The genetic testing amendment in the IVDR

ESHGLogo-2013The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is not getting the attention that it deserves, especially because the IVD revision is sparking off volatile things.

Medical devices definition

First, there is the ill-considered idea to change the core of EU medical devices regulation (the definition of medical device), just because rapporteur Liese wants to regulate ‘life style tests’ regardless of whether these fall within the Commission proposes GHTF harmonized definition of IVD or the current IVD directive definition. This has led to the viral effect in the Parliament’s proposals that the definition of medical device is proposed to include any device with an “indirect medical purpose”, which gives the regulations such an enormously wide potential scope that nobody can begin to define what the borderline of this concept would like. CE will then truly become “Confusion Everywhere”. But I already said a lot about this, for example here and here, so I won’t repeat that here.

Genetic testing proposal

Secondly – and the feature item of this blog post – there is the proposal on mandatory counseling prior to application of a genetic test to a person. Rapporteur Liese thinks this is necessary because the Commission’s proposal is too much about technical aspects of IVDs:

“The Commission proposal focuses very much on the quality of the product. Experts and many international organisations, like the Council of Europe, OECD and the European Society for Human Genetics have again and again articulated their position that in many case even more important than the quality of the product is the framework in which the product is applied. Especially in DNA testing it is very important to respect the principle of informed consent. This has also been asked for by the European Parliament several times. A legal opinion concludes that it is possible and appropriate to introduce respective wording in the proposal. Therefore the rapporteur proposes amendments on this issue. There is consensus that it should not be the intention of the European Union to limit the access of patients to DNA tests but appropriate genetic counselling should be offered in any case to inform about the consequences before a test is performed. To respect the principle of subsidiarity it should be left to the Members States to regulate the details and member states should have the option to go further than the regulation requires. One can even argue that it is mandatory to include informed consent in the proposal because it is a crucial element of the Charta of Fundamental Rights (Article 3) and the Charta of Fundamental Rights is legally binding for the European Union in those areas where it acts.”

There did not seem to be a lot of pushback against this proposal since it was proposed, even though there should be because it is not only a limitation on patients’ freedom to obtain information about themselves, but also a clear violation of the principle of subsidiarity. Since the member states in the Council have so far limited themselves to only looking at the Commission proposal in preparation of negotiation with Parliament and the Commission, it’s not surprising that there is no external feedback about how they see this. From the inside however I have heard unofficial positions that member states are very unhappy with this proposal.

But, say what you will – it is clear from the rapporteur’s clarification of the proposal that the Parliament itself is unsure about whether the EU has the competence to put this proposal into law and the rapporteur has decided that he needed legal back-up to support his position. To address this, the rapporteur commissioned the university of Passau, which produced the Passau university opinion to back up the rapporteur’s case. This is a far more reasonable and rational approach than we have seen rapporteur Roth-Behrendt take in the medical devices regulation dossier, in which her approach essentially consisted of fact-free statements and accusing everybody that actually did have a rational argument and/or data supporting a position of being a liar or biased and therefore disqualified as stakeholder: how is that for a rational approach? I did not vote for that kind of approach anyway.

However, one opinion is not yet a debate. A debate is what we need to address sensitive issues like this proposal.

A counter opinion

To address this, my colleague Julian Hitchcock of Lawford Davies Denoon and I wrote an opinion (executive summary here) at the request of the European Society of Human Genetics, a non-profit organization that promotes research in basic and applied human and medical genetics and obviously has an interest in the amendment not being passed. It also has good substantive arguments for this, which it has set out here and here. We believe that the Passau university opinion that Rapporteur Liese used to justify this amendment is incorrect in that it concludes that the EU has competence to intervene in the the provision of medicine by member states by prescribing physicians how they should treat their patients.

In essence ESHG has the – I think – quite justified fear that adoption of this proposal will limit developments in genetic testing that stand to benefit every person in society, both on an individual and collective level. If we want a society where people take responsibility for their health we cannot remain stuck in facilitating people in maintaining the (un)known unknowns. From my own family experience I can say that I would have benefited greatly from the approach advocated in Eric Topol’s book The Creative Destruction of Medicine, which describes a compelling case of genetic testing of each individual at a very early stage to optimize both individual and population medicine. If you can easily know important facts about a person’s health, there are only good arguments that compel that you find out. Yes, somebody may find out an unwelcome fact about him- or herself like a genetic defect that codes for serious illness. However, this will allow that somebody and society to take the best remedial measures or take measures that still lead to the best quality of life. The person concerned is empowered to be a responsible person that takes charge of their own health or the health of the children for whom the person is responsible. This is what the Enlightenment was about in philosophy, and now we need an Enlightenment in healthcare. For that to happen we need some creative destruction of old paradigms, in my view. The only way to keep healthcare affordable and maintain a basis for solidarity in healthcare reimbursement is that people must know what there is to know about their health, so they cannot hide from making informed decisions.

Let’s start the debate

With this counter opinion on the table there can be a debate. If we are wrong with our opinion, let us know. If we are right, it’s nice to know as well.

But if we are right, the conclusion must be that this amendment cannot be passed. This is a duty that the Parliament owes to its voters. I, for one, did not vote for the Parliament to intervene in matters it is not competent to intervene in. I have said this before: if the Parliament wants to have more powers, for example to intervene in national practice of medicine, it should work on changing the Lisbon Treaty and ensuing Treaty on Functioning of the EU that provide for pretty clear division of competences in healthcare rather than try to fudge in amendments that violate of the principle of subsidiarity and make the Regulation challengeable.

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