CAM REGULATION CRITIQUE BEING HEARD BY GOVERNMENT
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 regulations. Even the Allied Health Professions Council (AHPCSA), which has members serving on the Medicines Control Council’s non-representative Complementary Medicines Committee (CMC), wrote to all its registered petitioners on the 16th of July last year, informing them that the should not, as practitioners oppose their Council’s unwavering support for the regulations. This communication came soon after the TNHA and it’s long established elder practitioner members, many of whom have served on the AHPCSA Council and Professional Boards in the past, realised that the current regulations will hinder practitioners from obtaining innovative, integrative formulas for their patients, which they rely on for treating their patients. Most manufactures and importers who supply professional range products are now now under the threat and may have to withdraw their products from the market due to excessive, costly and onerous regulation.
Despite the threat issued by the AHPCSA and requests from the Homeopathic Association leadership (same persons who serve on the AHPCSA) to boycott certain ranges of practitioner-only products, the TNHA currently have 252 AHPCSA practitioner members, and new applications for membership on a daily basis as the word spreads about our campaigns, and how their businesses and patients will be affected.
Letters written by aggrieved stakeholders to the Minister of Health, the Director General of the Department and senior MCC officials from various stakeholders have remained unanswered for over a year, adding to frustrations. Correspondence from the TNHA addressed to the Minister of Health and the MCC requesting meetings or clarity on issues have received acknowledgements, but with no substantial replies. This is unacceptable.
In January and February 2014, there were two workshops hosted by the MCC in Pretoria and Cape Town just after the CAMS regulations were published, where officials tried to explain the 2013 – 2019 ‘Regulatory Road Map’. It was widely reported that many attendees left these meetings with more questions than answers. Some officials apparently did not have answers for many questions posed to the MCC and CMC, which has frustrated the industry. This was that last time the MCC were prepared to answer questions to the industry, or engage in a meaningful and transparent manner.
One would think that stakeholders from this R8billion sector would have been invited to participate in the deliberations leading to the drafting of the regulations before they were passed into law, but sadly this did not happen. In other democratic countries where similar regulations for natural health products have been promulgated, there was open dialogue, transparency and many public engagements in order to democratise the process.
For many decades the MCC have been a law unto themselves, making arbitrary regulations by degree, based on their ‘current thinking’ models. or on a whim This is due to the principal Act (the Medicines and Related Substances Act 101 of 1965) containing an overly broad definition of what constitutes a ‘medicine’. The original drafters of the Act intended the MCC to have broad-sweeping powers, and the Act to have wide general application. The late Hon. Mario Ambrocini MP, described the Act as ‘concertina legislation’, meaning it is purposefully vague and vastly open to interpretation, so that it can be expanded to encompass anything under its provisions as a medicine, even water if it is claimed to relieve dehydration.
Section 35 of the Act, allows the Council (MCC), in consultation with the Minister of Health (in reality the Minister merely rubber stamps these provisions) to publish regulations for new categories and classes of medicines without passing through the legislature and open democratic law making process.
After 1994, other national legislation with similar enabling clauses to allow regulators to create sub-legislation were redrafted to limit these activities, as they were too often abused. The TNHA believe there is no place for ‘legislation by regulation’ in an open democracy.
Although the Act was never intended by the legislature in 1965 to regulate products and substances like natural health products, cosmetics or even health foods, the regulator has over the last two decades begun seriously looking at bringing these substances and products it’s control, and to be regulated as quazi-drugs should they sport any health claims.
The TNHA have studied international trends in this regard, and have concluded that these ‘third category’ regulations (substances between foods and drugs) are merely a first step in subsuming these products into eventual pharmaceutical drug regulation, and a means to enable their expropriation by the pharmaceutical industry.
The regulatory process we have been subjected to over the last year is not dissimilar to the highly restrictive European Directives for Dietary Supplements and Herbal Medicines , which are similarly threatening the industry in the 27 block union.
Over the last 15 months the Department of Health have continued to publish a raft of regulatory amendments and new regulations which negatively affect Natural Health Products without stakeholder engagement. These include the –
- The Roadmap for Registration (15 November 2013)
- The Amendments to the Foodstuffs, Cosmetics and Disinfectants Act (29th May 2014)
- Labelling Compliance Notice (11th August 2014)
- The General Regulations Relating to Bonusing and Sampling (22nd August 2014)
- The Complementary Medicines Amendment Regulations (15th September 2014)
- The Upper Limits of Nutrients Regulations / Health Supplements (28th October 2014)
- The Complementary Medicines QSE Guidelines (15 November 2014)
- The Registration Licence & GMP Certification Fee Regulations (19th March 2015)
- The Scheduling Regulations for Probiotics (20th March 2015)
THE MEDICINES CONTROL COUNCIL FORCED TO LISTEN
As a result of the unacceptable manner in which the MCC and Department of Health officials have neglected serious matters arising, there is now industry-wide defiance and non-compliance with the new CAMS regulations. To date the TNHA are not aware of any single product having been registered as a ‘Category D’ Complementary Medicine or Health Supplement, despite being a year into regulation. In a recent query by the Health Products Association (HPA) to Ms. Joey Gouws, the Registrar of Medicines, asking for a list of registered CAMS since the regulations were gazetted more than a year ago, she stated that assessment is a process, and could not cite a single registered ‘Category D’ CAM.
