Czech Republic: Broadly conceived law comes into force on 1 April 2015
After years of preparation and discussion for a new law on medical aids and resulting changes to existing legislation, a new Act on Medical Aids has finally been approved in the past few weeks, providing a new and comprehensive statutory framework for regulating medical aids.
At the time when the previous Act on Medical Aids was written into law, the legislator predicted that medical aids would primarily be used, and made available, in the course and context of medical or pharmaceutical care. However, today’s reality is that medical aids are sold without restrictions and in many cases over the counter to the end user – the patient. This can even be observed with respect to sophisticated equipment (medical instruments sold over the internet in online stores). No adequate or effective regulation and supervision is in place to guarantee the end user that a particular medical aid is suitable for them, that they have received full professional instructions, that they will be able to arrange for maintenance and repair of the medical aid and that product safety is guaranteed.
The new Act on Medical Aids addresses the entire life cycle of medical aids, from manufacturing to distribution, sales, prescriptions, issue, use, repair and maintenance, to the basic rules of disposal for obsolete medical aids.
The new Act also anticipates a unified register of medical aids. The State Institute for Drug Control (SÚKL) will act as the supervisory body in charge of monitoring the market in medical aids.
Changes will also affect the rules for clinical assessment (and assessment of functional suitability) of medical aids. In this manner, the new rules affect the realm of general regulation associated with the legal framework in the area of medical aids (such as market entry, terms of distribution, use of medical aids within the context of providing healthcare), but they do not address aspects of economic regulation (in terms of prices for medical aids and compensation by public health insurance). Another question left open for now concerns future regulation of advertising for medical aids, since approval for existing normative proposals has yet to take place.
Source: Senate printing No. 367