New Danish act on clinical trials of medicine to take effect in 2018
In May 2016, the Danish Parliament adopted a new act on clinical trials of medicine to accommodate EU Regulation 536/2014 on clinical trials on medicinal products for human use. The Danish act will enter into force in October 2018, when the EU Regulation also enters into force, and brings substantial amendments to the Danish clinical trial application system as we know it today in Denmark.
The EU Regulation referenced was drafted with the purpose of making it easier and swifter for companies to apply for clinical trials in the EU. For example, applicants shall only apply one place in the EU via an EU clinical trial portal and one central data base (instead of having to apply in each of the EU member states). This requires amendments to the national clinical trials systems in the EU member states, including Denmark.
The Danish act recently adopted provides for a new composition of the medicinal research ethics committees, which shall only assess trials with human medicines and not, as today, all trials with humans. The act includes four main sections, namely
1) clinical trials (with the scope of application and definitions),
2) clinical trials with human medicine (describing, among other things, the rules on consent from the participants of the trial and the composition of the ethics committees),
3) clinical trials with veterinary medicine, and
4) concluding provisions (right to complain and sanctions)
Source: Act on clinical trials with medicine (as adopted) http://www.ft.dk/RIpdf/samling/20151/lovforslag/L142/20151_L142_som_vedtaget.pdf (in Danish)
Although the EU Regulation does not enter into force until 2018, the Danish act provides for amendments to the Danish Medicines Act and the Danish Act on Research Ethics Committees to take effect as early as of 1 July 2016. One of these amendments specify that sponsor, investigator and the Danish Medicines Agency’s GCP inspectors will have direct access to the patient journals of the participants of the clinical trials.
During the summer, the EU Commission has as part of the new EU regulation on clinical trials issued four guidelines for consultation, namely:
- Guidance on “Risk proportionate approaches in clinical trials” with the objective to provide further information on how a risk proportionate approach can be implemented in clinical trials;
- Guidance on “Summary of Clinical Trial Results for Laypersons” with the objective to provide recommendations as well as templates for the production of a summary of clinical trials results for laypersons by sponsors and investigators;
- Guidance on “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously known as investigational medicinal products and non-investigational medicinal products) with the objective to align the guidance on IMPs and AMPs with the new EU regulation on clinical trials; and
- Guidance on “Ethical Considerations for Clinical Trials on Medicinal products connected with Minors” with the objective to align the guidance with the new EU regulation on clinical trials.
Source: EU Commission http://ec.europa.eu/health/human-use/clinical-trials/developments/index_en.htm
The consultation period runs until 31 August 2016 and all citizens and organization may submit their contributions.
DELACOUR’s life science specialists follow the implementation of the newly adopted Danish act on clinical trials on medicinal products for human use and the underlying EU regulation with proposed guidelines.