Is there a European Regulation to encourage the development of orphan drugs?
Yes, the Orphan Drug Regulation 141/2000 came into force in 2000, the Regulation states that patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.
The aim of the regulation is written in article 1:
"...to lay down a Community procedure for the designation of medicinal products as orphan medicinal products and to provide incentives for the research, development and placing on the market of designated orphan medicinal products".
The regulation was, therefore, created to stimulate research and development and to bring to the market the appropriate medications for orphan disease patients.
The most important incentives are the market exclusivity for an orphan drug for a period of 10 years after the grant of marketing authorization, reduced fees for all steps of the market authorization centralized procedure at EMEA (European Medicines Agency).
The drugs need to meet certain criteria to be called as "orphan", the Committee for Orphan Medicinal Products (COMP) has the role to decide whether or not a drug is eligible to be called "orphan".