Treatment Action Campaign, et al. v. Rath, et al.

The applicants, T and S, applied for relief against the 12 respondents in relation to certain vitamin-based pharmaceutical products (“Products”) which T and S alleged were being unlawfully distributed and marketed in South Africa as a treatment for AIDS while the distributors discredited legitimate antiretroviral medicines. T and S produced expert testimony that antiretroviral medicines were effective at treating and reversing the course of AIDS, but there was no scientific evidence to suggest that vitamins were similarly effective.

T and S alleged that the first seven respondents (“Rath respondents”) had: (1) unlawfully distributed the products, which were medicines in contravention of the Medicines and Related Substances Act 101 of 1965 (“Medicines Act”); (2) conducted unauthorized clinical trials of the products in contravention of the Medicines Act; and (3) published unauthorized, false, and misleading advertisements concerning the products in contravention of the Medicines Act.

With respect to two of the respondents (“Government respondents”), T and S alleged that the Government respondents had a duty to take reasonable measures to prevent the Rath respondents from the unlawful actions referred to above and had breached that duty.

The Rath respondents argued that the products were not medicines for the purposes of the Medicines Act and were not subject to registration under the Medicines Act, and denied that the products had been sold in South Africa.

The Government respondents argued that no unlawful conduct had occurred giving rise to a duty or, if any such unlawful conduct had occurred, reasonable measures had been taken to discharge that duty.

[Adapted from INTERIGHTS summary, with permission]

Findings in favor of the applicants, the Court held that the products were medicines for the purposes of the Medicines Act. One of the products, VitaCell, had been and was still being donated by certain of the Rath respondents to the South African National Civic Organisation, which constituted a sale for the purposes of the Medicines Act, notwithstanding that no money had been paid. The court accepted the Rath respondents’ contention that the distribution of the products other than VitaCell (Vitacor Plus, Epican Forte and Lysin C Drink mix) had ceased a considerable time prior to the issuing of the applications.

The Court further held that VitaCell was not subject to registration under the Medicines Act as the purpose of Government Notice R 204 issued in 2002 (to which VitaCell was subject) was to allow the Medicines Control Council (‘the MCC’) to determine whether medicines are registerable, and their scheduled status under the Medicines Act. Accordingly, the donation of VitaCell did not contravene the prohibition in section 19 of the Medicines Act prohibiting the sale of registrable medicines which had not been registered.

In addition, the Court held that the Rath respondents had been carrying out clinical trials of the products, as demonstrated by their repeated statements in the advertising publications. The clinical trials were unlawful as no authorization had been obtained from the MCC.

In view of the purpose of Government Notice R 204 referred to above, it was inappropriate for the Rath respondents to make any claims concerning the effectiveness of VitaCell, pending a determination by the MCC of the safety, quality and effectiveness of VitaCell.

The Court held that there had been no breach of section 20 of the Medicines Act with regard to the statements concerning the effects of the products in the advertising literature because there was no consensus among the expert evidence as to what were the effects of vitamins and micronutrients in reversing the course of AIDS.

Regarding the Government respondents, the Court held they were subject to a duty under the National Health Act 61 of 2003 to take reasonable measures to ensure that the provisions of the Medicines Act are enforced. The investigation into the allegations of unlawful clinical trials made by T and S had not been sufficient to discharge this duty. However, as VitaCell was not subject to registration due to the terms of Government Notice R 204, there had been no violation of s 22A(5) of the Medicines Act which gave rise to a duty on the Government respondents to investigate.

The court granted an order declaring that the clinical trials of the products were unlawful and that the Government respondents were under a duty to take reasonable measures to prevent the first, second, fourth and fifth respondents from conducting unauthorized clinical trials in South Africa, and from publishing advertisements concerning the effectiveness of VitaCell, pending determination by the MCC. The court ordered the Government respondents to take reasonable measures to investigate these activities and take the appropriate action in accordance with their duty.

[Adapted from INTERIGHTS summary, with permission]

"There is no doubt in my mind that the activity of the Rath respondents, though they prefer to characterise it as a clinical pilot study, was an investigation in respect of micronutrients for use in human beings with AIDS and was intended to discover or verify the clinical effects of the micronutrients. It seems to me they were carrying out a clinical trial. Although they deny that they conducted clinical trials, that denial, in my view, is, however, entirely inconsistent with their own repeated statements none of which they denied having made. It appears to be an attempt to escape liability for their widely proclaimed conduct now that its legality is being challenged. In my view, the Rath respondents’ activity, (conducting a clinical pilot study) viewed subjectively constituted a clinical trial as defined in the Regulation. Their conduct was unlawful in that they did  not have a permission to run clinical trials." Para. 75.

"It is clear from the provisions of the National Health Act that the eighth respondent primarily is under a duty to take reasonable measures to ensure that the provisions of the Medicines Act, which she administers, are enforced in order to protect, promote, improve and maintain the health of the population of the country. The ninth respondent assists the eighth respondent in carrying out her primary responsibilities under the National Health Act by ensuring that the provisions of the Medicines Act are enforced. I therefore find that the eighth and the ninth respondents are under a duty to take reasonable measures to prevent the first to fifth respondents from conducting unauthorised clinical trials and to prevent the first to seventh respondents from publishing advertisements concerning medicinal effects of VitaCell on people with AIDS pending the submission of VitaCell to the MCC to review its medicinal claims." Para. 88.