This crisis has also resulted in the HPA seeking a court review of the procedural errors made by the government in passing the CAMS regulations.
The TNHA are in the final throws of drafting their Constitutional Court case to have these regulations repealed on various grounds, if and when they are enforced.
SINCERE ENGAGEMENT OR JUST WINDOW DRESSING?
Various stakeholders, including the TNHA, who presented their regulatory proposals on the Medicines and Related Substances Amendment Bill (Bill 6 of 2014) in Parliament late last year and earlier this year, highlighted to the Portfolio Committee on Health, the crisis the industry and consumers face if the mooted new regulator which will replace the MCC continues to attempt to regulate natural health products as they currently intend.
On the 25th of February the Committee chastised the Department of Health and MCC for allowing this crisis to develop and to fester, without prior and post regulatory engagement with stakeholders, including the Complementary Medicines and African Traditional Medicine sectors.
Almost immediately, following these Parliamentary presentations, both the Department of Health and MCC offered piecemeal engagements with some aggrieved role-players, in order to avert further critique from the legislature.
A hasty meeting between the Department of Health and the Traditional Health Practitioners Interim Council (THPC) was arranged in Boksburg on the 23rd of April, just one hour after two members of the THPC tackled Department officials and the MCC at a Parliamentary Portfolio Committee on Health meeting two weeks prior.
Stakeholders who submitted written comments on the Complementary Medicines Amendment Regulations and Upper Limits of Nutrients Regulations on or before December 2014 and January 2015 respectively, were hastily invited to attend ‘hearings’ at the MCC’s head office in Pretoria with only 5 working days’ notice on the 25th of April.
It appears the efforts of the TNHA and our alliance partners have created a cause for concern at higher levels of government and the MCC are now attempting to disentangle itself from the deepening crisis.
The TNHA remain skeptical of the spurious timing and reasons for these meetings, considering the MCC having historically ignored criticism and proposals by industry.
Whether these engagements were an attempt to genuinely hear and consider genuine grievances and consider regulatory proposals, or were just an exercise of going through the motions while under duress (from the legislature) remains to be seen.
FUTURE MCC ENGAGEMENT – THE CAM WORKING FORUM (CWF)
Over the last two months, various national associations which have members affected by the current CAM regulations have formed a unified front, where common issues and problematic regulations have been identified and will be presented to the MCC and Department of Health. This task group is called the CAM Working Forum (CWF). Presently the CWF is comprised of the following national associations –
- The Health Products Association of South Africa (HPA)
- The Traditional & Natural Health Alliance (TNHA)
- The Health Shops Association of South Africa (HASASA)
- Pharmaceutical Made in South Africa (PHARMISA)
- Self-Medication Manufacturers Association (SMASA)
- The Direct Selling Association of South Africa (DSA)
The CWF is officially the largest stakeholder group, representing all links in the natural health chain, vis a vis manufacturers, importers, retailers, practitioners (medical, allied and traditional) and the public.
The Department of Health, Pharmacy Council and MCC have committed to open dialogue with this task group going forward. On the 17th of April the CWF will meet with the Dr Anban Pillay the Deputy Director General of the Department of Health, Ms. Joey Gouws the Registrar of Medicines (MCC), and tentatively, Amos Masngo. the CEO of the Pharmacy Council.
Feedback from this meeting, which will be attended by the TNHA, will be carried in our next newsletter, on our website and Facebook page.
HEALTH MINISTRY SENDS DELEGATION TO CANADA TO STUDY THEIR ELECTRONIC MONOGRAPH REGISTRATION SYSTEM FOR NATURAL HEALTH PRODUCTS
In February the TNHA proposed a monograph-driven registration system and new Directorate for Natural Health Products, similar to that employed by Health Canada, to replace the current regulations which are practically unworkable. This was made in our written and oral submissions to the Portfolio Committee on Health on the 25th of February. Our alliance partner, the HPA have also been calling for such a system for a number of years.
We have recently learned that a small team of MCC officials were sent to Canada a few weeks ago to explore the Canadian ‘Natural Health Products’ registration system on the instruction of the Ministry of Health. We hold thumbs that a similar system will be adopted in South Africa, which will liberate the industry and allow consumers to continue to have freedom of choice.