Global Pharmaceutical Regulation 2007

The international system for the development, production and distribution of pharmaceutical products faces enormous challenges. The nature of the challenges is not universal. Instead, the problems facing patients, industry and regulators vary substantially by region.

The U.S. pharmaceutical sector, with the highest gross expenditure on research and development, is hampered by economic distortion and roadblock to genuine innovation, increasingly burdening consumers and the economy as a whole. Western Europe under-invests in research and development, but is adept at affording patient access. Eastern Europe faces a challenging integration of the Russian and Ukrainian pharmaceutical industries, while confronting a growing HIV-AIDS crisis. China and Indiahave emerged as major pharmaceutical suppliers to the world, while struggling to adapt domestic regulatory systems and address local patient needs. Africa confronts massive disease burden, not only from HIV-AIDS, malaria and tuberculosis, but also from intestinal disease, cancer and pulmonary disease, diabetes and neglected diseases such as sleeping sickness. Challenges in Africa are present at all stages of the medicine supply chain, including regulation, production, distribution, and finance. The Caribbean seeks to address an HIV-AIDS treatment crisis, and to develop effective regional production and distribution strategies. Latin American pharmaceutical producers increasingly confront challenges from Pharma companies demanding marketing exclusivity for their drugs. At the same time, income disparities among patient groups present major access problems.

Are there potential common solutions to the problems confronting the global pharmaceutical sector? Are there models for the research and development side that would reduce distortions and improve the environment for innovation? Could regulatory efficiency be improved by increased reliance on regional and/or multilateral regulatory agencies? What is standing in the way of regional production facilities with capacity to supply large patient populations? Is there an alternative to relying on monopolies and marketing exclusivity as a means to attract research and development capital? Should the U.S. be exporting costly regulatory structure for pharmaceutical supply? Why cannot pharmaceuticals be treated as "normal" goods subject to ordinary rules of competition?