In Finland there is a voluntary compensation system to protect medicine users: pharmaceutical injuries insurance. The policyholder is The Finnish Co-operative for Pharmaceutical Injury Indemnities who takes the insurance on behalf of its members.
Almost all pharmaceutical manufactures, importers, marketers and distributers have joint the Co-operative and the insurance.The insurance covers bodily injuries caused by medicines to the users, however minor injuries are not covered. Before any compensation can be paid, there needs to be a likely causal connection between the use of the medicine and the adverse effect. However, compensation is not paid if the medicine is used in violation of its intended use
The pharmaceutical insurance company receives approximately 200 claims per year. About half of them lead to a positive compensation decision and compensation.
The author of this post is Tiina Hellgrén, LLM, CEO of the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.
Likely causal connection is sufficient
The term ‘pharmaceutical injury’ refers to any bodily illness or injury or psychic disease likely to result from a medicine used by the injured person. There must therefore be a probable causal link between the use of the medicinal product and personal injury.
No full evidence is required, but there must exist a medical likelyhood between the use of the medicine and the injury.
In the pharmaceutical injury insurance, the compensability of an injury is determined purely based on the causal relation between the use of the medicine and the adverse effect. The culprits are not being etched.
How is a pharmaceutical defined in the insurance?
The term ’pharmaceutical’ refers to a preparation or substance, as specified in Section 3 of the Finnish Medicines Act. The term ’pharmaceutical’ refers also 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 shall also comprise blood or blood components supplied for human transfusion use.
The pharmaceutical insurance covers only authorized medicinal products.
Off-label use of a medicine is covered by the insurance and compensation paid in cases where the medical doctor has prescribed the medicine according to the established off-label policy in Finland. Traditional herbal and homeopathic preparations are excluded.
What is compensated?
Bodily injuries caused by a medicine are compensated provided that the medicine has been bought from a pharmacy in Finland or the patient has got the medicine in Finland from a medical doctor or in a health care unit situated in Finland. The insurance also covers medicines purchased from a licensed online pharmacy in Finland.
In addition, the compensation is subject to the condition that the manufacturer, importer, distributor or seller of the medicinal product has joint the insurance i.e. is a member of the Co-operation. The insurance also covers clinical trials, provided that the clinical trial was carried out in accordance with the law and the regulatory requirements.
No compensation is paid if the medicine was purchased or obtained outside of Finland, obtained from a foreign online pharmacy or acquired or used illegally or for substance abuse.
To qualify for compensation under pharmaceutical injury insurance, use of pharmaceutical must result in a loss of functional ability lasting at least 14 days without interruption or in a permanent physical injury or illness or death.
No compensation is paid for minor damage or temporary incapacity (so-called pain and suffering). However, if the damage is caused by the cost of more than EUR 85 or loss of earnings, they will be reimbursed.
The insurance pays out compensation for any necessary additional expenses and losses arising from the injury, such as medical fees and expenses for examinations or hospital care. In more serious cases even costs of home nursing and renovations in the home may be compensated.
Pharmaceutical insurance is a secondary compensation scheme supplementing the statutory social security in Finland. Therefore, any compensation payable from a statutory insurance or otherwise from public funds (for e.g. benefits paid out by KELA) will be deducted.
Occasionally the patient is treated for a disease or disability that would be fatal or could cause severe bodily injury and is prescribed a medicine that can with quite high probability cause more serious side effects. An injury is not covered if it results from medically necessary risk-taking in the treatment of a disease or injury which, if left untreated is life-threatening or may lead to severe physical injuries, even if the causal link is clear.
Pharmaceutical insurance does not cover failure of the drug to have the intended effect, i.e. failure to cure the disease or injury that was being treated.
Pharmaceutical injuries insurance only covers adverse effects caused by due medication. If a pharmaceutical has been incorrectly prescribed or administered, judging by the standard of experienced professionals, or if the injury results from a prescription drug delivered from the chemist’s contrary to the prescription or applicable regulations, the injury may be compensable under the Patient Injuries Act.
Application for compensation and claims handling
The patient makes a claim by filling out a notice of injury and sending it to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. An injury notice form can be printed out at www.laakevahinko.fi
After receiving a notice of injury, the insurance company will acquire all necessary documentation needed for handling the claim, directly from hospitals and/or health care centers. Once all the necessary documentation has been received, an expert physician will give his opinion on the case. In some cases, the opinion of the other physician may also be requested. The average processing time for an application is four months.
If the claim is rejected, it is usually not considered that there is a probable causal relationship between the use of the medicinal product and the patient’s symptoms. The patient can either appeal to the Finnish Financial Ombudsman’s Bureau (FINE) or bring the insurance company before a court of law.