Regulatory Discussion Group

,

Posted 06 April 2015 

Rene Doms, a member of the RDG, has supplied me this document for posting to CamCheck. This is the RDG submission to the Medicines Control Council. The RDG represents role players involved in advising companies selling CAMS, or the actual manufacturers or distributors of these products (see a list of members below).

It is pertinent to point out that the RDG has vested interests in the survival of this industry – the members all, directly or indirectly, earn a living from it. Some may argue that they do wish to protect the consumer but their financial survival derives from the survival of the industry, of which many products have little evidence, scientific or otherwise, to support their claims.

It is therefore vital that RDG create a sufficient ‘loophole’, or alternative method of appraising evidence for these products, one that has a threshold set far below that required for health claims for foods or that for medicines.

Readers should consider this: what level of proof would you wish to have for a claim for a product that you purchase, and in particular one that claims to influence or be effective for your health.

Consumer activists, like ourselves, argue that, say a product claiming to relieve the symptoms of menopause, should have good evidence to confirm that the product’s claims are justified. RDG argue the opposite, arguing among other, that since the product carries a lower risk than other Category A medicines, that a lower threshold of proof be allowed. We do not take this stance to protect Category A medicines (mainly Big Pharma products), but simply because we believe that all consumers deserve to have a decent level of evidence that a product’s claims are justifiable, i.e., whether you spend R30 or R300 on a product, that “it will do what it claims it can do”.


*Members of the RDG

I have asked Rene Doms for a list of the RDG members. His response was:

“The members of the RDG are mainly pharmaceutical consultants. In the interest of privacy, I am not prepared to disclose their names. 

You make of the content of what RDG supports/says at your discretion. Judge us on what we say and not who we are. We do not represent the complementary medicines industry or big pharma or any political party. Our members are from the pharmacy, medical, legal professions, allied practitioners and a dietician. All registered with a professional council. A few are professors in their fields and prominent members of society. “

My rejoinder is:

You ask us to judge the RDG on what you say and not who you are? If your members are refusing to publicly show themselves we have to rationally argue that they are unwilling to hold themselves to the principles espoused by the RDG. 

I actually have the list of members as of the date that I was furnished them and would add:

I therefore have to take issue with your statement that “[W]e do not represent the complementary medicines industry or big pharma or any political party” when in fact, it appears that almost everyone from this list (except for a few names I do not know) earn their living from enabling, supporting or working for the CAM industry in some or other capacity. The majority earn a remuneration from this industry, and in other words, the majority of the group are enabling the ongoing fraud being perpetrated on consumers by selling products of little to no value.

The list comes from an email forwarded to me with all the names included.

  • Allison Vienings; SMASA, MRA regulatory
    (substantiator of many dubious products as posted on CamCheck)
  • Anita Smal; Abex Pharmaceutica (Pty) Ltd
  • Anna Wagner; Anna Wagner Attorneys (Lawyers)
  • Ansie Savrda; Execu Regulatory Services
  • Antoine van Gelder;
    (now a Council member of the MCC (and this is a major conflict of interest!). He should forthwith resign from the RDG.  Also a ‘substantiator” for Antagolin (the ASA ruled against))
  • Barry Vlok; Association of Regulatory Consultants (set up by René Doms)
  • Cara Humphrey Kruger; Nutrition Services Agency
  • Christa van den Berg;
  • Christina Bezuidenhout;
  • Claudette Bartlett; ‎Pharmaceutical & Vigilance Consultant
  • Deepa Maharaj; ‎Regulatory & Quality Director, Africa CH at GSK
  • Elsa Havenga; ‎Regulatory Pharmacist
  • Engela S. M. Dedwith; Independent Regulatory Consultant at Pharmaceutical Regulatory Affairs (PRA) Consulting
  • Esthi Beukes;  ‎Regipharm Pharmaceuticals (Pty) Ltd
  • Fransa Fransa;
  • Graeme James; Head of Regulatory at Sanofi-Aventis
  • Grant Richards; Clicks group
  • Henk Krebs; ‎Managing Director at MC Pharma Consulting (Pty) Ltd
  • Henriette Vienings;
  • Ingrid van Vuuren;
  • Janet Welham; Saige Marketing (Pty) Ltd (Vital, HPA)
    (listed as a committee member of the HPA’s “Self Monitoring Advisory Committee”)
  • Leanne Blumenthal; SAAPI? [Inspector at The South African Pharmacy Council (SAPC)?]
  • Leneri du Toit; Pharmacorp CC; Tshepo Pharmaceuticals (Pty) Ltd
    Mario Botha; Execu Regulatory Services Regulatory Science Consultant
  • Marlene Papenfus; ‎Consultant at MedReg Consultants
  • Martin Wessels; ‎Head: Regulatory Solal Technologies;
    (Many ASA rulings against Solal; Solal taking the ASA to court)
  • Michael du Plooy;
  • Miranda Viljoen; ‎Director of Pharma Technical Affairs at SAAPI;
  • Monika O’Leary; Independent Pharmaceuticals Professional
  • Nicola Brink; Montana Healthcare Solutions
  • Nicole Edelstein;
  • Rene Doms;
  • Rhoda Kruger; Responsible Pharmacist at Norgine
  • Robyn Daniel; Regulatory Affairs Pharmacist, Partner and Director at MRA Regulatory Consultants
  • Rudi Oliver; DI Medicine Registration Consultants CC
  • Salima Mahomed; Regulatory Pharmacist at Twinz Regulatory Consultants
  • Salma Ismail; CEO at Twinz Regulatory Consultants
  • Tracy Burger; Director and Responsible Pharmacist, MC Pharma SA
  • Vivian Frittelli; Chief Executive Officer at National Association of Pharmaceutical Manufacturers

Regulatory Discussion Group submission to the Medicines Control Council

Tuesday, 31 March 2015 

THE REGISTRAR OF MEDICINES

PRIVATE BAG X828

PRETORIA

0001

Dear Registrar

MEETING WITH THE COMPLEMENTARY MEDICINES COMMITTEE OF THE MEDICINES CONTROL COUNCIL – 30 MARCH 2015

  1. RDG appreciated the opportunity given it by the CMC to clarify RDG’s proposal and views on the regulatory control of complementary medicines in South Africa. The existing Medicines Act framework is satisfactory for this purpose. 
  1. In this letter, we summarise RDG’s response to the Registrar of Medicines’ ask for comments on the proposed guideline for Health Supplements QSE guideline and a few points raised during discussion. 
  1. In sum, RDG’s proposal offers choices for the regulatory control and pathways for low-risk medicines such as health supplements making medicinal claims and herbal medicines. High-risk medicines need registration before sale. 
  1. Our drafting style for regulatory control is aimed at simplicity and intended for the public and not the industry in line with the objects of the objects of the Medicines Act and based on the following design: 
  • The Medicines Act’s regulatory framework is adequate. Stay away from complicated medicines sub-definitions that force interpretation, they are not necessary and will lead to legal problems. 
  • Write regulations that the man in the street understands. Remove nuances and a need for pre-understanding, guard against protecting healthcare providers and commercial interests. 
  • The Medicines Act is on the statute books to protect the public not the healthcare provider or industry. Regulations are for public service and not a select group of people. 
  • These products are medicines if they fall within the Medicines Act definition; they are so presented and distributed. How the MCC wants to administer the individual product is up to them. 
  • Write flexible MCC administrative guidelines to handle the licensing and manufacturing technicalities; use exemptions where suitable. 

