When a drug demonstrates efficacy in off-label use, the new indication should be recognized by regulatory authorities, regardless of the will of the pharmaceutical industry that holds the patent for that drug. This is the concept expressed in a letter signed by Silvio Garattini and Vittorio Bertelè, of the Mario Negri Institute for Pharmacological Research, according to which «regulatory authorities should be authorized to recognize on their own initiative the indications that best meet patients' needs. Alternatively, the EMA (European Medicines Agency) could impose a compulsory license on a company that makes the product available only for a specific indication". The two researchers suggest that the European Commission correct laws and regulations that now prevent the EMA from acting in this direction. The proposal refers to two drugs, bevacizumab and ranibizumab, both effective in the treatment of age-related macular degeneration (AMD). However, only for ranibizumab has this specific indication been requested by the company and recognized by the regulatory authorities; but many ophthalmologists have adopted the intraocular use of bevacizumab given its much lower cost than the other drug
DoctorNews – 1 July 2010 – Year 8, Number 120
