P
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eoples Health Alliance Rejecting Medical Authoritarianism, Prejudice, And Conspiratorial TyrannyMrs Precious Matsoso By Registered Mail
Registrar, Medicines Control Council 30 April 1999
Pte Bag X828 Pretoria, 0001
Copies to co-respondents: By Registered Mail
Dr H Rees, Dr P Makhambene, Dr A Ntsaluba, & A Nkomo
Dear Mrs Matsoso
MEDICINES CONTROL COUNCIL TYRANNY AND CORRUPTION, COMPLEMENTARY MEDICINES COMMITTEE CREDIBILITY CRISIS & PROPOSED ILLEGAL LISTING SYSTEM
Thank you for your letter of 14 April 1999. It is encouraging that a two-way dialogue is at last opening up.
I have in recent months penned several long and detailed letters to you in my capacity as National Co-ordinator, PHARMAPACT, namely: 7 October 1998, 26 February, and 9 & 24 March 1999. These all remain unanswered, in open disregard of our fundamental rights as set out in Sections 32 and 33 of the Constitution of South Africa, Act 108 of 1996, namely Access to Information and Just Administrative Action. We hereby once again formally invoke these clauses of the Bill of Rights and demand that you and the co-respondents meet these obligations within (another) 14 days. You are hereby formally advised that to further ignore these registered items of correspondence and the issues raised therein, will be construed as tacit acceptance of the facts and charges laid-out therein, and in this respect we reserve our rights.
Your letter presents incorrect perceptions or possibly out and out attempts at cheap propaganda in the face of the massive moral challenge before you, for which you appear to be ill-equipped to exercise the necessary leadership. I would like to extend to you the benefit of the doubt iro the latter judgement, in recognition of the significant role which you have played in exposing the corruption and abuse of power of the old MCC regime. It is difficult to accept that you have so quickly fallen into the mould as your predecessors, and hence I am extending a hand of friendship and support for co-operation towards genuine reform of medicines regulation in South Africa as regards natural health and therapeutic substances, which has been my research focus for the past 25 years. By the same token, continued non co-operation will be a declaration of war.
Your letter of 14 April 1999 does not address any of the above-mentioned outstanding matters, but rather raises two or more issues, which I shall address for the record, since the allegations are far too serious to ignore. I intend however to give you the benefit of the doubt, assuming that you act out of ignorance rather than malice. As mentioned in our letter of 7 October 1998, if you suspect that your official PHARMAPACT file has been laundered, which we suspect it might be, we will gladly provide you with an intact set on request. I fail to understand how you can, given your mandate, serve the evil plan initiated by the old order, except possibly because they still out-influence you, or because you do not have the will to make the necessary effort to completely realise the mandate given you by the honourable Minister, which was certainly not that of serving the old order, her erstwhile enemies who worked so hard to derail her socialist reform policies. Your continued support of the Folb initiated listing system is analogous to not wanting to do away with apartheid because of all the work that went into setting it up in the first place, which would be a clearly ridiculous notion and is similarly so with the listing system, which will not serve the interests of consumers.
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Firstly, your charge that "the spirit of your (my) letter does not in any way show a sign of commitment from yourself (myself) as an ‘individual’ to transformation and change in general" is a deliberate lie and you know it. I assume that this is a knee-jerk reaction to my putting you on the line, in your hope that the Minister will actually believe that I am to blame for the current state of affairs. This attempt at "shooting the messenger" is an insult to both myself and the Minister, indeed even to your own intelligence, and is clearly as a result of being up against the wall with a guilty conscience, but lacking the conviction to take the necessary responsibility for continued inaction to fairly resolve the real issues. As mentioned, I have penned four PHARMAPACT letters, and also one as Secretary of Health Freedom SA to you in recent months totalling seventeen pages, all of which have been constructive attempts at drawing these matters to a head, and besides the MCC’s 3 November 1997 and 27 February 1999 attempts to sham consultation, all attempts at arranging a meeting have been at PHARMAPACT’s initiative. Your recent unacceptable response to our 24 March 1999 demand for a meeting within 21 days fell far short of meeting even our minimal requisites before marching to Pretoria for possibly another waste of our valuable time and resources.May we also remind you that both you and Dr Rees on several occasions promised us documents for critique. All blame for failed progress irrefutably rests with you and the other even more arrogant respondents.
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Secondly, your charge that "All attempts that we (MCC) have made have been opposed by you (me) as an ‘individual’. We are however receiving co-operation from most role players and individuals except yourself" (myself) is likewise a deliberate lie, and again you know it. You are well aware of the existence and united position of the broader alliance "Health Freedom South Africa", which undisputedly by far represents the majority of role-players in the country, comprising as it does, the ICC, PHARMAPACT, Consumers for Health Choice/Freedom, the SA Herbalists Association, and the SA Safe Water Assoc. The Cape Lobby for Health Freedom, albeit no longer a member because of lack of strong leadership commitment to our more aggressive stance, nevertheless are also on record as opposing the listing system, a position confirmed at meetings these last two weeks. PHARMAPACT, as per its consistent position, besides its 500-odd registered members, has as its constituency, every one of the several million consumers of natural health substances not given an opportunity to take an informed position and be heard on these issues which affect them. PHARMAPACT is in essence therefore as per its acronym, a "Peoples Health Alliance Rejecting Medical Authoritarianism, Prejudice And Conspiratorial Tyranny".°
On 26 February 1999 as Secretary, Health Freedom South Africa, I wrote to all four respondents as follows: "I furthermore draw your attention to the fact that a letter on behalf of HFSA, dated 19 June 1998, addressed to the Minister of Health and forwarded to the MCC, calling for a halt to all deliberations on the listing system pending an officially constituted national indaba called by public notice, has gone unheeded, in spite of the fact that HFSA collectively represent by far the majority of stakeholders, and an informed position was legally served on the State outlining the strong sentiment of this united front."°
