The AMASA consortium is a collaboration of partners in Europe, South Asia and Africa investigating the complexity of pharmaceutical supply chains in low- and middle-income counties and their impact on access to essential medicines. This 3-year project received a €3 million grant through the European Commission’s Seventh Framework Programme (FP7). The eight institutions which are involved in the project are: University of Edinburgh (UK), as coordinating institution, University of Ghent (Belgium), Swiss Tropical and Public Health Institute (Switzerland), Mbarara University of Science and Technology (Uganda), Makerere University (Uganda), University of Western Cape (South Africa), Foundation for Research in Community Health (India), and Queen Mary and Westfield College, University of London (UK).
Access to medicines is a key concern of governments, NGOs and citizens around the world. Much of the research carried out in this area, however, investigates barriers to access through the prism of patient or health system variables; i.e., cost, price, availability, tolerance, compliance, distance and user charges. The alternative discourse is grounded in considerations of intellectual property and barriers to pharmaceutical production, distribution and research innovation.
These two elements dominate the policy discourses worldwide, but their interplay and the effects of other regulations at national and international levels are under-examined and not well described. This project was stimulated by earlier research on three pharmaceutical products in India and Nepal, which took a whole-system perspective grounded in public health and population approaches to health care and drug delivery.
This required an understanding of the clinical evidence base for each drug, and how this evidence plays out in practice when national and international regulations governing marketing approvals, production, public procurement and local distribution are considered. One of the main findings of this research was the need for further investigation of the complex interplay between the government agencies and the regulations which govern pharmaceutical production and delivery and the formal and informal networks of health care in the study countries and at the level of the WHO.
The main aim of the research was to investigate how the interplay of patent regimes, pharmaceutical regulation, availability of drug production facilities, health care infrastructure and service provision, and engagement by foreign donors influence appropriate, affordable access to medicines in South Asia and Sub-Saharan Africa. We mapped patterns of production, distribution, supply and consumption of seven tracer medicines within seven health care areas – HIV/AIDS, Malaria, Reproductive Health, Tuberculosis (TB) Control, Mental Health and Diabetes – with specific consideration for the situation our study countries. We have also investigated the strategies and influence of selected Indian producers who are active as exporters, partners in joint ventures, or as direct producers in the African countries.
The AMASA project goes beyond most studies on pharmaceutical policy that focus on only a small aspect of the supply chain whether it is research and development, pricing or patient adherence. In this project, we took a multi-disciplinary approach to incorporate the entire pharmaceutical supply chain from production down to consumption. In order to achieve this ambitious goal, seven tracer medicines were followed through the supply chain in three different settings: Uganda, South Africa and India.
In particular, the project draws upon and extends four perspectives:
As Indian companies invest more in production facilities throughout Africa, understanding more about these South-South partnerships and their associated knowledge and technology transfer policies becomes relevant. India’s approach to patent recognition is seen as a model that should be implemented in other developing countries. The unique perspective of the AMASA project is its ability to shed light on various aspects of these relationships including interactions between health and economic policies through the lens of our study countries.
The results of the AMASA project conducted in Uganda, India and South Africa are being used to provide recommendations to parliamentarians and drug regulators in India, South Africa and Uganda and to suggest improvements to the legal frameworks that affect the pharmaceuticals supply chain, using a plan of engagement with relevant stakeholders, such as regulatory agencies and training institutions.
Specifically, we seek to encourage capacity building initiatives in drug regulation from the perspective of safety and effectiveness, aimed primarily at personnel associated with national drug authorities. Analysing the impact of TRIPS, GMP and other aspects of international trade regimes on access to medicines in these countries has allowed us to propose measures to improve the regulatory and training arrangements to enhance rational access to medicines in the full range of meanings described in the original proposal.
We have generated both nationally and internationally targeted reports and academic publications, workshops, stakeholder meetings, publications, and policy briefs to ensure that the outcomes of the AMASA project will have maximum impact.