THE EFFECT OF NEW REGULATORY SYSTEM ON THE NATURAL HEALTH VALUE CHAIN, SECTOR BY SECTOR
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 required to upgrade their manufacturing facilities and product testing laboratories to the same standards as drug companies. Three local companies have provided us feedback on the cheapest quotes they received for entry level compliance: R75 million in outlay was the average figure.
According to a recent ‘workshop’ hosted by the MCC for the NHP sector, it was revealed that a permanently employed ‘responsible pharmacist’ and a junior pharmacist will have to run the manufacturing affairs of these companies. South Africa has severe skills shortage of trained pharmacists, with a shortfall of some 2 500 pharmacists required in the state health sector alone. The average starting salary of a pharmacist in South Africa is +/- R45045 000 a month. These high salary costs, among others will have to be calculated into price exit points and ultimately absorbed by consumers.
These are only the first steps in acquiring authorization to manufacture NHPs. Over and above this are hefty product registration fees, annual licence renewal fees, GMP certification fees, etc. One company which is a member of the TNHA has calculated that they will require around R50-million just in application fees for their products to be registered under the current regulations. This fee will be increased threefold, with the use of expert regulatory consultants, who must prepare Common Technical Documents (CTD) applications on their behalf.
All of these costs will have to be absorbed by the end users, being the public and patients. The affordability of high potency, integrative and innovative products will be severely impacted upon, causing most, if not all, to disappear from the market or to become unaffordable to most consumers.
What will be left on the market will be a glut of low potency vitamins and minerals, some single herbal teas, old traditional herbal formulas and homeopathic remedies with very limited claims. Many products will be re-formulated out of efficacy, with substitution of ingredients which may be rescheduled. All in all, the resulting lack choice in NHPs by consumers and health practitioners in SA will be detrimentally affected.
It is obvious that small and medium sized NHP manufacturers are not able to jump the hurdles set before them, and will have no choice but to stop producing NHPs or move their manufacturing to larger contract manufactures at higher costs.
Contract manufacturers have long lead times to produce products and require large quantities of product to be manufactured, based on their economies of scale. Many small and medium sized companies currently produce small batches of product on demand. They also supply extended ranges of niche products in very small batches at low production cost. Because contract manufacturers are not geared to produce small batches of niche stock, many valuable products will be lost in this way.
CONTRACT MANUFACTURERS – Presently there are approximately twenty registered contract manufacturers in South Africa who manufacture the bulk of NHP’s on behalf of most NHP producers. The MCC have made statements in the recent past to our members, that when the regulations for NHPs are fully implemented, they expect only five or six manufacturers to have the necessary expertise, licencing and GMP certification to manufacture NHPs. These are all large pharmaceutical companies. For these reasons the TNHA are exploring laying complaints with the Competition Commission, as this apparent collusion is anti-competitive.
RAW INGREDIENT SUPPLIERS
We have learned that raw ingredient suppliers of NHP ingredients used to make products will also soon come under the control of Act 101 and the MCC through regulatory amendments being drafted. The MCC intends for anyone or any company who imports or grows natural health substances for the NHP industry to first obtain a pharmaceutical supplier licence.
They will only be allowed to sell to bona fide manufacturers upon receipt of their manufacturing licences and the list of ingredients tied to registered NHPs. Suppliers who cannot demonstrate that they are supplying registered companies, and for approved, registered products, may be fined, imprisoned or even have their licences revoked.
In terms Pharmacy Act, health shops will have to register as pharmacies with the Pharmacy Council if they wish to continue selling NHPs which have been scheduled above Schedule 3. These retailers will also have to employ a pharmacist to legally dispense these products with an accompanying doctor’s prescription.
