E-DRUG: access to anti-retrovirals in South Africa
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[South Africa's Treatment Action Campaign has managed to get wide consensus
with academia and AIDS specialists about the need for access to ARVs.
The list of supporters reads like a "who is who" in AIDS related South
Africa.
The Department of Health is conspiciously absent.
Bredell is the location where the expert consultation was held. NN]
Bredell Consensus Statement on the Imperative to Expand Access to Anti-
Retroviral (ART) Medicines for Adults and Children with HIV/AIDS in South
Africa
Released: 19th November, 2001
On October 18th and 19th 2001 the Treatment Action Campaign (TAC)
hosted an expert consultation of doctors, scientists, nurses, policy
specialists and activists to discuss the benefits of using anti-retroviral
therapies (ART) for the treatment of HIV and AIDS in South Africa.
Participants included specialist clinicians and nurses who treat people with
HIV and AIDS and who prescribe or study anti-retroviral medications.
Included were representatives from diverse backgrounds, including the
public and private health sectors, academic medicine, tertiary hospitals,
urban, peri-urban and rural clinics. Several internationally respected
scientists from South Africa and elsewhere made presentations. Religious
bodies, trade unions, government and AIDS organizations also participated.
The following consensus emerged:
1.The AIDS epidemic is one of the greatest challenges confronting South
Africans. In facing up to the epidemic we confront not only a crisis of
illness
and death and a crisis of action, but a challenge to accept the truth, to
tell
the truth and to act on the truth.
2.Very large numbers of people are dying of AIDS or are sick with AIDS-
related illnesses. The Department of Health estimates that last year 628
000 (25%) public hospital admissions were for AIDS-related illnesses. The
Consultation also heard that AIDS-related illnesses are the most common
causes of death in the medical wards among adults aged 19-49 at teaching
hospitals affiliated to the Universities of Cape Town, Natal and
Witwatersrand. The first aim of ART is therefore to decrease HIV
associated illness (morbidity) and death (mortality). This goal can be
achieved.
3.Access to anti-retroviral therapy is a vital and indispensable complement
to both treatment of HIV disease and effective HIV prevention. It can
restore
hope to both health professionals and patients, and can assist us in
regaining control of this epidemic. Therefore treatment for HIV and AIDS
that includes anti-retroviral medicines should no longer be withheld as a
result of government policy. ART in the public sector is necessary and
possible, and a start must be made to implementing it as a matter of
urgency in the interests of millions of lives.
4.As with any potent and effective medication there are side-effects and
toxicities experienced by some patients taking ART. However, registered
anti-retroviral medicines are effective and safe when they are appropriately
prescribed and monitored. ART significantly improves the quality and
length of life of men, women and children with AIDS. In South Africa this
has been convincingly demonstrated in managed health care programmes,
mainly in the private sector. It is estimated that 20 000 people are now
using ART in South Africa. Extending access to these life-saving
medications has become a moral, political, social and economic
imperative.
5.Further delays in standardizing anti-retroviral use in the midst of a
severe
AIDS epidemic will undermine public health. Absence of appropriate
standards is already leading to widespread inappropriate prescription and
misuse - mainly by medical practitioners operating without training outside
the framework of protocols and guidelines.
6.'Anti-retroviral drug anarchy' may become a danger as more people need
access to ART, prices come down, and untrained doctors prescribe the
medicines. This threatens patient health, public health and the efficacy of
the medicines themselves because of the possible development of resistant
strains of HIV. In some cases, current prices have resulted in the
prescription of sub-optimal drug combinations with the likelihood that this
will result in the emergence of drug resistance. In view of this,
participants
agreed on the need for:
a. respect for patients' rights to information and to fully- informed
consent before starting treatment;
b. comprehensive and urgent training of nurses, doctors and
community health care workers in ART in the public and private sector
throughout South Africa;
c. establishing networks for sharing experience between all health
care professionals;
d. clear and strictly maintained criteria for ART access;
e. standardized but flexible protocols about when to start therapy and
the optimum choice of initial treatment regimens;
f. a minimum of three drugs as the standard of ART care;
g. guidelines for anti-retroviral management of patients with HIV who
also have TB;
h. guidelines for anti-retroviral management of pregnant women;
i. health systems ensuring patient care and support, efficient delivery
of medicines, adherence monitoring and staff support; and
j. public information and education that creates a culture of openness
about HIV and AIDS and awareness that it can now be medically managed
with ART.