One ally, Consumers for Health Choice/Freedom on 22 October 1998 wrote to PHARMAPACT: "We have repeatedly objected that vested interests in our industry have been driving the listing system without full consultation with all players in the field. As a consumer organisation we stand in the interests of the consumers whose rights are being violated by these actions and are therefore unconstitutional and we have 7000 signatures to support this. We also disagree that no public hearings have been held or that no notices have been made so that the public can be consulted on issues affecting them." CfHC/F then asked PHARMAPACT to object on their behalf at the Parliamentary hearings. (This position reaffirmed this week.)°
Another ally, the Interim Co-ordinating Committee of Traditional Medical Practitioners of SA (ICC) is on record as follows:a) In a written statement to the Health Freedom South Africa (HFSA) Indaba, 23 May 1998, the ICC stated: "We wish to confirm our support for the cause to prevent the listing. We reject with contempt that some professors, pharmacists, etc can decide on our customary and cultural products or herbs. Yes, we agree that safety or precautions be addressed and controlled. We must make sure all of us here today, at all means at our disposal, use the correct people to make these decisions for all of us. To prove our point, we have challenged the MCC and the CMC about their meetings without the ICC. A letter we wrote to them is available for your scrutiny. To date, we have not received any response to this letter. (addressed to Dr P Makhambene) Therefore, let us throw our combined forces behind this blatant abuse of our rights. Let us get our house in order, unite and stand together. Without us these decisions will not work. They need all participants and not vested interests. In the name of our almighty and our ancestors, we thank you. CAMAGO ‘SIYA BULELA’, Yours in madlozi’s name." Sindephi Spogter – Ka Mngcina
b) In the 26 February 1999 letter to all respondents, I also set out the following minuted frustration and disgust of the representative of what is undisputedly the largest group of role-players, as expressed at the 9 October 1998 BBRG meeting, and who was only aware of the event and their deliberate exclusion after PHARMAPACT, as the main ICC alliance partner, suggested that they send an observer to witness for themselves, these negative developments illegally taking place behind their backs to their detriment:
"My name is Sindehpi William Spogter. I am a traditional healer. I am from the I.C.C, the Interim Co-ordinating Committee For Traditional Medical Practitioners of South Africa. We are so disappointed today that we are hearing about the MCC and the SAMMDRA Bill where traditional medicines are defined. Why have we never been invited? Why were we not invited here? You are talking about medicines. You are talking about listing. As traditional healers, we represent eighty percent of the population of this country. We have never hid ourselves as the ICC. I feel very, very badly about this. We appeal to the Medicines Control Council to restructure yourselves. The CMC structure applies as well. Why do you leave ICC out? Those are the questions I would like you to answer. We need an INDABA, because we have been left out for a long, long time. Why do you leave traditional healers out? Only certain people elected by those of the previous regime are represented on the bodies here, without our knowledge. What is going on here? These are not our elected representatives". (Dr Makhambene passed the buck to Matsoso whose reply was evasive, deliberately confusing, and did not address these issues at all.)
c) On 23 October 1998, just prior to the Parliamentary Portfolio Committee on Health hearings (this time not by public notice), the Secretary of the ICC, T/Dr Spogter wrote to PHARMAPACT as follows:
"Thanks for informing us of the unexpected last-minute parliamentary hearings on the SAMMDRA bill. We are also disappointed that we come to hear only second-hand about important developments which affect our membership, when we are in fact the major role-player. This is a replay of the 9 October insult, in spite of the fact that we strongly objected to being excluded from what should be a democratic process".
"We still stand behind PHARMAPACT on the Health Freedom South Africa resolution that the Minister put developments with the listing system on hold until a national indaba, called by public notice has been held, to correct circumstances which have up till now clearly only brought financially vested interests to the table. We would appreciate it if you were able to voice these concerns to the Committee." (Dr S Spogter)
(You cannot wish away alliances. T/Dr Spogter, signatory to the 24 Feb 1999 letter, is HFSA Chairperson.)
d) In a letter to Matsoso, dated 25 February, 1999, Mervyn Desatnik (Dip Pharm), representing seven small manufacturing companies involved in traditional medicines, as well as T/Dr S Spogter, ICC, wrote: "We hereby wish to voice our outrage at the total lack of concern and communication on your behalf re the industry concerning complementary and traditional medicines and the SAMMDRA act. We did not receive notification of a very crucial meeting for our industry for 27 February 1999, called by "Public Notice" in but a few national newspapers as called upon by PHARMAPACT. We agree with PHARMAPACT that this is a devious forum to mislead the public into believing that all role-players were informed and notified. We support the other organisations who have and will voice their objections."
e) In a written Memorandum to the MCC dated 27 February 1999 and delivered verbally at the already criticised Pretoria "public meeting", the T/Dr Sindephi Spogter, Secretary ICC stated the following: "The ICC as one of the national major stakeholder representing the traditional medical profession is not even involved in this process. The ICC would like that our view be taken into account that we have not been part of this whole process, whoever claimed to represent the ICC (Solomon Mhlaba), had no mandate from the ICC nationally. We just cannot support the process and be part of it in its current form and approach. We still perceive it as one of the old order measures aimed at promoting the so-called Western Superior Medicine at the expense of traditional medicine. If it continues unabated, it will definitely reverse all the gains which have been attained by the traditional medical practitioners, and again impose measures that will not be acceptable and instead suppress it under the pretence that they have been consulted.")
