Monday, June 1, 2020

Now Will Europe Pull it Together?

Could Europe’s recent moves to provide bailout monies Europe-wide have implications for incentives for antibiotic R&D? A few months ago, Christine Ardal and colleagues published a paper discussing the European approach to these incentives. In their paper, they noted that decisions around drug pricing and everything related to drug reimbursement were the responsibility of the various national authorities and not the European Commission. They did suggest that the European Medicines Agency, the European regulatory agency from drugs, could identify products that would qualify for any incentives that might be available. They suggested that individual countries could contribute to the European Investment Bank to support a regional incentive. Ardal et al also pointed out that Europe assumed that their responsibility for such in incentive on a global scale would be about 30% based on antibiotic market data. I wrote an editorial response to their paper where I suggested that incentives for antibiotic R&D would have to be a European responsibility since that was the only authority with enough financial clout to provide effective incentives for the region. Relying on the contributions of individual countries, I suggested, would not be sufficient. Ardal et. al. did note that transferable exclusivity vouchers would be possible in Europe, but that any “guardrails” that might be required to limit the size of the reward would still be a decision of the national authorities. This, in my view, renders that approach impossible. Further, I noted that even if Europe could agree to provide an incentive that amounted to 30% of what is required, there might be no point since the participation of countries outside of Europe and outside Europe’s control would also have to agree to participate. I suggested that Europe as a region could take the lead in providing a more substantial incentive for antibiotic R&D if for no other reason than to protect their vulnerable populations.

Enter the coronavirus pandemic. According to the New York Times, “The European Commission, the bloc’s executive branch, on Wednesday proposed that it raise 750 billion euros, or $826 billion, on behalf of all members to finance their recovery from the economic collapse brought on by the virus, the worst crisis in the history of the European Union.” “’This is about all of us and it is way bigger than any one of us,’ Ursula von der Leyen, the commission president, told European Parliament members in a speech in Brussels. ‘This is Europe’s moment.’”

In my editorial, I cited Flora Lewis’ book, Europe, A Tapestry of Nations, in discussing the balance between lines of national sovereignty and European union. Since the establishment of the European Union in 1993, and its precursor, the European Economic Community back in 1958, all aspects of finances and health including taxes, health insurance, drug pricing and others were responsibilities of the national authorities. This changed little with the introduction of the Euro to a portion of European Union countries in 1999. But here we are today, 27 years after the formation of the European Union, with the first steps of Europe into federalism. And with federalism comes the ability to commit Europe, with all its member nations, to common financial activities for the good of all. Incentives for antibiotic R&D should be one of the first European priorities of this new federalism.

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