WHO Expert Committee on Biological Standardization : fifty-first report
The WHO Expert Committee on Biological Standardization met in Geneva from 30 October to 3 November 2000. The meeting was opened on behalf of the Director-General by Dr Y. Suzuki, Executive Director, Health Technology and Pharmaceuticals.
Dr Suzuki emphasized the contribution of the work of the Committee to global standardization and control of biological substances used in medicine. He also drew attention to the importance of promoting the role of WHO in setting recommendations.
Dr Suzuki noted that WHO is emerging from a period of considerable restructuring aimed at fostering better coordination and cooperation of activities at all levels of the Organization and minimizing duplication of effort. In the case of WHO’s Biologicals unit, a further driver for change has been the Report of the Independent Review of the Remit and Activities of WHO in the Biological Field and the Biologicals Unit submitted to WHO in November 1998. In line with the recommendations of the Review, the Biologicals unit has been renamed Quality Assurance and Safety: Biologicals (QSB) to describe more accurately its responsibilities and has been located in the Department of Vaccines and other Biologicals. The Quality and Safety of Plasma Derivatives and Related Substances (QSD) unit has been placed in the Department of Blood Safety and Clinical Technology to improve its visibility and funding.
QSB and QSD continue to work closely together to fulfil the normative functions of WHO and have special status as an intra-cluster biologicals team acting as a clear focus for biological activities within WHO, as recommended by the Review, as well as having the degree of independence necessary for the standard-setting process. Dr Suzuki also noted that recent scientific and technical developments have led to a rapid expansion in the number and complexity of biologicals, with new products and new biotechnologies posing new challenges for standardization, quality control and safety. The independent review of biologicals had recognized the need to strengthen WHO’s activities in biological standardization to meet these challenges. The shortfall in staffing and funding of biologicals that has occurred in recent years is now being made up. Dr Suzuki acknowledged the generous support of the Government of the United Kingdom, through staff secondment from the National Institute for Biological Standards and Control, Potters Bar, and thanked the French Government for its support for a new post in QSD. Although the regular budget had not increased, more financial resources are becoming available for biologicals through funding from various sources.
Another recommendation of the independent review of biologicals was that special consideration be given to the area of International Biological Standards for in vitro diagnostic procedures. It had suggested that high priority be given to the detection of microbial agents which could be transmitted to humans and recommended that WHO should consult international scientific organizations working in this field and seek advice on priorities in the development of appropriate biological reference materials with relevance to global public health. Such a consultation had been arranged recently by the Secretariat and good progress had been made in identifying and discussing issues related to a global approach to the development of International Biological Standards for in vitro diagnostic procedures.
Finally Dr Suzuki noted that the heavy agenda once again reflected the increasing complexity and sophistication of the biologicals field and its growth in volume. He commented that this presented a considerable challenge, especially for developing countries, which can expect to benefit greatly from the use of new biologicals such as vaccines. Some are developing their own capacity in this area and the need for a coordinated international approach to assure the quality and safety of biologicals cannot be overemphasized.