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In April 1998, a Crisis Committee for Democracy in Health comprising members of various dissenting groups, took a decision to actively stop the listing system. Party to the 23 May 1998 Health Freedom SA resolution calling for a halt to all deliberations on the listing system pending an officially constituted national indaba called by public notice, the Cape Lobby for Health Freedom are of the opinion that "employing the listing system is an error, which if implemented, would lead to the severe repression and restriction of natural healing. The suppressed systems models are clearly evident in Australia and Scandinavia, where the pharmaceutical interests have abused the system to eliminate competition. Any listing system would be inappropriate for South Africa, since a listing system cannot cater for all the substances used for healing in South Africa." (CLHF Proposals in Respect of the Regulation of Medicines in South Africa, 5 May 1998). Aims and Objectives of the CLHF are "to campaign for separate legislation and a separate regulatory body to govern and administer the affairs of natural medicines in South Africa." (Positions reaffirmed this week.)°
PHARMAPACT are undisputedly the most truly committed representatives of the most important constituency of all, namely that of the interests of consumers, paradoxically that which the MCC purport to serve, yet clearly do not; a statement I am prepared to defend in court if necessary, as appears increasingly will be the case. Attempts to dispute health sector or public support for PHARMAPACT will prove futile. For example, a comparison of visits to the PHARMAPACT and Shuttle Computer Systems websites, reveals double the traffic for PHARMAPACT, in spite of the fact that SCS is the official website serving the listing system and that users are practically forced to visit there to participate in the process. Consider also the correspondence from the Reverend Cairncross, CEO of our largest ally, the Christian Coalition, who when addressing one of our recent campaigns, wrote to me as the National Co-ordinator of PHARMAPACT on 27 August 1998, stating: "The Christian Coalition with its membership of 5500 churches with their following of 8, 500,00 (8 million) members endorse your educated and well-researched views and the views of your professional fraternity which you are associated with. God bless you and your family. His and your servant. Rev. R Cairncross"; this despite my not even being a Christian.·
Thirdly you repeatedly stress my role as "yourself (myself) as an individual", as though the latter word itself will magically diminish the opposition. Even if I were the only dissenter, which I have just proven beyond a doubt not to be the case, the logical and moral strength of my arguments would still win in the end, since your side are clearly in the wrong, and will in all likelihood face both criminal, and civil proceedings if matters are not soon resolved to our satisfaction. You furthermore claim that "you (I) seem to oppose every initiative." Sure, every initiative on the MCC’s behalf falls far short of its mandate and the provisions of the Bill of Rights of the Constitution, so I am only legally exercising my constitutional, and common law rights at this stage, the full extent of civil and criminal law is yet to be exercised, but is the next step, should this last attempt at peaceful resolution fail. Your further claim that "you (I) do not show a commitment to transformation and change" is a deliberate lie, since it is you and your colleagues who are resisting change in the direction of democracy, representation, transparency, access to information, public interest and safety etc. On the contrary, it is my colleagues and I who are trying to show you and other stubborn and arrogant regulatory officials the high road in this regard, including the institutions of Parliament, Public Protector and Human Rights Commission, and we are not even paid for this thankless sacrifice to the public service, who should be serving us and not the very reverse.By penning your recent letter, you condemn me for being honorable and doing the right thing, not realising that you are condemning the very principles which you, as a public functionary, are expected to be espousing yourself, not in appearance, but in actual deed. You deliberately ignore the fact that I have been fighting the corruption and criminality of the MCC for the past five years, not out of selfish need to prosper financially, which is why the industry connive with the MCC, but on the principle of having encountered something evil and rotten to the core, and recognising that something needs to be done, for society’s sake, to purge it of and prevent the re-entrenchment of said evil, which had at its helm (and still retains) some of the most evil animals ever to hold public office in this country and were and are responsible for the unnecessary loss of life and perpetuated suffering of untold numbers of our people. Plans conceived a decade ago are being progressively implemented whereby the public stand to lose the only natural health lifelines at their disposal, and you and the other ignorant respondents are about to put your seal of approval on the African chapter of that which will ultimately enslave humanity to the will of the New World Order.
You and your colleagues are but puppets of the NWO, its WHO front, and the medical-industrial complex. Pharmaceutical companies, including complementary medicines, are merely tools being used to achieve an end. None are truly concerned with health, but rather are obsessed with its antithesis, disease management. The New World Order capitalise on the greed of the pharmaceutical industry and world-wide, regulatory authorities are lobbied, bribed, infiltrated and manipulated, to belittle, suppress, and when all these methods fail, to finally expropriate the only remaining means to natural health. My colleagues and I devote often several hours each day or week, documenting and working against these developments. For you to criticise, rather than accommodate us, shows where your allegiance lies. You have no mandate to serve those trying to suppress the natural health resources of the nation. You are the public servant. Serve their interests!
I have personally, as have some of my colleagues, sacrificed my family life and recreational time as well as the growth potential of my business to fight this holy war. Those supporting the listing system, unwilling to fairly compete in the free market, do so to serve their own financial or vocational interests, engineering an unfair advantage over others. Our members contribute only to our essential travel and communications expenses. My own business, which is independent of the products we champion, sponsors the several hours which I selflessly spend each day researching and writing these detailed letters to you and others who would wield the sword against us in defense of their medical bastion. Paradoxically we are even sacrificing our health in the process, since the demands of protracted conflict are considerable, and we are not remunerated for our efforts. We fight purely on principle, rather than for profit. I, as an individual am only the scribe and the messenger. We do not need alliances or even a constituency, though it is encouraging to have support. As Gandhi said: "Even if you are a minority of one, the truth is still the truth." The truth will set us free.
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Finally, you claim that "You (I) have not even put a single proposal on paper. Once for progress, it would be of importance for you to put a proposal on paper, seeing that you refuse to meet with us as proposed." Once again, a deliberate lie. I will not argue against your intermingled statement that "For the benefit of the people of this country it would be appreciated if you send us a proposal", simply because I agree that our proposals will clearly be for the benefit of all the people of this country, but since this interpretation is irreconcilable with the rest of your letter, I will presume it to mean "send us a proposal so that we can sham consultation, representativeness and democracy, and get on with shoving our already developed, approved and up and running system through the statute books." This interpretation is more consistent with the trend, exemplified by MCC chair, Dr Rees affording PHARMAPACT a mere five minute presentation as the very last speaker at the 27 February "Public Meeting", despite our being first to request an early and longer slot.As far as your lies by way of "seeing that you refuse to meet with us as proposed" are concerned (you are getting almost as good as Dr Makhambene in this regard), consider first our constant complaint that we have never (before 26 February 1999) been afforded an opportunity to attend a legally constituted forum for the purpose under discussion (other than two public notices out of three sham Parliamentary hearings). Consider also the already mentioned treatment at the 27 February 1999 meeting (the first and only legally constituted MCC forum) and you ought to grasp the thrust of our position. Participation in this illegal process, especially at the crucial early stages when the unrepresentative and undemocratic structures were set up, and continuing up till now, has been deliberately selective and exclusive of those parties antagonistic to the pharmaceutical expropriation of natural health substances, and the process has as a result, from the outset been in the hands of those opposed to a competitive free market based on efficacy rather than singularly high quality criteria.
