Be warned …your favourite herbal, homeopathic and nutritional products will soon either be banned or become unaffordable, unless you say ‘NO!‘ This will later expand to include natural skincare products and African Traditional Medicines.
The current regulatory regime imposed on traditional & natural health products stems from controversial ‘Complementary Medicine Regulations’ first gazetted in November 2013, and broader regulations to regulate ‘health supplements’ gazetted in August 2017. In August 2017 these regulations and further restrictions were written into the general regulations for medicines in support of the controversial Medicines and Related Substances Amendment Bill which was gazetted in January 2015. All these regulations fall under the 1965 apartheid era drug control legislation, namely the Medicines & Related Substances Act [Act 101 0f 1965].
These draconian and unconstitutional regulations WILL soon result in the eradication of a thriving +/- R15 billion traditional & natural health product industry, leaving health conscious consumers with severely restricted healthcare choices, higher private and State medical expenses and the loss of over 50,000 full-time jobs and many more part-time income opportunities.
Good health is about choice in healthcare.
Natural health products and natural therapies are recognised by leading Governments around the world as “effective, appropriate and cost-effective” solutions to helping hundreds of millions of people manage their healthcare every day.
The fact is, 70 percent of South Africans make the choice to use natural therapies and products to help with common illness and manage chronic disease, yet access to services, products, education and accurate information is being increasingly restricted.
An ever growing body of scientific and historical evidence attests both to their high safety profile (low risk) and their ability to promote wellness and prevent and reverse many common 21st century lifestyle diseases. Yet for two decades, the South African Health Products Regulatory Authority (SAHPRA) and it’s predecessor, the Medicines Control Council (MCC), have been waging a war against these products, while aiding and abetting in the pharmaceutical expropriation of pockets of the traditional & natural health product sector.
The time to act is now
Whether you’re are a health conscious consumer or industry stakeholder, you need to urgently take action to save the traditional & natural health product sector in South Africa. We need your support to protect your rights by becoming a TNHA member or by donating towards our campaigns to protect, educate and empower the traditional & natural health product sector, the practitioners who prescribe them and health conscious consumers who have a constitutional right to access natural health choices.
The TNHA has been leading the charge in opposing the Complementary Medicines regulations since 2013. This has included active participation in Parliamentary hearings on health policy and new legislation, lobbying political parties, working closely with local and international alliance partners and monitoring international drug and food law harmonization programs. We are now considering legal and constitutional remedies to have the Complementary Medicine and Food Supplement regulations scrapped. It will also be spearheading lobbying efforts to have traditional & natural health products placed under the jurisdiction of a new Traditional & Natural Health Products Regulatory Authority under new legislation outside of the Medicines Act which was explicitly always intended to regulate high risk, new-to-man, chemical drugs.
Four years of regulation and not a single natural health product registered?
The SAHPRA (and previous MCC) have failed to register a single traditional or natural health product since they were called up for registration on the 15th of November 2013.
In April 2016 the previous Registrar of the Medicines Control Council, Ms Joey Gouws, made a presentation to industry stakeholders where she revealed that the Medicines Control Council had received approximately 120,000 product notifications by companies for traditional & natural health products sold on the market between February 2002 and December 2011. This was pursuant to regulatory notice R.204 gazetted on the 22nd of February 2002.
She also stated that out of these 120,000 products for which they had received notifications, approximately 150 applications for product registration had been received since the November 2013 regulations came into effect. This low number attests to the industry’s inability to comply with the stringent, costly and inappropriate registration requirements for pharmaceutical drugs. Of those 150 applications, only 6 [six] product applications were later deemed acceptable by the Authority for further assessment. These 6 products received the ‘right of sale’ in the government gazette on the 16th of April 2016, pending their application for registration.
To date none of these 6 products have had their applications approved or rejected. We have maintained contact with the applicants for some of these six products and have been reliably informed that there has been little progress in assessing them. Their queries concerning the progress of their assessment have have not been cogently addressed.
It appears the SAHPRA is either unable to assess traditional & natural health products under its current drug assessment framework, or they are deliberately obstructing and eliminating the entire traditional & natural health product sector by making it impossible for manufacturers and importers to comply financially and technically with procedures and standards which are only appropriate for novel chemical compounds (pharmaceutical drugs).
Our drug regulator is not fulfilling its statutory obligations
On the other hand, the Medicines and Related Substances Act [Act No. 101 of 1965] has imposed a primary responsibility on the SAHPRA (and previous MCC) to register high risk pharmaceutical drugs and to make sure they pass the litmus tests of quality, safety and efficacy before being sold to the public. The previous Medicines Control Council failed to fulfil it’s mandate in this regard by issuing blanket registrations to over 9,600 ‘old medicines’ or ‘grandfathered medicines’ between 1965 and mid 1987. These drugs have been allowed to be sold on the market for decades in various schedules without any modern assessment of their safety or effectiveness. This means that one in every three drugs currently sold in pharmacies today may not have been tested for their safety, or may have labels claiming cures and benefits which have never been scientifically validated.
