Regulations, assessments – in the end it’s about patients’ access to therapies

  • Posted on 22.11.2013

Regulations, assessments – in the end it’s about patients’ access to therapies


Serge Bernasconi

Chief Executive Officer, MedTech Europe

EU regulations

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I’m sure the evolutions will provide me with plenty to blog about.

But it is not only the regulatory developments that are high on our priority list. Improving the usefulness of Health Technology Assessment in Europe is something both Eucomed and EDMA fully support. Last month, a new step was taken towards possibly achieving that goal. You may remember that last June the European Commission formalised the establishment of an HTA Network under the cross-border healthcare directive. Objectives of this Network include supporting Member States in gathering objective, reliable, timely, and transparent information on Health Technology Assessment and avoiding duplication. At a strategic level, it decides upon the direction that HTA takes in Europe.

The HTA Network held its first meeting on 16 October during which it was confirmed that EUnetHTA will be supporting the HTA Network for technical and scientific issues. As Eucomed and EDMA, we are pleased with the stakeholder involvement in this first meeting and we fully subscribe to the importance of the HTA Network in advancing HTA in Europe. In the end, it’s all about European patients’ access to health technologies. And having such a broad range of industry representatives (EDMA, Eucomed, EFPIA, COCIR, EuropaBIO, EGA and AESGP) will hopefully ensure that the Network’s activities and outcomes are fit-for-purpose for the various health technologies and various market access models.

So, how far is the medtech industry in executing its 5-year strategy? Do companies recognise the need for change in the way they innovate, and if so, how will they go about it? All these and more questions form the basis for a Boston Consulting Group report “Slow Burn – The Need to Transform the MedTech Model in Europe”. The executive summary of this report was launched at the MedTech Forum and found that most companies recognise that change is necessary, but where they are in this process varies significantly.

Now, the full report digs deeper into the survey findings, but also adds background information on who was surveyed. The full report also includes results for a live polling session during the 2013 MedTech Forum in which attendants were asked about where their companies are in terms of making the switch to value-based innovation. The report is part of a larger “Strategy Toolkit” which we have put together, a collection of materials that have been developed to explain why we must change, how this should happen and who is already now doing so. The toolkit consists of videos, presentations, Q&A’s and much more and will be updated continuously. It can be downloaded for free at

And if you’re downloading the strategy toolkit, why not at the same time go to Here you will find all MedTech Forum 2013 presentations, photos taken during the event, videos and the post-event report. This year’s event was a great success with over 500 participants over the three days, over 250 downloads of the event smartphone app and almost 90% rating the format as good to very good. And already block 15-17 October 2014 in your agenda when the MedTech Forum will once again return to Dolce La Hulpe for the 2014 edition.

Lastly, I quickly wanted to remind you all that the registrations for the UDI (Unique Device Identification) workshop will close next Monday. So if you still want to find out the latest about technical aspects of UDI implementation (labelling/marking and database issues), or discuss about the feasibility of an effective UDI system, then make sure to sign up as soon as possible.

Talk to you next month!

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

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