New Danish act on clinical trials
The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new medicinal research ethics committees will be established. However, the act does not come into force until 2018.
The new act on clinical trials is based on a new EU regulation on clinical trials which enters into force in October 2018 and which will change with rules governing clinical trials throughout the EU.
The new EU regulation does not describe the national collaboration on clinical trials, and consequently the Danish Parliament has adopted a new Danish act on clinical trials of medicinal products which lays down the Danish rules that will apply when the new regulation becomes effective.
The new act contains four main sections:
- Clinical trials, which describes the definitions used in the act.
- Clinical trials of medicines in humans, which describes the rules governing consent and the new medicinal research ethics committees that will only be assessing clinical trials of medicinal products – and not, as is the case today, where the committees assess all clinical trials in humans. This section also describes the collaboration and the division of tasks between the new committees and the Danish Medicines Agency.
- Clinical trials of medicinal products in animals , which describes the requirements for applications and the reporting of adverse reactions.
- Final provisions, which describes the possibility of filing complaints and the entry into force in relation to the regulation as well as the provisions that take effect on 1 July 2016.
The act comes into force when the EU regulation becomes effective, most likely in October 2018. However, the present Danish Medicines Act and the Danish act on research ethics committees will be amended at 1 July 2016 and specify that the sponsor, monitor and the Danish Medicines Agency’s GCP inspectors have direct access to trial subjects’ patient records.
Links
The Danish Act on Clinical Trials of Medicinal Products (an extract in English)
The act is available in Danish at Retsinformation:
Lov om kliniske forsøg med lægemidler