The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote on on 22 October.
Now we can be sure what’s in the text, we can say something about details that are usually lost in translation to press releases. In this blog I will address some crucial things that I have been going on about for some time and that I have covered already in not very much detail, and some other things that have been lost in the mix but are interesting nonetheless.
The big picture that we had from the press releases is confirmed: ENVI proposes a PMA-esque procedure for market access for an open class devices that can be amended by delegated act. Currently in this class are:
- medical devices listed in class III,
- those implanted into the body,
- incorporating a substance considered to be a medicinal product,
- intended to administer a medicinal product, or
- utilising non-viable tissues or cells of human or animal origin, or their derivative
The PMA-esque procedure looks a bit like this (rough overview):
So, what we see here is that the Commission basically decides on PMA, and that has a mechanism baked in that led to the bitter fight between the Commission and the French company Laboratoires CTRS after the EMA and Member States repeatedly found that the product should be authorised, and the Commission opposed the authorisation nonetheless. If there is one thing clear here, it’s that the Commission takes all in the procedure and this has been set up as to make sure that you can just forget placing anything on the market via this procedure if the Commission is opposed against it.
The reprocessing proposal that will make you want to bring your own single use devices to the hospital remains a bad idea, even in its watered-down form. We are stuck with this because the rapporteur refuses to recognise safety aspects of reprocessing and is of the opinion that single use labeling is like printing your own money. As I have explained before, manufacturers are not deliberately labeling reprocessable devices as single use to earn more money, but to create devices that achieve better clinical outcomes.
The proposed resolution alters the scope in two ways: it adopts the definition that was proposed by Peter Liese for the IVD regulation (and which has also been adopted for the draft resolution for the IVD resolution), minus the element of “– providing information concerning direct or indirect impacts on health”, but still with the element “prognosis” and the spectacularly unclear extension of scope with “direct or indirect medical purpose”. This means we may be stuck with an incredibly expansive definition of medical device, which
- goes against the EU Court’s case law on scope of the concept medical device in the Brain Products vs Biosemi case;
- goes against the GHTF definition that we have negotiated as part of international harmonization;
but hey, why should parliamentarians care about the position of the EU in the global medical devices world, right? You might as well just put every product with an ‘indirect medical purpose’ in the medical devices regime as they propose.
It also contains an interesting limitation of the expansive scope of the definition of accessory proposed by the Commission:
“an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the device(s) to be used in accordance with its/their intended purpose(s); or to specifically assist the medical functionality of the medical device(s) in view of its/their intended purpose(s)“
The first part of the definition is current, the underlined part is new. This, I think, is intended to qualify the term assist as to make sure that off-the-shelf products that connect to medical devices are not immediately accessories, just because they “assist” the medical device one way or the other (e.g. a wifi router, a USB cable, a battery pack, etc.)
The planned exclusion of “viables” from the scope of medical devices in article 1 (2) (f) has been qualified further. The exclusion now reads:
“all products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable and that achieve their intended purpose by pharmacological, immunological or metabolic means, including certain living micro-organisms, bacteria, fungi or virus;”
I am not sure if the underlined additions make things clearer. Science in the borderlines discussion is precisely the hot button issue here, because the European Court just confirmed (following its Advocate General) in the Lycocenter case that every member state can have its own version of science and resulting differing outcomes in this respect (a blog about this case will be forthcoming shortly by the way). This way the border area becomes a border minefield because ENVI has just included a group of viables in the scope of the regulation that are viable but do NOT work as a medicinal product. Does that make sense? I’m not so sure. Also, the qualification “certain” means that other living organisms would fall outside the scope of the exclusion – and would be medical devices.
There is a new clause 1 (7a) that states that
“The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.”
which is obviously intended to create a big loophole in the internal market and give member states the possibility to limit free movement of approved devices. Of course they have to still observe the principles of the internal market here, but those are difficult to enforce. It just shows that there is less of an internal market for devices than you would think. Together with the Lycocenter case law this undermines the developing internal market for medical devices.
