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Since the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing medicines intended for conditions affecting small numbers of patients, the European Union offers a range of incentives to encourage the development of these medicines.
To benefit from the incentives, persons or companies ('sponsors') intending to develop orphan medicines must first submit an application to the European Medicines Agency requesting 'orphan designation' for their product. Once a medicine has been granted orphan status (by the European Commission, following a positive opinion on orphan designation from the Agency's Committee for Orphan Medicinal Products), its sponsor is then eligible to benefit from the following incentives.
- Inventory of Community and Member States' incentive measures to aid the research, marketing, development and availability of orphan medicinal products. Revision 2005
- The European Medicines Agency provides protocol assistance (scientific advice for designated orphan medicines) for sponsors intending to develop an orphan-designated medicinal product for marketing authorisation
- Fees payable to the European Medicines Agency
- Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products