We have learned recently that the MCC’s expert advisory committee, the Complementary Medicines Committee (CMC) is motivating for NHP extracts with measured pharmacological activity (e.g. curcumin, berberine, echinosides, pycnogenol, betasisterols, citrus bioflavonoids, lycopene, resveratrol, quercetin etc) to be reclassified as ‘Category A’ pharmaceutical drugs, which will no longer fall under the regulations for NHPs. This will immediately result in their scheduling and removal from over the counter (OTC) sales. These will only be available by prescription.
It has been reported that the CMC are being guided by the W.H.O General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine, published in 2000 in this regard.
In the W.H.O guidelines, herbal isolates are erroneously classified as pharmaceutical drugs. Are the MCC going to force sugar producers to register sugar, because it’s a sucrose is an isolate from sugar cane, single vitamins or amino acids expressed from natural sources, or caffeine from coffee?
Because manufacturers will be forced to either close down or comply, many larger companies will remove large swathes of product lines they currently produce and sell, in order to licence a few brand leaders. Most companies in South Africa do not have the financial backing or expertise to comply with these regulations. Those that rely on third-party contract manufacturers will also be at a disadvantage because they will only be able to produce cheap, low-potency multivitamins and minerals, and have to compete with large drug companies who have already captured the mass retail market (supermarkets and chain store pharmacies) of such products.
The direct marketing sector may also be severely affected now that NHPs are deemed to be ‘medicines’ under the Medicines and Related Substances Act. In terms of the new regulations which ban the bonusing and sampling of medicines gazetted on the 22nd of August 2014, free sample products and tiered financial bonus schemes will be outlawed when selling all medicines in South Africa, including NHPs. This means that products sold through multi-level marketing schemes may soon be outlawed once the 2019 deadline for the registration for NHPs has passed.
Despite claims from the Department of Health that NHPs sold over-the-counter (Schedule 0 – 3) will be exempt from these regulations, we are not optimistic that implementation will guarantee these assurances, as the MCC are well known to change tact at a whim and without consultation.
THE ROLE OF THE ALLIED HEALTH PROFESSIONS COUNCIL
The Allied Health Professions Council of South Africa(AHPCSA) is a statutory health council established for the control of prescribing Complementary and Alternative Medicines practitioners (ie Homeopaths, Naturopaths, Phytotherapists, Unani-Tibb practitioners and Traditional Chinese Medicine Practitioners) and various other therapeutic modalities. It is no secret that the AHPCSA have been calling for the removal NHPs from OTC sale in health shops and pharmacies, preferring to them being dispensed by practitioners only.
This was revealed in a 2013 report by the Registrar of the Council, Dr Louis Mullinder to all registered practitioners, titled ‘MANDATE OF THE ALLIED HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA (AHPCSA) AND RELATED MATTERS’.
In it, the day to day functions of the Council were described. Prominent on the list of priorities for AHPCSA, it stated:
.. I [we] now find ourselves being able to focus our attention on policy issues which might ultimately benefit our professions. Such important policy questions include: … Liaison with the Complementary Medicines Committee of the Medicines Control Council [of which AHPCSA dominates] with a view to regain complementary and alternative medicines (including aromatherapy essential oils) under the control of practitioners and therapists.
We challenge the AHPCSA to demonstrate to us how they come to the conclusion that NHPs sold in SA health stores and pharmacies are somehow unsafe, when our own MCC and Adverse Drug Reporting Centre at UTC can’t do the same.
It is this selfish, vested interest that has led the AHPCSA being selectively invited by the Medicines Control Council to form the MCC’s expert advisory committee, named the Complementary Medicines Committee (CMC). Presently the CMC is manly comprised of members of the AHPCSA. One of these members, Dr Neil Gower, was recently appointed by the Minister of Health to become a member of the Medicines Control Council.
The motives of the AHPCSA have dove-tailed nicely into the pharmaceutical expropriation plan for natural health products by the MCC, considering both statutory councils wish for most NHPs to be removed from open sale and their supply strictly controlled. This explains why the MCC has modeled their regulations on the Scopes of Practice of the AHPCSA prescribing professions.
