THE CAM CROSSROADS – WHERE ARE WE HEADING?

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 health and wellness.  Choices in healthcare we have taken for granted for decades will abruptly disappear unless the industry and consumers unite and say ‘NO!’ to the pharmaceutical expropriation of natural health.  

This November marks the 3^rd anniversary of the passing of highly contentious complementary medicine regulations into law. Regulations which we maintain are unconstitutional and were unlawfully imposed on the Natural Health Product industry by the Medicines Control Council (MCC) in November 2013.

To demonstrate the failure of the complementary medicine regulations over the last three years, only six (6) natural health products out of the estimated 120,000 products which were voluntarily declared by manufacturers and importers between 2002 and 2013 have been awarded the ‘Right of Sale’. This means either the Medicines Control Council don’t have the capacity to regulate the industry appropriately, or are deliberately plotting its demise.

To date the MCC have only publicly acknowledged that 120 products currently traded on the market have been submitted for registration. Of these, many applications were rejected outright, while others are gathering dust on the desks of bureaucrats in Pretoria without their application status being known to the manufacturers for over a year.

From the thousands of safe and effective products which have been manufactured and marketed as natural antibiotics, blood sugar remedies, heart and circulatory tonics, weight loss remedies, natural hormone balancing formulas, immune enhancers, body building products and nutrients exceeding the new maximum daily upper limits which were arbitrarily imposed in October 2014, how can it be that only a handful of products are deemed legal while the rest are now technically banned?

The fate of individual products submitted for registration are now left to the discretion and whims of individual assessors who are not qualified in either therapeutic nutrition or the traditional and allied health disciplines which these products are classified under in the regulations. We have to all intents and purposed allowed the fox to run the hen house.

According to recent revelations by the Department of Health, it takes the MCC between three to five years to register new pharmaceutical drugs before they are allowed to be sold on the market. The result of this is a major backlog of thousands of medicines waiting in an ever lengthening queue to be approved. Over and above this, there is a historical backlog of over 9,500 pharmaceutical drugs which were grandfathered and given ‘Right of Sale’ in previous decades, and which have never been assessed for their safety and efficacy.

This year the pharmaceutical sector lost it’s patience with the MCC’s inefficiency and successfully lobbied for political pressure to be exerted on the MCC.  The result has been the MCC has now promised to speed up pharmaceutical product applications, with an emphasis placed on generic drugs.  The MCC staff are now forced to do their job, and fulfil their original mandate which is to regulate high risk drugs. The impact of this enforced performance is that complementary medicine applications have seemingly been shoved to the bottom of work pile, with little apparent intention by the MCC to ever haul these out for review

Unfortunately the clock is still ticking towards the 2019 deadline for all NHP companies to submit their product applications for registration. The MCC has refused all requests to extend the imposed five-year Roadmap for the NHP industry to regularise it’s affairs.

With the microscopic pace of NHP applications being assessed, compounded by the small number of applications being submitted, we predict that no less than 50 products will eventually be legalised by 2019, meaning consumers will lose over 99% of their choices in natural health products which they have been using safely and effectively for decades, and the NHP industry will implode with total loss of jobs and assets.

This means that most manufacturers and importers will close down and most health shops will close their doors forever.

The net result will be that the public will be forced into dependency on the multi-billion rand pharmaceutical industry for their rapidly worsening health statuses.

THE EXCESSIVE COSTS OF GMP COMPLIANCE FOR SOUTH AFRICAN MANUFACTURERS

Setting up new manufacturing facilities to produce NHPs under the current regulatory regime is both expensive and time consuming. From discussions we have had with companies attempting to licence their facilities in order to legally produce NHPs, the cost to erect custom-built premises, high tech equipment and staff authorised to manage the facilities runs into tens of millions of Rand.  According to the Medicines and Related Substances Act (Act 101 of 1965) and Pharmacy Act (Act 53 of 1974) manufacturers and distributors of NHPs are a compelled by law to employ full-time pharmacists to oversee these facilities, adding significantly cost of doing business.

