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Microsoft word - tnha - comments on r. 37995

THE TRADITIONAL & NATURAL HEALTH
ALLIANCE
COMMENTS IN TERMS OF REGULATORY NOTICE R.37995
"General Amendment Regulations made in terms of the Medicines and Related Substances Act, 101 of 1965" Released: 12 December 2014
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. Holy Bible, New King James.

To: The Director-General
Department of Health
Private Bag X828
Pretoria, 0001
COMMENTS ON THE REGULATORY AMENDEMNTS FOR
COMPLEMENTARY MEDICINES

Attention: Ms. Malebona Precious Matsoso
Comment was invited to the draft Amendments to the General Regulations to the Medicines Act (Government Gazette No. 37995, published on 15 September 2014), published on 15 November 2013. We would like to place on record that TNHA was unable to consider commenting on these draft Amendments until the 26th of November 2014, due to the fact that there were no accompanying Guideline documents which defined the new categories of products envisaged to be regulated (i.e. ‘health supplements'). As a result we had less than three weeks to respond once the guidelines were finally published, and not the 90 days afforded by the original draft Amendments. A letter to you was sent by the TNHA on the 26th of November 2014, requesting an extension to the comment period for the draft Amendments, in order to synchronise the comment period cut-off date for the draft Amendments and the Guidelines, so that the comment process and timeframe would be procedurally fair. We have not yet received an acknowledgement thereto. (See Reference Documents, page 13) Our comments follow below. Natural medicines have been divided into ‘Category A' [Pharmaceutical Drugs] and ‘Category D' [Complementary Medicines]. We believe this is fundamentally flawed. CAMs do not generally cause serious side-effects or death when used in the recommended doses because their intended use is different to that of the biomedical paradigm. (See Appendix A, page 6). We believe that all natural health products should be regulated only by regulators, assessors and practitioners who are trained in, and understand the Integrative/Traditional Medicine paradigm, its philosophy and language. The TNHA rejects the current CAMs regulations under the current MCC (and what will become ‘SAHPRA'), and seeks a separate regulatory authority for CAMs and African Traditional Medicines from pharmaceutical medicines. Our regulatory proposals in this regard are currently being formulated, and a substantive submission to the Parliamentary Portfolio Committee for Health in this regard will occur early in 2015. The current MCC Council, envisaged SAHPRA Board, and current and future medicines registration assessors are constituted of biomedical (pharmacology / pharmacy) experts who are not trained in natural medicines, and have little understanding of the sector or the substances contained in the current CAMs regulations. The natural health product sector comprises of +/-14 000 health products currently traded on the market according to applications received by the MCC after the 2002 Call-up / Audit Notice (R. 204). A call-up roadmap spanning five years was imposed in conjunction with the CAMs regulations published on the 15th of November 2013 (R. 870). We are aware that at present there is a 4-5 year backlog in the registration of some 3000+ existing ‘Category A' medicines[pharmaceutical medicines], which the MCC have exclusively assessed for safety, quality and efficacy since 1965. This severe backlog is widely known to be the result of major capacity restraints, lack of good governance and legislation which has not kept up with the times. To expect these 14,000 CAMS products to now undergo the exhaustive and costly research and development required (by submission of ZACTD applications forms in most cases), plus expected MCC registration approval delays within the timeframes imposed, is a practically and logistically impossible. Although the first call-up took place on the 15th of May this year for antiviral agents, oral glycaemics, cardiac medicines and cytostatic agents, we have learned that only 15 products out of hundreds of known products in these respective categories have been submitted for registration, and not one having yet been registered or rejected. These draft Amendments and their principal Regulations remain excessively restrictive, vague and irrational; hence the majority of industry rejects them and has resorted to launching a court application to have them stuck down. We support the Health Products Association in this regard, and are ready to launch our own separate application on Constitutional matters arising if the status quo remains, or if our members are subjected to enforcement activities which prejudice their businesses or practices. We are of the opinion that the current legal lacuna created by the CAMs regulations makes it impossible for small and medium sized manufacturers (the majority) to comply, and they are as a result unlawful. We also reject the totally pre-selective, pharmaceutically biased, unrepresentative, uncommunicative and non-transparent nature of the development of the CAMs Regulations and these Amendments to date. We further the manner in which your Department published CAMs regulations (R. 870) without prior notice in November 2013, and without broad-based stakeholder consultations. The Department's opinion that the Draft Regulatory Notice for CAMs in July 2011 (R. 587) was the starting point for the November 2013 Regulations (R.870) is rejected. There was a two and a half year silence from the MCC, then promulgation without further consultation. This was highly irregular and therefore ultra vires. We are also of the opinion that the Draft CAMs Regulations of 2011 (R. 587), the CAMs Regulations of 2013 (R. 870), and these Draft Amendments of 2014 (R. 37995) are by extension all ultra vires. Up until the date of the closing of comments for these draft Amendments, the principal Medicines and Related Substances Act (Act 101 of 1965) has no medico/legal definition for ‘Complementary Medicine' of the products in the natural health product sector. In the absence of a definition for ‘Complementary Medicines' or ‘Health Supplements' in the principal Act, all existing regulatory drafts, promulgated regulations and amendments for natural health products contained therein are ultra vires and hence invalid. Until there is an unambiguous, stakeholder and MCC agreed definition for CAMs in the principal Act we do not view the published regulations or amendments as lawful or constitutionally valid. The Department's unilateral ‘Legislation by Regulation' for this massive health sector is scandalous, considering the widespread implications of CAMs regulations on public health, and the negative impact on the choice of citizens to utilise the health products of their choice in maintaining sovereignty over their bodily integrity. In terms of Chapter 2, Section 12(2) of the Constitution of the Republic of South Africa (Act 108 of 1996), everyone has the right to bodily and psychological integrity, which includes the right to security in control over their body. Citizens also have the inalienable right to health, which we believe will be severely infringed upon by these regulations. The CAMs Regulations and these draft Amendments create restrictive barriers to exercise these freedoms and are therefore rejected. In terms of the separate paradigm used in the integrative health fields using natural health products, the TNHA believes that the biomedical bias imposed on the CAMs industry runs