The lawyer by Honoré Daumier. Source.
Will the new complementary and alternative medicines regulations protect consumers?
Published: Sept. 8, 2011, 10:11 a.m., Last updated: Sept. 8, 2011, 10:25 a.m.
The Department of Health recently published draft regulations and guidelines governing complementary and alternative medicines (CAMs). We have not done an exhaustive analysis of the proposed changes. We are posting preliminary observations to spur discussion and public engagement with these important documents.
As a visit to most pharmacies would attest, products making unsubstantiated health claims are ubiquitous.
I recommend starting with the guidelines. They are easier to follow. Comments on the draft regulations must be submitted by 21 October 2011. Comments on the guidelines are due 21 September 2011.
Despite relatively strong legislation in the Medicines Act, so-called complementary and alternative medicines have remained largely unregulated in South Africa. As a visit to most pharmacies would attest, products making unsubstantiated health claims are ubiquitous. Many product labels misrepresent the available evidence. Sometimes the presence of harmful ingredients or possible side effects are not mentioned or underplayed.
This mess is in part what the Department of Health is trying to clean up with these new regulations. All complementary and alternative medicines manufacturers will now be compelled to submit their products for registration with the Medicines Control Counsel (MCC). The MCC will evaluate applications and either register the product or reject the application.
The obvious questions that come to mind are:
- Does the MCC have the capacity to do this work well enough and fast enough, given the already existing backlogs?
- Would the registration provide sufficient guarantees of safety and efficacy?
Even though the first question is important and something clearly needs to be done to accelerate the work of the MCC, that discussion is much wider and more complex than the focus of this article. In particular it would involve a discussion of the proposed South African Health Products Regulatory Authority. For that reason I will focus on whether the suggested regulations will give consumers sufficient safety and efficacy guarantees.
Before we get going though, it is worth pointing out that For the first time in the history of medicines regulation in South Africa, manufacturers of complementary medicines will be required to demonstrate the quality of their products. The guidelines seem to provide sufficient safeguards that the products will in fact contain what they claim to contain and nothing else. No safety or efficacy claims can be made if the quality isn’t assured.
Will consumers be properly informed?
According to the guidelines, the kind of safety and efficacy evidence required by the MCC will depend on the nature of the health claim or indication. To this end, claims are divided into three risk levels: high, medium, and low. This table has been copied, with footnotes omitted, from the guidelines:
| Level of claim | Type of claim | Evidence required to support claim |
|---|---|---|
| HIGH |
|
Clinical data to be evaluated. |
| MEDIUM |
|
Primary evidence: Two of the following three sources that demonstrate adequate support for the indications claimed:
|
| LOW |
|
Primary evidence: One of the following three sources that demonstrates adequate support for the indications claimed:
|
The classifications are vague and overlapping. Consider for example that in the high category we have "Prevention of any disease or disorder", but then in the medium category we have "Reduction of risk of a disease/disorder". These seem essentially the same and the "reduction of risk" claim should also require clinical data.
Similarly, "treats/cures/manages any disease/disorder" is very close to "aids/assists in the management of a named symptom/disease/disorder". Already many quacks use terms like "aids" or "assists" when selling their products as a way to obfuscate responsibility. Of course, a claim like "aids in the treatment of depression" would be understood by most people to mean that the product in question will alleviate depressive symptoms. If a high/medium/low risk differentiation is to be used, it should offer robust protection against these kinds of semantic games.
More worrying though, is the lack of meaningful safety evidence required for claims classified as medium and low. For example, according to my reading, medium claims can be accepted with only claims from recognised pharmacopoeia and written histories. Given that some of the recognised homeopathic pharmacopeia are based on very poor research conducted in the nineteenth century, consumers have reason to be worried.
Similarly, claims about symptom relief can be substantiated by as little as an independent written history. Elsewhere the guidelines also make provision for oral histories that have been written up in reliable sources.
This highlights a major concern with these guidelines and regulations: On the one hand there is a suggestion of consumer protection and the development of sensible standards for the regulation of CAMs, on the other, there is a naive reverence for the unsubstantiated claims made by homeopaths and other purveyors of pseudoscience. If the kind of consumer protection envisaged in the Consumer Protection Act is to find expression in the regulation of medicines, all reference to homeopathic pharmacopeia and dubious monographs has to go.
However, a bit lower down in the guidelines there is this line: "6 This evidence does not stand alone and may only be used in conjunction with primary evidence." This is good but it appears to be inconsistent with the table.
Will consumers be misled about efficacy?
The guidelines contain a deeply worrying section on the criteria used to assess efficacy. For example, the homeopathy section lists the following ‘acceptable’ sources of evidence of efficacy:
- Drug symptom pictures according to accepted Materia Medica
- Accepted Homoeopathic Pharmacopoeia
- The German Commission D Monographs
- Monographs from the Homeopathic Pharmacopoeia Committee of the United States and the French Pharmacotechny
- Appropriate clinical trials
- Monographs from any other source equivalent in standard to any of the above.
Of course, the only criteria by which we can really know whether a specific homeopathic medicine works is by doing a randomised controlled trial. As this review article in the Lancet indicates, homeopathic medicines are really no better than placebo. In other words, by accepting the nineteenth century pseudoscience of "accepted" Materia Medica, the MCC might soon be approving efficacy claims for placebos.
What is a complementary medicine?
The regulations define a complementary medicine as "a medicine that is used-
(a) or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal; and
(b) in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982)."
Part (a) of this formulation is so vague as to make it meaningless. Anything from aspirin to the MMR vaccine assists the body’s innate healing processes. "Innate healing processes" is the kind of phrase typically associated with products for which there is little or no evidence.
The second part of the definition makes more sense since it is much more precise. It refers specifically to ayurveda, Chinese medicine and acupuncture, chiropractic, homeopathy, naturopathy, osteopathy, phytotherapy, therapeutic aromatherapy, therapeutic massage therapy or therapeutic reflexology. In my reading, it excludes vitamin supplements, which must surely be a good thing.
However, categorising all the listed disciplines as a form of medicine nevertheless is a bit misleading since it implies at least some efficacy. However the categories include only those disciplines that are regulated by the Allied Health Professions Council of South Africa (AHPCSA) – which should be an additional safeguard for citizens. It is also the first time that medicines regulations take cognisance of the role of the AHPCSA. Is this a way of "passing the buck"? Was the AHPCSA consulted in the formulation of these regulations?
In fact, stepping back for a moment, this whole effort to provide separate regulations for CAMs, with more lenient regulation, is fundamentally at odds with consumer protection. It proposes that homeopaths have a right to make clearly dubious claims and disregards the consumer's right not to be misled.
Just to be clear, herbal, homeopathic or other so-called "complementary medicines" cannot and should not be banned from the market. People obviously have a right to buy and sell these products. However, companies who sell these products should not, and do not, have the right to sell products that do not meet stringent quality standards, are unsafe or make misleading claims about the efficacy of their products. The fundamental purpose of medicines regulation is to protect patients and consumers above manufacturers and sellers. As they stand, these regulations fall short.
Thank you to Roy Jobson for commenting on the draft version of this article. I take responsibility for the article's views and errors.
The law seems to be targeted to prevent toxic, or dangerous substances being sold. Under these requirements non toxic CAM should be easy to sell with vague enough health claims. Placebo's do provide relief, so based on that alone, Homoeopathy can get by on a Medium claim level, which if you know nothing about the structure of the law, is dishonest.