In Finland there is a voluntary system covering medicine related injuries: pharmaceutical insurance. This insurance covers injuries that users suffer from the side effects of drugs that have been supplied for consumption in Finland.

Pharmaceutical injuries insurance is taken out by the Finnish Co-operative for Pharmaceutical Injury Indemnities.

Insured are the users of pharmaceuticals. The insurance covers pharmaceuticals provided the product manufacturer, importer, distributer or marketer is a member of the Co-operative for Pharmaceutical Injury Indemnities. The insurance also covers investigational drugs used in clinical trials in Finland providing that the trials are conducted or sponsored by signatories to the insurance contract in accordance with legislation governing medical research.

Pharmaceutical injuries insurance applies to pharmaceuticals referred to in the Medicines Act.  The insurance also covers intrauterine contraceptive devices as well as blood and blood components. Traditional herbal and homeopathic preparations are excluded.

Pharmaceutical injuries insurance has been in force in Finland since 1984. In the beginning, the insurance was granted and managed by the Pharmaceutical Insurance Pool. Since 2012, the insurance has been granted and the claims handling processed by the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.

The insurance only covers medicines purchased in Finland.

The purpose of the insurance is to indemnify the adverse effects that are unexpected in the therapeutic situation, caused to the users by the pharmaceuticals complying with the Medicines Act and distributed for consumption as well as the injuries caused by medicines in clinical trials in Finland. The insurance also covers investigational drugs used in clinical trials in Finland providing that the trials are conducted or sponsored by signatories to the insurance contract in accordance with legislation governing medical research.

The injury can be compensated from the insurance if the medicine has been acquired from a pharmacy in Finland or if the patient has been given the medicine in Finland from a doctor or health care unit. Medicines purchased from a licensed internet pharmacy in Finland are also covered by the insurance. Medicines purchased or obtained outside Finland, or medicines purchased from a foreign internet pharmacy, are not covered by the insurance and are not reimbursed from the Pharmaceutical Insurance.

The term ‘pharmaceutical’ or ‘medicine’ shall refer to a preparation or substance, as specified in Section 3 of the Medicines Act, intended for human consumption. The term ‘pharmaceutical’ or ‘medicine’ shall also refer to vaccines as well as to intracorporeal contraceptive devices dispensed with prescriptions or requiring an internal procedure performed by a healthcare professional. Moreover, the term ‘pharmaceutical’ or ‘medicine’ shall also comprise blood or blood components supplied for human transfusion use as per the Finnish Blood Service Act. Traditional herbal and homeopathic preparations are excluded, and no compensation is payable from the insurance if an injury is caused by such preparations.

Pharmaceutical injuries insurance covers bodily injuries resulting either from use of pharmaceutical as medication or from investigational drug. However, if the medicine has been used for other purposes than as a medicinal product, for example for substance abuse the injury is not covered by the insurance.

Report on an adverse reaction

A drug injury and a side effect of a drug are different things. Not all side effects are compensable pharmaceutical injuries. For drug injuries the terms and conditions of the insurance is applied, and the compensability of any claim is determined according to those terms and conditions. An adverse reaction refers to a harmful accidental effect of a medicinal product. Fimea records information on adverse reactions to medicines and vaccines in Finland in its register of adverse reactions. Healthcare professionals and users of medicines can report suspected or reported adverse reactions. For more information on drug side effects and how to Reports A side effect, please visit: www.fimea.fi

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