MSF has been offering ARV treatment to patients in Yaounde, Cameroon, since January 2001.

© Juan Carlos Tomasi.

Background

As the price of antiretrovirals (ARVs) in lowand middle-income countries has fallen in recent years, governments, international agencies and non-governmental organizations (NGOs) have been able to start developing treatment programmes for people living with HIV/AIDS (PLWHA). Procurement strategies are a key element in this global scaling-up process. As Médecins Sans Frontières (MSF) was one of the first international NGOs providing ARV therapy, the World Health Organization (WHO) requested that MSF document its procurement experiences in 10 countries where it has ARV treatment programmes, so that others could benefit from what has been learnt.

The importance of assisting ARV treatment programmes to procure low-cost, quality ARVs cannot be underestimated. In sub-Saharan Africa, the region hardest-hit by the HIV virus, only one percent of the four million people in need currently receives ARV therapy. While other medicines can cure the opportunistic infections caused by HIV or provide relief from symptoms, these are ultimately only temporary measures. Conversely, ARVs decrease the level of the virus in the body, reduce morbidity, prolong and improve quality of life, and prevent most opportunistic infections.

MSF's experience shows that for numerous reasons ARV procurement is often more challenging than that of other types of essential medicines. Products are expensive and stock management is crucial to avoid disruption of treatment. Treatment protocols are diverse, and procurement systems have to respond quickly to evolving treatment regimens. Also, the limited amount of publicly available information, including the lack of quality reference standards, makes assessing the quality of generic ARVs more difficult than that of most other essential medicines - even though quality generic ARVs are being produced.

Method

Data collection for this report is based on MSF's purchasing experience over the past two years in 10 countries. Potential ARV sources, patent and registration status, prices, and distribution options have been analysed and systematically documented in each of the 10 countries - Cambodia, Cameroon, Guatemala, Honduras, Kenya, Malawi, Mozambique, South Africa, Thailand and Ukraine.

Before presenting the detailed country case studies, the report looks in some detail at ARV selection, pricing and procurement issues in general, as part of the medicines management cycle. Five issues of particular importance are highlighted: sources (quality); registration; prices; patents; and continuous availability of medicines.

Main findings

An important finding from the country case studies is that procurement works best when there is a national HIV/AIDS strategy that includes ARV treatment, and that is supported by government commitment and political will. Sufficient funding is crucial to implement national action plans.

Another major finding is that there is no single or ideal approach to ARV procurement. There are several effective strategies that can result in the supply of affordable, quality ARVs. Often a combination of these procurement strategies worked well for MSF country programmes. From MSF's perspective, the most effective and easiest systems are either one or a combination of: strong public procurement agency (Cameroon); local drug production (Thailand); and/or dynamic private sector distributors (Malawi).

It was also found that the following factors affected efficient procurement systems at country level: limited numbers of registered ARV products (generic and originator); unclear patent status of ARV medicines; lack of generic policies; limited information available about internationally publicized prices; and countries' eligibility for differential prices offered by pharmaceutical companies. The ability to use generics has been one critical factor for procurement success, to allow competition and guarantee a continuous supply of ARVs.

Although MSF was relatively successful in procuring ARVs in the countries described in this report, it is important to note that drug procurement continues to be a complicated and labour-intensive process, both in terms of ensuring the continuous supply of drugs in countries where projects have been begun and in starting up procurement in countries where MSF is opening new projects.

Main recommendations

The report's main recommendations on ARV procurement highlight that for

Ministries of health/national AIDS programme/policy-makers - it is important to have national HIV/AIDS treatment guidelines and ARVs included in the national list of essential medicines. Taxes, duties and markups on ARVs should be lowered or abolished by governments to avoid significant price increases that make products unaffordable. Systematically collected information on patents, and international and local prices of medicines will increase price transparency and will facilitate price negotiations and improve procurement.

Governments of Least Developed Countries (LDCs) - have no need to grant and enforce patents on pharmaceuticals until 2016, as stipulated in the Doha Declaration on TRIPS and Public Health, 2001. Also they can exercise their right to access low-cost medicines (compulsory licences or parallel importation), as provided for in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

ARV procurers - the most important task is to obtain appropriate ARV products and formulations of assured quality at the lowest price possible. Some of the key issues for successful procurement are: forecasting ARV needs accurately, having up-to-date price information and quality assessment (WHO's pre-qualification project) obtaining ARVs that are registered by the national drug regulatory authority (NDRA), introducing generic competition, knowing of reliable suppliers and distributors (international and national) and having guaranteed funding (e.g. from the Global Fund to Fight AIDS, Tuberculosis and Malaria).

Manufacturers - manufacturers worldwide should develop fixed-dose combinations (FDCs) and paediatric formulations, as well as more user-friendly and affordable diagnostics. They should also be committed to developing and participating in a differential pricing mechanism, in WHO's pre-qualification project and in maintaining stocks at country level.

United Nations and international agencies - a differential pricing system for newer medicines should be further explored at international level. Regional, as well as national, ARV procurement initiatives should be supported. If requested, UN and international agencies should stock ARV supplies on a country's behalf.

MSF ARV PROGRAMMES