“Clinical investigations for medical devices, where made compulsory in accordance with this Regulation, shall include randomised clinical investigations in the appropriate target population and well-controlled investigations.” – the word shall here signifies that we will see the rise of trial design that may not be very ethical or useful as I and others have argued before.
The draft resolution contains a new provision about advertising of medical devices (Article 5 – paragraph 2 b (new)), which does nothing more than duplicate rules against misleading statements that already apply based on the misleading advertising directive and unfair commercial practices directive, both of which apply to medical devices. It does not refer to the rules on comparative advertising in the misleading advertising directive (which also apply to medical devices), so it’s unclear whether the intention now is to exclude applicability of general comparative advertising rules to medical devices. Bad idea, and only causes incoherent legislation. Either you fully harmonize advertising for a specific product (and also amend the general advertising rules to exclude applicability to medical devices), and make it specific that general advertising regulation does not apply, or leave it to general advertising law. This solution will only create confusion and incoherence.
There is more but now it’s over to the plenary and Member States
There is a lot more that I could say about the draft resolution, but then I would keep writing forever. As I have been saying: ENVI does no one a favour with this. It will stick the EU with a procedure that will shoot its innovative capacities with respect to higher risk devices squarely in the head by making these products much more expensive and slower to reach the market. In the end the patients will pay for this with their lives two ways – one way because they will lose out on innovations that would have saved them if they had been on the market timely, and in another way because of the qalies that member states will not be able to afford anymore because they become prohibitively expensive. Especially the latter is something that the Member States do not seem to realise very well.
The Parliament’s plenary and the Member States can still put some sense in this proposal by excising the worst aspects out of it. The plenary will vote on the draft legislative resolution on 22 October, which is very, very soon (for reference about the procedure, see here). I am not hopeful that this will produce any radical changes to the proposal.
The changes will have to come from the dialogue between the Parliament and the Council, which will lead to other compromises and horse trading. Will that result in a text that makes sense? I am not hopeful and neither are the member states as I understand. What is more likely: member states will drag their heels and run the legislative proposal into the ground on the elections. This is what I hear more and more from different directions and becomes the more and more likely scenario, especially given that the Lithuanian (current) and Greek (next) Presidency are not the most resource rich presidencies and have not devoted a lot of time for this file. The clinical trials regulation, a dossier plagued by its own political problems in the field of transparency, seems to have priority for the member states. Also, member states seem to be interested in setting up a Joint Action Plan version 2.0 because of the success of version 1.0.
That, however, leaves a lot of known unknowns and unknown unknowns that will make it very difficult to influence the process, especially because member states always have interests at stake that you don’t know about.
Of course rapporteur Roth-Behrent will push for the project to finished before the elections, because she will go on to do other things after the elections and would like a nice crown on her political career. Also rapporteur Liese in the IVD dossier has his political creds in the game and wants to finish before the elections too. We can expect them to pull some procedural tricks to condense the normal trilogue process between the Commission, Council and Parliament to gain time. But since when is someone’s political career an evidence based ground for bad legislation that we will be stuck with for decades to come? I think a workable and affordable system is more important than politics. Because we still haven’t seen her claimed evidence supporting the proposed mechanisms, while the evidence to the contrary keeps piling up, just look at the websites of Eucomed and COCIR. I find it deeply sad and disturbing that the Commission is obliged to make an impact assessment for the initial proposal, and then all evidence base is out of the window as the ENVI committee goes to town on the proposal and its rapporteur can call concerned parties liars without ever providing a shred of evidence to prove her point. Mrs Spanou of the Commission’s DG SANCO is reported to have said at the MedTech Forum that she is no fan of the proposed PMA system because she does not have (nor will get) the resources for the Commission to effectively administrate the ENVI PMA-esque process. Nor will – I assure you – the member states. This means that the process that already looks bad on paper will turn out unmanageable in practice.
Madness of everyday politics
Nobody wants unsafe devices – but everyone (you would think) wants state of art affordable and available safe devices, right? The Commission’s proposal was already quite good – let’s make it better and not worse. Let’s not prioritize political careers over patient safety and innovation. That sounds very logical on paper, but in the madness of everyday politics this logic is clearly out of window.