201807 Sustainable Pharmaceutical Trade: Rights-centered Policies and Partnerships to Improve Pharmaceutical Security and Safety

Tuesday, November 10, 2009: 10:50 AM

Mei-Ling Wang, PHD, MPH , Social Sciences, USP, Philadelphia, PA
Background: “Sustainable pharmaceutical trade” should be enforced to improve population health. Inequitable pharmaceutical access and unsafe medicines have generated a negative impact on population health.

Sustainable trade model applies the human rights principles and pursues harmonized policies to maximize efficacy and efficiency in terms of pharmaceutical security and safety. Pharmaceutical security refers to the right to adequate access and choice of medicine. Pharmaceutical safety refers to the right of protection from unsafe pharmaceuticals.

Objective: to explicate the barriers to sustainable pharmaceutical trade and to generate solutions.

Method: A meta policy analysis of trade policies (e.g., WTO, FTAs, ACTA, etc.) on: 1. barriers in accessing generics; 2. challenges in surveillance in the supply and demand of counterfeits; 3. “sustainable” trade solutions.

Results: Serious problems exist in pharmaceutical security and safety in global trade. Sustainable pharmaceutical trade model is in order to promote low-cost and safe medicines. Its underlying principles are the rights to access, equity, open information, and freedom to choose. These principles should be embedded in: 1. Global regulations on intellectual property rights, pricing schemes, and equitable capacity building; 2. rules in generic production; 3. surveillance of unsafe medicines; 4. pharmaceutical informatics and data disclosure (e.g., the Bermuda Rule); and 5. sustainable development partnerships (MDGs).


This study shows that “sustainable pharmaceutical trade” is necessary to improve population health. It requires ensuring access to generics and deterring counterfeits through multi-level policy harmonization and partnerships. The conflicting interpretations between ACTA and WTO's Article 61 could jeopardize pharmaceutical security.

Learning Objectives:
1. explicate the sustainable pharmaceutical trade model 2. differentiate between pharmaceutical safety and pharmaceutical security 3. demonstrate the use of human rights principles in enacting trade policies 4. to identify major barriers to the production of safe and low-cost medicines

Keywords: Policy/Policy Development, Access

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have expertise on the issue.
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.