THE GOOD NEWSThere has been extensive and comprehensive work by the HPA Executive Council to engage with SAHPRA at the highest level, as well as other government aligned bodies and business organizations as part of the strategic lobbying, government liaison and industry alliance plan, which I fully disclosed to all members in my Chairperson’s report in December 2017. This goal has been underpinned by the HPA’s spirit of working towards a structured industry engagement as a source of strength, not conflict. This has been at the core of my personal commitment to both the HPA and the industry alongside the HPA Executive Council. This strategy is now coming to fruition and I am pleased to advise you that there is an imminent solution to the regulatory quagmire that the August 2017 regulations imposed on the CAMS/HS industry. I am so pleased to inform you all that this is about to be announced following enormous constructive engagement by the HPA with SAHPRA, in which my EXCO and I, have been fully involved. The imminent SAHPRA announcement is anticipated to provide the way forward for CAMS/HS, and thereby should also address the impending November 2019 deadline which has been a major cause for concern by industry - and the HPA is engaging constructively and working hard to resolve this. We have been successful in getting the HPA to host the “South African Port Health Requirements: Port Health and Importation Requirements” workshop with Mr Griffith Molewa that will take place at the Bryanston Country Club on Thursday, 30th May 2019, from 09h30 to 11h00. The goal of this workshop is to have SAHPRA address an issue which is impeding normal business operations for an Industry that is wanting to be responsible, legally compliant and to be able to effectively apply functional best practice to their respective businesses. Mr Griffith Molewa’s presentation is designed to empower HPA and general industry members to understand the step by step process of what needs to be done prior to importation in compliance with current regulations, what to do when the importation process is challenged by Port Health, with whom to liaise when this happens, and how to generally enable a beleaguered industry to resolve issues safely, expediently and effectively, hand in hand with SAHPRA. Yours in Service, Sincerely MARIA ASCENCAO Chairperson Health Products Association of Southern Africa "The HPA: Promoting and protecting the Health Products Industry"
TRADITIONAL MEDICINE – THE ROOT OF HEALTHCARETraditional medicine has been the root of healthcare around the world for centuries – Ayurveda, Unani Tibb, Traditional Chinese Medicine and African Traditional Medicine are a few examples. While opinions differ regarding the exact figure, it is accepted that a significant percentage of South African people choose to consult with traditional healers, the two main categories of which are sangomas (spiritual mediums), and nyangas (herbalists) who use various substances, including plants and minerals, to initiate healing.
CHAIRPERSON'S REPORT 20182018 was another period of high-level and high-speed activity, advocacy, achievement, disappointments, challenges and advancement for the HPA – on many fronts. This year there have been a significant number of changes within the industry primarily related to SAHPRA, over regulation, strikes, political chaos and the economy. What has not changed however is the unique ability of this organisation to continue to adapt to an environment that remains volatile and challenging and to respond in a manner that reflects our qualities, expertise and commitment to our members. The CAMS/Health supplement and functional food industry remains sustainable despite the regulatory challenges and economic environment and remains robust, resilient and respected. HPA members companies can pause and reflect on their invaluable contribution to health and wellness in South Africa and how this has positively contributed to the trade, professional and consumer support for the industry as a whole. It’s because of each individual member company commitment to a strong code of ethics and willingness to raise the bar by effectively self-regulating, within a confusing regulatory environment, towards responsible, appropriate GMP and operating standards, product integrity, focus on safety and best business practice, that the industry continued to thrive in the face of adversity. While 2018 has been a year of unpredictability and volatility with SAHPRA/DOH as leading players, this has also been a year of survival, increased stature, sustainability, sales and strength. The HPA Executive