HPA HEADLINES #46 AUGUST 2019

THE HPA – STRATEGICALLY FOCUSED ON THE FUNDAMENTAL STRENGTHS OF THE INDUSTRY

At the HPA Annual General Meeting held in Johannesburg on 18 July 2019, Maria Ascencao was re-appointed as Chairperson – a perfect position for a woman who is passionate about the health products industry and defending the small and medium-size companies that make up the spirit of the CAMS and wellness industry. “I would like to express my sincerest thanks and gratitude to my fellow members of the Executive Council of the HPA who have re-elected me as Chairperson. I am humbled and honoured that they continue to entrust me with this responsibility,” says Ascencao.

“Taking the reins at this time is made easier by the strategic plan that I formalised in December 2017 and which has successfully brought the industry together to work through the many challenges of doing business within a changing and uncertain regulatory landscape,” she continues. “We have also experienced enormously positive engagement with the South African Health Products Regulatory Authority (SAHPRA) at the highest level. Creative solutions were found, 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 negotiate a clearer understanding of the CAMS and natural health paradigm with the Department of Health and SAHPRA, but we have also successfully brought on board the Direct Selling Association (DSA) and the South African Society of Integrated Medicine (SASIM) as strategic alliance partners.

“We have successfully obtained exemption from Single Exit Pricing (SEP), down-scheduled many substances that are globally appropriate to be so, the updated CAMS marketing code is almost finalised and will serve as a self-regulating model, and the HPA’s Scientific and Technical Committee was set up under the excellent directorship of Wayne Robinson who provides an invaluable service to the industry and our esteemed members.

“The HPA continues to be strategically focused on the fundamental strengths of our industry, how it can 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 has enhanced our role and infrastructure with new, talented people who are bringing fresh perspectives to key challenges.

“To this effect, in March 2019 we welcomed Leigh Gunkel-Keuler to our EXCO. Leigh was appointed as the HPA’s official lobbyist and has already done an excellent job with organized business and government stakeholder engagement. I am also incredibly pleased that Leigh has been nominated for the position of Vice-Chairperson, and look forward to a wonderfully dynamic, superbly successful and positive relationship with her.
“I’m excited to continue my work on behalf of the HPA and its members to not only resolve the regulatory crisis, but also to promote positive communications, public relations, training and education – all aimed at finding a new approach to effectively communicate the benefits and strengths of the industry within the good health and wellness paradigm.

“The HPA and its members ultimately represent millions of South Africans who take health supplements and use CAMS for preventative and primary healthcare. Not only do CAMS and health supplement companies play a crucial role in South Africa’s economy by providing jobs and opportunities, they also give consumers the opportunity to make educated choices to fill critical nutrient gaps and thereby achieve better health.

“Above all, we will continue the good work of effectively representing the interests of the SA natural health and CAMS industry at all levels of the legislative, regulatory and parliamentary processes, and we will continue to work proactively with other industry associations to achieve this aim.”

Ascencao’s presentation is available to members only on the HPA website.

LEGISLATION

SAHPRA DISCUSSES INTENTIONS TO ADDRESS ISSUES PERTAINING TO CAMS REGISTRATION

The South African Health Products Regulatory Authority (SAHPRA) met with the ITG Complementary Medicines Working Group (ITG CM WG) in July to discuss issues that are having a negative impact on the CAMS and Dietary Food Supplements (DFS) industry. At this meeting, SAHPRA confirmed its intention to address specific and critical issues pertaining to registration of CAMS.

Various factors have hindered the original framework for medicines registration, causing delays. The Regulatory Authority utilised these delays as an opportunity to reconsider the original framework and make suitable adjustments to meet the priorities and opportunities of functioning under SAHPRA, and to meet the needs of an industry willing to comply. This revised process will focus on the immediate implementation of more simple and rational mechanisms for licensing and registration of medicines.

Members were informed that a new roadmap with transitional arrangements has been developed and is intended to be ready for publication on the SAHPRA website in August 2019. Online mechanisms for medicine registration and tracking are also being developed for introduction in association with the revised application deadlines.
All attendees felt that the revised direction was constructive and potentially catered for a developing industry and also ensured progression of well-established role-players. The discussed principles were broadly supported by ITG CM WG representatives, and members indicated they were optimistic about the way forward.

