(paragraphs 1-28)

(Revised & expanded version incorporating)



(paragraphs 29-56)


It is PHARMAPACT's considered analytical opinion that the proposed "listings system" for "natural health substances", as proposed by the MCC and supported by financially and power-play vested interests is ill-considered and illegal. We set out hereunder our main reasons, minus the political details dealt with in our Oct. 97 and Jan. 98 updates of developments subsequent to the farcical 1 Nov. 1996 meeting called by the Director-General of Health in Pretoria and titled "Natural Health Substances & The Enforcement of Act101 Of 1965".

Neither the above-mentioned meeting, where a non-democratic, pre-hatched decision was made by said interests to reconstitute the previously defunct Complementary Medicines Committee of the MCC, nor the equally crucial 15 Nov. 1996 call for nominations to the CMC, nor any of the subsequent inappropriately labelled Broad-Based Reference Group meetings were by public notice, as one would expect for the proper institution of such a radical departure from the status quo. Participation rather was by selective invitation, primarily to "interested parties" sympathetic to the MCC's call for over-regulation, in service of their own self-enrichment/empowerment, with no regard for the vast majority of role-players conveniently left out of crucial deliberations destined to severely prejudice their market survival, not to mention the erosion of the consumer's right of access to products of their choice.

PHARMAPACT's 16 Jan. 1996 letter tabled at the 17 Jan. MCC meeting and protesting the blatant vested interests of the CMC membership and calling for the non-ratification of said Committee, remains unattended to more than two years later, in spite of Constitutional Sections 32 & 33 appeals for access to information and just administrative action. Significantly the recent Amendments to the Act make specific provision (Sect. 6, subsect. 4) for a member of a MCC committee to have to declare their commercial interests related to the pharmaceutical or health care industry and to recuse themselves from discussion or decision-making to which said interests may relate, and so vindicating our concerns, to no avail, but we believe rendering the entire farce liable for legal review in terms of Sect. 33, subsect. 3, (a) of the Constitution, applicable also to the highly questionable circumstances which follow.

Also still outstanding almost a year later is a reply to our 25 Mar.1997 letter to the MCC requesting sight of written confirmation that the Minister has, in terms of Section 9 of Act 101 / 65, approved the appointment of said Committee, and in terms of such appointment, what precisely the mandate and constraints of said Committee are, and iro. which denial of our Constitutional rights, we once again invoked said rights by way of a 23 Oct. 1997 letter of protest, but to no avail, and hence a continued illegal infringement of our Constitutional rights of access to information and just administration, and thereby further compounding liability. Similar problems pertain to representations to the D-G, with which we will take issue should she not take our protests seriously enough to revoke her Office's support for the listings system. Dr. Shisana has however acknowledged PHARMAPACT's legislative proposals dated 1 Nov. 1997.

This brings us to the matter of the legality of the MCC's alleged jurisdiction of Act 101 over all "natural health substances", which term has been strategically perverted to encompass what some vested regulatory and market interests insist on classifying as "complementary medicines". The fundamental question here is what the original legislative intent of the Act was. Historically it is generally accepted that its primary function was to prevent a repetition of the "Thalidomide Tragedy", which was essentially a matter of unacceptable drug toxicity. Herbal products were illegally called-up for registration in 1973, as were vitamins with therapeutic claims; mega-dose vitamins in 1985, and homoeopathics in 1986, very curiously, yet instructively, approximately ten and twenty years respectively "after" enactment. Traditional African medicines however, have oddly never been called-up, and we will illustrate why.

What is even more instructive is that the assumed registrations which followed were (grand-fathered at vastly reduced fees and) not judicially pursued, because the Act never did cater for their registration, the MBR 1 documentation being intended to cater exclusively for toxic drugs. A recent landmark Transvaal High Court judgement in Jun.1997 (Medical Electronics vs A. de Stefanis & Others- Case no.2659 / 96) ruled that these call-ups represented not registrations, but only applications for registration, the legal implication being that none of these substances so called-up had ever been legally registered, since the Act did not make provision for their registration, which is why the listings system is being instituted to attempt to extend the Act's jurisdiction to include not only complementary medicines, but strategically serving a hidden agenda, all natural health substances.

