South African treatment activists defy patent laws to import generic antiretrovirals from Brazil
Graham McKerrow, HIV I-Base
A group of South African treatment activists returned home from Brazil in January carrying generic drugs for use in an AIDS treatment programme in Khayelitsha township near Cape Town.
The drugs smuggled from Brazil were the second shipment of Brazilian drugs and more than 50 people are already taking the Brazilian medicines in Khayelitsha.
To guarantee the quality of these drugs, an authorisation from the Medicines Control Council (MCC), the South African drug regulatory authority, was obtained prior to their use.
The activists included Joyce Pekane, Second Deputy President of the Congress of South African Trade Unions (COSATU), Zackie Achmat, Chair of the Treatment Action Campaign (TAC), and Matthew Demane, a person who is living with AIDS and currently being treated with anti-retroviral therapy (ART).
The delegates, hosted by the charity Médecins Sans Frontières (MSF), looked at Brazilian HIV/AIDS treatment programmes, visited factories that manufacture generic anti-retroviral (ARV) medicines and met government officials and people living with AIDS. The Brazilian government has formally offered the South African government help in fighting HIV/AIDS.
“In Brazil we saw what happens when a government decides to tackle HIV/AIDS. The Brazilians’ decision to offer universal access to antiretroviral therapy even in the poorest areas of the country is keeping tens of thousands of people alive,” said Zackie Achmat of TAC. “Central to the success of Brazil’s AIDS programme is their willingness to do anything necessary to source the lowest cost quality ARVs. The South African government should pursue compulsory licensing to ensure that generic antiretrovirals can be produced and/or imported in South Africa.”
The NGOs said that a court victory of the South African government against multinational pharmaceutical companies had opened the door to improved access to affordable medicines. “The South African government may need international financial help to provide treatment, but these needs will be dramatically reduced if the government takes steps to use the most affordable drugs available on the worldwide market, as the multinational pharmaceutical companies are still charging exorbitant prices for these drugs,” said Dan Mullins of Oxfam.
Despite the South African government’s refusal to provide antiretroviral treatment, three clinics run by MSF within the government primary health care centres, offer a comprehensive package of services to people living with HIV/AIDS, including antiretroviral therapy.
This project is part of an agreement between MSF and the government of the Western Cape, signed two years ago with the express intent to test the feasibility of generic antiretroviral therapy. These clinics, located in Khayelitsha, a sprawling township of 500,000 people, were opened in April 2000 and have provided treatment for opportunistic infections for more than 2,300 people living with HIV/AIDS.
In May 2001, combination ARV therapy was introduced for a group of people in advanced stages of AIDS. To date, 85 people have received ART and 50 of these are receiving Brazilian medicines. Using generic antiretrovirals offers the possibility of treating twice the number of people with the same amount of money.
“I have personally benefited from the MSF antiretroviral programme, and I have gone to Brazil to bring back generics so that more people like me can have access to these medicines,” said Matthew Damane, who is receiving ART as part of the MSF programme in Khayelitsha. “The government should publicly accept the effectiveness of these medicines and make them available to people with AIDS in South Africa.”
“Our project shows that antiretroviral therapy is feasible in a resource-poor setting, contrary to those who insist that poor Africans are not able to successfully take these drugs. Patients who were critically ill are now returning to their normal lives,” said Dr Eric Goemaere of MSF South Africa. “We have seen firsthand that these drugs can be used safely and effectively here in South Africa. As medical professionals, it is our duty to offer these benefits to as many patients as possible.”
Similar initiatives are springing up elsewhere around South Africa as medical staff become increasingly frustrated by the lack of action from their government. Nonetheless, the price of medicines continues to be a problem.
MSF has signed agreements with the Brazilian Ministry of Health (MoH) and Fiocruz, a public research body funded by the Brazilian government. 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 improve the delivery of treatment in resource-poor settings. The agreement with Fiocruz allows MSF to purchase antiretroviral drugs produced by FarManguinhos, the Brazilian national pharmaceutical producer, which is part of Fiocruz.
The money MSF pays will go directly into research and development of treatments for AIDS, sleeping sickness, Chagas Disease and malaria.
MSF is currently using the antiretroviral drugs AZT, 3TC, co-formulated AZT/3TC, and nevirapine produced by FarManguinhos. By using these drugs the price per patient per day falls from US$3.20 to US$1.55.
In 1996, in response to popular pressure, the Brazilian government began providing free access to antiretroviral therapy. This policy has allowed more than 100,000 people to receive ART and has reduced AIDS-related mortality by more than 50%. Between 1997 and 2000, antiretroviral treatment saved the Brazilian government $677 million it would otherwise have had to spend on hospital care and the treatment of opportunistic infections.
A COSATU statement said: “The importation of these drugs for use under strict conditions by MSF has been approved by the MCC. We are aware that it may infringe patent rights. However, we believe that, faced by an emergency caused by AIDS, and in the face of overwhelming support for the government’s view that patent rights should not be used to deny people access to life-saving medicines, this importation is in line with government and international policy.
“COSATU, TAC and MSF stand by their belief that the government and society as a whole must get antiretroviral medicines to the people who need then as quickly and cheaply as possible and must not let the vested interests of multinational pharmaceutical manufacturers prevent this. This is why these medicines are being brought in. The MSF programme in Khayelitsha is already improving the lives of more than 80 people. With affordable medicines many more people could be reached, not only in the Western Cape but throughout South Africa.”
The illegal importation is both a public relations and legal problem for the pharmaceutical companies that own the patents to the drugs. GlaxoSmithKline, which holds the patents on AZT and 3TC, will respond to infringements of its patents on a case-by-case basis, said spokesman Philip Thomson in London. The company prefers to focus on “generating greater access to medicine, and we would rather do that through partnerships than through conflict,” he said.
German-based Boehringer Ingelheim, which manufactures nevirapine, views importing a generic version of its medicine from Brazil as illegal, but has not decided how to respond, spokeswoman Judith von Gordon said.
More information is available on the websites of MSF and TAC:
These activists have committed an act of defiance. By importing generic drugs from Brazil, TAC and MSF have infringed GlaxoSmithKline and Boehringer Ingelheim patents. The South African constitution protects the rights to life and dignity, and by importing these medicines, TAC and MSF believe they are upholding these rights. It is worth remembering that patent infringement is a civil matter, not a criminal one.
Because there are patents on these medicines in South Africa, there is no competition between companies to make and market these drugs in South Africa. They are therefore much too expensive. By importing these drugs from Brazil in breach of the patent law at much lower prices, TAC and MSF are challenging both the South African government and the pharmaceutical industry to take steps to allow generic drugs to be made available to those who need them
Some pharmaceutical companies have made limited offers of supplying free or cut-price drugs to certain countries under particular conditions. However, there is no doubt they could do a great deal more. They have to stop making excuses about the lack of clean water and health facilities, and tackle the issue of allowing other companies to manufacture drugs in competition to their own products so that competition will drive down prices in poor countries. The way forward is for them to set their lawyers the task of finding a way of doing this that protects the patents they hold in rich countries.
At the same time, governments must act. Prime minister Tony Blair has said he wants to lead a project to assist Africa on a scale not seen before; and chancellor Gordon Brown has already made more money available to tackle Aids in poor countries than did his predecessors here or than have his counterparts in other countries. But still far too little is being done. Even the prices of generic drugs are too high for the governments of most poor nations. Taxpayers in European nations, and North America will have to foot the bill.