The AIDS medicines and diagnostics service (AMDS) is a mechanism created to expand access to quality, effective treatment for HIV/AIDS by facilitating the increased supply of antiretrovirals (ARVs) and diagnostics in developing countries. The AMDS represents the access and supply arm of the 3 by 5 initiative, which aims to multiply eightfold the number of people in developing countries receiving antiretroviral therapy by 2005.

The AMDS builds on years of work by UNAIDS, WHO, UNICEF, the World Bank, and the global health community, as well as on some recent initiatives to address the AIDS treatment gap in developing countries. It brings together stakeholders and partners to maximize impact towards meeting the 3 by 5 goal as rapidly as possible.

What the AMDS will offer

Manufacturers currently have little idea of global market demand and its development over time. This situation affects both the price and volume of medicine production. AMDS will provide the necessary forecasting information to ensure that volumes produced reflect the real need at an affordable price.

The AMDS will offer technical support to countries to improve drug procurement, in-country supply management services, and local production where applicable. The AMDS will assist buyers to obtain best prices for individual or pooled demand for core ARVs and diagnostics. Where necessary, advice will be given on alternative sourcing options and through existing procurement agencies.

The AMDS will provide a service to governments, public interest and nongovernmental organizations (NGOs), health insurance and employer-benefit schemes, and other not-for-profit supply channels.

Specific services provided to countries

• Selection of ARVs, guidance on simplified treatment regimes, and selection of essential HIV diagnostic tests; country-level technical support to promote clinical guidelines and update the national essential medicines list.

• Patent status and licensing. Information on patent status of ARVs in the country; global guidance and country-specific support on the legal importation of generic medicines and voluntary/compulsory licensing.

• Registration and quality assurance. Global guidance and information on regulatory matters and registration status of ARVs; strengthening drug regulatory agencies in dealing with ARVs (registration, inspection, importation, local production and combination products).

• Global quality and product specifications for ARVs to be used for procurement tenders and contracts, including quality specifications for new combination products.

• Information on prequalification of ARVs and diagnostics, operational standards for evaluating supply agencies and quality control laboratories.

• Market intelligence on sources, prices, raw materials. Access to information on sources and prices of ARVs, other AIDS-related medicines and diagnostics, price indicators for raw materials for local production.

• Procurement of core ARVs and diagnostics. Global guidance and training programmes on procurement; practical information for buyers; access to the services of the WHO/UNAIDS diagnostics buyers group; country assessments and country-specific technical support to improve procurement and distribution of ARVs; access to global procedures to obtain economies of scale through international rate contracts; procurement services by or through AMDS.

• Import taxes and margins. Information on tariffs, taxes and margins in other countries; country-specific technical and political support in efforts to reduce them.

• Supply management and monitoring. Global guidance and training programmes in drug supply management and monitoring; country assessments and consultant support in improving national supply systems; methods and technical support in preparing institutional and national estimates of ARV quantities needed; full-time (inter)national technical staff to assist national authorities.

• Local production and quality assurance (Global guidance on good manufacturing practices (GMP) standards; training courses on quality assurance and GMP; technical support to the national drug regulatory agency in inspecting national production facilities.

Parallel to the medicines scheme (1), a project run by WHO and UNAIDS assesses the quality, safety and suitability of HIV diagnostics for use in developing countries. Currently, 24 HIV test kits that have met the criteria are available at reasonable cost. Four of these are produced in transition economies. Information on the proprietary rights, licensing and patent issues related to these products is collected and made available.

WHO also evaluates CD4 and viral load tests to monitor the efficacy of HIV drug treatment and is helping countries to develop the skills to assess the quality of diagnostic technologies. WHO also provides training to health care workers to ensure correct use of diagnostic tests (2).

References

1. http://www.who.int/medicines and http://www.who.int 3by5/en/

2. http://www.who.int/eht