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THE HPA IS NOT TAKING LEGAL ACTION AGAINST SAHPRA

This statement serves to rectify a report by Natural Medicine World on 26 February, 2018, which stated that the HPA was involved in legal action against the SA Health Products Regulatory Authority (SAHPRA).

I confirm that the HPA is not taking legal action against the SAHPRA. This is in line with our strategy outlined in my Chairperson’s Report at the end of 2017,

The HPA’s strategy is to continue in a process of collaborative engagement with government, and this remains firmly on track. And, our goal of seeking a practical, workable solution for the CAMS/HS industry remains key to all of our engagement efforts. The HPA will therefore continue working towards fair CAMS/HS regulations to preserve an industry which millions of South Africans rely on daily for a healthy lifestyle.

The HPA is aware of the legal challenge by the Alliance of Natural Health Products Association (ANHPA) and other stakeholders and has communicated that it is ready and willing to help find a workable solution to be implemented expeditiously should the government agree to negotiate with the CAMS/HS industry.

The HPA has already drafted such a resolution and framework in the form of the “listing/screening” system, initially agreed to and then rejected by the MCC in 2012. This framework is currently being revised to incorporate an electronic notification and registration system that is used internationally by our peers, and will be ready for presentation when required.

In the interim, the HPA will continue to collaborate and engage with the Department of Health and SAHPRA, as well as with national and international alliances and associations, including IADSA, CRN, ITG, SMASA, ANHP, MCA, THO, TNHA and others, aimed at creating a strong and united drive for a workable regulatory framework for the CAMS/HS industry.

Sincerely


Maria Ascencao
Chairperson

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HPA HEADLINES MARCH 2018

 

THE MAGIC OF ESSENTIAL OILS

The popularity of essential oils is increasing exponentially. These organic plant compounds, most commonly associated with aromatherapy, have remarkable therapeutic properties that can benefit physical, mental, emotional and spiritual health. Essential oils are concentrated, fragrant liquids that are extracted from the bark, flowers, fruits, leaves, seeds or roots of plants, thus incorporating the highly aromatic ‘essence’ of the plant

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Health Product Industry News From Around The World

MAY 2018

The Analyst’s Take: 20 percent of supplement consumers expect to increase e-commerce purchases
http://www.newhope.com/market-data-and-analysis/analyst-s-take-20-percent-supplement-consumers-expect-increase-e-commerce?NL=NP-05&Issue=NP-05_20180514_NP-05_125&sfvc4enews=42&cl=article_1_1&utm_rid=CNHNM000000584083&utm_campaign=25754&utm_medium=email

Vitamin D More Effective than Pharmaceutical Drugs in Treating Herpes Virus
http://healthimpactnews.com/2018/vitamin-d-more-effective-than-pharmaceutical-drugs-in-treating-herpes-virus/

Global Astaxanthin Market to Exceed $1 Billion by 2020
https://www.nutraceuticalsworld.com/issues/2018-05/view_breaking-news/global-astaxanthin-market-to-exceed-1-billion-by-2020/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20FOCUS%20(4-26-2018)%20(Final)&utm_content=&spMailingID=1467627&spUserID=MjQwMzg5OTA5NDIS1&spJobID=520809313&spReportId=NTIwODA5MzEzS0

APRIL 2018

Study: Coconut Oil and Other Natural Products Kill Antibiotic Resistant Clostridium Difficile
http://healthimpactnews.com/2018/study-coconut-oil-and-other-natural-products-kill-antibiotic-resistant-clostridium-difficile/

Nutrition Companies Target Aging Boomers as Interest in Millennials Grows
https://www.nutraceuticalsworld.com/contents/view_breaking-news/2018-04-05/nutrition-companies-target-aging-boomers-as-interest-in-millennials-grows/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20eNewsletter%20(4-10-2018)%20(Final)&utm_content=&spMailingID=1420742&spUserID=MjQwMzg5OTA5NDIS1&spJobID=520308194&spReportId=NTIwMzA4MTk0S0

