Abstrakt
The aim of the article is to answer the question of whether the limitations of the access to unapproved therapies outside of clinical trials are permissible in light of the modern paradigm of health care which is based on the patients' autonomy of will. We only focus on the therapies consisting in the provision of unregistered medicinal products.
The law is often restrictive in allowing patients to be provided with experimental therapies even if they grant fully informed consent. The Czech law and a recent Czech case of an unapproved stem cell therapy provide a basis for the analysis of the problem with universally applicable conclusions.
We argue that the regulation of access to unapproved therapies serves an important public interest of the protection of public trust in the health system and hence is justified. The law should only permit access to experimental therapies that have sufficient scientific justifications.
Under certain conditions, the patients can be allowed to cover the costs of the therapy.