20130206ATT60626ENWell, the 26 February workshop is behind us. The expectations were high, but I think in the end the workshop turned out to be the dud I expected; some people I spoke with rather called it a theatrical sizzle or a dud with some drama. A nice factual and chronological overview can be found in the twitter feed of SFL regulatory consultants (@SFLServices) for 26 February that reports on the entire event. Or you could try the ever buggy and rarely working EU Parliament video feed of the event, good luck with that.  The presentations that people provided are here. The agenda for the event is here.

I didn’t attend myself in the expectation of precisely this result, so everything I’m writing down here is hearsay. I think it will reflect the sentiment well however. The overall sentiment of those I spoke with (mainly industry) was that of an orchestrated session with the sole purpose of making Mrs Roth-Behrendt, the Parliamentary rapporteur for the MDR proposal, look good, wise and on the ball. This sometimes led to embarrassing and tense situations like the rapporteur waving her watch at people to cut them off on time, and the people responding “Yes, you have a very nice watch” and continuing their submission because they felt that they were making important points that were falling on deaf ears. I did not speak in any detail with people about the IVD part of the workshop, but I may follow up about that on another occasion. You can find an account on the @SFLServices twitter feed too, as well as on the EU Parliament video feed of the event,

In the first session the Commission – represented by Mrs Testori Coggi (Director General of DG SANCO) – reiterated its initial proposal, saying that this will do the trick. The Commission also reiterated that full PMA would not work under the current circumstances.

There is no way the EU can muster the resources to set up a new agency like the EMA or EFSA for medical devices  approval.

EMA surprisingly said it had no interest at all in taking this devices business on board and saw its role limited to helping out in companion diagnostics and combination products, perhaps deciding on borderline questions.

The session on notified bodies was ugly and had ‘scapegoat’ written all over it. People were using the word ’embarrassing’ and said they felt sorry for the notified body representatives present. Why? Rather than doing the job herself the rapporteur had set up a reporter from the BMJ, a journal with a well-known bias against the CE system, to make the notified bodies look as bad as possible and chastise the member states and Commission in the process for doing a bad job. The message was that the Commission and the member states were lucky to have the European Parliament to save them from the embarrassment of such a bad legislative proposal making it to the finish line to become law. With Mrs Testori Coggi, the Director General of DG SANCO, being not a pushover herself I guess you can imagine the constructive atmosphere in the room.

An interesting discussion ensued about time to market, one of the big advantages of the EU system and a continuing bone of contention. Mrs Roth-Behrendt had obviously been taking inspiration from FDA arguments on the time to market under the EU system. She argued that time to market under regulatory market access procedures should include the time it takes for a device to be reimbursed, because only then the device is available to patients. She said she had ‘researched’ this. In fact, you don’t need much research to find out that this is an old discussion that mixes up different things. Market access is a harmonized EU affair, while member states firmly defend their national competence in reimbursement of medical devices. An instrument like the Transparency Directive for medicinal products – intended to speed up inclusion of products with regulatory approval into reimbursement systems – never made it in the medical devices. Ergo, including reimbursement in the discussion is relevant for effective time to patient but has nothing (I repeat: nothing) to do with regulatory approval. The last time a company tried to blur this distinction for its own purposes and argued that the date of regulatory approval was actually the date of admission of a medicinal product to the reimbursement system (with a view to obtaining longer supplementary patent protection for its medicinal product) it was severely slapped on the wrist by the European Commission and European Court for making such an evident mistake as part of a ‘self-serving’ plan. Really, the company was told in the strongest supervisory wording that these things cannot be mixed up. If Parliament wants to shorten time to patient after reimbursement it should whip the member states into shape on reimbursement and support the Commission on a proposal to speed up reimbursement for medical devices, which I think the Commission would be more than happy to cooperate on.

In the mean time the member states are flying under the radar. There is still no common position of the Council on the proposal, neither external nor (as far as I know) internally. As I have mentioned before, there was no news on the scheduled discussion of the Dalli Action Plan measures during the Irish Presidency, so my guess is that there is a degree of fundamental disagreement about how to handle the future because there is some fundamental difference on whether they want PMA or not (France, as far as we know, was the only one in favour last year). The Parliament and the Council (i.e. the member states) must agree on the regulation proposal for it to be adopted, so the position of the Council is the big known unknown in the equation now.

The session on reprocessing was a bit lost in the mix. Nothing spectacular than the usual happened: the manufacturers of single use devices defended that single use means single use and the others voicing the usual suspicion that this may not always be true. Anyway, the new MDR proposal will harmonise rules on reprocessing and regulate the activity just as strictly as manufacturing – which is the only sensible way to deal with this if you want to allow reprocessing of single use devices.

So, there you have it – a dud with drama, with the real issues misrepresented or not addressed, for example because there is no attention whatsoever to post market issues, except by industry and then even outside of the devices industry – for example Mr. Bergstrom from EFPIA made some very relevant remarks on this subject during the workshop.

This was met with a comment from Mrs Roth-Behrendt that this could only work for devices if there would be similar PMA for devices – which I believe is a complete misconception. Moreover, if there is anything that is significantly improved in the Commission’s proposal it’s post market obligations for manufacturers. Also, as I keep saying, if there is anything not addressed in this flawed PMA discussion, it’s post market surveillance.

With this in mind I would like to ask readers of this blog to get involved – do something or be stuck with flawed legislation. Let’s not destroy the good parts in a misdirected effort to repair the bad parts and end up worse off: patients, industry, everybody. Let’s not loose the 3. The bad parts do need fixing, everyone agrees with that – but then let’s really fix them instead of change the wrong things with the wrong arguments. The rest of the ENVI committee and the Parliament should really take a better look at this than has happened so far.