RECENT NEWS AND HEADLINES

On the 28th of July the Medicines Control Council, in consultation with the Minister of Health gazetted a regulatory notice scheduling various substances in terms of section 22A(2) of the Medicines and Related Substances Act (Act No. 101 of 1965). One of the substances hidden at the bottom of page 27 of the gazette was Cannabidiol, or more commonly known as CBD. All products imported and sold with claims relating to therapeutic effects were to be scheduled as Schedule 6 medicines, requiring the public first obtain a doctor’s prescription. In our communication to the industry this past Sunday we pointed... Read More

Yesterday we posted an article about the dodgy group of protesters outside the Pretoria High Court after linking them to certain organisations and individuals linked to this trial. Today Jules Stobbs of the Dagga Couple made a video of this mob as he returned to the court after a lunch recess. Below is a leaked photograph of the professional catering that was provided to the protesters outside the court at lunchtime (see below). As you can see, someone or some organisation with deep pockets has mobilised this crowd. None appear to be genuinely aggrieved citizens against cannabis use, due to... Read More

On what was supposed to be the first day of the Trial of the Cannabis Plant at the Pretoria High Court yesterday, a ragtag mob of about thirty predominantly male protesters stood in front of the court shouting rhetorical anti dagga epithets and holding placards with slogans like ‘No to dagga’ , ‘Dagga Ruins Lives’ , ‘Dagga Kills’ etc. What was apparent is that all the placards were produced by one person, having the same font style and constructed from the same materials. Who are thse people? The protesters appear to have been a coalition of two separate groups made... Read More

By: Anthony Rees (National Chairman – TNHA) On the 28th of July, and just four days preceding the Trial of the Cannabis Plant by the Dagga Couple, the Medicines Control Council, after consultation with the Minister of Health spuriously gazetted a list of substances to be included in the schedules in terms of section 22A(2) of the Medicines and Related Substances Act (Act No. 101 of 1965). One of the substances hidden on the bottom page 27 of the gazette is Cannabidiol, or more commonly known as CBD Oil. Cannabidiol is one of the most exciting cannabinoids — natural compounds... Read More

The Western Cape High Court has made a landmark ruling, declaring that it is an infringement to ban the use of dagga by adults in private homes. In making the ruling on Friday, it has allowed for the possession, cultivation and use dagga at home, for private use. It has also ruled that Parliament must change sections of the Drug Trafficking Act, as well as the Medicines Control Act. It has 24 months to do so. The successful application to decriminalise dagga was driven by Dagga Party leader Jeremy Acton and Rastafarian Garreth Prince who argued on December 13 and... Read More

From March 20th, 2017 the Austrian Federal Office for Safety in Health Care (Austrian Medicines and Medical Devices Agency) has become an associated member  of the ICMRA (International Coalition of Medicines Regulatory Authorities). ICMRA is voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to address current and emerging regulatory and safety-related issues with regard to human medicines by providing direction and identifying potential synergies.  

  At the end of last year we reported that government indicated it planned to legalise medical cannabis-derived drugs in South Africa. The Medical Controls Council (MCC) has just released its medical new guidelines for the cultivation, production and use of medical cannabis. This is of significant importance to prospective medical cannabis growers, patients and all South Africans who are interested in seeing a legal cannabis market. View the 32 page medical marijuana guidelines here: Strictly controlled The document provides strict guidelines and information to applicants wanting to grow, test or manufacture medical cannabis related products in South Africa. It... Read More

The Medicines Control Council have just released new guidelines for the CULTIVATION OF CANNABIS AND MANUFACTURE OF CANNABIS-RELATED PHARMACEUTICAL PRODUCTS FOR MEDICINAL AND RESEARCH PURPOSES. Stakeholders have been given one month to submit comments and suggestions to the MCC. These guidelines precede imminent new regulations for Cannabis-related medicines, and will accompany them as a framework for local licensed growers producers.    

