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Reflector is Pharm Exec's Brussels correspondent.
The Commission’s gestures toward enacting formal standards to digitize health records are masking wider policy gaps.
The subject of health merits only one mention in the European Commission’s entire planning for next year-and that relates to electronic health records. Advocates of digital health might argue that this shows a belated European Union (EU) recognition of the ever-widening opportunities of digitalization. Cynics might counter that the choice shows how little the EU cares about health in general, and that it has merely taken the easy option of a nod toward a small corner of its wider strategy on the digital economy.
Both could be right.
The formal recommendation in the 2019 action plan is to establish a format for a European electronic health record (EHR) as from the first quarter of the year. This certainly fills an obvious gap in EU planning. Europe’s embryonic eHealth infrastructure is at present limited to patient summaries and e-prescriptions, and does not cover EHRs. Exchange of patient data from one EU country to another currently depends on the voluntary cooperation of health authorities, and is subject to all the challenges of non-standardized systems.
So the Commission is pushing for agreement among national authorities on an EHR exchange format based on open standards-and, of greater significance for pharmaceutical executives, it wants the infrastructure future-proofed to take account of the use of data for research.
The aim is to link EHRs to the currently scattered national and regional banks of -omics data, biobanks, and other registries across the EU. Already there are officials within the Commission who are talking of access to one million sequenced genomes in the EU by 2022, and to a prospective population-based cohort of at least 10 million people by 2025. They see the scope for links to integrated molecular profiling, diagnostic imaging, lifestyle, microbiological genomics, and environmental data.
All very ambitious-in theory. The problem is, there is no real mandate for the EU to act here, and no real money either. Some EU countries-Estonia is always cited as the poster-child-are already heavily committed to taking advantage of digitalization in general, and on health in particular. Many show little enthusiasm. Most do not inject the resources into digital health to make a reality of it-and without that, no EU encouragement can make much difference. The Commission’s action plan makes only an imprecise passing reference to the EU’s own limited research and IT support programs-but as an expression of optimism rather than commitment.
There has been plenty of lip-service over the last few years to the perceived potential of digital health. A European Parliament request back in 2015 urged “improving patient safety to be explored, inter alia, via
electronic health records.” The EU Health Council remarked in December 2017 on the need to “remove obstacles to data exchange and sharing between health professionals for the safety and continuity of care.” And a Commission think-paper in April criticized the “incompatible formats and standards in electronic health record systems (that) continue to be used across the EU.” It mooted promoting interoperability of member states’ EHR systems “by supporting the development and adoption of a European EHR exchange format.”
Now, all that has emerged is a skeletal item in the work plan for what is, in any case, a lame-duck administration. This is the last year in office of the current European Commission, before a new set of commissioners-and a new president-is appointed to take over for five years from next November. So the EHR initiative is as easy to depict as a glass half empty as a glass that is half full.
What is absent from the Commission work plan for 2019 is perhaps as revealing as what is included in it-and particularly for pharmaceutical company executives.
There is nothing, for instance, on what is going to happen to the EU’s drug-research incentive schemes. Despite all the fevered debate since the Netherlands suggested back in 2015 that pharmaceutical companies were abusing orphan drug therapy awards or the benefits offered under the pediatric medicines scheme or the supplementary protection certificate, uncertainty will continue to hang over the future.
A Commission official involved in these lengthy reflections confirmed in November that no moves toward decisions would even begin to be discussed until 2020.
There is nothing either on what the EU should or should not do in respect of drug pricing-despite increasingly loud clamoring for tighter controls, particular on high-priced innovative products. Hardly a day goes by in Brussels without a new call from some influential quarter for radical change, principally a stricter reimbursement system.
There is nothing on how to reconcile the conflicts facing the research-based industry, which feels-as senior executives candidly admitted at a conference on pediatric medicines in Brussels in late October-under growing pressure, caught between governments and society demanding cheaper drugs, and physicians and patient advocates urging increased investment in R&D.
The pressure is intensified by the wave of concerns now sweeping European activist circles that society is paying twice for new medicines-not only in reimbursing pharmaceutical and biotechnology manufacturers, but in subsidizing their research through public funding of the underlying science they depend on.
Nor is there anything on how the Commission intends to square the circle of Europe’s health technology assessment (HTA) debate.
Its proposal of streamlining the multiple national HTAs into a single agreed joint assessment at EU level is stridently opposed by national governments and the European Parliament demanding any number of get-out clauses that would in essence perpetuate the current duplication, and defeat the object of the exercise.
The debate rumbles on without any sign of a breakthrough, leaving pharmaceutical executives facing persistent uncertainty over when they can expect a more rational European approach to evaluation of their products.
And there is nothing to signal any clear pathway toward adapting regulatory procedures that can accommodate the needs of the growing number of new therapeutic approaches, where classic randomized clinical trials may no longer be the best procedure for evidence generation to support marketing authorization applications for new treatments.
For more than five years, the discussions flashing across Europe have illuminated the urgency of building on real-world evidence, even in small populations, and on opening up the rigid frameworks of 20th century regulation.
Innovative efforts, particularly in rare and complex diseases, could benefit from a more flexible and benign climate, but opposition from national regulators and payers, anxious over relinquishing their habits, seems to have stymied for the present the thinking that had been pioneered not just by industry but also by the European Medicines Agency (EMA).
In other words, on many of the strategic issues of concern to the pharmaceutical industry right now, the Commission has little or nothing to say. In its defense, it must be acknowledged that the Commission’s own powers are limited, and especially on health. Much of it remains under national control-and therefore subject to agreement within the European Council of Ministers.
But those finer constitutional distinctions matter little to a company facing real-time decisions about its European future. Regardless of which EU institution or national government is to blame, the situation for companies seeking a conducive operating environment is always going to be judged on feasibility-and right now, feasibility is difficult to judge in European health policy.
Reflector is Pharmaceutical Executive’s correspondent in Brussels