Posted 24 February 2014
René Doms is a registered pharmacist and also holds a law degree. He has been closely observing regulations pertaining to complementary medicine.
In this article, first posted to the email discussion group, DrugInfo, he shares his interpretation of the new regulations governing CAMS published in November 2013.
GOVERNMENT’S PLAN TO CLEAN-UP THE COMPLEMENTARY MEDICINES INDUSTRY IN SOUTH AFRICA
The government through the Department of health has started the implementation of their plan to clean up the complementary medicines industry in South Africa, as we know it. The Director General of health is responsible for this task. Her powers flow form the Medicines Act. She does so through her inspectorate appointed in terms of the Act. These powers are extensive. They are aimed at protecting public safety.
The complementary medicines clean-up plan is straight forward and clear (see roadmap slides – www.mccza.com):
- Withdraw banned products;
- Withdraw scheduled substances;
- Withdraw medicines not fitting definition of CAMs; and
- Submit new CAMs.
The bullet pointed robust message needs explanation as it has a considerable impact on the complementary medicines industry. When fully implemented, the nature and characteristic of this industry will change dramatically, possibly be unrecognisable as we know it today.
The MCC’s powers to regulate originate from the Medicines Act itself as well as our administrative law, underpinned by the Constitution. Although the right freely to engage in economic activity is an important right in an open and democratic society based on freedom and equality, the Medicines Act limits this right. Its purpose is to achieve the widest and most efficient form of regulation and control of medicines in the interests of the public.
In determining whether or not the registration or availability of a medicine is in the public interest, the MCC may only consider the safety, quality and therapeutic efficacy’s merits of the medicine in relation to its effect on the health of man or any animal. The significance of such purpose speaks for itself – without proper regulation and control the health of the public would be threatened (Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and another 1998 (9) BCLR 1113 (1998 (4) SA 660) (T)).
2. WITHDRAW BANNED PRODUCTS FROM THE MARKET – MCC ADMINISTRATIVE LAW DECISION
There are a number of products that the Medicines Control Council (MCC) considers undesirable for use in medicines – banned substances for consumption in medicines. These substances are hazardous to health. The list has grown over a period of many years. The substances are: Apiol, Damiana, Kava-kava, Senecio plant species – pyrrolizidine alkaloids and Yohimbine. Any so-called complementary medicine containing any of these substances must immediately be withdrawn from the market as it poses a risk to public safety.
3. WITHDRAW SCHEDULED SUBSTANCES – MCC ADMINISTRATIVE LAW DECISION
More correctly, any medicine containing a substance listed in Schedule 1 and higher to the Medicines Act must immediately be withdrawn from the market as the substances contained in these unregistered self-styled complementary medicines pose a risk to public safety.
There are a large number of self-styled complementary medicines that contain these scheduled substances. Common are milk thistle (silymarin), Red yeast rice (lovastatin), slimming preparations (sympathomimetics), vitamins, minerals and probiotics in high doses, proteolytic enzymes, melatonin and phospholipids to mention a few frequently found in complementary medicines.
4. WITHDRAW MEDICINES NOT FITTING DEFINITION OF CAMS – CRIMINAL LAW
These medicines are misbranded, self-styled complementary medicines falling within Category A in Regulation 25 that require registration prior to sale. No person may sell any medicine that is subject to registration unless it is registered (Medicines Act section 14(1)).
Categorisation of such medicines is more difficult to establish as it entails the categorisation of the medicine in question into either a Category A or D medicine. Category A medicines necessitate registration prior to sale whereas complementary medicines as defined in regulation presently available on the market may continue to be sold provided they are labelled correctly and do not contain any Schedule 1 or higher substances.
The Medicines Act proscribes that no person may sell any medicine that does not comply with its prescribed requirements (Section 19(1)). It is a criminal offence to do so. These self-styled Category A complementary medicines are misbranded and must be withdrawn from the market as they are illegal and pose a risk to public safety.
A Category D complementary medicine (edited definition – “allied practitioner medicine”) means any substance or mixture of substances that:
- Originates from plants, minerals or animals;
- Is used in assisting the innate healing power of humans to mitigate, modify, alleviate or prevent illness or the their symptoms or abnormal physical or mental state; and
- Is used in accordance with the practice of the professions of Ayurveda, Chinese medicine and acupuncture, chiropractic, homeopathy, naturopathy, osteopathy, phytotherapy and therapeutic aromatherapy and Unani Tibb.
