New Structures to Tackle New Challenges in European Healthcare

Applied Clinical TrialsApplied Clinical Trials-05-01-2021
Volume 30
Issue 5

Pressure mounts in Brussels as calls for new ways to debate pharma policies come from all directions.

Pressure is mounting in Brussels for the creation of new structures to debate pharmaceutical policy—with the drug industry making most of the running. It's a critical moment in Europe for policy formation on healthcare (although COVID has made that observation true for practically everywhere in the world). The drivers in Europe are not just COVID, but a growing sense among many actors in the healthcare world that longstanding divisions amongst them are inhibiting the sort of improvements that European citizens are entitled to expect.

At official level, the European Union has already acknowledged the need for some closer alignment between its distinct but overlapping institutions, with the emergence of declarations of intent to create a European Health Union and promises of a radical review of EU rules on pharmaceuticals—all predating the arrival of COVID's additional impact of concentrating minds. In concrete terms, the most visible new official moves so far are the structures created for joint procurement of supplies of COVID vaccines, and new links between the European Medicines Agency and the European Centre for Disease Control for combating drug shortages. But there is support within the European Parliament and the European Commission for more ambitious official EU engagement in health policy and a corresponding extension of EU competences into traditionally national government territory—although as a telling demonstration of the sort of divisions that dominate Europe, this is viewed by many of the member states in the EU's Council with extreme caution and has even provoked some downright resistance.

But the pressures come from other actors too. A broad-based grouping, the self-styled EU Health Coalition, has entered the fray with a call for "a permanent multi-stakeholder forum for better access to health innovation." This is needed, it says, to "contribute to guaranteeing more equitable access to health innovations for all European citizens and patients." The group's make-up is an interesting mix: medical specialty organizations, rare disease support groups, patient federations, biobanks, the Wellcome Trust - and a phalanx of industry associations representing manufacturers and wholesalers of medicines and medical devices.

The agenda of this impressive line-up is also an interesting mix. According to its just-released manifesto, collaboration is needed between European policymakers, member states, and all other actors across the health community—and even more so in the wake of COVID. But the aims range from leveraging the latest scientific advances and positioning Europe "as a hub for innovation in health" with "a well-functioning research ecosystem" to recognizing "the right of everyone to timely access" to affordable care, tackling health inequalities, and responding to the widely differing health status of citizens across the economic divides of west and east Europe.

These goals are not, of course, mutually exclusive, or even—in principle, at any rate—antithetical. But their enunciation slides somewhat glibly over the underlying tensions that condition these issues in Europe. There is a suggestion among all the rhetoric that somehow all the problems will be solved if only new drugs and devices get faster market access. The distinctively pro-industry tone—"access to medical innovation and new digital technologies is very patchy across EU countries", with the blame laid largely at the door of "reimbursement processes whether national or regional"—is an odd match with the references to low life expectancy in Bulgaria or challenges in providing care to populations discriminated against by gender or ethnicity.

The strongly pro-industry messaging was reinforced when the head of the main European drug industry federation praised the manifesto during a multi-stakeholder conference on access to medicines at the end of April. "As an industry we have no doubt that it is only through jointly analyzing and addressing barriers to access, availability and affordability of medicines that we will reach successful and sustainable solutions for today and tomorrow’s patients," said Nathalie Moll, the director general of EFPIA—and a prime mover in the formation of the coalition. "This is why we strongly support the call of the EU Health Coalition to the Portuguese Presidency ahead of today’s event for the set-up of an EU Forum for Better Access to Health Innovation, a paramount steppingstone towards the achievement of the shared goal of equal access to innovation across the EU," she added.

Other healthcare actors in Europe who are not members of the EU Health Coalition have taken a different view—ranging from the most radical, who accuse the drug industry of ruthlessly exploiting powerful monopoly positions to lobby for profit, to respected politicians and officials who urge a healthcare approach that focuses more on prevention and health promotion than on treatment. Healthcare payers such as the mutual insurance association AIM, with a focus on patients rather than on healthcare providers, are actively seeking to build coalitions of other like-minded players, while groupings of national healthcare agencies—often incorporating patients and consumers in their deliberations on healthcare strategy—have refused to admit industry representatives.

This is not to argue against the principle of seeking better understanding between groups with—often—diametrically opposed interests. No-one would deny that Europe's healthcare provision is perfectible—to say the least. And the better solutions to the complex problems of healthcare are always going to come from seeing the bigger picture together rather than from trench warfare among hostile groups. But the process will be more constructive if it is based on precision and clarity and candor in forming groups and setting agendas—without which the prospects for better understanding are reduced rather than increased.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

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