29 January 2002
TAC AND MSF IMPORT GENERIC ANTIRETROVIRALS FROM BRAZIL IN DEFIANCE OF PATENT ABUSE
Joint Press Release of Médecins Sans Frontières (MSF), Treatment Action Campaign (TAC), and Oxfam, Generic AIDS Drugs Offer New Lease on Life to South Africans Importation of generics cuts price in half
29 January 2002, Johannesburg - Yesterday, three members of the Treatment
Action Campaign, (TAC) returned to South Africa from Brazil carrying
generic drugs manufactured for use in an AIDS treatment program in
Khayelitsha. At a press conference today, TAC and MSF explained that the
drugs carried from Brazil were the second shipment of Brazilian drugs and
that as of today 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.
"Last week 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 the Treatment
Action Campaign. "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."
At a press conference today, the NGOs said that the 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 national government's refusal to provide antiretroviral
treatment, three clinics run by Médecins Sans Frontières (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 outside Cape Town,
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 group
of people in advanced stages of AIDS. To date, 85 people have received
antiretroviral therapy 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, a person living with
AIDS who is receiving antiretroviral therapy 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
"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 the country as
medical staff become increasingly frustrated by the lack of action from
the national government. Nonetheless, the price of medicines continues to
be a critical 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.
An innovative aspect of this arrangement is that the money MSF pays will
go directly into research and development for AIDS and neglected diseases
such as sleeping sickness, Chagas Disease and malaria (all diseases for
which current treatment options are inadequate).
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 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%. Between 1997 and 2000, antiretroviral treatment has saved the
Brazilian government $677 million on hospitalisations averted and
treatment for opportunistic infections averted.
South Africa could launch a similar programme. To do so, the government
needs to have access to the lowest cost medicines, whether they come from
multinational pharmaceutical companies or from generic producers. This
means both taking advantage of offers from multinational companies and
being willing to seek compulsory licenses. These licenses can be used to
produce these drugs locally or import them and are an important way to
stimulate competition, which is a powerful tool to reduce prices.
Additional background information is available on the websites of
MSF and TAC
COSATU Statement on the Importation of Generic Antiretrovirals from Brazil
The Congress of South African Trade Unions (COSATU) and
the Treatment Action Campaign (TAC) have returned from a
visit to Brazil. The delegation included Joyce Pekane, Second
Deputy President of COSATU, Zackie Achmat, Chairperson of
TAC, Nomandla Yako, and Matthew Demane, a person who is
living with AIDS and currently being treated with anti-retroviral
The delegates, hosted by Médecins sans Frontières (MSF),
looked at Brazilian HIV/AIDS treatment programmes, visited
factories which manufacture generic anti-retroviral 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.
On their return the delegates brought back a batch of generic
anti-retroviral medicines for use by MSF in a treatment
programme in Khayelitsha. The Medicines Control Council
(MCC), having studied the safety of these medicines, has given a
Section 21 exemption which allows for them to be imported and
used by MSF.
The equivalent drugs are in fact available in South Africa,
produced by GlaxoSmithKlein (GSK) and Boehringer
Ingelheim. But they cost approximately R1000 per month
compared to the cost of R450 for the medicines being brought
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 face of overwhelming
support for the government's view that patent rights should not
be used to deny people access to life-saving medicines that 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 anti-retroviral
medicines to the people who need then as quickly and
cheaply as possible and must not let the vested interests of multi-
national pharmaceutical manufacturers to prevent this.
This is why these medicines are being brought in. The MSF
programme in Khayelitsha is already improving the lives of over
80 people. With affordable medicines many more people could
be reached, not only in the Western Cape but throughout SA.
Patrick Craven and Moloto Mothapo
Acting COSATU Spokespersons
011 339 4911 0r 082 821 7456