EU to create new biomedical research agency modelled on BARDA

European Commission president Ursula von der Leyen has scoped ambitions for the EU to play a greater role in health, with plans to create a new agency for late stage biomedical research modelled on the US Biomedical Advanced Research and Development Authority BARDA, reinforce the European Medicines Agency and the European Centre for Disease prevention and Control, and to open a discussion on increasing EU competences in health.

There are no details on the funding or governance of the EU BARDA, which von der Leyen said will build strategic stockpiles to protect against supply chain interruptions, notably for pharmaceuticals.

It will also support the EU’s capacity and readiness to respond to cross-border threats and emergencies, “whether of natural or deliberate origin,” von der Leyen said.

The BARDA plan can be seen as a response to criticisms from the CEOs of two European pharma companies, Pascal Soriot of AstraZeneca and Paul Hudson of Sanofi, who both said Europe needs an equivalent to BARDA, which made it possible to work with a single agency to negotiate advanced purchase agreements for COVID-19 vaccines for the whole of the US.

BARDA is managing ‘Operation Warp Speed’, set up by president Donald Trump to incentivise manufacturers, with the aim of getting 300 million doses of COVID-19 vaccines to Americans by January 2021.

A further call for an EU BARDA lookalike has come from Michel Goldman, former director of the EU public private research partnership, the Innovative Medicines Initiative.

In her first state of the union address since coming into office at the start of the year, von der Leyen aligned herself with the European Parliament in demanding more funding for the EU’s new programme, EU4Health, designed to help member states strengthen their healthcare systems.

The commission proposed EU4Health in response to lessons learned during the pandemic, saying it should get €9.3 billion from 2021 – 2027. In July, the EU Council chopped this to €1.7 billion. Von der Leyen told MEPs she is standing by the European Parliament in its “fight for more funding to remedy cuts made by the European Council.”

Making the case for increased competences in health, von der Leyen said the EU response to the pandemic demonstrated it can play a critical role, ensuring the smooth flow of medical supplies across borders and collaborating with industry to boost production of diagnostics, ventilators and protective equipment. Learning the lessons from this pandemic response, “we must discuss the question of health competences,” von der Leyen said.

What will an EU BARDA add?

In response, Belgian MEP Petra de Sutter said EU4Health and Horizon Europe need strong budgets to see off COVID-19 and protect against future threats. “These flagship programmes are crucial for the next generation of Europe, and we will fight for them,” de Sutter said.

Jan Palmowski, secretary general of the Guild of Research-Intensive Universities said setting up a BARDA lookalike is an important step towards strengthening Europe’s biomedical research and seeking new competencies in health. “All these things are to be welcomed from a research and innovation perspective,” he said.

But EU BARDA should not be funded from Horizon Europe, which is already stretched thin over many research and innovation priorities, said Palmowski. “It is crucial that it doesn’t take away Horizon Europe funding,” he said. “We will need to see where the money comes from.”

Thomas Jørgensen, senior policy coordinator at the European University Association wants more details about the new agency and what it can add to the EU’s existing biomedical research. “We have to see what it is, and what is the added value to what we already have,” he said.

The BARDA announcement apart, von der Leyen’s speech made it seem that research and innovation has “disappeared from the radar of the commission,” Jørgensen said.

The commission is due to announce a shake-up the European Research Area and launch a ‘Digital Education Action Plan’ and a separate set of objectives for refreshing the European Education, but neither were mentioned in the speech. Jørgensen said researchers and universities need to “have the reassurance that these are priorities for the commission.”

Prioritising digital sovereignty

That any of Europe’s economies were able to carry on functioning during lockdown is a potent illustration of the need for strong digital networks. Reflecting on that, von der Leyen said the economic recovery is, “a unique opportunity to develop a more coherent European approach to connectivity and digital infrastructure deployment.”

The EU will invest €8 billion in European-made supercomputers, help industry to develop the EU’s own next-generation microprocessors, and build a European cloud based on the Franco-German cloud computing project, Gaia X.

To better protect personal data, the commission wants to set up a universal secure European e-identity system. Instead of relinquishing data to any app or website that asks for it, Europeans will be able to use their unique e-identity for all transactions, from paying taxes to renting bikes.

That was welcomed by Estonian prime minister Jüri Ratas, whose country has been a trail-blazer in e-government.

These separate projects will come together in a coherent digital strategy that will reduce the EU’s dependence on foreign technologies, said von der Leyen. “None of this is an end in itself - it is about Europe's digital sovereignty, on a small and large scale,” she said.

Tougher climate targets

On climate change, von der Leyen announced tougher CO2 emission targets for 2030, shifting the goal from a 40 per cent decrease compared to 1990 levels, to at least a 55 per cent fall. To make this happen, the commission will revise all EU climate and energy legislation by next summer.

The green transition will result in a systemic modernisation of Europe’s economy, society, and industry, with von der Leyen saying she is puts her trust in SMEs to come up green technologies and ensuring, “we can have a successful economy without destroying the planet.”

“Without SMEs we cannot make much progress. We know that they are the backbone of our economy,” said von der Leyen. To fund the green transition over the next three years, the EU will spend 37 per cent of its €750 billion recovery fund, NextGenerationEU on Green Deal objectives.

Speaking on behalf of the European Council, Germany’s Europe minister, Michael Roth, said von der Leyen’s plans present an “optimistic vision of Europe”. However, he warned von der Leyen not to expect that “the council will support all your proposals unreservedly.”