Possibility to access Finnish Institute for Health and Welfare register data in clinical trials from 1 January 2024 onwards

Act on the National Institute for Health and Welfare and the Act on Clinical Trials on Medicinal Products are updated on 1 January 2024. After the change, the sponsor, their representative, researcher and a member of the research group have the right to obtain data from the Care Register for Health Care (Hilmo), the Register of Primary Health Care Visits (AvoHilmo) and on microbial findings from the Finnish National Infectious Diseases Register from the National Institute for Health and Welfare, if this information is essential for carrying out the trial.

In order to assess essentialness, the use of the data must be justified in the study protocol, for example in terms of the experimental design or methodology of the clinical trial. The register intended for use in data retrieval should also be included in the study protocol. More detailed information will be filled in in application for the National Institute of Health and Welfare (additional instructions will be available).

Disclosure of data for a clinical trial requires a positive decision of the clinical trial, which also includes an authorisation subject to conditions. Once the use of the register data has been justified in the study protocol and is available for inspection, a note on the use of register data is recorded in Fimea's positive decision: “According to the research plan, the purpose of the research is to utilise the register data referred to in section 34 of the Act on Clinical Trials on Medicinal Products. Fimea and Tukija have assessed the use of the data in relation to the requirement laid down in Articles 3(b) and 6(1)(b)(i) of the EU Clinical Trials Regulation on the reliability and robustness of the data produced in clinical trials and consider the use of the data to be essential for the experimental design of the trial.” 

If Fimea or Tukija finds that there are not sufficient grounds for using register data, additional questions will be asked during the assessment phase of the trial. If the use of register data is not considered justified even after the responses, the use of the data will not be authorised.

As usual, participants sign their consent to take part in the clinical trial. However, this right of access to register data may also be exercised in emergency clinical trials if the trial has received such authorisation. The patient information document template can be found on the Tukija website (pdf, in Finnish).