The Finnish Supreme Administrative Court (the “SCA”) passed two life sciences-related precedents concerning regulatory matters during 2008. Albeit that the SCA handles a number of cases within the regulatory and intellectual property area every year, only the most important ones are published in the SCA’s Yearbook and thereby are considered as having value as precedents.
In the precedent passed on 1 July 2008 (KHO 2008:49), the SCA deliberated upon the grounds which can form a basis for the rejection of the special reimbursement of a pharmaceutical product. According to the precedent of the SCA, the Pharmaceuticals Pricing Board had erroneously rejected the special reimbursement of a medicine used to treat hypertension.
In a precedent handed down on 30 December 2008 (KHO 2008:92), the SCA reversed the decisions of the National Agency for Medicines as well as of the Helsinki Administrative Court which had classified a product as a medicinal product. According to the SCA, a product called “Cholexit” containing plant stanols and plant sterols and decreasing cholesterol values was not to be classified as a medicinal product but as a food supplement. The SCA based its decision on, inter alia, the ECJ’s decision C-319/05 (Commission v Germany) and the fact that the same doses of the ingredients had been used in functional food products in several years.