A Category A medicine (“general medicine”) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in—
- The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or
- Restoring, correcting or modifying any somatic or psychic or organic function in man,
and includes any veterinary medicine.
A Category A medicine – general medicine – is therefore a substance used to diagnose, treat, mitigate, modify or prevent a disease or affect a physiological function – structure/function claim. Whereas, a Category D complementary medicines – allied practitioner medicine – is a substance of natural origin, designed to assist the innate healing powers of the body in illness management within allied practitioner’s practices. Most, if not all Category A medicines – general medicine – have been called up for registration.
There is a considerable difference in the scope and reach of the two definitions. A category A medicine – general medicine – goes much further. The second part of the Category A medicine’s definition has been deleted from the Category D medicine’s definition – effects a physiological function or structure/ function claims (US terminology) as explained below.
The latter complementary medicine – allied practitioner medicine – as defined in the regulation is designed to take care of the whole medical system that sits outside the framework of the biomedical structure of medicine as generally practised in our medical schools. This is necessary to cater for the constitutional imperative entitling people to practice their culture. It provides for different world views. Whole medical systems are built upon theories and practices that have evolved apart from, and earlier than, the biomedical or conventional medical approach. Allied practitioners generally make use of this practice as controlled by the Allied Health Professions Act, No 63 of 1982.
The definition of a disease is very broad. It may be defined as an impairment of health or a condition of abnormal functioning. Its terminology is referenced in the ICD 10 code of the WHO as used in South Africa. Disease best refers to an abnormal condition affecting an organism. This abnormal condition could be due to infection, degeneration of tissue, injury/trauma, toxic exposure, development of cancer, etc. This is what needs to be ‘cured’, especially if it’s life-threatening. While illness is the feelings that might come with having a disease. Feelings like pain, fatigue, weakness, discomfort, distress, confusion, dysfunction, etc. – the reasons people seek healthcare – and usually the way people measure their success with treatment.
It’s very important to appreciate that feelings of illness can be vastly affected by many non-disease factors, such as expectations, beliefs, fears, feelings/moods, and culture. Being ill is a very personal experience, and can vary tremendously and be affected by very different things between people with the same ‘disease’.
It is clear from the RSA ’s labelling disclaimer that an unregistered complementary medicine may not diagnose, treat, cure or prevent any disease nor may it effect any physical, mental or physiological function i.e. make a structure/function claim as the latter is excluded from the complementary medicine’s definition. But more about this later.
Common Category A misbranded self-styled complementary medicines include multivitamin preparations, probiotic and those that affect a physiological function such as hormone replacement therapy medicines (HRT), bio identical hormones, diagnose or treat diseases such as infections and parasites, neoplasms (cancer), blood disorders, disorders of the immune system, endocrine disease, metabolic diseases, endocrine disease, diseases of eye, nervous system, circulatory, respiratory, digestive, skin genito-urinary and musculo-skeletal systems. Self-styled DSHEA complementary medicines will be unlikely to survive regulatory scrutiny. Most are category A medicines requiring registration before sale because they are making structure function claims which are not excluded from the scope of the Medicines Act.
Any product that affects a physiological function – structure/function claim is also classified as a Category A medicine because this arm of the definition does not appear in the regulatory definition for a complementary medicine that is limited to the alleviation of an illness. Such products include slimming preparations, claims such as boosts, burns fat, calming, helps when crossing time zones, maintains normal mood balance, water balance, increases metabolic rate, repairs, restores, stimulates, stops craving and strengthens the immune system, amongst others.
All medicines are Category A medicines unless there are specific characteristic that indicate otherwise. Generally the product’s category should speak for itself through its presentation. Homeopathic remedies will contain potentised ingredients and the starting substances found in recognised homeopathic references such as homeopathic pharmacopoeias. Ayurvedic preparations are based on the doshas of Vata, Pitta and Kapha. Substances and formulations are found in the Ayurvedic Pharmacopoeia of India.
Traditional Chinese medicine (TCM) is based on Yinyangism (i.e., the combination of Five Phases theory with Yin-yang theory). While Unani medicine is founded on the concept of the four humours: Phlegm (Balgham), Blood (Dam), Yellow bile (Ṣafrā’) and Black bile (Saudā’).
