China and India are leading a transformation of the Asian and worldwide pharmaceutical supply market. However, the medicines regulatory structure in these two countries is weak compared with those of the OECD countries. Indian producers especially are targeting the developed country markets where higher returns may be earned. Indian producers are targets of acquisition by the major Pharma companies. Korea is involved in free-trade negotiations with the United States which seeks changes to its pharmaceutical cost control system. Similarly, Thailand is involved in FTA negotiations with significant implications for pharmaceutical regulation. ASEAN countries have increased cooperation among medicines regulatory authorities.
- Are the regulatory infrastructures of China and India keeping pace with the rapid growth of domestic industry? Where are the key regulatory gaps?
- Will China and India increase public-sector funding for research and development? Will that funding be focused on disease burdens prevalent in those countries or on disease burdens of Europe and the United States?
- Should China and India take steps to protect local ownership of domestic producers, or is combination with the Pharma companies just as well?
- How much focus should China and India place on enforcement of competition law?
- What are the implications of Singapore’s emergence as a research and development center?
- Can Bangladesh or other least developed countries in Asia serve as low-cost manufacturing platforms for other developing countries?
- How will free trade agreements between the United States, on one hand, and Korea and Thailand, on the other, impact the price and availability of medicines?