The Micronutrient Programme

  1. Continuing their strategy of false and deceptive allegations, the Applicants proceed to also attack the micronutrient programme and its composition of micronutrients.
  2. One of these attacks is to allege that the vitamins and micronutrients donated by the Dr Rath Foundation to SANCO are ‘unregistered medicines’.
  3. Most significantly, however, nowhere in this entire Application do the Applicants disclose that “Vitacell” was declared by the Department of Health on 18 March 2004 to be a ‘food supplement for distribution and importation into South Africa, in terms of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972’. This product is at the centre of this Application.
  4. In the same way, nowhere have the Applicants ever disclosed –again not even in this Application – that the label of every single bottle of Vitacell donated to SANCO explicitly states that ‘ this product has been approved by the South African Department of Health as a food supplement according to Act 54 of 1972’ (a fact that would have been abundantly apparent to the Honourable Court had the Applicants included a legible picture of the label of the Vitacell product).
  5. Related to the above is the fact that the Applicants have nowhere informed the public or the Honourable Court that each of the products mentioned in their Notice of Motion, far from being illegal drugs, are freely available in the USA, Europe and elsewhere as nutritional supplements or food supplements and that they are not classed as ‘medicines’ in any country, despite numerous (unsuccessful) attempts by pharmaceutical interest groups to have them so classified.
  6. Nor did the Applicants inform the Court that all the vitamin and micronutrient products mentioned in the Application are freely available everywhere as is attested to by Dr Christoph Kleiner , the Foundation’s attorney in Europe . Dr. Kleiner has represented me and the Foundation in numerous attempts by the pharmaceutical industry and associated stakeholders having made similar efforts as the Applicants in South Africa . All these efforts elsewhere were in vain. Dr. Kleiner ’s statement is annexed hereto.
  7. In an effort to distort the truth in this context, the Applicants underwent great efforts to document a case in the Court of Berlin, where in 2003 stakeholders of the pharmaceutical industry tried to seek a court decision to have our vitamins categorized as drugs. While the court found a minor mistake - namely that some of our research findings were not allowed to be used in conjunction with the vitamin products and issued a fine – in the very same case our vitamin products were explicitly defined as nutritional supplements and all allegations of violating any pharmaceutical laws were entirely dismissed.
  8. It is characteristic for the deceptive conduct of the Applicants in this litigation that they present the Honourable Court with half truths. They present only the information supporting their allegations while omitting even the most critical evidence, such as the fact, that in the Berlin case all our vitamin products were explicitly defined as nutritional supplements, a fact – if presented by the Applicants – that would have contradicted their own allegations.
  9. For the record, and as mentioned at the beginning of this affidavit, this ruling of the Berlin Court was recently affirmed by the Court in Hamburg, Germany.
  10. In their effort to achieve their goal of banning our vitamin formulas in South Africa , the Applicants are trying to interpret the presence of the amino acid N-acetylcysteine (NAC) in “Vitacell” as the reason why this product should be qualified as a drug. The following facts are irelevant in this context:
    1. NAC is in fact nothing other than a bio-available form of cysteine, a natural amino acid found abundantly in any protein rich food,
    2. moreover, NAC has been shown in several studies to provide strong nutritional support for the higher needs of HIV/AIDS patients,
    3. in a specific study already quoted above, this important nutritional supplement was shown to greatly benefit patients suffering from HIV / AIDS ( Annexure ‘Eur J Clin Invest 2000’ ) with the following significant findings:
      1. The study established that: “NAC treatment for 88 weeks safely replenishes whole blood GSH [the natural antioxidant Glutathione] and T cell GSH in HIV infected individuals. Thus NAC offers useful adjunct therapy to increase protection against oxidative stress, improve immune system function and increase detoxification of acetaminophen and other drugs.”
      2. While the Applicants try to portray the NAC supplement as an allegedly “dangerous drug”, the researchers of this international study from the USA , Japan and India unanimously concluded: “We found no adverse consequences of NAC ingestion at high doses even for relatively long periods (larger than 5 grams per day for 14 to 24 weeks).”
      3. It should be noted that 5 grams of NAC is an amount of NAC equalling more than 330 times the amount of NAC in one tablet of the vitamin formula “Vitacell.”
    4. NAC is being freely sold as a “nutritional supplement” in health food stores in South Africa and abroad.
    5. From a legal point of view, it is a significant fact that the “Department of Health of South Africa has explicitly approved the “Vitacell” product – which specifically includes NAC – as a “Food Supplement for distribution and importation in South Africa in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No54 of 1972)”.
    6. Moreover, in their affidavits the Respondents eight to twelve confirm NAC as part of our vitamin programme to be in compliance with the laws of South Africa.
  11. In summary, the allegations made by the Applicants that the contents of the nutritional supplement “NAC” would render the vitamin programme donated by the Dr. Rath Foundation to the community organizations in South Africa, a “prescription medicine” or drug are neither scientifically nor legally valid.
  12. It is inconceivable and particularly troublesome for me as a medical doctor that the “TAC” as well as the “South African Medical Association” – both organizations bound by their respective constitutions to serve the health of their people in South Africa – decide to deliberately ignore important international studies proving the health benefits of the nutritional supplement NAC particularly in HIV and AIDS patients. Moreover, they decided to launch a legal attack on it for one reason only: the nutritional supplement NAC challenges the key merchandise promoted by the Applicants – pharmaceutical drugs, namely ARVs.
  13. In summary, from a scientific point of view, much of the Applicants’ attack is premised upon showing micronutrient approaches to fight immune deficiency conditions as not being supported by “scientific consensus.” Fact is, however, that there is abundant “scientific consensus” documented in every textbook of biology that vitamins are essential for optimum immune function. Moreover these scientific facts do not change when some lobby groups challenge these facts.
  14. From a legal point of view, for lack of any legal rationale to stop the implementation of this micronutrient community programme, the Applicants are constructing their case around the following argument:
    1. First, they try to challenge the approval by the “Department of Health” of the Dr Rath Foundation’s micronutrient programme which was officially categorized as a “food supplement” according to the “ Foodstuffs” Act of 1972.
    2. Second, they try to outlaw the very same approved micronutrient programme by seeking refuge under another law, the so-called “Medicines and Related Substances” Act of 1965
  15. With this strategy the Applicants seek to prevent the implementation of this effective, safe and affordable community health programme in communities across South Africa , which are in desperate need for such effective and affordable public health solutions.