The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
Clinical Trial Regulation
The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce, i.a.:
- A more efficient application procedure for all clinical trials conducted in the EU via a single Clinical Trials Information System/database,
- A single authorization procedure for all clinical trials, to allow a more expedient assessment by all concerned EU member states,
- The extension of the silent agreement principle to the authorization process giving more legal certainty to sponsors and researchers, in particular SMEs and academics, and
- Strengthened transparency requirements for clinical trials data.
2. When are they likely to come into force?
While the Regulation entered into force in 2014, it has not yet become applicable. The delay is mainly due to the technical difficulties involved in the development of the single entry point database.
However, when the Clinical Trial Regulation becomes applicable, it will replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive.
In Denmark, the parliament has already adopted a new act on clinical trials of medicinal products based on the Clinical Trial Regulation. The Danish act is intended to enter into force when the new EU Clinical Trial Regulation becomes effective. According to the EMA, the new regulation will most likely become applicable in 2020.