 

Effects on functional brain activity of four weeks’ supplementation with a multivitamin and mineral supplement
https://www.naturalnews.com/2018-04-02-effects-on-functional-brain-activity-of-four-weeks-supplementation-with-multivitamin-and-mineral-supplement.html

Probiotics found to offset the detrimental effects of stress on the immune system
https://www.naturalnews.com/2018-04-01-probiotics-offset-the-detrimental-effects-of-stress-on-the-immune-system.html

Newsweek: “Is Marijuana the World’s Most Effective Treatment for Autism?”
http://healthimpactnews.com/2018/newsweek-is-marijuana-the-worlds-most-effective-treatment-for-autism/

MARCH 2018

Study: Magnesium Found to Treat Depression Better Than Antidepressant Drugs
http://realfarmacy.com/magnesium-depression/

Dietary Supplement Caucus Briefing Covers Sports Nutrition Products
https://www.nutraceuticalsworld.com/contents/view_breaking-news/2018-03-07/dietary-supplement-caucus-briefing-covers-sports-nutrition-products/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20eNewsletter%20(3-13-2018)%20(Final)&utm_content=&spMailingID=1345305&spUserID=MjQwMzg5OTA5NDIS1&spJobID=500416073&spReportId=NTAwNDE2MDczS0

Don’t Throw Calcium on the Trash Heap because of Possible Anomalous Study, CRN Urges
https://www.nutraingredients-usa.com/Article/2018/03/13/Don-t-throw-calcium-on-trash-heap-because-of-possibly-anomalous-study-CRN-urges?utm_source=newsletter_daily&utm_medium=email&utm_campaign=13-Mar-2018&c=SAsOqIf01s15l8D10SOpSw%3D%3D&p2=

Years of Pelvic Pain from Endometriosis Gone After Ingesting Virgin Coconut Oil for Six Months
http://healthimpactnews.com/2018/years-of-pelvic-pain-from-endometriosis-gone-after-ingesting-virgin-coconut-oil-for-six-months/

Cannabis proven an effective alternative form of pain relief for elderly patients, allowing many to quit taking dangerous meds, research finds
https://www.naturalnews.com/2018-03-09-cannabis-proven-effective-alternative-form-of-pain-relief-for-elderly-patients.html

Curcumin helps reduce muscle soreness and injury pain after physical activity, according to study
https://www.naturalnews.com/2018-02-28-curcumin-helps-reduce-muscle-soreness-and-injury-pain-after-physical-activity.html

TCM herbs found to be safe and very effective for treating “diabetic foot” (neuropathy): Meta-analysis and review
https://www.naturalnews.com/2018-03-08-tcm-herbs-found-to-be-safe-effective-for-treating-diabetic-foot-neuropathy.html

Brazillian Regs to be Altered to Finally Create Distinct Category for Supplements
https://www.nutraingredients-usa.com/Article/2018/03/06/Brazilian-regs-to-be-altered-to-finally-create-distinct-category-for-supplements?utm_source=newsletter_daily&utm_medium=email&utm_campaign=08-Mar-2018&c=SAsOqIf01s2YLKIjbLbzjQ%3D%3D&p2=

Keep Up Magnesium Intake To Make Vitamin D Effective
https://www.nutraingredients.com/Article/2018/03/02/Keep-up-your-magnesium-intake-to-make-vitamin-D-effective?utm_source=newsletter_product&utm_medium=email&utm_campaign=08-Mar-2018&c=SAsOqIf01s1ibXzozMf7zQ%3D%3D&p2=

Vitamin D Plus Olive Oil Could Aid Muscle Repait
https://www.nutraingredients.com/Article/2018/02/20/Vitamin-D-plus-olive-oil-could-aid-muscle-repair?utm_source=newsletter_daily&utm_medium=email&utm_campaign=20-Feb-2018&c=SAsOqIf01s1a6%2FX59au%2FMw%3D%3D&p2=

