[Community requirements relating to drugs derived from human blood and plasma].

Since the adoption of the first pharmaceutical directive in 1965, the pharmaceutical legislation of the European Community has constantly pursued two objectives: the protection of public health and the free movement of products. Directive 89/381/EEC covers stable industrially prepared blood derivatives, intended for a large number of patients, namely albumin, coagulation factors and immunoglobulins. Whole blood, plasma and cellular components are excluded from the scope of the directive. As a consequence of the inclusion of blood derivatives in Community pharmaceutical legislation, these products are now subject to its general provisions regarding manufacturing and marketing authorization. The principles of good manufacturing practice laid down in Directive 91/356/EEC and detailed in a guide for manufacturers have become mandatory, as well as the tests in Directive 91/507/EEC aimed at demonstrating quality, safety and efficacy for the purpose of marketing authorization. The European format for the application file as well as the Community procedures for marketing authorization are applicable. In addition to these general provisions, which are applicable to all medicinal products, Directive 89/381/EEC contains several elements which are specific to medicinal products derived from human blood or plasma. The measures for selection and control of blood donors recommended by the Council of Europe and the World Health Organization have become compulsory. Moreover, for these particularly sensitive products, the Council has explicitly demanded the application of validated manufacturing and purification processes, in order to guarantee, insofar as the state of technology permits, the absence of specific viral contamination. For new medicinal products, the Directive entered into force on 1 January 1992. For products already on the market, a transitional period of one year was provided, during which the Member States had to proceed with the review of these products. The objective of Community self-sufficiency in blood and blood derivatives by voluntary unpaid donations is clearly expressed in the text of the Directive and the Member States have to inform the Commission on measures taken in this area. Thus, in adopting the Directive, the 12 Member States established as an objective that self-sufficiency be attained through voluntary unpaid blood donation. But, in addition to the Directive, the general rules of the EC Treaty are applicable, namely with regard to free movement of products, public procurement and monopolies.