I have consistently, from the time of the non-democratic "election" of the Complimentary Medicines Committee, with all its allopathic bias, blatant financially vested interests and lack of representativeness and credible expertise, been attempting to have the process democratised, but to no avail. These attempts have been meticulously chronicled in my letter of 26 February 1999, so I will not repeat myself here. Also already dealt with previously and not to be repeated here, are the 3 November 1997 and 23 March 1999 MCC invitations, both declined because of MCC default in failing to comply with perfectly reasonable Sections 32 and 33 constitutional prerequisites. The alleged 23 March 1999 "invitation", was not even an invitation, but rather a response to our 9 March 1999 "demand" that we have a minuted meeting within 21 days. All of several other attempts to meet, including in Cape Town and Pretoria in October 1998 and February 1999, when our paths crossed, were at our request. Quite clearly, we are not refusing to meet with you, but rather you are making it impossible for us to meet with you by ignoring our considerable advances and repeatedly failing to meet even our basic criteria for progress to take place. The ball is back in your court.
As far as your lies to the effect of my having "not even put a single proposal on paper" are concerned, your ignorance, or gall in this regard are absolutely astounding. Besides the fact that the MCC have effectively, until recently, completely ignored all our legitimate approaches, including some 50-odd pages of unanswered registered correspondence from us, making it futile to attempt to advance our legislative proposals, and have been singularly backing the listing system from the outset and actively advancing its cause, your claim is nevertheless patently false, as is clearly evident in the documentational record below. We have sufficient evidence, by way of recorded procedural irregularities and constitutional breaches, to again topple the MCC upper hierarchy, not to mention more serious charges of genocide, even manslaughter being perpetuated by the new order for lack of commitment to their public mandate and in service instead, of the New World Order medical-industrial complex, against the interests of the nation. We have exhausted every available soft option, and failing this last attempt to finally turn events around to our satisfaction, we are headed for full-scale international expose¢ and criminal and civil proceedings against the MCC, Department of Health and Parliamentary Portfolio Committee on Health. We have no fear, for we work in the Light, with truth as our sword, and conviction as our shield. Some of us are prepared to die for our cause. Be warned. You are either for us, or against us. With or without you, we will win this holy war.
ÿ
In my first correspondence with the MCC on this topic, addressed to Dr Makhambene as Chairman, Complementary Medicines Committee, dated 16 January 1997 and tabled before full Council on 17 January 1997, we wrote as follows: (cc Zuma, Shisana, Baqwa, Nkomo & Hendricks)"
In this regard it is highly significant that the US Congress, via the Dietary Supplement Health & Education Act of 1994 were obliged to step-in to enact legislation to halt the FDA’s regulatory abuse with respect to natural health substances and thereby resolved four vexing issues as follows:1) Natural health substances have a unique statutory definition within the umbrella of food;
2) The FDA maintains the burden of proof to establish that a product is unsafe;
3) Natural health substances can have truthful, non-misleading statements as to how these substances affect human body functions and structures; and
4) Third party literature such as peer reviewed scientific articles can be used in connection with the sale of these products, provided the information is not false or misleading, so as to present a balanced view of the available scientific information."
"If Council is unfamiliar or out of step with these regulatory developments, it can make no claim to international professionalism and in any event its formal response on the possibility of submitting voluntarily to implementation of similar arrangements is sought with interest." This registered letter still remains unanswered more than two years later after several registered demands on 25.3; 23.10 & 13.11,1997.
For the record, as per earlier argument, we concluded my four-page letter stating that: "This communication represents but phase one of PHARMAPACT’s campaign on behalf of all prejudiced roleplayers." (We are prepared to provide the DSHEAct documentation to the transitional authority on a positive request.)
ÿ
On 20 January 1997 we wrote to the Minister of Health as follows: (cc Baqwa)"I offer the following documents as an introduction to recent developments and also my services in any possible manner likely to defuse the current situation and contribute to an equitable system of control in line with the Government’s health plan. I personally believe that some kind of fusion between the US and UK regulatory systems would be most appropriate and possibly this concept could be a starting point, since the FDA model is what we are stuck with and the UK model encapsulates the Western liberal tradition."
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On 29 January 1997 we wrote to Dr S Hendricks, Dept Health, as follows: (cc Zuma, Shisana & Nkomo)"Our position in this regard is firmly established by the United State’s congressional rebuke of the FDA’s prejudicial regulatory practices against the natural health substances industry, by way of timeous legislative amendments in the form of the Dietary Supplement Health and Education Act of 1994. This development is directly pertinent to our dilemma by virtue of Act 101/65 having been modelled on US legislation and the amendment being necessitated by similar regulatory abuse."
"Our position in fact is far more moderate than that adopted in the US in that we believe that a separate category and more socially responsible regulatory mechanism be adopted for those products occupying the grey area between health products/dietary supplements and genuine drugs/medicines. It is for this reason that we are proposing the adoption of United Kingdom’s licensing system for those products to be marketed as natural remedies suitable for specific non life-threatening conditions and where safety and efficacy are reasonably established." (Copies of the full text of DSHEAct were included in our submission)
(Note: Dr Steven Hendricks was appointed by Dr Shisana as CMC/Dept of Health liason. On instruction by the Director-General, Dr Hendricks contacted me telephonically to mediate a solution. D-G, Dr Shisana, after consultation with the MCC, was however not prepared to entertain our alternative regulatory model. Pers comm Dr S Hendricks, 12-3-97. Our letters 29 January 1997 and follow-up of 26 March 1997 were simply never acknowledged, nor replied to. The last discussion was at my irate initiative.)