roughshod over the thoughts, beliefs and opinions of the natural health sector. This is in violation of section 15 of the Constitution. By capriciously limiting the imparting of health promoting and restorative claims on natural health products, violates Section 16 of the constitution, which guarantees freedom of expression, including the freedom to impart information and ideas, and academic freedom in terms of scientific research. The Department's sidestepping of the legislature (National Parliament) and the democratic process, by not creating a negotiated regulatory framework for CAMs, was and remains unacceptable to us. Further, the unilateral and overzealous regulation of CAMs (traditional medicines of non-indigenous origin), and the non-regulation of our local indigenous traditional medicines simultaneously is discriminatory in terms of Section 12 of the Constitution of South Africa. (Equality & Discrimination) We have learned that the Department of Health has misinterpreted the WHO Traditional Medicines Strategy guidelines, which proposes that local indigenous traditional medicines must be regulated separately to other non-indigenous traditional medicines. This has occurred without due regard of our Constitution, which is the supreme law of our Republic. The supremacy of the Constitution and the rule of law must underpin all legislation and regulation passed since 2006. The Constitution is the supreme law of the Republic; law or conduct inconsistent with it is invalid, and the obligations imposed by it must be fulfilled. It is erroneous for the Department to be wholly influenced by international framework guidelines, without first screening its laws through the Constitutional litmus test. In terms of the ‘Equality' section of our Constitution, the State (including your Department) may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including race, ethnic or social origin, belief, culture. National legislation must be enacted to prevent or prohibit unfair discrimination. The CAMs regulations of November 2013 (R. 870) unfairly discriminate against CAMs stakeholders of both the non-indigenous and indigenous traditional health sectors. By creating and perpetuating separate (apartheid) laws governing traditional medicines of different cultures and ethnic origins separately under the Medicines Control Act, the current Regulations for CAMs and the draft Amendments are in our opinion, unconstitutional. Discrimination on these grounds is unfair, and we intend to vigorously oppose such discrimination in the Constitutional Court if the Regulations published on the 15th of November 2013 (R. 870) and these Amendment Regulations (R. 37995) are not withdrawn soonest, or when selective enforcement against the CAMs sector occurs. We reject the ‘regulatory creep' that has taken place over the last four years in terms of CAMs regulation, and what appears to be deliberate vagueness written into the regulations, reinterpreted by successive amendments and ever-changing guidelines that reflect the expedient whim of the regulators. We reject having to continually comment on amendments and guidelines that speak of the ‘current thinking of the Medicines Control Council'. We demand full disclosure, through negotiation, of the way ahead before accepting any such regulations or guidelines. The TNHA will therefore not be commenting on any further draft Amendments or Guidelines until the exiting CAM's regulations are withdrawn in their entirety and all stakeholders have been invited to the same table to create appropriate regulations in a transparent, democratic, equitable and inclusive process. The TNHA Executive Committee Appendix A
Comments by Dr. Bernard Brom (Chairman: TNHA)
We have two major concerns: A. The first is with the definition of Complementary medicine (Category D), in general, and in its detail. General: Natural medicines have been divided into ‘Category A' (pharmaceutical drugs) and ‘Category D' (Complementary Medicines). This is fundamentally flawed. Natural medicines do not cause nearly as many serious side-effects or death when used in the recommended doses because their intended use is different to that of the biomedical paradigm. Therefore, all natural medicines should be regulated only by regulators and practitioners who understand this paradigm and the language of this paradigm. A council which is largely made up of biomedical experts is not competent to make decisions about natural medicines of which it has little understanding. Including natural medicines in ‘Category A' is therefore a travesty. Detail: The amended definition in this Draft Amendment states that: It is highly problematic that the Council determines what an "other substance" is. This is (i) vague and (ii) requires the expertise of a Council of Integrative/Traditional Medicine experts, and not a medically-biased Council (see our argument above). (i) as a health supplement
This has not been defined in this particular regulation, and we have not had enough time to study the guidelines. We will address it in a later submission on the guidelines. B. Our second concern is the Amendment of Regulation 25. Many natural medicines have been placed in ‘Category A' according to the biomedical paradigm's understanding and use of medicines, which is very different from that of Integrative / Traditional Medicines. This is unacceptable to practitioners of Integrative / Traditional Medicine, as they are not used in the way as described by the biomedical paradigm. In all the above cases the products are used to support health according to our paradigm, i.e., as an ‘adaptogen'. (bring the body back to its homeostasis) These are not drugs, which are powerful enough to block biochemical processes and should not therefore fall into ‘Category A'. ‘Category A' should be reserved for powerful chemicals for which purpose is to act according to the biomedical paradigm and to block physiological processes, and which can cause serious side-effects or even death even when used at the recommended dose. DEFINITION OF A NATURAL MEDICINE, AND HOW THEY WORK
The definition of a ‘natural medicine' must take into account an understanding of the paradigm in which that natural
medicine is used. (A lay person may use the word ‘wave' in a very different context to that of a physicist.)
From the perspective of Integrative/Traditional healing systems, a medicine may be a food, a herb, a nutritional substance that is used to enhance the functionality of the living system. All these substances have a number of properties in common:  They are complex (in the case of herbals);  They enrich, enhance the natural innate healing potential of the body;  They are recognized by the body as natural in the majority of people. The terminology used by these Integrative/Traditional practitioners should not be confused with the terminology of
the Biomedical paradigm
For example: Anti-inflammatory Action of Drugs vs ‘Natural anti-inflammatory medicines'
THE BIOMEDICAL PARADIGM