7. Adherence to treatment requires informed and motivated patients
together with an enabling clinical care environment. These conditions are
practical and feasible. Research and ongoing treatment access in a variety
of settings in South Africa have shown that people with HIV in poor and
disadvantaged areas can adhere successfully to treatment regimens and
thus can achieve treatment outcomes that are the same as in developed
countries.
8.The capacity and infrastructure to use anti-retrovirals safely and
effectively and to treat tens of thousands of people with AIDS already
exists
within the private health sector, parts of the public sector, and within
some
non-governmental organizations. These provide a foundation to devise and
implement a national treatment plan, while simultaneously identifying
needs and gaps in under-resourced sectors to promote equity.
9. Administration of anti-retroviral medications to reduce mother-to-child
transmission must be introduced country-wide.
10. Post-exposure anti-retroviral prophylaxis for sexual assault is a moral
necessity and an essential public health intervention.
11.Tuberculosis (TB) is the most common AIDS-related opportunistic
infection and cause of death amongst HIV patients in South Africa. ART
substantially reduces the risk of acquiring TB disease. Access to ART will
relieve the burden and cost of TB and other common AIDS-related
opportunistic infections on the public health system. New and recurring TB
cases will be reduced and prevented by ART and TB treatment.
12.Anti-retroviral medicine prices must be further reduced. Price reductions
should be across the board, and not limited to the public sector. Generic
competition of bio-equivalent medicines is essential in order to arrive at
the
lowest and most sustainable prices for essential medicines. This is
especially important if treatment is to be accessible to and sustainable by
all people in South Africa.
13.Price reductions for diagnostic tests and tests monitoring the efficacy
of
ART are a priority. The price of these tests contributes substantially to
ART costs and can result in inadequate clinical management.
14.However, even at current prices, HIV/AIDS medications could pay for
themselves through reduced hospitalization, prevention of opportunistic
infections, and improved quality of life and productivity of persons with
AIDS. This has been demonstrated worldwide, including developing
countries such as Brazil.
15.Most clinical research into ART in South Africa is currently driven and
funded by pharmaceutical companies. This needs to change to grant-driven
research that investigates issues such as:
* determining the most appropriate and well-tolerated combinations
of medicines taking into account the needs of women and children as well
as conditions that exist in developing countries such as South Africa;
* improved clinical algorithms or simple laboratory markers that can
replace some expensive current laboratory monitoring;
* long-term cohort studies investigating adverse drug events; and the
* interactions between TB and HIV therapies.
On the basis on the above points of consensus we state our belief that
advocacy for access to anti-retroviral treatment is an ethical duty for
health
professionals. In addition, expanded capacity to treat HIV is an immediate
imperative. Treatment literacy, support systems and de-stigmatizing
HIV/AIDS is a duty of community activists and institutions of civil society
such as trade unions, faith-based organizations, community organizations
and NGOs at every level. Ensuring expanded, equitable and sustainable
access to life-saving and prolonging medicines is a moral and legal
responsibility for government, business, international agencies and private
health-care funders.