The TNHA believe that pharmaceutical Good Manufacturing Practice (GMP) imposed on the majority of the sector is inappropriate, considering the extremely low risk profile of most natural health product ingredients used to produce NHPs.  Most NHPs are more food-like than drug-like in terms of risk, and should be afforded scaled-down GMP requirements more suitable for foodstuffs.  21^st century Food GMP also focus on risk-based preventive controls, i.e. those that would have the greatest impact on assuring safety.  It caters for the safe and sanitary manufacturing and processing of products, the fidelity of raw ingredients used and honest labelling. Setting up a production facility under food GMP guidelines will be a lot more affordable and achievable in the short term.

Obviously, there will be a few NHPs which will require pharmaceutical GMP, based on their higher risk and/or their dosage form. Companies which manufacture pharmaceutical drugs will require pharmaceutical GMP, due to the possibility of cross contamination of high risk drug ingredients ending up in NHPs produced with the same equipment. Certain substances like homeopathic mother tinctures prepared from potent poisons which have to be carefully handled, and products like eye drops and injectables will require strict sterility conditions in their production.

We, the TNHA propose a spectrum of GMP from Food GMP for low risk, Generally Regarded As Safe (GRAS) ingredient-based products, and higher pharmaceutical GMP specifications if the risk base increases.

The current requirement that all NHPs must be manufactured, distributed or imported by licensed manufacturers (drug companies) with pharmaceutical GMP certification is prohibiting most NHP manufacturers from submitting application to register their products. By 2019 all NHP manufacturers will have to be fully licenced.  Failure to obtain licencing before then will render all products sold by non-compliant manufacturers, distributors and importers illegal.

The MCC does not recognise foreign licensed NHP manufacturers without first sending inspectors to inspect the manufacturing facilities abroad. Importers are required to register as local pharmaceutical companies, regardless of whether they produce products in South Africa or not. They also have to employ full time pharmacists to oversee compliance.

The MCC has only eight inspectors who are tasked to approve manufacturing and distribution facilities in South Africa and abroad. Presently, the delay in ordering a site inspection to obtain licensing is between two and three years. We are aware of companies which applied for registration long before the regulations came into being, and have patiently waited for seven years for someone from the MCC to call and arrange an inspection.

The fact is, with the MCC’s slow pace of registering NHPs and approving manufacturing facilities, it will be literally impossible for them to regulate the NHP sector according to the 2019 deadline. Legally speaking, it is not lawful that a government department imposes regulations on an entire industry which can not be reasonably complied will with. It is irrational.

One cannot believe the MCC lacks the capacity to comprehend or acknowledge this crisis, or whether there is a deliberate attempt to bludgeon the NHP industry out of existence.

STATE & PHARMACEUTICAL CAPTURE OF THE NATURAL HEALTH PRODUCT SECTOR

It’s not surprising that the pharmaceutical industry is supportive of the pharmaceutical regulation of NHPs.  Its bargaining council with the MCC, namely the Industry Task Group (ITG) approved of this draconian regulatory scheme and have been dismissive of genuine concerns raised by the NHP sector.

The reason for this is that established drug companies do not have to jump any hurdles in order to comply with the NHP regulations and to expand into the health and wellness market. They already have manufacturing licences and the facilities and staff to produce NHPs.

From our consultations with local NHP sector over the last two and a half years we are aware of a only a tiny handful of licenced NHP manufacturers, who will be compliant in the future. This handful of companies has been in the business for decades and were licenced when certain classes of natural health products were called up for registration in the 1980’s.  When our country was under sanctions during that time they were the only legal traders who enjoyed the lion’s share of the NHP market.

After sanctions were lifted and the MCC relinquished control over the NHP industry, a flood of new competition diluted their market share. These NHP companies are now playing the game and supporting the NHP regulations in an attempt to recapture their lost market.

We are aware that these licensed NHP manufacturers and multinational drug companies are already gearing up to expropriate the largest segment of the natural health product sector, i.e. ‘health supplements’. They are waiting for 2019 to flood the market low potency ‘health supplements’ in the form of predominantly low potency, synthetic single nutrients and multivitamins.  These are products which do not interfere with, or compete with their primary business of disease.

As whole-herb, homeopathic and other high potency products disappear from health store shelves, the vacuum created will be quickly be replaced with these inferior, non-therapeutic products. Health conscious consumers will be left with a dazzling array of junk products presented as ‘choices’.

