Title:
A new approach to gathering pharmaceutical market data to support policy implementation and access to medicines: as demonstrated by malaria medicines in Zambia.

Abstract:
The steady supply of quality, affordable medicines is a pillar of a functioning health system. In addition to the public sector, the private, mission and not-for-profit sectors often serve a large part of the population in Africa. However, while there is generally systematic recording of public sector supply of medicines, detailed, systematic and reliable national market data including these non-public sectors are not commonly available in most countries in Africa. Understanding the total market is a missing part of the access puzzle: without this information, policy makers and health practitioners are not able to fully measure the impact of interventions, measure access to effective products, or fully evaluate the rational use of medicines. This article reports on a unique innovation which provides routine, national-level data on the total pharmaceuticals market, through a system which can be replicated elsewhere. It demonstrates how national-level market data contribute to the evidence base for policies on access to essential medicines, using the Zambian anti-malarial medicines market as a case study.
A new, routine national database on pharmaceutical market size and structure was established through a multi-partner collaboration. Information was extracted from import authorizations and allows for information on local manufacture. Data included value and volume of products as well as pack details, manufacturer and importer. The system was continually updated: data for this analysis were extracted for 6 years: 2009-2014 inclusive. Data were analysed using Microsoft Excel and validated against other sources including donor procurement data. Analysis included public and private sector markets. The policy relevance was demonstrated through analysis of four aspects of national policies on access and rational use of malaria medicines: (i) volume of product relative to disease burden; (ii) distribution by sector relative to treatment-seeking; (iii) consistency of products with respect to national policy guidelines; (iv) market concentration as a proxy for security of supply.
The system developed provides the first accurate, systematic data on the breakdown of a national pharmaceutical market in an African context. The total value of the anti-malarials market in Zambia, including all sectors, was USD 5.5-6 million. This included 22 different molecules or combinations, produced by 56 different manufacturers, with 142 different permutations of molecule/manufacturer/strength. Such data provide a complementary mechanism to confirm key trends in malaria treatment and control in Zambia: (i) sufficient supply relative to disease burden, (ii) value and volume of the private/non-profit sector; 29%-2% of market value and 17%-2% of market volume (from 2009 to 2014), (iii) dominance of the 3 molecules recommended in the national treatment guidelines; and (iv) an evidence-base for national discussions on medicines quality, security of supply and rationale use. The system extracts information on all medicines and therefore could be used to analyse other therapeutic classes. Data have been used for several policy purposes, notably by ZAMRA to monitor the quality of products in Zambia, monitoring implementation of WHO Resolutions on artemisinin monotherapy as well as monitoring trends in product choice across sectors.
Routine data are important for researchers and policy makers alike. This study shows how medicines data can be systematically gathered at national level-comprising range, volume and value in the public, private and not-for-profit sectors-to monitor more detailed trends in the market and allows triangulation of supply-side data against other sources. This systematic approach can contribute significantly to support access to medicines, monitor treatment and public health policies and create healthy markets. It can be used to monitor changes between therapeutic areas, for example the impact of improved malaria treatment on the use of antibiotics in the context of anti-microbial resistance monitoring. As data contain commercially confidential information, appropriate safeguards should be put in place to balance public health and commercial interests.