Promoting public health is a significant component of the 2030 Agenda for Sustainable Development and a critical prerequisite for national development. Recently, the United Nations Secretary-General’s High Level Panel on Access to Medicines recommended, inter alia, that governments adopt and implement legislative and regulatory initiatives to facilitate access to health care particularly with respect to essential medicines. GAiA offers a custom-made approach to the public-health challenges in participating countries, partnering with the Ministry of Health and other relevant government agencies in each country to support national efforts to address the misalignments that characterize public-health goals, intellectual property policies, trade and innovation. We focus on three primary strategies: (a) the optimization of legal and policy frameworks that facilitate access to medicines; (b) the regulation of pharmaceutical intermediaries, supply chains and arbitrage to optimize the distribution of drugs and facilitate differential pricing; and (c) the optimization of drug approvals and related reforms to promote domestic pharmaceutical manufacturing capacity.
GAiA’s Initiative provides unique, context-specific recommendations and technical assistance to each participating country, unlike previous efforts by international entities that have advocated the transplant of model laws and regulations to foreign countries.
Pilot Project for Regulatory Change in Sub-Saharan Africa
GAiA’s Initiative started in Sub-Saharan Africa. We provide assistance to each participating country to develop a public health-sensitive legal framework that can deliver a sustainable supply of low-cost medicines while continuing to provide pharmaceutical manufacturers with the legal protections necessary to incentivize future innovation.
GAiA’s approach is innovative for two key reasons: first, it combines legal and technical expertise with public policy analysis to provide a comprehensive, interdisciplinary review of access barriers in LMICs. Where previous efforts have focused solely on intellectual property reform, GAiA’s Initiative will work closely with in-country partners to review drug regulatory systems, competition laws, intellectual property laws, supply chain management, and anti-counterfeiting systems to identify and address context-specific barriers to access.
The goal of the Initiative is to reduce the communicable disease burden in Sub-Saharan Africa by expanding access to affordable health technologies on a sustainable, long-term basis. The projected outcomes of the project are threefold:
- The development of effective, context-specific, legal, policy and regulatory infrastructure in each participating country, combined with the development of local technical capacity to utilize this infrastructure to promote public health;
- A significant reduction in the average price of available treatments for high-priority diseases in each country, including HIV/AIDS, MDR-TB, and malaria;
- A significant reduction in mortality rates and disease burdens in each participating country, measured over the long-term.