As it should be!
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.