On Monday the 7th of March the regulatory fate of a large segment of the natural health product industry will be argued before a full bench of five judges in the the Supreme Court of Appeal (SCA) in Bloemfontein. The appeal comes after our alliance partner, the Alliance for Natural Health Products South Africa (ANHPSA) won a Gauteng North High Court judgement (Case 11203/2018) which struck down as unlawful and unconstitutional, the 2017 complementary medicine regulations under the Medicines and Related substances Act (Act 101 of 1965).
The High Court judge presiding was Judge Elizabeth Kabushi and her judgement was delivered on the 1st of September 2020. In her judgement Judge Kubushi found that not all complementary medicines and health supplements are necessarily medicines requiring pre-approval (registration) by the SAHPRA, and by extension companies selling such products would not be required to be licensed as pharmaceutical importers, wholesalers, or distributors.
It is only when manufacturers sell natural health products and make claims that they can cure a disease, that they could potentially become subject to regulation. This reinforces the provisions of the Medicines and Related Substances Act of 1965 since in inception over half a century ago. She found the definitions of complementary medicines and health supplements gazetted in the 2017 General Regulations were inconstant with the definition of medicines in the principle Act, and declared them ulta vires, and therefore beyond the Minister’s legal power or authority.
Par. 124 – ” I’m inclined to agree with the applicant on its point that the Medicines Act does not empower the Minister to regulate all complementary medicines. For complementary medicines to fall within the proper contextual definition of a medicine in the Medicines Act, only those that purport to be suitable for use, manufactured or sold for use for a therapeutic purpose, that is, for the prevention and treatment of a malady, may be regulated. Hence, only those complementary medicines and health supplements that purport to be used or manufactured for use or sale to address the prevention, diagnosis, treatment, mitigation or modification of physical or mental disease ought to be regulated “
Read full judgement here.
Judge Kabushi further ordered a 12 month ‘suspension of invalidity’ of the regulations in order for the Minister of Health and SAHPRA to gazette proper and lawful complementary medicine regulations. No attempt has made to do so.
The Minister and SAHPRA then made application to appealed the judgement on the 12th of February 2021. The ANHPSA have naturally opposed the appeal.
Instead of remaining in abeyance of the judgement and awaiting the future judgement of the SCA, the SAHPRA has proceeded to roll out it’s controversial regulatory regime with the issuance of a complementary medicine Guidelines and a Road Map for industry to adhere to on the 17th of December 2021, as well as coerced companies to apply for pharmaceutical manufacturing, import, wholesale and distribution licences on or before the 28th of February this year.
The SAHPRA and the Port Health Authority have also begun illegally blocking all imports of complementary medicines and health supplements entering the country though its ports and demanding that importers apply for their products to be released through an electronic assessment portal. This is despite the fact that no complementary medicines or health supplements have been called up of registration as ‘medicines’ under Section 14 of the Medicines Act.
We deem this action illegal and we are reserving our rights to launch a new High Court application to declare these administrative actions of overreaches unlawful and an abuse of process.
In Bloemfontein on Monday the ANHPSA will be represented by Advocate David Borgström SC, and legal representatives from Cliffe Dekker Hofmeyr (CDH).
The Minister of Health and SAHPRA will be jointly represented by Advocate Gilbert Marcus SC and other legal representatives.
The five seat bench of the SCA will be made up of judges Christiaan Van der Merwe JA, Ashton Schippers JA, Fikile Mokgohloa JA, Caroline Nicholls JA and Moroa Tsoka AJA.
The outcome of this case will have have a major influence over the future of the majority of the natural health products sector and the public’s continued access to natural health products of their choice.
For the most part, industry is struggling with crippling compliance costs and SAHPRA delays (up to 8 years) in order to be duly licensed to trade, as well as having major difficulties with adhering to the dense thicket of inappropriate ‘allopthic’ regulations and stipulated guidelines in order to be in a position to attempt to register their products.
Ever since 2013 when the complementary medicines regulations first came into being [nine years ago], no company has been successful in having their complementary medicines fully registered under the current regulatory framework imposed.
If the Minister’s and SAHPRA’s joint appeal is upheld, this will mean that ordinary South Africans will soon face large discontinued stock-out gaps in the natural health products shelves at pharmacies, health shops and other retail outlets. The R15 billion per year industry and thousands of jobs in the sector and related industries may be shed. This will be due to products which people have relied on for decades becoming illegal due to not being registered, or companies deemed trading illegally without the relevant pharmaceutical manufacture, import, wholesale or distribution licences now required. Penalties for purveying ‘medicines’ while unlicenced, or selling ‘unregistered medicines’ are hefty, including being liable to a hefty fine, or to imprisonment for a period of up to 10 years for each offence.
An upheld appeal will have negative outcomes on the population’s health and wellness, as the majority of South Africans use traditional & natural health products on a frequent basis. In fact, the last two years during the Covid-19 pandemic has reinforced the necessity of maintaining optimal health with the use of immune supporting health supplements. Imagine if these were suddenly declared illegal !
South Africans must continue to enjoy their right to continued access to safe, affordable natural health products and their freedom to choose the modalities of their choice in obtaining and maintaining their health. Citizens have the right to control over their bodies (Section 12 of the Constitution). They have a right to practice their own culture and traditions [including use of traditional medicines from different world cultures] without Western allopathic medicine dominance (Section 9 of the Constitution). Further, the State must protect and promote the public’s right to healthcare in general, and this extends to the promotion of health and wellness using natural health substances and products (Section 27 of the Constitution).
The TNHA is the only natural health product association represented within the ANHPSA alliance. Other associations represented in the sector are unfortunately heavily influenced and dominated by large pharmaceutical companies which pay the lion’s share of their membership dues. Due to their incumbent lead in the market these companies view such regulation as an opportunity to expropriate and monopolize certain sections of the health supplement market, namely the low potency single nutrient and mutivite sector. The THNA is the only organization which has precluded allopathic pharmaceutical companies from membership in its admittance policies, and remains true to the interests of the bona fide natural health product sector.
The TNHA is the only national association affiliated to the ANHPSA and actively litigating to defend the health rights of South Africans to choose non orthodox natural health products, and supports the natural health product industry in court. If you own a manufacturing, wholesale, importation, distribution or retail company (shop) in the natural health products sector, the time has come to become a THNA supporting member. If you are a practitioner who prescribes or recommends natural health products in your practice or consultancy, please support us in order that we can protect the tools of your professions. Without your valued support, we can not continue defend your businesses at this high and necessary level.
The ANHPSA is lead by its Chairman Anthony Rees, who is also the Chairman of the Traditional & Natural Health Alliance (TNHA).
Updates on developments after Monday’s court hearing will follow in coming days.
If you have any queries, contact Anthony Rees on 0723777598, or email the TNHA at [email protected]