Well, we had the Council meeting last Tuesday on among other things Health, in which the medical devices regulation proposal was debated at quite a length. Where are we now and where are things going?
My impression is that it’s a mixed bag or rather a wheelbarrow of frogs and it really depends on who you ask. To me the picture was of a
- Commission that wants to move on with the dossier but needs to appease the Parliament even though they don’t agree,
- number of member states that have difficulties dealing with the complexity of the dossier and but could generally live with the proposal (like the Latvians) and
- a growing number of member states that know very well what this is about but are having difficulties getting their point across to the others about why they are not happy with the proposals as they ended up after the Parliament’s plenary vote.
The debate concentrated on the two points that are really important to the Council: the market approval procedure and reprocessing. The IVD proposal was not discussed at all, regardless of the quite important role that IVDs play in modern healthcare, which will only increase in the coming decades. As we have seen in Parliament the discussion is at such a high level that it really does not do justice to a very important piece of highly complex and technical draft legislation that will have an important impact on healthcare and healthcare costs for decades to come.
The Commission reported that the Greek presidency has already confirmed it will work on it as a matter of urgency, but there are still problems to sort out. It confirmed that it can live with basically any solution, as long as it does not delay market access unduly. Regarding reprocessing it defended its initially proposed solution: that a reprocessor must be subjected to the same rules as manufacturer, combined with opt-out on a national basis.
The member states
The member states are always a colorful lot, and make it a sport to each do something completely different, even in the same game. Below is a selection of the member state views. If you want a concise overview, check the Twitter report of Robert van Boxtel (@RobertMDProject), who tweeted summaries of all member state positions successively during the debate.
Let’s start with some of the extremer and (in my opinion) less realistic views of some member states. The Belgians and Austrians made a splash by arguing that the proposed rules are still way too lenient on implants and high risk products. Hungary decided it would be a good idea to reverse harmonization by requiring manufacturers to notify devices nationally before that can be placed in the market, i.e. back to the situation before the medical devices directive.
Then there are the member states that were a lot more critical about the basic assumptions in the proposal. The UK is in favor of beefing up notified body review rather than adding an additional layer of review, and is against reprocessing. They kindly applauded the Dutch leadership in the medical devices dossier (go Dutch!). Ireland later joined this point of view. Germany thinks the same about the approval mechanism, but completely different about reprocessing because they have 12 years of positive experience with that. The Italians are against PMA and strongly against reprocessing. The Dutch are also against the PMA proposed and emphasized that it is not realistic to frontload the market access procedure in a way that safety does not improve. Rather, post-market surveillance requirements should be strengthened so products can be improved quickly. The Swedes concurred with that and stressed it’s better to not have a regulation at all at the moment than a flawed one. They also stressed that single use products should not be re-used because they are not built to be re-used. The French, on the contrary, are very much in favor of PMA and seem to head up the movement of member state supporters of the PMA system as proposed by Parliament.
Most of the member states have big problems with reprocessing. Basically only the Germans are really positive about it (remember, Rapporteur Roth-Behrendt is also German), supported by the Croatians and Slovakians. Many member states say this should be left to national discretion so they can scuttle this nationally. It seems a consensus could be found around the Commission’s initial proposal as many member states say they could live with that. The Commission proposed that
“reprocessing of single-use devices is considered as manufacture of new devices so that the reprocessors must satisfy the obligations incumbent on manufacturers. The reprocessing of single-use devices for critical use (e.g. devices for surgically invasive procedures) should, as a general rule, be prohibited. Member states retain the right to opt out on national level.”
The Fins were the only ones really in a hurry and urged finishing the dossier before the elections. The Portuguese stood out by not wanting national exceptions for reprocessing, but rather a single European framework.
The Greeks said this dossier will be their highest priority during the Greek presidency starting on 1 January and that it has to move forward as far as they are concerned. On the other hand, they also say that a new regulation should not jeopardize the advantages that the EU currently has in medical devices marketing approval, so there’s your reason to hit the brakes.
There were more member states points of course, but this gives a good overview of the different positions.
The Commission summarized as the end that it had understood during the debate that there is another balance to be struck: between the procedure’s administrative burden and the speed of approval and that the door has definitely not been closed on the proposals on the table in the debate.
The Commission also said that the relation between pre- and post market requirements might be relaxed in the future when the notified bodies function better and the scrutiny procedure could be abandoned again in favor of an approach with more focus on post-market surveillance. I was puzzled to hear this: why first put the EU industry years back by shooting it in the knee with a system that will not work to subsequently shift to a system that might and that you could (and should) start with immediately? Appararently the only reason for this is appeasing political public opinion fed by the misguided and fact-free idea of framing legislation as stricter and therefore better even if that regulation that does not achieve its goals to everybody’s detriment, industry, patients and taxpayers alike. That does not make sense.
So, now you probably understand my earlier remarks about compromises as we can only make them in Europe, because this wheelbarrow of frogs needs to reach the finish one way or the other with all frogs still on board.
The reactions to the debate have been mellow so far, if it was even picked up in the first place. FierceMedicalDevices reports on the Irish being retroactively more against PMA, while MedTechEurope (Eucomed and EDMA) gives a diplomatic and objective overview of the different positions and timing without whipping out the crystal ball to make predictions.
To paraphrase: it isn’t over until the fat lady has stopped singing. After singing to the Lithuanian Presidency she is now singing to the Greek Presidency, trying to see if she can speed things up to get the deal sealed before the elections. By the way, we from the outside still haven’t seen the data she says she has to support her proposals. So far the only real public data came from the Commission in its initial impact assessment underlying its proposal and from an attempt by Eucomed to quantify the costs of the ENVI proposal. Some member states have also thought about whether the proposals will achieve what they claim. As far as I’m concerned the rest is free-fact conjecture and political framing, which is of course the best evidence-based foundation for regulations that will impact on everyone’s health, quality of life and the associated costs in the EU for decades, as you will no doubt agree. It reminds me of a favorite Yogi Berra quote: “If you don’t know where you’re going, you might not end up there.” – that’s why you need facts to support proposals.
It will be a kind of magic
As the Lithuanian health minister presiding the Council meeting underlined in his conclusion: the magic has to happen in the months of January to March during the Greek Presidency (“the best months”) so we will have a good idea where things will be going by the start of April. Magic also means a surprise move here and there, which I do not exclude.