Responsibility for medical devices and pharmaceuticals is to be returned to the Directorate-General for Health and Food Safety (SANTE) after being removed five years ago. Germany’s health insurance funds had repeatedly called for this.

UM – 09/2019

Kyriakides to get medical devices

Cypriot Stella Kyriakides, Commissioner-designate for Health, is also expected to be given responsibility for medical devices and pharmaceuticals. The current bodies responsible will be removed from the Directorate-General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) and transferred to the Directorate-General for Health and Food Safety (DG SANTE). In specific terms, this concerns the relevant parts of Unit D3 (Biotechnology) that deals with pharmaceuticals. As far as medical devices are concerned, Unit D4 (Health Technology and Cosmetics) is affected. The relevant parts of the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA) are also to be relocated.

Patients’ well-being

The health insurance funds welcome this development, as it meets their demand to place medical devices back under the responsibility of DG SANTE. This changes the way medical devices are viewed and significantly improves patient safety.

Pharmaceuticals and medical devices under one roof again

It was only in 2009 that medical devices were allocated to the Directorate-General for Health (then DG SANCO). However, Jean-Claude Juncker, the President of the Commission elected in 2014, withdrew responsibility for medical products from the Directorate-General for Health and transferred it to the Directorate-General for the Internal Market with effect from 2015, a highly problematic change in perspective for health insurance providers. This was preceded by a political tailspin that resulted in medical devices falling under economic responsibility in the last legislative period, while responsibility for pharmaceuticals remained with health.

Health to be strengthened

The decision of the Commission President-elect, Ursula von der Leyen, rectifies this serious irregularity. The significant increase in public awareness regarding the safety of medical devices is certainly a major contributing factor to this decision. The scandal surrounding the ‘Implant Files’ continues. Nevertheless, von der Leyen’s move confirms the view of the health insurance funds that the increasingly important issue of health must also be reflected institutionally at European level in the form of an independent, specialised Directorate-General. And that is a good thing.