A tale of two workshops – A lively day at the European Parliament ENVI hearing

  • Posted on 20.03.2013

A tale of two workshops – A lively day at the European Parliament ENVI hearing


Serge Bernasconi

Chief Executive Officer, MedTech Europe

European Parliament

By now most of you will have noticed that we have launched our “Don’t Lose the 3”-campaign. (If you haven’t, watch the 1-minute video and patient stories here). The basic message of the campaign is that, thanks to our decentralised approval system for medical devices in Europe, Europeans have access to life-saving and life-enhancing technologies three to five years before US patients without compromising safety. This is also the message I brought forward during the 26 February hearing of the ENVI committee at the European Parliament. Those of you who read my previous blog will no doubt remember that I was invited as CEO of Eucomed and CEO of EDMA to lay down the position of the medical devices and in vitro diagnostics industries regarding the upcoming revisions of both legal frameworks. And an interesting hearing it was…

I was very grateful to have been invited by both Rapporteurs, Peter Liese (EPP) for the IVDD and Dagmar Roth-Behrendt (PES) for the MDD. Starting with the second workshop, I was really pleased with the recognition that “IVDs are the parent of healthcare”. This basically means that in vitro diagnostics are present at every point in the healthcare pathway by providing the medical data necessary to help guide any treatment action. In this respect, I could not agree more with Dr. Liese’s concluding remarks on the potential that lies within future developments in in vitro diagnostics. My speech can be downloaded here but in short, the in vitro diagnostics industry is committed to delivering upon four key areas of the proposed revised IVD framework. In terms of:

  • The enhanced role of Notified Bodies, 80% of IVD tests will need to obtain their market approval through Notified Bodies. Such an enormous change for industry as well as for Notified Bodies, will require an appropriate transition time to implement. 
  • Systematic clinical evidence, IVDs will be subject to even more stringent pre-market requirements that will help to ensure patient safety, assay accuracy and the clinical value of the information provided.
  • The reclassification of IVDs, this process will lead to a more consistently safe and effective approach to IVDs 
  • Setting up reference laboratories, we welcome this measure with the hopes of further clarification of the exact role they will play.

The first workshop of the day centred around the MDD revision and was being chaired by Ms Roth-Behrendt. The key takeaway from my talk was that centralised pre-market authorisation is not the way forward. I emphasised how a centralised PMA-system as advocated by some will not lead to increased patient safety and rather cause unnecessary delays in patient access to our innovations. Despite having my arguments backed by several studies from Boston Consulting Group and Professor Josh Makower from Stanford University (see here, here and here), our statement that Europeans enjoy a 3-5 year advantage over the US was questioned using the argument that innovations only truly become available to patients after reimbursement. The London School of Economics (LSE) recently conducted a study on behalf of the European Health Technology Institute (EHTI) which found that in most member states (approximately 70%) early patient access is ensured through special payment mechanisms and / or by using available reimbursement for innovative medical technologies. Consequently, these special payment systems bridge the gap between product approval and reimbursement of the new technology.

The fact that the reimbursement argument is used leads me to believe that we could all do with an easy-to-understand and always up-to-date repository of reimbursement systems in Europe. And purely coincidentally, Eucomed happens to have just launched its fundingmedtech.eu portal, a website that provides medtech manufacturers with a visual overview of national reimbursement systems and offers critical information on how to obtain reimbursement in European and neighbouring countries. To make sure the information offered is of the highest quality and always up-to-date, we have chosen to partner with Hull Associates and Synergus, both experts in field of reimbursement. And for our members, we will offer the package at a discount of up to 30%. Visit fundingmedtech.eu and take the first step in developing more effective funding and reimbursement strategies.

Also, if you are a EDMA or Eucomed member, make sure not to miss the opportunity to get 50% off of the normal registration price for the European MedTech Forum.

Talk to you soon,


– Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA & Eucomed

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