Pharmaceutical insurance is voluntary insurance protecting pharmaceutical product users. It has been arranged by the Finnish Co-operative for Pharmaceutical Injury Indemnities, an organisation of manufacturers, importers, distributors or sellers of pharmaceutical products in Finland. Pharmaceutical insurance covers medicines released for consumption in Finland, and injuries that have been sustained in clinical trials of pharmaceutical products or caused by donated blood or by blood products.

All of the medicines referred to in section 3 of the Medicines Act (lääkelaki, no. 395 of 1987) that are sourced or obtained from Finland and intended for human use fall within the scope of pharmaceutical insurance if their manufacturer, importer, marketer or seller is a member of the Finnish Co-Operative for Pharmaceutical Injury Indemnities. This means that the insurance covers nearly all medicines sold in Finland.

Medicines are very safe in Finland. They contain biologically active substances that are intended to cure, alleviate or prevent illnesses or their symptoms. They are extensively and carefully tested before they are released to the market. Even when used correctly, all medicines are liable to cause side effects, but these are usually mild and pass rapidly.

Pharmaceutical injury refers to any physical illness or injury or mental disorder that was probably caused by a medicine. Pharmaceutical insurance does not cover mild pharmaceutical injuries. Check the terms and conditions of insurance for further details.

The Finnish Medicines Agency (Fimea) is a national executive bureau of the Ministry of Social Affairs and Health that exercises regulatory control over medicines and blood and tissue products, and develops the pharmaceutical industry. Fimea maintains a register of adverse reactions to pharmaceutical products. Healthcare professionals and users of medicines may report suspected or verified adverse reactions to this register. The principal purpose of the reporting system is to detect previously unrecognised and rare adverse reactions.

An adverse reaction refers to a harmful and unintended impact of a medicine.

An adverse reaction to a medicine is not the same as pharmaceutical injury. The latter is defined much more narrowly than the former, meaning that a mere report of an adverse reaction does not immediately imply that pharmaceutical injury has occurred under the terms and conditions of pharmaceutical insurance.

You should notify the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities of any suspected pharmaceutical product damage.

The insurance covers personal injuries caused by a medicine. There must be a probable causal link between use of the medicine and the damaging consequences. Pharmaceutical injury refers to any physical illness or injury or mental disorder that was probably caused by a medicine. A probable causal link means that the damaging consequences were either the certain or likely outcome of using the medicine.

Pharmaceutical insurance does not cover consequential pharmaceutical product damage.

An illness or disability caused by the failure of a medicine to have the intended effect is not regarded as pharmaceutical injury.

Pharmaceutical insurance does not cover damage:

• if there is no probable causal link between use of the medicine and the damage.
• if the risk was necessary. Certain medication risks sometimes have to be taken when treating serious illnesses or injuries, with medicines used to save the life of the patient or prevent an injury or illness that is more serious than a potential adverse reaction. Pharmaceutical insurance will not cover damage arising from essential medical risk-taking when caused by a medicine used for treating a life-threatening illness or disability.
• if the damage caused by the medicine is reasonably tolerable.
• if the medicine was used incorrectly. For example, if the dose was too high or the injured party took a medicine prescribed for another person.
• if the user of the medicine or the injured party caused the damage wilfully.
• if some error occurred in prescribing or supplying the medicine. For example, if a medical practitioner miswrote the prescription, or if a pharmacy or treatment facility gave the wrong medicine or dose to the injured party. The injured party may be entitled to Patient Insurance compensation in such cases.

An illness or disability arising from the failure of a medicine to have the intended effect is not regarded as pharmaceutical injury. No pharmaceutical insurance compensation is available for the ineffectiveness of a medicine.

Pharmaceutical insurance only covers medicines purchased in Finland or obtained from a medical institution in Finland. No pharmaceutical insurance compensation is available for medicines purchased or obtained abroad. You may be entitled to compensation from Swedish, Norwegian or Danish pharmaceutical insurance if you bought the medicine in Sweden, Norway or Denmark.