 A. RESEARCH 

  1. RDG has researched the TGA (Australia), European Union, Health Canada and US regulatory systems for the control of complementary products. For the proposal, RDG blended the findings with the South African legal framework. 

 B. OVERARCHING COMPLEMENTARY MEDICINES DEFINITION EXPANDED IF CONSIDERED NECESSARY 

  1. Whether an overarching umbrella complementary medicines definition is necessary, is questionable. The disciplines involved are very diverse and defy singularity. Creating a singular definition will invariably limit future developments in this field and most likely require frequent revision. 
  1. Should there be a necessity for a definition, we propose that the definition categorises complementary medicines into two distinct sections, one for “modern” complementary medicines (health supplements and herbal medicines) and the others into discipline specific medicines used by allied healthcare practitioners – discipline specific medicines.[1] 
  1. Multi-disciplinary herbal medicines (not Phytotherapeutic medicines used by allied practitioners) did not find a comfortable home in the discipline specific category as these herbal substances follow the biomedical model for justification and are not akin to any one discipline specific class. The European Union approach found favour here as the EU has developed monographs for herbal substances that give guidance for the safe and effective use of these herbs. 

 C. EVIDENCE INCLUDES LONG-STANDING TRADITIONAL USE 

  1. Of significance in RDG’s proposal, is the shift from the scientific understanding of safety and therapeutic efficacy to a broader interpretation for herbal medicines. This procedure is intended for herbal medicines with a long tradition (at least 30 years, others say 75 years), which do not fulfil the rules for scientific validation whereby an applicant can show by references to published scientific literature (approved monographs) that the constituent or the constituents of the herbal medicine, in its currently indicated route of administration, has a well-established medicinal use with recognised efficacy and assumed safety. Posology and correct labelling is an important factor in the use of the herbal medicine. Furthermore, the procedure allows registration of herbal medicines without requiring details on tests and trials on safety and efficacy if there is enough evidence of the medicinal use. 
  1. Health supplements and herbal medicines that do not meet the complementary medicines’ definition or a guideline requirement and are considered high-risk medicines (non-monographed) must follow the typical scientific regulatory pathways. Proof of therapeutic efficacy and safety is necessary. 
  1. On the subject of the quality and manufacture of health supplements and herbal medicines, these medicines must meet acceptable quality and manufacturing standards (GMP). 

 D. GOVERNMENT’S RESPONSIBILITY AND THE REGULATORY GAP:  

  1. Medicines are not ordinary consumer products.[2] In most cases, consumers are not in a position to make decisions when to use medicines, which medicines to use, how to use them and to weigh potential benefits against risks as no medicine is completely safe. Professional advice from either authorised prescribers or pharmacists are needed in making these decisions. 
  1. The pervasive use of complementary medicines raises several concerns. Many of these stem from an inherent lack of quality systems as the applicants were not previously required to license their operations and the. evidence of their quality, efficacy and safety has not been assessed by the regulator. Medicines of uncertain quality, safety and efficacy can be worse than no treatment. It is the responsibility of government to protect patients from harm. Medicines affect the lives of people who take them. Government has the responsibility to guide and protect their citizens where they cannot protect themselves. 
  1. In medicines regulation, the government acts as the guardian of the public by controlling private powers for public purposes. Ensuring the safety, efficacy and quality of medicines available to the public is the main aim of medicines law. If regulatory goals are to be achieved, proper structures must be established and suitable activities carried out to realise the desired goals. 
  1. To protect the public from harmful and dubious medicines and practices, medicines laws should be comprehensive enough to cover all areas and functions of pharmaceutical pursuits in the country. 
  1. Since the purpose of medicines regulation is to promote public health and protect the public from harmful and dubious medicines, it should cover products for which medicinal claims are made and activities associated with the manufacture, importation, distribution, dispensing and promotion of medicines. 
  1. Counterfeit products, spiked products of dubious quality and faulty information, especially exaggerated claims of efficacy, are often widespread in this currently unregulated sector. Monitoring of pharmaceutical activities should cover all sectors. 
  1. Each medicines regulatory function within the national regulatory system helps to promote the efficacy, safety and quality of medicines and their rational use. Rational use of medicines means patients receive medications suitable to their clinical needs, in doses that meet their own individual needs, for an adequate period, and at the lowest cost to them and their community. 

 E. REGULATORY ELEMENTS – WHO MODEL: 

  1. A host of challenges threatens the safety, efficacy and quality of medicines at every stage of their life cycle: Weaknesses in research and development, deficiencies in dosage form design, varying standards in ongoing production, damage during transport and storage, and inadequate use of products by prescribers and patients. An effective system must therefore provide the full range of regulatory functions, covering every stage of the cycle. 
  1. The main functions of regulatory control include control of medicines by registration and post marketing surveillance (quality monitoring and pharmacovigilance), as well as control of activities by licensing and inspection of manufacturers, importers, exporters, wholesalers, distributors, pharmacies and retail outlets, control of clinical trials and control of promotion of medicines. All elements are necessary for effective control to safeguard the quality, safety and efficacy of medicines and suitability of use for its intended purpose. 

 F. REGULATORY ELEMENTS FOR THE CONTROL OF COMPLEMENTARY MEDICINES IN SOUTH AFRICA 

  1. Using the WHO regulatory model as a foundation and linking the criteria to the control of complementary medicines in South Africa, RDG suggests its Seven Point Plan: 
RDG’S SEVEN POINT PLAN
REGULATORY FUNCTIONSTATUS OF CAM IN RSARDG PROPOSAL
1.     Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines xLicense all CAM facilities with Medicines Act Section 22C licenses with minimum barriers to entry based on the introduction of phased improvements over a 2-year period to meet GMP norms and standards.
2.     Assessing the safety, efficacy and quality of medicines, and issuing marketing authorization for individual medicines xEvaluate high-risk medicines and register prior to sale. Low risk medicines to follow a pre-approved monograph system, without needing to submit a CTD (“exemption”). Inspectorate to audit monograph “exempted” medicines for quality, safety, efficacy and compliance. Call up specific medicines for registration if warranted.
3.     Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of medicines xImported medicines sourced from approved manufacturing facilities. Medicines only imported by South African Section 22 C licensed pharmaceutical facilities and released for sale by an authorised facility if registered or low-risk category. Follow MCC guidelines.
4.     Controlling and monitoring the quality of medicines on the market xResponsibility of the local Section 22C licensed facility and its responsible pharmacist. Standard MCC procedures for pharmacovigilance in South Africa.
5.     Controlling promotion and advertising of medicines x“Re-instatement” of the ASA and its procedures in conjunction with Section 18C and supporting regulation. Expand Regulation 45 to promote public welfare, health and safety and foster information flow in the public interest.
6.     Monitoring safety of marketed medicines including collecting and analysing adverse reaction reports xFollow MCC guidelines for Reporting of Post-Marketing Adverse Drug Reactions to Human Medicinal Products in South Africa. Product Quality Review reports can be called for and audited.
7.     Providing independent information on medicines to professionals and the public xPre-approved monographs, registered package insert, or patient information leaflet. Monitor advertisements for compliance with approved package insert and other suitable references, e.g. Journals.

