Antimicrobial Agents and Chemotherapy

Biography

Biography: Nazim Serdar Turhal

Abstract

The information on the efficacy of newer agents is spreading rapidly on internet era. It is increasingly difficult in a democratic society to say “no” for a particular treatment for patients no matter how expensive it is. The bureaucracy is showing many obstacles in registration, marketing authorization, licensing steps of these new agents in many developing countries with limited resources. These obstacles may emerge in many forms. These measures are justifiable under budget pressures but instead of complicating the authorization process and testing the patience of both the industry and the patients who are waiting for the approval, I propose forming an advisory board similar to FDA and EMEA for the developing countries and simplifying the approval process under one authority which will be practical for the industry too. The industry will finance this board with application fees and the board then can use its influence on bringing down the price of these molecules in representing countries and justify the lower prices with commitment to substantial contribution to phase I-III trials in these particular countries. A correlative link can be established in between the contribution and the price. Difficulties of this will be: 1) Agreeing upon who will represent a particular country (politicians, physicians, clinicians and pharmacologists); 2) Getting together in harmony; 3) Agreeing upon representation; 4) Administrative power; 5) Convincing the industry. It may be difficult and painstakingly slow process but certainly worth trying!