The compensation payable varies according to the details of the individual case. The nature and extent of damage covered will depend on the kind of damage that was caused by using the medicine. These forms of damage vary widely, so the compensation also varies in nature and size.

Assessments of compensation apply the provisions of the Finnish Tort Liability Act (vahingonkorvauslaki, no. 412 of 1974) and any applicable norms and guidelines of the Traffic Accident and Patient Injury Board.

The following types of compensation may be paid for pharmaceutical product damage:

• The costs incurred from pharmaceutical product damage. The insurance covers necessary extraordinary medical expenses caused by the damage, such as hospitalisation and outpatient fees, medical fees, laboratory tests, the costs of medicines and physical therapy. Other eligible costs include travelling expenses incurred for extraordinary treatment.
• Temporary incapacity. Compensation for temporary harm compensates the injured party for the pain, suffering and other temporary harm caused by the injury, seeking to make up for the associated loss of quality of life. The size of this compensation will depend on the nature and severity of the damage, the type and duration of treatment required, and the duration of the harm suffered. Compensation for temporary harm covers the time between the incidence of the personal injury until the state of health of the injured party has either been restored or has otherwise stabilised.
• Permanent harm. Pharmaceutical insurance will pay compensation for any permanent functional disability caused by pharmaceutical product damage. This compensation is determined according to a decision of the Ministry of Social Affairs and Health (incapacity categories 1-20), and depends on such factors as the nature of the disability and the age of the injured party.
• Permanent cosmetic harm. Compensation for cosmetic harm is payable for any permanent disfigurement, such as scarring due to pharmaceutical product damage. This compensation is determined in accordance with the guidelines of the Traffic Accident and Patient Injury Board, and depends on such factors as the size, shape, colour, location and visibility of the scar or other cosmetic harm. It also varies according to the age of the injured party.
• Loss of earnings. Insurance compensation may be payable for a loss of earnings suffered by an injured employee or self-employed person. This compensation for lost earnings may be transitory or permanent. Transitory compensation for lost earnings may be payable for a period during which the injured party was unable to work normally. Permanent compensation for lost earnings may be payable if the pharmaceutical product damage has caused the injured party to suffer a permanent incapacity to work. Compensation for lost earnings is payable from pharmaceutical insurance only insofar as the injured party does not receive statutory compensation. This means that any per diem allowances and pensions payable pursuant to such statutes as the Health Insurance Act (sairausvakuutuslaki, no. 1224 of 2004), the Traffic Insurance Act (liikennevakuutuslaki, no. 460 of 2016), the Workers’ Compensation Act (työtapaturma- ja ammattitautilaki, no. 459 of 2015)earnings-related pensions legislation, the National Pensions Act (kansaneläkelaki, no. 347 of 1956) and the Patient Injuries Act will be deducted from the compensation payable under pharmaceutical insurance.
• Necessary compensation for maintenance is payable to eligible beneficiaries in the event of death. The beneficiaries eligible for maintenance are a surviving spouse and minor children, together with children in education under 21 years of age in certain cases. This compensation is only payable insofar as other income and statutory benefits of the beneficiary, such as survivors’ pension, do not guarantee the necessary maintenance.
• Funeral costs. The reasonable funeral costs and associated expenses of the injured party may be reimbursed in the event of death. This insurance compensation may cover such items as the costs of a burial plot, coffin, gravestone, funeral service, flowers, obituary notice and mourning clothes. The costs of compiling the estate inventory are not covered. Funeral costs are reimbursed to the death estate or to the person who incurred the said costs out of pocket.

The compensation depends on the damage suffered.

The costs incurred through pharmaceutical product damage will be reimbursed in full against receipts or other supporting documents.

The compensation payable for temporary incapacity (pain and suffering) depends on the degree of incapacity involved, which is assessed on medical grounds with the compensation determined according to the norms and guidelines of the Traffic Accident Board. Incapacity due to pharmaceutical product damage is generally not especially great, with most assessed to fall into incapacity categories between 1 and 3.