 

 G. RISK MANAGEMENT

  1. The regulator approves products based on risk assessment against benefits. Medicines carry potential risks, some minor, others serious. A regulator, in its decision-making process must make sure that the benefits of a product outweigh any risk. 
  1. A low-risk product may be safely sold through open shops or business premises (Schedule 0) such as general dealers/shops to which the public has access while higher-risk products may be supplied with a prescription. 
  1. The risk assessment method as described in the ZA GMP guide should be followed and assessment reports with resulting management resolutions should be available for inspection. 

 H. PROPOSED TWO-TIERED REGULATORY MODEL 

  1. As a way of control, RDG suggests a two-tiered system to register/permit sale of medicines. If the product is a medicine, it follows either of two regulatory pathways – high risk or low risk. High-risk medicines must be registered before sale while low risk medicines containing pre-approved, low-risk ingredients, dosage and claims can be marketed if manufactured and released for sale by a Section 22C licensed pharmaceutical facility including imported products. 
  1. Products must undergo stability testing and low risk medicines evaluated for quality compliance by the inspectorate during inspections of the licensed or approved manufacturer. Furthermore, products must go through release testing before sale to make sure no adulterants or contaminants are present and meet finished product release specifications. Formal finished product release authorisations must be performed by the responsible pharmacist to give the public the assurance that the medicine is of suitable quality, safe, effective and suitable for its intended purpose. 
  1. This practice will lessen the immediate capacity burden on the regulator while at the same time give comfort that medicines available to the public are under scrutiny and surveillance. Auditing the most widely used (highest volume) medicines will further add to reducing public risk exposure and potential harm. 

 I. HEALTHCARE PRACTITIONERS INCLUDING TRADITIONAL HEALERS 

  1. The Medicines Act does not regulate health practitioners and traditional healers. The focus is on commercially available medicines. Healthcare practitioners and traditional healers are not bound by the provisions of the Medicines Act when operating within their scopes of practice and interfacing directly with a patient in a contractual relationship. If healthcare practitioners sell medicines where no direct relationship exists (doctor/patient) then the Medicines Act prevails and such medicines are subject to registration and control. 

 J. PROPOSED LOW RISK MEDICINES CLASSIFICATION RULES 

  1. The proposed low risk medicines classification rules are: 
  • Ingredients or dosage forms not listed in Schedule 1 and higher under the Medicines Act schedules; 
  • There is a low and well-characterised incidence of adverse effects, interactions with commonly used substances or food and contra-indications; 
  • The risk profile of the medicine is well defined and the risk factors can be identified and managed by a consumer through proper packaging and labelling; 
  • The use of the medicine at established therapeutic doses is unlikely to produce dependency, and the medicine is unlikely to be misused, abused or illicitly used; 
  • The medicine is for minor ailments or symptoms that can easily be recognised and are unlikely to be confused by the consumer with other more serious diseases or conditions. Treatment can be managed by the consumer with no medical intervention. 
  • The use of the medicine at established therapeutic dosage levels is not likely to mask the symptoms or delay diagnosis of a serious condition; and 
  • The use of the medicine is safe for short-term treatment and the potential for harm from wrong use is low. 

 K. CAVEAT 

  1. RDG’s suggestion covers but one perspective of the current complementary medicines industry in South Africa, there are many others. RDG has distilled out the elements it believes are in the stakeholders’ interests. Since most RDG members are pharmaceutical consultants, its perspective may be broader than others as its members see difficult cases and have to solve problems encountered by their clients at the coalface, a valuable learning experience in itself. This proposal is a work in progress. 

If you are interested in receiving the full report, please contact Ms Henriette Vienings ([email protected]) who will send you a free electronic copy as submitted to the Registrar of medicines (451 pages).CamCheck admin: The RDG report is available here: RDG_HS_aurora_final__V3.pdf (7 Mb)  Please contact Henriette on 012 803 6223 /803 5955 /803 1039 to get involved. Our next task is to look at the advertising of medicines (point 5 of the RDG’s Seven Point Plan) in South Africa. We believe there is scope for improvement.

Yours sincerely for the Regulatory Discussion Group 

 Henriette VieningsMobile: 083 435-4453 | [email protected]Fax Mail: 086 617-4616 | Skype Name: henriette.vienings MRA Regulatory ConsultantsTel. No.:  +27 (0)12 803-6223 /-5955 /-1039 | Fax  +27 (0)12 803-3575 381 Rossouw Street | Murrayfield | 0184 | Pretoria | South Africawww.mra-regulatory.com René Doms RPh FPS Healthcare Regulatory Consultant                                    Dip Pharm Adv Dip (B&A) BIuris LLB                             South African Registered Pharmacist Fellow of the Pharmaceutical Society of South Africa   Phone: +27 11 884 4888 Mobile: +27 82 555 7621 Email: [email protected] Skype: renedoms

[1] A complementary medicine is defined as:

 

Complementary medicine” means a sub-category of a medicine that:

 

  1. originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other approved substance as determined by Council, and

 

  1. is a health supplement:
  2. with an approved Schedule 0 active ingredient and health claim;
  3. presented in a non-injectable pharmaceutical dosage form or delivery system taken orally;
  • used to change a nutritional physiological metabolic effect in humans in a way that complements, assists, maintains and promotes health; and
  1. is not intended to diagnose, treat, cure or prevent any disease; or

 

  1. is a herbal medicine:
  2. containing one or more approved Schedule 0 herbal substances or herbal preparations, alone or in combination;
    1. herbal substances are whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed dried form but may be unprocessed and fresh including exudates;
    2. herbal preparations are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation and include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates;
    3. notwithstanding, the inclusion in the herbal medicine of a vitamin or mineral is allowed provided the vitamin or mineral action is ancillary to the herbal active ingredient about the claimed indication;
  3. herbal substances and preparations have a long-standing use, experience and well-established documented efficacy recognised over a period of at least 30 years;
  • data on the coherent tradition and traditional use are adequate and not harmful and with an acceptable level of safety in the given conditions of use;
  1. the pharmacological effects or efficacy are plausible on the basis of long-standing use and experience;
  2. indicated for a self-limiting disease condition capable of self-diagnosis of symptoms and treatment intended and designed for use without health care practitioner supervision;
  3. administrated in accordance with a stipulated strength and posology;
  • presented in a non-injectable pharmaceutical dosage form or delivery system taken orally, applied topically or by inhalation; and
  • is not intended to diagnose, treat, cure or prevent any disease; or

 

  1. is a discipline specific traditional medicine prepared and used according to the principles of:
  2. Ayurveda;
  3. Chinese medicine and acupuncture;
  • Homeopathy;
  1. Phytotherapeutic medicine;
  2. Therapeutic aromatherapy;
  3. Unani Tibb; or
  • Other similar traditional medical discipline; or

 

is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary medicine.

 

In other words, a health supplement is directed at maintaining or promoting health and not suitable to treat or prevent a disease or pathological state. Health promotion is the practice of enabling people to increase control over, and to improve their health. Therefore, health promotion is not just the responsibility of the health sector, but goes beyond healthy life-styles to well-being.

[2] Not considered a commodity of trade but a dangerous article as it can do harm.

span style=”font-family: ‘arial’, ‘helvetica’, sans-serif; font-size: 10pt;”

,

48 Responses to Regulatory Discussion Group

  1. Rene Doms 7 April, 2015 at 6:34 pm #

    @All

    I am interested to hear from the forum whether Harris’ comments are fair in the circumstances bearing in mind the proposal RDG submitted to government that should be read in totality. I wrote it and look forward to seeing Harris’ submission.

    The claims, dosage and warnings would be pre-approved by the regulator and are extracted from Health Canada, the European Union, TGA and tweaked according to local regulations.

    None of the permitted active substances are Schedule 1 or higher as listed in the Schedules to the Medicines Act (low-risk). Products are to be manufactured in licensed facilities and inspected for compliance by the DOH for the MCC. Stability testing is necessary as is finished product release criteria amongst other analytical tests. Stability testing forms part of the analytical work.

    These standards are similar to many other conventional medicines on the market such as cough mixtures etc. Several health claims were put forward by the MCC in their guideline for Health supplements such as vitamins etc.

    Is Harris suggesting these low risk products be subjected to clinical trials and toxicological testing? Such thinking is extremist, lacking in proportionality and bizarre, if so.

    The insinuations about the RDG are unfortunate, in bad taste and lack objectivity.

  2. RENE DOMS 7 April, 2015 at 8:30 pm #

    @Harris

    In light of the RDG proposal, is this comment true as all claims for substances are pre-approved by the regulator. In my view, you are misleading your readership about the RDG proposal.

    Harris says; “Consumer activists, like ourselves, argue that, say a product claiming to relieve the symptoms of menopause, should have good evidence to confirm that the product’s claims are justified. RDG argue the opposite, arguing among other, that since the product carries a lower risk than other Category A medicines, that a lower threshold of proof be allowed. We do not take this stance to protect Category A medicines (mainly Big Pharma products), but simply because we believe that all consumers deserve to have a decent level of evidence that a product’s claims are justifiable, i.e., whether you spend R30 or R300 on a product, that “it will do what it claims it can do”.

  3. RENE DOMS 7 April, 2015 at 8:37 pm #

    @Harris

    Is this true? It is definitely not so for me and has a malicious twist. How do you honestly justify such a comment as being fair?

    “It is pertinent to point out that the RDG has vested interests in the survival of this industry – the members all, directly or indirectly, earn a living from it. Some may argue that they do wish to protect the consumer but their financial survival derives from the survival of the industry, of which many products have little evidence, scientific or otherwise, to support their claims”.

  4. RENE DOMS 7 April, 2015 at 8:44 pm #

    @Harris

    Taking the RDG proposal into consideration – have you actually studied it carefully, how do you justify this statement:

    “It is therefore vital that RDG create a sufficient ‘loophole’, or alternative method of appraising evidence for these products, one that has a threshold set far below that required for health claims for foods or that for medicines”.

    Your bias goes beyond respectability and is blinding your understanding.

  5. Kevin Charleston 8 April, 2015 at 12:02 am #

    @Rene Doms
    Do you and Harriet Vienings (the only names you are willing to provide as representative of the RDG) earn any income from providing services to CAM manufacturers? If so – how much? I believe that if you are going to present a position as you have – the consumer has to be made aware of how much that position is in debt to the CAM industry. If you are unwilling to provide details of the membership of the RDG – then you and Ms Vienings are the sole exemplars of the positioning of its members. Just as we would demand to know the interests of any participant in an open medical trial – you owe the consumer an explanation of where your interests lie.

    Are you seriously asserting that your proposal offers an equivalent or higher standard of proof of efficacy for existing CAMS products than the current MCC draft regulations?

    I don’t believe that to be true, I believe it to be a significant loosening of the proposed regulation to the benefit of the existing industry players – and I believe that your members are hiding rather than expose the true extent to which this proposal represents the industry’s interests.

    I also think you are playing coy. If your members aren’t hiding their true nature – then pray tell exactly what do they believe they have to hide?

  6. RENE DOMS 8 April, 2015 at 9:55 am #

    @Kevin

    I shall not share my client base with you nor shall I tell RDG members to do so. If it makes you happy, hold me out as the RDG and my alter ego. So what! This does not change the position. I and Henriette signed the proposal submitted to government. My interests lie in providing a regulatory framework for the control of complementary medicines in South Africa which goes back to 1985 (30 years). Well thought out comments are welcome.

    The RDG proposal does offer a standard equal to that of the MCC because it follows the WHO guideline used by regulatory authorities throughout the world including the RSA. You missed that from your comments so far. If you read the proposal and understood it, you would come to the same end about standards offered and gained from the experiences of Health Canada, European Union, TGA and MCC. Did you bother to study the 451 page proposal? Did you do so? If not, please read the document. While undertaking this exercise, cross check the RDG proposal against these regulatory systems and let me know how you perceive RDG has improved on them or not? I need to understand why you think otherwise.

    Since we now limit the attack to me, where does that leave your procedural spat? It may be useful for you to study the proposal and discuss what is before you and government or do you and Harris offer nought but cheap shots at the author? Let the readership make up their own minds and convince them and me that you have a better suggestion.

    I would appreciate a copy of your and Harris’ proposal to government so I can review, perhaps I can learn something from both of you? Without your proposals, these discussions are fruitless and unbecoming of anyone of your talents. Let’s compare like with like. We are beyond verbiage and diversionary tactics. Get to the point by producing on paper your offer. This is the rub. Procedural attacks are a waste of time, both yours and mine as they do not discuss the merits at issue. It is time to show your alternatives. I wait in anticipation and look forward to reading both government submissions on Camcheck.

  7. Kevin Charleston 8 April, 2015 at 5:29 pm #

    @Rene I haven’t asked you to share your client base. I asked you to reveal your financial interest in the CAM industry. I believe your refusal to be honest and open about it speaks volumes, as does the continued secretive nature of the RDG. You are welcome to believe that doesn’t change ‘the position’ – but it may well change public perception of where your loyalties lie.

    I certainly haven’t made a proposal to government – so I’m afraid you’ll have to wait in vain. But really now – are only those who make a submission allowed to comment? What fatuousness. This is not some ego-stroking, page-counting contest – and it is puerile to suggest it should be.

  8. roy 8 April, 2015 at 8:46 pm #

    My concern with firstly the 451 page RDG proposal and then the revised 9 page proposal is:
    – Pages 17-50 of the first proposal deviates from the request by the MCC for comments on the quality, safety and efficacy of health supplements by introducing a new category into the comments called herbal medicines. The MCC did not ask for comment about herbal medicines. The MCC did not even propose a subcategory of herbal medicines under “health supplements.” This is quite bizarre and in my view extraordinarily arrogant. The RDG redefines what the MCC has asked for comments on, then comments on their own re-defined version!
    – Pages 51 to 451 are Annexures for the health supplements and the herbal medicines. These are not proper monographs. It is extraordinary how much they appear merely to be regurgitated versions of Mr Peter Kreft’s 2002 (inappropriate, unsuitable and not accepted) documents.
    Annexures B to P are irrelevant to the document the MCC requested comments on. That document has Annexures A to F with others to follow. There is not an annexure dealing with “herbal medicines” in the original (7.04_QSE_Health_Supplements_Nov14_v1 Nov 2014).

    The subsequent 9 page document – reproduced on CamCheck on this webpage, also goes so far as to “redefine” complementary medicines to include herbal medicines. This is preposterous – and clearly not intended as a benefit for consumers, but as a profit-making activity for the so-called health products industries.

    I am particularly concerned that with the emphasis on accepting herbal medicines (based on traditional use), that there has been no mention of the “Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement” published in 2006. See: http://www.consort-statement.org/Media/Default/Downloads/Extensions/CONSORT%20Extension%20for%20Herbal%20Interventions.pdf Clearly the RDG has not in fact done its homework properly.

    The CONSORT statement on herbal interventions is the evidence-based approach that the MCC / DoH should be implementing – not vague traditional uses from foreign countries.

    One must also acknowledge that the recorded traditional uses of herbal medicines used by the RDG are not African / or South African traditional uses. It can in fact be considered another legacy of apartheid, mainly for white consumers, that the herbal medicines mentioned in the 451 page RDG document, mass produced on an industrial scale, are included. This is an aberration.

    It is clear that the RDG’s proposal is completely unacceptable as it stands.

    • RENE DOMS 9 April, 2015 at 9:57 am #

      @Roy

      Thank you for your comments. Please send me your proposal. Thanks.

      By the way, it is for the MCC to decide what they want to use or not. They are in a better position to extract from various proposals because they have insights far greater than ours.If the MCC does not like what RDG put forward then its their prerogative to do so. RDG’s proposal is hopefully but one of many. That is the beauty of the consultative process.

    • RENE DOMS 9 April, 2015 at 10:03 am #

      @Roy

      Unfortunately the HS supplement did not cover all the disciplines envisaged as complementary medicines. The traditional medicines guideline refereed to does not exits. To come up with a definition, we had to complete these to create a full picture (scope) of the umbrella concept for a complementary medicine which we believe is unnecessary as these products are medicines as defined. In doing so we concluded that herbal medicines as was the case we found in the EU did not fit any one traditional category and consequently followed the EU approach for substances such as senna which is used in both conventional and traditional medicines.

      • roy 9 April, 2015 at 12:04 pm #

        I agree that complementary medicines should not need a separate definition or separate regulations / legislation, and that the 2003 (and 2008) versions of the Medicines Act are sufficient. But the cry from the Health Products Association (HPA) for many years has been that complementary medicines should not be regulated / legislated in the same way as “pharmaceuticals.” The MCC has gone a long way in accommodating the demands of the various industry lobby groups.

        The traditions RDG referred to were the “30 year” (or perhaps “75 year”) traditional use. This is too vague for the 21st Century, no matter what the EU states.

        Clearly the “industry” (and RDG) wish to ensure that they can continue manufacturing / selling herbal medicines (from mainly “western” traditions at will, and meeting a lower standard of “proof.” (Unless they can get away with simply referring to an EU monograph.)

        The RDG’s *intent* (in my view) is epitomised by its statement: “[RDG’s] research indicates the amended draft definition for a complementary medicine must (sic) be expanded to include the various complementary medicines ranges in line with current trade practice in South Africa.” (point 4 on page 1 of 451)

        “In line with current trade practice”??? Current trade practice is completely out of control and the industries are selling “anything” making “any” claims they like, without being accountable to anyone. Should they not perhaps be subject to a “windfall” tax?

        The mandate of the MCC has, as you well know, nothing to do with trade practices. It is to ensure that all / any medicines *available* meet acceptable, predetermined standards of quality, safety and therapeutic efficacy, in the public interest. (Not in the trade’s interest.)

        The current trade interest has been facilitated, unfortunately, by the MCC itself [2002 “call up”] (and the lack of proactive interventions by the Inspectorate). The industries have taken huge advantage of this, knowing full well that at some stage they would have to provide data for their products’ quality, safety and therapeutic efficacy.

        Since Notice R870 of 15 Nov 2013 was gazetted, the industries have been trying to safeguard their “current trade interest” (i.e. the status quo) by challenging the regulations. As I see it, the authority has bent over backwards in accommodating the industries’ demands, even revising their original definition of a complementary medicine to include “health supplements.” But the RDG wants “health supplements” and “herbal medicines.” It is probably the “herbal medicines” that are the most problematic of all products, if you glance over Dr Steinman’s list of complaints to the ASA on this website.

        • RENE DOMS 9 April, 2015 at 5:57 pm #

          @Roy

          These health supplements which is a recent innovation from the CMC in their latest version of the definition is form over substance in my view made up of a range of vitamin/mineral combinations as a base. See the expanded definition for the details. I think this is a compromise on government’s part.

  9. roy 8 April, 2015 at 9:07 pm #

    According to the RDG’s 7 point plan, point 1 states:

    “License all CAM facilities with Medicines Act Section 22C licenses with minimum barriers to entry based on the introduction of phased improvements over a 2-year period to meet GMP norms and standards.”

    This is a shocking lowering of (quality) standards. Many CAM facilities have deliberately and defiantly not applied for licences from 2002 and prior to that. There was nothing that ever explicitly or implicitly “exempted” CAM facilities from having to apply for Section 22C licences. They broke the law, and now want some sort of “amnesty”? or easy way out?

    Why should the consumer / public have to wait for a phase-in of two years before they can be sure that there is at least minimal compliance with cGMP norms and standards? (current good manufacturing practice)

    Should we not suggest to the Minister of Finance that all these companies that have profited for so many years, and not had licences, “pay back the money” to Treasury or SARS?

    • RENE DOMS 9 April, 2015 at 10:05 am #

      @Roy

      It may be shocking to you but no different to what happened when licensing was introduced in 2004. I believe government will accept this approach as a starting point. Better to start creating the regulatory framework than what is happening now.

      • roy 9 April, 2015 at 12:11 pm #

        I am aware that special dispensations were given at different times. But the complementary medicines industries “excluded” themselves from obeying the law from 2004. That’s over a decade of lawlessness from industries that wish to now appear as “upright citizens.” (The HPA refers to the companies that do not abide by the law as “cowboys” who are the exception, not the rule. If this were true, there’d be no need for a special “licencing” dispensation for these companies.)

        • RENE DOMS 9 April, 2015 at 6:01 pm #

          @Roy

          Unfortunately government participated in this process through the 2002 audit. It had disastrous consequences which I warned about at the time but not heard.

  10. roy 8 April, 2015 at 9:56 pm #

    According to the RDG’s 7 point plan, point 2 states:

    “Evaluate high-risk medicines and register prior to sale. Low risk medicines to follow a pre-approved monograph system, without needing to submit a CTD (“exemption”). Inspectorate to audit monograph “exempted” medicines for quality, safety, efficacy and compliance. Call up specific medicines for registration if warranted.”

    All medicines can be considered “high risk” depending on what the health claims made are. A supposedly harmless “increases your energy” claim, in a person suffering from chronic anaemia, and taking the product for “tiredness” could delay the correct diagnosis. Indeed, if certain supplements were taken, they could even mask the correct blood findings and eventual diagnosis.

    The RDG has “redefined” low risk medicines and this is different from “7.01_CAMs_QSE_Dec13_v2_1 Dec 2013.” The range of “low risk” is made much wider and more vague. This is unacceptable (and arrogant?).

    NO exemptions should be granted. This is again a shocking and unacceptable lowering of standards. After more than a decade of an uncontrolled selling frenzy, the manufacturers and retailers of “self-styled, mass produced, industrial scale complementary medicines” have literally sucked the marrow from the bones of consumers’ disposable income and gullibility.

    The concept of “low risk” – although accepted by the MCC in its “Complementary Medicines-Quality Safety and Efficacy” guideline document (7.01_CAMs_QSE_Dec13_v2_1 Dec 2013) – is now being *re-defined* by the RDG. The comments on the latest version of that document closed more than a year ago! It is blatantly disingenuous to now start making suggested comments which are essentially about that document and not just about “health supplements” (inherently an oxymoron?)

    Too much is left to the Inspectorate to decide post-facto in the RDG’s proposal. This is not acceptable. Prevention is better than cure. Rather disallow the majority of these spurious products as soon as possible than have the “Inspectorate” (why not the MCC itself?) “audit” exempted medicines at a later stage. Again the RDG proposal builds in a lower standard and demonstrates a lack of public responsibility.

    • RENE DOMS 9 April, 2015 at 10:12 am #

      @Roy

      We have to be realistic. Government resources are limited. Product history checks to which RDG alludes was the process adopted in the 70’s for conventional medicines while various categories of medicines were being called up for registration. The proposal is no different to what happened then for conventional medicines. It works.

      I fail to understand your use of the word “arrogant”. Like you, I am entitled to express my views on the technical issues having lived through the regulatory process for the last 44 years in industry and now consulting. If you mean that I disagree with you and consequently arrogant then it’s your problem and not mine.

      • roy 9 April, 2015 at 12:25 pm #

        I do not see what is not realistic about making self-styled mass produced industrial complementary medicines meet the absolute basics of quality, safety and therapeutic efficacy without resorting to new definitions of complementary medicines and expanding the meaning of “low risk.”

        I disagree that the process you’re referring to “works.” We still have “old” medicines on the market that have never had their quality, safety and therapeutic efficacy verified by the MCC. The Minister of Health stated that there would not be any “grandfathering” of the 155,000 (+) complementary medicines on the market as of 29 October 2010.

        My reference to the word “arrogant” comes from point 4 (on page 1 of 451), where the RDG states that ” . . .
        the amended draft definition for a complementary medicine *must* be expanded to include the various complementary medicines ranges in line with current trade practice in South Africa.” I read the word “must” as being arrogant.

  11. roy 8 April, 2015 at 10:08 pm #

    According to the RDG’s 7 point plan, point 3 states:

    “Imported medicines sourced from approved manufacturing facilities. Medicines only imported by South African Section 22 C licensed pharmaceutical facilities and released for sale by an authorised facility if registered or low-risk category. Follow MCC guidelines.”

    Imported medicines in particular must have demonstrable safety, quality and therapeutic efficacy. They must be registered. It is not acceptable to have them released for sale if they’re “low risk” and not registered. The risks of compromised quality are increased with importation from certain countries and certain companies. The risks of exaggerated claims are increased with importation from certain countries where some of these medicines have been in “traditional” use for many years, and minimal evidence for these claims is available.

    • RENE DOMS 9 April, 2015 at 10:14 am #

      @Roy

      This is taken from the existing guideline for imported medicines. There is no difference in standard being made. The WHO model must be read in its totality and not pieces taken out of context. Government understands and practices this approach.

      • roy 9 April, 2015 at 12:27 pm #

        It cannot be in the existing guideline for imported medicines if the category “low risk” has not yet been implemented.

        • RENE DOMS 9 April, 2015 at 2:59 pm #

          I see it applicable to all medicines irrespective of their risk rating.The High risk low risk concept originates from Australia and New Zealand. This is a regulatory pathway the medicine follows on licensing entry. There is now talk that a number of products such as paracetamol (OTC) should also follow this path.

          In my view the term complmentary medicine is a red herring in law. A product is either a medicine or not. There is no half breed.

          • roy 9 April, 2015 at 6:58 pm #

            The issue is that the RDG itself in point 3 of its 7 point plan states that:
            “[Imported] Medicines [can be] released for sale . . . if . . . low-risk category.”

            Your subsequent comment about medicines appears to not distinguish between high risk and low risk. It seems to contradict the RDG’s position?

  12. roy 8 April, 2015 at 10:16 pm #

    According to the RDG’s 7 point plan, point 4 states:

    [Quality is the] “Responsibility of the local Section 22C licensed facility and its responsible pharmacist. Standard MCC procedures for pharmacovigilance in South Africa.”

    This is a non-sequitur. It is standard procedure for all medicines. However, the responsible pharmacist only has the quality information provided by the supplier for “health supplements” and complementary medicines. It should be the MCC’s job to verify the quality of every medicine, including so-called “health supplements,” on the market. The responsible pharmacist in a licenced facility can only check that the necessary verification has indeed been done – by the MCC.

    Here again the RDG has suggested a system which potentially leads to an effective lowering of standards and possible loopholes.

    • RENE DOMS 9 April, 2015 at 10:16 am #

      @Roy

      It is clear you do not thoroughly understand how medicines are controlled in South Africa. The standards suggested for all medicines are identical.

      • roy 9 April, 2015 at 12:36 pm #

        Except that I have seen products being sold in large pharmaceutical chain stores and smaller pharmacies where the “responsible pharmacist” has allowed spurious and dubious products onto their shelves. These spurious and dubious products would also have been “allowed” by the responsible pharmacists at manufacturing / importation level. It is the lack of responsibility (sic) and control of medicines in South Africa that I have problems with. If I missed particular references to “in accordance with good pharmacy practice” in your submission, I apologise. I do not necessarily take it for granted.

        • RENE DOMS 9 April, 2015 at 2:32 pm #

          @Roy

          Unfortunate but agree and why inspectorate product history check so important.

  13. roy 8 April, 2015 at 10:30 pm #

    According to the RDG’s 7 point plan, point 5 states:

    ” “Re-instatement” of the ASA and its procedures in conjunction with Section 18C and supporting regulation. Expand Regulation 45 to promote public welfare, health and safety and foster information flow in the public interest.”

    It is completely unclear what “re-instatement” of the ASA and its procedures means. It was never decommissioned. But coming from the RDG, this could imply that the ASA has been largely ignored (because it cannot remove products?) It could also imply that the industry’s “Marketing Code Authority” has failed – although that explicitly excluded complementary medicines.

    The expansion of Regulation 45 to include “truthful” information flow should be welcomed, provided the industries do not subvert this.

    • RENE DOMS 9 April, 2015 at 10:18 am #

      @Roy

      Yes this is still a work in progress based on the assumption that the ASA offers the public a valuable service.

      • roy 9 April, 2015 at 12:39 pm #

        It would also be good if Section 18C was actually gazetted by the Minister of Health (as per the Act) and not merely “issued in terms of Section 18C” by the industries.

        • RENE DOMS 9 April, 2015 at 2:31 pm #

          @Roy
          Agree and part of the proposal.

  14. Harris 8 April, 2015 at 10:31 pm #

    Hi Rene,

    In your three posts in response to me, you bring up three aspects:

    1. I am “misleading your readership about the RDG proposal” for me arguing, among other, that the RDG is asking “that a lower threshold of proof be allowed.” You claim “In light of the RDG proposal, is this comment true as all claims for substances are pre-approved by the regulator.”

    2. That my statement “[I]t is pertinent to point out that the RDG has vested interests in the survival of this industry – the members all, directly or indirectly, earn a living from it” is not correct, you stating: “Is this true? It is definitely not so for me and has a malicious twist. How do you honestly justify such a comment as being fair?”

    3. That you are offended by my statement, “[I]t is therefore vital that RDG create a sufficient ‘loophole’, or alternative method of appraising evidence for these products, one that has a threshold set far below that required for health claims for foods or that for medicines”, by stating “Your bias goes beyond respectability and is blinding your understanding.”

    It is clear from the RDG document that a number of additional Appendices have been included above those being proposed by the MCC. These have no real benefit to consumers – but are of major benefit to the CAM industry, e.g., Annexure K (bioflavonoids), Annexure G (protein and amino acids), Annexure L (aminosaccharides – amino sugars).

    One of these makes it acceptable for CAM sellers to claim “antioxidants” for a number of ingredients, in some cases bizarrely (see below). There is a significant body of research that indicates that an average balanced meal supplies more balanced antioxidants, and to have to argue that consumers require or seek out “African wild mango” for the indication “Provides antioxidants” is somewhat ludicrous. In fact, you as a pharmacist would appreciate that the primary claim for African wild mango is its use as an ineffective weight-loss agent. What is the rationale for the RDG to propose it be included for this indication, a smokescreen to make other claims?

    Worse, Annexure L lists chitosan with the indications of, among other, “Helps maintain healthy cholesterol levels” and “could be a complement to a healthy lifestyle that incorporates a calorie-reduced diet and regular physical activity for individuals involved in a weight management program”. This is offensive for the following reasons: The conclusion of many years of studies on chitosan is that it has an insignificant effect on weight loss and cholesterol levels. In fact, the Natural Medicines Comprehensive database (NMCD) reaches this conclusion as well as the European Food Safety Authority (EFSA) – and for a dosage of around 6 grams per day. Yet the RDG suggests 1– 6 g per day, i.e., the RDG suggests that even a low dose of an ineffective ingredient could benefit consumers.

    And most egregious, it was the use of chitosan in Glomail’s Fat Attack, ‘substantiated’ by a member of the RDG (Alison Vienings), that precipitated me becoming a consumer activist.

    Similarly, for White kidney bean, its indication is among other, “Helps reduce the (enzymatic) digestion of carbohydrates”, an indication rejected by NMDC and EFSA.

    But wait, there is more.

    For Citrus Bioflavonoids, “Up to 1000 mg citrus bioflavonoids, per day“ can be used. In other words, CAM sellers could use only 1 mg and still make this claim. For L-Glutamic acid the dose recommended is “> 0 mg – 1 500 mg per day”: there is no need for a CAM seller to use more than 1 mg to make the claim.

    In Annexure G (protein and amino acids), the indications (claims can be made) is among other, “Assists in the building of lean muscle [tissue/mass] when combined with regular [weight/resistance] training and a healthy balanced diet” when the vast body of evidence is that sportswomen and men, with few exceptions, ingest more protein than the required amount of protein physiologically required to build protein per day, and that supplementation is a waste.

    The RDG proposal states: “Of significance in RDG’s proposal, is the shift from the scientific understanding of safety and therapeutic efficacy to a broader interpretation for herbal medicines” – is the RDG suggesting that ‘belief” and anecdotal evidence should trump science and particularly related to therapeutic efficacy?

    I can go on to support my contentions with further illustrations from the RDG document that the RDG document is in favour of the industry and NOT consumers, supports a lowering of standards of evidence required for claims, and that the RDG appears to be creating a ‘loophole’ or alternative method of appraising evidence – one that conflicts in many cases with established evidence.

    It is apparent that the RDG proposal was circulated to, among other, Clicks and Solal. It would be unusual for a potential proposal not in favour of industry but consumers to be circulated to them, unless…

    Therefore your statement “[Y]our bias goes beyond respectability and is blinding your understanding” conflicts with the very evidence I present from the RDG document.

    I repeat my point: “we believe that all consumers deserve to have a decent level of evidence that a product’s claims are justifiable, i.e., whether you spend R30 or R300 on a product, that ‘it will do what it claims it can do’”.

