MOST TRADITIONAL & NATURAL HEALTH PRODUCTS SOLD IN SOUTH AFRICA WILL SOON BE OUTLAWED!
Be warned … Your favourite herbal and nutritional products you use daily for keeping good health, will either be banned or become unaffordable.
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. 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.
Food and traditional & natural health substances are the cornerstone of maintaining health for the majority of South Africans. 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 harmonisation 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.
NOT A SINGLE NATURAL HEALTH PRODUCT REGISTERED IN OVER FOUR YEARS
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).
THE SAHPRA CAN’T COPE WITH NEW DRUG APPLICATIONS
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 2,300 novel drugs and 4,700 generic drugs which drug companies have applied for and are still awaiting registration. Many of which were applied for as far back as 2012. The Medicines Control Council claims it only has the capacity to assess and register 150 drugs per year, however in 2017 only 75 drugs were registered.
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 7,000 pharmaceutical drugs stuck in the 5-7 year assessment pipeline, it is incumbent on the SAHPRA to prioritise 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.
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 deadline 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 and to job creation, 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 drafted and 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.
FACTS YOU NEED TO KNOW
Did you know:
- That the majority of traditional & natural health products are on the verge of being regulated out of existence, in effect banned?
- That no Regulatory Impact Assessment (RIA) was conducted by the MCC or National Department of Health to first ascertain if there would be any negative impacts on the industry, the ficus and human health prior to passing the complementary Medicine and Food Supplement regulations, despite them being legally required to do so?
- SAHPRA claims jurisdiction over non-indigenous herbal other natural health substances as medicines (drugs), when it is clear that these are impacting positively on health and negatively on medical profits.
- That the SAHPRA is unconstitutionally discriminating against demonstrably safe non-indigenous traditional medicines by regulating them out of existence, while turning a blind eye on thousands of deaths caused by acute poisoning from indigenous herbal medicines (African Traditional Medicines). In fact, the SAHPRA refuses to acknowledge or control various known indigenous plant-based poisons. African Traditional Medicines are consumed by over 80% of the population. Are indigenous black South Africans still 3rd grade citizens, not worthy of being protected by the SAHPRA more than two decades after the fall of apartheid?
- 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).
- It’s illegal for you as a consumer to learn about the benefits of traditional & natural health products from truthful product labelling and associated marketing materials unless companies spend billions of Rand on pharmaceutical research and development. At present no South African traditional & natural health product manufacturers can afford this, nor will they be prepared to expend such vast resources on natural materials which cannot be patented.
- That big 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 (low daily dosage) health supplements, or ‘Me too’ products manufactured mainly with cheap synthetic nutrients, and sold principally by large pharmaceutical companies (false choices).
- That it will be illegal to sell traditional & natural health products through direct marketing schemes, or to hand 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’s if the manufacturers and importers of these prescribed products remain in business.
- 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 dosage limits (UL’s) will be illegal and 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 imprisonment.
- 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 will suffer great financial losses.