Netherland medical devices compliance update from Erik Vollebregt

What are they up to?

So what are the Dutch up to these days? The Dutch have clearly decided that they are going to make a difference in the medical devices space, which I much applaud as there was certainly room for improvement. The Dutch have taken a very sensible stance in the revision project, and are clearly serious about applying more intensive scrutiny to the Dutch market. The competent authority is increasing its staff for medical devices, which is a good thing because so far it was really strapped for recourses in devices enforcement. However, as we will see below, I think that they sometimes put the focus on the wrong things or color outside the lines of the law in their enthusiasm.

European lobby to incorporate HCP interaction regulation in the EU regulations

The Dutch have started a lobby in Brussels to incorporate HCP interaction regulation in the regulation proposals, as was confirmed by a communication of the Dutch Healthcare Minister to Parliament on 19 December 2013. At present this subject is harmonised up to an extent at EU level by branch associations codes (Eucomed, COCIR, EDMA), but these are not law and the Dutch would like to have these standards hardwired in EU law. Yes, notwithstanding that this is royally late in the day of the legislative process (they haven’t gotten much traction so far, the Minister writes herself) and notwithstanding that the Dutch government has just leaned on industry to set up its own self-regulatory system for the Netherlands in a very short time frame, which it is now seems to be proposing to make obsolete again.

Given that the Dutch are not gaining much traction in Brussels and that they are probably betting on the regulation proposals not being finished in time before the elections, they have a plan B and are planning to incorporate HCP interaction rules in the Dutch act on medical devices in any event. The Minister of Health indicated that she will make a proposal in 2014, with a view to entry into force early 2016.

Double jeopardy in clinical investigations

There seems to be a development of the Dutch competent authority not being very satisfied with the work of the Ethics Committees (yes, the very committees that the Parliament wants in the loop for clinical investigation approval according to its amendments to the medical devices regulation) with respect to clinical investigation approvals.

Currently the medical devices directive contains a notification requirement for approved studies in article 15 (1) of the Medical Devices Directive. The Dutch competent authorities seem to have started the policy that they will use this notification requirement as a basis for a second approval of clinical studies. They have started to send companies letters that they can’t start their already Ethics Committee approved investigation until they have satisfied additional competent authority requirements set out in the letter, which may overlap with what the Ethics Committee already did and/or address completely new subjects.

This is not only in contravention of the Medical Devices Directive mechanism for clinical trial approval, but also against the Dutch Clinical Trials Act itself, which provides for the division of competence between the Ethics Committees and the competent authority and is pretty explicit about the competence of approval of clinical trials with medical devices being reserved to the Ethics Committees. Granted, the competent authorities can enforce after a clinical trial has started on grounds of violation of GCP, but that’s something very different from an additional test as a condition to start a clinical trial.

This new way of doing things is administrative practice, which does not have a basis in law (since there is no attribution of competence to do this), so it may just be the competent authority asserting its authority to the market and doing its best to bend the rules to find a solution for their problem. However, this is an extremely onerous practice to be confronted with as a company and I have also heard that the body responsible for the Ethics Committees, CCMO, is very annoyed about this second-guessing of Ethics Committees.

Should you be confronted with this practice as manufacturer: keep in mind that the competent authority has no legal basis to require this. Maybe the Commission’s SANCO department (I hope they are listening) could tell them that this is an incorrect way of implementing EU medical devices law.

Authorised representatives in the crosshairs

A disturbing  development in the same vein is the competent authority’s (what seems to start to look like) policy to enforce against authorized representatives rather than against the manufacturers that they represent. I have seen ARs getting warning letters with huge fines threatened for things they have not done themselves and cannot even influence.

This practice seems to be based on a misunderstanding by the competent authority of the definition of authorized representative as it was ambiguously translated into the Dutch language version of the Medical Devices Directive and subsequently wrongly transposed in Dutch medical devices law in a way that it looks like the AR may be enforced against for manufacturer actions. It’s like the whispering game where you have to convey a sentence via a number of people that in the end comes out garbled. Big fun at children’s parties but not so much if legal certainty is at stake for a company in AR services or a manufacturer dealing with a freaked out AR that is being enforced against.

If you carefully read EU law and guidance on the subject of ARs, like the Authorised Representative MEDDEV, Regulation 765/2008 that (re)defines the concept as part of the Goods Package, the Blue Guide (the bible on CE marking), just to mention a few sources, there is absolutely no basis whatsoever to interpret the concept of AR in the sense that the AR can be fined under medical devices law for non-compliance of the manufacturer. Granted, they’re an easy target for enforcement – a proverbial sitting duck because they have to notify themselves to the authorities – but that does not mean that they can become a regulatory bullseye just because they’re a convenient target for the authorities.

This is another prima facie contravention of the Medical Devices Directive by the Dutch competent authority (the Commission should talk to the Dutch about that too). The concept of AR is defined at European level in several different instruments, so the Dutch competent authority does not have the final word on this and most definitely not on a manifestly wrong implementation of the medical devices directive. Maybe the ARs should start a class action for all the damages resulting from wrongful enforcement, as this practice is  obviously contrary to European law and therefore unlawful. In any event the ARs should seriously consider a complaint to the Commission (which I would be happy to help with, by the way). If you are an AR or manufacturer with this problem: I have already given the issue a lot of legal and regulatory thought. I would recommend that the Minister, if she is changing the law anyway to put in extra stuff, fixes this problem as well and just copies the Dutch language version of the definition of AR in Regulation 765/2008.

Sunshine in devices

Like in France and Denmark, the Netherlands is also going to require publication of HCP interactions in a public register, timing: by 2015. What interactions will be in there? Not with respect to certain groups of devices or anything above a particular value (that would be way too precise) but rather initially only “interactions relevant to the patient”. What does that mean? Good question! The Dutch minister explains it to Parliament like this:

“Ties that the HCP could have with a manufacturer of rubber gloves are not relevant to a patient. Ties of a manufacturer of pacemakers or hip implants are relevant to the patient. […] We will start with ties for devices which the patient has a very close relationship with in treatment, but for which the HCP decides on the choice of the device. An example are implants.”

Do I smell some bias here against the implants side of industry? There has indeed been a lot of buzz in Parliament about the naughty implants industry and their consultancy contacts in 2013. But what is relevant to me as a patient? If you have an internal exam or ultrasound, you bet that the HCP interaction with the gloves / transducer cover manufacturer is just as relevant for a patient as with implants. An HCP selecting the new extra thin glove that ruptures more easily because he receives a kickback is of course also a big health risk too. Or what about endoscope cleaning fluid? Hepatitis C is really not that fun to contract.

This argument of the Minister of ‘relevance to patients’  is not very well though out and has a strong ‘some animals are inherently more ethical than others’-feel about it,which in my view makes the argument not convincing at all. If you want a phase-in of reporting for different classes of devices, one can do much better than this in defining categories, like for example by the value of the contract or by risk class of the devices concerned. Anyway, as this is still under development, the government will have the opportunity to set this up in a more objective way.

“Interesting”

Interesting developments in the Netherlands, however some of which are probably not the most promising when it comes to the Dutch interpretation of how to implement the Joint Immediate Action Plan and EU medical devices law. I think a reality check on EU law compliance is in order – hopefully the Commission is watching too and will invite the Dutch competent authority for a meeting on the correct application of EU medical devices law.

For the rest, start to prepare for sunshine compliance in the Netherlands – it’s coming your way one way or the other.