Why we should support the new complementary medicines regulations
It has been a year since regulations were published to protect the public from poor quality complementary medicines. The industry’s response has been characterised by obfuscation, denial and blatant contraventions, writes Professor Roy Jobson.
Poorly regulated complementary medicines (CMs) in South Africa pose a serious public health risk according to the National Department of Health. The main health risk is that there is no control whatsoever as to what is contained in these medicines. Anyone could put anything in them, make claims about what they can do, and sell them to the unsuspecting public. No-one’s any the wiser – it’s almost the perfect scam.
One year ago new regulations were published to begin to remedy this situation. These regulations were the culmination of previous draft regulations published for comment over many years since 2001. The last comment period being from July to the end of November, extended to the end of December, 2011. Notice R870 of 15 November 2013 – ‘final’ regulations – was in many ways just a refinement of the July 2011 draft.
This means that the public and the CMs industry have had opportunities to comment and give input for over ten years.
The main new requirements are:
a re-worked definition of complementary medicines, linking them to the allied health professions regulated by the Allied Health Professions Council of South Africa.
a new category of medicines called ‘category D’ medicines (i.e. CMs).
a requirement for all CMs that have not yet been registered by the MCC to state on the label that: ‘This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.’ (The label must also state which discipline of CM it belongs to.) The industry has for the most part ignored this.
a series of deadlines for ‘applications for registration’ of various CMs spread over six years, starting with the most controversial.
It is the last point that the CM industry most fears. It means that they will have to pass three major criteria for each and every medicine they sell.
A) That it meets quality criteria (it contains only what is claimed on the label it contains).
B) That it is safe to take (and in what dose, etc.).
C) That it does what it is supposed to do.
But, as consumers, surely this is the minimum we have been assuming all along? Most citizens, misled by credible-looking packaging and the claims made, have had no idea that the medicines they’ve been buying could contain nothing of healing value. Not even those CMs sold in a pharmacy.
It doesn’t count for a manufacturer or seller of a CM to say – “Trust me. The medicine’s of the highest quality, manufactured in a GMP-compliant factory, it’s safe, and it works.” That’s called advertising, not evidence!
Obtaining the required data will be expensive. One of the perennial (repetitive) arguments made by the CM industry against obtaining the data, has been that one cannot patent a natural substance. This is only partly true. If an original, unique formulation has been developed, this can certainly be patented.
An example is the series of patents taken out by researchers at the Cape Peninsula University of Technology for a combination of omega 3 fats, carotenoids and Vitamin E-related substances. Although this is patented as a ‘food supplement’ it was launched in South Africa with the medicinal claim of reducing the risk of cancer. It is therefore a medicine in South African law (a medicine is defined by its claimed uses - and if these are medicinal, the product is a medicine). The CM regulations will ensure that such a patented product can indeed reduce the risk of cancer, if there is sufficient evidence, before it legally becomes widely available.
Another important component of the CM regulations is the role envisaged for various allied health professions, such as homoeopaths, naturopaths, phytotherapists and others. One of the key features of almost all allied health professions is their focus on the individual patient (or client). They may even formulate, compound and dispense individualised medicines for their patients. The reason for this is that they genuinely want to help and be of service to those who come to them for help.
This is in sharp contrast to the CM industry which is focused on selling as many products as possible for a profit. The regulations are there primarily to ensure that CMs sold directly to the citizens of South Africa are not fraudulent products.
One of the main objections to the regulations has been that they take away individual’s freedom of choice. This is not true. Freedom of choice is only possible if full and accurate information is available. Many of the products people were “freely” choosing did not provide such full and accurate information. Indeed as has been shown over and over again at the Advertising Standards Authority (ASA), the manufacturers and sellers of these products are often unable to provide sufficient substantiation to support the claims made for what they’re selling.
Since the regulations were published, a draft amendment regulation was published recommending a change in the definition of a CM to include an undefined component called ‘health supplements.’ The comment period closes on 15 December 2014. Another related development has been the passage of ‘The Medicines and Related Substances Amendment Bill, Bill 6 of 2014’ through parliament, and is presently being deliberated by the Parliamentary Portfolio Committee on Health.
The concerns, petitions, letters to the Minister of Health, and objections to the regulations are misplaced. We should all be supporting the Department of Health’s initiatives to ensure, for the sake of the citizens of this country, that every CM has been properly assessed and evaluated and registered, before it’s made available to the public.
Jobson writes in his personal capacity. Disclaimer: These opinions are not necessarily those of Prof Jobson’s employer; nor necessarily those of the Allied Health Professions Council of South Africa, of which he is a council member.
Which CMs registration applications must be submitted and by when?
Antiviral agents, Oral hypoglycaemics, cardiac medicines, cytostatic agents - immediately.
Slimming preparations, male sex hormones, female sex hormones, and androgen-oestrogen combinations claiming sexual stimulation and sexual dysfunction [uses] - within 24 months (i.e. by 15 November 2015)
Medicines claiming immune stimulation or expressions of similar connection, and medicines acting on muscular system, and vitamins claiming to be sport supplements and exceeding the upper limit of vitamins and minerals - within 30 months (i.e. by 15 May 2016)
All remaining CMs by December 2019.
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