The main problem in definitively determining the legislative intent of Act 101 is it's absurdly all-encompassing definition of a medicine as "any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in-

(a) the diagnosis, treatment, mitigation, modification, or "prevention" of disease, abnormal physical or mental state or the symptoms thereof in man; or (even more absurdly)

(b) restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine.

This definition arose as the result of one Dr. Hertzog having evaluated the US medical drug regulatory laws following the "Thalidomide Tragedy" and copying them for local application. The legal point to be considered as a direct result of this virtual blueprinting, are the subsequent legislative developments in the US, namely the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417, Oct.25, 1994). Significantly Sect.39 of the Constitution- (Interpretation of the Bill of Rights), subsect. (1)(c) makes provision for the consideration of foreign law, which in this instance would give the US amendment the upper hand, considering that it is the US blueprint which is in dispute and the plagiarised Australian Therapeutic Goods Administration listing system has no direct relation to Act 101.

Significantly, the enactment of DSHEA stood as a sharp rebuke to the FDA's regulatory practices and tactics, including those regarding labeling, third party literature, and structure-function claims, whereas conversely, the Review Report on the TGA, released by the parliamentary secretary to the Australian Minister of Health, stated that "it was not appropriate that herbal and complementary medicines must now go through the same evaluation and approval process as prescription pharmaceuticals - much tougher than in other countries, particularly North America, where such products are largely unregulated." Shades of things to come ?

This report did state that "a committee would have to look at those herbs which were currently insufficiently restricted to protect public health." (The Sydney Morning Herald, Jan. 25, 1997) With the US DSHEA however, when bringing an action based on safety, the FDA now bears the burden of proof, according to very strict criteria. PHARMAPACT's two year old Legislative Proposals (available as a concise summary dated 1 Nov. 1997) include the adoption of DSHEA amendments (for no indication claim products) and the (British) Product Licensing System (for indication claim products).

The DSHEA definition of a dietary supplement is inclusive of vitamins, minerals, herbs, amino acids or a concentrate, metabolite, constituent, extract or combination of any of these ingredients, in short, natural health substances, the subject of absurdly restrictive MCC regulatory proposals, completely out of keeping with Sect. 39, subsect. (1) (a) of the Constitution, which states that " When interpreting the Bill of Rights, a court, tribunal or forum must promote the values that underlie an open and democratic society based on human dignity, equality, and freedom", and further, subsect. (2) "when interpreting any legislation, and when developing the common and customary law, every court, tribunal or forum must promote the spirit, purport, or objects of the Bill of Rights."

Significantly, in the preamble to DSHEA, it is stated that "Congress finds that although the Government should take swift action against products that are unsafe or adulterated, it should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers."

The above-mentioned is more in keeping with Sect. 12 of the Constitution (Freedom and Security) which states that (2) "Everyone has the right to bodily integrity and psychological integrity, which includes the right: (b) to security in and control over their body." The DSHEA is also more in keeping with Sect. 16 (Freedom of Expression), which includes (1) (a) "freedom of the press and other media"; (b) "freedom to receive and impart information and ideas"; and (d) "academic freedom and freedom of scientific research."

Further constitutional clauses being infringed by Act 101 and the listing system include:

Sect. 14 (Privacy), which includes "the right not to have (a) their person or home searched; (b) their property searched; (c) their possessions seized; or (d) the privacy of their communications infringed."

Sect. 33 (Just Administrative Action) (1) "Everyone has the right to administrative action that is lawful, reasonable and procedurally fair." (2) "Everyone whose rights have been adversely affected by administrative action has the right to be given written reasons."

In a recent judgement in the Transvaal Supreme Court (Registrar of Medicines vs. MSI -Case no. 413 / 95), Judge J. Roux, remarked that "a wider definition (of a medicine) is hardly conceivable. Thus water may or may not be a medicine." The judge stated further that he "could find no substances or mixture of substances which pose any threat to the physical wellbeing of man," and further that "but for the wide definition of a "medicine", I do not believe that the applicant (MCC), would have properly been involved in the matter at all."

