Tamar Kahn
13 March 2008
Cape Town — Treatment Action Campaign (TAC) lawyers yesterday asked the Cape High Court to instruct controversial vitamin entrepreneur Matthias Rath and his associates to stop promoting his products as alternatives to AIDS drugs.
The case goes to the heart of SA's legal framework for medicines, and has potentially wide-reaching implications for the growing complementary health products market.
"It (the case) has very important implications -- to protect public health and to protect people from unscrupulous money-makers," TAC chairman Zackie Achmat said.
TAC and the South African Medical Association (Sama), SA's biggest doctor organisation, have charged Rath with systematically contravening the Medicines Act by distributing unregistered medicines, conducting unauthorised clinical trials, and publishing "false and misleading" advertisements that claim vitamins and micro-nutrients reverse the course of AIDS.
They have also drawn the government into the case, claiming it failed to fulfil its duties to protect citizens from harm by not taking reasonable steps to investigate and halt Rath's allegedly unlawful activities.
The court was asked to issue a structured interdict compelling health department directorgeneral Thami Mseleku and the government to probe Rath's activities, stop him if he was indeed breaking the law, and report their findings to the court.
Rath's employees, David Rasnick and Alexandra Niedwiecki, the government, Mseleku, the chairman of the Medicines Control Council (MCC), the registrar of medicines and the MEC for health in Western Cape were cited as co-respondents.
TAC and Sama originally included Anthony Brink and his Treatment Information Group in the application, but the parties settled out of court last week.
TAC lawyer Geoff Budlender told the court that the Medicines Act defined a medicine as any substance that was used, claimed to be suitable for, or was manufactured and sold for diagnosing, treating, or preventing disease. The act required medicines to be registered with the MCC , prohibited the sale of certain medicines except by qualified people such as pharmacists, and made it illegal to make unauthorised claims about medicines.
All experiments intended to assess the safety and efficacy of medicines had to be registered with the council. The purpose of the act was to protect patients and prevent quackery, he told Judge Dumisani Zondi.
Rath's products were medicines, Budlender argued, because he had distributed them for treating AIDS. They were therefore subject to the act's provisions. He said Rath had breached the act by failing to register his products and had broken the law by failing to register his experiments on HIV-positive people living in Khayelitsha.
Rath's lawyer, Dumisa Ntsebeza, said his client had never claimed his products were medicines. "We are saying they are nutritional supplements. "
As for the issue of clinical trials, Rath donated vitamins to the South African National Civics Organisation for distribution, while participants in so-called trials were told they were getting vitamins, not medicines, and willingly took them. With Sapa
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