The Finnish Parliamentary Ombudsman (“Ombudsman”) issued a decision (Docket no 1918/4/11) on 17 December 2012 regarding the off-label prescription of pharmaceuticals. A complaint was filed with the Ombudsman on the use of the pharmaceutical Avastin, a pharmaceutical for cancer, which is used off-label in the public healthcare sector in the treatment of wet age-related macular degeneration (“AMD”).
The current legislation in Finland does not explicitly regulate the off-label use of pharmaceuticals. However, according to an established practice, a physician may prescribe a pharmaceutical for off-label use, provided that the patient is sufficiently informed about such use, i.e. the physician must, inter alia, inform the patient about the (underlying) therapeutic reasons for prescribing a pharmaceutical off-label. A patient may refuse the off-label use as part of his/her right of self-determination.
According to the Ombudsman’s decision, several Finnish (public) hospital districts used Avastin for the treatment of AMD without informing the patients about the off-label use of the said pharmaceutical. There are other pharmaceuticals on the market for the treatment of AMD in Finland. However, these pharmaceuticals are much more expensive than Avastin. The Ombudsman stated in his decision that patients have the right to be treated with a pharmaceutical with indications covering the patient’s illness, provided that such pharmaceutical is available on the market, and that there is no therapeutic reason preventing the use of such pharmaceutical on the patient. The Ombudsman further states that patients must be provided with treatment that is supported by medical research, and that current medical research does not support Avastin being used for the treatment of ADM.
The Ombudsman’s decision has been submitted to the Ministry of Social Affairs and Health and the National Supervisory Authority for Welfare and Health (Valvira). The Ombudsman has requested Valvira to elaborate by 31 May 2013, which measures it will take in the hospital districts pursuant to the Ombudsman’s decision.