The judge then ruled that the respondent's earlier relief against being further harassed by the MCC, granted as an urgent interdict against the MCC by Judge J. Preiss (Oct.1994), pending the outcome of MSI's appeal against the MCC's decision that it's natural food supplement was a medicine in terms of the Act; or of an action to declare that the products are not registerable under the Act; or an application to the Constitutional Court relating to the validity of the definition of a "medicine", be upheld and that the MCC's action be dismissed with costs.

An application in the Transvaal Supreme Court in Feb.1997 by Reitzer Pharmaceuticals against the MCC for leave to refer the validity and enforcement of said Act, (also over their food supplement similarly arrogantly declared by the MCC to be registerable in terms of said Act,) to the Constitutional Court, has curiously had judgement reserved by Judge de Villiers for a year. In the former case, the abusive gestapo-type raid, as also in the case of Hersol Laboratories, are a disturbing phenomenon, rarely brought to court out of fear of reprisals. An anonymous additional application to the Constitutional Court is in preparation in Gauteng, further re-enforcing our conviction that Act 101 / 65, and in particular its ludicrous definition is far from being cast in stone and the coup de grace is about to follow.

Whilst we have no desire to bring our African colleagues under any undue regulatory pressure, and we believe that the foregoing arguments, plus that of allopathic pharmaceutical iatrogenic and nosocomial morbidity and mortality, hold more than sufficient ammunition to defend our position, the traditional African medicine regulatory double-standard is a hand we have to play as a moral necessity, for reasons to be outlined shortly.

We are always impressed by how perceptive ordinary people are when this subject is discussed and they invariably remark "but what about the traditional African herbs and muti-medicines ? Sect. 9 of the Constitution (Equality), subsect. (3) states that "The State may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including ethnic origin or culture, and subsect. (5) states that "Discrimination on one or more grounds listed in subsection (3) is unfair, unless it is established that the discrimination is fair."

Were we to invoke subsect. (5) in a court of law by way of an urgent interdict to restrain the MCC, we would be guaranteed relief pending the MCC's establishment of the discrimination as fair, which onus is uniquely on the party wishing to discriminate, and hence the MCC would have to take the initiative and convince the Constitutional Court that the discrimination in the circumstances at hand is fair, which is a long shot and would really open a rotten can of worms, which the MCC, possibly the D-G, but hopefully not the Minister, would prefer to leave unopened.

In fact, the hygienic and contamination conditions, which are the biggest safety issues of regular concern, are limited primarily to Third World herbs and substances, and locally the pavement on which these wares are displayed in the urban setting are of legitimate concern, being as they are, tainted with sputum, urine and faeces from animal and pedestrian traffic, plus a fair measure of vehicular combustion petrochemical deposits.

We must however, be careful not to pursue purity to absurdity, as is the case with the pharmaceutical levels of manufacturing standards being insisted on for natural health substances, which ought to be maximally set at those for food standards, which products are consumed in far more significant quantities and are subject to similar conditions and are after all, also perfectly subject to the same absurd definition of a medicine, but for the fact that the MCC would have a riot on their hands if their argument were pursued to it's logical conclusion.

The alleged toxicity concerns of the international herbal traditions as a safety issue is really nothing but a smokescreen against the iatrogenic reality of drugs and an attempt at suppression of alternatives adversely affecting medical profits. North American mortality statistics over a nine-year period from 1985-1994 as compiled from the American Association of Poison Control Centers national data collection system by University of Pittsburgh researchers showed only one herbal fatality over the entire period, attributed to "intentional" ingestion. (Krenzelok, E. et al, Veterinary and Human Toxicology, 38 (4) August, 1994)

Comparable annual statistics for FDA medical drug- induced mortality is 180,000 deaths and more than 1 million drug-induced injuries per year. (Holland E. & Degruy, F. Drug-induced disorders. American Family Physician, 1 November, 1997, 56(7)) The local statistics are expected to be relative, conservatively 5000 deaths per year from MCC registered drugs (who would not have died of their afflictions had they not used the drugs) Registration merely establishes and limits toxicity, it does not appreciably prevent it and therefore clinically significant toxic substances should be banned.

