EU Commission Shifts Responsibility for Pharmaceuticals, Medical Devices, Biotechnology and Cosmetics
On September 10, 2014, European Commission President-elect Juncker issued a press release unveiling his new EU executive team and announcing a reshuffling of certain responsibilities. In the new Commission, oversight of pharmaceutical products, medical devices, health technology and cosmetics will be shifted from the Directorate General for Health and Consumers (DG SANCO) to the new Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG ENTR) under the leadership of Commissioner-elect Elžbieta Bieńkowska.
The new DG ENTR merges the former DG Enterprise and Industry, DG Internal Market and Services, and certain parts of the Executive Agency for Small and Medium-Sized Enterprises. According to the President-elect, the new DG ENTR “will be the engine house of the real economy”. DG ENTR will also be responsible for relations with the European Medicines Agency (EMA).
This reassignment, effective November 1, is far more significant than a mere reallocation of tasks between different offices of the European Commission. Rather, it signals a shift towards a more innovation-enabling approach to EU policy on pharmaceuticals and medical devices in line with the President-elect’s promise to “put Europe back on the path to jobs and growth”. In particular, the shift of healthcare responsibilities to DG ENTR signals an intent to:
- secure additional investment in research and development and create new job opportunities in the life sciences sector;
- strengthen the internal market by removing residual obstacles to the free movement of pharmaceuticals and medical devices; and
- make Europe more competitive to attract global investment.
The new DG ENTR is expected to speed up approval of the proposed new Regulations governing medical devices and the new Transparency Directive on price and reimbursement measures. These legislative acts will harmonize the legal framework for medical devices, setting common rules uniformly applicable across the 28 EU Member States, introduce new obligations to strengthen patient safety, and require Member States to apply objective and transparent criteria when determining price and reimbursement conditions of pharmaceutical products.
For more information regarding the content of this Sidley Update, please contact:
|Maurits J.F. Lugard
To receive future copies of this and other Sidley updates via email, please sign up at www.sidley.com/subscribe.
Sidley Austin provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.