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On 6 June 1997, I delivered a verbal presentation to the Parliamentary Portfolio Committee on Health, making reference to the US Dietary Supplement Health and Education Act of 1994 (a full copy of which was included as part of PHARMAPACT’s written submission of 78 pages) as "legislation which strikes a balance between safety, efficacy, and the consumer’s access to information and freedom of choice". Reference was also made to the fact that Dr Hendricks, the D-G’s representative had referred us to the Parliamentary Committee as the correct forum to raise the issues under discussion. This "hearing" was a sham, my being forced to combine my Gaia Research Institute and PHARMAPACT presentations into half the time otherwise available since only three hours were allocated to all submissions on the MRSC Amendment Bill, a situation which I had advised the Committee organisers of almost a month before, would be insufficient time. Moreover, for the greater part of the proceedings, after the MCC presentation, the Committee had thinned-out to only a handful of members, and as a final insult, our pile of printed PHARMAPACT written submissions, of which none were even circulated amongst Committee members, had mysteriously been removed before the end of the proceedings, making it impossible to raise an objection.°
On 18 September 1997 we presented to renewed Parliamentary Portfolio Committee on Health public hearings, essentially the same documents insofar as they related to our regulatory proposals, adding inter alia:"Kindly note that due to the current free reign of the MCC over its own affairs, both the Minister and Director General of Health have been unable to intervene in these matters and hence Dr Steven Hendricks, D-G's representative has specifically referred PHARMAPACT to the Parliamentary Portfolio Committee on Health as the correct forum at which to raise these issues. Included is a copy of the US Dietary Supplement Health and Education Act, and a precis thereof for detailed legislative analysis." Once again, I was unacceptably forced to share half of the time for both constituencies. My presentation was furthermore cut short on my having described earlier false testimony by O’Brien and other pro-listing presentations as "utter bullshit", in reference to their blatantly lying about the critical issues of democracy, representativeness and unanimity of the system by all role-players supposedly supporting the listing system. In the altercation that followed between Dr Nkomo, dictatorial chairman of the Committee and myself, the honourable Committee members (of which few were still in attendance), Mrs Baloyi and Njobe defended our position and promised an additional hearing with PHARMAPACT. Nkomo simply disallowed this.
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On 18 September 1997 we wrote as follows to Dr Nkomo: (cc Baloi & Njobe)"We reiterate our request for an adequate opportunity to properly present our position on the above issues to the Committee, especially in the light of yesterday’s fiasco where we were allocated a mere 15 minutes, in spite of earlier requests for sufficient time, or alternatively a private presentation to the Committee to which we were specifically referred by the Department of Health to properly deal with these issues some six months ago. As could clearly be deduced from yesterday’s situation, these are very serious issues indeed and we would like you to honour the commitment to afford us a private presentation as promised by the honourable Committee members, Mrs Baloyi and Njobe. Please accept my apologies for yesterday’s outburst and choice of language, which was regrettably necessitated by the circumstances at hand." No reply was received.
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On 6 October 1997 we again wrote to Dr Nkomo as follows: (cc Zuma, Baloyi & Njobe)"We refer you to our urgent faxed letters of 24 August and 8 September and also our letters of 12, 16 and 18 September protesting lack of reasonable attention to these requests and hence zero progress in this regard and without which insight it is simply not possible for the Committee to make informed decisions. We also wish to record our protest at the pathetically poor Committee attendance at the afternoon session of the hearings on 17 September, (again an exodus after the MCC session) which situation casts seriously in doubt the integrity of the process of lawmaking and hence our ability as citizens to obey such laws."
The PPCH’s responses have under Dr Nkomo’s dictatorial chairmanship, approximated that of the old MCC.
"Kindly take cognisance of our further protest that to date, other than a brief heated exchange of words with yourself and the other two chairmen, all of whom denied me my constitutional rights of equality, freedom of expression and just administrative action within the sanctity of Parliament itself on 17 September, we have still not received even the courtesy of a reply to any of our communications and hence are forced by simple logic to question whether you and the other chairmen are capable of exercising the impartiality required to head the Committee or its hearings and whether you have not perhaps been unduly influenced and compromised by amongst other things, the false testimony given in June and repeated in September by eg. Professor Fold and Dr Michael O'Brien." The pro-listing camp repeatedly claimed full CMC democracy.
"We also wish to commend the few Committee members who did make the effort to attend the afternoon session on 17 September and especially the honourable members Mrs Njobe & Baloyi, who raised their voices in support of our desperate appeal to properly deliberate these issues with the Committee, and their personal committment to ensuring that we are afforded the necessary opportunity to do justice to this matter. We trust that we have misjudged your suspected complicity in any of the above and that you will see your way through to urgently accommodating our requests for an opportunity to properly present details and proof of the aforementioned very serious developments to the Committee." No reply to a single letter to date.
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On 23 October 1997 we wrote to Mrs Baloyi as follows: (cc Zuma, Shisana & Baqwa)"Regarding our proposals, PHARMAPACT have for the past year (see letter to Dr Steven Hendricks dated 29 January ‘97 and our September 17 submission to the Parliamentary Portfolio Committee on Health) been calling for the adoption of a suitably modified version of the US DIETARY SUPPLEMENT HEALTH & EDUCATION ACT OF 1994 as passed by the United States Congress (Public Law 103-417-Oct. 25, 1994) as submitted in original form to your Committee, as a regulatory solution for energy, homoeopathic, herbal and nutritional substances."
"We furthermore propose a similarly modified version of the United Kingdom’s PRODUCT LICENSING SYSTEM for natural "medicines", where medicinal indications are required. These two models represent the most liberal and uncomplicated systems internationally and could be further simplified to suit our 2nd World conditions and be ready for implementation within mere weeks, if the process were to be handled by the Dept. of Health without dominance by the MCC and the previously mentioned vested interests."
"PHARMAPACT, who have stood steady on the moral and democratic issues involved, are willing to participate in the proposed deliberations provided that all roleplayers are invited to participate in the proceedings, by public notice, after the preliminary discussions required to level the playing fields have been concluded, with PHARMAPACT as full participants. We propose that the absolutely simplest systems be adopted, since there have been absolutely zero problems with the free availability of these substances in South Africa, without restrictive regulation. The MCC ought to get on with their original mandate of protecting the public from toxic drugs, to which they appear to be turning a blind eye."
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On 1 November 1997, PHARMAPACT’s regulatory proposals, a year in development, were released as a memo to external interested parties in summary form. The introductory paragraphs stated the following:"Exactly one year ago, the Director General, Dept. of Health, hosted a meeting (not by public notice) titled "Natural Health Substances & The Enforcement of Act 101 of 1965". This subject was strategically perverted by the MCC to encompass what they preferred to classify as "complementary medicines" and thereby serve their own hidden agenda which blurred an essential distinction which only we have maintained. PHARMAPACT's policy on legislation for "Natural Health Substances" was set out as early as January 1997 in official correspondence with the Dept. of Health and reiterated in a stream of official correspondence." These proposals are appended to this document with updated explanatory detail.
