The country has no central ARV drug procurement to date but both generic and originator drugs are available through a variety of local distributors. Price negotiations are done on a case-bycase basis.

4.7.1 Overview

¹ UN: World Population Prospects: The 2002 Revision. (www.un.org/esa/population/publications/wpp2002).

² Report on the global HIV/AIDS epidemic. UNAIDS/WHO 2002.

* FDC.

4.7.2 Details of procurement

Context

Availability at country level: Mozambique has so far been perceived by drug manufacturers as a small market and therefore most companies do not have direct representation in the country. GSK is the only originator company that is present.

Both originator and generic companies tend to sell their products through private importers/distributors who are often supplied from South Africa. In addition to originator companies' ARVs, Ranbaxy and Cipla products are readily available.

Registration: Mozambique does not yet have a registration system but there are controls on the importation of medicines and in principle, only drugs included in the National Formulary can be imported. However, special permission for the use of unauthorized drugs can normally be obtained through the Ministry of Health.²³

²³ Article 22 of the Medicine Act 4/98: "When, against clinical justification, they are considered as being indispensable for the treatment or diagnosis of certain pathologies" or "exclusively aimed at clinical research and tests".

Patents: Mozambique enacted its first Intellectual Property Code in 1999 and joined ARIPO in 2000. That is why no ARVs are patented in the country. In any case, patents should not constitute a problem since Mozambique is an LDC and therefore doesn't need to enforce pharmaceutical protection until 2016 according to the WTO Doha Declaration (paragraph 7).

Prices: ARV drug pricing is regulated by government control on price mark-ups. For example, drug importers are allowed to add a maximum 10% margin on imported drugs and retailers are allowed to add up to 15% to their purchase price. In practice, implementation of the system is inconsistent and private pharmacies sometimes sell ARVs at inflated prices.

MSF procurement strategy

When the programme began MSF sourced many drugs from abroad, as few ARVs were available locally and they were being sold at premium prices. When local distributors began selling ARVs, MSF procurement switched to local purchases. In some cases, local distribution only began when MSF suggested local distributors to companies, e.g. MSF facilitated contacts for Roche and Merck & Co.

The case of Merck & Co's 600 mg formulation of EFV is illustrative. Although the company had made an international announcement about a differential price and widespread availability of this product in developing countries, when the MSF team attempted to order the product in Mozambique, they were told that it was not available. It was only after discussions with Merck & Co headquarters and its South African office that the company found a way to deliver the drug to Mozambique from Europe. In June 2003, the team was also attempting to gain access to Roche's NFV at the newly communicated differential price but at the time of writing had had no response from their local agent.

4.7.3 Comments/analysis

In the absence of a central purchasing agency, MSF has relied on local distributors who represent originator and generic producers. By informing distributors of the international price offers MSF was often able to get prices that were close to these international offers. Some originator products have been the exception, for example, MSF paid 35% more than Merck & Co's publicized price for EFV 200 mg.

The fact that the Mozambique government has been quick to give authorizations for the import of generics has fostered competition between manufacturers, and brought prices down.

With the assistance of both the Bill Clinton Foundation and the Global Fund, the Mozambique government is embarking on ambitious plans to increase access to treatment. The immediate plan is to have 8,000 people on treatment by the end of 2003. This will be done partly by strengthening CMAM, the centralized national drug procurement centre, so that it can handle the nationwide supply of ARVs.

Summary of ARV supply in Mozambique in October 2002