Balancing adoption and affordability of medical devices in Europe.

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