Posted 27 November 2013
An article (opinion) written by Kevin Charleston in relation to the new complementary medicine regulations recently published, has been published on the GroundUp website. The CAMS Regulations were published on the 15th November and can be downloaded from here or from the Government website. They need to be read in context with the document, Complementary medicines – Quality, safety, and efficacy, which can be downloaded here. It should be read in conjunction with those of Andy Gray and published here.
Kevin Charleston has written an excellent overview/opinion of the new CAM regulations and is best read on the GroundUp website, but we are posting the article below.
Untested nonsense medicines and adverts to buy them are prolific. But after years of chaos in the alternative medicine market, it seems the Department of Health (DOH) is intent on fixing the mess.
The DOH has recently gazetted changes to the General Regulations of the Medicines Act to provide for the regulation of complementary medicines. The Medicines Control Council (MCC) is the body appointed to regulate the sale and use of medicines in South Africa, and they have recently released an updated draft of their guidelines for registering complementary medicines. Here’s a layman’s guide to what that means.
When I buy a packet of headache tablets from my pharmacy I expect them to contain what the packet says it does (quality), to not endanger my life (safety), and most of all – to relieve my headache (efficacy). Before the manufacturer can sell the pills, they need to get approval from the Medicines Control Council. This is the body appointed to regulate the sale and use of medicines.
Companies do this by submitting details of the product: e.g. what it contains, how it’s made, how it works, proof that it does work, factory inspection certificates, quality assurance tests, copies of package inserts and much more. To make sure that all medicine manufacturers provide the same level of detail, the MCC requires it to be submitted in a specific format: the ZA-CTD (South African Common Technical Documentation format).
Once approved, the manufacturer receives a product registration number, and is allowed to sell it, and also make the therapeutic claim “relieves headaches”. The MCC has an inspection and law-enforcement unit, and could withdraw the approval should the manufacturer fail to adhere to the safety or quality standards.
Registration with the MCC is a guarantee of quality, safety and efficacy, when the product is used in accordance with its intended dosage regimen.
If I buy, from the same pharmacy, a skin-care ointment which claims to be based on Ayurvedic principles (a system of Indian traditional medicine) and imported from India, I should expect the same level of quality, safety and efficacy.
Since many people claim that complementary and alternative medicines (CAMs) are less toxic than the evil “Big Pharma” products, perhaps I should expect it to be much safer? Unfortunately for eight Durbanites using the product Skintocare, their belief in CAMs became a nightmare when they suffered poisoning from toxic levels of lead. That isn’t an isolated incident; Ayurvedic and Traditional Chinese Medicines have a long history of mercury, lead and arsenic use. Poisonings have been reported all over the planet, particularly with interest in CAMs rising. Modern medicine has long abandoned those metals for more effective and safer alternatives.
There have been no regulations to prevent health shops and pharmacists from selling products like Skintocare. The MCC may become involved when dangerous products are reported to it and may issue a notice preventing its import or sale, but that might only happen after consumers have been harmed.
The MCC has had a hands-off approach to CAMs for many years. CAMs manufacturers, vendors and adherents have convinced government and the regulator that their alternative therapies cannot be held to the same standards as scientific medicines. It didn’t help that both our President and Minister of Health (MOH) from the early noughties held controversial views of medicines and disease and placed enormous faith in Traditional African Medicine.
As with any gap in regulation, the unscrupulous find ways to exploit it and abuse it. Shopkeepers will sell what the public want to buy. It’s hard not to sympathise with a pharmacist these days. The Single Exit Price (SEP) mechanism gives them little leeway to make money from prescription medicines and the public wants CAMs. That’s one reason (apart from the gigantic container size of the sport’s nutrition supplements) that we increasingly see pharmacy shelf-space occupied by vitamins, sports nutrition products, homeopathic and herbal remedies.
Regular medicines are classified according to the health-risk of substances they contain. They are assigned schedules numbered from 0 (low risk and may be sold in any shop) through to 7 (high risk and requires a permit from the Director General of the DOH to use). You’ll generally find the schedule 0 products on the shelves. Schedule 1 and higher will be behind the pharmacy counter. In theory no-one may sell any scheduled substance without it being registered with the MCC; including CAMs. In practice though, the MCC has shown little interest in complaints of CAMs products incorporating scheduled substances.
In 2002 the MCC issued a call-up notice intending to audit the use of CAMs in the market. The MCC received between 6,000 and 8,000 responses in the six month period it was active. In answer to a 2010 question in Parliament, the Minister of Health said there were over 155,000 CAMs on the market and that they had never been evaluated for quality, safety, or efficacy in any way because “the process, procedures and guidelines are not yet in place”.
The CAM marketplace has been constantly expanding. There are likely to be many more in the three years since that statement. This is scary. Products that could potentially poison you are being freely sold without being tested or monitored in any way.
Some CAM manufacturers have fraudulently claimed their submission to the 2002 call-up is “registration” with the MCC. That is not true. They did not submit any proper documentation and have not received a registration number.
So what’s being changed in the Medicines Act?