°
On 13 November 1997 we again wrote to Mrs Baloyi as follows: (cc Zuma, Shisana & Baqwa)"Further to our 22 October discussion and 23 October letter, we have prepared a synopsis of our proposals which we trust you will agree are fair and reasonable and further meet the essential criteria of clarity and simplicity, so lacking in current proposals before the MCC.
"We would appreciate your consideration of this document as the basis of our fundamental position, and the more detailed US legislation referred to the Committee, as the working document for pro-active natural health substances. As far as post-active natural therapeutic substances are concerned, the UK legislation is freely available in eg the publication "Pharmacy Law and Practice" (Blackwell Science) and this can serve as the working document, suitably trimmed of exclusively allopathic criteria and other unnecessary regulations. We would dearly appreciate your meeting with and discussing these proposals with Dr Shisana, if not with the Minister herself, whom we know is hard pressed for time."
When it finally became evident that the MCC, Dept of Health, Parliamentary Committee and even the Public Protector were not prepared to put themselves out to ensure equity in this matter, PHARMAPACT’s negotiation policy was out of necessity, progressively changed to one of legally eliminating the hierarchy. This took the form of preparation for legal action and also our genocide expose¢ . After detailed attentive disclosures to the Medicines Regulatory Review Task Team, we decided to withdraw from collective legal action in the hope that the MRRTT might solve the problem, which it did, by leading to the sacking of the MCC upper hierarchy, but only temporarily, since the new transitional appointments (Rees & Matsoso) regretably almost immediately began supporting the original agenda, probably not even aware that they were serving the old master-plan. The external members of the MRRTT were however strategically chosen to further Folb’s listing pharmaceutical expropriation model, which significantly had its genesis in Norway and Australia, from whence Dukes and Hill not coincidentally respectively hail. After a period of intense research and formation of alliances, we again find ourselves planning increased public expose¢ , including international lobbying and increasingly, aggressive legal action.
26 October 1998 saw PHARMAPACT’s illegal expulsion from Parliament, putting us in the unique position whereby the SAMMDRA Act has been rendered unconstitutional from our perspective, and hence any regulations not meeting our approval, having invalid jurisdiction. Proof of various actionable activities being perpetuated by the transitional leadership of the MCC and to be unleashed if the MCC continue to endorse the listing system, will prove decisive in a final showdown in the courts, and will expose to the entire world the death machine soon to be launched as the SAMMDRA.
Our next major PHARMAPACT documents, assuming that genuine negotiations do not begin shortly on our terms, will critique the MCC proposed regulations, and serve as the basis for legal action should they be promulgated. By this time the entire health sector will be aware of the devastating pharmaceutical expropriation of natural health substances trap into which they have been blindly led by the Health Products Association and Chiropractors, Homoeopaths and Allied Health Service Professions Council of South Africa. Why are CHAHSPC and other professional associations so involved but the ICC deliberately excluded? The MCC, Dept of Health and Parliamentary Committee are extended one last chance to resolve these issues.
Yours Sincerely
Stuart Thomson & Anthony Rees, National Co-ordinators, PHARMAPACT
cc Hon Minister of Health Dr Zuma; Public Protector, Adv Baqwa. (Appendix follows)
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APPENDIX
Note: This document was created on 1 November 1997.
Recent additions (in italics) add a little more explanatory detail. Stuart Thomson, 30 April 1999
MEMO: TO PHARMAPACT MEMBERS & INTERESTED PERSONS/PARTIES
SUBJECT: NEW LEGISLATION (REGULATIONS) FOR NATURAL HEALTH SUBSTANCES
1. Natural Health Substances: Pro-active (Health Products)
No claims permitted relating to disease conditions on label, (package insert), or promotional literature, but permits unrestricted distribution of peer reviewed journal material and scientifically substantiable magazine articles, provided that the substance and not the product are mentioned "in context".
However, permitted are substantiable claims relating to function and structure i.e. health building / maintenance educational claims (not mentioning disease conditions) on label, (package insert) and promotional literature, including in-house material. Traditional cultural names permitted if not diseases.
Solution: Adoption of a simplified version of the 1994 US Dietary Supplement Health & Education Act (DSHEA). Bottom line: MCC has no jurisdiction. Food and Toxicology Directorate has jurisdiction, to ensure food safety standards, or if toxic. Existing legislation applies/modified. If disease indication or claims made, then product automatically eligible for category 2.
We do not consider the above-mentioned in this context to be medicines. The SAMMDRA definition of a Complementary Medicine as "any substance complementing the healing power of the body" is absurd. Furthermore, natural therapeutics can hold their own and the term "complementary" is derogatory.
2. Natural Therapeutic Substances: Post-active (Complementary Medicines)
Claims permitted relating to disease conditions on label, insert or promotional literature, including journal articles, providing for the product also to be mentioned, including in-house material. Claims to be scientifically substantiable via pharmacopoeia, textbooks, encyclopaedia, journal articles and original research. Substantiable traditional cultural claims permitted provided that usage is well-established and historically pure (100 years), limited to self-limiting conditions, and that it is not already or subsequently established by modern science as useless or hazardous (capable of causing significant adverse reactions).
Solution: Adoption of a simplified version of the UK Product Licensing System. Bottom line: No disease condition claims unless scientifically substantiated, except for traditional cultural claims, which are subject to review in the face of scientific challenge. (The listing system is substitutable for the Product Licensing System, provided that it is purged of all scientifically unsubstantiated indications and pseudo-scientific references such as eg the homoeopathic pharmacopoeia and materia medica, in which case single remedies would simply bear no indications and would fall into category 1 above if lactose tablets or powders, or under alcoholic beverages within the food "quality" legislation if EtOH / H2O drops.)
Randomised placebo controlled trials mandatory for homoeopathics and other non-scientific modalities.
Two options (for administration of category 2.):
1. Possible Option. MCC has jurisdiction, but only if disbanded and completely reformed to include "equal representation" from non-allopathics and proceedings fully transparent. No industry members.
2. Preferred Option. MCC has no jurisdiction. Dept. of Health has jurisdiction via a sub-directorate with a representative Council and proceedings fully transparent. No one from industry or linked to industry.
