Philippe Juvin et le scandale des prothèses PIP et la prochaine révision européenne des dispositifs médicaux – article du Parliament Magazine

Monitoring matters: Philippe Juvin

The breast implants scandal proves that we need to take a fresh look at the medical devices directive, writes Philippe Juvin.
Parliament’s plenary session on14 June 2012 adopted the resolution on the Poly Implant Prothèse (PIP) implants affair by a large majority.

I am delighted to see that all my colleagues, across the political spectrum, have been able to draw lessons from this matter and shine the spotlight on the gaps in our current system of medical device monitoring.

It has to be acknowledged that this implants scandal is not just simple domestic healthcare fraud. It is regrettable that we are able to see the extent to which this issue has, and will have, an impact at European level as well as internationally. To quote but a few figures in order to illustrate the impact : while breast implants have been marketed in 71 countries worldwide, i.e. around 400,000 breast prostheses, it is estimated that the number of women who have received PIP implants in France, the UK, Spain and German stands at around 87,500.

Although directive 2007/47/EC on medical devices is due to be reviewed in September 2012, my colleagues and I have been able to bring a positive contribution to the table. We have set out recommendations in our resolution which would make for a secure, transparent and flexible monitoring and materiovigilance system.

First, if we want to strengthen our market monitoring system, we must ensure Europe-wide clarification and harmonisation of the operation, roles and qualifying criteria of the bodies notified as part of the medical device inspection process, particularly in the case of class IIb and class III devices. We must allow notified bodies to make full use of their powers to carry out frequent, compulsory spot-checks and annual inspections throughout the supply chain and at every stage in the life of a medical device. This tightening of checks on the part of notified bodies should go hand in hand with similarly tightened monitoring of notified bodies by domestic healthcare authorities.

In addition, we must upgrade the traceability and monitoring of devices put on the European market, particularly the high risk devices. Traceability could be improved if we were to put in place unique device identification systems, national implant registers and a product feature summary in the case of each medical device. Our resolution also recommends the introduction of a recipient passport which would list not only the features of the implant and any potential harmful effects, but also any potential health risks and post-operative monitoring measures.

Furthermore, improved supervision and monitoring of medical devices already on the market requires improved cooperation and better dissemination of information among member states and the commission on any harmful effects of a device which may have been detected and the measures which have been taken to avoid the repetition of such an incident, as with the PIP implant affair. Lastly, the European parliament is calling for greater public awareness of the potential risks presented by breast implants. It is requesting member states to regulate cosmetic breast implant advertising more rigorously so that patients can be fully aware of the risks involved. While I welcome this resolution overall, I note with regret that my colleagues in other political groups have upheld the idea of introducing a marketing licence, as is the case with drugs.

When the time comes to pore over the review of medical device legislation, we must adopt a coherent, balanced approach between protecting our European patients on the one hand, and supporting research and innovation on the other.

The first of these steps will be not to treat medical devices like drugs. Indeed, three basic differences exist between them.

First, a difference in kind. The scope of definition of a medical device is far greater than that of drugs, ranging, as it does, from a simple plaster to a hip replacement. Second, there is the difference in marketing life-span. Whereas a medical device has a marketing life-span of around two to four years, that of a drug can be as long as several decades. Third, there is a difference in terms of numbers arriving on the market. Around 654 drugs reach the market every year, whereas, in the case of medical devices, there are several tens of thousands.

It is obvious, therefore, that the introduction of a marketing licence for medical devices would merely clog up the system with red tape and only serve to further lengthen the time it takes to put products on the market. Marketing licences, which would neither improve the level of market supervision nor offer our European patients any greater protection, would, in the end, merely act as a brake on research and innovation.

As referent for the EPP on the PIP resolution I am saddened to note that in what amounts to a healthcare scandal, my colleagues in other political parties have not seen fit to step back and take a good hard look at the way things stand. Naturally, we must upgrade our system for the prior inspection, as well as the monitoring of medical devices already on the market, but not at the cost of research and innovation.

Philippe Juvin is a member of parliament’s internal market and consumer protection committee