Another CIOMS key programme: The Programme on Drug Development and Use — Medical, Social and Economic Implications.

Another CIOMS key programme: The Programme on Drug Development and Use – Medical, Social and Economic Implications has focused largely on what is now referred to as pharmacovigilance and the reporting of adverse drug reactions. The aim of this Programme, which has been one of the two priority areas of CIOMS activities in recent years, were described in a 1994 CIOMS publication as follows: “to present objectively and persuasively the benefits that society as a whole derives from access to modern drugs and vaccines, and to make the case that, unless society is prepared to accept the possibility of remote risks to the individual as the corollary of modern medical care and further therapeutic progress, the basis of contemporary drug development will ultimately founder. Society must be assured that a responsible and committed effort is in hand to minimize drug-induced injury, and that the risks of such injury compare favourably to those accepted in other aspects of daily life.” Most of the substantive achievements of this Programme are the outcome of a series of Working Groups or other projects, which have addressed such issues as: International Reporting of Adverse Drug Reactions (CIOMS 1); Periodic Safety-Update of Drugs (CIOMS II); Core Safety Data Sheets of Medicinal Drugs (CIOMS III); and the Harmonization of Adverse Drug Reaction Terminology. CIOMS also convened, in 1993, a major Conference on “Drug Surveillance: International Cooperation – Past, Present and Future”, and published an extensive series of technical papers on specific aspects of drug safety in specialized journals. This Programme, it may be asserted, has made many critically important contributions to the vital field of drug safety. At the request of WHO, and with its cooperation, CIOMS also generated “Ethical Criteria for Medicinal Drug Promotion”. These were endorsed by WHO’s governing bodies, the Executive Board and the World Health Assembly, in 1994.

The principal objective of the Programme on the International Nomenclature of Diseases (IND) was to provide, for every pathological entity, a single internationally-agreed name. Carefully identified criteria for the selection of the name were formulated. Another objective was that the IND would serve as a complement to the WHO International Classification of Diseases (ICD). Eight volumes of the IND were published between 1985 and 1992. This Programme had to be suspended due to lack of funds.