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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
The search for a coronavirus vaccine is just one of many questions unanswered on European health policy.
As Europe goes into its habitual summer vacation—as effective as any lockdown in stalling activity, there have never been so many questions unanswered on European health policy—and never have they been so urgent.
Top of the list is the search for a coronavirus vaccine. The key question here is of course if and when a vaccine will emerge—and if it will prove effective. But the EU has adopted an assertive stance in support of the necessary innovation efforts. Last month it boldly announced its plan to reach advanced purchase agreements with manufacturers of vaccines to secure adequate supplies for its citizens. The central role of a vaccine was highlighted by no less an authority than the President of the European Commission, Urusula von der Leyen, back in April, delivering the ‘joint European roadmap towards lifting Covid-19 containment measures’. "Societies will have to live with the virus until a vaccine or treatment is found,” she acknowledged. And the 'roadmap' underlined the point: "The development of a safe and effective vaccine is crucial”, and “its development and fast track introduction are therefore essential.” European health ministers and the European Parliament have also endorsed the approach.
Since then, the EU has put millions into companies conducting vaccine research and has offered billions of dollars more in an adventurous scheme for advanced purchase agreements to defray companies' upfront development and manufacturing costs. So far however, there are no final agreements with any of the leading candidates. All it has done to date is to purchase 30,000 doses of the anti-viral remdesivir from Gilead for $6 million—possibly useful, but at best only a stopgap for a marginal treatment. It did, at the end of the last day of July, announce it had completed "exploratory talks" with Sanofi on a possible purchase of 300 million doses of a possible vaccine. But the questions remain, after all the fanfare, when will deals be struck with vaccine manufacturers, and with whom? What terms will be set for access to any resulting products? How will the EU's super-deals be coordinated with the separate deal already signed by Germany, France, the Netherlands and Italy in a novel four-country vaccine alliance with AstraZeneca? Or with whatever comes of the UK's defiantly independent backing for other candidates?
There are other imponderables on which there may not be many answers until the fall. Most topically, a crucial and long overdue report on EU incentives for research into rare diseases, which had still not appeared as July drew towards a close. Word on the street is that the EU is looking for justifications to cut back on these controversial incentive schemes, because of widespread criticism that they encourage the drug industry to impose abusive terms and prices for limited innovations. Ironically, however the pandemic has focused new attention on the need for more research, and more innovation—and so much of the running in the vaccine race is being made principally by the maligned private sector. So, will the new change of heart about the practical merits of innovation blunt the political ardor for tightening controls drug firms?
How far will the recent recognition of the key role of drug research influence the evolution of two other European initiatives that are supposed to come to fruition over the coming months—the two new parallel programs for tackling cancer? And by coincidence, the early discussion of a promised new pharmaceutical strategy for Europe, scheduled to appear in November, is now heavily conditioned by the drug shortages that Europe experienced over recent months. As a result, much of the thinking is devoted to incentives to strengthen the industry—and even to fiscal or government aid encouragement for drug firms to repatriate to Europe their manufacturing. Will the fall mark a rise in drug industry political fortunes in Europe?