Elsevier

Health Policy

Volume 92, Issues 2–3, October 2009, Pages 218-224
Health Policy

Balancing adoption and affordability of medical devices in Europe

https://doi.org/10.1016/j.healthpol.2009.03.016Get rights and content

Abstract

Dramatic increases in health expenditures have led to a substantial number of regulatory interventions in the markets for devices over the last years. However, little attention has been paid thus far to the regulation of medical devices and its effects. This article explores the policies pursued by European countries to find the right balance between improving access to new medical devices and restricting market forces to contain costs and ensure affordability. We outline the medical device policies of the four European countries with the largest expenditures on devices: Germany, France, Italy, and the UK. Subsequently, we discuss how these policies attempt to balance technological adoption and affordability by illustrating two case studies from Italy and Germany. We find that reference prices, if defined as maximum reimbursement levels, can help to achieve balance, because they are supposed to contain costs effectively, but do not necessarily act as a hurdle for the adoption of innovations. We also find that policy tools that encourage technological adoption should be used carefully since the benefits of a new technology are often difficult to predict. Finally, we draw a number of policy implications based on our observations.

Section snippets

The market for medical devices

The market for medical devices in Europe (€63.6 billion) is nearly as large as that in the US (€79.4 billion) (Table 1). Both markets include items as diverse as medical aids (e.g. wound-care products), artificial bodyparts (e.g. hip endoprostheses), and technical equipment (e.g. MRIs) and are thus very heterogeneous. Devices are used for diagnosing, preventing, monitoring, treating, or alleviating disease. In contrast to pharmaceuticals, however, they do not achieve their principal intended

EU directives on medical devices

Market access for manufacturers of medical devices has been regulated in most European countries by three EU directives since the 1990s. On March 21, 2010 the new directive 2007/47/EC, updating and amending directives 90/385/EEC, 93/42/EEC and 98/8/EC, will come into effect. One of its main goals is to increase transparency, better coordination and communication of market surveillance activities [9]. An EU directive is a legislative act that requires member states to achieve a particular result

Decisions on coverage, reimbursement, and pricing

Although the three EU directives may give the impression that the regulation of medical devices is uniform throughout the EU, many regulatory decisions – especially those dealing with coverage, reimbursement, and pricing – are made at the level of the individual EU member states (Table 2). Indeed, with some countries, such as Italy, having devolved certain powers to their regions, there are possibly 100 different approaches to regulating devices in the 27 countries of the EU. In the following

Different policy approaches in Europe and the US

Medical device policy generally involves the attempt to reconcile two contrary goals: cost-containment and ensuring access to medical devices. To this end, the US and Europe follow different approaches. Manufacturers must prove the effectiveness of their products before these can be licensed in US, but they do not need to do so in Europe. Moreover, in the US, the Center for Medicare and Medicaid Services (CMS) may decide to cover a device and other large insurers may follow suit. In Europe,

Conclusion

Governments all over the world are faced with the dilemma of facilitating the adoption of medical devices while ensuring their affordability. Without reimbursement, many patients would be unwilling or unable to pay for the devices. As a consequence, many manufacturers would have little incentive to develop new products, and providers and payers would be unable to offer innovative technologies. Thus, insurance providers and governments have the responsibility to balance technological adoption

Policy implications for the future

It can be observed that markets for medical devices do often not work without problems due to asymmetric information. In this situation policy makers should try to make use of coverage policy as the chief instrument for regulating medical devices. Coverage decisions should be taken by governmental or self-governmental institutions in each country but require some kind of evidence for the cost-effectiveness of the products. Thus, manufacturers should be required to provide evidence for the

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