“First one down”… And I have to admit that I was pleased to read all your positive feedback and comments. This really gives me the enthusiasm to do even better in this second blog. If there is one thing I’ve learned from this whole process, it is that starting a new blogpost is like having to wake up in the morning: at first when the alarm is still buzzing you wish you didn’t have to, but once you get that first leg out of bed, you’re happy you did and everything else sort of follows from that first step.
But enough about my morning habits. Much more interesting is of course the upcoming hearing in the ENVI committee on the 26th of February. This event will be part of a workshop organised by the European Parliament on the MDD and IVD revision. I will be sitting on a panel together with the Commission, European Members of Parliament, patients and doctors to discuss industry’s point-of-view on the revision. Our press releases and other blogs the past few months have made it clear that we agree with most of what is in the proposal for the Revision of the Medical Devices Directives. But there are elements being proposed which we feel will not fix what is currently broken. I like to put each element of the proposal to my own 3D-test by answering 3 simple questions:
- Does it guarantee patient safety?
- Does it ensure patient access?
- Does it keep innovation in Europe?
In most cases, the answer is yes on all three questions. But when it comes to the proposed “scrutiny procedure” or giving the responsibility for approving Class III medical devices (the most technologically advanced ones) to a central agency, the answer is 3 times “no”. Research has proven that a centralized system for medical devices will not lead to increased safety but results in an unnecessarily delay of 3-5 years of lifesaving medical devices reaching patients in Europe. We really need to keep what works and fix what needs to be improved without radically changing the system. Above all we need to make sure we don’t lose the 3-year advantage European patients enjoy today. For an eye-opening example what can happen if Europe would indeed centralise the approval process, make sure to read the guest blogpost by Dr. Marazzi which we will publish on Monday.
Speaking of publishing, on 20 March a report on personalised medicine will be released which will discuss the current state, challenges and opportunities of this exciting field of medicine which of course relies heavily on IVDs. Its aim is basically to offer a unique treatment, specifically tailored to each patient. The report will be released in conjunction with the Conference on Innovation and Patient Access to Personalised Medicine, hosted by the European Alliance for Personalised Medicine (EAPM). The conference is especially relevant for our industry as the upcoming revision of the IVD Directives provide the opportunity to do away with some of the existing obstacles in terms of research, innovation and access to personalised medicine. I have the impression that some of these obstacles are only there because of differing interpretations of the legal framework surrounding personalised medicine. Once we identify these ambiguous parts of the legislation, they will hopefully be taken out and replaced with clear, unambiguous language.
Closer to home, and a little further down in the calendar is of course the European MedTech Forum. And I am pleased to say that, together with the opening of the registrations on 15 March 2013, this year, we are introducing a Very Early Bird Discount. More specifically, if you register before 30 March 2013, we take 50% off of the price for EDMA and Eucomed members. At this point, I cannot yet go into details about the agenda, but what I can say is that the MDD/IVD regulation, and its impact on businesses will be a central part of the conference. So, on 15 March, let’s all go to www.medtechforum.eu and benefit from that 50% off for members.
– Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA & Eucomed