EU ENVI Parliamentary Committee resolution re Review : "learn the lessons of this fraud" and an FDA internal report

The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of the Review of the medical devices directives, still scheduled for the end of Q2 2012 as far as I know. At its meeting on 25 April is unanimously passed a resolution requesting the Commission to implement among other things in the words of the press release:

A breast implant register, more stringent checks and product traceability, and a premarket authorisation system are among the measures proposed by the Environment and Public Health Committee on Wednesday to prevent a recurrence of the PIP defective breast implants case.

Goals of the ENVI resolution are (in the words of the press release):

  • “Market surveillance, vigilance and the functioning of notified bodies must be improved”
  • “increased traceability of implanted medical devices”
  • “increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done”
  • “patients’ associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape”
  • “shift to a pre-market authorisation system for certain medical devices”
  • “patients must be made aware of breast implant risks”
  • “introduction of an implant recipient’s passport, stating the implant’s specific characteristics and its potential adverse effects, and a breast implant register in each Member State”
  • “a system of collective redress should be put in place to help patients to obtain compensation”

What these proposals mean in detail can be seen in the last version of the amendments to the text, which I expect is the one approved (I could not locate the final approved text yet but this is the draft motion for a resolution that ENVI started out with). The Commission is not obliged to take all of this on board in its proposal at this stage, but this is a clear shot across the bow from Parliament telling the Commission what Parliament wants to see in the proposal if it is to have a chance to make it through Parliament. Parliament  can make life difficult on the Commission by killing or crippling its proposal with amendments the Commission won’t stand for or by not even agreeing with it. So this is a clear signal for the Commission of what Parliament expects from it in the proposal.

The resolution has been received with mixed feelings by the industry, as Eucomed reports in yesterday’s press release. On the face of it, the resolution’s goals are not a great departure from what the Commission was planning to do anyway, except for the pre-market authorisation for certain devices (plans for a collective redress system have been in the works for some time but are progressing slowly). My guess is that the Commission will stick to the current plan of not setting up a pre-market approval system, because there is no budget a) to create a new agency, b) to put it in the EMA (and how well are they really doing on the approval process of their recent addition ATMPs in the first place?) or c) to task member states with it in a decentralised way because they have no budget because they don’t even have budget for market surveillance. The Commission will have to look for other ways to appease the Parliament on this point and guide its proposal through.

It’s a pity that the Commission’s well thought out plans have been caught up by a scandal that everybody recognises could not have been prevented by rules alone, but still causes the rules themselves to be blamed. I think the only party that took the right action here was Commissionar Dalli with the request to member states to take vigilance seriously. Everyone is blaming Europe while the problem really is lack of decentralised follow-up and lack of commitment from the member states. This cannot be fixed except with the member states stepping up and committing more resources, whether or not in a centralised fashion. For that reason everyone should not look at the Commission only, but also look at the member states (as the resolution does – to give it credit – it repeatedly “urges the Member States” to take actions; they have the power in the European Council that votes on the draft regulation later on to step up efforts on a national level). I hear back from Dutch sources at the Danish Presidency that a non-paper has been drafted at the meeting of the Council of Ministers of Health on 23-24 April 2012  to address crisis management for medical devices and the role of the Health Security Committee (in Dutch) and the Dutch Minister of Health spoke out with a proposal that includes starting to speak the same language in market surveillance.

Anyway, and then there is this “lambasting” internal report of the FDA saying that the EU devices market approval system is ineffective that is bound to create some additional pressure (full text here). I hear from my sources that the European Commission was not happy with this report at all and that it does not help with maintaining good EU-US relations. Nor am I happy with it. Apart from it being wrong and/or inaccurate on the law on points, which we have seen before with crititcs of the EU system time and time again, it looks looks to me like a textbook ‘wag the dog’ exercise to distract everyone from the FDA’s own problems with the present criticism accusing the FDA market approval system to be less-than-perfect. The argument used in the report is built up in the way that smokers often defend that smoking is not unhealthy: you point at case studies about 12 heavy smokers that  turned 80 in good health and then conclude that smoking cannot be unhealthy. This a a well known trick we lawyers use in litigation when we have no significant evidence but still need to make a point that looks like it is supported by evidence. With all due respect: for an agency that also looks at whether clinical studies for devices stick together correctly statistically I would have expected more sophistication to support the sweeping conclusions in the report. “Seek first to understand, then to be understood” if you want to make a point well, to quote a highly effective American, and: why can’t we all just get along?

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