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By Anthony Rees – National Chairman (TNHA)

It has been nine months, give and take a few days, since the Supreme Court of Appeal (SCA) in Bloemfontein delivered its five-seat unanimous judgement, upholding the 2018 North Gauteng High Court judgment declaring the 2017 complementary medicines regulations under the Medicines and Related Substances Act ultra vires (invalid), and unconstitutional.

Although the High Court and SCA both found the SAHPRA’s overreach in regulating non-medicinal health supplements and non-scheduled substances without disease or symptom claims inconsistent with the stated definition of ‘medicine’ in the Medicines Act, the SCA suspended its declaration of invalidity of the regulations for twelve months so that the Minister of Health, and not the SAHPRA, can decide on whether to regulate this group of products differently or allow the suspension to lapse and not regulate them at all. The twelve-month suspension ends on the 9th of April 2023, three months from publishing this report.

Ever since the scathing SCA judgement, which the Minister and SAHPRA abandoned an appeal against in the Constitutional Court, the Minister has not reached out to the industry to find an amicable and appropriate solution, despite our letter to the Minister offering a legislative proposal to responsibly and appropriately regulate the sector based on easily adaptable real-world models administered successfully by other regulators around the world.

We have reliably learned that the SAHPRA, through the Minister’s rubber stamp once again, are intending to publish surprise complementary medicines regulations for comment in early 2023. These will be open for comment for ninety days (3 months) in terms of Section 35(2) of the Medicines Act. This has not happened yet, therefore we are unable to comment on them prematurely.

If the forthcoming regulations are again ultra vires, or as draconian as the last set of regulations, we will be sure to vigerously oppose them.

We also are aware that the SAHPRA holds monthly Industry Task Group (ITG) meetings by invitation only, where the ongoing regulation of complementary medicines and health supplements are regularly discussed in an allotted time dedicated to them. The prevailing attitude at these meetings is that its ‘business as usual’ in terms of complementary medicines regulation, despite the looming deadline for the regulations to fall away.

The ITG is made up of senior SAHPRA officials, pharmaceutical lobby group representatives (trade associations), individual pharmaceutical company representatives and two pharmaceutically infiltrated and dominated health product associations which mischievously claim to represent the whole of the natural health products industry. The TNHA is not a member of this group, and neither is the Alliance for Natural Health Products South Africa (ANHPSA), which took the Minister of Health and SAHPRA to court, despite being legitimate stakeholders.

Neither of these two rival associations collectively represent the broad base of the natural health products industry. They mainly represent pharmaceutical companies which sell low-potency, iffy supplements in major chain stores as a sideline to their predominant drug market. The TNHA or ANHPSA have not been invited to participate in these closed-door meetings, undoubtedly because the SAHPRA and its agreeable stooges know that we will reject their attempts to circumvent the SCA judgment and continue to exercise regulatory overreach with industry-choking regulation that threatens the existence of small and medium-sized natural health products companies which have pioneered the natural health product sector, and which the public rely on for their and their family’s health and wellness needs, and through freedom to choose.

The external ITG scheme is neither honest nor legal, as neither the Medicines Act nor its regulations prescribe it nor the joint decisions and negotiations made at these secretive meetings.

We reject the illegitimate ITG with the contempt it deserves. Secret deals between regulators and their clients (the regulated) behind closed doors are repugnant in a democratic dispensation.

We have also recently learned that the SAHPRA are actively lobbying the Minister of Health to amend the definition of a medicine in the Medicines Act in order to capture and regulate all animals, vegetables and minerals in the form of natural health products, and to further broaden their regulation to products like foodstuffs, cosmetics and Traditional African Medicines under the Medicines Act.

This is despite foods and cosmetics being currently regulated under the 1972 Foodstuffs, Cosmetics and Disinfectants Act and the 2007 Traditional Health Practitioners Act requiring Traditional African Medicines to be regulated under its own regulations.

In order the amend the Medicines Act, an Amendment Bill will have to be tabled in Parliament and will have to go through various constitutionally prescribed legislative and consultative steps before being passed into law. This will include the proposed amendments being made open to public comment (written and/or oral) before the Portfolio Committee for Health, public presentations and comments by the public in the nine provinces under the oversight purview of the National Council of Provinces (NCOP), debates in the National Assembly and final assent by the President one he/she has reviewed it in terms of its constitutionality.

The last Amendment Bill (Bill No. 6 of 2014) which amended the Medicines Act took three long years to proceed through the law-making process in Parliament and for final signature by the President. During that process, the TNHA and 250 traditional healers from the Traditional Healers Organization (THO) successfully lobbied our lawmakers to remove the definition of complementary medicine from the Bill before being passed into law. (View the first tabled draft and second draft as evidence).

We will return to Parliament again if need be, and we will lobby for new separate legislation and a new regulator to regulate the natural health products sector, outside of the inappropriate Medicines Act, especially in light of recent court rulings and the history of oppression of our industry has suffered under the former Medicines Control Council and now the SAHPRA.

There is currently a three-year to a four-year backlog in tabling and processing of new Bills and Amendments Bills in Parliament as a result of the severe constraints imposed by the Covid pandemic and the devastating fire at Parliament last year which burned down the National Assembly and other office wings of the legislature.

Realistically, even if the Minister of Health tables an Amendment Bill including ‘complementary medicines’ and a long wish list of other SAHPRA inclusions and exclusions before April 2023, the legislation would not amend the Act for at least three to four years to come.

