At the 11th hour, the South African Parliament has removed the ‘Complementary Medicine definition’ or ‘enabling clause’ of the restrictive Medicines and Related Substances Amendment Bill (Bill 6 of 2014), rendering the Bill toothless for regulating natural health products. Bill 6 – dubbed “medical apartheid”, by our alliance partner the Traditional & Natural Health Alliance (TNHA) in South Africa, has been a huge threat to South Africans’ access to natural health, in favour of Western allopathic medicine. It looks like the efforts of the TNHA are succeeding in derailing this controversial law and regulations preceding it, for Complementary Medicines.
TNHA’s challenges to the legislation have included lobbying and representations in Parliament, with huge support from their supporters —Parliamentary protests, and a 17, 000-strong signature petition. Fatal flaws in the relevant legislation have been highlighted, and a repeal of existing regulations will be necessary as soon as the new Bill passes into law.
Natural product regulation on the back foot
South Africa’s Bill of Rights in their Constitution, requires that indigenous African traditional medicines, and non-indigenous traditional medicines collectively, such as Western herbal, Unani Tibb, Chinese and Ayurvedic medicines, must be regulated on the same playing field. But African traditional medicines have been excluded from Bill 6, since the text was published in September 2014, which TNHA highlights as being unconstitutional. Members of the Traditional Healers Organization have been working together with TNHA against this legislation, as they had been informed by the Department of Health that they would be brought under the control of the Bill in 2019.
The purpose of Bill 6 is to amend the existing Medicines and Related Substances Act 101 of 1965. It has been dubbed the SAHPRA (South African Health Products Regulatory Authority) Bill, as it is set to enable a restructuring of South Africa’s medicines regulator, the Medicines Control Council (MCC), into an autonomous regulator following the model of the US Food Drug Administration (FDA). The TNHA believes that this latter purpose is considered the more pressing matter by South Africa’s Department of Health, and that “with a possible constitutional challenge from TNHA on the horizon, which would stall the modernisation program, they (Parliament) let the controversial complementary medicine definition go”, and effectively derailed existing regulation.
Cart before the horse
Crucially, the over-arching regulation, South Africa’s 50-year-old Medicines and Related Substances Control Act 1965 “was originally intended to control pharmaceutical drugs after a proliferation of high risk new-to-man drugs were sold in the Republic, without safeguards to protect the public from their potential harm (e.g. Thalidomide)”. This coincided with similar medicines legislation in Europe, the USA and elsewhere. Aside from the fact that despite this, many of pharma’s drugs continue to be patently unsafe, Anthony Rees of TNHA explained that the ‘categories’ referred to in the Act were those of the pharmacological activities of different types of drugs. The term was not intended to apply to an entirely different system of medicine, let alone one that consists of products that in 1994, the FDA considered a special category of foods that it said were ‘generally regarded as safe’.
The definition or ‘enabling clause’ in this Act has never been expanded to include complementary medicines in the 50 years the Act has been in existence —“Therefore they are not included”. To include them, places the burden on the manufacturers of natural products to first prove that their products are not unsafe drugs.
Nevertheless, in 2013, the Medicines Control Council (MCC) was given the right under the 1965 Act to publish complementary medicine regulations as a ‘new category’ under the Act, the legality of which the TNHA has disputed. The TNHA and ‘various legal experts’ have stated that “the ‘Complementary Medicines’ regulations are ultra-vires, meaning they have no proper authority in law”. They clarified this saying “Without an enabling clause in the principal Act expressly defining ‘Complementary Medicines’, they are simply not covered by the Act or its subordinate regulations”.
Consequently, the manner in which the MCC has required that complementary and alternative medicines be called-up and registered, is unlawful. In addition, the ‘Road Map circular’ which was distributed to industry, marking dates over a five year period to register certain categories of CAMs was illegal, as it was not a legal call-up as prescribed in the Act. The TNHA says that natural products manufacturers now “have the lawful right to withdraw any existing applications (for MCC registration)”, and that any who wish to comply are willfully submitting “to being regulated in the same way as a pharmaceutical manufacturer”. The TNHA has told its members that will support them if they are experiencing difficulties withdrawing their applications.
TNHA to demand that the ‘CAM Regulations Must Fall!’
Now with the removal of the enabling clause in Bill 6, South African regulators’ elusive jurisdiction over natural products seems set to continue. TNHA tell us that with the imminent signing into law of the Medicines Amendment Act, the existing regulations under the old Act will have no basis in law, and the 2013 MCC CAM regulations will have to be repealed immediately. The consequence will be that South Africa reverts to the status quo of no regulation at all. TNHA said “If a new regulatory regime for natural health products and traditional medicines be created, it must occur in a constitutional and inclusive manner, and that the regulations must be appropriate for these low risk products”.
The TNHA is currently in the process of drafting legislative proposals which will regulate both CAM and African Traditional Medicines inclusively. It proposes that a new statutory regulator will be required to do this, separate from the drug regulator. The TNHA is consulting with a well-placed political party in Parliament to help draft and table a Bill to this effect.
In these choppy waters, when there is a clear desire to regulate natural health into oblivion, yet also a fear among health authorities that they may be overstepping their legal capacities which could result in them facing legal challenge, anything could happen. But what it does show us is that a committed few with a passion to maintain and protect the ability to practice natural health in all its guises can make an enormous difference.
At risk of over-using, Margaret Mead’s famous quote, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”
So it might be a rough new year for the South African government, when the full consequences of this become clear.