New European Leadership Backpedals: EU Device Oversight Will Stay In Health Division
This article was originally published in The Gray Sheet
Executive Summary
The incoming president of the European Commission has reversed a decision that would have moved EU oversight of medical device and drug policy issues from the health division to the markets/industry division following criticism from lawmakers and health care advocates.
Oversight of medical device and drug policy in the European Union will remain with the European Commission’s health directorate (DG Sanco), and not be switched to the internal markets/industry directorate (DG ENTR) as previously planned.
The news was announced just before the European Parliament voted Oct. 22 in favor of the new European Commission, led by President Jean-Claude Juncker, which will officially begin work on Nov. 1. There were 423 votes for the new commission and its new group of commissioners, 209 votes against and 67 abstentions.
Juncker said he had changed his mind about his earlier decision to shift responsibility of medical devices and drugs to DG ENTR after listening to the concerns of Parliament and other stakeholders. (See (Also see "EU Device Reform Updates: Setting For Next Round Of Talks Takes Shape" - Medtech Insight, 29 Sep, 2014.).)
This is a coup for Glenis Willmott, the parliamentarian who will play a leading role in moving the pending medical device regulatory reform package forward as the newly designated rapporteur for the legislation. She strongly opposed
the move to DG ENTR and initiated a lobby against Juncker's plan.
With the new field of EU commissioners voted in, Vytenis Andriukaitis, a former cardiosurgeon and Minister for Health for Lithuania, will be the new Commissioner for Health and will be overseeing medtech policy as the European Commission, European Parliament and Council of the EU continue work on the proposed medical device and in vitro diagnostic reform regulations. (See .)
Norbert Lameire, acting chair of the European Chronic Disease Alliance, is quoted in the EU Observer online magazine as saying: "The original proposal of Juncker to move these issues of the agency and health technology to an economic DG could easily give the impression that economics come before health and before the well-being of the patient - something that we cannot accept".