Our rights to natural health are under threat in this country. This since the Department of Health, during November 2013, passed new regulations to control complementary medicines in the same way as pharmaceutical drugs.
In response the Natural Health Alliance was formed last month, chaired by Dr Bernard Brom (photograph on the right)), an Integrative Doctor, who has used natural medicine safely and efficaciously for more than 30 years.
According to these new regulations your probiotics will need the same rigorous research as something like Prozac. This is clearly inappropriate and irrational. Complementary medicines are not drugs. They are not used in the same way as drugs are, and they do not carry the same risks.
The regulations are being challenged in court by the Health Products Association.
No broad consultations – big surprise
The new regulations for natural medicines, or complementary and alternative medicines (CAMS) could effectively remove 60 to 85% of CAMS from the shelves, depending on whose estimate you go on. There was no broad consultation and the regulations came as a surprise to the industry and the public. Only now are people waking up to their broad implications.
The regulations define a new category of medicines, Category D Complementary Medicines. Category D medicines include herbal medicine, Chinese medicine, other traditional medicines and homeopathy. It remains to be seen how this category is affected - the expense of registration may mean companies simply cannot afford to register.
Anything that doesn’t fit into that definition moves to Category A, general medicines, which are pharmaceutical drugs.
This includes:
- high dose Vitamin C (which has excellent research behind it)
- doses higher than 500iU of Vitamin D3 (the Vitamin D Council in the United States recommends a dose of 5000iU)
- any combination products
- bio-identical hormones
- probiotics
- any product containing an extract like Silymarin (Milk Thistle)
- high dose vitamins
65% of natural products now become ‘drugs’
Around 65% of products now on the market will fall into the “general drugs” category.
The reasons given for the regulations are that it is in the “interests of public safety.” No one is suggesting that we allow unsafe medicines on the market. But consider: Complementary medicines are not drugs. Drugs are toxic, have patent laws which apply to them and require research required to make sure they are safe.
Natural medicines cannot be patented and are generally safe, with hundreds of years of safety record behind them. There is also extensive research on many of the products on the market.
Few are against regulation. There are some dodgy products on the market – especially in the slimming, body building and sexual enhancement sector. There may even be some CAMS which could need to be used on prescription only. Some may need to carry warnings.
No one is against good manufacturing practices: as a consumer I want to know that what the label says is what I get, that it is not adulterated with anything else, and that it has been manufactured in hygienic conditions.
Spending millions to comply with toxicological studies
It’s the Category A medicines which will be hit hard. Because the new regulations are so stringent, companies will need to spend millions of rand to comply with toxicological and clinical studies required, with no way to recoup costs, as there is no proprietary protection for them.
Already some substances are on the banned list, and as such cannot be sold. Others fall under the May 2014 call-up for registration.
What about our free choice around the management of our health?
Dr Bernard Brom is concerned that innovative natural products used by Integrative Medical doctors around the world will require regulation under the new system, which would make it almost impossible for them to be registered.
“I think we need a significant change in the way natural medicines are regulated that comes with the understanding that the practitioner and public should be able to have free choice around the management of ill health, just as we have in choosing to smoke, drink alcohol and buy junk foods.”
The situation is very serious, and requires prompt action if your natural medicines are to remain on the shelves.
By Jeanne Viall
Join the alliance
Please join the Natural Health Alliance to add your support or go to www.naturalhealthalliance.co.za or find them on Facebook.
Help stop the natural health crackdown
The new regulations put out by the MCC will mean that 85% of all natural medicines will disappear from the market place, thousands of people will be out of work and the economy will lose millions. We will have the most stringent and highly regulated natural health industry in the world.
This move by the Medicines Control Council of South Africa (MCC) will mean that 85% of all natural medicines will disappear from the market place, thousands of people will be out of work and the economy will lose millions.
Sign the petition now and stop the crackdown on natural health products.