Why Magnesium Is Essential For Your Health And Energy Levels
https://naturallyhealthynews.com/articles/healtharticles/magnesium-essential-energy-levels/?smclient=7c41db02-5b78-11e7-bb6b-0cc47a6bceb8&utm_source=salesmanago&utm_medium=email&utm_campaign=default

Four Science-Backed Benefits of Chlorella
https://www.naturalnews.com/2018-02-15-four-science-backed-benefits-of-chlorella.html

Researchers Stress the Potential for Nutraceuticals
https://www.nutraingredients.com/Article/2018/02/15/Beyond-diet-but-before-drugs-Researchers-stress-the-potential-for-nutraceuticals?utm_source=newsletter_daily&utm_medium=email&utm_campaign=15-Feb-2018&c=SAsOqIf01s1A6vTRoPb%2Fcg%3D%3D&p2=

 “Yo-Yo” Weight Gain May Be Casued By Gut Bacteria
https://www.nutraingredients.com/Article/2016/12/06/Yo-yo-diet-weight-gain-may-be-caused-by-gut-bacteria?utm_source=newsletter_daily&utm_medium=email&utm_campaign=14-Feb-2018&c=SAsOqIf01s2VGVvlaCXONw%3D%3D&p2=

Better, safer, less expensive than drugs: Scientists say vitamin D could replace your meds, prevent and even reverse disease
https://www.naturalnews.com/2018-02-12-better-safer-less-expensive-than-drugs-scientists-say-vitamin-d-could-replace-your-meds-prevent-reverse-disease.html

Curcumin Supplement Takes the Pain out of Rugby Tackle After-Effects, Study Finds
https://www.nutraingredients-usa.com/Article/2018/02/09/Curcumin-supplement-takes-the-pain-out-of-rugby-tackle-after-effects-finds-study?utm_source=newsletter_daily&utm_medium=email&utm_campaign=12-Feb-2018&c=SAsOqIf01s0iDJIu0BdAww%3D%3D&p2=

Mintel Finds Over Half of Americans Report Living Healthier in 2017

Although physical health is a top priority, mental, and emotional health habits are also high on the list.
Read more: https://www.nutraceuticalsworld.com/contents/view_breaking-news/2018-01-17/mintel-finds-over-half-of-americans-report-living-healthier-in-2017/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20eNewsletter%20(1-23-2018)%20(Final)&utm_content=&spMailingID=1185793&spUserID=MjQwMzg5OTA5NDIS1&spJobID=460690566&spReportId=NDYwNjkwNTY2S0

For Herbs, 2017 was a Very Good Year

The past year has been a good one for the industry, with sales reising towards $8 billion and supporting clinical evidence for the category contnuuing to accrue.
Read more: https://www.nutraingredients-usa.com/Article/2017/12/20/For-herbs-2017-was-a-very-good-year?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

 

Nutrition Survey Finds Consumers Seeking Fermented Foods

National survey of over 2,000 dietitians reveals movement toward clean, natural, and simple foods.
Read more: https://www.nutraceuticalsworld.com/contents/view_breaking-news/2017-12-21/nutrition-survey-finds-consumers-seeking-fermented-foods/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20eNewsletter%20(1-2-2018)%20(Final)&utm_content=&spMailingID=1081447&spUserID=MjQwMzg5OTA5NDIS1&spJobID=460056819&spReportId=NDYwMDU2ODE5S0

Reliability Reigns for Vitamin & Mineral Supplements

Consumers take and trust products to achieve their health and wellness goals, and to fill nutrient gaps in their diet.
Read more: https://www.nutraceuticalsworld.com/issues/2018-01/view_features/reliability-reigns-for-vitamin-mineral-supplements/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutraceuticals%20World%20Issue%20Alert%20(1-10-2018)%20(Final)&utm_content=&spMailingID=1119739&spUserID=MjQwMzg5OTA5NDIS1&spJobID=460297653&spReportId=NDYwMjk3NjUzS0

 

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CHANGES IN THE CAMS AND PHARMACEUTICAL INDUSTRY

Wayne Robinsons has been appointed to the Board of Directors at Afriplex (Pty) Ltd in Paarl, Western Cape. The HPA is pleased to announce that Wayne Robinson will remain on the HPA Executive Council as the Director of Scientific and Regulatory Affairs. Wayne will also remain the HPA representative on the Industry Task Group (ITG), CAMS Working Group and the Marketing Code Authority Board.  We at the HPA wish Wayne every success in his future endeavours, and we are delighted that he will remain an integral part of the HPA Executive.

