P.H.A.R.M.A.P.A.C.T

Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny

PHARMAPACT

SAYS NO !

To The Tyranny Of Monopolistic

PHARMACEUTICAL EXPROPRIATION

Of Natural Health Substances.

Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny.

Ph / fax: 044-532-7765; PO Box 2404, Knysna, 6570. E-MAIL: pharmapact@hotmail.com or gaia.research@pixie.co.za

Web-site: http://www.angelfire.com/biz/pharmapact

REGULATORY PROPOSALS

FOR NATURAL HEALTH & THERAPEUTIC SUBSTANCES

Presented to the SA Medicines Control Council, 23 July 1999.

-CONTENTS-

1) PHARMAPACT OBJECTIONS TO THE LISTING SYSTEM:

  1. PRIOR MORAL & LEGAL OBJECTIONS,
  2. CURRENT TECHNICAL & LOGISTICAL OBJECTIONS.

2) MAIN PRINCIPLES

3) REGULATORY SCHEMATIC

4) INTRODUCTION TO PROPOSED REGULATIONS

5) APPENDICES:

(I) GENOCIDE/ETHNOPIRACY REPORT,

(II) HOMOEOPATHY CRITIQUE

Stuart Thomson, Director, Gaia Research Institute, National Co-ordinator, PHARMAPACT.

Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny

PHARMAPACT

SAYS NO !

To The Tyranny Of Monopolistic

PHARMACEUTICAL EXPROPRIATION

Of Natural Health Substances.

Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny.

Ph / fax: 044-532-7765; PO Box 2404, Knysna, 6570. E-MAIL: pharmapact@hotmail.com or gaia.research@pixie.co.za

Web-site: http://www.angelfire.com/biz/pharmapact

Ms Precious Matsoso

Registrar, MCC / MRA

19 July 1999

Dear Ms Matsoso

PHARMAPACT PRESENTATION TO THE MEDICINES CONTROL COUNCIL: 23 JULY

Thank you for your communication of 7 July 1999 extending the above-mentioned invitation, which we are happy to accept in an urgent spirit of co-operation towards an equitable solution to a long-standing dispute with Council over the unconstitutional so-called "Listing System".

We will require, prior to our presentation, the provision and setting up of an overhead projector capable of projecting A4 size transparencies. We will provide sufficient printed copies of our abbreviated outline of proposals on arrival prior to the meeting.

Should Dr Theo van der Venter, Director, Food Control not be scheduled to attend the meeting, would you kindly ensure his presence for the presentation and deliberation thereof.

I really do look forward to seeing you again and hopefully further advancing our cause for the equitable benefit of all health consumers and service providers, inclusive of the regulatory authorities themselves. We hope and pray that Council’s hearts and minds will be suitably opened on this occasion and that it will finally reject the mistakes of the past and walk with us in peace towards a positive new dawn in natural health care for all of our citizens alike.

Yours faithfully

Stuart Thomson

National Co-ordinator, PHARMAPACT.

 

PHARMAPACT OBJECTIONS TO THE LISTING SYSTEM (Expedited Registration Procedure)

(ST/PP-22/7/99)

PHARMAPACT’s objections are recorded in considerable unanswered registered correspondence to the authorities to date. Without elaborating further, these are briefly recorded as follows and more specific technical objections to the procedure are added to outline our principle objections:

-PRIOR MORAL & LEGAL OBJECTIONS-

  1. The totally pre-selective, biased, exclusive, unrepresentative, undemocratic, uncommunicative, non-transparent, illegal and unconstitutional nature of the development of the entire procedure;
  2. The total absence of any professional expertise on the CMC and Technical Committee;
  3. The MCC initiated, promoted, logistically assisted and endorsed development of the procedure;
  4. The 30 - month MCC bias in favour of this procedure to the total exclusion of all other models;
  5. The financially vested interest homoeopathic pharma-industry driven nature of the procedure;
  6. The central role of Rene’ Doms, as ex head of MCC Inspectorate/industry leader in the process;
  7. The MCC inaction in reforming the process over and in spite of 30-months of legitimate protest;
  8. The MCC’s repeatedly failed promises to make the procedure available for detailed critique;