We have a choice NOW to meekly abdicate to this unfolding eradication of true natural health modalities, or to say “NO” to the pharmaceutical expropriation of natural health, and to demand our Constitutional rights to our health freedoms and choices!

HERBAL PRODUCTS ARE HIGHLY ENDANGERED

Multi-ingredient herbal products and botanical isolates, which are potent and effective alternatives to drugs, are the most threatened segment of the NHP sector. The hoops which herbal product manufacturers companies have to jump through in order to obtain pre-market approval are exceedingly onerous and the research and development costs are high if any company wishes to convey their health benefits to consumers in the form of health claims.

We are aware that the MCC are contemplating declaring concentrated botanical extracts like curcumin from turmeric, lycopene from tomatoes, berberine from barberry, epigallocatechin gallate (ECGG) from green tea etc. as ‘Category A’ medicines (pharmaceutical drugs), eliminating them from open-sale and to make them only available by a doctor’s prescription only.

The MCC’s current mode of thinking is that HERBS ARE DRUGS.

Although the MCC claims to accept health claims based of long-standing traditional use, backed up by prescribed bibliographic references we have not yet seen a single product registered under this provision.

The European Medicines Agency (EMA) are at the international forefront in making provision for traditional herbal product health claims, and are still debating on how this will be practically achieved. We believe the MCC and its expert Complementary Medicines Committee lack the expertise and capacity to deal with this issue, and have chosen the easy way out by declaring herbs as quazi-drugs.

Herbs used traditionally from the World’s herbal traditions are prescribed and sold based on systems comprised of ‘energetics’ and ‘pattern of disease’ principles, and not pharmacological indications like modern drugs.

For instance, Traditional Chinese Medicine focuses on balancing Qi [pronounced Chee] with the artful balancing of elements and tastes. In Traditional Ayurvedic Medicine, individuals are treated according to their Doshas, and like Traditional Chinese Medicine, incorporates herbs which balance the five elements, which manifest as a pattern of dis-ease when out of sync.  Traditional Western Herbal Medicine too, has its roots steeped in balancing the energetics of the body, and the use of tonics and balancing formulas intended to treat the symptoms of excesses and deficiencies or organs and systems.

Modern drugs are classified and prescribed according to pharmacological actions, and usually employed to suppress symptoms.

Traditional health claims for herbs are irreconcilable with the health claims for modern drugs. They stem from separate paradigms in the understanding of the cause of disease and their treatments are diametrically opposed to each other. Natural health products support health and therefore arrest dis-ease, while most pharmaceutical products don’t treat disease but symptoms, nor support health. In fact the vast majority of pharmaceutical products are accompanied by inherent risk of causing additional adverse symptoms, as admitted and indicated on their own package inserts.

The MCC lack the capacity to accommodate these different systems, and instead are trying to force herbal products to be registered like drugs. Their reductionist regulatory system and their assessment tools can only accommodate health claims based on established pharmacological classifications for single molecule drugs, hence the reason the registration Roadmap has called up NHPs based on pharmacological classifications, i.e.  Antiviral agents, Oral Hypoglycaemics, Cytostatic agents etc.

Companies selling NHPs with health claims based on established modern pharmacological classifications will have to play by the rules and accept that their products will be assessed and registered as ‘Category A Medicines’, or drugs. These applications will have to be accompanied by modern evidence-based research, costing companies millions or rand and no patent protection. These draconian demands of evidence-based research are contradicted by pharmaceutical companies now lobbying world-wide to be allowed to submit  empirically supported evidence on drugs of which the component pharmacokinetics are well known or accepted as GRAS.

FALSE NATURAL HEALTH CHOICES ON THEIR WAY

The new daily upper limits imposed for NHPs containing single nutrients under the ‘food supplement’ regulations published in October 2014 are in most part set below the threshold of proven therapeutic value, therefore rendering most of them ineffective in reversing the course of many chronic diseases resultant from long term, sub-clinical deficiencies.

Companies that manufacture nutrient-based products that exceed the capricious maximum daily dosage limits will either have to register these products as ‘Category A’ medicines (pharmaceutical drugs), or reformulate them out of efficacy (lowering the potencies).