The long awaited draft General Regulations which will accompany the new Medicines and Related Substances Amendment Act towards mid-year this year, and which will create the legal mechanism to launch the new South African Health Products Regulatory Authority (SAHPRA), were gazetted for comment by the Department of Health on the 27th of January. The SAHPRA will replace the Medicines Control Council which has existed for over half a century. The SAHPRA will no longer fall directly under the National Department of Health’s control and will become a Section 3(A) public entity in terms of the Public Finance Management Act (Act... Read More

On the 26th of January we submitted written comments and made an oral submission to the Parliamentary Portfolio Committee on Science and Technology on the Protection, Promotion, Development and Management of Indigenous Knowledge Systems Bill (Bill 6 of 2016). This controversial Bill in its current form threatens the on-going practice of African Traditional Medicine by an estimated 200 000 traditional healers by restricting their accreditation criteria for registration to practice legally, and could potentially create a new government bureaucracy called the National Indigenous Knowledge Systems Office (NIKSO) under the Department of Science and Technology. The NIKSO, if established by law,... Read More

ICMRA HARMONISATION UPDATE In June this year the TNHA broke the news of an international medicines regulatory harmonisation scheme being orchestrated behind closed doors by the heads of twenty international drug regulatory bodies, called the International Coalition of Medicines Regulatory Authorities, or ICMRA in short. We are particularly concerned about this secretive organisation, following revelations about it having established a Complementary Medicine and Herbal Medicine Working Group which was first mooted by, and now chaired by the Australian Therapeutic Goods Administration (TGA). The first meeting of this working group took place in the Netherlands in 2014. In a response to... Read More

THE CAM CROSSROADS – WHERE ARE WE HEADING? Today the South African Natural Health Product (NHP) industry stands at a crossroads and its stakeholders remain dazed and confused like antelope caught in oncoming headlights.  With only two years left for manufacturers, importers and distributors to submit applications to the Medicines Control Council (MCC) to register their products, we are fast reaching a tipping point, where without renewed political will and a true desire to protect the industry by its stakeholders, millions of South Africans will lose their access non-drug therapies and natural health products which they rely on for their... Read More

HAVE YOU EVER WONDERED WHY LABELS ON SUPPLEMENTS ARE SO VAGUE? By: Julia Rucklidge, PhD & Bonnie Kaplan, PhD   The NZ government is currently writing a new law (Natural Health Products Bill) aimed to regulate natural health products (NHPs). What is happening in New Zealand is not unique: the push for tighter controls on NHPs is occurring all over the world, including Europe, Canada and South Africa. However, if it wasn’t evident before, these newer regulations make it crystal clear that prescription drugs have a monopoly over the terms “medicine” and “therapeutic benefit,” and that it is very difficult... Read More

OPPOSITION TO INDIGENOUS KNOWLEDGE SYSTEMS BILL MOUNTS The Protection, Promotion, Development and Management of Indigenous Knowledge Systems (Bill 6 of 2016) is facing strong head winds from traditional healers and some political parties, leading up to the Public Hearings which are expected to be held in Parliament early next year. The Portfolio Committee on Science and Technology have been meeting various governmental stakeholders to discuss the bill over the last six months. The TNHA have attended a key meetings on the bill and have noted that there is still a lot of confusion about the bill, and even reservations about... Read More

CHINESE MEDICINE FOR AFRICA On the 2nd of November last year (2015) South African President Jacob Zuma and Chinese President Chinese Xi Jinping officiated 26 new trade and skill-based transfer related agreements on President Jinping’s first state visit to South Africa. During this visit the Forum on China-Africa Cooperation (FOCAC) was established and deals between both countries worth R96 billion were pledged. A Special Memorandum of Understanding on Co-operation in health and medical sciences was countersigned by Chinese Health Minister Li Bin and South African Health Minister Dr Aaron Motsaolaedi, which included a strong focus on introducing of Traditional Chinese Medicine... Read More

THE COMPLEMENTARY MEDICINE REGULATIONS MUST FALL! Anthony Rees (TNHA Chairman) In last month’s newsletter we announced that the long awaited draft regulatory amendments for natural health products had been gazetted on the 25th of July, and that we would provide you with our official comments on them. After reading them closely we have concluded that the Medicines Control Council (MCC) have not listened to any of the comments raised by stakeholders over the past two and a half years, and that they have again attempted to widen their net to capture the CAM sector. Despite many warnings from the TNHA... Read More

