keep-calm-it-will-happen-14The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December. That is, for this Presidency (the Luxemburg one). If the  Commission, Parliament and Commission do not manage to reach consensus on everything, the trilogue negotiations will continue under the Dutch Presidency in the first half of 2016. If that happens, the expected date of entry into force of the regulations may also move into the second half of 2016. It also looks like the housekeeping necessary for publication of final texts after a successful trilogue will take more time than expected (implement all agreed compromises in 400+ pages of legal text, peer review it and translate that into 20+ languages) in that it may take several months.

While the trilogue meetings are completely closed door and therefore black box, there are some things that are being heard in grapevines. So far it’s slow going on reaching consensus and from what I understand there seem to be especially divergent positions on the subjects of liability, transparency, reprocessing and hazardous substances regulation. This is just what I’ve heard indirectly, not verified at the source, and my perspective on these subjects.

Liability

Liability is a tricky one, because it’s about the proposals to include additional liabilities in the regulations for authorized representatives, manufacturers and notified bodies. I am getting a lot of signals about how this will impact these actors. ARs and notified will go out of business as they cannot afford the insurance cover required (except the very big ones); which may be the same for smaller manufacturers. Everybody will seek to pass on these costs and/or liability, so the net result is that devices will become more expensive while lawyers and insurance companies will be very happy and thrive. Mandatory insurance cover as such, in my opinion, has never made things better for patients because insurance companies are not in the business of paying out money, but doing that as conservatively as they can get away with. The only reason to do this right for patients is to harmonize the criteria under which a fight about liability can never be the patient’s problem (which, of course, was not considered in any of the amendments).

Transparency

Transparency is about what will go into the Eudamed database and what levels of access will apply for what categories of users. It concerns for example the debate if all adverse events need to be reported or only serious ones, which will make a lot of difference in terms of regulatory burden. There is also serious doubt about whether the competent authorities even have the resources to do a meaningful review of all that data.

It’s also about the proposal of the Parliament to include transparency for clinical investigations data like the EMA is currently implementing and I understand this is a very important point for Ms Willmott, the ENVI Committee rapporteur, who was rapporteur for the clinical trials regulation for medicinal products.

This would have big consequences for the medical devices market because it will likely create an instant market for generic medical devices without any of the regulatory protections that medicinal products have. The result will be a situation where innovative medical devices companies will be more than reluctant to invest in expensive clinical investigations because their results will be on the street immediately upon obtaining a CE mark, allowing competitors to follow up with a “me too” product quickly and efficiently.

Reprocessing

Reprocessing is politically volatile because of the very different member states positions on the subject and the polarized Parliament position (“single use labeling is like printing your own money“) which may (hopefully) be less polarized under the new ENVI Committee rapporteur for the MDR.

Hazardous substances

Hazardous substances regulation is a not that well considered Parliament amendment that is very controversial to industry as it overlaps with current regulation and the sweeping phase out requirements would lead to widely relied on medical devices needing to exit the market with no alternatives being available currently.

Reclassification of substance based devices

This is mainly about the famous Rule 21, the new classification rule for ‘substance based devices’ (‘devices that are composed of substances or combinations of substances that are intended to be ingested, inhaled or administered rectally or vaginally introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body’) which will be upclassified considerably, sometimes from class I to class III. This will of course impact industry that produces these product enormously.

Quo vadis trilogue?

The above four issues were controversial up to now but other and additional potentially controversial subjects are still to be discussed in the upcoming trilogue meetings because we are only halfway in the trilogue agenda, such as notified body oversight and organisation (e.g. will there be special notified bodies or not). Since these meetings are as closed as they can be, it’s difficult to know what’s really going on and every statement in that regard is speculative.

Next formal public update will be at the next EPSCO Council on 8 December – we will likely know then whether the trilogue was successful during the current Presidency.