MSF imports generic drugs from Brazil to South Africa and can now treat five people for the price of one, but these less expensive versions of the drugs are not widely available because most are still not registered.

4.8.1 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.

4.8.2 Details of procurement

Context

Availability at country level: As of March 2003, generic ARVs are still not available commercially in South Africa and originator ARVs are only available in the private sector. This means that generics are only available to a small number of projects (see below under MSF procurement strategy).

In theory, because of voluntary licences that have been granted by GSK and BI to a local manufacturer (Aspen Pharmacare), generic versions of ZDV, 3TC and NVP should become available soon. However, this only applies to the public sector.

Registration: Most originator ARVs are registered, as are a handful of generics (3TC 150 mg from Cipla, ZDV 100 mg from Apotex and Garec). The regulatory authority, the South African Medicines Control Council (MCC), has set a target of registering between 7 to 10 generic ARVs by mid-2003. It is possible to import unregistered generics by requesting special importation and use authorization from the MCC (section 21 of the Medicines Act). There is also concern that the terms and conditions of the voluntary licences granted to Aspen Pharmacare may prevent the company from offering their ARVs at internationally competitive prices.

Patents: Originator companies have patents in South Africa for all ARVs except zalcitabine (Hivid®, a drug which is not recommended in WHO treatment guidelines) and saquinavir (Invirase®), two Roche drugs.

Prices at country level: Patents and the lack of registered generics have seriously handicapped access to low-cost ARV drugs. In the absence of generic competition, differentially priced originator products are the only ones available to patients outside pilot programmes such as MSF's.

In March 2003, the lowest annual cost for a triple therapy regime purchased in South Africa was US$400 ppy (ZDV/3TC*+NVP) for the NGO and public sectors. The same treatment costs US$2007 ppy in the private sector.

* FDC

* FDC

MSF procurement strategy

Initially MSF was procuring ARVs from a private pharmacy at full price while exploring less expensive alternatives. The project is attempting to demonstrate the feasibility of more widespread treatment in South Africa, and drug affordability has been a key objective. For this reason MSF obtained permission from the MCC to use less expensive but as yet unregistered generic ARVs.

In January 2002 MSF managed to establish a collaborative agreement in which the Brazilian state manufacturer, FarManguinhos, supplies ARVs to MSF in Khayelitsha. Since the introduction of generic sources in the MSF programme, the price of first-line treatment (ZDV/3TC + NVP) ppy has been reduced from US$2000 to US$400. Using the same provision of the Medicines Act, MSF is currently importing several generic ARV products. Originator products are now used only when generic alternatives cannot be sourced.

4.8.3 Comments/analysis

Although MSF has found a means of accessing affordable ARVs in South Africa, the section 21 provision is a complex administrative procedure. South Africa has recently announced that it will develop a comprehensive plan to treat people living with HIV/AIDS ensuring that they can access ARVs to extend their lives. The authorization for use and distribution of generic versions of these drugs must come from the national government.