-CURRENT TECHNICAL & LOGISTICAL OBJECTIONS-

  1. The absurdly suppressive regulation of food and its nutritional and relatedfactors as medicines;
  2. The concept of product registration based on pre-existing lists of so-called approved substances, particularly bearing in mind the financially vested interest nature of the inclusion process;
  3. The inability to reliably verify the scientific validity of the inclusion of each listed substance and its alleged actions, due to the absence of specific cross-referencing to the cited sources;
  4. The resulting inability of the authority to make regulatory provisions and decisions having an acceptable degree of scientific certainty or likelihood of scientific validity, due to the arbitrary process of inclusion to the lists, as well as the validity of associated claims and risks, not only of the substances, but also the authorised applications thereof. Who will bear legal responsibility?;
  5. The failure to apply the modern trend of "evidence-based" criteria to a new regulatory model, which will have the regressive effect of endorsing quackery in the guise of "traditional use".

    PHARMAPACT’s model on the other hand specifically embraces "evidence-based criteria" for all medicines, whilst protecting foods and related substances from suppressive regulatory fervour. Our concerns iro medicines quackery are exemplified in our report titled "Homoeopathy: A Critique".

  6. The logistical inability of the indigenous African medicines to be equally and urgently included in the process, let alone the process enforced on this significantly high-risk sector. The gross moral, legal and constitutional implications of ignoring or exempting this sector, which is directly responsible for an estimated 10-20 thousand tragically unnecessary deaths per annum has been detailed in our recent 15,500 word report titled "MCC/DoH Traditional African Medicine Genocide and Ethnopiracy Against the African People".

PHARMAPACT’s model on the other hand not only specifically addresses and accommodates this problem as its regulatory priority, but has the active participation and support of its main ally, the statutory Interim Co-ordinating Committee of Traditional Medical Practitioners of South Africa.

 

PHARMAPACT REGULATORY PROPOSALS FOR

NATURAL HEALTH & THERAPEUTIC SUBSTANCES

(ST/PP-22/7/99)

--MAIN PRINCIPLES--

And God said, "See, I have given you every herb that yields seed which is on the face of all the earth, and every tree whose fruit yields seed; to you it shall be for food". Genesis 1:29. The Holy Bible, New King James Version.

All kinds of trees…Their fruit will be used for food, and their leaves for medicine. Ezekiel 47:12 The Holy Bible, NKJV.

The leaves of the tree were for the healing of the nations. Revelations 22:2 The Holy Bible, NKJV.

  1. Foods, their nutrients and related constituents are rarely, if ever, truly classifiable as medicines.
  2. If these factors positively influence conditions, then their action is food corrective, not medicinal in action. Only non-food remedies to which resistant conditions alone will yield, are medicinal.
  3. A remedial claim for a food cannot render a food a medicine, but the claim may be challenged.
  4. Foods may bear risks as well as benefits. It is the right of consumers to know and to choose.
  5. Food altered from its natural form may become more suspect in terms of both risk and benefits.
  6. Processed foods may bear risks and benefits. It is the right of consumers to know and to choose.
  7. Dietary supplements are processed/synthesised foods and may bear risks and benefits. As with natural and processed foods, it is the right of consumers of supplements to know and to choose.
  8. Traditional remedies, which may variably more or less resemble foods or dietary supplements, may also bear risks as well as benefits. It is the right of consumers to know and to choose.
  9. Dietary supplements and traditional "remedies" loosely interface between foods and medicines. Besides their food or ritualistic placebo benefits, claimed further benefits may be challenged.
  10. Traditional and complementary "medicines" cross the interface into the paradigm of medicines.
  11. Traditional and complementary medicines may, as with foods, supplements and traditional remedies, possess some of the risks and benefits of these, but are chosen as medicines because they bear special benefits additional to foods, supplements and more traditional remedies.
  12. If traditional and complementary medicines bear additional benefits, they may bear additional risks. As with foods, supplements and traditional remedies, it is the right of consumers of traditional and complementary medicines to know these risks and benefits and to choose.
  13. At the medicinal stage, the traditional or complementary practitioner enters the equation, if the consumer so chooses, prior to which the consumer retains responsibility and the right to know and choose. Only should the consumer choose to delegate this right to the practitioner, does the consumer relinquish their responsibility and becomes a consumer-patient. Not knowing and choosing the risks and benefits, the patient now becomes vulnerable and needs to be protected.
  14. It is the mandate of the medicines control authority to protect the consumer who chooses to self-medicate with traditional or complementary medicines within the confines of that which is safe and effective for that purpose. It is further the mandate of the medicines regulatory authority to protect the patient who has delegated their care to a traditional or complementary medicine practitioner, by ensuring that the risks and benefits of those medicines to be used exclusively by that practitioner are safe and effective for that purpose. This mandate is irrespective of culture.

