Written by: Anthony Rees (National Chairman: TNHA)
The TNHA have begun receiving an alarming number of reports from our members relating to millions of Rands worth of inbound shipments of natural health products being impounded by the Port Health Authority at various official points of entry into the country.
On inquiry by clearance agents and importers, Port Health Authority officials are now demanding South African Health Products Regulatory Authority (SAHPRA) issued medicines import licenses for medicines in terms of Section 22(c) of the Medicines & Related Substances Act (Act 101 of 1965) before releasing shipments.
This includes all products containing Aromatherapy oils, Ayurvedic products, Homeopathic products, Traditional Chinese Medicine products, Unani Tibb products, Western Herbal products, Probiotics, Cannabidiol (CBD), Prebiotics, Vitamins, Minerals, Amino Acids, Fats, Oils and Fatty Acids, Carotenoids, Bioflavonoids, Aminosaccharides, Saccharides, Enzymes or any combination of the above in dosage forms. Notably, this excludes African Traditional Medicine products, which is blatantly discriminatory.
A small number of pharmaceutical companies already in possession of these licenses continue to have their shipments cleared immediately, while the vast majority of small and medium sized companies without these licenses are referred to Dr Kaizer Thembo, SAHPRA’s Director for Complementary Medicines to ‘discuss their import issues‘.
When importers get hold of Dr Thembo, which is no easy feat according to many, his standard retort is that all complementary medicines and health supplements are ‘medicines’ under the Medicines Act, and that all importers of such products first require Section 22(c) import licenses to bring them into the country legally. In addition they are also informed that they now require either medicines wholesale licenses or medicines distribution licenses to sell natural health products legally in the country.
He then refers all inquiring importers to the SAHPRA’s Complementary Medicines Licensing Portal on the SAHPRA website, where importers must apply for the relevant licenses. Dr Thembo then states that no further shipments will be allowed to be cleared by Port Health until the relevant pharmaceutical licenses have been issued.
Dr Thembo then allegedly asks for companies to provide all their contact and foreign manufacturer’s info, as well as a comprehensive list of all the products the local company imports and / or sells in the country in order to secure a last, once-off, final import. Companies are then threatened by stating that companies who refuse to obtain these licenses will be flagged and no longer be able to import. It appears that for many in possession of MBR 20.8 registry letters issued by the former Medicines Control Council pursuant to the rescinded 2002 call for complementary medicines, they are no longer considered valid for import purposes. Imported products by unlicensed companies now have to be either returned to sender, or have to be destroyed (incinerated) by SAHPRA.
IS THIS ACTION LEGAL?
The TNHA are of the opinion that the this new SAHPRA import blockade in collaboration with the Port Health Authority is an attempt coral small and medium sized company importers of natural health products into a flawed and inappropriate regulatory regime from pharmaceutical drugs by coercion. It is like forcibly herding sheep to a kraal to their ultimate demise by business strangulation by reams of red tape, delays and exorbitant costs.
The TNHA and others recently launched a High Court case to challenge the constitutionality, rationality and procedural legality of the controversial complementary medicines regulations. Our case was heard on the 26th and 27th of May, and as of date we await judgment.
On various occasions SAHPRA officials who head up the complementary medicines regulatory scheme have advised regulatory consultants and company CEO’s at stakeholder workshops, that companies have up until August 2021 to comply with Section 22(c) of the Medicines Act, and to apply for either import, export, manufacture, wholesale or distribution licenses for natural health products on their Complementary Medicines Licensing Portal. This obviously isn’t the case.
By enforcing Section 22(c) licensing requirements on companies a year before the compliance deadline communicated to them, plus flagrantly ignoring the current legal dispute relating to the entire complementary medicines regulatory scheme is totally unacceptable, and snacks of corruption and malfeasance against the traditional & natural health sector.
With companies now no longer being able to import their products, many of which have been imported without issue for decades, they can not trade and will have no choice but to retrench all their staff and close down. Vested rights have been completely ignored and artificial international trade barriers are now being arbitrarily imposed.
Those most affected are Consumers who will not be able to access these health-giving products which they rely on for their health a wellness.
None of these de minumus risk (extreme low risk) products have resulted in any demonstrable harm to the public, as per the SAHPRA’s own High Court admissions, and their own official adverse reaction database which began recording of traditional & natural health product adverse events in 2011. Most of these imported products are already approved by regulatory authorities in their countries of origin.
We believe this regulatory scheme is nothing more than a desperate attempt to eradicate the original natural health products sector made up of pioneering small and medium sized companies by excessive and costly regulation, while advancing the interests of large pharmaceutical companies and their trade associations (Self Care Associations made up of drug companies) which have been working tirelessly in collaboration with the SAHPRA through its Industry Task Group (ITG) to expropriate (Capture) the growing natural health products industry. This is further evidenced by the SAHPRA not having registered a single ‘complementary medicine’ since 2013 when the regulatory regime for these products begun.
This is a wholly unacceptable SHAM which we reject with contempt!
The TNHA urgently calls upon all natural health product importers affected by this embargo to join us in exposing this crooked scheme, and to vigorously challenge this illegal and artificial trade barrier imposed. If your company is being targeted by this illegal blockade, please contact us urgently so we can launch a collective court application to declare this embargo illegal, and sue the SAHPRA and Port Health Authority for pecuniary losses incurred.
Further, we intend taking legal action against certain complicit SAHPRA and Port Health Authority employees in their personal capacities for acting outside their legal mandate, and for losses incurred.
Our Upcoming Exposé
- Find out all about the dense thicket of regulations and compliance requirements imposed on the Traditional & Natural Health Products industry by the SAHPRA in cahoots with pharmaceutical interest groups.
- Find out how the regulatory system has been stacked against small and medium sized companies in favour of Big Pharma, which is poised to take over the sector with dumbed-down (low potency / censored health benefit ) products.
- Learn who is driving this process inside SAHPRA and outside SAHPRA. Who are these people? What are their vested interests?