Legislation on clinical trials approved by Parliament
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the Medical Research Act. The amendments to the Medical Research Act aim to align the legislation on medical research with the regulations concerning clinical trials. These amendments to Finnish legislation will enter into force at the same time as a relevant EU regulation, on 31 January 2022. However, provisions on the processing of personal data will enter into force before this date.
Act on Clinical Trials clarifies the application of EU regulation in Finland
The Act on Clinical Trials contains provisions on the matters governed by a relevant EU regulation, making national regulation in Finland possible. These matters include:
- the qualifications of a researcher carrying out a clinical trial
- the language of application documents
- certain conditions for trials involving vulnerable populations
- main principles for the assessment responsibilities of Fimea and the ethics committee
- principles of fees for sponsors and compensation paid to subjects
- matters related to the processing of personal data in clinical trials
- matters related to the supervision of clinical trials
The Act also contains provisions on matters related to the processing of applications for clinical trials during the EU regulation on clinical trials (536/2014). The Finnish Medicines Agency Fimea is responsible for preparing Part I of the assessment report and making a decision on clinical trials in accordance with the EU regulation.
The Act also proposes the establishment of a new National Committee on Medical Research Ethics, which would be responsible for the ethical assessment of all clinical trials conducted in Finland and which would draw up Part II of the assessment report stipulated in the EU regulation.
Fimea and the ethics committee assess applications for clinical trials independently, but also cooperate to ensure a high quality assessment and the smooth running of the assessment procedures.
EU regulation changes competent authorities’ assessment of clinical trials 31 January 2022
The EU regulation on clinical trials (536/2014) will enter into force 31 January 2022, which is when the now approved Act on Clinical Drug Trials will also enter into force. However, provisions on the processing of personal data will enter into force before this date.
During the EU regulation on clinical trials, sponsors will submit research applications electronically via a shared EU portal (Clinical Trials Information System CTIS) to all Member States in whose territory each study is to be conducted. The Member States’ national competent authorities will assess applications simultaneously with the authority of one Member State acting as the reporting Member State while the authorities of the other Member States act as Member States concerned.
The EU regulation provides for a transition period of one year during which sponsors may submit their applications either in accordance with the procedure laid down in the EU regulation or in accordance with the current EU Directive (2001/20/EC) and national legislation adopted under it.
Amendments to the Medicines Act and the Criminal Code
The Parliament has also adopted amendments to the Medicines Act and the Criminal Code of Finland. These amendments to the Medicines Act relate to the manufacture and import of investigational medicinal products to the extent that the matter is not provided for in EU legislation. The amendment to the Criminal Code concerns violation relating to clinical trials.
Parliament proceedings on the matter (in Finnish)
- Juliana Raitis, Legal Advisor, tel. +358 29 522 3641
- Pirjo Inki, Head of Section Clinical Trials, tel. +358 29 522 3362
- E-mail addresses are in the format email@example.com