The amendments to the regulations now clearly define what a CAM is. That’s a great start, because without a definition anyone can claim their product is not a CAM and escape regulation. The definition refers to products used (for healing) in accordance with the disciplines regulated by the Allied Health Professions Council. This includes Ayurveda, Homeopathy, Naturopathy, Osteopathy, Phytotherapy (Herbs), Therapeutic Aromatherapy, TCM and Unani Tibb.
One disappointing aspect is the lack of regulation of Traditional African Medicine, whose practitioners are not a discipline of the AHPC.
All CAMs must be labelled with the discipline it follows (e.g. ‘Homeopathy’) and, if not registered with the MCC, must state: “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease” In order to make a claim as a treatment, the product must be registered with the MCC.
All new CAMs making health claims must be registered with the MCC after the regulation changes are effective.
The regulations also give a timetable for when existing CAMs must be registered by the MCC. If they fail to meet this deadline the products must be withdrawn, or the sellers may face prosecution.
CAMs that claim to treat cardiac problems, diabetes or act as antiviral treatments must apply for registration within six months. Those claiming to aid slimming, or boost sexual performance have two years. Vitamins and sports supplements have 30 months. All the others have six years.
What’s needed for MCC registration of a CAM?
The MCC only has draft guidelines for the registration of a CAM. They will have to turn these into final documents by the time the new regulations are implemented.
At the moment there are two drafts open for industry comment, one regarding the way documents are submitted for registration (the ZA-CTD), and another regarding the costs of registration. There are slightly fewer documentation requirements for registering a CAM than other medicines, and it may also be slightly cheaper (R5,500- per registration) provided it doesn’t require a toxicology report.
If all 155,000 items from the 2002 CAM audit were submitted, that’s at least R850-million that will have to be paid by the CAM industry (ultimately by the consumer). Don’t think this is a money-making scheme though: the actual costs to the MCC of implementing the systems and people needed to manage such a registration over six years are going to be huge.
The most important guideline at the moment is now closed for industry comment (it was opened in 2011). These are called the “QSE” for Quality, Safety and Efficacy. The guidelines make it clear that the first two, quality and safety, are an absolute requirement. Consumers have a right to products that won’t kill them and that contain what they say on the packet. That’s sometimes is a little difficult though. For example homeopathic remedies require repeated dilution and shaking (succussion). Oscillococcinum, a popular homeopathic product almost certainly does not contain a single molecule of the boiled-duck-liver that made up the mother-tincture1. It’s easier to prove it is safe though.
The guideline is very thorough about quality and safety, and the MCC has done a good job of ensuring that all of the disciplines are covered. If they can follow through on implementation, this alone will be an excellent achievement and huge improvement over the current lawlessness. All of the important factors are there: Good Manufacturing Practice, Good Laboratory Practice, Good Dispensing Practice and Good Regulatory Practice.
The guideline is more lenient when it comes to efficacy though. This is a little disappointing. To me the evidence that a product works is just as important as the Quality and Safety. But, as a realist, I’d prefer a little regulation of the efficacy of health products rather than none at all.
The different disciplines regulated by the AHPC have different ways of determining and interpreting whether a treatment actually works. As an evidence-based medicine proponent I’d suggest that they are merely struggling to prove that the treatment is more efficacious than a comparably applied placebo.
CAMs are important to a large number of people though. It is a large industry and, placebo or not, some people sincerely believe they are healed by these products. That belief alone has value which must not be discarded.
The MCC has attempted to cut through the “Gordian Knot” of efficacy of treatment by the different disciplines through characterising therapeutic claims as ‘high risk’ or ‘low risk’. So a high-risk claim, such as treating heart disease, must carry a higher burden of proof, and consequently requires more evidence (e.g. a clinical trial).
Low risk claims (E.g. “you’ll feel more energetic”) don’t require much evidence, provided there is enough supporting documentation from within the discipline to justify making such a claim. Some of that proof may be historical in nature. For example, in the case of a homeopathic headache treatment, mention in Materia Medica may be sufficient.
The guideline provides a comprehensive list of approved resources for such “evidence” and much of it is based on the Australian guidelines for CAM regulation.
So is this good or is it bad?
Neither supporters of evidence-based medicine nor CAM followers aided by the current lack of regulation. The quacks are fouling the marketplace and turning CAM into a laughing-stock.
Consumers aren’t being served by the chaos either. They are being harmed directly through toxic products, and indirectly in the pocket through products that don’t contain what they promise or do what they claim.
The new regulations are no panacea. It will be difficult and costly for the CAM manufactures and importers to get registered. Also, the regulations don’t directly cover traditional African medicine and are quite lenient when it comes to proving that a product actually works.
But perhaps that means the MCC have got it just about right: a compromise with which neither side feels they have won the absolute advantage. It is not perfect, but I think it is workable.
Most importantly, this is a good line in the sand. Register the product – or make no therapeutic claims. That is a far cry from the wild-west that is the CAM marketplace of today. But this means that we need an active and visible sheriff. The MCC has to function well in order for the regulations to work as intended. Have no illusions: this is a massive task and we would do well to be sceptical based on the MCC’s past performance. It will require a large injection of funding and energy to make it work; but the regulations deserve the willing support of consumers, manufactures and sceptics.
Disclosure: I am being sued by Solal Technologies, a health supplement manufacturer. See: this article on Quackdown.