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HPA LAUNCHES FACEBOOK PAGE

The HPA is excited to announce the launch of its new Facebook page, which is being managed by an experienced and dynamic social media company, Leap Communications. The Facebook page has been created to educate the public about the HPA and health-related subjects, as well as to inform consumers, professionals and the industry about the new regulations that severely affect the industry at large.

Please visit and like our new page here: https://www.facebook.com/HPASA-178616436074856/

 

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HPA CHAIRPERSON’S REPORT, DECEMBER 2017

“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.

Milestones:
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.

New Chair
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.

Legal Challenge
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.

Advocacy
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.

Driving Education
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.

Subscription News
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.

Maria Ascencao
Chairperson

December 12th 2017

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HPA HEADLINES OCTOBER 2017

PROBIOTICS – THE FOUNDATION OF HEALTH

Probiotics, the friendly bacteria that line our digestive tracts, are crucial to gut health. And gut health forms the foundation for overall health. “An unhealthy gut contributes to a wide range of diseases, including diabetes, obesity, rheumatoid arthritis, autism spectrum disorder, depression and chronic fatigue syndrome,” says Vanessa de Ascencao, nutritional consultant and member of the Health Products Association (HPA). Probiotic supplements are the fastest growing sector in supplements in South Africa, with a growth of 25 percent in 2016: a Euromonitor report predicts that the probiotic industry in South Africa could be worth over R527 million for 2017.

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MESSAGE FROM NEW HPA CHAIRPERSON, MARIA ASCENCAO

“I extend sincerest thanks and appreciation to my fellow members of the Executive Council of the Health Products Association who have elected me Chairperson of the HPA. I’m humbled and honoured that they have entrusted me with this responsibility.

Taking the reins at this time is made easier by the groundwork laid by previous Chairmen; Bruce Dennison, Dr Alan Thomlinson and Norman Fels, and their right-hand powerhouse, HPA Secretary, Deirdre Allen. Despite the unprecedented events confronting this industry, my predecessors and their respective EXCO members successfully brought the industry together to work through the many challenges of doing business within a changing and uncertain regulatory landscape.  Creative solutions were found, some difficult decisions were made, and overall great strides were achieved in the best long-term interests of the entire industry.

The biggest achievement, however, was not just to successfully negotiate through a clearer understanding of the CAMS and Natural Health paradigm with the Department of Health and the Medicines Control Council but also that, through these many efforts, a CAMS Committee was set up within the MCC. In the last five years, the CAMS Marketing Code was created by the HPA, and the HPA’s Scientific and Technical Committee was set up under the excellent directorship of Wayne Robinson. The HPA strategically focused on the fundamental strengths of our industry, how it could be improved, and how it can best be positioned for the future.

As a result, the HPA has dramatically improved relationships with regulators and other more allopathic industry associations, has embraced transparency and good governance and enhanced the HPA’s role and infrastructure with new, talented people who are bringing fresh perspectives to key challenges.

I’m excited to begin work on behalf of the HPA and its members to promote positive communications and public relations, training and education, to the highest standards of products and services, and to find a new approach to effectively communicate the benefits and strengths of the industry within the wellness paradigm.

The HPA and its members ultimately represent millions of South Africans who take health supplements and use CAMS for preventative and primary health care. Not only are CAMS and Health Supplement companies a crucial part of South Africa’s economy and provide jobs and opportunities in South Africa, they give consumers the opportunity to make educated choices to fill critical nutrient gaps and achieve better health.

