TREATMENT ACTION CAMPAIGN v MINISTER OF HEALTH

ADDITIONAL INFORMATION

• Timeline of Case
• International Treaties
• Legal System of South Africa
• Studies on AZT and Nevirapine
• Plaintiffs / Respondents’ Court Documents
• Defendants / Appellants’ Court Documents

TIMELINE OF CASE

International Treaties

Universal Declaration of Human Rights

The Universal Declaration of Human Rights was adopted and proclaimed by the United Nations on December 10, 1948.  While it is not a legally binding document, it has become part of customary international law because countries generally treat it as being such.  The Declaration includes thirty articles that enumerate rights such as the right to life, liberty and security of the person, the right to an education, and the right to be free from torture.

International Covenant on Civil and Political Rights

The International Covenant on Civil and Political Rights (CCPR) came into being on December 16, 1966.  It was founded on the Universal Declaration of Human Rights, which was split into two documents in order to encourage more signatories.  The CCPR is a legally binding document once it has been ratified by individual countries.  It contains 53 articles guaranteeing certain civil and political rights such as the right to life, the right to be free from torture and slavery, the right to be presumed innocent, and the right to vote in free elections.  A total of 152 states have ratified the CCPR including Canada, The United States, and South Africa.  The Human Rights Committee of the UN monitors compliance with this treaty.

The CCPR also contains two optional protocols.  The first optional protocol allows individuals from states who have ratified this protocol to submit complaints to the Human Rights Committee.  States who have accepted the authority of this committee to hear these matters are bound by their decisions.  There are 104 state parties to the first optional protocol including Canada and South Africa.  The second optional protocol abolishes the death penalty.  There are 50 state parties to the second optional protocol including South Africa.

International Covenant on Economic, Social, and Cultural Rights

The International Covenant on Economic, Social, and Cultural Rights (CESCR) came into being on December 16, 1966, at the same time as the International Covenant in Civil and Political Rights.  It was founded on the Universal Declaration of Human Rights, which was split into two documents in order to encourage more signatories.  The CESCR is a legally binding document once it is ratified by individual countries.  It contains 31 articles guaranteeing certain economic, social, and cultural rights such as the right to health, education, special protection of mothers, and enjoyment of the benefits of scientific progress.  A total of 149 have ratified the CESCR including Canada.  The United States and South Africa have signed the CESCR but have not ratified it.  The Committee on Economic, Social and Cultural Rights monitors compliance with this treaty.

Convention on the Elimination of All Forms of Discrimination against Women

The Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) came into being on September 3, 1981.  CEDAW is a legally binding document to those countries that have ratified it.  CEDAW contains 30 articles that guarantee women such things as the right to vote, the right to paid maternity leave, the right to equality before the law, and the right to health particularly during and after pregnancy.  A total of 177 countries have ratified the CEDAW including Canada and South Africa.  The United States is the only developed country not to have ratified CEDAW.  The Committee on the Elimination of Discrimination against Women monitors compliance with this treaty.

On December 10, 1999 the UN opened an optional protocol for CEDAW for signatures.  This protocol allows individuals or groups from states that have ratified the protocol to submit communications of violations of women’s rights directly to the Committee on the Elimination of Discrimination against Women.  The Committee then can make recommendations to the state and request a response from the state and, if necessary, ask for follow-up information from the state at a later period.  A total of 60 countries have ratified this protocol including Canada.  Neither the United States nor South Africa has ratified this protocol.

Convention on the Rights of the Child

The Convention on the Rights of the Child (CRC) came into being on November 20, 1989.  The CRC is a legally binding document for those countries that have ratified it.  The CRC contains 3 sections.  The first section contains 41 articles containing such rights as the right to life, health and education for children.  Children are generally defined by the CRC as people under the age of 18.  The second and third sections of the CRC deal with compliance, signatures, ratification and other administrative issues.  A total of 192 countries have ratified the CRC including Canada and South Africa, though Canada has made some reservations concerning the CRC.  The United States has signed but not ratified the CRC.  The CRC is monitored by the Committee on the Rights of the Child.

The CRC also contains two optional protocols.  The first optional protocol concerns the involvement of children in war.  A total of 107 states have ratified this protocol including United States and Canada.  South Africa has not ratified this protocol.  The second optional protocol concerns the sale of children, child pornography and child prostitution.  A total of 107 states have ratified this protocol including the United States, Canada and South Africa.

African Charter on Human and Peoples’ Rights

The African Charter on Human and Peoples’ Rights entered into force on October 21 1986.  It was enacted by the Organization of African Unity, which later became the African Union (AU).  It has been ratified by every member state of the AU.  The oversight of the Charter is done by the African Commission on Human and Peoples’ Rights, which was set up in 1987.  The Commission originally had the responsibility of hearing complaints of violations of the Charter, but could not make binding decisions.  In 1998 a protocol was adopted that called for the creation of the African Court on Human and Peoples’ Rights.4  The African Court on Human and Peoples’ Right was to be established in 2004.  Before it was established the African Union decided it would be amalgamated with the African Union Court of Justice.  In 2005 the AU decided that the African Court on Human and Peoples’ Rights should be established despite the fact that the Court of Justice was not yet operational.  On January 22, 2006 the Executive Council of the AU elected 11 judges to sit on the African Court on Human and Peoples’ Rights.  The court will be able to make binding decisions on matters of human rights violations by states who have accepted the court’s jurisdiction.  At present 23 states, including South Africa, have ratified the optional protocol accepting the jurisdiction of the court.  The court will be able to consider not only the African Charter on Human and Peoples’ Rights but also any other international treaty dealing with human rights that the state has ratified.  The court will also grant standing to non-governmental organizations and individuals.5

The Charter contains three sections.  The first section is on individual rights and duties.  The chapter on rights contains 26 articles guaranteeing rights such as the right to life, liberty and security of the person, the right to equality before the law, and the right to health.  The second chapter on duties contains three articles on duties that individuals owe to others and to their state including the duty to respect others, to pay taxes, and to promote African unity.  The second part of the Charter deals with the safeguarding of these rights and duties by the establishment of the African Commission on Human and Peoples’ Rights.  This part also deals with the mandate of the Commission and its procedure.  The third part deals with the Charter itself and when and how it is ratified and altered.

In 2005 a protocol to the Charter on the rights of women entered into force. This protocol contains guarantees of equality rights, political rights, economic rights, as well as a section devoted entirely to sexual health and reproductive rights.  Article 14 guarantees women the right to control their fertility, to choose any method of contraception, and to receive proper pre-natal, delivery and post-natal health services, among others.  At present 18 countries, including South Africa, have ratified this protocol.

For More Information:

A handbook for advocacy in the African human rights system: Advancing reproductive and sexual health. Second edition: Ipas

http://www.ipas.org/english/publications/international_health_policies.asp

Center for Reproductive Rights, “Bringing Rights to Bear: An Advocate's Guide to the Work of UN Treaty Monitoring Bodies on Reproductive and Sexual Rights” (2002)

http://www.crlp.org/pdf/pub_bp_brb.pdf

The substantive law of South Africa is based on Roman-Dutch law.  When the English defeated the Dutch settlers in 1806 the English did not impose their laws on the people of (now) South Africa and left intact the substantive law.  The procedural law of South Africa, however, is largely based on the English system with adversarial trials and a hierarchy of courts.  South Africa also operates under the principle of Stare Decisis which means that the decisions of higher courts bind the decisions of lower courts.  Other sources of law in South Africa are statute, custom, the South African constitution, and international laws and treaties.

South Africa’s judiciary is composed of the Constitutional Court, the Supreme Court of Appeal, thirteen High Courts, and many Magistrate Courts.  Magistrate Courts hear local matters dealing with minor criminal offences or small civil disputes.  High Courts can hear appeals from the Magistrate courts and serious criminal offences.  They also are the court of first instance for large civil disputes.  The Supreme Court of Appeal is the highest court for all cases except constitutional cases and can hear appeals from all of the High Courts.  On Constitutional matters the Constitutional Court is the highest court.  It is composed of 11 judges and deals exclusively with Constitutional issues.  An appeal can go to the Constitutional Court either straight from one of the High Courts or from the Supreme Court of Appeal.  As in Canada, the appeal courts deal with questions of law and do not generally revisit questions of fact but instead rely on the findings of the trial court.

Civil Procedure

The rules of civil procedure for the High Courts are contained within the High Court Rules of Court.  Proceedings can be launched in the High Courts in one of two ways: proceedings by way of actions and proceedings by way of application.  In a proceedings by way of action evidence is given to the court orally by sworn witnesses.  In a proceedings by way of application evidence is given to the court by written affidavits.

Application proceedings are prescribed by law in certain circumstances, are not permissible in others, and can be elected by the applicant in others.  If the applicant has the choice to proceed by application or by action the applicant must consider whether there is a dispute of fact that cannot be resolved by written submissions alone.  If the court finds that there is a dispute of fact that can only be settled by oral argument the court has three options.  The court can dismiss the application if the applicant should have known it could not proceed by written evidence alone.  It can order a trial if the applicant could not have known a dispute of fact would arise that required oral arguments.  Finally the court can hear oral evidence on a specified issue if the question of fact is narrow.

To begin an action by way of application a notice of motion must be filed with the court along with a founding affidavit.  These set out the facts relied on by the applicant.  The respondent must then file a replying affidavit with her or his version of the facts.  The applicant can file other affidavits in response if appropriate.  Applicants must submit to the court all relevant facts in their possession, even if they are unfavourable to their case.

To begin an action by way of action the plaintiff must serve a summons to initiate proceedings.  After the summons both parties must submit pleadings to the court outlining the dispute between them.  Following this is the discovery phase where the parties exchange evidence, examine the other party’s witnesses and attempt to settle the dispute or narrow issues at a pre-trial.  At the trial the oral evidence is given and the parties can address the court.

After all the evidence is given to the judge in either the application or the action the judge renders her or his verdict and awards costs.  If a party is not satisfied with the judgement they can appeal to a higher court, however, no civil appeal is guaranteed by law.

The Constitution

The South African Constitution Act took effect on February 4 1997.  The South African Constitution is similar to the Canadian Constitution.  It creates a federalist state with the provinces having exclusive jurisdiction over provincial roads and traffic, cultural matters, liquor licenses and other minor areas of purely local concern.  The provinces are able legislate on other matters such as health care, housing, education and the environment, but the federal government can override provincial legislation.  The Constitution also provides for the separation of powers into a legislative, and executive and a judiciary branch.

The South African Constitution also contains a Bill of Rights.  The Bill of Rights contains both negative rights, such as the right not to be subjected to slavery, and positive rights, such as the right to healthcare.  Section 36 of the Constitution allows for limitations on individual rights if they are “reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom.”  Section 37 allows certain rights to be violated in cases of emergency. 

For More Information:

Van der Merwe, C. G. (2004). Introduction to the Law of South Africa. The Hague, Netherlands : Kluwer Law International.

AZT AND NEVIRAPINE

Both AZT and nevirapine are drugs used for antiretroviral therapy in the treatment of HIV.  AZT was the first drug approved of for treatment of HIV.  AZT is also known as zidovudine, azidothymidine, or ZDV.  It works by preventing the virus from converting its own genetic material (RNA) to the DNA of the cell it has infected.  If the virus cannot convert the DNA of the cell it cannot replicate and therefore the progression of the virus is slowed.6  The Thai / Bangkok Study found that AZT can be used to help reduce Mother-to-Child Transmission (MTCT) of HIV.  To reduce MTCT  AZT must be administered starting at least at 36 weeks of pregnancy, as well as given during labour.  Some courses of treatment also call for the infant to be given AZT for six weeks after birth.  This cost of treatment ranges from about $50 to $1,000 per pregnancy.7 GlaxoSmithKline originally held the patent for AZT but that expired in 2005 so generic versions of the drug can now be manufactured.

Nevirapine, which is also known under the trade name Viramune®, reduces the production of enzymes called reverse transciptase.  The HIV virus uses these enzymes to make more of the virus.  Therefore, by lowering the activity of these enzymes the progression of the virus is slowed.8  The HIVNET 012 study and the later South African Intra-partum Nevirapine Trial (SAINT) have shown that nevirapine can also be used to prevent MTCT with even better results.  To help prevent MTCT a single dose of nevirapine is given to the mother during labour and the child following birth.  The cost of this treatment is about $4 per pregnancy. Nevirapine is currently under patent by Boehringer Ingelheim.

HIVNET 012

HIVNET 012 is a study that took place over 18 weeks in Kampala Uganda which demonstrated that a short course of nevirapine given to mother and child during and shortly after labour is effective in reducing Mother-to-Child Transmission (MTCT) of HIV.  The results of the preliminary study were released in July 1999 with a five year follow-up completed in 2004.  In the study 642 HIV positive women were randomly selected for the trial.  About half the women received a single oral dose of nevirapine at the onset of labour and a single oral dose of nevirapine was given to the infant at 24-72 hours old.  The other half of the women were given an oral dose of AZT every three hours from the onset of labour to delivery.  The infant was given AZT twice a day for seven days.  Nearly all the children were breast fed until at least 16 weeks.  By week 16 the estimated risk of MTCT of HIV was 25.1% for AZT and 13.1% for nevirapine.  Side effects were few, mild and similar between the two test groups.

The results of the HIVNET 012 study have been called into question due to the perception by some of the lack of scientific rigour and deficiencies in quality control 9.  The study was not meant to serve as a backbone for the approval of nevirapine for the prevention of MTCT by health organizations but its results were so striking that is what it became.  However, many other independent trials have validated the results of HIVNET 012 and the WHO continues to support its findings 10.

For More Information:

HIV Prevention Trials Network, HIVNET 012, http://www.hptn.org/research_studies/hivnet012.asp

THAI / BANGKOK STUDY

The phase three randomised placebo-controlled trial to evaluate the safety and efficacy of short course oral antenatal zidovudine to reduce prenatal HIV transmission, Bangkok, Thailand (Thai / Bangkok study) was a randomized, double-blind, placebo controlled study that found that a shorter course of AZT was sufficient to help prevent Mother-to-Child Transmission (MTCT) of HIV.  From May 1996 to December 1997, 397 HIV positive women participated in the study.  99% of the women attend all weekly antenatal visits and 90% of the expected labour doses were given. Half the women received AZT and have the women received a placebo.  The drugs were taken twice a day from approximately 36 weeks of gestation to labour and then every three hours during labour.  The mothers were asked not to breastfeed and were given formula.  The results of the study were about a 50% drop in the risk of transmission when the short course of AZT was administered opposed to the placebo group. The 50% drop in the risk of transmission is less than the 66% drop found in studies on long course treatments of AZT.  This could be because the course of treatment was shorter (approximately 3.5 weeks instead of 11 weeks), the drug was given twice a day instead of 5 times a day, the drug was given orally instead of intravenously, the infants were not given the drug after birth, or because of different populations or other variations.  The cost of this treatment is $50 as opposed to about $800 for long course treatments.  The lower cost and the fact that it can be started later into pregnancy and requires less follow up makes it a good alternative to long course AZT treatment for the reduction of MTCT of HIV in developing countries where the long course treatment is not feasible.

For More Information:

Shafer, Dr. Nathan, et al. Short-Course Zidovudine for Perinatal HIV-Transmission in Bangkok, Thailand: a Randomised Controlled Trial.THE LANCET,353(9155), 773-780 (1999).  Available Online: http://www.sciencedirect.com

SOUTH AFRICAN INTRA-PARTUM NEVIRAPINE TRIAL (SAINT)

The South African Intra-partum Nevirapine Trial (SAINT) was a randomized, open-label study in 11 public hospitals between May 1999 and February 2000.  Half of the 1317 women who participated in the study were given short course AZT and half given nevirapine. The women given nevirapine were given one dose during labour, one 24-72 hours after delivery.  The infant was given one dose after birth.  Women were advised on feeding practices but not specifically asked not to breast feed.  Approximately 42% of the infants in both groups were breastfed.  Estimated infection rates were 12.3% in the nevirapine group and 9.3% for the AZT group.

For More Information:

Moodley, Dhayendre, et al., A Multicenter Randomized Controlled Trial of Nevirapine Versus a Combination of Zidovudine and Lamivudine to Reduce Intrapartum and Early Postpartum Mother-to-Child Transmission of Human Immunodeficiency Virus Type 1. JOURNAL OF INFECTIOUS DISEASES, 187, 725-735 (2003).  Available Online: http://www.journals.uchicago.edu

High Court Case Documents

• TAC Heads of Argument (Facta)
• Notice of Motion
• Affidavit of Second Applicant: Haroon Saloojee (Save Our Babies)
• Affidavit of Second Applicant: Cati Vawda (Children's Rights Centre)
• Affidavit on Epidemiology by Quarraisha Abdool Karim
• Affidavit on Medical Science by Robin Wood
• Affidavit on Economics by Nicoli Nattrass
• Affidavit on Price of nevirapine by Chloe Hardy
• Personal Affidavit by Bongiwe Mkhutyukelwa
• Personal Affidavit by Busisiwe Maqungo
• Personal Affidavit by SH
• Personal Affidavit by  Tshidi Mahlonoko
• Personal Affidavit by Vivienne Matebula
• TAC's Replying Affidavit by Siphokazi Mthathi
• Robin Wood replying affidavit on nevirapine
• Helen Schneider affidavit responding to the state's defence of operational complexity
• Hermann Reuter affidavit responding to Nono Simelela's allegations about the Khayelitsha mtct programme
• Prof N Nattrass affidavit replying to the affidavit of Dr Ntsaluba
• Allan Colm affidavit with regards to the Eastern Cape Health Department's work on combatting HIV/AIDS, and the resources available to it
• Prof Cooper affidavit in reply to Dr Ntsaluba
• Quarraisha Abdool Karim reply to Makubalo

Execution of Judgment Documents

• TAC's Heads of Argument on Appeal
• Notice of application for leave to execute MTCT court case judgment
• Tac's Execution Affidavit by Siphokazi Mthathi

Constitutional Court Documents

• Heads of Argument by CLC & IDASA
• Heads of Argument by Cotlands Baby Sanctuary
• Heads of Argument by TAC – Part One: The Facts
• Heads of Argument by TAC – Part Two: The Law

 Contempt of Court Documents

• Notice of Motion
• Founding Affidavit
• Affidavit by Nurse Stella Dubazana, of Cotlands Hospice (Not included in final court papers because it was considered new evidence)

Note: Most of these documents were supplied by the Treatment Action Campaign and are available on their website at http://www.tac.org.za

• Heads of Argument (Facta) on Appeal
• State Paper - Jonathan Bernhard Levin – Supplied by TAC
• State Paper - Philip Chukwuka Onyebujoh - Supplied by TAC

Note: Every effort was made to locate additional court documents so that a balanced and full description of the case could be given, however, attempts to gather documents from the defendants / appellants met with limited success.

Back to Introduction

1 O’Connor, EM, et al, Reduction of Maternal Infant Transmission of Human Immuno
Deficiency Virus Type 1 with Zidovudine Treatment, NEW ENGLAND JOURNAL OF MEDICINE 331 (1994).

2 Mark Heywood,  Preventing Mother-to-Child HIV Transmission in South Africa: Background, Strategies and Outcomes of the Treatment Action Campaign Case against The Minister of Health, SAJHR 19 (2003) at 286.

3 Parts of this letter are contained in the founding affidavit.

4 http://www.africa-union.org/root/au/Documents/Treaties/Text/africancourt-humanrights.pdf

5 http://www.pict-pcti.org/courts/ACHPR.html

6 Canadian AIDS Treatment Information Exchange, AZT (zidovudine Retrovir) Fact Sheet www.catie.ca (May 31, 2006).

7 Canadian HIV/AIDS Information Centre, AIDS: Mother-to-Child Transmission, http://www.aidssida.cpha.ca/ (May 31, 2006).

8 Canadian AIDS Treatment Information Exchange, Nevirapine (Viramune) Fact Sheet, www.catie.ca (May 31, 2006).

9 http://www.usatoday.com/news/washington/2005-01-04-nih-aids_x.htm

10 http://www.who.int/hiv/pub/mtct/en/NevirapineStatement072003.pdf

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