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Towards a more rational regulation of the development of new medicines. Report of a European Workshop held in Sestri Levante, Italy, September 28-30, 1976.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY. 1977; 11(3):233-8.A Group of European scientists held a workshop in Sestri Levante, Italy, September 28-30, 1976, proposing a more rational approach towards regulation and development of new medicines. The dual theme of the workshop was the influence of regulatory agencies on new medicines, and discussions on current medical research and discoveries. The scientists, while acknowledging the importance of regulatory agencies with regard to public safety and welfare, did question the agencies' objectives; they admit these objectives are well intended, but may, with the passage of time, have become too cumbersome. The group also suggests regulation may be interfering with the development of new medicines that could prove helpful to patients. These speculations are highlighted in detail, and reasons are given scientifically, administratively, and politically, why these interferences occur. Offered too are methods regulatory agencies could employ to alter this situation in favor of patients and communities as a whole. The report concludes that the public should be made aware that medicines are not, nor can they be, 100% safe. Public education is the only rational approach towards the development of new medicines.