In a previous blog I have addressed the genetic testing amendment to the IVD regulation proposal and have provided argumentation why this proposal is outside the scope of the legislative competence of the EU. To make it interesting I have also explicitly challenged the author of the amendment, rapporteur for the IVD regulation proposal Peter Liese, to prove me and my colleague Julian Hitchcock wrong in our conclusions (executive summary here).

We were actually right

Nothing happened and nobody challenged our conclusions. That may be because we were actually right. So we were not challenged by the University of Passau that admitted that their report’s conclusion that provided the foundation for the Parliament’s amendment was wrong (which it is, and the report was commissioned because the rapporteur himself also doubted that the EU had this competence in the first place). Nor did Mr Liese admit that he had misjudged EU competence.

Rather, the EU’s sovereign member states comprising the Council backed us up. The Dutch government recently stated in answers to the Dutch Parliament (in Dutch, sorry – we’re working on a translation) that a majority of member states in the EU Counsel consider this proposal outside the scope of EU legislative competence, on the exact same grounds that Julian and I concluded in our report: subsidiarity and proportionality prevent posing medical-ethical requirements for national practice of medicine with genetic testing.

Compromise

The Dutch government states that it looks like the Counsel can accept a compromise to the effect that member states may deal with this matter themselves at national level, much like where things look to be  going with respect to reprocessing of medical devices.

Insufficient attention for IVDs

Also, the Dutch confirm a point that I have lamented often on this blog: the lack of attention for the IVD regulation in the legislative process. The Dutch say that the negotiation process regarding the IVD regulation is though going (“moeizaam“), and that there has been little attention for IVDs in the whole revision process so far because priority is given to the medical devices regulation. This is also painfully obvious in the progress report of the Counsel for preparation of the Employment, Social Policy, Health and Consumers Council meeting on 1 December 2014 (more about this progress report in a future blog).

Cause for concern

The Netherlands thinks that this is a cause for concern and will give efforts to ensure that sufficient time is dedicated to this important subject during this presidency and the following ones. I agree. It would be useful if there would be more attention for the IVD regulation. Not only will there be very big changes for the IVD industry as a result of the IVD regulation proposal, but the importance of IVDs in modern personalized medicine is enormous. IVDs are just too important for society to be overlooked and underprioritised this way.

What happens next?

Well, the Parliament may realize that you cannot conjure competence to legislate out of thin air under rule of law and revoke its proposal because it has no legal basis to be adopted.

Except that this is not how politics work, because this amendment will of course not be revoked but will go in the big horse trading mix between the Commission, the Council and the Parliament. Let’s hope that the Commission and the Council keep in mind that negotiation can only take place with bargaining chips that actually exist and that there really is nothing to negotiate on this point: the comprise on the table is actually just explicit codification of the current situation at member state level.