380px-EU_Consilium_Logo.svgTo get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently.

EPSCO council 18/19 June

With the Latvian presidency drawing to an end and the EPSCO council of 18/19 June in sight, the question is whether the Council will manage to come to an agreement that enables the text of the medical devices and IVD regulations to progress to the stage of trilogue.

As I have blogged, the negotiations in the Council concerning this dossier have been all over the place, down into painstaking detail and sensitive.

Fluid

With the next EPSCO council meeting  very close, the Latvian Presidency is making a last push now to make progress, as the preceding Presidencies also tried in the EPSCO councils that were always planned towards the end of the Presidency. As they say, under pressure everything become fluid and that is noticeable on the outside. Fluids, if not properly channeled, tend to go everywhere.

In an attempt to reach compromise in the points that member states still differ considerably the horse trading has started, which is never a good sign for the quality of legislation. In EU lawmaking this invariably leads to compromise texts that are drafted in a way that each party can claim that the text mean what that party thinks or texts that trade extreme positions for each other so each party can claim that they scored on their politically important issue. As we have seen in the initial public council debate, reprocessing of single use medical devices is a typical candidate for this kind of compromise.

General approach

From what I understand from my sources the current idea is to try to achieve a general approach in the Council at the 18/19 June EPSCO meeting and there is optimism that this may actually be achieved. Kudos to the Latvians if they manage the wheelbarrow of frogs across the finish!

A general approach is an agreement on headlines that allows the Council to finally progress into negotiations with the Commission and Parliament with a view to achieving a final text for the regulations. As reported earlier, the Parliament put its cards on the table in April 2014 and reported ready for trilogue right after the 2014 elections. The Commission has issued its view on the Parliament’s proposed amendments in June 2014.

The trilogue will then likely run through the Luxemburg Presidency in the second half of 2015 with the final texts being agreed during the Dutch presidency in the first half of 2016. The texts would likely be agreed during the last EPSCO meeting towards the end of the presidency, so publication of the final texts could take place after the summer in 2016 and the three years transitional period would start for medical devices (still unclear if it will be three or five years for IVDs).

Reset?

table flip

Reset!

But there are also different signals. I also hear that there is still the backup option to just abandon the whole project and start from scratch with regulation proposals that fit the current political climate better, although this was never on the table formally and does not seem to be on the table anymore given the optimism about the actual possibility of a general approach this presidency.

Although a reset would cost a lot of precious time, there are still some things that could be taken on board in a new project.

 

Remember that the 2012 Commission proposal was intended as an incremental update to the existing directives that had to suddenly account for the jump in political awareness regarding safety of medical devices following the PIP case. Speaking of which – the German courts have recently referred preliminary questions to the European Court of Justice about the degree of diligence required of notified bodies under the medical devices directive – the outcome of this case may well affect EU regulation of notified bodies. This could be accounted for in new legislation.

Also, the TTIP negotiations are still (sort of) progressing. While the EU has quite firmly stated that TTIP will not impact the medical devices and IVD regulation in the works that seems quite inevitable to as that would defeat the purpose of including medical devices in the TTIP scope. My expectation is that the TTIP results (if any) will find their way in through the many delegated and implementing acts foreseen under the medical devices and IVD regulations.

A reset may also be beneficial with regard to future proofing of EU medical devices regulation. As I have blogged, the current proposals are modeled on ‘medical device as widget’ thinking under the EU goods package. Consequently, they are not very well suited to regulate devices evolving into ‘devices as service’ and lack any significant thinking on modern software design requirements and cybersecurity. The Commission has now planned to partially remedy this (and the interface with data protection regulation (another of these important dossiers stuck in the Council)) by means of an EC Code of Conduct on Mobile Health Apps. That could should be finished in the 2nd quarter of 2016. If the regulations pass now, they will require considerable work on the fly for future proofing.

360+360+300

If (if) the general approach is reached on 18/19 June, the expectation is that the trilogue will likely still take considerable time because of the rather extreme nature of the many of the Parliament’s proposals and of course how much the rapporteurs for the medical devices and IVD regulation feel committed to some of the politically showy but not evidence based, not even constitutional (e.g. genetic testing proposal under the IVD regulation) or outright unworkable amendments (e.g. redefinition of medical device as anything with an ‘indirect medical purpose’) proposed. From what I have heard the rapporteurs have become more realistic, meaning that the Parliament is likely to take a more flexible approach than it looked to take initially.

The fun begins in earnest then because the Luxemburg Presidency will have the Herculean task of aligning 360 pages of proposed medical devices regulation, 360 pages of proposed IVD regulation, and the ~ 300 amendments proposed by the Parliament. This will be an interesting puzzle. Also a lot can still change and move in this process because the Parliament’s position has to be reconciled with the Council’s general approach and the Commission’s position has it has evolved since the initial proposal in 2012.

So

With the Council currently a black box with proposals ricocheting around in it and horse trading going on people are optimistic that a general approach can be reached on 19 June. Let’s hope for the best – it’s way past time that this dossier progresses because pending these legislative procedures most work on modernizing guidance documents has been suspended. Industry is confused because the proposals go all over the place and it’s not possible to plan for the very considerable efforts needed to phase existing devices into the new system (the EU will not allow grandfathering). This hurts the EU’s medical devices industry and EU medical devices law is starting to lag behind internationally, eroding competitiveness.