Finland

Although there is a new legislation on cross-border healthcare 346/2023 effective as of 1 May 2023, this does not cover cross-border access to clinical trials.

There are no national health authority requirements in Finland for a patient living in Finland who wants to participate in a clinical trial in another country.

The ethics committee responsible for clinical trials in Finland is not involved when patients participate in clinical trials abroad. 

The site in the other country is responsible for choosing whether to include the subject or not, to facilitate informed consent in native language and to ensure insurance covers the trial participant.

There are no requirements for clinical trial liability insurance in Finland to cover the costs of trial associated damages occurring in the participating patient’s home country.

However, the relevant Finnish authorities would review the clinical trial liability insurance conditions presented in the clinical trial application dossier to ensure that treatment of adverse events are reimbursed by liability insurance and/or sponsor.

Trial participation of the patient is voluntary, travel insurance coverage should be considered. 

If a participant is participating in a trial and staying for a shorter period than 6 months in an EU country, EEA country or Switzerland, the subject is entitled to health care in Finland and emergency health care according to local health care costs in Finland and the target country. The target country healthcare is not obliged to provide the following, if needed to treat an adverse event: vaccines, operations, transplants or long-term treatment. These risks should be covered by (trial) insurance and/or trial Sponsor. 

The Nordic countries have additional social security contracts, which differ by country. 

Coverage of trial costs that occur when the patient is back home

The Social Insurance Institution of Finland recommends making an application to them for the special permit before joining a trial in another country to ensure continued post-trial healthcare coverage.

For countries outside of the EU, a special permit is required before joining the trial from Social Insurance Institution of Finland to ensure continued post-trial healthcare coverage. If permission is given, the subject is entitled to health care in Finland and emergency health care with local health care costs in Finland and the target country. The subject themself would pay for any extra costs due to treating an adverse event and then be reimbursed by the Social Insurance Institution of Finland.

All conditions of the national legislation need to be applied to participants joining a trial in Finland who are resident in other countries. E.g. all information provided to the patient needs to be understandable to the patient. 

If the patient fulfills trial specific requirements participation in Finland is possible. However, remote participation outside Finland is not acceptable.

All ethics committee requirements for clinical trial participation in Finland need to be applied to participants joining a trial in Finland who are resident in other countries. E.g. all information provided to the patient needs to be understandable to the patient. 

As an EU-citizen, patients are entitled to emergency health care in Finland to treat any adverse events, the cost of which should be reimbursed by the participant´s home country.  Also, this topic would be of special interest during review of the trial upon review by Finnish authorities.

Additional costs (costs not covered by the trial sponsor) are not covered by the Finnish health care system.