LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines.

The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.

At this stage, there are no details about funding or governance of European BARDA, but Von der Leyen said it will build strategic stockpiles to protect against supply chain interruptions, notably for pharmaceuticals.

In a set piece speech to the European Parliament, Von der Leyen, a medical doctor, said COVID-19 has exposed “the fragility all around us” and laid bare “the strain in our health systems.”

In response, she is calling for the European Commission (EC) to have more influence over health, an area where currently member states hold – and fiercely defend – all responsibility.

In addition to the BARDA lookalike, Von der Leyen said she wants the EU to “reinforce and empower” the EMA and the European Center for Disease prevention and Control.

Ursula von der Leyen, president, European Commission

She also took aim at the World Health Organization (WHO), saying it needs reform, but that this should be “change by design – not by destruction,” adding, “I want the EU to lead reforms of … WHO so [it is] fit for today's world.”

Von der Leyen lined herself up on the side of the European Parliament and in opposition to EU national governments, in demanding more funding for a new program, EU4Health, designed to help member states strengthen their health care systems.

The commission framed EU4Health in response to lessons learned during the pandemic, proposing it should get €9.4 billion (US$11.2 billion) from 2021 – 2027. However, in July, heads of state in the EU Council chopped that back to a meagre €1.7 billion. Von der Leyen said she is standing by the European Parliament in its “fight for more funding and [to] remedy cuts made by the European Council.”

The European Commission may have very little influence over health, but Von der Leyen said despite that, the EC has demonstrated it can play a critical role, ensuring the smooth flow of medical supplies across borders, arranging for COVID-19 patients to be treated in different countries, and working centrally with industry to increase production of diagnostic tests, ventilators and protective clothing.

That underlines the need to give the EU a far stronger role. Learning the lessons from the pandemic response, “we must discuss the question of health competences,” Von der Leyen said.

After a stuttering start, it was agreed in June that the EC would negotiate COVID-19 vaccines advance purchase agreements on behalf of all 27 member states, using a €2.3 billion emergency fund for down payments. That led to outline agreements with leading vaccines developers in late July and August.

The U.S. moved much faster, making investments in two vaccines being developed by European pharma companies Sanofi SA/Glaxosmithkline plc as early as February, and with Astrazeneca plc in May.

Both Pascal Soriot, Astrazeneca CEO, and Paul Hudson, CEO of Sanofi, have called for a European equivalent to BARDA, to back companies to develop treatments for infectious diseases. Operation Warp Speed, run by BARDA to speed development of COVID-19 vaccines, made it far easier to negotiate U.S. advance purchase deals, the two CEOs said.

Lobbying also has come from other sources, such as Michel Goldman, former head of the Innovative Medicines Initiative, the EU-funded public-private biomedical research program. Europe has “fallen short” in matching the U.S. effort to incentivize COVID-19 vaccine innovation, Goldman said, calling for the creation of a U.S. equivalent to BARDA to redress that.

In addition to stepping in to negotiate COVID-19 vaccine contracts on behalf of all member states, Von der Leyen pointed to the way in which the EC took the lead in the effort to ensure global access to a vaccine as proof of its competence to set up a European BARDA.

“At the beginning of the pandemic, there was no funding, no global framework for a COVID vaccine – just the wish to be the first to get one,” Von der Leyen said. The EC brought together more than 40 countries to raise €16 billion to finance vaccine research. “This is the EU’s unmatched convening powers in action,” she said.

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