"How does the regulatory framework affect incentives for research and development: developing countries' perspective"

Precious Matsoso, Director TCM/HTP WHO
Martin Auton Management of Medicines in Public Health
Shabir Banoo, Medicines Control Council
Henry Fomundam, Medicines Control Council Committee
Henry Leng, Medicines Control Council Committee / University of Western Cape
Sassan Noazin, TCM/HTP WHO

This study will have three parts, each of which will be based on a review of existing literature combined with qualitative research. The first part will consider the particular regulatory challenges that may exist in relation to specific areas of R&D of relevance to developing countries, namely the development of new formulations and delivery systems, as well as vaccines and other biologicals. The second will consider regulation within the global landscape, including recent trends towards international and regional harmonisation of regulatory requirements, and what it means for developing countries. The third part will investigate the specific question of clinical trials, considering the interplay of economic, ethical, safety and scientific concerns on the part of industry, government, and patients.