Health Communities and the Trade of Counterfeits and Substandard (CAS) Medicines: In Need of Public Health Solutions

Background: Resolving the trade of the counterfeit and substandard medicines (CAS) needs public health solutions because they have become a serious public health threat worldwide. The solutions require global actions at the top-stream, upstream, and downstream levels. Method: A meta and content analysis of global policies and documents and interviews related to CAS trade regulations and programs (TRIPS, FTAs, ACTA, Operation Pangea III, IMPACT, ACP, WHA 47.13, and EU's IPRED2) on : 1. the trade of the counterfeit and substandard (CAS) medicines; 2. the factors underlying the increase of the CAS; 3. the supply and demand chain barriers; 4. the global regulatory barriers.

Results: Serious challenges exist in controlling the trade of the CAS medicines globally. A public health framework is more effective in protecting population health than the abuse of a business model: 1. A top-of-the stream strategy is an inclusive partnership and rights-based model to address access and equity issues, especially pricing and IPR. 2. An upstream strategy requires capacity building for resource-poor countries in policymaking and supply and demand chain surveillance (i.e. GMP, WHO pre-qualification programs, ePedigree, mPedigree forensic palynology, DQI, RFID and OVDs). 3. A downstream strategy requires generics provision for resource-poor populations (e.g., WHO's coartem program).

Discussion and Conclusion: Public health solutions need to be in place to ensure equitable, safe and secure pharmaceutical access in the supply and demand chain. The abuse of the business model, such as using ACTA to counter the generics production , could jeopardize population health.