XVIII International AIDS Conference

Abstract

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A rights-based model to improve HIV pharmaceutical security and safety

M. Wang

US P, USP, Uruguay

Background: The major barriers in HIV-related pharmaceutical rights are security and safety. Pharmaceutical security is the right to adequate access and choice of medicine. Pharmaceutical safety is the right of protection from unsafe pharmaceuticals. The purpose of this study: examine the application of these rights in HIV-related-pharmaceutical provision in the global trade context and propose a rights-based model.
Method: A meta analysis of global agreements in: 1. trade, 2. intellectual property rights 3. surveillance/quality control in supply and demand chain; 4. development aid and capacity building for pharmaceutical access. The sample: WTO agreements (TRIP, DOHA, WIPO, TRIP-plus (free trade agreements [NAFTA, FTAs, EFA, EFTA, etc.]; unilateral trade policies; bilateral investment treaties, IPR agreements, science and technology and agreements; development cooperation and partnership agreements; WTO accession agreements), US Foreign Assistance Act, EU development aid policies, US HR5480, Bermuda Rule, ACTA, IMPACT, SECURE, The Security and Prosperity Partnership of North America), APEC's ACPI, MDGs, etc.
Results: A meta-analysis of pharmaceutical access to HIV medicine in the global trade context shows that barriers exist in pharmaceutical security and safety rights. The barriers to pharmaceutical security: TRIP-plus agreements contradicting DOHA (e.g., the case of Thailand and FTA); technical barriers to generic production (data exclusivity); illogical IPR regimes; global supply and demand/need imbalance (e.g., in neglected diseases); inflexible pricing schemes; and development aid deficiency. The barriers to pharmaceutical safety: confusing safety with security measures (ACTA vs. WTO's Article 61); lacking supply and demand and supply chain safety, and lacking integrated surveillance and monitoring.
Conclusion: Major barriers exist in protecting HIV pharmaceutical security and safety rights. A human rights-based model needs to apply the principles of inclusion, access, equity, and beneficence (harm reduction) in global trade, IPR, generics, pharmaceutical investment and pricing, global aid and development, and supply and demand chain safety and balance.


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