15) It is the mandate of the food control authority to protect the consumer from unreasonable risks from and also from unreasonable claims for the benefits of foods. Nowhere in the world does a food control authority succeed in either function. By way of example, consider all the junk-food that is available at considerable risk to consumers, and the foods which are allowed to be advertised as healthy, eg margarine, even with a Heart Foundation symbol, whereas nothing could be worse for heart health, including butter. The unnatural trans- fatty acids in margarine raise Lp(a), a strong risk factor in atherosclerosis (degeneration of the walls of the arteries and valves of the heart) and derange beneficial essential fatty acid metabolism. (Enig M, Trans- Fatty Acids in the Food Supply: a comprehensive report covering 60 years of research. Enig Assoc. 1993) Hundreds of examples exist.

16) The SA Food Control Directorate not only does not protect consumers from unreasonable risks, it has even outlawed information about the benefits of foods. From 1977 until 1993, its Law, Act 54 read: "Prohibited statements: Any person selling a foodstuff bearing on a label any word, indication or claim that conveys the impression that the foodfstuff possesses health-giving properties shall, unless such a word, indication or claim can be scientifically substantiated, be guilty of an offence".

Fair enough, but for the conspiratorial fact that just before the transition to a democratic government, the old repressive regime promulgated an amendment to the regulations, Govt. notice R. 2034, dated, 26 October 1993 which ominously declared: "Prohibited statements: The following information or declarations shall not be reflected on a label or in a advertisement of a foodstuff:

(b) the words "health" or "healthy" or other words or symbols implying that the foodstuff has health-giving properties as part of the name or description of the foodstuff;

(c) subject to the provisions of the Medicines and Related Substances Act No. 101 of 1965, the words "heal" or "cure" or "restorative" or any other medicinal, therapeutic or prophylactic claim".

17) The Foodstuffs Act 54/72 is clearly unconstitutional and the SAMMDRA Act 132/98 is even more unconstitutional than its predecessor, Act 101 of 1965. PHARMAPACT and its allies are in a position, where having been unconstitutionally evicted from the SAMMDRA parliamentary hearings and having had its 62-page submission struck from the parliamentary record for legitimately criticising the disgraced former Medicines Control Council upper hierarchy, we are in a unique legal position whereby it is not legally obliged to recognise the SAMMDRA Act. Only PHARMAPACT’s voluntary acceptance of the regulations to be promulgated under the Act can be binding, and we have no intention of accepting regulations which do not meet our highest ethical standards, in particular the Listing System (Expedited Registration Procedure) which is so seriously flawed procedurally, technically and constitutionally, that we do not even consider it an alternative to our proposed system, which is but briefly outlined in this preliminary presentation.

18) PHARMAPACT are, on rejection of the expedited registration procedure, and on a specific invitation to expand the details of our proposals, prepared to put in the necessary effort to have a viable set of regulations ready for work-shopping within 6-weeks of said invitation. Besides our objections to the ERP, elements of our proposal to be presented verbally here at this time, include:

  1. Co-operative self-regulatory product dossier submissions for all claim categories of natural health and therapeutic substances which will respectively require a formal a) monitoring in the case of health foods and beverages and simple traditional remedies; b) evaluation and possible rejection in the case of dietary supplements and complex traditional remedies; and c) evaluation and either rejection or registration in the case of complementary or traditional medicines.
  2. A self-funding system incorporating confiscations, market withdrawals, admission of guilt fines, prosecutions, product sell-backs, self-sector infringement reporting, emergency powers, free editorial communications space in all media carrying more than 10 % of advertising for each category; updated online dossier lists for each category by each authority, accessible by the inspectorate via laptop / cell-phone internet access, and to all internet access points generally. Also catered for is random basket sampling, claim substantiation on the preponderance of available scientific evidence, scheduling, and adverse reaction reporting and monitoring etc etc.

Website: http://www.angelfire.com/biz/pharmapact E-mail: pharmapact@hotmail.com

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