Council has worked extensively to defend, promote and enhance the best interests of HPA members and the CAMS/HS industry as a whole. Here are some of the highlights of the HPA work throughout 2018: SAHPRA CAMS CEO MEETING 12TH JUNE 2018 The HPA provided an extensive presentation prior to the 12th June 2018 meeting and were vocal and hugely engaged with the SAHPARA committee throughout the meeting. HPA Chair, Maria Ascencao, Director Scientific and Regulatory Affairs, Wayne Robinson, Exco member Steve Parker successfully voiced industry concerns throughout the CAMS CEO meeting. This resulted in Ms. Mandisa Hela, Vice Chairperson of SAHRPA, inviting the HPA to form an independent to ITG, CAMS working group to engage with SAHPRA, which the HPA has proceeded to do. The CAMS/HS Working group is in the final stages of a united alliance with the Direct Selling Association (DSA); the Health Shops Association (HSA) and others and will be formalised to meet with SAHPRA in February/March 2019. PRICING REVIEW COMMITTEE: The HPA engaged with the SAHPRA Pricing Committee for a section 36 exemption for 18A, 18B and 22G of the Medicines and Related Substances Act No 101 of 1965 as amended, on Single Exit Pricing, Sampling, and Bonusing issues (including all health supplements and discipline specific S0 products – registered and unregistered) – to be indefinitely exempted from 18A, 18B & 22G of the Act. And, additionally, for a section 36 exemption for all S1 Complementary Medicines – to be exempted for a three year period from 18A, 18B & 22G of the Act. HPA Chair, Maria Ascencao, Imtiaz Ebrahim (DSA) & Moeketsi Letlala (DSA) as combined Associations representing the R8.2Billion industry shared between HPA and DSA members, and to furthermore, provide the expertise on both the direct to consumer marketing models via retail and direct selling respectively. The HPA effectively requested that the following be considered: CAMS/HS The HPA made a dynamic presentation (see attachment) which included showcasing the current regulatory challenges, the different paradigms of CAMS, the reasons consumers choose their respective CAMS as a healing modality of choice, how CAMS/HS work within the free market system as relates to both retail and direct selling models, how the HPA continues to support the development and implementation of appropriate and equitable regulations and guidelines pertaining to the entire paradigm of Complementary and Alternative Medicines (CAMs), and the HPA supports constant supply and free access to all South Africans to affordable CAMs. 18A: The practical & commercial Impact of the pricing regulations: The HPA emphasised that the practical and commercial effect of the pricing regulations, in the absence of an exemption for all S0 CAMs, would be unfair, unreasonable and an infringement of their right to trade freely. It is without doubt that the implementation of the pricing regulations (without exemptions) would have a detrimental effect on the HPA’s Members ability to continue trading. The HPA contended that due to the free trade retailing environment and freedom of choice for the consumer that all Category D S0 Health Supplements and Discipline Specific Complementary Medicines (registered or un-registered), should be exempt from 18A indefinitely. The HPA is pleased to report that on 13th December 2018, The Minister of Health, Dr Aaron Motsoaledi, signed a Notice authorising the exemption of Schedule 0 Medicines from section (18A) and (22G) of Act 101 of 1965. HPA will continue the engage with the Pricing Review Committee to seek exemption for (18B) Schedule 0 Medicines, as also, (18A); (18B) and (22G) for Schedule 1 Complementary Medicines ENGAGING WITH THE PHARMACY COUNCIL Regulation 23 of the August 2017 and Related Substances Act No 101 of 1965 as amended, as relates to licencing requirements are of overall concern to the HPA, and in particular, as regards the responsible person having to be a Pharmacist. Considering that the number of Registered Pharmacists currently available in South Africa is limited, the HPA believes that the increase in demand (created by this requirement) will not meet the supply, and as such the HPA would like to propose an approach that would help address this issue. The HPA would therefore recommend the following suggestion be taken into consideration as it relates to the expansion of the definition of a Responsible Pharmacist to a Responsible Person.
- Expanding on who can be the Designated Responsible Person (as it relates to Regulation 19 specifically) especially as it relates to Health Supplements and SO Complementary Medicines.