Dr Craig Wright says
Dear Jeanne. I am commenting in my personal capacity. Unfortunately your article contains many unsubstantiated claims (60-85% of CAMS? Where does that come from?) and downright easily verifiable errors e.g. Scheduling of Vitamin D was INCREASED from 500 to 1000IU earlier this year - meaning that any Vitamin D supplement of 1000IU or below per daily dose does not need to go for ‘full category A’ registration, Vitamin C level increased too. The public should be welcoming these regulations as it means we will get more reliable, better quality complementary medicines, which is what we all want! And on the topic of herbal isolates: digitalis, morphine and aspirin are or were ‘herbal isolates’. Why should complementary medicines that contain herbal isolates be treated any differently from conventional medicines, unless proven to be safe? And in order to prove that they are safe they must submit full safety, quality and efficacy data to the regulator - i.e. full registration / evaluation process!
It upsets me at the amount of misinformation being spread by mostly well-meaning people. Journalists however, have an obligation to FULLY investigate and report in an unbiased manner.
Jeanne Viall says
Hi Craig. Thanks for your response. The figures I used in the article are from Rene Doms, a consultant and expert in the field of CAMS regulations, whom I’m sure you know, as well as the Health Products Association, which represents many of the companies responsible for the products affected. (my original article did contain those refs). The HPA has long been in consultation with the DoH. There are also precedents in the EU regulations and the Canadian ones where similar regulations have resulted in 65% of products disappearing from the shelves - and not because they are “unsafe”.
I agree with you we need safe complementary medicines - what I am still looking for is documentation on the supposed “dangers” of many of these substances. Where there is a risk, tell the consumer with a warning label. But don’t make registrations prohibitive, so that I cannot decide for myself because the product is not available.
As for misinformation: I have indeed done my homework, speaking to many people in the industry, and it is both the cost (for consultants) and the process of registration (onerous) which means companies will not be able to afford to register many excellent products. Already companies are telling me that it will be impossible to register their products (and these are NOT high-risk ones) and they will have to close down. That’s serious.
I have studied the regulations, I have read the MCC papers, spoken to experts - and very little is clear. Very few consumers have an inkling of the regulations; even companies don’t know how they will be affected. Which products go into Category A? What kind of research will be needed to register combination products? Getting the answers from the DoH and MCC has proved impossible.Do you have answers?
I am also not inspired that people trained in an allopathic paradigm have the expertise to evaluate efficacy and safety when it comes to CAMS, and it does seem that at this stage it is not that easy to say with certainty which products will or will not be registered. I also cannot get straight answers on whether Category A products will need to undergo pharmaceutical-like trials (please tell me I’m wrong about this, as no one is committing themselves to a straight answer).
My interest is not in what scheduling was changed to (but thanks for the info), but rather what will be unavailable in the future. I personally take Vit D3 in doses far higher than 1000iu, and Vitamin C higher than 1000iu when needed. Will these, and many more from my medicine chest, be available in a few years time?
I would be happy to continue this conversation and will contact you privately in an email.
Anthony Rees says
Dear Dr Craig Wright,
As Chairman of the Allied Health Professions Council of South Africa (AHPCSA), and a serving member of the Medicines Control Council’s expert Complementary Medicines Committee (CMC), I thought you would be in a unique position to join the dots, but that seems to be too far a stretch for you and your CMC / AHPCSA team to grasp.
Perhaps its because of the fact that you and your team have cunningly convinced your practitioners into accepting the idea that these regulations will remove many Complementary Medicines (CMs) from over-the-counter (OTC) in health shops and pharmacies, and by default have customers filling your appointment books for prescriptions to continue to access them. Evidence of self interest couldn’t be more blatant.
The fact is, all those so-called ‘dangerous’ products that you would prefer to be kept under lock and key in your practices won’t even find their way to your dispensary shelves after the full implementation of the 5 year roll-out plan. These regulations strangle the life out of all affected manufacture companies. I can guarantee you most of the spoils you are after (scheduled practitioner only products) will disappear from the market, as companies voluntarily withdraw their offerings from market. They are in their majority, unable to comply with the onerous pre-market authorization regimen for pharmaceutical drugs imposed.
The cost of complying is exceedingly expensive, sometimes costing million of Rands per product. There are very few companies, except pharmaceutical companies who will be able to supply the market with CMs, and I’m not banking on them selling anything effective which competes with their allopathic (pharmaceutical drug) offerings.
The fact is, your practitioner pool in South Africa is too small for companies to produce ‘practitioner only’ products on a sustainable basis. The cost of compliance, waiting period for studies and subsequent evaluation and registration will not be financially feasible for any company to bother registering.
