22.1.2000 Official Journal of the European Communities L 181 (Acts whose publication is obligatory) REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal products THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the Economic and Social Committee (%), Acting in accordance with the procedure laid down in Article 251 of the Treaty (%), Whereas: 1) some conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition would not be recovered by the expected sales of the medicinal product; the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions; these medicinal products are called ‘orphan’; patients suffering from rare conditions should be enti- tled to the same quality of treatment as other patients; it is therefore necessary to stimulate the research, develop- ment and bringing to the market of appropriate medica- tions by the pharmaceutical industry; incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993; in the European Union, only limited action has been taken so far, whether at national or at Community level, to stimulate the development of orphan medicinal prod- ucts; such action is best taken at Community level in order to take advantage of the widest possible market and to avoid the dispersion of limited resources; action at Community level is preferable to uncoordinated meas- ures by the Member States which may result in distor- () O] C 276, 4.9.1998, p. 7. () O] C 101, 12.4.1999, p. 37. (*) Opinion of the European Parliament of 9 March 1999 (O] C 175, 21.6.1999, 1999 (O] C 317, 4.11.1999, p. 34) and Decision of the European Parliament of 15 December 1999 (not yet published in the Official Journal). p. 61), Council Common Position of 27 September tions of competition and barriers to intra-Community trade; orphan medicinal products eligible for incentives should be easily and unequivocally identified; it seems most appropriate to achieve this result through the establish- ment of an open and transparent Community procedure for the designation of potential medicinal products as orphan medicinal products; objective criteria for designation should be established; those criteria should be based on the prevalence of the condition for which diagnosis, prevention or treatment is sought; a prevalence of not more than five affected persons per 10 thousand is generally regarded as the appropriate threshold; medicinal products intended for a life-threatening, seriously debilitating or serious and chronic condition should be eligible even when the prevalence is higher than five per 10 thousand; a Committee composed of experts appointed by the Member States should be established to examine applica- tions for designation; this Committee should also include three representatives of patients' associations, designated by the Commission, and three other persons, also designated by the Commission, on a recommenda- tion from the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as ‘the Agency’); the Agency should be responsible for the adequate coordination between the Committee on orphan medicinal products and the Committee on proprietary medicinal products; patients with such conditions deserve the same quality, safety and efficacy in medicinal products as other patients; orphan medicinal products should therefore be submitted to the normal evaluation process; sponsors of orphan medicinal products should have the possibility of obtaining a Community authorisation; in order to facilitate the granting or the maintenance of a Community authorisation, fees to be paid to the Agency should be waived at least in part; the Community budget should compensate the Agency for the loss in revenue thus occasioned;