- To allow consultants (i.e. not in their full time employ) to act as the Designated Responsible Pharmacist.
- Exemption for an Importer and Distributor of Health Supplements and SO Complementary Medicines to have a Responsible Pharmacist in their full time employ.
- To expand on the list of allowable strains for health supplements - to include:Lactobacillus amylolyticus; Lactobacillus amylovorus; Lactobacillus brevis; Lactobacillus buchneri; Lactobacillus coryniformis; Lactobacillus crispatus1; Lactobacillus curvatus; Lactobacillus delbrueckii (including Lactobacillus delbrueckiisubsp. bulgaricus & Lactobacillus delbrueckii subsp. delbrueckii); Lactobacillus farciminis; Lactobacillus gallinarum1; Lactobacillus hilgardii; Lactobacillus kefiranofaciens; Lactobacillus kefiri; Lactobacillus mucosae; Lactobacillus panis; Lactobacillus paraplantarum; Lactobacillus pontis; Lactobacillus sanfranciscensis; Lactococcus lactis; Saccharomyces boulardii and Saccharomyces cerevisiae and Bacillus coagulans.
- To expand on current general -purpose health supplement claim for probiotics;
- The increasing of allowable levels for most vitamins and minerals [SO - as health supplements],
- The down-scheduling of Silimarin (Milk Thistle) [S0]
- The introduction of probiotics as health supplements [S0],
- The down-scheduling of Methionine - 210mg limit [S0] and
- The down-scheduling of 5HTP - less than 220mg with health supplement claims [S0].
- How the system will ensure quality healthcare is provided; how it will be administered and how it will be funded?
- Another is around the proposal that there be a single public purchaser and financier of health services for the country.
- How the system will accommodate the entire paradigm that is Complementary and Traditional Medicines, Natural Health Professionals, Practitioners and Products.
- An extension to the implementation date to match that of the introduction of point b below.
- The introduction of a simplified registration / notification system that addresses the registration of all HS CMs and simple DS CMs
- A lower once-off fee of R1800 / product for all HS CMs and simple DS CMs (with no on-going fees / annual fees being introduced).
- Specific time frames need to be published as to the expected service delivery by the SAHPRA.
- All products need to register via the CTD format, which is almost impossible to complete for multi-substance CAMS
- Current time taken to register other Medicines can be up to 5 years.
- Currently companies are unable to import or innovate in regard to new products without a registration number
- The HPA proposes that Health Supplements be included within dedicated Foodstuffs legislation and that the regulatory and legislative provisions appropriately provide for this category of products within Foodstuffs.
- The HPA proposes that an interim measure be provided for so as to how to deal with new products
- The HPA would welcome a simple, inexpensive, fast track registration procedure, which facilitates swift and appropriate entry and access to market (inclusive of the review
- procedure) for all SO / low risk Complementary Medicines.
- The HPA proposes that a simplified, and appropriate criteria within the e-CTD registration system for the balance of products
- The HPA suggests that the Minister consider “grandfathering” Complementary Medicines and Health Supplements already on the market and apply the registration processes to new entrants going forward
- Address the concerns with certain aspects of the current regulations under the Medicines and Related Substances Act, 101 of 1965 (Medicines Act) which include complementary medicines (CAMs), traditional medicines (TMs) and health supplements (HS) General Regulations (R.8590, Government Gazette 41064), dated 27 Aug 2017; including content, time frames and logistical impact as well as viability of implementation of these regulations.
- The case for Health Supplements as Foods in line with global norms.
- Short presentation and review of the HPA Listing/screening’ system in electronic format for fast track applications: How to present this to SAHPRA
- Case to present a Risk/ benefit assessment approach to SAHPRA
- CAMS/HS working group Committee: CAMS expertise driven in alliance with technical committee experts
- POSITIVELY INFLUENCE PUBLIC PERCEPTION OF CAMS/HS AND FUNCTION FOOD with the goal to endorse the safety and benefits of this vibrant industry and promote a positive industry image
- BUILD HPA MEMBERSHIP with the goal to expand HPA membership to be representative of all aspects of the industry, to enhance the associations voice on behalf of all industry stakeholders, and to generate necessary resources for expanded HPA programming.
