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.
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 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.