Drugs which are anti-inflammatory block certain biochemical processes in the body which are inflammatory producing. This is an extract from Medscape, which explains the "Mechanisms of COX Inhibition by NSAIDs": "All  NSAIDs  variably  inhibit  COX‐1  and  COX‐2  and  the  mechanisms  of  inhibition  fall  into  three broad categories, although there are exceptions. For example, nimesulide is a weak competitive inhibitor  of  COX‐1  but  a  potent  time‐dependent  inhibitor  of  COX‐2,  whereas  celecoxib  exhibits slow  competitive  binding  and,  at  higher  concentrations,  binds  irreversibly.[26]  The  three categories are:  The body has both inflammatory and anti-inflammatory processes. These are natural innate intelligent processes taking place in the body and are generally extremely well controlled. Inflammation is the natural response to injury and will be controlled and replaced by the body's own innate anti-inflammatory processes. Drugs are powerful enough to block these processes. Because of this powerful action, which will continue just as long as the concentration in the blood is at a certain level, drugs interfere with the body's own regulatory processes. The good doctor, by constant monitoring of blood levels, may be able to adjust the dose of the drug so as not to interfere too long and allow the body to take over sooner rather than later. Few doctors will monitor this closely however because the paradigm of medicine they follow does not recognise the body's own innate intelligence. Drugs must be powerful enough to interfere with a function of the body. It is this interference with function that can cause serious side effects. THE INTEGRATIVE/TRADITIONAL PARADIGM
When Integrative Health Practitioners (Medical Doctors who utilise Integrative Medicine) and Traditional Health Practitioners use the word ‘anti-inflammatory' they use it with a different meaning. They are recognising that there are natural anti-inflammatory processes in the body, as well as inflammatory processes, and that this process of balancing the two modalities requires a very careful approach, allowing the intelligence in the body to guide the process. For this reason they do not use powerful synthetic chemicals to interfere with functions, but rather use natural substances which do not have the power of drugs. These natural substances do not need to be powerful because they are generally more complex and support the balancing process of inflammation and anti-inflammation. So, instead of blocking chemical processes herbs support the body's natural response to injury (see below) A natural health product may be called an anti-inflammatory product by practitioners from both paradigms, but the meaning is very different, and this is why each paradigm must be controlled only by specialists which understand the philosophy and language that is being used. As indicated any injury is followed by an inflammatory response which is modulated and eventually reversed by the body's own anti-inflammatory processes: INFLAMMATION PRODUCING
INFLAMMATION CONTROLLING
Anti-inflammatory drugs block inflammation Natural products support the control of Need to be powerful Don't need to be powerful A healing response Often has side-effects Seldom has side-effects While natural health products seldom have side effects because they are used differently to pharmaceutical drugs, which are used for one of their side-effects, natural health products can nevertheless cause discomfort in people. These are nearly always minor, and disappear if the product is stopped. There are however natural products which are more likely to cause problems if taken in excess, and a few herbs which are toxic. These toxic herbs are well known and not generally found in commerce. For this reason using the Australian classification system of high risk down to low risk is useful. A ‘Listing System' could easily handle this kind of classification. Examples of ‘high risk' products: These mainly include herbs which are well known to cause side-effects in high doses such as colchicine, Digitalis, Rawolfia, Belladonna and Atropinum. Most of these herbs are used by medical doctors only, and are already scheduled accordingly. SIDE-EFFECTS OF NATURAL MEDICINE
Again this must be understood from the paradigm understanding and this is why it is essential to understand this paradigm difference. Drugs are synthetic chemicals developed to block biochemical pathways in order to alleviate symptoms. They are symptomatic medicines, essential in their own right and for this purpose. Nevertheless, because they act like poisons in the body they can cause anything from minor and all the way to major and serious side effects, even death, to the individual. Hundreds of thousands of people die every year from the side-effects of pharmaceutical drugs. Twenty thousand Americans die every year from anti-inflammatory drugs alone. Paracetamol is the main cause for liver failure in children. Natural medicines as indicated above do not block physiological processes. They are exceedingly complex with numerous points of activity and centres of activity. Natural substances function much closer to the idea of an ‘adaptogen'. Wikipedia defines an Adaptogen as: "Adaptogens  or  adaptogenic  substances,  compounds,  herbs[1]  or  practices[2]  refer  to 
the  pharmacological  concept[3]  whereby  administration  results  in stabilisation of 
physiological processes and promotion of homeostasis, an example being by decreased 
cellular sensitivity to stress". 
This is an acceptable definition. While most natural medicines may not fit exactly into the definition, the idea of adaptogens does in fact convey the paradigm understanding of the use of natural medicines, i.e. medicines which support the innate (homeostatic) intelligence of the system. The practice of Integrative Medicine and Traditional Medicine is to support health rather than treat disease. Natural health products support health by nudging the homeostatic process and bring the correct balance back. Drugs simply block physiological processes, and follow a different paradigm, i.e. alleviating symptoms by blocking physiological processes. DISCUSSION AND SUMMARY
It is the Constitutional Right of every South African to live according to the culture and beliefs of their own paradigm, provided it does not interfere with the rights of others. The medical paradigm, like religion, does not constitute a single uniform paradigm. The biomedical paradigm assumes it has the right to place its understanding of health and disease over everyone else's belief and knowledge systems. This is a gross injustice. The language, definitions, and management approach of the Integrative / Traditional Medicine paradigm is very different and needs to be acknowledged. Its practitioners use natural medicines in a very different way to that of the Biomedical model, and have done so for hundreds and thousands of years before modern pharmaceutical medicine. So-called ‘Experts' of one paradigm cannot rule, control and decide definitions for another paradigm. AREAS OF CONFLICT
Members of the Allied Health Professions Council of South Africa (AHPCSA) who serve on the Complementary Medicines Committee, do not represent practitioners of Integrative and Traditional Medicines. They openly state that they use Complementary Medicines to treat disease (symptomatically), following the paradigm of the biomedical model. This is because their training at local universities takes place at biomedical faculties, where they are taught to manage disease on a symptomatic basis, and not the vitalist, integrative model. There are over 200,000 African Traditional Health Practitioners, Medical doctors who practice Integrative Medicine and many natural health practitioners who use natural health products on the vitalist, integrative approach. We do not believe that natural medicines can treat disease as discussed above. The AHPCSA represent a very small group of mainly Homeopathic Practitioners, and their voice is a lone voice within the greater natural health sector. We reject them being the sole appointees to the regulatory structures (CMC) and having their Scopes of Practice affixed to the definition of Complementary Medicine. Reference Documents

To: The Director-General
Department of Health
Private Bag X828
Pretoria
0001
Date: 26 November 2014 Attention: Ms. Malebona Precious Mtsoso On the 15th of September 2014, Amendments to the General Regulations made in terms of the Medicine and Related Substances Act for 'Complementary Medicines' were published. (Regulatory Notice 716) A period of three months from the date of publication of this notice to submit substantiated comments was afforded to stakeholders. The cut-off date for comments is the 15th of December 2014. In order to make sense of the said Regulatory Amendments, and more specifically to the previously undefined categories of products described therein (e.g. 'Health Supplements') we have been eagerly awaiting definitive 'Guidelines' which clearly define these categories, as had been done in the past with the original regulations. Without them we could not interpret them or comment substantively. After waiting for a month for 'Guidelines' to be published, and becoming frustrated by the lack thereof, we contacted Mr Keizer Themba, who heads the Complementary Medicines Unit at the MCC six weeks ago. He informed me that guidelines were imminent. We are of the opinion that Regulations and their associated Guidelines must be published simultaneously, so that full disclosure is provided for stakeholders to correctly interpret the regulations. Without this disclosure, stakeholders are expected to interpret the law in a vacuum, which inevitably leads to misunderstandings and strife down the line. By not doing so, the State also fails the requirements of providing just administrative action in terms of the Promotion of Administrative Justice Act (Act 3 of 2000), and good law-making in general. Guidelines, titled "Complementary Medicines - Health Supplements - Quality, Safety, Efficacy" were finally published last week on the 20th of November 2014, just three weeks prior to the cut-off date for comments on the Regulatory Amendments. These Guidelines have a stakeholder comment deadline on or before the 26th of February 2015. In lieu of the fact that we were unable to make substantive comments on the said Regulatory Amendments until the publication of the Guidelines, we formally request that the comment period on the Regulatory Amendments also be extended for three months, after the publication of the Guidelines, making the new cut-off date synchronous on the
26th of February 2014.
This would be reasonable, procedurally fair and lawful.
We look forward to your favourable response.
Regards
Anthony Rees
General Secretary
Traditional & Natural Health Alliance
+27 72 3777 598
Applicable excerpts from the Constitution of South Africa
Chapter 1 (Founding Provisions)