We are also concerned about members of the CMC having direct pecuniary interests in the NHP industry, as this can can potentially lead to the biased assessment of NHP product applications in future. We have received reports from many people in the manufacturing industry, who are also registered practitioners with the AHPCSA, that they received verbal and written threats informing them that they must deregister as practitioners if they wish to continue manufacturing, distributing or importing natural health products. According to archaic regulations under the Allied Health Professions Act, practitioners may not have involvement or an income derived from the medicines industry.
Oddly enough, the Chairman of this same council, Dr Craig Wright, who serves on the Complementary Medicines Committee of the MCC, offers his professional consulting services to companies to assist them in preparing their dossiers for application for registration. Formal complaints from the TNHA about these vested interests will soon follow now we have evidence to this effect. Other members of the CMC are also known be involved in the manufacturing sector.
The AHPCSA’s only expert appointed to the CMC for her expertise in aromatherapy essential oils, Mrs Dorice Sher is founder and owner of Aromatic Apothecary, a manufacturer and retailer of aromatherapy essential oil products.
Were these CMC members required to declare their commercial interests on the prescribed forms handed out to all MCC and sub-committee meetings, in terms of the Policy Management Directive for Potential Conflict of Interest, adopted by Council in November 2011? Will they be fit to make fair and unbiased decisions in assessing products submitted for registration? Why was the establishment of the CMC by selected invitation and not by an open, transparent process? Why won’t the MCC openly reveal those names of those, and their qualifications who serve on the CMC?
There is growing disquiet among AHPCSA registered practitioners about the circumstances in which their leadership serving on the CMC appears to be serving their private, narrow interests. Despite obvious vested interests and double standards, few practitioners registered with the AHPCSA have ever received notification from the AHPCSA on how the existing regulations, or pending regulatory amendments will affect their ability to prescribe. Many have lamented the lack of transparency and consultation in this regard.
The fact is that most AHPCSA practitioners who do prescribe natural health products do not have compounding facilities in the form of an adjoining dispensary and a full inventory of base health substances to prepare one-on-one medications for their patients as required by the Pharmacy Act. The cost of setting up and stocking such compounding dispensaries is cost prohibitive, especially for recently qualified practitioners who are struggling to establish themselves and pay off student loans.
Most AHPCSA prescribing practitioners rely on pre-purchased, pre-formulated NHPs sourced from various companies, many of which supply practitioners exclusively. All these products are either imported or manufactured locally. Companies that import or distribute these products who we have contacted, have all expressed reservations on whether they will be able to comply with the new regulatory regime and continue to supply practitioners. Some of the companies selling leading practitioner-only brands have been forthright in stating that they will be forced to cease business if the situation does not change.
In their fervour to serve their own sector’s vested interests by removing NHP from direct access from people at health shops and pharmacies, the AHPCSA has been complicit in removing the very products which AHPCSA practitioners have been relying on for their patients for decades.
There are now rumbles in higher education circles, where AHPCSA practitioners are trained. Some feel the current regulatory system their the AHPCSA is drafting and rubber stamping will severely impact on the future of the CAM professions. “What good are practitioners without the tools to treat their patients?” some ask.
The AHPCSA will be holding its general elections for Council members mid-2016, and we surmise that many practitioners will be calling for sweeping changes in the leadership. Will practitioners vote for the same people who have kept them in the dark and are stripping them of their livelihoods through the restrictive NHP proposals drafted and endorsed in collusion with the MCC? We will see.
OTHER PRACTITIONERS AFFECTED – With the AHPCSA having been given all the modality-specific expert seats on the CMC (for reasons explained above), many other health practitioners and therapists have been locked out of the legislative drafting process, including several hundred medical practitioners who practice Integrative Medicine, dietitians and therapists who provide nutritional counseling. All these people who prescribe and distribute natural health products will be prohibited from making them available to patients and clients after 2019, according to the current regulations.