Brazilian generic drugs in South Africa - the background

MSF project in Khayelitsha, South Africa MSF-South Africa is based in Khayelitsha, a sprawling township of 500,000 people outside Cape Town. The project works in collaboration with the provincial government. It provides support to a government-run programme to prevent mother-to-child transmission of HIV and runs infectious disease clinics within the government primary health care centres. These clinics were opened in April 2000 and have provided treatment for opportunistic infections for over 2,300 people living with HIV/AIDS. In May 2001, combination antiretroviral therapy was introduced for a select group of people in advanced stages of AIDS. To date, 85 people are receiving antiretroviral therapy, and 50 of these are taking generic medicines from Brazil. ARVs still very expensive in South Africa Despite South Africa's landmark victory against the Pharmaceutical Manufacturers' Association last year , antiretroviral drugs remain very expensive in South Africa. Annex 1 at the end of this document shows the price difference between patented drugs and generics produced by the Brazilian national pharmaceutical manufacturer, FarManguinhos. For instance, in October last year, MSF-South Africa's project in Khayelitsha was paying twice the FarManguinhos price for the antiretroviral drug it uses most, the AZT/3TC co-formulation. The South African government's response to AIDS The South African government's response to AIDS has been beset by a string of controversies. At various points, the government - and particularly President Thabo Mbeki - has questioned the link between HIV and AIDS and questioned the magnitude of the AIDS epidemic despite the overwhelming evidence that AIDS is the leading cause of death in the country. Most recently, the Treatment Action Campaign, South Africa's leading AIDS activist group, won a lawsuit against the government on mother-to-child transmission, where the High Court found that the government was violating its constitutional obligation to improve access to health care services and to safeguard the rights of children. To date, the government has also refused to provide antiretroviral treatment to adults. The Brazilian response to AIDS In contrast to South Africa, Brazil is responding effectively to AIDS by virtue of its strong governmental commitment to tackling the epidemic. In 1996, in response to intense pressure from civil society, the Brazilian government began providing free access to antiretroviral therapy to people with HIV/AIDS. This policy has allowed more than 100,000 people to receive antiretroviral therapy and reduced AIDS-related mortality by more than 50%. In addition to political will, several other factors are key to Brazil's success, including willingness to allocate increased resources to health care, create a nationally coordinated AIDS prevention and treatment programme, and use whatever means are necessary to bring down drug prices to affordable levels. Brazil has been constantly reducing drug costs by importing and producing generics (most ARVs are not patented in Brazil), and by using the threat of compulsory licensing as a lever to get affordable prices from drug companies when drugs are patented. For example, Roche's drug nelfinavir costs half as much in Brazil as in African countries, because Roche knew Brazil would override their patent if the company did not give a price that was considered affordable by Brazil. MSF Agreement with the Brazilian government and FarManguinhos MSF has signed agreements with the Brazilian Ministry of Health (September 2001) and Fiocruz, a public research body funded by the Brazilian government, of which FarManguinhos is a part (November 2001). The former established a cooperative agreement involving technical collaboration on the response to HIV/AIDS, so that MSF and the Brazilian MoH can collaborate to share experiences in the provision of treatment in resource-poor settings. The agreement with Fiocruz allows MSF to purchase antiretroviral drugs produced by FarManguinhos. An innovative aspect of this arrangement is that the money MSF pays will go directly into R&D for AIDS and neglected diseases such as sleeping sickness, Chagas Disease and malaria (all diseases for which current treatment options are inadequate). MSF-South Africa is currently receiving the antiretroviral drugs AZT, 3TC, co-formulated AZT/3TC, and nevirapine from FarManguinhos. Authorisation from South African regulatory authorities To ensure that the quality of the drugs meet South African standards, MSF sought and received authorisation from South Africa's Medicines Control Council (MCC), the national pharmaceutical regulatory authority in South Africa, to use the generic versions of AZT, 3TC, co-formulated AZT/3TC and nevirapine produced by FarManguinhos. Current use of Brazilian ARVs in the Khayelitsha project In the pilot project, which has already demonstrated the feasibility of implementation from a medical perspective, both the antiretroviral drugs and the laboratory monitoring are provided free of charge. In addition to providing needed treatment for individual patients, the programme is designed to help develop a model for a much larger programme that could potentially be rolled out nationally in South Africa. Lowering the costs of the drugs needed is a crucial component of the pilot programme. For the South African government, international donors, and individuals that may pay part or all of their treatment costs, sourcing drugs at half the price currently charged by multinationals would have enormous financial implications. Treatment Action Campaign - an act of provocation Zackie Achmat, Matthew