Serge Bernasconi is the chief executive of Eucomed, the medical technology industry in Europe.
In the next few weeks, the European Parliament will vote on the medical devices regulation. This process starts with the Environment Committee voting on 25 September. A set of amendments have emerged in the last few weeks which most MEPs have not had time to assess, but which are being rushed through to vote.
We set out the position of European industry and ask MEPs some key questions to consider before voting.
The upcoming discussions in the Parliament are the latest step in reviewing the current Medical Devices Directive. Last year's proposal from the Commission followed the PIP scandal of breast implants, centred in France and known to many, after which all agreed changes needed to be made to the current system.
A number of changes have been proposed, and many of these are accepted by all. The most contentious issue, however, is around the approval system before new medical devices can be placed on the European market.
The Commission proposed what it called a scrutiny procedure. Before the summer, there was little consensus in the Parliament. But in the last few weeks some surprising new proposals have emerged. Most concerning to us is amendment 22.
Below, we express our concerns with amendment 22. At the end we lay out questions we believe are appropriate to ask, and we ask MEPs to discuss these with colleagues before voting.
If the questions can be answered and everyone is confident this has been carefully thought through, then that is a good test of the process. If not, we ask policy-makers to think through this further - this is too important both for European patients and European industry.
- Amendment 22 is rushed. This amendment is a complex proposal of committees and sub-committees, including 600 experts to be appointed; yet it only appeared in the last few weeks. No assessment has been made of any kind as to what real safety gains there would be; what delays would this cause for new devices reaching hospitals; what is the cost of the added bureaucracy to European governments? Even if this turns out to be the best approach, which we doubt, how can anyone know without assessing it?
- We honestly don't believe it will bring any benefits to patient safety. No-one has shown how any part of amendment 22 would have changed the outcome of PIP or any other safety issue. We welcome discussion of any worked example which shows how patient safety would have been improved by this Amendment 22 system.
- Many agree that the measures that will make a difference include: unannounced visits, better qualification and control of notified bodies at national level, effective traceability and labelling systems, implant cards and wide post-market controls, checks of manufacturers and hospitals. It is these measures which we all should check appear in the final agreement.
- European patients currently receive new devices earlier than in any other system in the world. A number of governments including Japan are changing their system because of the success of the European approach. Whereas in the US, which has a bureaucratic system similar to this amendment, in one example of many, seven million hypertension patients are still waiting to receive renal denervation treatment which Europeans are already receiving. US doctors are vocal in calling for their system to move towards the European approach. Have MEPs discussed the implications of the proposed approach with US doctors who live with this system? Why are we moving in the opposite direction?
- If the benefits to patient safety are negligible as we believe, then what will we all pay for this in terms of delays for patients? The Commission procedure was already adding 5 months. With 21 sub-committees now added in this amendment, how much time and bureaucracy will this add? Why don't we know even an estimate?
- Financial analysts and others have noted that this is the one sector within the technology industry where Europe has a leadership position over the US. They also note that the proposed changes could wipe out this advantage, for over 25,000 innovative SMEs in Europe. Have policy-makers looked at the scenarios that analysts are discussing?
- Voting in favour of Amendment 22 could actually delay agreement on a new system. European governments in the Council of Ministers want to maintain the current system of national notified bodies, but building in extra checks and safeguards. This proposal moves the Parliament so far away from the Council, it risks that no agreement is reached before next year's European elections.
We see our role as a stakeholder not as asserting our view more and more loudly, but in asking questions that policymakers and others can use, to reject or accept as they wish.
We have the following questions for voting MEPs.
- Regarding how to ensure that the PIP scandal is never repeated, will Amendment 22, once assessed, do anything to prevent the PIP scandal from happening again? What exactly would have changed in the PIP scandal if the new system was in place? Or is it the case that the real improvement to prevent future PIP scandals is actually the system of 'unannounced visits' proposed by the Commission and already welcomed by all?
- When it comes to other patient safety improvements, if the system proposed by amendment 22 does not prevent a future PIP, then what other impacts on patient safety will it have? Can those arguing for this approach give one worked example of a problem device which would have been solved by the changes proposed?
- When it comes to patient access to new devices, if the Amendment 22 system has less concrete benefits than claimed, then what are the negatives for patients? If the estimated delay of the original Commission proposal was five months, what will be the delays of this system of 21 sub-committees? Has anyone taken a real example such as renal denervation and assessed how much longer this would have taken to reach European patients?
- If the answer is that no assessment has been made to understand what the delays in the Amendment 22 system will be, why is this being voted only two weeks after the system was dreamed up? Why has no proper assessment been planned? Is this being pushed through deliberately before it can be properly checked?
- Do we know whether the concerns of analysts are correct that this risks Europe’s leadership in this area, or are their concerns overstated? Shouldn't we know before we vote through such a radical overhaul to the system?
These are our five questions to the MEPs. Whenever this revision has proposed measures which will improve the system, we have tried to be supportive. Amendment 22, however, is a cobbled together compromise that may look good to rapporteurs on the surface but may look increasingly rushed as the impacts get assessed in the coming weeks.
We think that the Council is asking some of these questions. We ask MEPs similarly to ask the real questions, their own questions, not to rush into mistakes that may be more difficult to unravel later.
Too much is at stake.