(Section 2) This Constitution is the supreme law of the Republic; law or conduct inconsistent with it is invalid, and
the obligations imposed by it must be fulfilled.

Chapter 2 (Bill of Rights)
(Section 7)(2) The state must respect, protect, promote and fulfil the rights in the Bill of Rights.
(Section 8)(1) The Bill of Rights applies to all law, and binds the legislature, the executive, the judiciary and all organs
of state.
(Section 9)(2) Equality includes the full and equal enjoyment of all rights and freedoms. To promote the
achievement of equality, legislative and other measures designed to protect or advance persons, or categories of
persons, disadvantaged by unfair discrimination may be taken.
(Section 9)(3) The state may not unfairly discriminate directly or indirectly against anyone on one or more grounds,
including race, gender, sex, pregnancy, marital status, ethnic or social origin, colour, sexual orientation, age,
disability, religion, conscience, belief, culture, language and birth.
(Section 9)(5) Discrimination on one or more of the grounds listed in subsection (3) is unfair unless it is established
that the discrimination is fair.

(Section 12)(2) Everyone has the right to bodily and psychological integrity, which includes the right : (b) to security
in and control over their body.

(Section 15) Everyone has the right to freedom of conscience, religion, thought, belief and opinion.

(Section 16)(1)(b) Everyone has the right to freedom of expression, which includes freedom to receive or impart
information or ideas.
(Section 16)(1)(d) Everyone has the right to freedom of expression, which includes academic freedom and freedom
of scientific research.
(Section 33)(1) Everyone has the right to administrative action that is lawful, reasonable and procedurally fair.
(Section 38) Anyone listed in this section has the right to approach a competent court, alleging that a right in the Bill
of Rights has been infringed or threatened, and the court may grant appropriate relief, including a declaration of rights.

Source: http://naturalhealthalliance.co.za/TNHA%20-%20Comments%20on%20R.%2037995.pdf