medicaldeviceslegal

Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt.

It’s Glenis Willmott

The new rapporteur is UK MEP Glenis Willmott, of the S&D group in the European Parliament, who is certainly familiar with health issues as she has served for example as rapporteur for the recently revised Clinical Trials Regulation.

Her mandate, with the EU Parliament’s first reading having been fixed on 2 April, is to guide the new rules through the Parliament as well as negotiating with the Commission and national governments joined in the Council.

How will she do?

So, how will Ms. Willmott do different from Ms. Roth-Behrend, who polarized the political debate like no other and was always good for some spectacle and not always evidence based drama? In other words: are the wings on fire or not?

In the announcement of her appointment she said:

“I am delighted to have been appointed as rapporteur for this vital legislation. After the scandals involving PIP breast implants and ‘metal on metal’ hip replacements, the public are rightly concerned about the regulation of medical devices. Patients deserve better and so action at EU level is needed.”

and

“We must ensure the industry is transparent and works in the interest of patients. This legislation will go a long way to achieving that and I look forward to taking it further in the coming months.”

“I am concerned, however, with the proposals that medical devices should fall under the responsibility of the industry commissioner. Our first priority with these products must be health, and they should be overseen by the health commissioner. I will be doing everything I can to ensure that this is the case.”

For one, Ms. Willmott was an ardent supporter of the transparency initiatives in the new clinical trials regulation. Since the European Parliament’s proposal also contains such provisions for devices, we can expect that this agenda will be pushed. Given her experience with clinical trials, expect more focus on clinical evidence requirements for devices, which may mean that the discussion about RCTs for devices as gold standard will persist. In her acceptance press message she has further announced to put patient safety above everything else – not surprising, what else are you going to say? And I think nobody in industry would say that this is also not what industry wants, even if Ms. Roth-Behrend thought that was not the case. So are the wings (still) on fire? It’s – again – too early to tell at this point in time. Sorry.

Move to Enterprise

From what I know about Ms. Willmott she is certainly a different person than Ms. Roth-Behrendt. But – and that is to be expected for a labour parliamentarian – she is not pro-industry at all and and she has announced that strive to bring devices oversight back to the Health Commissioner after it was decided only recently to bring it back to DG Enterprise after it was with DG SANCO during the last Commission’s term. How she intends that this will be achieved is not clear for the moment.

Eucomed, for its part,

“welcomes Ms. Willmott to the file, who brings a wealth of experience and insight on health issues to the MDD file, and a clear desire, which we share, for driving legislation that puts patients first.”

Eucomed also says it looks

“forward to engaging with her to ensure a Regulation for medical devices that is able to efficiently address patient and user safety requirements, patient access to safe and effective medical devices, effective and non-bureaucratic support systems to authorities and continued medtech innovation in Europe.”

Again, and with all due respect: what else are you going to say, right?

Out of the window

As I have blogged in the past, “effective and non-bureaucratic support systems to authorities and continued medtech innovation in Europe” were out of the window with the Parliament’s text as it was fixed in the first reading on 2 April 2014.

To achieve this we will need a very rational compromise between the Council and the Parliament, brokered by the Commission. So far the efforts of the Council have been aimed at keeping things mostly the way they are (less than effective, fragmented and bureaucratic due to lack of harmonization and different views by national competent authorities).

The efforts of the Parliament, on the other hand, were aimed at maximum disruption of existing structures into a system of market access that has been proven to be hostile to innovation while failing to cause a marginal increase in safety of products. Where will we end up? It’s still too early to say but given the expectation

I have heard from my sources that it may take until the Dutch presidency (first half 2016) before this dossier finally closes, which means that a lot of proverbial water will need to pass through the political Nile before we have a new medical devices regulation in the EU that everybody can agree with.

IVD’s, the regulatory stepchild

In IVDs, which everybody seems to just ignore in the legislative discussion, persistence is the virtue with Peter Liese staying on as rapporteur. Whether that is a good thing or not remains to be seen, as he will defend his unconstitutional genetic testing amendment. If this passes, we can expect an attack on the validity of the IVD regulation that may well succeed, which will set IVD regulation reform back a year or so at the very least.

Mr. Liese, you are still welcome by the way to consider our counter opinion on the competence of the EU to legislate in this area and reconsider this amendment. It would save a lot of hassle.

Otherwise, the only controversial point under the IVD regulation seems to be the transitional period (3 or 5 years) which will make it nearly impossible or just difficult for the IVD industry to re-certify the large majority of self-certified IVDs on the market by notified bodies. I have started to refer to this situation as the regulatory cliff for IVDs – too many IVDs to rectify, too little regulatory expertise in the market and too little capacity at the notified bodies. Brace for impact if you’re in IVDs and better plan ahead for this transition because if you don’t you will run out of road at some point during the transitional period and drive right off the regulatory cliff.

So

is there any impact on timing of the legislative procedure with these developments?

The pessimist view is that it still may take until early 2016 for the regulations to be agreed, with the possibility of the IVD regulation being even more because of an attack by one or more of the member states at the European Court of Justice immediately when it is adopted.  This will make the work on improving market surveillance under the Joint Action Plan and the unannounced audits in the mean time more and more important as these will be the major moving targets.

The optimist view is that of the Italian presidency put forward after the Greek presidency terminated: the announced pre-pack first reading and then a speedy close of the dossier.

Next week the Parliament will have hearings of the new Commissioners, and no doubt the Enterprise Commissioner will receive a thorough quizzing on the plans with the move of pharma and devices oversight to DG Enterprise. These hearings will produce additional clarity on what the Commission intends, and whether Ms. Willmott’s statement that she will strive to bring devices oversight back to the Health Commissioner may have any chance of succeeding.

So, watch this space heat up as things have started moving again!