SAHPRA, an independent body is engaged in a massive power grab currently, trying to regulate all it can under its power-hungry and fee-hungry bureaucracy made up of unelected technocrats and enforcement tyrants. With budgetary constraints evidenced in their recent Annual Report to Parliament, SAHPRA is actively looking for more sectors to expand into and to derive revenues from. Complementary medicine is one of them.

The SAHPRA is not a representative body trusted to regulate the natural health product industry.

Its male fides and extreme bias against the industry are well documented over several decades. In recent years their efforts to expropriate the natural health product industry and hand it over the Big Pharma interests have ramped up dramatically. It has scheduled many beneficial natural health substances such as vitamins, minerals, amino acids, enzymes pro-biotics and other useful supplement ingredients to capaciously low maximum daily limits without an up-to-date evidence base or concern for their health-giving properties. Products containing ingredients exceeding these arbitrary and low daily limits are placed in higher schedules, often requiring a doctor’s prescription to access them, that is if there are products registered by SAHPRA in the higher schedules at a much higher cost.

SAHPRA has continued to impose its myopic pharmaceutical licencing requirements on all importers, manufacturers, wholesalers and distributors in the natural health product value chain despite the regulations being declared unlawful and soon to fall away. It has literally intercepted tons of natural health products imported through our ports of entry into the country and resorted to what importers describe as extortion tactics, coercion and even alleged corruption to clear products (more about these issued in a follow-up report).

Many strong companies with well-established and trusted brands have gone out of business because of these unscrupulous activities over the past year, while others get a free pass for their goods if they have a cosy relationship with certain key SAHPRA officials. Despite an electronic portal being imposed which was supposed to eliminate the arbitrary clearance of imports and make clearances more efficient and fair, it has been used as a fishing exercise by the SAHPRA and as a coercive tool to force desperate companies to self-declare their companies as pharmaceutical companies (by having to obtain Section 22 licences) and self-declare their products medicines despite their products not being medicines. Those who have not fallen for this trap and objected to these exploits have continued to have their imports denied entry at great cost and frustration. Official appeals to the SAHPRA have been stonewalled or dragged out without resolution, with some businesses having declared bankruptcy or disinvested in South Africa as a country to do business with as a result.

A few months ago SAHPRA inspectors ramped up their harassment of local manufacturers. In one example two alleged ‘inspectors’ pitched up at a manufacturing plant unannounced a few weeks ago, without a single verifiable complaint [which they said was the basis for their insistence to enter and inspect the premises], or SAHPRA Inspectorate ID credentials.

One of the ‘inspectors’ tried to pass off his expired pharmacist registration card issued by the SA Pharmacy Council as a SAHPRA Inspectorate ID card. Luckily the company, a TNHA member, knew their rights and prohibited them from gaining unlawful entry. Unfortunately, this did not deter these ill-behaved goons. They returned shortly thereafter, after visiting the local police station with two armed policemen and again attempted to gain entry using the police as a backup. Again they were denied entry and left. A case was opened against the manager of the company by the ‘inspectors’ despite them neither having a legitimate complaint nor appointment letters required by them to identify themselves to the manufacturer or police under section 26 of the Medicines Act. The company is legally opposing this unlawful action and reserves its rights in this regard.

It is fair to say that our industry has reached a crisis point, with a power-drunk regulator which has gone rogue.

The idea that unelected SAHPRA bureaucrats who have never put their name on a ballot can supersede the powers delegated to them in legislation in an unconstitutional manner repeatedly (as recorded in multiple court rulings and internal appeals), while not representing or speaking for the natural health sector, must end.

The SAHPRA doesn’t have a single complementary medicine or health supplement expert serving on its governing Board or Administration staff, yet claims to have ‘superior knowledge’ of all things related to the natural health sector.  It has relied on one external expert to cobble together its disastrous regulations and guidelines since 2013, namely a homoeopathic academic who has never worked in the natural health product industry and doesn’t possess the necessary expertise in manufacturing or selling natural health products commercially. This individual proclaimed that ther doomed regulations were the ‘best in the world, yet most of the foreign importers we have engaged with say they are the most onerous and inappropriate ever seen worldwide.

We will not allow an entire sector to be subsumed under pharmaceutical regulation without broad-based, inclusive representation, nor through legally questionable coercive means or by incompetent ‘experts’. We won’t stand for jackboot tactics by the inspectorate on unlawful fishing expeditions.  The courts have spoken, and so have we.

Regulation without representation is tyranny.

There can be no regulation beyond April 2023 for us, without us!

Next year the TNHA will be expanding its efforts in order to try to find real solutions to fix this mess.

  • We will continue to protect the consumer’s right to choose.
  • We will continue to protect the true natural health industry and ensure its sustainability.
  • We will continue to lobby the government to adopt appropriate standards of production, quality control, marketing and advertising of natural health products.
  • We will continue to educate and provide information on natural health that protects consumers.
  • We will continue to be a credible source to the media by representing the natural health sector.
  • We will continue to foster and nurture cooperation among local and international associations and practitioner bodies.
  • We will continue to consult with local and international businesses on local regulatory issues.

We wish to thank all our loyal members for their continued and unwavering support and encouragement over the past year. Without your support, we would not be able to stand up, speak up, and litigate to support you and your customer’s right to choose.

Please pass this report on to other natural health product companies, practitioners and stakeholders you think may benefit from taking up TNHA membership, just as you have over the past year.

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