Even if some companies do manage to jump the new regulatory hurdles, they will have to jack up the prices of their products, making them unfordable to the average person on the street. The government’s endeavors over the last decade have been to drive the prices of medicines down, and not up.
Your Council’s rubber stamping of these regulations as they stand is truly scandalous! Many practitioners who are registered under your Council are beginning to wake up and have come to the realization that you and your team are sending them down a treacherous river, where in a few years time they will not have medicines they require to treat their patients. The pot of gold at the end of the rainbow you have promised them is just an illusion.
At the end of the day, the public and your patients will be the losers.
But, I think you are aware of this, otherwise you would not have instructed your Registrar, Dr Louis Mullinder to issue a position statement to all your prescribing practitioners, containing veiled threats that if they dare express their own opinions on this serious matter in the public domain. Since when did AHPCSA become a fascist organization that gaggs those who disagree with it’s leadership?
In 2016, yours and others in your team will have to run for re-election in yuor Council, and I’m pretty sure many of the practitioners who elected you in 2011, won’t be singing your praises then. Perhaps you and your friends may be asked to leave sooner, who knows?
I also note that you have set yourself up as a ‘Medicines Regulatory Consultant’, profiteering from the panic and disarray the regulations bring to the industry; the very panic, disarray and confusion you and your CMC/AHPSCA are fomenting and perpetuating. As Chairman of a Statutory Health Council, which is directly influencing public health policy by virtue of your relationship with the Medicines Council Council (CMC), and the co-authoring of the regulations, don’t you think there is a conflict of interest in all of this?
drcraigwright says
Oh Anthony! You are charmingly consistent over all these years. Dark plots, machinations and conspiracies everywhere!!
Ricki Allardice says
Please answer the allegations of Anthony Rees, Dr Craig. As a member of the public I have a right to know what is going on. The allegations of Mr Rees are very serious but you can’t dodge them by simply calling him a conspiracy theorist.
drcraigwright says
Dear Ricki. The allegations of Mr Rees were too preposterous to warrant giving them credence. The fact is that new Regulations have been put out for public comment which will address many of the concerns of industry - Regulations that where in an advanced state of drafting while this storm in a teacup above was in progress. As a member of the public you should indeed inform yourself, don’t just believe the wild tales of certain people who may be in bed with industry - make your own informed decision - have a look at the new Regulations that have been gazetted for public comment and see if you think, as a consumer, that they are unreasonable in helping to ensure that we have safe, effective and reliable complementary medicines on the market in this country. with best wishes. Craig
Adi Buchu says
From a consumer point of view - it makes me feel powerless when it comes to my own health. If I get flu, I won’t be able to take extra vit c anymore, what about Echinacea?
When my mom got jaundice, the doctor told her there’s about nothing he can do for her apart from b co. If it wasn’t for some common sense & milk thistle, my mother would’ve passed away when I was 5 years old! Milk Thistle is God to me and I use it regularly for detox. It’s becoming more difficult to find it these days though.
And what about the Traditional South African Medicine. Will the Sangomas be submitted to these strict & costly regulations as well?
Years ago I was friends with a Sangoma. I once asked her how they are taught to identify the herbs. She then told me that they are not taught to identify herbs. She told me how she harvested muti, by throwing a hand full of coins into the bush and veld to honour her ancestors so they can remove all the snakes and then her ancestors told her which herbs to gather for which medical or psychic disorder.
What a safe practise indeed, don’t you experts and doctors all agree? But hey, It’s South Africa. As long as it’s for the harm of all, anything goes.
From a consumer point of view there’s only one beneficiary here: The pharmaceutical industry.
And everybody knows by now that the Government and Medical doctors assume the general public is stupid, thick and inadequate to think for themselves. The polititians and doctors treat us like that all the time, it’s nothing new. That’s how they play the game.
You can spin & spit anything, twist it into beautiful bs phrases like public safety, consumer welfare, etc, etc.
But… at the end of the day we will always know who the sole beneficiaries are of these new regulations. It’s as obvious as daylight. The pharmaceutical companies
The public is NOT stupid enough to get spinned like that.
With a lump in our throats and hatred in our hearts, we will welcome the new more impoverished (because now we will have to pay more for cams) and very ill nation of South Africa.
Just a thought… what does the government get from this? Population control?
Jac says
Long live the whole compliment of natural remedies.