- EXPANDED POSITIVE PUBLICITY and PROACTIVE MESSAGING THROUGH:
- News, Newsbytes HPA Newsletter: as the key tools for the above goals and initiatives
- HPA Facebook Page: as the leading direct to consumer social media tool
- Press Releases
- EDUCATIONAL EVENTS:
- HPA will collaborate with industry for educational opportunities and events. In mid-2019 the HPA is bringing world renowned MD and Functional Medicine Practitioner, Dr Mark Hyman, to South Africa to present a CPD accredited Educational.
The current edition of the newsletter can be viewed now by clicking here.
All available editions of the IADSA newsletters are listed below. To view any of them, simply click on the edition's title and it will open in a new window.
IADSA INTRODUCTORY GUIDE TOLERANCES FOR FOOD SUPPLEMENTS
Tolerances for food supplements – An introductory guide
IADSA PUBLICATIONS & CODEX GUIDE
- IADSA CONNECT MAGAZINE: IADSA Connect_Magazine-May2018-F
- IADSA NEWSFLASH: F_IADSA Newsflash APR2018
- IADSA NEWSFLASH: IADSA Newsflash FEB 2018 F
- IADSA NEWSFLASH:IADSA Newsflash Nov 2017_F
- IADSA NEWSFLASH: IADSA NEWSFLASH SEPTEMBER 2017
- IADSA NEWSFLASH: IADSA Newsflash JUNE 2017
- IADSA NEWSFLASH: IADSA Newsflash March 2017_ F V2
- ASEAN Health Supplement Sector Set to Become a Global Powerhouse – April 2015
- IADSA and CFDA Celebrates 10 Year of Cooperation – July 2014
- CRN and IADSA Partner for Broader Reach – July 2014
- Korea Health Supplements Association (KHSA) to Become Member of IADSA – June 2014
- IADSA Global Leadership Award Annoucement in Verona, Italy – April 2014
- First scorecard published on Health Supplements Harmonisation in ASEAN – February 2014
- IADSA focuses on stability testing and safety as part of its 3-year scientific and technical programme – August 2013
- IADSA holds expert workshop on applying Codex guidelines – August 2013
- Codex adopts NRVs at levels supported by IADSA – July 2013
- Codex increasingly a key reference point for food supplement regulators says IADSA – July 2013
- IADSA gives first-ever Global Leadership Awards – May 2013
- IADSA to hold Annual General Meeting in April – April 2013
- Codex endorses IADSA recommendations to prioritise Magnesium Stearate evaluation for GSFA inclusion – April 2013
- IADSA keeps the focus on health food regulations in China – October 2012
- Codex additives inclusions good news for the dietary supplement sector says IADSA – August 2012
- IADSA re-elects chair Peter Zambetti for second term – April 2012
- India FSSA a positive step for supplements says IADSA – April 2012
- Key supplement additives up for inclusion in Codex standard – March 2012
- IADSA welcomes Mexico association into its fold – February 2012
- IADSA keeps the focus on additives at Codex – February 2012
- Codex sets up e-Working Group on Nutrient Reference Values revision – November 2011
- IADSA suggests framework for bioactives recommended intake – November 2011
- Scientific Forum debates food supplement science and regulation issues – October 2011
- IADSA lays out the science in support of supplements for micronutrient adequacy – October 2011
- Latin America gets first regional food supplement association – September 2011
- Supplement regulation discussions in Latin America promising, says IADSA – September 2011
- Supplement regulation across Latin America on ‘official’ agenda – August 2011
- IADSA to hold 4th scientific forum – August 2011
- Demand grows for global food supplement GMP guide – August 2011
- India nutraceuticals market on the rise – July 2011
- Codex decides on key issues for food supplement sector – July 2011
- IADSA saves key additive from deletion at Codex – July 2011
