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Harmonization, regulation, and trade: interactions in the pharmaceutical field
1World Health Organization, Jakarta, Indonesia. timmermansk@who.or.id
Summary
The International Council for Harmonisation (ICH) process for drug registration may create barriers for generic drug manufacturers in developing countries. This could limit competition, hinder access to affordable medicines, and maintain high drug prices globally.
Area of Science:
- Pharmaceutical policy
- Global health economics
Background:
- Harmonization of drug registration requirements, exemplified by the International Council for Harmonisation (ICH) process, is a global trend.
- The World Trade Organization's Agreement on Technical Barriers to Trade influences pharmaceutical market entry.
Purpose of the Study:
- To analyze the impact of the ICH process on medicine accessibility in developing nations.
- To investigate how ICH standards, combined with trade agreements, affect market entry for generic drug manufacturers.
Main Methods:
- Qualitative analysis of regulatory harmonization processes.
- Examination of trade agreements and their implications for pharmaceutical markets.
- Assessment of economic factors influencing drug pricing and access.
Main Results:
- The ICH process, particularly with the Agreement on Technical Barriers to Trade, may erect significant barriers for new entrants, especially generic manufacturers from developing countries.
- These barriers can protect established pharmaceutical companies from competition, potentially preserving higher drug prices.
- This situation may impede efforts to increase access to essential medicines in developing countries.
Conclusions:
- Developing countries must carefully evaluate the consequences of adopting ICH standards as global benchmarks.
- Vigilance is required regarding the explicit or implicit inclusion of ICH standards in international trade agreements to safeguard medicine access.