Further to this, there are reportedly over 16,000 drugs which drug companies have applied for and are still awaiting assessment since 2011. In 2017 the MCC only had the capacity to assess and register 150 drugs in that year. At their current bench-marking of assessing and registering 150 products a year, it will take an estimated 170 years to clear the existing backlog of a combined 25,600 drugs. It will take another 800 years to assess the 120,000 traditional and natural health products which require the same CTD documentation and rigor to be assessed as drugs. It is patently absurd to expect the traditional and natural health products industry to have their products registered by 2019 for discipline specific complementary medicines and 2022 for health supplements.
It is abundantly clear that the SAHPRA does not have the capacity, whether financial, technical or human, to begin making a dent in its historical backlog of pharmaceutical drug applications. Each year the application numbers keep piling up. With a combined 25,600 pharmaceutical drugs stuck in the assessment pipeline, it is incumbent on the SAHPRA to prioritize its scarce resources to exercise its primary mandate of registering high risk, novel and generic pharmaceutical drugs. Within this shocking reality, there is zero possibility, capacity or intention by SAHPRA to address its own demands for the registration of the massive number of natural and herbal health products.
A new vision and solution is required
It is irrational that 120,000 low risk traditional & natural health products of which many have been sold for decades without any verifiable reports of harm, and which are not explicitly defined in the Medicines Act be forced to be registered as quazi-drugs by the 2019 and 2022 deadlines imposed by the SAHPRA. For the Government to take such extreme legislative measures against an industry which on the one hand contributes significantly to the economy (estimated R20 billion) and to job creation (estimated 120 000 income opportunities), while on the other hand saves the country hundreds of millions of Rands through disease-prevention, indicates that fatal errors in logic and merit-assessment have occurred.
Any Laws being drafted or enforced should address modalities, systems, materials, scenarios and conditions where clear harm is being done or has the potential to cause injury, which in the case of natural medicine is so extremely low, and which has demonstrated globally to have zero proven deaths associated with their usage.
The TNHA demands that the existing Complementary Medicine regulations and Food Supplement regulations which have been gazetted since November 2013 under the Medicines and Related Substances Act be scrapped in their entirety, and that a new Traditional & Natural Health Products Act be passed by parliament which clearly separates these essentially safe products from pharmaceutical drugs. This envisaged legislation will clearly define these products and subject them to an appropriate regulatory framework administered by experts in the modalities represented.
Did you know?
- That the majority of traditional & natural health products sold in health stores, pharmacies, through direct marketing and prescribed by natural health practitioners are on the verge of being regulated out of existence, in effect banned?
- That no Regulatory Impact Assessment (RIA) was conducted by the Ministry of Health, National Department of Health or Medicines Control Council (now SAHPRA) prior to gazetting the Complementary Medicine and Food Supplement regulations into law, despite it being incumbent to do so in terms of Guidelines for RIA issued by the Presidency in 2012. RIA is a tool for assessing the impacts of regulation, which is used to examine and measure the possible benefits, costs and effects of new or changed regulation, in order to provide decision-makers with empirical data and a comprehensive framework in which they can assess their options and the consequences their decisions may have.
- SAHPRA claims jurisdiction over non-indigenous herbal other natural health substances as a sub-category of medicines (drugs), when it is clear that these are impacting positively on health and negatively on medical profits.. There is no explicit enabling clause in the Medicines and Related Substances Act which defines natural health products, therefore the regulations are considered by us to be ultra vires*. You can not legislate by regulation!
- That there are no verifiable or documented reports of a single death caused by commercially sold natural health products (vitamins, minerals, amino-acids, herbal remedies, homeopathic remedies or sports supplements) in South Africa since the Medicines Control Council (now SAHPRA) begun tracking adverse reactions to medicines and natural health products in 2009. This attests to their high safety record, and is consistent with the international safety profile of these substances and products around the world.
- All foods and skincare products containing purported scheduled substances (by implication all natural health product ingredients), whether they convey health claims or not, will have to be registered as medicines (drugs). This means superfoods, functional foods and natural skincare products will soon also be adversely regulated.
- It’s illegal for you as a consumer to learn about the benefits of traditional & natural health products on product labelling and associated marketing materials unless companies spend billions of Rand on pharmaceutical research and development on their products. At present no independent South African traditional & natural health product manufacturers can afford this, nor will they be prepared to expend such vast resources on natural products which cannot be patented.
- That large pharmaceutical drug companies can take herbs, vitamins and minerals found in nature, claim them as their own (though unique patentable extraction and modification processes), and then demand much higher prices for them.
- That after November 2019 the only traditional & natural health products you will find in pharmacies and health shops will be non-efficacious, low potency (non therapeutic) health supplements, or ‘me too’ products, manufactured principally with cheap, synthetic, coal tar synthesized nutrients, and sold principally by large pharmaceutical companies. For consumers, these will be false natural health choices..