- IADSA releases first ever global GMP guide – June 2011
- Codex abandons definition and labelling work on GMOs – June 2011
- Central America and Caribbean regulators meet to discuss supplement regulation – May 2011
- IADSA saves key additives from deletion at Codex – April 2011
- IADSA to release first ever global GMP guide – March 2011
- IADSA highlights global food supplement trends in 2011 agenda – February 2011
- IADSA expands global arena as Brazilian and Vietnam associations join – February 2011
- La regulación de los suplementos alimenticios en América Latina toma impulso en la Conferencia de IADSA – Noviembre 2010
- IADSA Conference gathers momentum on food supplement regulation across Latin America – November 2010
- Global food supplement associations meet to define world regulation – March 2010
- Global food supplement sector hold their Annual Meeting – February 2010
- IADSA clarifies myths surrounding Codex’s work on food supplements – October 2009
- Top officials meet in Moscow forinternational food supplement conference – July 2009
- Codex adopts key provisions for food supplements – July 2009
- Top officials to meet in Moscow at international food supplement conference – May 2009
- Codex agrees additives for use in food supplements – March 2009
- South East European officials meet for Training Forum on supplements – March 2009
- IADSA keeps the spotlight on Latin America in 2009 – February 2009
- IADSA strengthens ties as two associations join – January 2009
- Codex agrees risk analysis principles for nutrients – November 2008
- Codex agrees to consider ALL evidence for scientific basis of health claims – November 2008
- IADSA pushes for consideration of ALL evidence for Codex scientific basis of health claims – October 2008
- Health claims based only on human intervention studies not practical says IADSA – August 2008
- IADSA workshop keeps the focus on Latin America – July 2008
- Seminar looks to global TMHS regulations for ASEAN model – June 2008
- Workshop highlights dietary supplement regulation in Mexico – June 2008
- IADSA celebrates decade of global regulatory achievements – May 2008
- IADSA welcomes new chairman at 2008 Annual General Meeting – May 2008
- Expert workshop targets food supplement regulation in Mexico – April 2008
- IADSA strengthens ties as new association joins – January 2008
- Regulatory change a boost for emerging supplement markets says IADSA – January 2008
- Codex to redraft health claims recommendations – December 2007
- IADSA keeps up the fight for reasonable food additive levels – November 2007
- Health claims based only on human intervention studies unrealistic says IADSA – October 2007
- Senior regulators give guidance on accessing Russian market – September 2007
- IADSA helps companies access Russian Supplement market – August 2007
- IADSA strengthens ties with the Philippines – August 2007
- IADSA workshop targets supplement market in Russia – August 2007
- Regional ginseng regulation should focus on just one species, says IADSA – July 2007
- Codex adopts additives at IADSA’s advised levels – July 2007
- Companies urged to take part in global market survey – June 2007
- IADSA’s action to retain additives yields positive results – May 2007
- IADSA Workshop an ‘official’ success – April 2007
- IADSA rates global regulatory improvements ‘six out of ten’ – April 2007
- Hopes for Codex inclusion of Precautionary Principle dashed – April 2007
- IADSA highlights healthier ageing at Yokohama Workshop – March 2007
- IADSA workshop gathers official momentum – March 2007
- International experts dispute conclusions of antioxidant review – February 2007
- IADSA sets the agenda for 2007 – February 2007