The trend we are seeing is that most of the beneficial NHPs currently sold on the market today, and used by millions of South Africans will disappear at the end of 2019.

“If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” – Thomas Jefferson.

THE CHANGING LANDSCAPE OF CONTRACT MANUFACTURING

There are a few licensed pharmaceutical manufacturers which are prepared to manufacture natural health products on behalf of existing NHP companies who lack the capacity to manufacture themselves. These are referred to as Contract Manufacturers.

Contract Manufacturers have recently restructured their client bases to effectively lock out small and medium sized NHP companies which want to continue trading post-2019.

The current GMP requirements for manufacturing NHPs and orthodox drugs are identical. Contract Manufacturers are now compelled by law to compile large volumes of documentation to accompany product development and manufacturing for each product their produce, and must conduct a large battery of expensive and time-consuming tests in order to fulfil the GMP requirements for each product they produce.

For this reason they are no longer prepared to manufacture small and medium sized product batches like they did in the past, and are now giving preferential treatment to larger companies with large production runs.

Many small and medium sized HNP companies which have relied on contract manufacturers in the past are having their business turned away. In terms of the Medicines Act, all companies in the manufacturing and distribution chain must be licensed. Even if your company markets NHPs and is wholly reliant on a registered and licensed GMP manufacturer to do your production, your company still has to register as a manufacturer and distributor of medicines. You will still have to hire a full-time pharmacist at your sales office to oversee your paperwork.

With the frail economy and regulatory uncertainty continuing to dampen investment in the NHP industry, these demands simply can’t be met. Consequentially, innovation in the sector has practically stagnated. NHP companies are not prepared to take regulatory and financial risks to bring new products to market.

PORT HEALTH AND THE ILLEGAL IMPORTATION BLOCKADE

The MCC have embarked on an illegal blockade of new products being imported from abroad, having instructed the Port Health Authorities to withhold products not accompanied by MBR20.8 registry letters, issued pursuant to the February 2002 regulatory audit.

The 2002 notice was mired in controversy and been subject to fierce debate.  At one point the MCC conceded it needed to be rescinded, but reversed this decision after pressure from the pharmaceutical sector. At the time it was gazetted, neither the Medicines Act nor General Regulations under the Act empowered the MCC to call up NHPs. Despite the notice specifically stating that the audit was for products sold on the market prior to, and within six months after its publication, the MCC continued to process applications illegally for over a decade.

There is still no legitimate or lawful reason why Port Health Authorities are imposing this illegal trade barrier. We have written to the MCC demanding they put an end to this activity.  The TNHA will be taking up this issue with the Department of Trade and Industry.

SARS AND THE UNEQUAL APPLICATION OF CUSTOMS DUTIES

Despite the fact that NHPs have been legally defined as new category of human medicines since November 2013, Customs agents (South African Revenue Service) are continuing to declare NHPs as foodstuffs.

Foodstuffs are classified under tariff code 21.06 and attract a 20% import duty (tax), whereas medicines are allowed to be imported duty free under tariff code 30.04.90. Medicaments carry no duty worldwide due to their intrinsic necessity for human health.

We are aware that one company did challenged SARS on this matter and that SARS have conceded to allowing them to import their products as medicines without incurring import duties. However, this concession has not been afforded to all importers. The TNHA will soon be calling on the Tariff and Trade Affairs Directorate of SARS to apply a consistent, internationally accepted and lawful approach in this regard.

REGULATORY CONSULTANTS – HELPERS OR OPPORTUNISTS?

Every week we receive reports from aggrieved manufacturers and importers which have had the misfortune of contracting pharmaceutical regulatory consultants to prepare their product applications on their behalf, or to advise them on becoming compliant with the manufacturing requirements.

Few of these consultants bother to ask the companies if they are registered as manufacturers, or have the required GMP certification. Instead they start filling in the prescribed Common Technical Documents (CTDs) applications for products, dragging out the process to keep the billing clock ticking, knowing full-well that their clients don’t stand a chance of registering their products.

