Insurances of the person

What is the Medicines-Related or Pharmaceutical Injuries Insurance?

The pharmaceutical injuries insurance is a voluntary compensation system created to safeguard medicine users. The purpose is to compensate for the unexpected adverse reactions caused to users by the pharmaceuticals and blood products sold and distributed for consumption in Finland.

What is indemnified by the insurance?

The purpose of the insurance is to compensate for the personal injury caused by a medicine, i.e., a pharmaceutical injury in cases where the medicine has been released for consumption in Finland, and the pharmaceutical manufacturer, importer, distributor or seller has joined the insurance scheme.

The insurance compensates for a bodily illness or injury or a psychic illness likely to result from a pharmaceutical taken by the injured party. Likelihood here means that the injury may result from several potential causes but the use of the medicine is, in an overall judgement, the most likely among them. The assessment of the causal relationship is based on medical knowledge and experience.

The compensation for a pharmaceutical injury is paid to the extent prescribed by the Tort Liability Act. The person affected by the pharmaceutical injury can be compensated not only for the expenses and loss of income caused by this injury but also for pain and suffering and for other temporary or permanent handicap.  In certain situations, the immediate family members of the injured party may also be compensated for the expenses and loss of income caused by the care of the injured party. If the injured party has died because of a pharmaceutical injury, the insurance will cover the burial costs and loss of maintenance of a person under the maintenance obligation of the injured party or otherwise dependent on the maintenance of the injured party.

Statutory compensation systems are primary and the pharmaceutical injuries insurance is secondary in order. This means that when the amount of compensation is calculated, any benefits due to the injured out of public funds or under statutory insurance schemes shall be deducted. Such benefits include, for example, national health insurance benefits and pensions.

Major exclusions

In practice, all insurance policies include some exclusions. The major exclusions in pharmaceutical injuries insurance are the following:

The pharmaceutical injuries insurance will not compensate for an injury occurring in connection with action or measures that should not have been taken in view of the intended or recognised effect of the pharmaceutical concerned. Likewise, it does not cover an injury resulting from an error in the prescription or administration of the pharmaceutical or from the fact that the prescription of the pharmaceutical or its administration for experimental purposes has not been medically justifiable. In other words, the pharmaceutical injuries insurance compensates for sudden adverse effects of the medicine in situations where the medication has, as such, been properly administrated. In cases where it is suspected that the medication was not appropriate and this has caused injuries, the compensability of the injury can be clarified by filing a notification on injury with the Finnish Patient Insurance Centre.

No compensation is payable in respect of a pharmaceutical injury if it  results from a medically inevitable risk inherent in the treatment of an illness or injury that, left untreated, would be mortal or might cause severe bodily injury. The treatment of serious illnesses and injuries may require conscious risk-taking.  In such situations, even serious consequences will remain outside the scope of cover of the insurance. A typical example of injuries excluded from the scope of coverage of the insurance are the various adverse effects of cancer medications.

Moreover, the compensation will not be paid for so-called reasonably tolerable consequences of medicine use. When assessing the situation, the nature and severity of the treated illness, the general state of health of the injured party, the scope of the injury, the expert’s possibility to anticipate the medicine impacts and other similar aspects will be weighed. The focal aspect of the assessment is to establish whether the injury has been more serious than the well-known and noted risk.

To read more about the practice of past decisions regarding the insurance coverage exclusions, please read the FINE database of recommended solutions.

Notification of loss made by the insured

The notification of loss shall be addressed to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities within one year from the date in which the person involved became aware of the validity of the insurance, the injury and its consequences.  In all circumstances, the claim must be made no later than within 10 years from the occurrence of the consequences of the injury.

Appeal

If you are dissatisfied with the insurer’s decision, the first step in the process is to take direct contact with the insurance company, asking for an adjustment of the decision. You should tell the insurance company why you think their decision is erroneous.

You can turn to FINE regarding any decisions made by the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities issued on 1 January 2012 and after that date.  FINE provides advice and solves disputes in questions related to these issues.

The claims made prior to the year 2012 were handled by the Finnish Pharmaceutical Insurance Pool. FINE is not competent to examine decisions made by the Finnish Pharmaceutical Insurance Pool. Complaints about these decision can be addressed to the Finnish Pharmaceutical Injuries Board.