Week's news analysis

Building the European Health Union

By The Editor - 18 November 2020

The European Health Union is on track; mid-November European Commission president, Ursula von der Leyen offered a €5 billion budget dedicated to health over the next seven years.

In the scheme, the Centre for disease prevention and control (ECDC), with strengthened skills, would become the " armed wing " of this new strategy while the European Medicines Agency would also be reinforced and empowered. Last but not least, a new agency would support capacity and readiness to respond to cross-border health threats and emergencies, "whether of natural or deliberate origin". "We need strategic stockpiling to address supply chain dependencies, notably for pharmaceutical products", she added.

According to Mrs von der Leyen, Covid-19 has exposed "the fragility all around us" and laid bare "the strain in our health systems." Before adding that the European Commission has also 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.

Von der Leyen's opinion marks a very big change in Europe. While American drugmanufacturers race to be first to bring to market a vaccine against Covid-19, European companies seemed to have been left behind for months. Several companies' CEO even complained against the situation. In Pharmanetwork's last issue on relocation, CDMOs also claimed for such an organization In The United-States, alongside American Big Pharma, the US Biomedical Advanced Research and Development Authority (BARDA) plays an amazing part, financing R&D programs and scheduling what could be the launch of future and promising vaccines candidates.

Created in 2006, BARDA has been at the forefront of research since the beginning of the pandemic. Linked to the department of Health, it is in charge of ensuring the availability of sufficient quantities of drugs in the case of a major sanitary crisis. With a $1.6 billion budget, BARDA finances private laboratories for their R&D projects and also to ensure their manufacturing capacities. For the last months it has concluded several partnerships with Pfizer, AstraZeneca and even Sanofi. 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.

Europe has not the same organisation. The EMA only gives approvals to new treatments; its doesn't grant subsidies to R& D projects and its budget doesn't exceed €400 million. That is why Ursula von der Leyen's ambitions for the European Union to play a greater role in health, is so important, as the new agency "for late stage biomedical research" will be modelled on the US Biomedical Advanced Research and Development Authority (BARDA).

In June, it was agreed that the European Commission 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.

Mid-November, the EC finalised an advance purchase agreement with Pfizer and BioNTech for the initial supply of 200 million doses of their experimental Covid-19 vaccine, with an option to request up to a 100 million more. Other deals were signed with AstraZeneca, a partnership with Sanofi and GlaxoSmithKline, and another one with Johnson & Johnson. "With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials," remarked Ursula von der Leyen. The coming months will bring information on the accuracy of the European plan.

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