Applied Clinical Trials
A continued struggle for healthcare and healthcare innovation to be taken seriously by the EU.
Even when the UK ceases to be a member of it, the 27-country European Union will still be among the most powerful and richest trading blocs and markets in the world-an important terrain, therefore, for any established players in healthcare, or any rising stars. But how much does the EU really care about health, and about the infrastructure that is a precondition to successful healthcare and healthcare innovation?
A couple of key developments in early summer offer some clues, some hints, as to the answer. Exhibit A is the EU’s current convulsion over its next long-term budget, and the priorities that this indicates between now and 2027. Discussions are reaching a crescendo in the EU institutions and among the thousands of competing lobby groups over who should get what from the roughly $1.5 trillion up for grabs.
On the face of it, health isn’t in line for a lot-perhaps little more than $400 million. Amid the myriad budget headings-ranging from humanitarian aid to agricultural subsidies and border management to security and defense-health barely features at all, and when it does, it is only as one component among many others in sub-programs with broad-ranging titles such as Investing in People, the European Semester, or Horizon Europe.
The European Patients’ Forum has pointed out that the funding specifically earmarked for health is lower than at present, despite “the formidable common and increasing challenges that European countries are facing” in healthcare. Not much of that will go toward boosting medicines development, either: the focus will be on health promotion, disease prevention and protection, focused largely on combating smoking or alcohol abuse. The two latest calls for tender under the current program are offering more than $200 million for “Implementation of best practices to promote health and prevent non-communicable diseases and to reduce health inequalities”-hardly topics to set the pulses racing of developers of innovative therapies.
The EU’s research program, with a proposed budget of $100 billion to cover fields as diverse as aeronautics, information technology or energy, envisions some allocation for health with the emphasis on the treatment of rare diseases, orphan drugs, and preparedness for pandemics. The European research-based drug industry has offered a muted welcome, accompanied by a plea for a big share for medical innovation.
But these are just proposals at present, and not everyone is pushing for more spending on health, or for spending to be directed to innovative medicines. Non-governmental organizations are chorusing their concern over a failure to target global health challenges, and what they see as a dangerous shift toward a pro-industry focus in the proposals. “When issues of public concern and that are reliant on public investment, like health research, are pitted against private sector interests, there will only be one winner-and it won’t be the billion people living today with a poverty-related disease,” said Cecile Vernant of the German Deutsche Stiftung Weltbevoelkerung charity, urging a fight-back against what she depicts as excessive generosity to drug innovators.
Exhibit B in this brief analysis was a paper discussed in June by the national health ministers who constitute the EU Health Council. This paper, entitled “The Future of Health in the EU,” is intended to prompt ministers to “contribute to shaping the political agenda in the health field at European level”-an apparently curious idea, after more than 60 years of the EU and more than a decade of EU health policy. But it exposes the reality that health policy-such as it is in the EU-is still adrift, still incoherent, blown hither and thither at the whim of circumstance rather than springing from a clear and agreed strategy. The EU treaty provides only limited powers for the EU in health, leaving much of it to national authorities-and the indifference that this has bred about EU engagement in health is all too obvious.
As Council officials said in launching the discussion, there is currently intense debate on the future of all EU policies, and if there is to be a health policy it needs to be seen against “the rapid development in fields such as eHealth, pharmaceuticals, and medical devices.” But the paper itself, authored by Bulgaria, the country in the rotating chair of the health council for the first half of 2018, hardly aims high in its reflections. “Where harmonization cannot be the solution, cooperation can be a bottom-up way to identify best practices and make improvements,” it boldly suggests.
The paper’s main thrust appears to be to deploy EU health policy as a brake to prevent private industry dominating the public health agenda. While the paper acknowledges “the role of industries in generating growth, jobs, and revenues,” it insists health policy should support “delivery for patients,” and “act as a broker, whenever public and private interests diverge.” It concludes by posing two questions to ministers: how can member states shape the agenda on health and respect the EU treaty limitations, and which areas should be the focus for action?
Even before the health ministers’ answers are available-if indeed they choose to answer at all-it seems grimly clear that health is going to continue to struggle to be taken at all seriously in EU policy formation.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium