Treatment Action Campaign and Another v Rath and Others (12156/05) [2008] ZAWCHC 34; [2008] 4 All SA 360 (C) (13 June 2008)

Treatment Action Campaign and Another v Rath and Others (12156/05) [2008] ZAWCHC 34; [2008] 4 All SA 360 (C) (13 June 2008)

The court found that VitaCell, distributed by the Rath respondents, qualifies as a 'medicine' under the Medicines Act due to the medicinal claims made about its efficacy in treating AIDS. The supply of VitaCell to SANCO constitutes a sale under the Act, even if no consideration is received. However, VitaCell is not...

Source-derived case information.

Citation
[2008] ZAWCHC 34
Parties
Applicant: Treatment Action Campaign; Applicant: South African Medical Association; Respondent: Matthias Rath; Respondent: Dr Rath Health Foundation Africa; Respondent: Sam Mhlongo; Respondent: David Rasnick; Respondent: Alexandra Niewiecki; Respondent: Anthony Brink; Respondent: Treatment Information Group; Respondent: Government of the Republic of South Africa (Minister of Health); Respondent: Director General, Department of Health; Respondent: Chairperson, Medicines Control Council; Respondent: Registrar of Medicines; Respondent: Members of the Executive Council for Health, Western Cape Province
Court
Western Cape High Court, Cape Town
Jurisdiction
South Africa
Judgment Date
13 June 2008
Case Number
12156/05
Procedural Posture
Review Application / Final Judgment on Application for Declaratory and Interdictory Relief
Outcome
Application granted in part; declaratory and interdictory relief issued against the first, second, fourth, and fifth respondents; Minister of Health and Director-General ordered to take reasonable measures; costs apportioned.
Judges
Zondi
Legal Topics
Medicines and Related Substances Act, Clinical Trials Regulation, False Advertising, Ministerial Duties, Judicial Review, Public Health Policy
Administrative Law Civil Procedure Health Law Medicines and Related Substances Act Clinical Trials Regulation False Advertising Ministerial Duties Judicial Review +1 more

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Summary, issues, holding and outcome

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Parties

Treatment Action Campaign

Applicant

South African Medical Association

Applicant

Matthias Rath

Respondent

Dr Rath Health Foundation Africa

Respondent

Sam Mhlongo

Respondent

David Rasnick

Respondent

Alexandra Niewiecki

Respondent

Anthony Brink

Respondent

Treatment Information Group

Respondent

Government of the Republic of South Africa (Minister of Health)

Respondent

Director General, Department of Health

Respondent

Chairperson, Medicines Control Council

Respondent

Registrar of Medicines

Respondent

Members of the Executive Council for Health, Western Cape Province

Respondent

Procedural Posture

Review Application / Final Judgment on Application for Declaratory and Interdictory Relief

Legal Issues

  1. 1 Whether the Rath respondents distributed medicines in contravention of the Medicines Act.
  2. 2 Whether the Rath respondents conducted unauthorised clinical trials in contravention of the Medicines Act.
  3. 3 Whether the Rath respondents published unauthorised, false and misleading advertisements concerning vitamins, multivitamins, and certain products.

Ratio Decidendi

The court found that VitaCell, distributed by the Rath respondents, qualifies as a 'medicine' under the Medicines Act due to the medicinal claims made about its efficacy in treating AIDS. The supply of VitaCell to SANCO constitutes a sale under the Act, even if no consideration is received. However, VitaCell is not subject to mandatory registration as a medicine under the 2002 call-up notice, which only initiates a process for potential registration. The Rath respondents conducted clinical trials without authorisation, which is unlawful under the Medicines Act and its regulations. The advertisements published by the Rath respondents regarding the efficacy of VitaCell are unlawful pending...

Court Disposition

Application granted in part; declaratory and interdictory relief issued against the first, second, fourth, and fifth respondents; Minister of Health and Director-General ordered to take reasonable measures; costs apportioned.

Orders

  • It is declared that the clinical trials conducted in South Africa by and/or under the direction of the first, second, fourth and fifth respondents are unlawful.
  • The first, second, fourth and fifth respondents are interdicted from conducting unauthorised clinical trials in South Africa.