Interim Solution: MCC has no jurisdiction if no disease condition claims/indications for natural health substances. MCC jurisdiction over existing applications via a new and representative Natural Therapeutic Substances Committee with decision making powers and use of secretariat. This Committee composed of researchers, educators and practitioners having no pecuniary links to industry. This is a temporary solution until a separate Natural Therapeutic Substances Council is constituted by new legislation / regulations.
Full transparency essential and both NTS Committee and final NTS Council to be open to criminal and civil action iro their decisions, if appealed decisions on the basis of the scientific or constitutional aspects are unresolved in disputed decisions, ie no indemnity against legal challenge and litigation.
The End Result
Legislation which promotes both pro-active natural health products and post-active natural therapeutic products in a deregulatory fashion, whilst protecting the consumer from toxicity and unsubstantiable claims. Regulations which restrict the regulatory authority’s jurisdiction to food quality standards, false and substantiated claims and real issues of toxicity or significant health threatening adverse reactions.
NHS (Food, herbs & supplements) – Food quality & safety. NTS (Complementary medicines) – Moderate to high GMP *quality, safety & **efficacy, relative to degree of *processing & **claims.
The Key To Success
Keep it clear and simple. Not pay mere lip-service as does the Medicines Control Council, to safety, efficacy and consumer protection. Keep vested financial interests out of the equation and be guided by noble intention to serve consumers first and the service providers secondarily. Keep regulations to an absolute minimum and ensure that administrators (The Committees and Councils) do not become the lawmakers (without full public hearings and critique on proposals) and are accountable for their decisions.
STUART THOMSON
National Co-ordinator, PHARMAPACT
ANTHONY REES
Co-Co-ordinator
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Mrs Precious Matsoso 24 March 1999
Registrar of Medicines By Urgent Fax
Medicines Control Council
Dear Mrs Matsoso
MEDICINES CONTROL COUNCIL REGULATORY TYRANNY AND CORRUPTION: COMPLEMENTARY MEDICINES COMMITTEE CREDIBILITY CRISIS AND PROPOSED ILLEGAL LISTINGS PROCEDURE
.Dept. Health Refs: D3/2/2/4 & 5; and 41/11/15/1/2; MCC Refs: 26/6; 26/6/2/1; & 26/7/10 COMPL 3109.
I trust that this finds you well.
Thank you for your faxed letter of 23 March 1999, confusingly addressed incorrectly to my colleague Dr A Rees, SA Herbalists Association, but yet to my fax number and quoting my correspondence date and correct subject heading. I am therefore going to assume that you were indeed responding to my 9 March letter, even though you also apparently incorrectly refer to the PHARMAPACT group therein as "your company".
For various reasons we are reluctant to simply accede to your request that we meet with you on 6 April since in fact, we have requested this meeting, subject to basic criteria, which have not been met within the requisite time-frame. I refer specifically to our minimal prerequisites, namely that we should meet with all four respondents at one sitting, and that we receive a detailed written response from each respondent to our letter of 9 March and its attachment dated 26 February, one week prior to said meeting. We do not consider this to be unreasonable, since our letter of 26 February has been time enough in receipt. Regretably, none of the other respondents has seen fit to even acknowledge receipt, let alone reply, and you do not indicate a mandate to negotiate on their behalf. This arrogance is typical of the insults we endure.
Time is running-out, and if not rectified "immediately", this opportunity will be lost until possibly late-April at the earliest, since my colleague, Anthony Rees, will be attending a health freedom rally in north America as a guest speaker, where he will also be collecting pledges towards our legal campaign, widely considered by many to be crucial to future international success against global regulatory tyranny towards natural health products and their prejudicial planned strategic pharmaceuticalisation, without scientific or ethical rationale.
We are reluctant to once again waste our time and travel at our expense to Pretoria without the mentioned prerequisites, especially in view of the manner in which we were treated at the 26 February public meeting, where explaining that it was the first meeting in 2 years which we were able to legally attend, we requested 20 minutes to deliver a presentation on our viewpoint as early as possible in the proceedings, but instead were afforded 5 minutes, as the very last speaker to address the meeting, and where our constituency were repeatedly denied equal opportunity to put forward their views and raise matters of serious vested interests both within and without the MCC, yet speaker after speaker, supportive of the elusive proposals, were allowed earlier and protracted opportunity to voice their opinions.
We will incidentally, be processing a claim through the Small Claims Court for our expenses for that trip, not iro the above-mentioned ill-treatment, but more specifically because of the wasted expense arising out of the mis-advertised purpose of the meeting of 27 February, namely:
simply never materialising, and by all accounts was never intended to, since the meeting was prematurely drawn to a close at 1 pm, in spite of my protesting this unexpected announcement without the purpose of the meeting having to any degree been realised, whereas when we made enquiries earlier in the week, we were told by Isaac Mayeng, to whom we were specifically referred, that the meeting would take as long as necessary to finish the advertised purpose, and had confirmation of an opportunity for role-players to interact.
It is our impression that the meeting was a mere window-dressing by the MCC to late sham transparency, representativeness and democracy to counter our legitimate criticisms in this regard over the past 2 years. We are aware that only 30 persons were originally catered for, until it became apparent that PHARMAPACT and its allies, the ICC, would be arriving en masse. If it were not for the short notice and the late change of venue, we would have had 300 members at the meeting, two busloads having got lost, 500 if not for the late notice.
We have received 1 out of 4 replies, none meeting our prerequisite criteria. If the State will cover our expenses, we will risk wasting our time by attending the suggested meeting with you, without these criteria having been met. If not, these criteria will have to be met immediately, otherwise all respondents are equally responsible by default, adding further insult to injury, and clearly declaring their arrogant pro-war intentions.
It is an insult to PHARMAPACT to be summonsed to Pretoria without the requested minimal signals of goodwill. We do not see how we can possibly, in one hour, cover the necessary ground without having first received at least the courtesy of minimal reciprocal effort from the respondents, since we are in fact entitled to replies to all of the unanswered correspondence referred to in our letter of 26 February, as well as to that and subsequent correspondence, not to mention the empty goodwill promises made by both the Chairperson and Registrar, MCC on numerous occasions, of the full documentation on the listing procedure, so that we could provide a critique thereof and consider the possibility of salvaging at least some of its components.
Yours Sincerely
Stuart Thomson, Director, Gaia Research Institute, National Co-ordinator, PHARMAPACT.