The fees these consultants are charging small and medium sized companies to complete CTD applications are astronomical. From the bills and quotes we have seen, these unscrupulous companies and individuals are charging an average of R75 000 for a single ingredient product application and over R350 000 for multi-ingredient formulation applications. Some of these consultants are charging up to R20 000 for a one hour meet-and-greet consultation before they are even contracted.

With these extortionist fees to be made from unsuspecting manufacturers, it’s plain to see why these consultants circle around like vultures at regulatory workshops where confused manufacturers meet. If any industry requires urgent regulation, it’s the private pharmaceutical regulatory consultancy sector.

Most small and medium sized companies do not have the capacity or technical knowledge to complete the registration applications forms and source the associated attachments required, therefore they are at the mercy of consultants to compile these documents on their behalf should they wish to stand a chance of registering their products. Most companies have ranges of products and the cost of hiring consultants to get them into a position to apply for registration for them is cost prohibitive. It appears the only sector currently benefitting from the NHP regulations is a largely unscrupulous pharmaceutical regulatory consultancy sector.

Notwithstanding, there are a few honest consultants who are ethical and do warn potential clients in advance that they will not be able to assist them, either due to the companies not being registered manufacturers (a precondition to register products), or that they will have difficulty registering their products with their present ingredients, health claims or dosages.

ILL CONSEQUENCES TO INDUSTRY, GOVERNMENT & SOCIETY

The unintended or perhaps calculated harm being inflicted on the NHP industry will intensify exponentially over the next two years if not challenged vigorously. The NHP industry sector, as it stands, generates R14 billion per annum and represents a significant tax base to our public purse.  This revenue is the equivalent of 0.4 percentage points of GDP in 2016.

It is not acceptable that rogue bureaucracy like the MCC can gazette and enforce regulations which threaten to eliminate an entire economic contributing sector when our fragile economy is teetering on the brink of recession and a sovereign downgrade to junk status?

We can confidently predict that the current complementary medicine regulations, once fully adopted and enforceable in November 2019, will trigger approximately 10,000 formal job losses throughout the formal manufacturing, import, distribution and retail sector, and take the bread out of the mouths of approximately 35,000 direct sales purveyors who are in many cases the sole bread earners in their households.

There will be a significant knock-on effect to associated supply and service sectors, including the media, packaging, printing and logistics industries.

These regulations WILL hurt the SA economy, exacerbate the broader fiscal and societal costs associated with unemployment (UIF pay-outs), decrease the choices and increase the cost of NHPs currently available. An unintended consequence will be more pressure on the Government Health System due to the lack of traditional self-medication, and the emergence of unscrupulous black market vendors selling dangerous products with the concomitant adverse reactions.

Most NHPs are out of pocket expenses by the public and are a considerable saving to the public health system by virtue of them keeping people healthy and being able to exercise self-care.

The Registrar of Medicines at the MCC, Ms Joey Gouws, has admitted that no regulatory impact assessments were conducted by the Ministry of Heath, National Department of Health or MCC prior to the passing of the NHP regulations in 2013. This is despite governmental guidelines and a Presidential order demanding the same.

Had the MCC consulted with the sector openly and applied their minds in a dutiful manner we are sure that these regulations would never had seen the light of day.

We acknowledge that there are a few bad apples in our industry that cut manufacturing corners or make outlandish heath claims and dupe the unsuspecting public, however they are in minority.

With appropriate regulation, we believe we can begin to reign in the cowboys by making it easier and less costly for them to comply.  What is transpiring now is that some companies have realised that they will not be able to comply with the NHP regulations by 2019, and are going underground by selling their products though non-traditional marketing streams such as on social media and informal traders.

The very practices the MCC have attempted to bring under control (false health claims and substandard products) are now flourishing as a result.

THE SOLUTION

The TNHA aims to ensure regulations effectively protect consumers while still encouraging innovation and accountability.  So for the future the answer is both simple and complex.

The simple answer is that before anything else can work, natural health product regulations must be appropriate and tailored for the industry regulated. To protect the consumer and enable practitioners and businesses to carry out their proper function without monopoly control from a competing modality, good regulations are vital.  Poor regulations like those currently imposed can do just the opposite.

If natural health regulations don’t set the proper framework, innovation within the natural health industry is stifled while only a handful of large conformists prosper. The complex part of the answer is ensuring that the regulations work for us and not against us and they safeguard both consumers and the industry against future manipulation.