PROTECTION OR ETHNOPIRACY? Is Government Protecting The Traditional Medicine Knowledge of Our Indigenous People, or Imposing a State-Run Ethnopiracy Scheme for Big Pharma and the Biotech Industry? A Critical Review of the Protection, Promotion, Development and Management of Indigenous Knowledge Systems Bill Written by Dr Anthony Rees (National Chairman- TNHA) GLOSSARY OF ACRONYMS USED IN THIS DOCUMENT DST – Department of Science and Technology IK – Indigenous Knowledge IKS – Indigenous Knowledge Systems IP – Intellectual Property NIKSO – National Indigenous Knowledge Systems Office THPHCSA – Traditional Health Practitioners Council of South Africa INTRODUCTION Southern Africa possesses a remarkable diversity... Read More

ADVERTISING STANDARDS BODY SLAMMED BY HIGH COURT Anthony Rees (Secretary : TNHA) The private company known as the Advertising Standards Authority of South Africa (ASA) was ordered by the Gauteng High Court on the 5th of May to stop accepting complaints or making rulings on advertisements published by non-members.  The interdict effectively prohibits the ASA from banning ads by marketers of natural health products (and any other advertiser in any industry) which do not subscribe to the ASA’s private Advertising Code. In August last year we broke the story in our newsletter about the difficulties manufacturers and distributors of natural... Read More

ONLY SIX HEALTH PRODUCTS PASS FIRST ‘COMPLEMENTARY MEDICINES PRE-REGISTRATION TEST Anthony Rees (Secretary-General TNHA) The Medicines Control Council (MCC) gazetted a notice three weeks ago on the 15th of April in terms of section 14(3) of the Medicines and Related Substances Act (Act No. 101 of 1965). This notice served to inform stakeholders, including the public, which current products are to be further considered for evaluation and possible registration with the Council as ‘Category D’ Complementary Medicines. In terms of the Road Map circular which was issued on the same day the complementary medicines regulations were gazetted on the 15th... Read More

IFP AND ANC MAKE DEAL TO LIMIT MEDICAL INNOVATION BILL TO CANNABIS DERIVED DRUGS FOR PALLIATIVE CARE ONLY Anthony Rees (Secretary-General: TNHA) The Inkatha Freedom Party (IFP) and the African National Congress (ANC) have settled on a compromise on the Medical Innovation Bill (Bill No. 1 of 2014), agreeing that the scope of the Bill will be limited to the provision of Cannabis derived medicines for palliative care only. Essentially this means that these medicines may only become available to terminally ill patients where no orthodox medical treatments are considered viable. At a press briefing I attended today on the... Read More

OUR CONTINUED ACCESS TO NATURAL HEALTH PRODUCTS IS A FUNDAMENTAL HUMAN RIGHT Anthony Rees General-Secretary: TNHA Despite the best efforts of our National Department of Health to reduce the burden of disease in South Africa, many of today’s most common diseases including cancer, heart disease, diabetes and other diseases of lifestyle continue to rise sharply in numbers. Just yesterday I read in the foreign and local media that the number of those diagnosed with type 2 diabetes continues to rise unabated, despite increasing disease management interventions. In 1980 the World Health Organization estimated there were 108-million adult diabetes sufferers in... Read More

THE “DRUG-IFICATION” OF NATURAL HEALTH PRODUCTS By Richard DeSylva RH DNM The Canadian experiences with Natural Health Product regulations, similar to those adopted by South Africa It has been a little more than 10 years since the Natural Health Product Directorate (NHPD) officially brought into force the regulations governing the manufacture & sale of what are now known as ‘NHPs’ (Natural Health Products) in Canada.  While it may well be argued that there is greater validity and social sanction given to these substances, the trade-off seems to have been that the Natural Non-Prescription Products Directorate (NNPPD) will only assign a... Read More

