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 below paragraph i am describing different handling ways of the coverage, reimbursement and pricing by three major nations of Europe especially Germany, France and UK as an examples.
France and Germany are exemplary for social health insurance systems. The French healthcare system is based on a national social insurance system complemented by elements of tax-based financing (especially the General Social Tax, CSG) and complementary voluntary health insurance (VHI). The health system is regulated by the state (parliament, the government and ministries) and the statutory health insurance funds. Germany’s financing system is characterized by three co-existing health care financing schemes. The majority of the population is covered by statutory health insurance based on income-related contributions while 10% of the population are covered by private health insurance or governmental schemes (4%). All these countries fund health care mainly through national taxation, deliver services through public providers and have devolved purchasing responsibilities to local bodies.
Coverage policy: – Decisions on the coverage of medical devices in France and Germany are made by self-governing bodies. In France, devices must be shown to be cost-effective in order to be classified as reimbursable. Devices that fulfill this requirement are included in a positive list. In Germany, health
Benefits are defined by the Federal Joint Committee consisting of representatives from health service providers and SHI funds. This committee may take into account assessments that have been prepared by the Institute for Quality and Efficiency (IQWiG). Decisions on the coverage of medical aids are made by the Federal Association of SHI Funds. Medical aids that have been approved are included on a positive list, currently containing around 15,000 products. In the UK, decisions on medical device coverage are made centrally by the NHS Business Service on behalf of the Department of Health. Due to different agencies involved medical device policies varies from regions to regions.