end of the year.

Nathalie Moll, director-general of the European Federation of Pharmaceutical Industries and Associations, says HERA and the EU pharmaceutical review are “locked together”. There is overlap on broad issues — such as ensuring the European medicines regulator can move as nimbly as others — and on specific measures, like the incentives for combating antimicrobial resistance by investing in new antibiotics.

Pierre Delsaux: ‘We don’t want to be limited to Europe, we really want to reach outside of the EU’
Pierre Delsaux: ‘We don’t want to be limited to Europe, we really want to reach outside of the EU’ © European Commission/Claude M Cauwe

However, Moll worries that the EU could be too prescriptive in how it funds research, and fail to understand how breakthroughs occur. For example, BioNTech’s Covid-19 vaccine come out of investments that the German biotech had made in cancer therapies.

“If we get it right, and the pharma legislation review has all the right policy instruments and environment, it will attract innovation into Europe and feed into a HERA that works,” she says. “If you get it wrong, you will see innovation leaving. It doesn’t matter how many HERAs you have, setting up a response will be harder if you don’t have innovation here and are dependent on the other countries.” 

She believes in improving access to medicines but says this challenge should be addressed separately, fearing it is “risking penalising innovation”.

But Ellen ’t Hoen, a lawyer and public health advocate with Medicines Law & Policy, a think-tank, says HERA should guard against pandemic preparations becoming “another Big Pharma bonanza”.

She suggests the agency is right to emphasise the importance of financing research and development, but that it also needs to consider how to ensure intellectual property — and the technical knowhow required to implement it — is shared.

“This will be wonderful corporate philanthropy, if it comes without strings attached that ensure the measures become internationally available,” ’t Hoen says.

Rosa Castro, manager of the European Alliance for Responsible R&D and Affordable Medicines — which comprises consumer, patient and public health organisations — warns that innovation should only be part of the plan to respond to a future outbreak.

“If you look at what’s happening right now, we have the fantastic development, from a scientific point of view, of vaccines and their approval,” she says. “[But] the big problem we have is access around the world.” 

HERA’s mission also includes leading the response to threats when they develop. To do this, it is building a bloc-wide stockpile of medicines, and creating a network of “ever warm” domestic production facilities for essential drugs, known as EU FAB.

But the industry is concerned that other EU rules — such as limits on state aid, outside of the poorest regions — could interfere with efforts to improve preparations for a future pandemic.

Generic-drug manufacturers are pressing the EU to recognise the need for reliable supplies of even the least innovative medicines, backing a French proposal to suspend state aid rules and allow more government investment in the production of drugs.

Michele Uda, director-general of the Italian generics and biosimilars association, says the EU needs to understand that there is important innovation in the manufacturing of off-patent drugs, such as the sterile injectable medications that were in high demand during Covid surges.

“You can have the best Covid antivirals but, if you don’t have the drugs for ICU, you can’t keep the patient alive,” he points out.

Unlike its US forerunner, the Biomedical Advanced Research and Development Authority, HERA has to juggle the needs and desires of 27 countries. And, as many other countries rush to secure their own domestic production — prompting fears of even more ruthless vaccine nationalism — Delsaux says his agency also understands the need to work closely with the rest of the world.

HERA has already been in touch with countries from Africa to Asia to the Americas, giving it a more international perspective than BARDA’s “more inward focus”, he notes. It wants to help build production capacity and surveillance for future threats in Africa.

“Clearly, we don’t want to be limited to Europe, we really want to reach outside of the EU,” Delsaux says. “We realise that, if we want to find a solution for the next crisis, like the one in which we are, we need to help poor countries.”

This article has been amended to clarify that Nathalie Moll said HERA and the EU pharmaceutical review were “locked together”, not that HERA and the European Federation of Pharmaceutical Industries and Associations were

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