The TNHA works closely with many other groups both in South Africa and around the world to address these issues. To act as an effective lobbying force the natural health industry needs a single umbrella entity that has its only focus to act as a regulatory watchdog without hidden agendas.

Change has to occur at the regulatory level though an Act of Parliament to ensure all businesses are able to operate in a fair and reasonable way without double standards or pharmaceutical bias. There needs to be controls on bureaucracy to ensure that large companies do not achieve monopolies by regulation. There also needs to be a system that encourages innovation and demands accountability.

The natural health industry is facing serious threats from a number of directions. If these threats are not countered soon then the ability of individual consumers to take responsibility for their own health and make their own decisions from a range of effective and safe products and therapies will be seriously diminished, if not destroyed.

The TNHA believes in ‘Consumer Empowerment’ – the understanding that being responsible for looking after our own health is the most fundamental of human rights.

For all of us who are concerned about our government’s relentless attack on our health freedoms, we need unity through organization and to become a single voice calling for change. For the last three years the TNHA has been that voice.

Now, more than ever, we need your immediate support to reverse the course we are heading. The TNHA urgently needs to raise funds to intensify its campaign and to legally challenge these regulatory threats and to unite role-players in a new vision.

WE NEED A TRADITIONAL & NATURAL HEALTH PRODUCTS ACT

We need new legislation that protects our Constitutional Rights by giving traditional and natural health products their own Act of Parliament. We wish to protect access to traditional & natural health products by creating a separate legal category for them that is neither foods nor drugs.

The TNHA are currently lobbying political parties in Parliament to adopt and table new legislation in the form of a Traditional & Natural Health Products Bill, which will regulate NHPs in an appropriate framework, taking into account their low risk, the public’s right to choose and the preservation and promotion of cultural and traditional expressions.

Some political parties we have canvassed thus far are receptive to this this proposal, agreeing that the current regulatory model is neither sustainable or in the public interest.

Our goals of a new regulatory system include:

• That a new stand-alone Regulatory Authority for traditional & natural health products be established. That it be completely separate from the Medicines Control Council (and soon to be established SAHPRA), and involve the creation of a new ministerial position as its head.
• That the 50 year old definition of a medicine in the Medicines and Related Substance Act (Act 101 of 1965), be amended to specifically exclude traditional & natural health products.
• That the regulations for complementary medicines passed in 2013 (as amended), be repealed in their entirety upon the establishment of the new Authority.
• That the continued unconstitutional discrimination by virtue to having different regulatory requirements for indigenous traditional medicines and non-indigenous medicines ends. All traditional medicines must be regulated on a level playing field.
• Persons appointed to run the new authority should be free of conflicts of interest, have expert knowledge of traditional & natural health philosophies and be generally acceptable to the industry.
• The availability of naturally occurring ingredients (or their ‘Generally Recognised As Safe’ (GRAS) synthetic equivalents) should only be restricted when there is robust evidence of harm. The same criteria should also apply for setting maximum dosage levels. Such restrictions should apply only to the form of the ingredient where harm was verifiably demonstrated.
• That the new regulatory authority be initially government funded at a level similar to other industries.
• That the new regulatory authority be internationally accepted and promoted for the benefit of exporters.
• That a multi-tiered structure for allowing natural health claims be established. Advertisers would be required to maintain appropriate research files for claims made at any level.
• That clear guidelines should exist to differentiate the validity of claims such as ‘clinically proven’, ‘supports’, or ‘may support’.
• That affordable, pragmatic testing requirements are established for importers of products from countries without a robust regulator, or for small and medium sized South Africa manufacturers
• That GMP is imposed on a sliding scale of potential risk, with most products produced from ‘Generally Recognised As Safe’ (GRAS) ingredients be maximally regulated under GMP suitable for foodstuffs.
• That all products, ingredients and dosages currently available in South Africa would be acceptable for sale in South Africa (grandfathering provisions).
• That efforts be made to educate medical practitioners on the benefits of certain nutritional supplements for non-critical medical conditions.
• That a penalties structure for lack of compliance be set at levels considered normal for other industries in South Africa.