Balancing adoption and affordability of medical devices in Europe
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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