Damane and Nomandla Yako, three members of the Treatment Action Campaign, and Joyce Phekane of the Congress of South African Trade Unions (COSATU) have gone to Brazil to bring back cheaper, generic antiretrovirals from FarManguinhos for use in the MSF project. All three TAC members are living openly with HIV, and Matthew and Nomandla are themselves receiving treatment in the Khayelitsha antiretroviral programme where more than 85 patients are already on ARV treatment. They are doing this to show that if the South African government had the will and took the necessary actions, antiretrovirals could be provided at half the cost currently offered by multinational drug companies in South Africa. If the multinational companies are not willing to charge affordable prices, the South African government can go to generic suppliers in India or Brazil and/or can begin production itself. Since most antiretroviral drugs are patented in South Africa this would require issuing compulsory licenses. With political will, antiretroviral treatment is possible in South Africa Antiretroviral therapy(ART) feasible in resource-poor settings The AIDS epidemic is one of the greatest challenges facing Africa today. Access to antiretroviral therapy is a crucial element of both treatment and prevention of HIV/AIDS, and implementing ART is as a matter of urgency for millions of people. MSF's successful programme in Khayelitsha, as well as pilot programmes in countries such as Cameroon, Malawi and Kenya, are demonstrating that the use of combination ART in both urban and rural settings in African countries is feasible. ART can be affordable and even cost-effective if prices are reduced to the levels offered by generic producers. MSF's projects seek to develop a model of care for people with HIV/AIDS that can be widely adopted, particularly by governments. These projects are also intended to debunk the myth that antiretroviral treatment cannot be implemented in resource-poor environments. This will be supported quantitatively by clinical and cost data from all of MSF's programmes; these data have been submitted for presentation at the international AIDS conference in Barcelona in July 2002. South Africa has a comparatively advanced medical infrastructure, with good facilities and laboratories available to most of the population, particularly the 54% who live in urban areas. With political will, it would be feasible for the government to reproduce on a nation-wide scale what MSF is achieving on a small-scale. Cheaper ARVs accessible using TRIPS safeguards MSF believes that patients' lives should be put ahead of intellectual property rights. The declaration on TRIPS and Public Health adopted at the 4th WTO Ministerial Conference in Doha supports this viewpoint by clearly acknowledging the right of countries to take measures to protect public health. TRIPS safeguards, such as compulsory licensing, can be put to use to overcome intellectual property barriers to access to medicines. Despite the recent adoption of the Doha Declaration, the South African government has not yet used any of the available tools to reduce the price of antiretroviral therapy, and continues to refuse to provide antiretroviral treatment for people living with HIV/AIDS. Nothing is preventing South Africa from accessing cheaper antiretrovirals - they have the ability and responsibility to take proactive steps to provide cheaper antiretrovirals for the patients who urgently need them. To do so, the government needs both to take advantage of the offers from multinationals when they are lower than generic offers, and to be willing to issue compulsory licenses when generic prices are lower. These licenses can be used to import drugs or produce them locally. International aid A necessary first step for implementation of ART programmes is political commitment from national governments. But once South Africa makes this commitment they will need financial help from the international community. For those governments that have already made the commitment, such as Cameroon, Uganda or Malawi, international funding will be needed. The current situation is dismal. Kofi Annan estimated that the Global Fund on AIDS, tuberculosis and malaria would require US$8 billion a year to meet its targets. So far, only US$1.7 billion have been pledged over an average period of three years - or 7.5% of the amount needed for that period. This is the time for donors to follow up on their commitments and make needed resources available. Summary of key points:
  • ART is feasible in resource-poor settings. MSF South Africa's project in the Khayelitsha province is helping to demonstrate this.
  • Without a change in policy in South Africa, people will continue to die prematurely from a treatable disease.
  • The South African government must take measures to access cheaper antiretrovirals for HIV/AIDS patients who urgently need them. National legislation permits it and the international context is supportive - there is nothing stopping the government. Annex 1 ANTIRETROVIRAL DRUG PRICES Difference between proprietary company offers and generic producer prices Price of AZT/3TC:
  • GlaxoSmithKline (proprietary company), special discount price: US$ 2 per day
  • FarManguinhos (generic): US$0.96 per day (52% cheaper) Price of Nevirapine:
  • Boehringer Ingelheim (proprietary company): US$1.19 per day
  • FarManguinhos (generic): US$0.59 per day (50% cheaper) Price of AZT:
  • GlaxoSmithKline (proprietary company): US$1.6 per day
  • FarManguinhos (generic): US$0.09 per day (94% cheaper) Price of 3TC:
  • GlaxoSmithKline (proprietary company): US$0.64 per day
  • FarManguinhos (generic): US$0.41 per day (36% cheaper)