In this article Mike Kreuzer of ABHI outlines what this restructure means for our industry as well as providing some background information about the changes underway in the Commission.
What the restructure means to the medical technology industry.
The impact on the medical technology industry will result from the transfer of responsibility for medical device legislation, trade and broader industrial policy from the Directorate-General for Health and Consumers (DG SANCO) to a newly created Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (brought about through the merger of DG Enterprise and Industry [ENTR] and DG Internal Market and Services [MARKT]) under Polish Commissioner-designate Elżbieta Bieńkowska.
This means that this “new” DG will take over the responsibility for the ongoing revision of the legislation which governs medical devices.
DG SANCO assumed responsibility for medical devices regulation in 2010. Prior to that, it had resided with DG Enterprise and Industry (ENTR). In that context, this change could be referred to as ‘moving back to DG ENTR’, except that the reconstituted directorate will have much wider responsibilities than its predecessor.
In ABHI’s view this move has the potential to be beneficial for industry – the move to a Directorate that, in broad terms, is focusing on economic growth, societal improvement and better regulation is positive. Topics such as UDI and the EUDAMED database should be addressed in a more focussed manner.
However there has been a significant reaction from non-industry health pressure groups suggesting that the move from SANCO is seen as something which plays into industry’s interests and reduces the “health element” from the drafting and control of the future regulations.
Therefore both ABHI, and EUCOMED, believe that a carefully considered public reaction is needed having regard for the need to establish relationships with senior officials in the new directorate and to ascertain their priorities and work programme.
I will continue to support EUCOMED’s activities in engaging with the new directorate to ensure that they are aware of the industry position as regards the revisions to the devices regulations. Importantly, a UK MEP Glenis Willmott has been appointed new European Parliament rapporteur for the on-going negotiations on the medical device legislation and ABHI looks forward to engaging with her as well.
The European Commission (EC) is the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the Union’s treaties and day-to-day running of the EU.
A New Focus for the European Commission:
Juncker wants to renew the European Union on the basis of an Agenda for Jobs, Growth, Fairness and Democratic Change, i.e. a greater emphasis on growth. That is job creation, targeting increased investment, and getting banks to lend more.
Underpinning that strategy will be 10 priority policy areas and Juncker proposes an organisational structure for the Commission that caters directly to deliver against those priorities – form has indeed followed function.
A Restructure That Creates a Tier of “Super-Commissioners”:
Until now, the Commission has always had one representative from each member state take up the role of Commissioner. There are 28 member states, hence there are 28 commissioners, and all on an equitable peer-to-peer basis (in theory). They head up their respective Directorates-General (DGs), working through their civil servants.
In this restructure Juncker is creating a tier of Vice-Presidents – seven of them, each with a remit to focus on one or more of his priority areas. The current structure of DGs will be merged, and clustered against those priority areas that they relate to.
They will come under the reach of their respective VP. The intent is that each VP will coordinate the work of the other Commissioners and their respective DGs – but not lead.
This in effect creates seven teams, a reduced number of DGs, and a core team of “super-commissioners.”
What the Restructure Means to the Working of the European Commission:
It is a clear signal that 28 Commissioners has been too many when trying to keep things together in such a large political and administrative body. It is also an admission that greater quality was needed – four of the seven VPs are ex-Prime Ministers, although with varying years of experience and not one from a single large EU country, Italy excepted. It is to be expected that such individuals, used to leading roles, will create a strong central core through which to focus power.
What is not clear though is how the “coordinating” VP will work effectively with their Commissioner. It is also not clear, in the instance where a Commissioner (and their DG) comes under the coordinating influence of one or more VPs, how such coordinating activity will be coordinated!