The European Union Guessing Game


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-10-01-2018
Volume 27
Issue 10

A new report on EU's digital health strategy also calls for closer coordination of national HTA arrangements-but both policy initiatives couldn't be more different.

The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it (to say nothing of those who should know more-as an upcoming debate about digital health will reveal).

The byzantine relations between the EU’s institutions and the Jesuitical distinctions in its terminology are aptly illustrated by the fact that the European Council is quite different from the EU Council of Ministers, and the President of the Council is not the same as the rotating Presidency-and none of those are to be confused with the Council of Europe, which is a different animal altogether with nothing to do with the EU. Similar nuances between the rights and powers of the EU and its member states, and between concepts such as the single market, the customs union, and border controls, are currently bedeviling the EU’s own discussions on issues as diverse as migration policy, the rule of law or-most conspicuously-Brexit.

In the highly specific field of health, there are inevitable confusions because of the curious arrangements in which the EU has some responsibility for public health while the individual countries are in charge of their own healthcare. But that halfway-house is not the focus here.

What provokes this reflection is a report that was discussed last month in the European Economic and Social Committee on “Digital Transformation in Health and Care.” The EESC is one of the EU’s institutions, boasting 350 members, who have an advisory role in EU affairs. In dealing with the “Impact of digital transformation on social and health systems,” the draft report says it supports “the four-pillar process for cross-border joint work on digital transformation in health and care.”

But in reality it doesn’t support any such thing. Because that process simply doesn’t exist. What the report then lists-over the course of an entire page-is the EU plan for developing a system for closer coordination of national health technology assessment (HTA) arrangements. There is only one common point: HTA and digital health both concern health. But in other respects, they are utterly different.

Many readers of Applied Clinical Trials are familiar with the EU draft regulation on HTA, and would recognize the account-incongruously situated in this report supposedly on digital health-of legislative proposals for a European coordination group of experts from national HTA bodies, and the four key elements of joint clinical assessments, joint scientific consultations, cooperation on horizon scanning, and voluntary cooperation among member states on assessments for products not covered by the new law. But they would be understandably and justifiably surprised to see them listed in this EESC report on the EU’s digital health strategy.

Just for the record, there is an EU network on eHealth. It was created in 2012 to advance interoperability, as a result of the EU directive on patients’ rights in cross-border healthcare. This connects national authorities responsible for eHealth, and offers advice on interoperability and standardization in line with a 2018-2021 work plan, and it has recently held its 13th meeting. And since 2004, two EU “Action Plans” on eHealth have been agreed, along with the creation of an eHealth Stakeholders Group. But none of them have anything to do with HTA.

There is also a joint EU project to provide the eHealth network with technical and scientific advice, which focuses on setting up a digital service infrastructure for eHealth. There is an eHealth stakeholder group, which includes European umbrella organizations in research, industry, standardization and associations representing patients, professionals, and hospitals. And also just for the record, the Commission is planning to review the role of the eHealth network so as to improve the interoperability of patient data and access by the citizen. It also intends to move ahead with technical specifications for a European electronic health record (EHR) exchange format,.

But you won’t read any of this in the EESC report on the subject. Instead it will tell you all about HTA. They mixed up two completely different and unrelated EU health policy initiatives. And this despite four months work in a specially-constituted “Study Group on Digital Transformation/Health and Care,” with six members and three experts.

So if they can’t get it right-and that is their sole job-then who can be blamed for occasionally mixing up the European Council with the Council of Europe?


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


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