Above all to continue the good work of effectively representing the interests of the SA Natural health and CAMS industry at all level of the legislative, regulatory and Parliamentary process and to work proactively with other industry associations to achieve this aim.”

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CHAIRMAN’S REPORT JULY 2017

Chairman’s Report – July 2017
Condolences:
It is with great sadness that we heard of the recent death of Greg Anderson who served on our Executive Council for many years. He made a significant contribution to the HPA; particularly in working with Howard Snoyman in having our CAMS marketing code incorporated into the MCA Code. Greg was killed while cycling, a sport which he loved and at which he excelled. Our condolences to his family and friends. The HPA will be contributing to his family’s charity of choice.
An overview of Technical and Regulatory Developments:
This AGM is a milestone for me as it will mark the last day of my tenure as Chairman of the HPA. Having served on the Executive Council for 32 years, (as Treasurer and Vice Chairman) and as Chairman for 4 years, a great deal of turbulent water has passed under the HPA bridge. It’s been a bumpy ride. I have decided that it’s a good time to hang up my gloves, step down and make way for new, younger leadership. The HPA has a very strong Exco, President and Secretary. I have total confidence that they will actively pursue our stated objectives of promoting and protecting our industry and our members. Based on current evidence, it may well be that the quest for an appropriate and workable legislative and regulatory regime is not yet over.
My position as Chairman started with the publication of the November 2013 CAMs Regulations which, as you are acutely aware, were inappropriate, unacceptable and unnecessarily destructive to the CAMS industry and the economy. New products could neither be launched or imported without prior registration. The CAMS industry was stifled and innovation blocked.
Then followed a concatenation of events:
• The HPA had a 6-month window of opportunity to legally challenge the regulations
• Despite our every effort, the regulators were not willing to engage – Papers were served on the Minister and DoH in May 2014 after extensive consultation with our legal advisors.
• The DoH breaks off all communication with the HPA
• Ethicore is appointed to advise on political strategy.
• The HPA agrees to suspend litigation provided that meaningful engagement takes place.
• A CAMS Working Forum is established comprising all major CAMS stakeholders.
• Good progress is made.
• The Registrar then decides that the interface of engagement should be via the established Industry Task Group [ITG]
• The CWF is abandoned and a CAMS Working Group ITG sub-committee is formed.
• Wayne Robinson is appointed as HPA Director of Technical and Regulatory Affairs.
• Progress is made but, to date, no CAMS products have been registered as per the stipulated Road Map in the 2013 Regulations
• Draft Regulations and Guidelines are published in September 2014 and July 2015 to which the HPA makes comprehensive comment.
• In July 2016, amendments to the consolidated General Regulations supporting the Medicines Act as amended by Act 72 of 2008 were published. The concept of a Health Supplement was also introduced and a definition was included. A comment period was allowed and 40 submissions were received.
• Final publication was to have been in September 2016, then December 2016, then April 2017, then June 2017 and then 21 July 2017. Regulation are still awaited.
• In February 2017, the call-up of 2002 was rescinded thereby causing confusion and nullifying the status of the MB20.8 document which only the Port Health authorities continues to recognise; albeit inconsistently and to the detriment, in particular, of CAMS importers.
• Bill 6 (the Medicines Act 14 of 2015) was finally signed into law on the 1st of June 2017 enabling the MCC to be replaced by SAHPRA (the South African Health Products Regulatory Authority). However, in order for SAHPRA to become functional, the SAHPRA Board has to be constituted and a CEO appointed – an event which is yet to take place.

The HPA has been consistent, over the past 30 years, in requesting that CAMS should have its own Directorate and Registrar with separate and appropriate regulations (as was contemplated in the SAMDRA Act of 1998). Sadly, this Act was repealed early in 2002. It now appears that CAMS are to be subsumed into an allopathic paradigm – this despite our interaction with the ITG, other Government Departments and a presentation to the Parliamentary Portfolio Committee on Health [PPC]. The consequence of this is an onerous and expensive registration procedure with prohibitively high costs of compliance. Licensing and GMP requirements remain problematic. Hopefully amended regulations, when published, will recognise that these constraints are to the detriment of the regulators, the industry, the economy and the consumer.

