PharmExec Blog

Europe: EMA and EUnetHTA Agree Three-Year Work Plan

By Leela Barham.

Collaboration seems to be ‘in’ thing and it’s set to continue in Europe with the European Medicines Agency (EMA) and EUnetHTA agreeing a three-year joint work plan.

The EMA is of course the result of a collaborative approach across Europe: it acts as a hub of a European medicines network covering some 40 national regulatory authorities. An important feature of this collaborative approach is the compulsory nature of the centralized procedure for products such as those treatments for cancer and biotech products (although there are drugs that aren’t covered by this procedure). And since no-one can market a drug in Europe without a marketing authorization, this is an important collaboration that can either support access across Europe or no access across Europe for those products.

EUnetHTA, on the other hand, is voluntary in nature but recently got boosted by formally becoming the scientific and technical cooperation to support the EU network of national authorities or bodies responsible for health technology assessment. This is all part of meeting the requirements of the European Commission Directive on cross border healthcare.

EUnetHTA too has an impressive list of agencies taking part including some of those seen as most influential in HTA: the National Institute for Health and Care Excellence (NICE), the Institute for Quality and Efficiency in Health Care (IQWIG) and the Swedish Council on Technology Assessment in Health Care (SBU) for example.

EMA and EUnetHTA have been working together for some time. In 2010 they began working on the European Public Assessment Reports (EPARs) — these are scientific assessments of drugs that EMA have looked at. They have been working together to make the EPAR more useful for HTA agencies who have a keen interest in not just the money, but the clinical effectiveness of drugs. But these concepts are linked, after all, if it’s not clinically effective it’s probably not going to be very cost effective either.

Now they’re going to look at a wider range of issues, including:

  • scientific advice/early dialogue with sponsors, involving medicines regulators and health-technology assessment (HTA) bodies;
  • exchange on the development of scientific and methodological guidelines to facilitate clinical-trial design that can generate data relevant for both benefit-risk and relative effectiveness assessments;
  • developing approaches for collection of post-authorisation data to support activities of both medicines regulatory authorities and HTA bodies;
  • orphan medicinal products, exploring ways of sharing information for the common benefit of patients affected by rare diseases and the financial sustainability of the healthcare systems.

That’s a long list and it’s by no means clear what this will really mean in practice. With the results of their joint work on EPARs not yet fully reported it’s also clear that collaboration at this level takes some time (more than 3 years in the case of EPARs). It could be a while before concrete changes can be seen.

And of course, some of these issues will be controversial: more data is often desired by HTA agencies and regulators but it’s often at the substantial cost to industry so they will want to know that joint work from the EMA and EUnetHTA will actually lead to requests for more efficient approaches to generating further data.

Similarly industry will have a view on the financial sustainability of healthcare systems and the part that orphan medicines have to play.

Leela Barham is an independent health economist. You can find out more about her athttp://leelabarhameconomicconsulting.blogspot.co.uk and contact her on leels@btinternet.com

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