Of immediate interest is that Units SANCO B2 (Health technology and cosmetics), SANCO D5 (Medicinal Products – Authorisations, EMA) and SANCO D6 (Medicinal Products – Quality, Safety and Efficacy) will no longer be handled by DG SANCO but will fall under DG Enterprise.
Although DG Enterprise in the past handled these topics before they were delegated to DG SANCO, this decision by President Juncker has already met with significant backlash from health stakeholders, over 30 of which published a letter on 16 September 2014 which condemned the decision by Mr. Junker and described the change as “unjustified and represents a major step back”.
Key Members of the European Parliament who are strong health leaders such as recently appointed Rapporteur for the Medical Devices Regulation, Glenis Willmott (S&D, UK) are also adamantly opposed to this change.
Given that this change is likely driven by both the European Federation for Pharmaceutical Industries and Associations (EFPIA) and Member States themselves with large health-industry markets; it is difficult to tell if such opposition could lead to a reversal of this decision.
The change of portfolios could make the Commission more open naturally open to industry arguments and macro health economics arguments rather than the need to focus on specific health areas. It is important to note that it is still to be determined what will be the impact of this refurbishment of competences on the attributions of the different European Parliament’s Committees; in this light the forthcoming months will offer a good indication of the future modus operandi. One possible scenario would be a progressive transfer of pharmaceutical and medical devices’ legislation from the current responsible committee, ENVI, towards those Committees more closely related to DG Enterprise: Industry, Research and Energy (ITRE) and Internal Market and Consumer Protection (IMCO).
Moreover this shift of medical devices’ competences in favour of DG Enterprise could also have an effect in the negotiation process for the new Medical Devices Regulation. Indeed, the European Commission is still an important voice in the process as it holds a relevant role in the trialogue, striving to bring the European Parliament and the Council’s positions together. As a consequence of this reshuffling, the Parliament could perceive the Commission as more biased towards the internal market and on the side of those Member States less favourable to the Parliament’s proposal that was adopted back in April 2014.
The European Commission’s press release on the appointments and portfolios of the Juncker’s Commission can be accessed here.