54th report: WHO TRS N°927: 2003

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 21 November 2003. The meeting was opened by Dr Vladimir Lepakhin, Assistant Director-General, Health Technology and Pharmaceuticals, WHO, on behalf of the DirectorGeneral.

Dr Lepakhin emphasized the importance to Member States of the work of the Committee in preparing recommendations for biological products and for the development, establishment and distribution of reference materials for biologicals. During the meeting, a number of proposals for reference materials and draft recommendations would be considered. Dr Lepakhin informed the Committee that the World Health Assembly had endorsed many resolutions on the subjects of quality, safety and efficacy of medicines, blood products, vaccines and other biologicals. Despite considerable progress made both by WHO and its Member States in the implementation of such directives, urgent action was needed to sustain and expand basic normative regulatory functions underpinning public health efforts to assure access to quality biological medicines. Furthermore, as a result of rapidly changing global environments, increased international trade and the opening of borders, many biological medicines, including blood products, were circulating more freely than ever. Unless they were subject to control, biological medicines such as those derived from blood and plasma could be vehicles for the transmission of infectious diseases and/or other emerging agents. Dr Lepakhin reminded the Committee that the establishment and functioning of national regulatory systems with reference to WHO recommendations, norms and standards was essential to protect patients and public health from fraudulent practices and economic waste. WHO was therefore seeking political commitment and support from Member States to sustain and increase capacity building and training in all aspects of regulatory functions, including the efficient implementation of good regulatory practices. Finally, Dr Lepakhin reminded the Committee that its decisions should be based on sound science and common sense and not on partisan considerations.