How other European action affects health
4.1 What is the EU trying to achieve?
4.2.2 Medical devices
If regulation of pharmaceuticals is at one end of a scale (with strict scrutiny of detailed trials before products can be marketed) and the general EU approach for product safety is at the other end (with it being primarily up to manufactur-ers to ensure the safety of their own products), regulation of medical devices is somewhere in the middle.24 While the relevant EU legislation has some require-ments for initial scrutiny, these are lighter than for pharmaceutical products.
Moreover, whereas licensing of pharmaceutical products is undertaken by public bodies (the EMA and national agencies), the scrutiny of medical devices is
21 EUnetHTA [web site]. Copenhagen, European Network for Health Technology Assessment, 2014 (http://
www.eunethta.eu/contactus/all/356/all, accessed 14 July 2014).
22 European Parliament and Council. Directive 2011/24/EU of 9 March 2011 on the application of patients’
rights in cross-border healthcare. Official Journal, 2011, L 88/45.
23 See European Parliament. Medicinal products for human use: information on products subject to medical prescription. Luxembourg, Publications Office of the European Union, 2008 (http://www.europarl.europa.
eu/oeil/popups/ficheprocedure.do?reference=2008/0256(COD)&l=en, accessed 14 July 2014).
24 A good account of the background can be found in Hancher L, Sauter W. EU competition and internal market law in the health care sector. Oxford, Oxford University Press, 2012.
Health technology assessment
New technologies with the potential to improve the health of populations are continuously being introduced. But not every technological development results in clear health gains.
Health technology assessment (HTA) provides evidence-based information on the coverage and usage of health technologies, enabling them to be evaluated properly and applied to health care efficaciously, promoting the most effective ones while also taking into account organizational, societal and ethical issues.
Health technology assessment and health policy-making in Europe. Current status, challenges and potential
Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla Palmhøj Nielsen and Reinhard Busse
European Observatory on Health Systems and Policies, 2008 http://www.euro.who.int/en/about-us/partners/observatory/
studies/health-technology-assessment-and-health-policy-making-in-europe.-current-status,-challenges-and-potential
Ensuring value for money in health care: the role of health technology assessment in the European Union
Corinna Sorenson, Michael Drummond and Panos Kanavos European Observatory on Health Systems and Policies, 2008 http://www.euro.who.int/en/about-us/partners/observatory/
studies/ensuring-value-for-money-in-health-care-the-role-of-health-technology-assessment-in-the-european-union These two studies provide a detailed review of the role of HTA in the EU and review the relationship between HTA and policy-making. By analysing the situation in Sweden, the Netherlands, Finland, France, Germany and the United Kingdom and examining both method and process in the prioritization and financing of modern health care, the authors identify ways to improve the HTA process in Europe and to increase its contribution in policy- and decision-making processes. They also highlight the contribution that HTA can make in supporting value and innovation in health care and ultimately in improving the health status of the population through the delivery of optimum health services.
Marcial Velasco Garrido Finn Børlum Kristensen Camilla Palmhøj Nielsen Reinhard Busse
Observatory Studies Series No14 on Health Systems and Policies
This book provides a detailed review of the role of health technology assessment (HTA) in the European Union. It examines related methodological and process issues in the prioritization and financing of modern health care, and presents extensive case studies on the situation in Sweden, the Netherlands, Finland, France, Germany and the United Kingdom.
A number of issues are examined and there is a particular emphasis on the responsibility and membership of HTA bodies, assessment procedures and methods, the application of HTA evidence to decision-making, and the dissemination and implementation of findings. The book aims to highlight ways in which the HTA process in Europe could be improved by examining key challenges and identifying potential opportunities to support value and innovation in health care.
The authors
Corinna Sorenson is a Research Officer at LSE Health, London School of Economics and Political Science, and a Ph.D. candidate in the Department of Social Policy.
Michael Drummond is Professor of Health Economics at the University of York, Centre for Health Economics.
Panos Kanavos is Senior Lecturer in International Health Policy in the Department of Social Policy and Merck Fellow in Pharmaceutical Economics at LSE Health, London School of Economics and Political Science.
The role of health technology assessment in the European Union
Sorenson, Drummond,KanavosENSURING VALUE FOR MONEY IN HEALTH CAREThe role of health technology assessment in the European Union
Observatory Studies Series N° 11
undertaken by private companies that have been designated as “notified bodies”
by the competent authority of the Member State in question; there are around 80 such bodies in Europe.
The requirements for marketing medical devices in the EU vary according to the level of risk that different medical products represent. At the low-risk end (class I devices), manufacturers may simply declare that the products meet relevant standards themselves. At the high-risk end (class III devices), notified bodies must be involved throughout their design and manufacture.25 However, again unlike pharmaceuticals (and unlike the regulatory regime for medical devices in the United States), medical devices are not evaluated for their safety and effectiveness; rather, a narrower assessment is made of their safety and whether the medical device functions as intended. In practical terms, this means that higher-risk medical devices tend to be authorized more quickly in the EU than in the United States, where clinical trials are required – but also that patients in Europe may thereby be exposed to medical devices with potentially adverse consequences that are not shown by the more limited assessment required.26 Doubts have also been expressed about the role of notified bodies in the regula-tory process; as private companies whose income comes from the fees that they charge to manufacturers, the notified bodies face a complex set of objectives, balancing the need to fulfil their obligations with the need also to continue to receive approvals business from manufacturers. There is also a serious lack of data about how effective the controls are in practice, with a lack of public access to data about product licensing or adverse events.27
As ever, crises have a way of driving change, and the Commission has proposed some strengthening of the oversight for medical devices, in particular following recent serious problems with faulty breast implants and some hip replacements.28 While these proposals may reinforce the existing regulations to some extent, they do not change the core features of the system in terms of the use of notified bodies, the narrower evaluation criteria in comparison with pharmaceuticals or the lack of public data that would allow independent evaluation of the effective-ness of regulation. The final nature of the revisions remains to be determined, however, as at time of writing these are still under discussion in the parliament and Council.
25 Chai JY. Medical device regulation in the United States and the European Union: a comparative study.
Food and Drug Law Journal, 2000, 55:57.
26 Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. New England Journal of Medicine, 2012, 366(9):848–855.
27 Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European Union? A systematic review. PLoS Medicine, 2012, 9(7):e1001276.
28 European Commission. Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals (COM(2012)540 final). Luxembourg, Publications Office of the European Union, 2012.