Sadly, I would have to acknowledge that after over 30 years of actively seeking appropriate CAMS regulations and taking legal action, the HPA has not yet achieved a workable outcome. What was achieved was an acceptance by the regulators that the 2013 regulations which, at this point in time remain law, had to be revisited. I guess our legal action bought a reprieve which allowed us to continue trading for 4 years. The law has not been actively enforced. All is not lost and we remain open for business.

We also succeeded in resurrecting an ongoing engagement across a broad front which has yielded some positive results and a recognition by the DOH/MCC and PPC that the HPA is a responsible organisation which does indeed seek regulation which is risk related and appropriate. They have a better understanding of our position and appear to be taking cognizance of our comments. I believe that the perception that the HPA is averse to being regulated has been dispelled.
Publicity and Promotion:
The stated mandate of the HPA and its Executive Council is to protect and promote our industry. Of necessity, we have been largely preoccupied in the protection aspects of legislation and appropriate regulations. However, promotion has not been neglected and the HPA has undergone a complete “face lift”. A new logo has been created and a comprehensive website launched. This contributes to enhanced membership benefits. Our Public Relations agents have given the HPA extensive exposure.

Our relationships with the media, other associations and stakeholders has been greatly enhanced.
We continue to interact with IADSA who assist us and provide valuable input in terms of global best practice. Our president, Bruce Dennison, attends the AGM and maintains close liaison with IADSA. Simon Pettman and Cynthia Rousselot have visited us and met with the Registrar and Chairman of the CMC. Cynthia will be making a presentation at the forthcoming workshop in Gauteng. Neil Gower has undertaken to address the content of the imminent General Regulations at both the Johannesburg and the Cape Town HPA workshops.

ASA and MCA:
Having severed links with the ASA, the HPA has entered into an agreement with the Marketing Code Authority which binds our members to joining the MCA and to compliance with their code which now incorporates CAMS. The MCA confines its jurisdiction to health products and medicines and has wellestablished mechanisms in dealing with advertising/marketing complaints. A commitment to the MCA is a good credential for the HPA and is an undertaking by our members that they will advertise and market their products in a responsible and honest manner; i.e. synonymous with our HPA code of conduct. In addition, our internal Self-monitoring and Advisory Committee [SMAC] continues to serve and assist our members.
Finance:
The HPA’s financial position remains strong. The Annual Financial Statements for the year ending in December 2016 will be tabled for adoption.
The Future:
Whilst we cannot anticipate the content of the forthcoming General Regulations, our quest for a degree of independence may well be ongoing.
Having achieved recognition and established our credentials as the major association representing the CAMS industry, we have the ear of the Regulators who have acknowledged that the Regulations of 2013 are unworkable. I believe that they now have a better understanding of the complexity and diversity of our industry and will take cognisance of our position going forward.
I have no doubt that the HPA will grow in stature and will continue to work in a spirit of cooperation with the regulators in the pursuit of a mutually acceptable legislative and regulatory environment for CAMS.
The HPA has a strong membership base and a capable Exco, well equipped to deal with any future challenges.
Conclusion:
My tenure as Chairman of the HPA has been an interesting time. It has been a pleasure and a privilege to work with a dedicated and competent Executive Council.  I could not possibly have managed to lead the HPA without the fantastic support of our members, the Exco, our President, Bruce Dennison, Janet Welham, Wayne Robinson, IADSA and Deirdre Allen who has been a pillar of strength, help and encouragement.

Words cannot adequately express my thanks and appreciation to all of you.
I have been persuaded that, if re-elected to the Exco at our AGM, I should continue in the role of Treasurer. I would be honoured to further serve the HPA and its objectives.
Best wishes for the forthcoming year.

NORMAN FELS

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