- That it will be illegal to sell traditional & natural health products through direct marketing schemes, unless they are low potency multivitamins. They will also be prohibited from handing out samples of products or use bonus product incentives when selling them.
- That you will need a doctors prescription to access high potency nutrients, herbal and homoeopathic remedies in future. And that is if manufacturers and importers of these prescribed products decide to remain in business due to high compliance costs and serving this small niche market.
- That you will need a foreign doctor’s prescription to import or carry more than three months’ supply of traditional & natural health products across the border into South Africa. Products with ingredients exceeding local daily upper limits (UL’s) will be illegal and may be seized and destroyed by customs officials.
- That importing, manufacturing, wholesaling, selling or possessing of any unregistered traditional & natural health products will be a criminal offence which may result in a hefty fine or long-term of imprisonment.
- That health shops will no longer have specialty natural health products, which has traditionally set them aside from larger retail pharmacies. They will not be able to sell natural health products which become scheduled (schedule 2 or higher) without registering as a pharmacy and hiring pharmacists to dispense these products. With most of their suppliers being unable to jump the regulatory hurdles the majority of current leading brands will no longer be available to sell. This will force health shops to diversify their sales into other non-remedy products or close their doors.
- That due to rising costs, we will see a reduction in consumers using preventive medicine, and an increase in chronic disease. This will put more strain on an already under-funded public healthcare system, while also driving more demand towards pharmaceutical companies.
- That thousands of independent community pharmacies across South Africa will be forced out of business, as their survival depends heavily on their sales of traditional & natural health products as over-the-counter (non-prescription) products. Subsequent to the government’s capping of dispensing fees for prescription drugs most dispensaries are running at a loss and function merely as a service to their communities. If the majority of traditional & natural health products disappear from shelves through overzealous regulation and/or the regulator’s inability to register products timeously, many community pharmacies will become unprofitable and their continued provision of essential drugs to their clients will be severely affected. This runs roughshod over government’s continued efforts to make essential medicines available to people, especially in rural communities where community pharmacies are the only place to access life-saving drugs.
- That chain-store pharmacy retailers make up to 25% of their annual turnover from over-the-counter products, of which the largest segment is made up of traditional & natural health products. If these products become unavailable, these companies and their shareholders will suffer great financial losses. Their ongoing expansion plans will be jeopardised.
- That full-time Pharmacists, registered with the Pharmacy Council of South Africa, will have to be hired by importers, manufacturers, wholesalers and retailers as ‘responsible persons’ to sign off on the importation, manufacture and distribution of natural health products. Pharmacists are not trained in the various complementary medicine philosophies and do not study natural health substances in their pharmacy degree courses. They will also have to create and sign off on the necessary paperwork required which detail the steps used in manufacturing products, create site master files detailing how the premises are being run, and most importantly generate and submit the voluminous Common Technical Documentation (CTD) which form part of product registration applications. According to the Departments of Health, and Trade and Industry there is a dire shortage of qualified pharmacists in South Africa within the pharmaceutical sector, retail pharmacy sector and in the public health service. It is estimated that there is a current shortage of over 12,000 pharmacists in South Africa.
If the status quo remains, the majority of natural health products enjoyed and trusted by millions of South Africans will disappear from the market due to voluntary withdrawal from the market as small and medium sized manufacturers will be unable to comply with the current regulations set to be enforced in November 2019. The reason for this will be purely economic, as these enterprises will not be able to see viable returns on investment by becoming pharmaceutical drug manufacturers in decades.
The only sector which will continue to sell natural health products will be the large incumbent pharmaceutical drug manufacturers, who will fill the vacuum created by the loss of wholesome, high potency and innovative remedies made by small and medium sized manufacturers, with cheaply produced (often synthetic) low potency (non therapeutic) multivitamins and single nutrients.
If any local natural health product companies do manage to register their products the cost of their registered products will increase significantly in order to offset the high compliance and registration costs.
The ultimate losers will be South African consumers who will no longer be able to access affordable and effective natural health products. Their ability to choose the form of healthcare they desire will be lost.
We are at a point in history where natural health products are being scientifically validated and have proven to be valuable and cost effective agents in preventing and reversing the course of modern lifestyle diseases, thereby potentially holding the key to saving billions of Rand in healthcare costs. Recent international research has proven that hospitalized patients who use natural health products before and after medical procedures enjoy speedier recovery rates in hospital and results in decreased costs for the state healthcare system and private patients who foot their own healthcare bills alike.
We encourage all South Africans to join the THNA so we can reverse these destructive and ill conceived policies and regulations
*Ultra Vires. [Latin, Beyond the powers.] Invalid excess of authority or power exercised by an entity.
By Anthony Rees, Traditional and Natural Health Alliance