According to the Patient Injuries Act, all healthcare service providers must take out patient insurance. As those taking part in clinical research are deemed equal to patients receiving treatment, the insurance obligation also applies to anyone carrying out such research, even if the participants were ‘healthy’ individuals.
The party obligated to take out patient insurance is the one who in practice carries out the research. Therefore, insurance cannot be awarded to, for example, a party who has commissioned the research.
Patient insurance taken out for the public sector cover the clinical research carried out in conjunction of public healthcare provision. Universities have their own patient insurance to cover medical research carried out in them.
In case clinical research is carried out in the private sector in connection with normal healthcare service provision, patient insurance taken out to cover for these operations usually also covers the research activities.
In situations where clinical research is carried out as separate from other health care provision, a patient insurance must be taken out to cover the research activities. The party obligated to take out insurance depends on whether the research is carried out by a private enterprise or institution or an individual researcher as a self-employed professional.
A private enterprise or institution is obligated to take out patient insurance to cover for their research activities. Self-employed researchers in turn are responsible for ensuring that patient insurance has been taken out. Private sector actors take out patient insurance from insurance companies awarding such insurance.
Patient insurance covers the bodily injuries received by patients as a result of the actions of those carrying out the research or the equipment used in the course of research as provided in more detail in the Patient Injuries Act.
However, it does not cover adverse effects caused by a pharmaceutical substance that has been appropriately administered or prescribed to the patient; liability for injury caused by investigational drugs must be covered through other channels, such as voluntary pharmaceutical injuries insurance awarded by the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.
The Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities