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
MEETING WITH THE COMPLEMENTARY MEDICINES COMMITTEE OF THE MEDICINES CONTROL COUNCIL – 30 MARCH 2015
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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:
- Medicines are not ordinary consumer products. 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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
- 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 FUNCTION||STATUS OF CAM IN RSA||RDG PROPOSAL|
|1. Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines||x||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.|
|2. Assessing the safety, efficacy and quality of medicines, and issuing marketing authorization for individual medicines||x||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.|
|3. Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of medicines||x||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.|
|4. Controlling and monitoring the quality of medicines on the market||x||Responsibility 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||x||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.|
|7. Providing independent information on medicines to professionals and the public||x||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.|
G. RISK MANAGEMENT
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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
- 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.
- 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|
 A complementary medicine is defined as:
“Complementary medicine” means a sub-category of a medicine that:
- originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other approved substance as determined by Council, and
- is a health supplement:
- with an approved Schedule 0 active ingredient and health claim;
- 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
- is not intended to diagnose, treat, cure or prevent any disease; or
- is a herbal medicine:
- containing one or more approved Schedule 0 herbal substances or herbal preparations, alone or in combination;
- 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;
- 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;
- 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;
- 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;
- the pharmacological effects or efficacy are plausible on the basis of long-standing use and experience;
- 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;
- 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
- is a discipline specific traditional medicine prepared and used according to the principles of:
- Chinese medicine and acupuncture;
- Phytotherapeutic medicine;
- Therapeutic aromatherapy;
- 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.
 Not considered a commodity of trade but a dangerous article as it can do harm.
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