28 October 2014, Brussels – MEPs, patients and the European public health community are today asking President-elect Juncker to clarify whether medical devices and health technologies will remain in the directorate for health or not. Fears over patient safety remain as Mr Juncker has so far failed to publicly clarify his ambiguous statement (1) last week to the European Parliament.
Last week’s statement of the European Commission’s President-elect that the competence for medicines and pharmaceutical products will remain with the European Commissioner for Health was met with thanks and celebration by the public health community (2) and many MEPs. Several concerns remain however about the exact scope of this decision which did not state exactly where the competence for medical devices and health technologies would lie.
“I was always clear that medical devices, just like medicines, are first and foremost about health, and should not be treated as ordinary products. The ambiguity of Mr Juncker’s statement, and his subsequent silence on the issue, is of real concern,” said Glenis Willmott MEP (S&D, UK), rapporteur on the Clinical Trials Regulation and Medical Devices Regulation.
As the Poly Implant Prostheses (PIP) scandal over faulty breast implants demonstrated (3), it is crucial to ensure that patients are supplied with high quality and safe medical devices and health technologies. By placing these under the responsibility of Internal Market and Industry, Mr Juncker risks compromising patient safety for industrial interests.
“The barrier between medicines and medical devices has become blurred, indeed we tend to observe growing competition between these two industries for the same treatments. In order to guarantee the same conditions of security and efficiency and preserve current EU actions in health we must regulate these two industries under the only directorate competent in this field: the directorate for health,” added Michèle Rivasi, MEP (Greens/EFA, France), co-rapporteur on Medical Devices Regulation.
“We highlight and approve the decision of European Commission President Jean-Claude Juncker to keep medicines and pharmaceutical products into DG SANCO, thus, not to consider patients as simple clients. However, several shadow zones persist and especially, the destination of medical devices. That’s the reason why I have officially asked for the details this week to European Commission,” said MEP Marc Tarabella (S&D, Belgium).
In an open letter sent today (4) to Mr Juncker the public health community has called on the President-elect to protect patient safety and provide clarification over his decision regarding medical devices.
- Notes to the editors
1. President-elect Juncker’s Main Messages from his speech before the European Parliament.
3. EPHA Position on Medical Devices Revision
4. [Open letter to President-elect Jean-Claude Juncker] [Are we to understand that the portfolios for medical devices and health technologies will not remain with the Health Commissioner?
->https://www.epha.org/a/6212]
- Contact information
Javier Delgado Rivera, Communications Coordinator- +32 2 233 38 76 or javier@epha.org