Any permanent functional incapacity is defined in accordance either with the Decree (1649/2009)  or the Decision of the Ministry of Social Affairs and Health, depending on the time of receiving the injury, and the norms and guidelines of the Traffic Accident Board. Pharmaceutical product damage seldom causes permanent injury.

The size of compensation for lost earnings will be determined according to the income of the injured party.

Pharmaceutical insurance is a secondary compensation system, meaning that any statutory compensation for which the injured party is eligible will be deducted from the insurance compensation payable.

The injured party must complete an accident report and send it to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.

The injured party’s medical records related to the damage in question are required when examining pharmaceutical product damage. The accident report form includes the injured party’s authorisation enabling the insurance company to obtain the documents required for processing the claim. There is accordingly no need for the injured party to obtain documents, as the insurance company will do so when these documents are required for processing the claim. This usually expedites processing.

You should complete and sign the accident report carefully and send it to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities, PO Box 115, FI-00181 Helsinki.

The patient ombudsperson can help you file a notice of injury. The wellbeing services counties are responsible for providing patient ombudsperson services.

All accident reports are registered and given a processing number on reaching the insurance company. The insurance company uses the information and authorisation provided in the accident report to request the information required for processing the claim from the health service institutions concerned.

After obtaining this information, the company determines whether the claim concerns pharmaceutical product damage of the kind referred to in the terms and conditions of insurance. This crucially involves clarifying whether the symptoms of the reporting party could probably be due to using the medicine. A claims settler initially examines the case, after which a specialist physician from the company issues an opinion.

A written decision is prepared when the case has been processed. This decision always includes instructions on how to seek further review of the decision.

All cases are processed by the company in confidence, with information related to the incident handled only by the individuals responsible for processing the claim. All insurance company employees are bound by the absolute duty of confidentiality prescribed in the Act on Insurance Companies (vakuutusyhtiölaki, no. 521 of 2008). Further details of the data security practices of the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities are available here.

While the average processing time is over six months at the moment, it always depends on the volume of documentation required in the case. Most of the processing time is spent waiting for the necessary documents, with the company always proceeding immediately on receiving them.

You are entitled to appeal against any decision that you find unsatisfactory.

It’s a good idea initially to contact the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities and request correction. When doing so, you should supply any further details that were not available to the insurance company when processing the case.

You may also request a recommendation for settling your case from the Finnish Financial Ombudsman Bureau (FINE). There are no formalities involved in submitting such a request. FINE processes settlement recommendation requests by an in-house procedure or by referring them to the Finnish Insurance Complaints Board. Requests concerning pharmaceutical insurance are generally referred in this way. Either FINE or the Finnish Insurance Complaints Board will issue a substantiated written settlement recommendation in the case. This procedure is free of charge to applicants. You must submit your request to FINE no later than three years after receiving notification of the decision of the insurance company.

You may also initiate legal proceedings by bringing an action against the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. This action must similarly be brought no later than three years after receiving notification of the decision of the insurance company.

FINE is an independent agency that advises consumers, small businesses and similar clients in questions of insurance and other financial matters. You may ask FINE for advice and request settlement recommendations, for example if you are dissatisfied with a compensation decision made by an insurance company. The services of FINE are free of charge to clients.

The Finnish Insurance Complaints Board is a voluntary dispute resolution body that operates like a court of law and can be called upon to settle disputes in questions of insurance. Though the decisions of the Board take the form of recommended settlements, insurance companies generally comply with them.

The Finnish Insurance Complaints Board has five chambers that hear disputes related to various types of insurance. Settlement recommendations concerning pharmaceutical insurance are heard in the 5^th chamber.

The insurance company receives normally annually about 200 injury notifications.

About 35-50 per cent of pharmaceutical injury notifications are upheld with compensation paid.