HERBAL HEALTH PRODUCTS: SHOULD THEY BE REGULATED AS FOODS, DRUGS OR AS A NEW CATEGORY? Anthony Rees (General-Secretary: TNHA)  As a person who has practiced herbal medicine clinically, and worked in the natural health retail sector, and even owned a herbal health product companies over the last twenty years, I often pondered on whether herbal health products were merely unprocessed drugs, a segment of the food matrix, or whether they are unique substances which need to be defined and regulated separately.   I have steadily come to the conclusion that for the most part, herbal health products fit somewhere between what... Read More

AFRICAN MEDICINES REGULATORY HARMONIZATION A NEW THREAT TO TRADITIONAL & NATURAL HEALTH PRODUCTS THROUGHOUT AFRICA Anthony Rees (Secretary-General: TNHA) A newly adopted African Union Model Law on Medical Products Regulation and the establishment of an African Medicines Agency threatens to undermine the sovereignty of all African Nation-States in their regulation of medicines. This scheme, drafted behind closed doors, will significantly boost Big Pharma’s market-share on the continent, and will ensnare Traditional & Natural Health Products, foods and cosmetics into a harmonised regulatory framework. THE AFRICAN MEDICINES AGENCY AND THE MODEL LAW ON MEDICAL PRODUCTS REGULATION A few days after President... Read More

TNHA REJECTS DRAFT REGULATIONS FOR THE REGISTRATION OF TRADITIONAL HEALTH PRACTITIONERS On the 3rd of November last year the National Department of Health gazetted draft regulations for the registration of traditional health practitioners (Gazette No 39358 / Notice 1052).  Three months have been given for comment, ending on the 3rd of February 2016. The draft regulations lay out the criteria which practicing traditional health practitioners and those who undergo training must adhere to before they will be eligible to register with the statutory Traditional Health Practitioners Council of South Africa (THPCSA).  Registration with the THPCSA will be mandatory for all... Read More

BILL 6 SIGNED INTO LAW On January 8 President Jacob Zuma assented to, and signed the Medicines and Related Substances Amendment Bill 6 of 2014 into law in terms of section 84(2) of the Constitution of the Republic of South Africa. Anthony Rees (Secretary-General: TNHA) 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 (sic) Regulatory Authority (SAHPRA), similar to the FDA in the USA (read on to see why). The SAHPRA will no longer be an organ of State, but... Read More

NATIONAL HEALTH INSURANCE WHITE PAPER MAKES NO PROVISION FOR TRADITIONAL & NATURAL HEALTHCARE On the 11th of December last month, Health Minister Aaron Motsoaledi released the White Paper on the National Health Insurance (NHI) as approved by Cabinet.  The R220 billion universal healthcare scheme was announced immediately after the axing of Finance Minister Nene, who was putting a halt on major government spending. The burning question is how the NHI will be financed, considering the precarious and fragile state of our economy. The TNHA have studied the White Paper and note that nowhere are Allied Health Practitioners, registered with the... Read More

CAMS REGULATIONS DERAILED Anthony Rees (Secretary-General: TNHA) Are natural health product suppliers still compelled to register their products as ‘Complementary Medicines’? Many companies in the natural health product industry scrambled recently to meet the November 15 deadline to apply for registration of certain of their products deemed ‘Complementary Medicines. These products included weight-loss products and sexual enhancement products. Many retailers have become nervous about acquiring or retaining stock of these kinds of products, fearing many may end up being illegal. THE ROAD MAP TO NOWHERE Section 14 of the Medicines and Related Substances Act of 1965 (Act 101 of 1965),... Read More

UNNATURAL REGULATIONS Anthony Rees (Secretary-Gerneral: TNHA) There is no denying that the last year was a frustrating for many stakeholders in the natural health industry, as well as for many patients and consumers who rely on these products to achieve and maintain wellness.  Each passing day we receive queries from either retailers, practitioners or health conscious consumers, asking us where they can source natural health products which are no available longer on health store of pharmacy shelves.  Sadly, some of these products have been either scheduled and reclassified as pharmaceutical drugs (requiring a doctors prescription), or have been withdrawn from... Read More