Signed:
Individuals endorsing statement: Professor Quarraisha Abdool Karim,
Epidemiologist, Nelson Mandela School of Medicine, University of Natal,
Durban and past national Director of HIV/AIDS and STD Programme,
Department of Health; Mr. Zackie Achmat, Chairperson, TAC; Dr Steve
Andrews, GP with special interest in HIV; Mr. Ralph Berold, University of
Witwatersrand, HIV/AIDS Co-ordinator; Ms. Edna Bokaba, Registered
Nurse, HOSPERSA; Dr Brian Brink, Board of Health Care Funders; Justice
Edwin Cameron, Supreme Court of Appeal; Mr. Henri Carrara,
Epidemiologist; Professor Sharon Cassol, Molecular Virologist, Nelson
Mandela School of Medicine, University of Natal, Durban; Professor Salim
S. Abdool Karim, Epidemiologist and Head of Research, University of Natal
Durban; Dr. David Coetzee, Epidemiologist, Department of Community
Health, University of Cape Town; Dr. Karen Cohen, Clinician, University of
Cape Town; Dr. Francesca Conradie, Clinician, Wits HIV Clinical Research
Unit; Dr. Shaun Conway, Physician, International Association of
Physicians in AIDS Care; Professor Hoosen Coovadia, Head: HIV/AIDS
Research, Nelson Mandela School of Medicine University Natal Durban;
Ms. Sharon Ekambaram, AIDS Consortium; Professor Gerald Friedland,
Director AIDS Program, Yale School of Medicine; Dr. Eric Goemaere,
M�decins Sans Fronti�res, Head of Mission, South Africa; Professor Gary
Maartens, Senior HIV Physician, Groote Schuur Hospital; Rev. J.P. Heath,
Aids Co-ordinator, Anglican Church; Mr. Mark Heywood, Head of the AIDS
Law Project; Dr. Prudence Ive, Physician, HIV Clinical Trial Unit, Wits
Health Consortium; Ms. Jenifer Joni, Attorney AIDS Law Project; Ms. Anita
Kleinsmidt, Attorney AIDS Law Project; Ms. Mapule Khanye, Director,
AIDS Consortium; Mr. Teboho Kekana, TAC NEC Member; Ms. Nonkosi
Khumalo, TAC Executive Secretary; Mr. Stephen Laverack, HIV/AIDS
Education Awareness Consultant; Sister Tshidi Mahlonoko, Registered
Nurse; Ms. Thembeka Majali, TAC Co-ordinator; Sister Nondala Noziphiwo.
Registered Nurse; Ms. Tsakane Mangwane, Southern African Catholic
Bishops Conference HIV/AIDS Office; Dr. Nyameka Mankhayi,
Psychologist; Dr. Des Martin, Chairperson Southern African HIV Clinicians
Society; Mr Willie Madisha, President COSATU; Sister Zola Mathebula,
Registered Nurse; Professor James McIntyre, Chris Hani Baragwanath
Hospital; Ms. Tanya van Meelis, CEPPAWU Researcher; Ms. Anneke
Meerkotter, Researcher, Community Law Centre, University of Western
Cape; Dr. Tammy Meyers, Chris Hani Baragwanath Hospital; Dr. Clarence
Mini, NAPWA Board Member; Ms. Precious Modiba, Senior Researcher,
Centre for Health Policy; Mr. Tumi Modise, HIV Co-Ordinator, National
Council of Trade Unions; Ms. Teboho Motebele, Attorney AIDS Law
Project; Mr. Dan Mullins, HIV/AIDS Co-Ordinator OXFAM; Archbishop
Njongonkulu Ndungane; Dr. Lana Oatway, Ethembeni Clinic; Mr. Lew
Oatway, Ethembeni Clinic; Ms. Annie Parsons, SHARPP; Ms. Joyce
Pekane, Vice-President COSATU; Sister Penny Penhall, Registered
Nurse; Mr. Pholokgolo Ramothwala, TAC Co-ordinator; Dr. Leon
Regensberg, AID for AIDS; Sister Sue Roberts, Registered Nurse, Helen
Joseph Hospital; Dr. Ian Sanne, Specialist HIV/AIDS Physician, University
of Witwatersrand Health Consortium; Ms. Mercedes Sayagues, Advocacy
and Media Officer OXFAM; Ms. Judy Seidman, Graphic Artist; Mr. David
Shaproski, OXFAM; Mr. Christopher Shaw, Registered Nurse Saint Mary's
Hill Hospital; Dr John Sim, Virologist; Ms. Theo Steele, Campaigns Co-
ordinator Cosatu; Dr. Francois Venter, Johannesburg General Hospital
Infectious Diseases Clinic and Wits Health Consortium; Professor Robin
Wood, Senior HIV Specialist and Infectious Diseases Specialist, Somerset
Hospital; Mr. Zamokuhle Zwane, TAC Organiser.
Organizations endorsing statement: AIDS Law Project, AIDS Consortium,
Board of Healthcare Funders, Church of the Province of Southern Africa,
Congress of South African Trade Unions (Cosatu), Federation of Unions of
South Africa (Fedusa), HIV Clinicians Society, Hospersa, M�decins Sans
Fronti�res, National Council of Trade Unions (Nactu), Oxfam GB, Southern
African Catholic Bishops Conference, University of Witwatersrand Health
Consortium, Ethembeni Clinic.
We encourage you to endorse it. If you wis8h to endorse it, please
send an email to info@tac.org.za with your name, designation and
organisation in the body.
In the subject line, please write: endorse bredell
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