Czech Republic: After years of wrangling, a new Act on Medical Aids has finally been passed in Parliament
After years of preparation and discussions regarding a new law for medical aids, and regarding the changes to existing legislation which it would necessitate, the Medical Aids bill was finally approved by the Chamber of Deputies and by the Senate. Provided that the bill takes the last hurdle of the law-making process, it will bring a new and comprehensive statutory framework for regulating medical aids.
At the time at which the previous Medical Aids Act (Act No. 123/2000 Coll.) was written into law, the lawmaker 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 final user – the patient. This can even be observed with respect to sophisticated equipment (medical instruments sold over the internet in online stores). No adequate and effective regulation and supervision is in place to guarantee the final user that the given medical aid is suitable for them, that they have received comprehensive 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 bill addresses the entire life cycle of medical aids, from the manufacturing process to distribution, sales, prescriptions, issue, use, repair and maintenance, to the rules of disposal for obsolete medical aids.
It also anticipates that a unified register of medical aids will be created. The decision on health insurance imbursements will lie with the State Institute for Drug Control (SÚKL) which will also act as the supervisory body in charge of monitoring the market in medical aids. Changes are also going to affect the rules for the clinical assessment (and the assessment of functional suitability) of medical aids. In this manner, the changes to legislation affect both the level 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, advertising, etc.) and the level of economic regulation (in terms of prices for such medical aids and the compensation (if any) of these prices by public health insurance). A number of areas was previously not addressed by the lawmaker at all, or only in an inconsistent manner (advertising, uniform decisions on health insurance reimbursements).