TNHA TAKES THE HEALTH FREEDOM BATTLE TO PARLIAMENT On October the 29th, more than 300 traditional healers and many other guests crowded into the Old Assembly Hall of Parliament to listen as the Traditional and Natural Health Alliance presented its views on an amendment to the Medicines Act Bill 6 (also known as the SAPHRA Bill) to the Portfolio Committee of Health. Almost 50 years had passed since the Medicines Act of 1965 was passed in the same Parliamentary building, in the era of stiff suits and white faces. Now, the benches were filled with African Traditional Healers, mainly dressed... Read More

THE EFFECT OF NEW REGULATORY SYSTEM ON THE NATURAL HEALTH VALUE CHAIN, SECTOR BY SECTOR MANUFACTURERS In terms of the current regulations, NHP manufacturers are compelled to first register as pharmaceutical companies, following the letter of the Good Manufacturing Practice (GMP) regulations and guidelines imposed on multi-billion rand pharmaceutical manufacturers.  They are compelled to place a disclaimer on all their products stating that ‘This medicine has not been evaluated by the Medicines Control Council’, a trap ensnaring companies to hand over jurisdiction of their products under the Medicines & Related Substances Act and to the MCC. All manufacturers are now... Read More

THE CAM BAN SCAM THE FUTURE AS WE SEE IT According to many opinion leaders in the Natural Health Product (NHP) industry, the public’s future access to natural health products (NHPs) and those tied to them by profession looks bleak in South Africa.  There is a systematic ‘shut-down’ of natural health products (NHP’s) and choice underway, and it needs to be stopped NOW! We do not want to find ourselves in a situation like in Canada, where tens of thousands of safe, effective and good quality products were withdrawn either voluntarily from the market because of the high cost of... Read More

REGULATORY UPDATE About six months months ago rumours begun to trickle through to the natural health sector that the Medicines Control Council were realizing that the November 2013 Complementary Medicines regulations were unimplementable for various reasons. We heard the Medicines Control Council were looking abroad for a system that would (a) be less human-resource dependent, and (b) allow for the fast-tracking of applications for the majority of Complementary Medicines.  In the few rare meetings held between the industry and the MCC, the MCC revealed that the five-year Road Map for the phased registration for Complementarty Medicines had also become problematic.... Read More

HOW MUCH OF ORTHODOX MEDICINE IS EVIDENCE BASED? Anthony Rees (Secretary-General: TNHA) Many medical ‘experts’ deplore natural health products, claiming that their use isn’t supported by orthodox scientific rationale. In the absence of cost prohibitive, double blind, randomized, placebo controlled trials for most natural health products, this notion persists, despite these substances being used traditionally with success for hundreds, and if not thousands of years. While natural health products continue to be subject to these negative rantings, these ‘experts’ conveniently ignore the mounting evidence that over 50% of the pharmaceutical drugs they prescribe or sell are unlikely to be beneficial... Read More

  IS THE ADVERTISING STANDARDS AUTHORITY A SHAM? – YOU DECIDE WHAT POWER DOES THE ADVERTISING STANDARDS AUTHORITY OF SOUTH AFRICA REALLY WIELD? Anthony Rees (Secretary-General: TNHA) Let us introduce you to the Advertising Standards Authority (ASA).  This is not a government body as you might expect from the “Authority” in its name. It is a private, limited company that is self-appointed, self-regulating, and industry funded. It is registered and incorporated according to the Companies Act of 1973. As such, its powers are circumscribed by its Memorandum of Incorporation and Articles of Association (“Articles”), and not an Act of Parliament.... Read More

NATURAL HEALTH THERAPIES AND PRODUCTS CAN SIGNIFICANTLY REDUCE GOVERNMENT HEALTH SPENDING There is mounting evidence that daily use of natural health products can decrease national healthcare costs.  In a recent article published in the Journal of Dietary Supplements, researchers conducted a cost/benefit analysis that, when applied to at-risk populations who take natural health products, demonstrated a reduction in the odds of individuals experiencing a costly medical interventions. The publication of this article follows a ‘game changing’ economic report released in September last year, which concluded that dietary supplements could save billions of dollars in healthcare costs in the United States. ... Read More