    • RENE DOMS 9 April, 2015 at 10:24 am #

      @Harris

      What do you propose? Unfortunately this industry is not going to go away nor is government moving in that direction. The final call on acceptable monographs is governments not the RDG’s. Not all the substances are bad. I explained to Roy why we expanded the monographs above.

  15. roy 8 April, 2015 at 10:45 pm #

    According to the RDG’s 7 point plan, point 6 states:

    “Follow MCC guidelines for Reporting of Post-Marketing Adverse Drug Reactions to Human Medicinal Products in South Africa. Product Quality Review reports can be called for and audited.”

    It is astounding that the RDG document includes this, for it is, in effect, an admission that it is not presently being done. Just as with licencing, this is something that should have been implemented by responsible industry players years ago. The MCC set up its Pharmacovigilance Committee in 2003. The procedures are clear and well documented.

    A particular adverse drug reaction which is included in the definition in the Regulations is “lack of efficacy.” A concerted effort should be made to ensure that all incidents of lack of efficacy are reported to the MCC.

    Product Quality Review reports should be on file for every manufacturer in any case. Of particular concern with “health supplements” would be to ensure there is “batch to batch consistency.”

    • RENE DOMS 9 April, 2015 at 10:27 am #

      @Roy

      But you know it is not being done. It follows the 7 point WHO plan. I suggest you re-read the RDG document when you have calmed down. There is little new in it that deviates from the control of conventional medicines.

      • roy 9 April, 2015 at 12:42 pm #

        Thank you. I still do not understand why a R7b a year industry is not complying with reporting of adverse drug reactions.

        • RENE DOMS 9 April, 2015 at 6:04 pm #

          @Roy

          That is a policing issue for government to sort out.

  16. roy 8 April, 2015 at 11:03 pm #

    According to the RDG’s 7 point plan, point 7 states:

    [Providing independent information by] “Pre-approved monographs, registered package insert, or patient information leaflet. Monitor advertisements for compliance with approved package insert and other suitable references, e.g. Journals.”

    Package inserts and patient information leaflets are required in terms of Regulations 9 and 10 in any case. The authority’s approval of these items is what is needed.

    Definitive criteria must be determined by the authority for the “pre-approval” of a monograph. Statements such as “helps relieve,” “supports,” “assists,” or “provides” must be avoided and/or excluded.

    Monitoring of advertisements to ensure they comply with the information approved by the authority is to be welcomed. Illegal, dishonest, untruthful and misleading advertisements should not only be disallowed and barred by the authority, but the possibility of removal of the products involved from the market should be considered, in the event of contraventions.

    • RENE DOMS 9 April, 2015 at 10:28 am #

      @Roy

      Agree and current practice.

      • roy 9 April, 2015 at 12:46 pm #

        But it is NOT current practice in reality. Some of the industries are “thumb-sucking” their package inserts and patient information leaflets. These are not being approved by the MCC. Some companies still refer to “Schedule C0” – on their packaging and package inserts etc.

  17. Kevin Charleston 9 April, 2015 at 7:59 am #

    @Rene My understanding from this is that you gave the document to Harris and agreed he could post it here. I have no idea if you placed any restrictions on how it was to be presented – but likely not, as I trust Harris’s discretion based on past behaviour. Knowing Harris and the purpose of this site, it beggars belief that you want to now control the direction of commentary from the sidelines.

    Academic Sources 101 – understand the explicit and implicit biases in the reference material.

    I would not trust a man dressed in rags living in an alley to take care of my money. I do trust a properly run banking organisation. I would be stupid to embark on a detailed analysis of 45 pages without understanding or questioning its provenance – let alone 441.

    Let me be quite clear: as a consumer who has experienced some 3 years of your input to Druginfo – I do not trust you or Ms Vienings to hold the benefit of the consumer as anything but secondary or tertiary. The other 27 years of regulatory experience for which you pat yourself on the back – are meaningless in that context. I commented on your draft 12a of the document on Druginfo, and my stance on the MCC regulations has been published on Groundup.

    What do you offer now that mollifies my distrust in you and Ms Vienings – or my suspicions (also voiced by by Harris) that the RDG is funded and operated by and for the CAMs industry? What on earth do you have to offer that would tempt me to waste my un-funded spare time on your likely-biased offering?

    • RENE DOMS 9 April, 2015 at 10:31 am #

      @All

      It may be useful to look at my responses to Roy (ex regulator) who at least is raising valid technical issues bearing in mind that the RDG document was directed at the regulator who understand all the underlying concepts (WHO regulatory model for medicines) that do not need repetition from their point of view. The document was directed at an informed audience.

  18. RENE DOMS 9 April, 2015 at 9:49 am #

    @Kevin

    I am not restricting Harris’ right to comment in any way. However, why not address what is before you than attacking the author. My sentiments about you are equal. It appears you have nothing to offer but hollow verbiage and so for your judgement. Is that so for Harris as well? In the past at least he has made some valuable contributions. Any objective comments about the merits of the RDG proposal are most welcome.

  19. Kevin Charleston 9 April, 2015 at 10:43 am #

    @Rene Who is ‘attacking’ the authors? What kind of petulant hyperbole is this? Harris has questioned the authors’ standing – as I have I. Questioning is not attacking. Your continued choice to not support the standing of the authors by avoiding responding merely deepens the suspicions of the motives of the RDG. You ignored my prior comments on your draft. Why would you expect ‘objective’ comments on something that appears to have been crafted for a very subjective purpose?

  20. RENE DOMS 9 April, 2015 at 1:19 pm #

    @Kevin

    Let’s agree to disagree, I do not have time for this nonsense.

  21. RENE DOMS 9 April, 2015 at 6:08 pm #

    @Roy

    Having worked through the RDG proposal, what is the material difference between what you ask and what we presented?

  22. Harris 17 April, 2015 at 11:25 am #

    René Doms and the RDG gives great credence to Health Canada’s regulation of CAMS. Many of us have repeatedly pointed out how poor it actually is, offering little in the way of protecting consumers adequately.

    This recent article published in the National Post points out just how dismal Health Canada has been in protecting consumers, illustrated by the fact that following a landmark retraction, that Dr Oz promoted Green Coffee bean extract is still on the market.

    (Reproduced here: http://www.camcheck.co.za/green-coffee-still-available/)

    “At issue is a tiered approval process that Health Canada calls a ‘risk-based approach to safety and efficacy’. Under this system, the level of evidence required to approve a product can vary depending on the specific health claims and the perceived level of risk. So low-risk products require little hard evidence to be approved.”

    “Williams calls this ‘risk-based’ approach ridiculous. ‘We have a regulatory framework, but the tendency is toward rubber-stamping, toward bending over backwards to make things easier for industry rather than safer for consumers,’ he says. ‘It’s not that useful, what we have’.”

    This is very similar to what Prof Roy Jobson expressed to René.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.