This Tuesday morning 10 December the EU Council will meet to discuss the dossier of medical devices and IVDs revision for the last time during the Lithuanian Presidency, from 10:00 to 12:00. It looks like live coverage by video feed is available, but you can also download the coverage afterwards, see the links in this document.

After 1 January 2014 it’s up to the Greek Presidency to see if they can close this deal before the European elections in May 2014.

As has become quite clear by now, the Parliament wants to move on the dossier to get it finished before the elections – there are political careers at stake. The Council is not so keen, as witnessed by the empty chair policy during the Parliament’s plenary vote.

In the mean time the Parliament has finally published the voted-in amendments: see here for MDR and here for IVDR. We thought we would improve on this with tracked changes versions of the text of both regulation proposals that show precisely what has been changed compared to the Commission’s initial proposal at a glance. We did our best to be thorough, but no guarantees and use at your own peril: see here for the MDR consolidated text and here for the IVDR consolidated text. If you spot any mistakes, please let me know and I’ll publish the amendments.

So what can we expect on the 10th? A Dutch briefing document for their Parliament gives a very nice insight (from the perspective of the Dutch of course).

Council not ready yet

The document states that the Parliament is fully ready to start the trialogue with the Council and the Commission, but that the Council is not quite there yet. Some critical remaining points have to be addressed on the 10th, among others the system of market approval and reprocessing, precisely the two items that everybody except the wise EU Parliamentarians has found a bad idea.

The document states literally that

“the coming months will determine if the Council and the Parliament will enter into negotiations to arrive at a common position in 1st reading, the so-called trialogue. There are no clear positions in the Council yet on various issues. [document discusses PMA as proposed by Parliament] In the Council working groups a large number of member states have expressed their concerns about these PMA propositions.”

The document also states that member states are very divided over the question of whether reprocessing should be allowed in the first place (remember, the Parliament wants it to be the standard), while some member states do not want to prohibit it on an EU level but want to leave it up to national discretion. The Dutch plan to move slowly rather than be stuck with legislation that’s no good.

False security and harmful to innovation

The Dutch government quite literally says in the document what everybody (except of course the wise Parliamentarians in their comfy bubble of fact-free political statements) already knows and has been repeating like a broken record for months and months: these amendments will undermine the current innovation friendly system, create false security and unnecessarily raise the costs of the system. The system will introduce significant extra complexity that harms innovation, which is bad for patients, without leading to additional safety. And again, that’s not me or industry speaking: these are literally the words of the Dutch government.

So what should be done?

The Dutch say the following:

“The Netherlands suggests that improvements are targeted interventions on the weak links in the system, such as strengthening the quality of the notified bodies and increasing the quality of clinical research and clinical expertise in the pre-market phase. However, in the pre-market phase only limited data are available that give insight into the actual safety of the product when it is applied on large(r) scale used and corresponding intended patient population. By taking measures in the post-market phase, timely intervention becomes possible, so devices  can be preventively improved timely and major incidents can be prevented. The Netherlands therefore calls for increasing patient safety through post-market surveillance by manufacturers. The Netherlands has therefore submitted a proposal to the Council. There is broad support in the Council to tighten the requirements of post-market surveillance.”

This makes a lot of sense (and not only because I have already suggested this was the way to go almost a year ago). It completely fits the iterative mechanism of innovation in short cycles that is so characteristic for the medical devices industry and even corresponds with the current thinking in medicinal products PMA legislation that the Parliament would like to mimic that is moving in this very same direction. Yet, the Parliament can’t seem to burst its own bubble that insulates it from listening to people that have a better claim to knowing what they are talking about.

What will happen?

We don’t know yet, because the political constellations between member states are very opaque from the outside and member states are notoriously prone to solve things by means of spontaneous political horse-trading that is difficult to predict from the outside. We can only hope that cooler heads will prevail and the Council decides that it will rather take more time than be stuck with legislation that is systematically flawed in its approach, will produce false security and rack up the costs of healthcare considerably. Because who has two thumbs and will pick up the bill for all of this? Indeed, tax payers and patients – and that’s not a good message for member states to deliver to the voters back home, especially if the so-called improvements do not improve safety and delay innovations from becoming available to patients in the EU.

Also, this Tuesday the Greek Presidency will present its health policy priorities at the EPSCO meeting, having spoken already with the ENVI Committee and among others rapporteurs Roth-Behrendt and Liese for the MDR and IVDR proposals. This should give us something of an idea of the intentions of the Greek Presidency to finish this dossier before the elections.

So, lot’s of known unknowns for the moment, but we’ll get a clearer picture soon when the conclusions of these meeting on Tuesday are published. Watch this space!