HEALTH SUPPLEMENTS PLAY AN IMPORTANT ROLE IN REDUCING HEALTHCARE COSTS

The prestigious Frost & Sullivan Group recently published a series of reports commissioned by Food Supplements Europe, a primary objective of which was to evaluate whether healthcare cost savings can be realised through the use of nutritional supplements. The reports investigated calcium, omega 3s, phytosterols and lutein & zeaxanthin supplementation. The results of these reports were eloquently presented by HPA Exco Member and Amway Pharmacist/ Senior Technical Regulatory Specialist, Allen Frank, at the HPA AGM.

In his presentation, Frank covered information on developments of the EU Association, Food Supplements Europe; the health supplement industry, working groups and networks in Europe, and an overview of the important health cost reduction benefits of taking supplements.

The Frost & Sullivan reports demonstrated that nutritional supplements have the potential of effecting significant healthcare cost savings. The food supplements market is also financially viable as it is one of the fastest growing markets in Europe – expected to be valued at $6.67 billion by 2020 in Western Europe and approximately $2.49 billion by 2020 in Eastern Europe.

Established in 1991, Frost & Sullivan is a business consulting firm involved in market research and analysis, growth strategy consulting and corporate training across multiple industries. It is headquartered in Mountain View, California, and has 40 offices on six continents.

Frank’s presentation, as well as the full Frost & Sullivan reports, can be accessed by HPA members only on the HPA website.

WHAT’S HAPPENING

INSIGHT INTO REGULATORY AFFAIRS

In the current regulatory climate, knowledge of regulatory affairs is paramount, and the expertise of regulatory consultants is much in demand. Twinz Regulatory Affairs Pharmacist Consultants have been instrumental in servicing pharmaceutical companies with new regulatory submissions and amendments across the African continent with positive outcomes, and assisted some of the world’s leading companies by providing regulatory-based training to their staff, thereby enabling South African regulatory affairs as a whole to attain international standards. TWINZ CEO, Salma Ismail, was instrumental in arranging for SAHPRA’s recently retired Head of Law Enforcement & Compliance, Griffith Molewa, to give his Port Health presentation for the HPA, and her company offers a wide range of invaluable courses.

Courses are based on demand, and those on offer include: A Day in the Life of a Regulatory Affairs Pharmacist or Officer; Variations to marketing authorisations in the EU; Pharmacovigilance; Duties of the Responsible Pharmacist & Deputy Responsible Pharmacist; Professional information for medicines for human use and patient information leaflet training; Product QC Release by the Pharmacist & Non-Pharmacist – “Ethical” & Complementary Medicine; Marketing Code; Inspection readiness; Comprehensive training on ZA CTD compilation, as well as Company Specific Training.

For more information: https://www.twinztraining.com/

CONGRATULATIONS TO SASTEL FOR ACHIEVING FULL FOOD SAFETY CERTIFICATION

INTERNATIONAL

INTERNATIONAL COOPERATION – THE KEY TO HARMONISATION

As the CAMS and Dietary Food Supplements (DFS) industry continues to grow, the HPA continues to enjoy excellent relationships with many trade associations around the world, including those in Europe, the United Kingdom, the United States, New Zealand, Australia, and Vietnam. One of the most influential and relevant is IADSA, of which the HPA is a founder member. HPA President, Bruce Dennison, who keeps a finger on the pulse of the international industry, says: “IADSA celebrated its 21st anniversary in May this year in Sydney – at which the HPA was awarded the IADSA annual grant for innovation.”

In his internal report at the HPA AGM, Dennison further stated that IADSA maintains excellent relations with CODEX and has assisted a great deal in developing scientific and regulatory models for the industry worldwide, including South Africa. “The HPA will continue to maintain close ties with this organization,” he promises.

“Meetings were held in London in May 2019 with the management of IADSA to establish how the association can assist with the development of a regulatory system in South Africa that is in line with international best practice.”
Dennison also reported that progress throughout the world of DFS has increased dramatically in the last 21 years, particularly in Asia, including China and the ASEAN countries such as Australia and New Zealand. “Regulation has matured to the extent that harmonisation in regions is developing in the ASEAN region and Central America, and major progress is being made in India where the concept of notification as opposed to registration is making progress.”