MCC SCHEDULING COMMITTEE REVERSES RESTRICTIONS ON MILK THISTLE HERB The TNHA confirmed yesterday that the Milk Thistle herb (Silybum marianum) and its main active constituent ‘silymarin’ have been rescheduled from Schedule 3 to Schedule 0, after months of appeals to the Scheduling Committee of the Medicines Control Council (MCC). This herb has been proclaimed safe by many drug regulators around the world, and has an unblemished safety record when used responsibly. Last year this herb and / or silymarin was unilaterally recalled from all health stores and front-shop pharmacy shelves, forcing tens of thousands users to obtain these products with... Read More

TNHA REFUSES TO JOIN PHARMACEUTICAL INDUSTRY SECTOR BARGAINING GROUP Anthony Rees (Secretary-General: TNHA) Just over a month ago the CAMS Working Forum (CWF), of which the TNHA has been a member since its inception, met with Ms Joey Gouws, the Registrar of Medicines of the Medicines Control Council (MCC).  This was the second meeting which she has afforded the CAMS industry since the Health Products Association (HPA) launched its Gauteng High Court action in May 2014.  After the HPA suspended its court case, and after sustained pressure brought to bear on the MCC by the TNHA and HPA, it appeared... Read More

  TNHA JOINS THE INTERNATIONAL CHORUS AGAINST GMO CROPS Anthony Rees (Secretary-General: TNHA) During last weekend’s cold and rainy weather, hundreds of Captonians from all walks of life took to the streets of Cape Town to protest against Monsanto, as part of a global march on the same day in over 500 cities and towns across the globe. This was the TNHA’s first debut into lobbying for GMO-free food and the call for the ban on potentially carcinogenic (cancer causing) glyphosate, a common weedkiller manufactured by Monsanto as RoundUp, and found in other licenced products. The Monsanto Company has continually... Read More

DEMOCRATIC ALLIANCE PARTY SHUNS AFRICAN TRADITIONAL MEDICINES Anthony Rees (Secretary-General: TNHA) While on a visit to the friendly city of Port Elizabeth on Monday last week an article in the EP Herald proclaimed that the Democratic Alliance (DA) had voted on whether they would or wouldn’t support the inclusion of African Traditional Medicines (ATMs) into the Medicines & Related Substances Amendment Bill (Bill 6 of 2014). This took place at their federal congress in Port Elizabeth over the previous two days. This contentious Bill has been hotly debated by the Portfolio Committee on Health in Parliament for almost a year,... Read More

GOVERNMENT INTENDS REGULATING AFRICAN TRADITIONAL HEALERS AND THEIR MEDICINES Anthony Rees (Secretary-General: TNHA) By May 1st all African Traditional Practitioners were required to have been registered with the Traditional Health Practitioners Council, or face jail time for practicing illegally. However, almost a year after an Interim Council was set up and eight years since the passing of the Traditional Health Practitioners Act, it is still not functioning due to lack of government seed funding. The TNHA has been monitoring efforts by the government to regulate Traditional Healing Practice and African Traditional Medicines, and I have personally been following this process... Read More

CAM REGULATION CRITIQUE BEING HEARD BY GOVERNMENT Anthony Rees (Secretary-General: TNHA) Over the last 15 months, since the Medicines Control Council published its regulations for Complementary Medicines (CAMS) in November 2013, there has been little or no dialogue afforded between a growing number of aggrieved stakeholders and the Medicines Control Council (MCC), despite a plethora of requests for urgent clarity on matters affecting the manufacturing industry, health practitioners and consumers. It is rumored that various officials and sub-committee (CMC) members of the MCC received instructions from high up in Department of Health not to engage with parties who oppose the... Read More

BOILING THE FROG SLOWLY WITH CAM REGULATORY CREEP Complementary Medicines Regulations:  Unacceptable Regulatory Creep Anthony Rees (Secretary-General: TNHA) The ‘boiling the frog’ story is a widely-known anecdote describing a frog slowly being boiled alive. The premise is that if a frog is placed in boiling water, it will immediately react and jump out, but if it is placed in cold water that is slowly heated, it will not perceive the danger and will be slowly cooked to death. True or not, the metaphor could not be more fitting for the regulatory regime for the natural health product sector in South... Read More