247087 Health Communities and the Trade of Counterfeits and Substandard (CAS) Medicines: In Need of Public Health Solutions

Tuesday, November 1, 2011

Mei-Ling Wang, PHD, MPH , SS, USP, Philadelphia, PA
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.

Learning Areas:
Advocacy for health and health education
Communication and informatics
Ethics, professional and legal requirements
Provision of health care to the public
Public health or related education
Public health or related public policy

Learning Objectives:
Learning objectives: 1. describe the public health challenges in the trade of the counterfeit and substandard medicines 2. explicate the supply and demand chain in the trade of the counterfeit and substandard medicines 3. analyze the regulatory barriers contributing to the increase in the trade of the counterfeit and substandard medicines 4. demonstrate the use of public health strategies in controlling the trade of counterfeit and substandard medicines

Keywords: International Health, Community Health

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have conducted research myself and have no conflict of interest
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.