Przeciwdziałanie off label use w prawie europejskim. Zarys wybranych problemów
Countering off label use of Medicinal Products in European Law. Outline of Selected Problems

Summary/Abstract: The author presents European regulations, which are to increase the availability of medicinalproducts by increasing patent protection as well as financial and organizational support for researchinto new medicinal products. Shortages of medicinal products cause authorized medicines to beused outside the scope of their authorization, which is defined as the concept of their off label use.The article clarifies the scope of this concept. It also brings up the causes, the scale and the risksto the patients’ health related to the phenomenon of the use of drugs outside the scope of theirauthorization. The author argues that the practice of the off label use of drugs occurs not only inpaediatrics and the treatment of orphan diseases. The European legislator has established, however,a system of incentives for clinical trials on drugs for rare diseases and drugs for paediatric use. Theevaluation and outcome of these regulations is positive. However, they are insufficient, given thescale of the phenomenon andthe risks to which patients are exposed.

• Details
• Contents