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
• 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. GLOBAL LIFE SCIENCES: EU UPDATE
For more information regarding the content of this Sidley Update, please contact:
Maurits J.F. Lugard
Sidley EU Life Sciences Practice
Sidley Global Life Sciences Practice
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