“The HPA objective is defending, promoting, and enhancing the best interests of HPA members and the CAMS/HS Industry as a whole.
2017 was yet another period of high-level and high-speed activity, advocacy, achievement, disappointments, challenges and advancement for the HPA – on many fronts.
The year began very much in the same vein as 2016 ended, with impending regulations following four years of dedicated work by the HPA Scientific and Regulatory Committee’s work through the ITG to establish fair and appropriate regulations for Natural Health Products sector in South Africa.
Our first meeting of 2017 on the 26th of January hosted a presentation by Neil Kirby of the legal environment which was thrown into further confusion by the rescindment of the 2002 call-up/in. Draft regulations were published on the 27th of January, the day after our meeting. A definition of Health Supplements was included for the first time, but the draft regulations were devoid of a revised road map. However, we were informed, via the ITG, that the regulations of 2013 were still in force. These did contain a call-up roadmap.
Comments to the draft regulations were prepared by the HPA and submitted. Issues such as compliance costs and having to employ a responsible pharmacist remain problematic. A simplified CTD or electronic pre-registration screening system was once again suggested.
Work continued with the Marketing Code Authority in trying to incorporate a CAMS marketing code. Workshops were held in both Johannesburg and Cape Town during March and April with presentations by Deryck Smith, Debbie Flandorp and Herman Julsing. GMP and Stability were discussed. Later in the year the HPA hosted Dr Neil Gower in both Johannesburg and Cape Town that was very well attended
A successful joint PR project with the Sunday Times gave the HPA some good exposure. There were two articles in the Pharmaceutical & Cosmetic Review and we would like to thank the Editor, Abby Vorster for providing the HPA with this platform. Wayne Robinson as the HPA’s Director of Scientific & Regulatory Affairs was interviewed and once again we thank him for providing such a balanced view of the state of the industry. Our normal, ongoing media campaign was sustained. The HPA website and news letters continue to drive interest in the HPA.
Our relationship with IADSA remains strong and HPA President, Bruce Dennison, met IADSA Executives Cynthia Rousselot and Simon Pettman in London.
The SAHPRA board was announced but no CEO has yet been appointed. Only an informal SAHPRA meeting was held to preserve the MCC – in the interim it is expected that SAHPRA will be instituted early in 2018. Dr Joey Gouws, Registrar of Medicines has resigned from the MCC to take up a position with the WHO in Geneva.
Port Health inconsistencies persist and are exacerbated with the 2002 call-up rescission but the old MB20.8 seem to be standing the industry in good stead and by all accounts, these are still the officially recognised documentation supporting imports.
In July the HPA had its AGM and I was voted in as Chairlady of the HPA and Pravashini Govender as Vice-Chairlady.
Long Awaited Regulations
No sooner had I taken up position as Chairlady the long-awaited General Regulations to the Medicines and Related Substances Act, 101 of 1965 (Regulations, 2017) was published on 25 August 2017. These regulations have effectively defined ‘complementary medicine’ and ‘health supplement’ as Medicines. Legal experts believe that the regulations are broader than the definition of ‘medicine’ in Act 101 of 1965. It appears that the regulations purport to regulate substances that are not medicines, under the guise of regulating complementary medicines and health supplements.
It appears that the MCC / DOH has not taken cognisance of any of the concerns and many submissions made by the HPA regarding the impossible nature of the Regulations. As they have been published it is extremely difficult for most HPA members to comply and we will continue to pursue our objectives for appropriate regulations. The HPA is already working on a strategic plan that will involve professional lobbying, social media, the consumer, trade and the like.
Above all, the HPA will continue to try and engage with the MCC & DoH.
The HPA will not be pursuing legal action. However many major natural health stakeholders are now involved in a possible litigation strategy, and an independent stakeholders group has been formed, namely, the Alliance of Natural Health Products (ANHP). Their preparation for a legal challenge is already underway as this must be done before February 25th 2018.
Current Regulatory Environment as Risk to Industry and SA Consumer
The current regulatory framework demonstrates how the classing of Natural Health and Nutritional Products such as CAMS and Health Supplements as a subset of drugs will negatively impact the industry and the South African Consumers who use them; and it argues the legal and constitutional case for suspending, reviewing and revising the August 25th 2017 Regulations.
The DoH has not done a single risk-analysis or impact study to determine the risk of these regulations on an industry that promotes and provides good health and wellness. The onerous requirements for licensing, responsible pharmacist, amongst other major concerns have the potential of not only stifling innovation at the heart of CAMS but also potentially enforcing the removal of tens of thousands of CAMS/HS supplements, safely accessible for years, from South Africans who rely upon them, by personal choice, for the maintenance of health.
In short, the CAMS/HS industry and community is being dismantled by “Medicine is a Medicine” drug-style regulations now designed and destined to restrict access to health enhancing, health promoting natural health products in South Africa.
Since 2013 regulations, the DoH have effectively halted new product innovation in the CAMS/HS industry to a virtual standstill. By stifling future discoveries and innovations, the continued regulatory sagas are exerting control over South African consumers’ health options and preventing an untold number of CAMS/HS benefits from reaching the public and providing health benefits, promoting wellness and keeping health care costs down.
The latest regulatory challenge has inspired advocacy and drawn together several stakeholders on a united cause. A joint strategy has been formulated and the HPA along with the other parties have been working incredibly hard to prepare for the challenges ahead with a clear goal of continued engagement with the DoH as also Government as a whole.
The joint collaboration with the broader industry has clearly shown that the Regulations are harmful to South Africans both physically and economically.