It must be noted that so-called “dietary supplements” which make medicinal claims, including those of “supporting” or “assisting the body”, satisfy the statutory definition of a medicine. Also, that foreign statutes such as the United States Dietary Supplements, Health and Education Act 1994 (DSHEA) are not law in South Africa and thus have no bearing on the conduct of bodies such as the Medicines Control Council.
5. DSHEA AND THE MODERN SOUTH AFRICAN COMPLEMENTARY MEDICINES INDUSTRY
The majority of complementary medicines brands as we know them on the shelves of the various retail chains, is built on the DSHEA model as practised in the US. The Dietary Supplement Health and Education Act of 1994 (DSHEA) is not law in South Africa. There is no similar statute in our country. There is no “food” safe harbour for these medicinal products. Our medicines law is different. Products based on the DSHEA model clash with our Medicines Act. The Medicines Act prevails in such circumstances.
Generally, a person can only consume a foodstuff or medicine, as defined. If in doubt, the Medicines Act will triumph. Such dietary supplements including body building products are regulated either as foodstuffs or medicines depending on how they present to the consumer or are generally used. They may not contain Schedule 1 and higher substances.
So what is the difference between the DSHEA model and our Medicines Act? The answer lies in the US Federal Food, Drug, and Cosmetic Act (FD&C Act). It spawns the exemption permitted for the sale of dietary supplements in the US but not in our country.
21 US Code chapter 9, subchapter II defines a drug as (abbreviated for clarity):
(g) (1) The term “drug” means:
(A) Articles… and
(B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) Articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement … is not a drug under clause (C) solely because the label or the labelling contains such a statement. [Structure/function claim but not so in our Medicines Act – these products are classified as medicines in South Africa.] A US defined dietary supplement is:
(ff) The term “dietary supplement”—
(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).
In terms of US law, dietary supplements containing the listed substances (vitamins, minerals, amino acids and extracts form plant etc) may make therapeutic or medical claims without being classified as a drug or medicine. This is not the case in South African law as no such exemption exists in the Medicines Act. Products making such claims directly or by implication are classified as Category A medicines as they do not comply with the regulatory definition for a complementary medicine. Such category A medicines require registration prior to sale. Body building products can hardly fall within the scope of an allied practitioner’s practice. A number of these so called DSHEA complementary medicines also contain Schedule 1 and higher substances, some that may only be made available on prescription in South Africa. This poses a potential risk to public safety.
The Medicines Act is “use” based. The seller’s intention is not the only consideration taken into account when determining what a product is used for in the circumstances or for its classification. Evasive or deceptive tactics are not acceptable when in fact the products falls within a particular provision of the Medicines Act. A product that has been used for years and promoted as a medicine to the public unexpectedly does not become a foodstuff because it now suits the seller. Such a product continues to retain its medicinal or therapeutic characteristic as a medicine in the minds’ of the consumer. Simple side-steps or thinly veiled disguises are hollow in law. Such products continue their existence as medicines. The consumers use such products for therapeutic purposes.
NOTE: Structure/function claims (DSHEA model) are not exempted from the Medicines Act provisions. Products bearing such claims are most likely unregistered Category A medicines – general medicines – requiring registration before sale.
However, each product must be assessed on its own merits. The legal categorisation principles should not be applied in a vacuum. If uncertain about the categorisation of a particular product, it is advisable to discuss it with the regulator. A large number of misbranded self-styled complementary medicines are negatively struck by this new addition to the Medicines’ legislation.
6. SUBMIT NEW CAMS – MCC ADMINISTRATIVE LAW
Medicines are called up for registration in terms of section 14(2) of the Medicines Act. The MCC may from time to time by resolution approved by the Minister, determine that a medicine or class or category of medicines or part of any class or category of medicines mentioned in the resolution is subject to registration.
Products (complementary medicines must comply with the regulatory definition and not be misbranded, self-styled complementary medicines) at the time of the call up that were available on the market may continue with sale (“grandfathered”) until registered or rejected by the MCC after due process. This can take about 2 years if all the documents are in order. However, often the MCC would ask for further particular which may take the applicant time to collect. This will extend the period for registration depending on how long it takes for the applicant to respond to the query.
