Complementary Medicines Regulations Declared Unlawful –
Supreme Court of Appeal [11 April 2022]
The Supreme Court of Appeal (SCA) in Bloemfontein ruled on 11th of April that the controversial regulations for complementary medicines under the Medicines and Related Substances Act (Act 101 of 1965) are invalid and unlawful.
YOUR RIGHT TO CHOOSE NATURAL HEALTH PRODUCTS IS UNDER THREAT !
Be warned … YOUR favourite herbal, homeopathic and nutritional products YOU use daily for keeping good health and wellness will soon either be banned or become unaffordable, unless YOU say ‘NO!‘ This will later expand to include natural skincare products, functional foods 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 5,000 full-time jobs and many more part-time income opportunities.
Good health is about choice in healthcare.
Natural health products and natural therapies are recognized by progressive 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, between 70 – 85% percent of South Africans make the choice to use traditional & 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 relentless war against free access 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 and taking legal action in our courts. We are currently launching legal cases to have the Complementary Medicine and Food Supplement regulations scrapped. We are also 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, an Act which was explicitly intended to regulate high risk, new-to-man, chemical drugs. This will be facilitated through the tabling of a Traditional & Natural Health Products Bill which is being drafted by our expert legal team and will be tabled by supportive MPs in Parliament.
Eight years of inappropriate and draconian regulation and not a single natural health product registered yet?
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.
Fair, Responsible & Responsible Regulation is Needed!
The Natural Health Alliance supports responsible regulation which provides a level playing field for the industry. This will allow the sector to realize its full potential for the benefit of all.
The TNHA aims to ensure regulations effectively protect consumers while still encouraging innovation and accountability. So for the future the answer is both simple and complex.
The simple answer is that before anything else can work, natural health product regulations must be right. To protect the consumer and enable practitioners and businesses to carry out their proper function without monopoly control from a competing modality, good regulations are vital. Poor regulations though can do just the opposite.
If natural health regulations don’t set the proper framework innovation within the natural health industry is stifled while only a handful of large conformists prosper. The complex part of the answer is ensuring that the regulations work for us and not against us and they safeguard both consumers and the industry against future manipulation.
The TNHA works closely with many other groups both in South Africa and around the world to address these issues. To act as an effective lobbying force the natural health industry needs a single umbrella entity that has its only focus to act as a regulatory watchdog without hidden agendas.
Change has to occur at the political and regulatory level to ensure all businesses are able to operate in a fair and reasonable way without double standards or pharmaceutical bias. There needs to be controls on bureaucracy to ensure that large companies do not achieve monopolies by regulation. There also needs to be a system that encourages innovation and demands accountability.
The Natural Health Product Industry is facing serious threats from a number of directions. If these threats are not countered then the ability of individual consumers to take responsibility for their own health and make their own decisions from a range of effective and safe products and therapies will be seriously diminished, if not destroyed.
The Natural Health Alliance believes in ‘Consumer Empowerment’ – the understanding that being responsible for looking after our own health is the most fundamental of human rights.
Recognizing the interconnection between growers, importers, manufacturers, suppliers, practitioners and consumers of natural health products.
A commitment to educating our members and the public about policies and regulations that affect them, our planet and future generations.
Putting health before wealth, upholding traditional values and being open to new ideas that serve to strengthen and protect the natural health sector.
Seeking to understand opposing views and the merits of those views so we can work towards policies that support a common vision.