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Reflector is Pharm Exec's Brussels correspondent.
Must maintain trust in face of customary, non-pandemic challenges.
COVID-19 remains at the forefront of the priorities of the leaders of the European Union. The discussion of Europe’s responsiveness was a major item on their October summit in Brussels, to such an extent that the pandemic was right up at the top of the statement the 27 member states’ prime ministers and presidents signed up to at the end of their two-day meeting.
“The European Council”—as these summit meetings are known—“assessed the current epidemiological situation, which is unprecedented and gives rise to very serious concern,” the statement concluded. That may seem nothing more than a routine statement—even an understatement—of the obvious. But in the context of Europe’s complex governance, the statement is the equivalent of diplomatic dynamite. Placing health issues at the top of the EU agenda—ahead of the customary topics of climate change, economic recovery, Brexit, or relations with Russia or Turkey—is an inversion of more than 50 years of EU policymaking, during which health languished as barely more than an occasional footnote to the deliberations of heads of state and government.
The statement explicitly welcomed “the work at EU level on the development and distribution of vaccines”—work which has itself reached unprecedented levels of intrusion into the EU’s customarily hands-off approach to the way its member states handle health matters. Not only has the EU ploughed upwards of $2 billion into backing half-a-dozen selected companies developing vaccine candidates, it has also issued what amounts to instructions to national authorities about how to allocate and distribute any of the vaccines that become available. And it has set up an EU-wide system interoperability gateway between the multiple national contact tracing apps. On top of that, it has started to make purchase agreements for other COVID drugs. Shortly before results emerged from the WHO trial about the indifferent performance of Gilead’s Veklury (remdesivir), and amid shortages of the medicine in Europe, the EU arranged to buy sufficient doses of Veklury to treat some 3,400 patients.
And this is where the stakes are getting very high. The vigorous EU action on promoting a response to the pandemic has won praise for establishing a new level of coordination among countries notorious for going their own way on health policy. Advocates of greater EU collaboration on this fundamental aspect of European citizens’ lives see the pandemic as a catalyst for a radical and long-overdue change in the EU’s approach to health, and have revelled in the EU Commission’s evident ambition to create what is now being referred to as a European Health Union. But already questions abound on the effectiveness and appropriateness of this top-down drive toward systematic—and manifestly centralized—collaboration.
The most immediate question as October drew to a close was the decisions taken over remdesivir. The EU authorities granted the product conditional approval in early July for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen (the US approved Veklury for COVID last month). Now, in Europe, questions are being raised as to the quality of that rushed decision, and over the wisdom of an advance purchase arrangement of a medicine whose efficacy was still to be demonstrated. The EU’s own medicines agency then revealed that its safety committee had started a review of potential severe renal adverse events of Veklury. A wave of skepticism arose rapidly about crisis-driven action, with demands for further information about how the EU could have made such decisions.
But that is a side-show compared with the questions that will have to be answered about the massive investments the EU has promised to drug firms to develop and manufacture effective vaccines. Awkward queries are starting to be raised about the trial protocols for the subsidized products, about their likely efficacy, and about the return that manufacturers are likely to make on the back of major public investment: at least one of the beneficiary firms has provoked ire already by conditioning non-profit promises to only “as long as the pandemic lasts.” Wider realization is also dawning that—contrary to the depiction of vaccines as something like a cure-all that could restore normality by next year—it will need a much wider therapeutic arsenal to control COVID, and restoration of normality is far from guaranteed, next year or even in the years after.
The EU’s assertive approach can be seen as noble. Few would argue against the logic of combining forces to fight a pandemic. But the EU has set itself a difficult challenge at a difficult time. If its plans do not produce dramatic positive results in 2021 that match the expectations it has built up, the disappointment will be overwhelming. That could tip the balance against maintaining its credibility—and not just for health.
REFLECTOR is Pharmaceutical Executive’s correspondent in Brussels