Anthony Rees, Chairman, SA Herbalists Association, Co-coordinator, PHARMAPACT
cc Dr A Ntsaluba; Dr H Rees; Dr P Makhambene; Hon Minister of Health, Dr NCD Zuma; Public Protector.
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9 March 1999
By Registered mail
Dr Ayanda Ntsaluba, Director-General, Dept. of Health;
Dr Helen Rees, Chairperson, Medicines Control Council;
Mrs Precious Matoso, Registrar, Medicines Control Council;
Dr Peter Makhambeni, Chairman, Complementary Medicines Committee.
Dear Sir/Madam
MEDICINES CONTROL COUNCIL REGULATORY TYRANNY AND CORRUPTION: COMPLEMENTARY MEDICINES COMMITTEE CREDIBILITY CRISIS AND PROPOSED ILLEGAL LISTINGS PROCEDURE
.Dept. Health Refs: D3/2/2/4 & 5; and 41/11/15/1/2; MCC Refs: 26/6; 26/6/2/1; & 26/7/10 COMPL 3109.
You are referred to my letter of 7 October 1998 to the Registrar and to my letter of 26 February 1999 to the above respondents, the import of which ought to have been worthy of your urgent attention, yet the subsequent BBRG meeting of 9 October 1998 and the 27 February 1999 public meeting, does not give us an iota of hope of a resolution to this crisis, since neither of you appear to have altered your apparent commitment to the long-standing unconstitutional and illegal course embarked on over two years ago and stubbornly maintained ever since, in spite of our long record of registered protest as chronicled in the attached letter of 26 February 1999.
That the 9 October 1998 meeting launched into the familiar authoritarian rhetoric, apparently undeterred by the appalling facts again drawn to the attention of the Registrar, MCC just a day before the BBRG meeting, and in particular, the opposition expressed at that meeting towards the CMC/BBRG and the "Listing Procedure" by the undisputed major role-players, the ICC and it’s ally PHARMAPACT, both of whom were deliberately excluded from the process from the outset, bodes ill for future co-operation and compliance, since you are all content to pay mere lip-service to addressing the serious vested interest, non-representative, non-democratic and non-transparent illegitimate creation which you are illegally propping-up, in disregard of our constitutional rights.
If you are as honorable as you publicly portray yourselves and would have us believe and truly wish to redress the documented wrongs of the past, we would expect you to at least demonstrate minimal goodwill by resolving the main obstacles meticulously chronicled in summary form in the attached 26 February 1999 letter to all of the above respondents so as to further minimalise the effort required for you to act in accordance with our constitutional and common law rights in this most distasteful of matters repeatedly brought before you to no avail and which if not addressed to our satisfaction, will leave us no option but to pursue this matter in courts.
All of the above respondents are referred in particular to the relevant clauses in the Bill of Rights of the Constitution of South Africa, Act 108 of 1996, which are once again hereby formally invoked as follows:
Section 1. Supremacy of Constitution
This
Constitution is the supreme law of the Republic; law or conduct inconsistent with it is invalid and the duties imposed by it must be performed.
Section 7. Rights
(2)
The State must respect, protect, promote and fullfill the rights in the Bill of Rights.Section 8. Application
(1) The Bill of Rights applies to all law and binds the legislature, the executive, the judiciary and all organs of state.
Section 9. Equality
(3) The State may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including.... ethnic or social origin, conscience, belief...or culture.... .
(4) National legislation must be enacted to prevent or prohibit unfair discrimination.
(5) Discrimination on one of more of the grounds listed in subsection (3) is unfair unless it is established that the discrimination is fair.
(Onus is on the respondents to establish in court that the discrimination is fair.)
(This section is invoked in terms of allopathic bias, discrimination against the International herbal traditions without equal treatment of the African herbal tradition, which represents too hot a political potato, and further the double-standard in supporting fraudulent homoeopathics whilst discriminating against genuine nutritional and herbals.)
Section 12. Freedom & Security
(2) Everyone has the right to bodily integrity and psychological integrity, which includes the right:
(b) to security in and control over their body.
Section 14. Privacy
Everyone has the right
to 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 communciations infringed.
Section 15. Freedom of ... Belief .... .
(1) Everyone has the right to freedom of .... belief .... .
Section 16. Freedom of Expression
(1) Everyone has the right to freedom of expression which includes -
(a) freedom of the press and other media;
(b) freedom to receive and impart information and ideas; and
(c) academic freedom and freedom of scientific research.
Section 32. Access to Information
(1) Everyone has the right of access to -
(a) any information held by the State; and
(b) any information that is held by another person and that is required for the exercise or protection of any rights.
(2) National legislation must be enacted to give effect to this right .... .
Section 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.
(3) National legislation must be enacted to give effect to these rights and must -
(a) provide for the review of administrative action by a court, or where appropriate, an independent and impartial tribunal;
(b) impose a duty on the State to give effect to (1) & (2).
Section 34. Access to Courts
Everyone has the right to have any dispute that can be resolved by the application of law decided in a court or where appropriate, another independent and impartial forum.
Section 39. Interpretation of Bill of Rights
(1) When interpreting the Bill of Rights, a court, tribunal or forum -
(a) must promote the values that underlie an open and democratic society based on human dignity, equality and freedom; and
(c) may consider foreign law.
(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.
Every single right listed above has been violated by the MCC, Department of Health and Parliament but we draw your attention in particular to those aspects which are accentuated in bolder print as being our priority concerns for immediate attention, if outright war between the respondents and PHARMAPACT and some of its allies is not to be declared after the illegal promulgation of regulations based on the foregoing and attached extremely serious infringements of our fundamental and sacred constitutional and common-law rights.
We are already in a legal position where we are not obliged on constitutional grounds to recognise SAMMDRA as valid, and should the above matters proceed as per current trend, we shall neither have any legal obligation to recognise the resultant regulations as valid, also on constitutional grounds, and the above respondents shall bear full responsibility for this state of affairs. We demand a minuted meeting within 21 days with all respondents at one sitting and a prior (14 days) detailed written response to this letter and its attachment from each respondent.
Yours sincerely,
Stuart Thomson, Director, Gaia Research Institute, National Co-ordinator, PHARMAPACT
cc The Honourable Minister of Health
The Public Protector