Causal link

Pharmaceutical product damage refers to any physical illness, injury or mental disorder that was probably caused by a medicine used by the injured party. There must be a probable causal link between use of the medicine and the personal injury. While this means that wholly conclusive evidence is not required, the injury must be medically assessed as a probable consequence of using the medicine. In other words, use of the medicine must be the most likely cause of the injury when all possible causes have been considered as a whole. No compensation is payable if a causal link is found to be merely possible and no more probable than several other potential causes of the injury.

The assessment of a causal link will allow for the illnesses and general health of the injured party, any care and treatment administered, and other medication that may have been used. The assessment will also draw on such sources as medical research findings, information published in registers of adverse reactions to pharmaceutical products, and published reports compiled from this material in digests and medical periodicals.

Eligibility for pharmaceutical product damage compensation does not require any finding of fault in the product nor, for example, any defect in its manufacturing process or prescription for use. The question of eligibility depends solely on the causal link between using the medicine and the injury that occurred.

Eligible pharmaceutical product damage

To be eligible for compensation, pharmaceutical product damage must be followed by a continuous period of not less than 30 days of reduced functional capacity, permanent bodily injury, illness or death. The compensation payable to an injured party for less severe injury only covers costs incurred through the injury and loss of earnings totalling more than EUR 85 after deducting public or statutory compensations.

Eligible pharmaceutical product damage and exclusions are specified in the general terms and conditions .