Insurances for Study Subjects
Insurance for Covering Pharmaceutical Injuries
For clinical trials with medicinal products in Finland, the study sponsor’s responsibility is to confirm the validity of the study subjects’ insurance to cover all pharmaceutical injuries related to the investigational medicinal product. This may be either the Pharmaceutical Injuries Insurance, or other equivalent Insurance. In the context of the terms and conditions in the Pharmaceutical Injuries Insurance, signatory to the contract refers to any drug manufacturer, importer or marketer or research company that has signed the contract. Likewise, signatory to the contract is considered to refer to any drug manufacturer on whose behalf another company of the same group or any other entity has signed the pharmaceutical insurance contract.
Pharmaceutical injuries insurance or other equivalent insurance must cover any bodily injury (pharmaceutical injury) of study subjects during the clinical trial resulting from:
- Therapeutic use of a pharmaceutical, provided the product manufacturer, importer or marketer that is a signatory to this contract has in the normal course of business supplied the pharmaceutical for consumption in Finland.
- An investigational drug while tested in a clinical trial by or under the sponsorship of a signatory to the contract in accordance with legislation governing clinical pharmaceutical research conducted in Finland (Act 488/1999). Bodily injuries resulting from pharmaceuticals used as comparators in the trial are covered, if the specified criteria are met.
In Finland, all health and medical care providers must be covered by Patient Injuries Insurance against liability arising as provided under the Patient Injuries Act. All legally operating health care units in Finland (i.e. hospitals, public health centers and private health care clinics) are obliged to have the insurance for all employees working with patients, and for a valid insurance cover all employees must have valid and signed employment contracts with the unit or hospital where they (i.e. study personnel) are working. For more information please see Patient Insurance Center.