keep-calm-it-will-happen-14It’s been a matter of a lot of speculation where the devices policy and HTA policy will finally end up in the European Commission.

When the Commission-elect was presented, one of the interesting elements was that medicinal products and medical devices policy were going (back) to DG Enterprise. Remember that the new rapporteur for the medical devices regulation, Glennis Willmott, was very much against this and vowed to bring devices policy back in the fold of DG SANCO. In the mean time the Commission has been elected, but it’s still not clear where the devices will end up.

Something of a concession

Some time ago it already became clear that president Juncker had made something of a concession to the European Parliament with regard to medicinal products and medical devices policy on 22 October:

“Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other,” he said, adding that Andriukaitis and Bieńkowska will develop the relevant policy jointly. (EurActiv)

But it was not very clear what that concession was exactly because what are “medicines and pharmaceutical products” if not more of the same? Or was something lost in translation resulting in this tautology? Was  everthing that was plannend to be moved (back) to DG Enterprise going back to DG SANCO?

Hey, and what about medical devices – they’re not goods like any other either, right? Or are they? This is really a less than well-chosen statement by President Juncker that the Parliament will probably hurl right back at the Commission as ammunition to support some of its more politically motivated amendments in the legislative procedure for the medical devices and IVD regulations.

Clinica permutations

As matters stand currently, it looks like medicinal products may actually go back (again) to DG SANCO and that HTA plus devices will stay with DG Enterprise. At least, that says Clinica now on 31 October. But Clinica has in the mean time reported every possible permutation in this story as final.

No final word it seems

MedTech Europe is still reserving its position on that same date.

Schermafbeelding 2014-11-01 om 12.30.13 The final word, it seems therefore, has not been given yet.

What would it mean?

What would it mean if devices and HTA would go to / stay with DG Enterprise? As I have blogged, devices started out as a typical internal market policy and this move may signify a re-orientation on the market for medical devices with potentially more attention to innovation friendly policies.

A slip of the tongue that would lead to conclude that President Juncker sees devices as goods like any other contrary to medicinal products may tentatively support this. Such re-ortientation would for one benefit the eHealth industry, which the Commission has put a lot of cards on for its healthcare policy.

Another benefit of more emphasis on internal market might be some efforts of the Commission to deal with the consequences of the Lycocentre judgment that confirmed that there actually is no internal market for medical devices because every member state may qualify a product differently based on different scientific argumentation.

Keep calm

And carry on – the EU’s devices policy will sort itself out sooner or later, possibly next week already. In the mean time, enjoy all the speculation and join the fray it you like!