Consumers are going to be faced with the loss of products they want and need. Products they have used successfully for everything from the sniffles to primary health care, to keeping healthy are set to cost more and potentially disappear altogether from the South African marketplace. The net effect, whether products become unavailable or unaffordable will be dramatically reduced access to the right of choosing health care of choice.
Natural Health Practitioners will be professionally and financially challenged by no longer being able to source the products they used to create effective therapeutic protocols for their clients’ health and wellness. Skilled professionals are being dictated to by untrained and inexperienced bureaucrats.
Retailers are losing all manner of unique specialty products. As even more of these products are set to potentially either disappear or cost more, the selection in health and wellness categories will be affected.
Distributors are unable to plan or trade, as all manner of products are increasingly challenged at or by Port Health and these are technical barriers to trade that are undermining our economic growth.
This has put many respected suppliers of superior international products in a tenuous business situation, questioning the survival of their business.
Manufacturers are having all manner of safe, effective and reputable products steamrolled into full Pharma GMP. Today, once robust and thriving South African CAMS/HS manufacturers are in a waiting game.
The DoH ignorance and failure to engage with this vibrant industry is potentially directly harming the economic welfare of the large number of South African business’s whose livelihood is invested in this vibrant and growing business sector. A lot of jobs are at stake.
The DoH is not applying the CAMS/HS regulations based on what is good for South Africans or for the economy. They are taking natural substances and traditional medicines which have been part of traditional use and/or global food chain for millennia and, enforcing regulations that are clearly inappropriate to the levels of risk involved, and which are now set to set to drive up costs, and putting at risk many good quality businesses.
Growers, manufacturers, distributors, retailers, health professionals and researchers will all suffer when the DoH’s full enforcement and compliance takes place.
The South African Government and our Health Ministry and our MPs must be encouraged to support the development of a healthy CAMS/HS industry which is rich in entrepreneurial vitality instead of allowing the DoH to dismantle it.
The greatest crisis facing South Africans in our healthcare system, for which millions of South Africans are privately insured, is the growing tension between constantly rising costs and declining outcomes. When South Africans use CAMS/HS, they ease the burden.
It is the HPA’s intention to ensure a workable system that is sustainable, in developing and implementing a framework that best serves CAMS; Food/ Nutritional/Health Supplements; the DOH, Government Health Policies, and the South African Consumer.
Engagement with Government on a workable alternative: It is essential that when papers are served on the government by parties other than the HPA, and if and when the government agree to negotiate and work with the CAMS/HS industry, that industry has a resolution to the problems it faces and a solution that is workable and quick to implement. The HPA has had such a resolution and framework ready and available for many years, particularly as in 2012, the MCC had in principle agreed to the use of the “listing/screening’ system and at the last hour walked away from it. Thus the HPA has the “screening/listing” system ready to provide to the DoH/SAHPRA as well as an electronic method of registration. The details for this fast track registration needs very little updating and can be instigated very quickly. HPA and the overall CAMS/HS Industry is prepared to fund this system and it will resolve the massive backlog of registrations that are waiting for screening at the DoH as is currently the case.
Engagement with Alliances to Preserve the Industry
We will act to ensure not only that fair and appropriate CAMS/HS regulations meet the objectives for which they were intended, but also so that we can preserve an industry that many South Africans rely on for healthcare. The HPA will also collaborate with the Alliance for Natural Health Products, the THO, the TNHA, SMASA and other associations with the objective of creating a strong and united drive for a workable regulatory framework for CAMS/HS.
Year 2018 beyond Regulatory Challenge is set to be a most dynamic year for the industry and we have many positive plans and goals in place. We will embark on an exciting strategy to showcase and upscale the knowledge, benefits, innovation, international trends and ground-breaking science that underpins the industry. We will do this through a comprehensive multi-channel communication strategy which will effectively uplift the credibility factor and thereby promote the positive, life-enhancing benefits of industry. This will be achieved through a combination of PR, social media and CPD education initiatives amongst other innovative marketing concepts.
In July 2018 the HPA is bringing to South Africa world renowned Professor David Richardson to present a CPD accredited Longevity Conference: “Redesigning a Long Life”. Nutrition and the ageing population is a very sought-after topic worldwide – we are all living longer and seeking to act and look younger! This lecture tour will be handled by a professional conference planner and will have a full PR and media plan around it designed to promote longevity within a health and wellness paradigm – which is so representative of HPA members. In addition there will be other business networking opportunities, seminars and workshops organized throughout the year. We are always pleased to have your suggestions for events, especially if this is backed by a willingness to help make it happen! Please contact me or any of the committee to discuss your ideas and any other issues you would like to bring to our attention.
CAMS Marketing Code
The HPA will finalise its CAMS Marketing Code and seeks to establish a self-regulatory model as also to continue to collaborate with the MCA and ASA for an independent CAMS Marketing Ethics Code. We will also ensure that the HPA Advisory Committee continues to handle all queries and complaints from both members and non-members. It will become more pro-active and companies will be encouraged to submit advertising/claims/labelling/marketing concerns directly to the HPA Advisory Committee.
The HPA has this year had to increase its annual subscription by 9% – 7% of the increase is for general administration and the 2% increase will go directly to the HPA’s legal fund. It is hoped that the HPA will not have to call for a further legal levy during the year.
I take this opportunity to thank our President, Vice Chair, EXCO Council, and Secretariat for hours and hours of tireless work, generous sharing of expertise and know-how and for working as a team to keep the HPA at the forefront of CAMS/HS industry in South Africa.
On behalf of the HPA EXCO, let me end by once again thanking you for your support and endorsement of our efforts, and pledge to work even more strenuously for you in the year ahead.
We wish you a safe and very happy Christmas and a New Year filled with peace, joy, productivity and prosperity.
December 12th 2017