Proposals for EU regulatory change: a labyrinthine puzzle
Monday 22 September 2008 Amanda Maxwell - Editor, European Regulatory Affairs

It seems as if the industry is swimming in a sea of ideas that has resulted in the generation of yet more ideas Photo: Craig Jewell

It seems as if the industry is swimming in a sea of ideas that has resulted in the generation of yet more ideas. How, indeed, will it end?

So to keep up this analogy of the sea, I imagine that as the industry experts lie on their sunloungers staring out to the horizon over the month of August, many will linger - at least for a moment - on the subject of what future changes will lie ahead.

So far, however, we have no certainties. What the Commission has done is open the floodgates for ideas. And they have started to pour in – not only as an official reaction to the Commission’s consultation, which in theory finished on July 2 (although it seems there has been an unofficial end-of-month extension), but also as public statements, such has been the shock reaction of the industry to the proposals contained in the consultation document.

The group representing the medical device industry associations was the first to find the courage to speak out strongly against the European Commission’s proposals that contained some very radical departures, not only from current medical device regulations, but also from the very foundations that underpin these directives. Centralisation “is not for us”, the industry replied, adamant that these proposals are premature, given that the changes agreed in the context of the review of the Medical Devices Directive and the Active Implantable Medical Devices Directive have not even been implemented yet, let alone tested and tried.

But even Eucomed is feeling cautious in this political game, and was quick to respond to the Clinica statement that the group reaction to the consultation document had been angry and defensive. Not so, Eucomed’s Dario Pirovano told Clinica. Rather, he said, “the medical device industry is happy to engage in the debate”. National associations, notably those in Germany, also made their views known (see Clinica No 1315, p 6)

EDMA, meanwhile, although part of the pan-European industry group above, issued its own 27-page statement (see Clinica No 1315. pp 5-6 ) in which it warned the Commission that the impact of the proposals, if they went ahead, would be “to increase regulation, slow innovation, and make unviable the development and introduction of a significant number of new device products”.

The next to speak out publicly was one of Europe’s most active notified bodies concerned with medical devices, the UK organisation, BSI. It is highly unusual for BSI to come up with such a public statement, and experts there were keen to communicate their 17-page statement to Clinica.

This statement is a careful and weighted consideration of what the Commission has proposed, but contains the message that BSI, too, believes that the discussion is premature given that the review has not yet been implemented.

BSI has taken the Commission at its word when it comes to opening a dialogue on all possible regulatory solutions and has put forward its own landmark proposal as a cornerstone for a new, workable regulatory system. That proposal is for a central committee, or reference group, to provide a consistent structure within which EU notified bodies can operate and flourish. This, BSI believes, would make any of the other more radical ideas for an agency or premarket approval redundant.

There had originally been an expectation of the publication of the results of the consultation from the Commission during August, but with the extension of the comment period, this now seems unlikely. With responses such as those that have been made public so far, it had looked as if the industry was to be provided with good alternative late summer reading material to War and Peace. Now it looks as if they will have this to read along with their backlog of Clinica copies and other in-tray items when they return from holiday and have eventually got their feet back under their desks.

I, for one, feel more uncertain than ever before about which way things will now go. The competent authorities have, not surprisingly, kept their cards close to their chests. But the likelihood is that they may be more receptive to some of the more radical ideas put forward by the Commission. This is all the more likely because the overall responsibility for the medical devices department almost always lies with the head of the pharmaceutical regulatory department, who is usually more acquainted with the pharma than the medical device regulatory structure.

The real immediate challenge is going to be for the Commission. John Brennan had emphasised to me on May 19, when I was last at the Commission, how he wanted me to help drive the message that the Commission was open to all new ideas.

The question now is how the Commission is going to channel the new ideas and the strong reactions into a proposal: a proposal that is not going to set out a train of reactions that could create a major distraction from the main job of everyone to ensure that the current regulations are upheld and that products are as safe as possible.