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Reflector is Pharm Exec's Brussels correspondent.
EU tasked with translating bold declarations into reality.
The European Union was in self-congratulatory mood by the end of 2020. In his end-of-year dispatch, EU Council President Charles Michel not only hailed the bloc’s December agreement on a hard-fought multibillion dollar seven-year plan to recover from COVID-19. First on his list of key moments was health—and specifically vaccines, which were just beginning their rollout across Europe. He saluted “the international community’s achievement in developing vaccines in record time,” and claimed that the EU “took a leadership role in mobilizing international funds for vaccine research.” In similarly triumphant mode, European Commission Vice President Margaritis Schinas saluted the European vaccines strategy as “a historic breakthrough in European integration and the beginning of a new era.” Along with the raft of health-related initiatives that it has announced during this difficult year, the EU is setting itself up as a major new power in internal and international health policy. As 2021 unfurls, it is time to explore just what this may mean for pharmaceuticals.
The most obvious challenge is of course effectively combating COVID, and the performance of the vaccines now reaching European citizens is going to be critical—as is the EU’s ability to coordinate availability and successful delivery in its population. Key variables are going to be how far mutations of the coronavirus frustrate the development work so far and how ready populations are to accept vaccination. The EU will have to do better in collaboration than it did at the outbreak of the crisis, when member states notoriously operated in competition rather than in concert with one another. And the European health authorities will have to overcome residual concerns over their competence and agility, after they took more than three weeks longer than other agencies to authorize the first vaccine. The EU has also committed itself to ensuring vaccine access in the poorer countries of the world—and its international credibility will hang heavily upon how far it lives up to that undertaking.
Among the wider goals that have been enunciated for EU health policy, the stakes are highest on making good on the oft-repeated promises to provide European citizens with access to affordable high-quality medicines. In the face of the persistent and deep divergences in medicines availability across Europe, this multi-headed challenge will demand radical engagement not just from policymakers responsible for health, but also the finance and economics and social policymakers who have invariably been preoccupied with other concerns. Effecting real change here will also confront the EU yet again with the dilemma that despite its ambitions, the EU treaty gave it little power in health policy, because national governments remain solely responsible for decisions on healthcare delivery.
New mechanisms for chipping away at this blockage of national sovereignty on health are under active discussion. A grandly titled pharma strategy for Europe was presented by EU officials in November, filled with ringing declarations of intent on satisfying patients’ aspirations and needs. An even more grandly titled European Health Union had already been announced in September, partly to focus thinking on joint responses to COVID, but more to open up the prospect of deep coordination and perhaps treaty changes to give the EU more clout in what have been purely national decisions on health. A number of nuts-and-bolts programs are also being put in place at a more tactical level: a Beating Cancer Plan, a Cancer Mission, a so-called European Health Data Space for sharing drug information for epidemiology and for research, a specific health program with—for the first time—a substantial $2 billion budget.
Europe is currently awash with policy papers saying all the right things about preventing drug shortages, adjusting incentives for research, harmonizing health technology assessments, and promoting a competitive and innovative European industry. At the same time, the policy papers frequently inveigh against drug industry monopoly powers, price-gouging, patent abuse, and prioritizing profit over patients. The goals may be admirable, but they are frequently bordering on the incompatible. And in consequence, the ambitions are articulated as just that—ambitions, with little indication of how to get from ambition to realization.
To make good on its boasts, the EU must find agreement not only with member states in realizing its dream of a bigger role in health policy, but must also grapple with the widely differing political currents in the national governments that make up the European Council, and within its own European Parliament. That kaleidoscope, too, is no more than the crystallization of the numerous conflicting views among “stakeholders” about the purposes and priorities of health policy, and the place of profit in the provision of medicines. As more concrete proposals emerge, 2021 will show how far the confidence of late 2020 is justified.
Reflector is Pharmaceutical Executive’s correspondent in Brussels