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Pharmaceuticals injury - who indemnifies?
Asko Nio, Head of Unit, Finnish Pharmaceutical Insurance Pool
• The voluntary pharmaceutical insurance covers all unexpected inconveniences caused by medicines and medicines in clinical trials.
• The insurance cover for damages to individuals caused by adverse effects of medicines exceeds the product liability cover.
• The compensation claim for pharmaceutical injury must be made within three years from the injury and no later than ten years from the end of the medication in question.
Pharmaceutical insurance
The Finnish voluntary pharmaceutical insurance system dates back to 1984. The purpose is to indemnify the unexpected adverse effects caused to the users by the pharmaceuticals distributed for consumption and by medicines in clinical trials in Finland.
Formed by three insurance companies, the underwriter is the Finnish Pharmaceutical Insurance Pool, while the policyholder is the Finnish Co-operative for Pharmaceutical Injury Indemnities.
The insurance covers such pharmaceuticals distributed for consumption in Finland, the manufacturer, importer or marketer of which has taken out the insurance through membership of the Finnish Co-operative for Pharmaceutical Injury Indemnities. The insurance also covers the clinical trials conducted under the Medical Research Act by the pharmaceutical company or research company, a member of the insurance co-operative, or to which it contributes. If the trial involves a comparator product, which is a medicine manufactured by another company or a medicine already on the market, it will be covered by the insurance if a member of the insurance co-operative has distributed it for consumption in Finland.
It also covers blood and blood preparations as well as intrauterine contraceptive devices. Traditional herbal medicinal products and homeopathic products are not covered by the insurance.
Comprehensive insurance providing security
Most pharmaceuticals marketed in Finland are covered by the pharmaceutical insurance. There are only a few companies on the market who have not joined the co-operative. Pharmaceutical injuries are mainly caused by common pharmaceutical substances, those in most frequent use. The Finnish pharmaceutical insurance system provides the injured party with security beyond the normal product liability, with the possibility of receiving compensation for the personal injuries caused by pharmaceuticals.
A pharmaceutical injury is a personal injury
Only personal, or physical, injuries qualify as pharmaceutical injuries. Therefore, the insurance does not indemnify the failure by the drug to produce a desired therapeutic impact. A pharmaceutical injury refers to a physical disease or injury or corresponding serious mental disease, likely to be caused by the medicine used by the injured party. There must be a probable causal relationship between the pharmaceutical and the suspected injury. The causal relationship is assessed based on medical knowledge and experience. The assessment is based on the information and studies published in the records of adverse effects and the respective reference books, as well as in scientific journals.
According to the insurance terms and conditions, the pharmaceutical injury can be indemnified when the injured party has been unfit for work or his functional ability has been reduced continuously for at least 14 days or has a permanent physical defect or disease or has died. Even if the injuries suffered by the user of the medicine were not so serious, he can receive indemnity for the costs and loss of income caused by the pharmaceutical injury if their total value exceeds EUR 85 after the statutory benefits payable to the injured party have been co-ordinated.
Tolerability of a pharmaceutical injury
The use of medicines entails the possibility of different adverse effects. When serious diseases or injuries are being treated in hospitals, the choices made for a good treatment outcome will often involve conscious risks. If the pharmaceutical causes an adverse effect as a consequence of a medically indispensable risk, such a consequence will not be indemnified based on the pharmaceutical insurance. The more serious the disease or injury being treated by the medicine, the more serious the adverse effect which the user of that medicine has to accept as part of the treatment. The adverse effect may not qualify for an indemnity in the case of less serious diseases or injuries if it is deemed that such an adverse effect should be reasonably tolerated. Tolerability is evaluated considering such aspects as the nature of the disease or injury being medicated, the overall state of health of the injured party, the seriousness of the injury, as well as the frequency and probability of the adverse effects.
If there has been a mistake in prescribing or administering the medicine, or if the injury is caused by the pharmacy dispensing a prescription medicine contrary to the prescription or regulations, it is not a pharmaceutical injury but the injured party can claim damages for the personal injury based on statutory patient insurance from the Finnish Patient Insurance Centre.
Compensation
The compensation paid by the pharmaceutical insurance is determined by the same criteria applied, for example, to the patient insurance. The compensation is quantified based on the Damages Act. The types of compensation include temporary or permanent defect or handicap or cosmetic injury, medical expenses, other additional costs and loss of income, as well as in the case of death, funeral expenses and survivors' pension.
The pharmaceutical insurance indemnifies the additional costs and losses caused by the pharmaceutical injury. Such costs or losses as would have been caused without the injury, cannot be indemnified. Therefore, no compensation is paid for the expenses incurred for the treatment of the disease or injury being primarily treated, or for the purchase of the pharmaceutical that caused the injury. Since the pharmaceutical insurance is of a secondary nature, intended to complement the statutory insurance cover, it can be used to pay compensation to the extent in which the injured party is not entitled to receive compensation from the statutory systems.
The indemnity is applied for by filing a notification of injury to the Finnish Pharmaceutical Insurance Pool within three years of the date on which the applicant became aware of the injury caused by the pharmaceutical. However, the indemnity must be applied for no later than within ten years from the end of the use of the medicine in question. The form of the notification of injury can be downloaded from the homepage of the Finnish Pharmaceutical Insurance Pool.
The number of the notifications of pharmaceutical injuries to the Finnish Pharmaceutical Insurance Pool has increased during the past few years. In 2005 there were 282 notifications, with about half of them leading to indemnities. About EUR 1 Million is paid out in compensation annually. Most of the indemnified injuries were non-serious, with a maximum of one week's hospitalisation or two months' disability period. In 10-15% of the cases, the injured party has been left with a permanent functional handicap. There are also a few fatal injuries every year.
Indemnified adverse effects
The pharmaceutical substance classes with most frequent injuries include the anti-infectives for systemic use, nervous system drugs and the musculo-skeletal system drugs. The pharmaceutical substances most frequently involved in the pharmaceutical injury cases are the quinolone antibacterials, anti-inflammatory and antirheumatic products, as well as hormonal contraceptives for systemic use. The most frequent adverse effects caused by a pharmaceutical injury include tendon damage, changes in the liver, skin reactions and rashes.
Additional information:
Tarja Udd, tel. +358 (0)9 6150 4927
Riitta Mellin, tel. +358 (0)9 6150 4916
Further information:
• Finnish Co-operative for Pharmaceutical injury Indemnities
• Finnish Pharmaceutical Insurance Pool
