The signing of the Medicines and Related Substances Amendment Bill 6 of 2014 into law by President Jacob Zuma has natural health and complimentary medicines as well as traditional healer’s organisations in an uproar.
“This new Act creates a new legal framework for the Medicines Control Council (MCC) to be scrapped, and for the establishment of a new South African Health Products Regulatory Authority (SAHPRA), similar to the FDA in the USA,” said Anthony Rees of the Traditional and Natural Health Alliance.
He claimed the new structure would no longer be an organ of State, but a self-funded, autonomous, semi-private entity at an arm’s length from the South African legislature.
The other problem was, Rees said, the definition of complementary and alternative products -and African traditional medicines – was dropped from the text of the Bill during its passage through parliament.
With about 250 000 practitioners in South Africa and about 70 000 on its books, the Traditional Healers Organisation of South Africa national coordinator Phephsile Maseko was not surprised traditional healers had been left out of Bill 6.
“The MCC never helped us promote African traditional medicine, nor did it do anything for the development of allied health professionals, instead it concentrated a lot on Western drugs,” Maseko said.
“So now we are saying it cannot be we support Bill 6 and we do not want to be part of this legislation because it does not represent our interests.”
Maseko said the replacing of the MCC by SAPHRA showed how little regard government had for traditional medicine and wondered how government would protect intellectual property gained by healers over eons.
“Through Bill 6 all that information will be exposed to the pharmaceutical industry, how is government going to protect us now?”
Norman Fels of the Health Products Association of South Africa said there was “legitimate concern” from the industry SAHPRA would only be populated by representatives of big pharma.
“It might be dominated by big pharma, when one doesn’t have a transparent process and accountability; there is always an element of discomfort,” said Fels before cautioning against generalising that big pharmaceutical companies were all against complimentary medicines.
“There are some large companies with a huge investment in complimentary medicine and I think because they are looking at the gross figures globally, it’s not a bad market to be in.
“So I’m not sure they would want to strangle it. What they might do is see an opportunity – let’s call it an entry barrier- where if the bar is set very high the smaller companies which won’t have a full time registration pharmacist and the like, and will find it difficult to survive.
“So we are hoping the regulations are not too onerous and the registrations are not too extensive and the timelines are not too long.”
Fels noted the industry in South Africa was worth up to R9bn, depending on how widely the net was cast in defining what a complementary medicine was.
“If you start taking energy drinks into the equation, it’s much, much bigger.”
Rees said since legislation had been enacted in 2013 for complementary medicine producers to register their medicines, only 15 had complied out of a possible 20 000 and not one application had been processed by the MCC.
“So effectively the industry is boycotting the MCC. We are saying the MCC never consulted with us, there is no transparency, it proposed regulations without discussing anything with us and it is fundamentally unconstitutional for a State to discriminate on the different culture of medicines.
“So we’re in a Catch-22 situation where the MCC is scared to proceed against any companies or bring out any kind of law enforcement because it knows we have a Constitutional case hanging over its head.
Rees said regulation was needed in the industry.
“We would like to see regulation for natural products which protect the public, that the products are safe, are of good quality, and that was it says on the label is in the bottle.
“We’d also like to see the efficacy of the product guaranteed to some degree, bearing in mind the health claims are the biggest problem for the regulators.
Many of these products have been used for hundreds if not thousands of years however because they haven’t gone through scientific scrutiny yet, the Westernised drug model is now been imposed on natural products.
Rees pointed out that SAHPRA would also become a springboard for the Pan-African ‘Model Law for Pharmaceuticals’, a harmonized regulatory regime hatched last year by the African Medicines Regulatory Harmonisation (AMRH) Program, implemented as part of the Pharmaceutical Manufacturing Plan for Africa (PMPA).