The fog of war following a tsunami of amendments

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‘A speedy market access procedure of only this long.’

That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we are currently in with the medical devices and IVD regulation proposals and the amendments proposed.

Tsunami of amendments

The period for tabling amendments in the ENVI committee following Mrs Roth-Behrendt’s (general medical devices) and Mr Liese’s reports (IVDs) has passed, and there are a lot (more than 1000). I hear that it is expected that they will be published by the end of this week. I expect to have to sink a considerable investment in time to make sense of this tsunami of amendments. A first set published by the IMCO committee is here. IMCO’s proposed amendments include:

  • no PMA
  • no scrutiny procedure for devices but rather MDCG governed scrutiny of notified bodies and national competent authorities responsible for notified bodies (which I agree with being the better approach because the flaws in the EU system are in its supervision)
  • EMA consultation for ancillary blood derivatives
  • definitions of ‘safety’ and ‘performance’
  • definition of sponsor includes ‘funding’ as alternative criterion (so funding a trail without managing is sufficient to be sponsor)
  • exclusion of possibility to justify not engaging in PMCF for class III devices
  • strict and high standards for reprocessing
  • compatibility requirements for implantable modular devices
  • refurbishment criteria and a requirement to assume manufacturer incumbent obligations
  • attention to compatibility of UDI systems
  • language harmonization for Eudamed
  • For devices classified as class III and implantable devices, the summary of safety and clinical performance shall be updated at least annually with clinical evaluation reports
  • data on adverse events and safety data shall not be considered commercially sensitive information
  • criteria for use of equivalence for iterations of implants and class III devices

But this is IMCO talking (with amendments 88-212 out of what I understand about 1000), so we’ll have to see what the rest proposes before we can really get a feel of where things are going.

IMCO’s IVD amendments are here, which overlap with the above ones on medical devices as far as applicable to IVDs and further include:

  • tweaking of definition of companion diagnostic to “device specifically intended to and essential in selecting patients with a previously diagnosed condition or predisposition as suitable or not suitable eligible for a targeted therapy with a medicinal product or a range of medicinal products
  • tweaking of scope for home brew devices classified as class D and required to be used for transfusion or transplantation purposes
  • summary of safety and performance requirements for class C and D devices (shall be accompanied by the dataset collected during the clinical investigation and the post-market clinical follow-up)
  • Realization of the clinical performance studies shall be subject to a positive opinion by the responsible Ethics Committee.

What happens now?

A good way to get a feel of how the important actors are thinking can be gotten from this video report of the recent discussion of the proposals. You will have the opportunity to see what Mrs Roth Behrendt and Mr Liese are saying about the proposals when you give them the floor. You’ll also have the possibity to make up your mind about the explanation of the underlying argumentation, which I found glaringly lacking sometimes. Just some examples by Mrs Roth Behrent:

  • ‘PMA will not cause delays in market access – well, may a little, just some months – but that ‘s the same’ – the same as what? I have not seen any data to compare against in the justifications to the proposals in the report , so what is the comparision with? We don’t even know what to compare with because we don’t know what ‘innovative’ devices might be regulated under proposed procedure – that was left to the Commission to sort out, remember? I think it is inappropriate to accuse others of bad lobbying and even outright lies if they question this shaky factual basis.
  • ‘Single use labeling is like printing your own money’. Yes, she actually said that on the record. So this is what motivates the reversal of regulatory logic proposed that all devices (yes, your hips, cranial plates, pacemakers and stents) are reprocessable unless you can prove it’s not possible to do that safely.  This statement about printing your own money is so biased that I cannot believe it – my compliments on the lobbying on this subject. If this enters into force I am bringing my own sterile devices to the hospital like you do in developing countries, because in my law practice I see the cases of the people that are harmed by medical technology that fails because it is not (re)used as intended by its manufacturer. I see how clinical insitutions struggle with quality systems. If you compare quality systems in aerospace and healthcare, the difference in procedure success rates is 20% (99,9 vs 80 in healthcare), I heard on a podcast about healthcare statistics. The medical profession gets away with that by calling it complications and these harm only one person at a time that spends years fighting in court against a hospital that will just stonewall the patient. If you still need to train doctors to wash their hands, how will this go with reprocessing? Hospital infection anyone? Really, this is leading us nowhere.

You will also note the critical reactions from the other parliamentarians and the Commission, who are not at all convinced that this is the solution to the problems.

But Mrs Roth Behrendt will not be around to be accountable for her proposals as she is now in the race to become European Ombudsman, a  political career move after having spent a long time in the European Parliament. Perhaps she can help these harmed patients then, and make sure that public hospitals at least compensate them quickly if they have contracted something dangerous from badly reprocessed invasive single use products.

Where do we go?

Anyway, see for yourself how the political wind is blowing in the three hour video. I still think the Commission’s inital proposal makes a lot of sense expect for the sacrifical lamb of the scrutiny procedure, which could be fixed (and there are amendments for that, I’ve seen). Incidentally, the Commission remarked that the Dalli Action Plan has been implemented for 70% by now, with joint audits happening and all.

While the proposals are moving up in the Parliament the member states will also be taking a closer look with a view to the first reading in the Council (see below).

Next steps are now:

  1. The publication of the amendments (soon, I expect end of this week)
  2. Discussion of amendments in ENVI (29 May)
  3. Vote on amendments in ENVI (10 July)
  4. Plenary vote in Parliament (scheduled for 11 November 2013)
  5. Council first reading (who may not get to this before spring next year) to agree on a joint text, as is required under the Ordinary Legislative Procedure.
  6. Will we make the elections and Commission change in early summer 2014? If we don’t, there will be some delay because the new Commission and the new parliament have to make up their mind about this.

This delay might actually not be bad in the end because it gives some people time to go do other things and other people time to apply logic and evidence based argumentation to rules that will shape the delivery of healthcare for decades to come. To give it my own Yogi Berra spin: ‘if rules don’t change they tend to stay the same’. Which is not bad if you realise that the current rules already allow for a 100% Dalli Action Plan rollout. If we can accompish that, we are already where we should be.

Watch this space

More news on the amendments will be forthcoming, just give me some time to collect the information and boil it down to managable proportions.


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