Moving in the right direction – a fit-for-purpose HTA for devices and diagnostics

  • Posted on 23.07.2014

Moving in the right direction – a fit-for-purpose HTA for devices and diagnostics


Serge Bernasconi

Chief Executive Officer, MedTech Europe


I just read the minutes of the joint meeting EDMA, Eucomed, COCIR and EUnetHTA had last May and it got me thinking: why try to put a square peg in a round hole? Medical devices, in vitro diagnostics, imaging equipment and pharmaceuticals – while all health technologies – are very different in nature, in their mode of action, in the benefits they bring to people’s health and well-being, and in the way they contribute to sustainable healthcare. Because of these and many more differences, trying to apply a Health Technology Assessment (HTA) model designed for pharmaceuticals to other health technologies is like trying to shove a square peg into a round hole – it won’t work.

So it is encouraging to see that the international dialogue on Health Technology Assessment that is currently ongoing is moving in the right direction. That direction is moving away from a pharma copy-paste approach. Because the HTA process for pharmaceuticals is well-adapted to informing decision-making based upon health outcomes and economic consequences, and works well to inform pricing and reimbursement of pharmaceuticals. Simply duplicating and applying this approach for medical technologies will not be productive due to the specificities of our technologies and the various ways in which HTA is used in various member states. And that’s bad news for the European Commission, for the HTA agencies, for industry, and even for patients.

HTA – come again?

Health Technology Assessment is a tool to help assess medical technologies before further decisions on funding and reimbursement are made. It does this by evaluating the properties, effects, and/or impacts of healthcare technology – devices, diagnostics and pharmaceuticals. More specifically, HTA tries to answer various questions, including:

  • Is the technology safe and effective?
  • If so, which patients will benefit most from it?
  • What are the economic consequences and the cost-effectiveness?
  • What are the organisational consequences?
  • What are the ethical, social and legal considerations associated with its use?

All stakeholders meet for the first time

Back in 2008, the European Commission together with member states decided to set up a voluntary network of HTA agencies called EUnetHTA. Its aim is to exchange information and guidelines, and to pilot joint assessments between different member states. Eucomed and EDMA COCIR have been monitoring EUnetHTA’s activities from the beginning and providing advice. Last May, however, together with other stakeholder representatives, we met with EUnetHTA for the first time. It was really great to have all parties concerned around the table at the MedTech Europe offices for a frank and open discussion on how to ensure that HTA for medical devices, diagnostics and imaging equipment is fit-for-purpose.

As industry, we pointed out how HTA informs the route to market access differently for pharmaceuticals and medical technologies. And even within medical technologies market access pathways differ from country to country and from device to device, again unlike pharmaceuticals which have one pathway.

Because of all considerations, I’m glad to see that after this first meeting all parties have a better understanding the need for a medtech HTA that is fit-for-purpose. As such, I am very much looking forward to continuing our collaboration and to make this a joint success for all parties so that patients in Europe will continue to benefit from lifesaving and life-enhancing technologies.

Post-election moves

And it’s not only me saying this. At a recent event hosted by the European Policy Centre, Commissioner for Consumer Policy Neven Mimica also emphasised that “Swift access to innovative and life-saving technology is an important aspect of public health”. The statement was made in light of progress on the revision of the Medical Devices Directives (MDD) where the Commissioner made clear that he is dedicated to the file and wants to see progress swiftly. So what do we know, and what don’t we know yet?

Now that the European elections are behind us, we now know who’s who in the European Parliament’s committees, including the ENVI Committee which of course is of particular interest to the medtech industry. What we don’t yet know is who will take over the Rapporteur role for the MDD file, which the Council is still hard at work on. Indeed, in line with Commissioner Mimica’s wish for swift progress, the freshly minted Italian presidency has committed to making progress on device legislation a priority of its health policy agenda. Both the new Rapporteur and the Italian presidency are sure to play essential roles in MDD trilogue negotiations which, if all goes according to the timelines we’ve been hearing, will begin by the end of this year.

How harmonisation can impact your holiday plans

I have been getting many questions around the topic of “harmonisation” of principles that govern the IVD industry in other parts of the world. This topic is high on EDMA’s agenda with the on-going revision of the IVD regulatory framework, particularly since increased harmonsation translates directly into benefits for patients all over Europe. Did you know that thanks to increased harmonisation diabetic patients would have access to their test strips anywhere in the world? This is unfortunately not yet the case today and won’t be for the foreseeable future because test strips are not yet harmonised.

Another way in which more harmonisation benefits patients is that any potential issues can be spotted and communicated more easily throughout various regions of the world than is the case today.

And IVD companies too would benefit greatly from more harmonisation, for instance in the field of clinical evidence (see my previous blogpost to find out more about clinical evidence for in vitro diagnostics). Knowing which evidence is required for IVDs is of course a tremendous boost to bringing new technologies to market. And by making it easier to move these products from one region to another, more harmonisation will considerably increase Europe’s competitiveness.

So it looks like the second half of 2014 promises to be very interesting indeed. Will medical device HTA be fit-for-purpose? Will the negotiations between the European Commission, the European Parliament and the Council still be started in 2014? And how much harmonisation can we expect between Europe and other continents? 

Enjoy the holidays!


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

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