Pharmaceutical injury insurance covers both unexpected bodily injuries sustained through the use of pharmaceuticals sold or supplied for consumption in Finland and injuries caused by pharmaceuticals during clinical trials. The insurance applies to pharmaceuticals as defined in the Medicines Act.
The voluntary compensation scheme (which changed in 2012) is based on an insurance contract concluded between the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities and the Finnish Cooperative for the Indemnification of Medicine-Related Injuries. Entities manufacturing, importing or marketing pharmaceuticals in Finland are members of the cooperative.
The most commonly disputed questions referred to the Finnish Insurance Complaints Board regarding recommended decisions relate to causality between injury and the use of pharmaceuticals and the insurance cover exclusions – for example, reasonable tolerance to pharmaceuticals and inevitable risks connected to the treatment of severe illness or injury.
Typically, complaints concerning pharmaceutical injury insurance involve complex medical issues, which is why the board uses medical experts. However, a recent recommended decision (VKL 743/14) illustrates that pharmaceutical injury insurance is also subject to regular legal issues associated with mandatory insurance legislation.
The insured had been diagnosed with psoriatic arthritis in 2001 and prescribed Trexan in 2004. From 2008 the insured suffered various respiratory disorders. Tests carried out in 2009 appeared to indicate that the disorders resulted from Trexan and its use was discontinued. The disorders worsened and on September 26 2011 the Finnish Medicines Agency was informed. On July 4 2014 the insured filed a claim on the grounds that the respiratory disease (pulmonary fibrosis) resulted from Trexan.
The insurer rejected compensation, alleging that the claim was reported too late. Pursuant to the insurance conditions, any claim for compensation must be submitted to the insurer within three years of the date on which the claimant becomes aware of the injury caused by the pharmaceutical involved and no later than within 10 years of the date on which the injured party ceases taking the pharmaceutical in question. The insurer was of the opinion that the alleged pharmaceutical injury had already manifested itself in early 2009. In a statement dated March 23 2011, Metotreksat was found to be a likely cause of the disease. The insurer also held that causality was unlikely.
The insured appealed on the grounds that it had not become aware of the possibility of compensation until participating in an education programme targeted at those suffering from rare respiratory diseases. After that, an insurance claim was filed immediately.
Pursuant to Section 73 of the Insurance Contracts Act:
"Any claims based on an insurance contract shall be made to the insurer within one year from the date at which the claimant becomes aware of an in-force insurance policy, of the occurrence of an insured event and of the loss, damage or injury that resulted from the occurrence. In any event, the claim shall be made within ten years from the occurrence of the insured event or, if the insurance has been taken out to cover against bodily injury or liability for damages, from the occurrence of the loss, damage or injury. Reporting the occurrence of an insured event is considered to equal the making of a claim for this purpose."
The Insurance Complaints Board found that as the conditions concerning the limitation period deviated from the mandatory provisions of the Insurance Contracts Act to the detriment of the insured, the insurance conditions were null and void. The board stated that pharmaceutical injury insurance is not in the public domain, as it is not mentioned on pharmaceutical packaging. The board's understanding was that an insured usually becomes aware of such insurance from a doctor after the injury has occurred, and hence awareness must be judged on a case-by-case basis. The board found that the insurer was not entitled to rely on its insurance conditions and the claim was not time barred.
Regarding causality, the board accepted that the disease likely resulted from Trexan.
The board's decision is a reminder that it can take years before pharmaceutical users experience symptoms which cause bodily injury and can be traced to a particular pharmaceutical. It can take many more years for an insured to become aware of the possibility of claiming insurance compensation.
For further information on this topic please contact Matti Komonen at Hammarström Puhakka Partners, Attorneys Ltd by telephone (+358 9 474 2207) or email ([email protected]). The Hammarström Puhakka Partners, Attorneys Ltd website can be accessed at www.hpplaw.fi.
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