So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date for the vote on the general medical devices regulation proposal the IVD proposal seemed to stay on track. That turns out not to be the case.

As expected, IVDs vote delayed too

As I predicted, ENVI would not vote on the IVD regulation proposal out of sync with the general medical devices regulation proposal. There are just too many important overlaps, such as proposals to also give EMA a task for centralised market authorisation of certain IVDs. As you can see in the draft agenda of the ENVI committee for 10 and 11 July: there is no mention of the IVD regulation proposal vote, so this will likely move to 18 September or around this date, the date that the general medical devices vote has been scheduled for. Maybe the agenda will be amended, but that seems unlikely.

Will we make the elections?

With these delays, it becomes less and less likely that these two dossiers will be finished before the European elections end of May 2014, unless people start working miracles behind the scenes. Mrs. Roth-Behrendt, the rapporteur for the general medical devices regulation proposal, has not been voted European Ombudsman so she will be around for longer. She may work miracles, but probably not the ones the market and the patients are looking for. If the dossier is not finished before the elections, it will suffer considerable delay. With all the craziness hanging over the market like a big fat dark cloud, I am sure industry doesn’t mind that.

But in the mean time

The question is how things will develop: the ENVI committee seems more and more divided on the big ticket issues, so the proposals will need compromising in order to have a chance to be adopted – but how? I am sure the members of the committee will receive a lot of useful suggestions from all directions over the summer.

Also, you  bet that the ENVI committee will be working on closing its ranks to the outside world, compromising like it’s 1999, with Mrs. Roth-Behrendt’s reputation on the line because she has misjudged her committee members’ willingness to enact legislation that EMA itself says does not work anymore in the pharma system that Mrs. Roth-Behrendt seeks to copy (see more here). Very rational, carbon-copying a solution of which even the agency that applies it says it’s outdated, harms innovation, doesn’t benefit patients and needs to be fixed – wouldn’t you agree? Fortunately more and more ENVI members don’t and neither does the Council. The Commission has shown with an impact assessment supporting its proposal that this will not work for medical devices. Mrs. Roth-Behrendt however claims it will. She even has data to back that up – she says. There’s no way to tell, because of this data that is supposed to back up this wisdom we have seen nothing, rien, nichts, niks, ingenting, nada, intet, нищо, ei mitään, semmi [add 13 remaining EU official other language versions of ‘nothing’] and, in the newest official EU language Croatian: ništa. Zilch, in other words. I hate to sound like a broken record here, but that’s apparently what it takes.

There is more

But then there is more – while everybody is looking at ENVI and fears the worst because of its possible proposals on the big ticket items, the Council working groups have been beavering away in the background on the more technical parts of the regulation proposals: the annexes. I have had some insight in what they are doing and what they propose to change to the Commission proposal. I can say: there will be some surprises for certain medical devices sectors if these proposals make it to the finish line, because the regulatory burden will increase.  And the proposals may well make it, because the Parliament is completely uninterested in the annexes – except maybe as political currency. More about that over the summer!