In closing, it is appropriate to comparatively evaluate the risk from traditional African herbs to the local population and to pose some pertinent questions. Some 75% of the local population are estimated to use traditional herbs, usually in combinations. According to the database established by Noristan Laboratories over 30 years of research; of 350 plant extracts, 79 % showed definite pharmacological activity, and 12 % definite toxic effects. (Hughson, L. Pharmaceutical & Cosmetic Review, Jul. / Aug. 1995)

In fact, Professors Folb and Schlebusch, chairman and registrar of the MCC respectively, opinioned internationally a decade ago that 'The issues of traditional (and homeopathic) medicines need to be addressed." (Folb, P et al, J. Clin. Pharmacol. 1988: 28). In South Africa today, homoeopathics, arguably the safest medicines in the world, are controversially subject to MCC control, yet apparently a moratorium exists iro. traditional medicines, in spite of Folb writing nearly 10 years ago, under the sub-heading Traditional drugs and indigenised pharmaceuticals, that "some give rise to serious adverse reactions, and others contain chemicals that have long term effects such as carcinogenicity and hepatoxicity." (Folb, P, SA Jour. Science, Vol. 85, Aug. 1989)

PHARMAPACT consider it ludicrous that the professors profess to having jurisdiction over herbal and other natural health substances as medicines when it is clear that these exotics are impacting positively on health and negatively on medical profits, but we expect will now profess not to have jurisdiction when it is clear that some of the indigenised medicines and eg. tobacco and other unregulated toxic substances are impacting negatively on health and positively on medical profits, whilst hypocritically using public safety as a red herring to suppress public access to the former.

In the case of tobacco, over which the the FDA have jurisdiction, yet do little about it in spite of its having distinct pharmacological activity (the MCC's equivalent of a wet dream), causing some 50 diseases and complications and ultimately directly killing one in two user's, how can the MCC merely be doing its job, as claimed by the D-G when confronted with the facts, when quite clearly they are not.

Surely some serious reprioritisation is called for and the bad professors will have to face this moral dilemma, forced by a court of law if necessary. Whilst there is little difference between an African medicinal plant and an exotic from eg. China, India, South America, or even North America and Europe, all of which except for the former are currently the target of such vicious regulatory fervour by the MCC, the essential difference which we have identified, is that the latter exotics have significantly had their problematically toxic items excluded from international commerce for fear of litigation internationally, whereas this process has not occurred with the indigenous substances but for a few commercials. With current budget constraints, we cannot conceive of the listing system justifying the high priority afforded it for immoral ideological and vested commercial reasons and we will fight it and the MCC's injustices to its logical and moral conclusion.

Whilst researching this report, we assumed that the morbidity and mortality incidence for South Africans using indigenous medicines would be minuscule, but we were stunned to uncover the shocking scientifically recorded and published clinical observation that "in South Africa, the major cause of death (from acute poisoning) among black (direct quote) South Africans are traditional medicines." To reassure the reader that this was not a typographical error, the editor, a Clinical Professor of Medical Toxicology, added in brackets "(about 50 % of deaths)". (Ellenhorn's Medical Toxicity: Diagnosis and Treatment of Human Poisoning, Williams & Wilkins, 2nd. Edn.1997)

(The above corrected statistics were however mis-contextualised in the textbook by not qualifying that it related not to all fatalities but to all those from acute poisonings. This error was in good faith carried over into the original version of this report and a resultant inaccurate extrapolation made by us with the highly publicised AIDS epidemic which receives such disproportionately high attention and expenditure. A revised comparison of traditional African medicines resulting in roughly the same to twice as many deaths as is collectively dying from AIDS is a shocking situation by any standards.) (In addition to these corrections we have expanded the main thesis by modifying and adding the next 24 paragraphs to the original report.)