“In South Africa, we continue to have old fashioned and unrealistic regulations for DFS which have contributed to a potentially dangerous situation, both from a safety point of view and the stultification of business. We are advised by SAHPRA that there will be a relaxing of the regulatory requirements in the very near future. Details are not entirely clear, but the dispensation will allow DFS to be marketed more freely. It will also allow for the easier importation of DFS,” he concludes.

HERB CORNER

PROSOPIS – DESTRUCTIVE INVADER OR HEALTH SAVIOUR?

Prosopis (mesquite) – which originated in northern Mexico and southern Texas – was introduced into the arid parts of South Africa to help farmers with fodder and shade for livestock, and as a source of firewood. It has since become the second most widespread invasive tree species in South Africa, according to Dr Ross Shackleton, DST-NRF Centre of Excellence for Centre for Invasion Biology, Stellenbosch University. It is also, however, a powerful health saviour, the seeds of which possess remarkable blood-sugar management properties. This was discovered by Brandt Coetzee in the Northern Cape in 1997.

When the Department of Water Affairs and Forestry began its battle against invasive alien plants and trees in the Northern Cape, Coetzee was doing research on the utilisation of the biomass of these alien plants. He noticed that animals enjoyed eating the prosopis seeds. “I collected different samples from the different species, and processed them into a special mixture which I sent to different laboratories in South Africa for analysis.” The results showed the seeds to be high in amino acids, vitamins, minerals, proteins and sugars, which prompted him to investigate their potential as supplements for humans.

Coetzee asked the University of the Free State to perform a study specifically relating to the support of blood-sugar control in the human body. After receiving the positive results of this study, the Glycaemic Index Foundation of South Africa did two further studies, conclusively showing the effectiveness of this mixture and its GI-lowering effect on food. After eight years of research – during which Coetzee identified the primary efficacy of only three of the 42 different species of tree – he formulated the specialist range of Manna nutritional supplements which are made from these seeds. Not only did he find a way to utilise the prosopis species for health benefits, he also provides work for the community that helps with seed harvesting which also controls the spread of the invasive seeds in the province.

An article that appeared in the 2004/5 edition of Conservation and the Environment in Namibia looked at the many uses of the hardy prosopis tree that requires very little water and is able to grow in most soil types. Different parts can be used for livestock fodder, firewood, building material, tools, furniture, cooking fires, cloth, baskets, rope, hair dye, face paint, glue and various medicinal purposes such as lice control, the treatment of sore throats, skin sores, ulcers, eye conditions, open wounds, dermatological ailments and digestive problems, among others.

The benefits of prosopis trees might well outweigh their disadvantages, says Andreas Wienecke, Research Manager at the Habitat Research and Development Centre of Namibia, who suggests that these trees should be regarded as a multi-purpose species.

https://www.mannaplus.co.za/
http://academic.sun.ac.za/cib/news/2015/0423_prosopis_weed_or_resource.htm

COMPANY NEWS

AIM FOR QUALITY

The AIM Companies is an international group whose common goal is to provide high-quality wholefood concentrates and supplements that improve people’s lives .The AIM network marketing company was formed in Nampa, Idaho, in the 1980s to market green barley products. Today the company grows, harvests, processes and markets Barley Life as well as 20 other products, and has centres around the world. Committed to research, development and product improvement, AIM has been recognised for innovation in food technology.

The company’s business philosophy is built on care and concern for others. It is committed to promoting the Healthy Cell Concept and the highest principles of free enterprise. The core values are: respect for the individual, commitment to excellence, dedication to customer service, and success through personal initiative.

As a leader in the health and nutrition industry, AIM has pioneered green-juice drinks and an assortment of wholefood concentrates while maintaining a consistent income source for its member-distributors. Since 1982, AIM has been promoting health and providing economic opportunity with an unparalleled product line and a rewarding compensation plan. What began as a tiny company has blossomed into an international corporation with tens of thousands of active member-distributors worldwide.

http://www.theaimcompanies.com/

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