International challenges and public policy issues.

The paper presents an overview of current public policy issues relating to biological standardisation and control, drawing on the extensive background material assembled for two recent international reviews, and previously published work. It identifies a number of factors which are destabilising the current system and promoting a climate for change. These include the squeeze on public sector resources, the growth in volume and complexity of biologicals, developing world needs, concerns about harmonisation and new social and ethical issues. It is argued that this situation presents important opportunities for reviewing the existing boundaries between regulatory scientists, industry, and the public, for international agreement on priorities and for harmonisation and mutual recognition. While considerable progress has already been made on these issues at national, regional and global level, there is a need for fuller international participation and the additional impetus that would come from a higher-profile commitment by governments. Such commitment will also be important for the vital questions of sustaining the scientific base and securing the resource for an effective, truly worldwide programme of standardisation and control. An international approach will also be essential in steering biologicals control through the difficult social and ethical questions of the future. WHO, in collaboration with national authorities, has a key role to play in these developments.