Complementary medicines complying with the regulatory definition that were not available for sale before the call up notice (15 November 2013) may not be sold until registered.
The regulations published on 15 November 2013 contained call up notices for complementary medicines as defined in the regulation. The pertinent call up notice reads:
Regulation 48C 2 (d) (ii) Complementary medicines falling in category D and in the pharmacological classifications as per Regulation 25(2) and (3) [all pharmacological classifications] that become available after the date of publication of this notice shall be subjected to registration as per the provisions of the Act.
There are two points of note. No new complementary medicines may be put on the market unless registered. Secondly, the product must comply with the regulatory definition for a complementary medicine. Medicines submitted that are otherwise (Category A medicine) will probably be rejected by the regulatory authority. In other words, the Category D complementary medicines call up notice for new Category D medicines has “closed” – no sale of a new complementary medicine unless registered.
This concept is ill understood by sellers of self-styled complementary medicines. “Grandfathering” is an exemption that allows persons to continue with an activity they were engaging in before it became illegal through a change in regulation. For instance, if a product was on the market when the law changed it may continue with sale until registered or rejected. Section 14(3) of the Medicines Act creates this vested right of sale pending final adjudication of the product. Such products must be labelled with the valid application number issued by the MCC at the time.
No complementary medicines submitted after 1990 are grandfathered. They do not have a vested right of sale. In the Treatment Action Campaign and another v Rath and others  4 All SA 360 (C) case, Judge Zondi ruled that in his view it was not the purpose of the 2002 call up notice to subject to registration the nutritional substances (so called complementary medicines) mentioned in the notice. Its primary purpose was to bring the substances about which medicinal claims are made to the attention of the MCC for it to determine the correctness of the claims and whether the claims constitute a public health hazard. The notice states categorically that submission of an application in its response would not constitute product registration but would be considered a primary step in the registration process. The 2002 notice does not render the substances it identifies subject to registration as medicines. It renders them “subject to a call-up process instituted as a primary step towards registration of such as medicines. In other words the substances identified in the 2002 notice do not automatically become registrable.
Consequently, the 2002 call up notice was an “audit” and not a call up notice as understood in terms of Section 14(2) of the Medicines Act. Registry audit numbers are therefore not valid application numbers as issued in terms of the Medicines Act. They have no force or effect in law nor do they create a moratorium permitting the sale of these self-styled complementary medicines so submitted for audit purposes until registered. Only complementary medicines on the market on 15 November 2013 that comply with the regulatory definition of a complementary medicine may continue with sale until registered or rejected after due process. It is illegal to sell a misbranded self-styled complementary medicine.
In 2010 the Registrar of medicines sent out a circular telling the industry that a registry number issued in terms of the 2002 audit did not entitle one to sell the product.
In sum, the Medicines Act, the roadmap issued by the Registrar of medicines read with the regulations and guidelines for complementary medicines instructs one to:
- Immediately withdraw products from the market that contain: apiol, damiana, kava-kava, Senecio species – pyrrolizidine alkaloids and Yohimbine as they are potentially hazardous and pose a risk to public health and safety – MCC administrative law resolution;
- Immediately withdraw all misbranded unregistered non-grandfathered products without a valid application number (Section 14(3)) and not a registry audit number containing Medicines Act Section 22A substances listed in Schedule 1 and higher as they pose a potential risk to public health and safety – MCC administrative law resolution;
- Withdraw all misbranded self-styled complementary medicines that do not comply with the regulatory definition for a complementary medicine as they are considered Category A medicines, previously called up for registration and currently in conflict with the provisions of the Medicines Act (Section 14(1)) – Criminal law offence; and
- Submit all new complementary medicines meeting the regulatory definition for registration prior to sale – MCC administrative law resolution.
The regulatory framework to control the complementary medicines industry in South Africa is all embracing and pervasive. The process to clean up the market has begun. Its impact will slowly start filtering through into the public domain. Product recalls will drive and highlight the progress. A large number of products presently available to the public will not meet the very restrictive regulatory criteria and will have to be withdrawn from the market.
René Doms 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 Fax: +27 86 617 1614 Mobile: +27 82 555 7621
Website: Forensic Pharmacy Corner
Email: [email protected]