- IADSA keeps up the fight for key additives in food supplements – February 2007
- Asia in the spotlight as dietary supplement regulation evolves – December 2006
- IADSA assesses safety levels for Bioactives – November 2006
- Regional dietary and health supplement industry grouping created in Singapore – July 2006
- What next for Food Supplements in Europe – October 2005
- International agreement reached on vitamins and minerals in Food Supplements – November 2004
- Codex Commission makes historic decision on Guidelines on Vitamins and Minerals – July 2004
- All Eyes on Prague for Future of Supplement Legislation – July 2004
- Enlarged European Union will meet to develop the Future of Food Supplements – April 2004
- Latin American governments agree need for common approach to supplements regulation – Nov 2003
- Codex Committee breaks through the barriers to Consumers’ use of Food Supplements – November 2003
- Supplements Essential to Manage Japanese Health Care – October 2002
- First Asian Conference demands increased dialogue on Food Supplements – September 2002
- IADSA Summary of Vitamin and Mineral Recommended nutrient intakes – July 2002
- Dietary Supplements: First Asian Conference of Government and Industry – May 2002
- Three More Dietary Supplement Associations Join IADSA – March 2002
HPA MEETINGS 2019
JOHANNESBURG: Bryanston Country Club
HPA EXECUTIVE COUNCIL MEETINGS: 11H30 – 15H00 GENERAL MEETINGS: 15H30-17H00
• THURSDAY JULY 18TH (AGM)
• THURSDAY OCTOBER 24TH
• THURSDAY DECEMBER 4TH (Jhb Exco & General Meeting)
CAPE TOWN: Kelvin Grove
HPA EXECUTIVE COUNCIL MEETINGS: 09H30-11H30 GENERAL MEETINGS: 12H00-14H00
• THURSDAY MAY 23rd
• THURSDAY SEPTEMBER 19TH
• THURSDAY NOVEMBER 28TH
SAHPRA PORT HEALTH WORKSHOP 30 MAY 2019, JOHANNESBURG
SAHPRA CLINICAL TRIALS WORKSHOP 31 MAY
SAHPRA DOCUMENT -INVESTIGATOR WORKLOADS IN CLINICAL TRIALS: 2.53_Investigator_Workload_Clinical_Trials_Apr19_v1_for_comment
GMP WORKSHOP – 6 JUNE 2019
GDP WORKSHOP – 10 – 11 JUNE, CAPE TOWN
We are pleased to announce that Andrea Julsing Keyter, Deputy Director Medical devices of SAHPRA has agreed to present at the GDP workshop in Cape Town. The early bird date has been extended to 24 May to allow more delegates to register .
ANALYTICA LAB AFRICA: 9 – 11 JULY, JOHANNESBURG
TWINZ 2019 SEMINAR AFRICAN REGULATORY AUTHORITIES
TWINZ FOUNDATION FOR PHARMACEUTICAL SCIENCES: COURSES 2019
For more information, please visit: https://www.twinztraining.com/
TWINZ: A DAY IN THE LIFE OF A RA PHARMACIST OF OFFICER: 2019.08.20 A Day in the Life of a RA Pharmacist or Officer
UGANDA: UGANDA MANUFACTURERS ASSOCIATION TRADE FAIRS 2019
The Noakes Foundation:
‘Professional Training in LCHF/Ketogenic Nutrition & Treatment’
TENTH ANNIVERSARY CONFERENCE OF COUNCIL OF DIETARY SUPPLEMENT PRODUCERS (CDSP)
The International conference “Food supplements industry and modern society: challenges, science, regulation” took place in Moscow on November 26 – the first ever specialised event on food supplements (BAFS) in Russian history! The conference, which was a huge success, was held by Self-regulatory Organisation Council of Dietary Supplement Producers (CDSP), whi
ch celebrated its 10th anniversary this year. Amway, one of the founders of the association, is a permanent Council member.
Its agenda consisted of two main parts:
a) a scientific symposium
b) round table with industry representatives and governmental stakeholders.
This year the focus was on uniting efforts to maintain Amway’s high standing in the association whilst devoting special attention to increase the credibility of the organisation among the stakeholders. Elena Pletneva (Amway Regulatory Policies Advisor, R&D) and Andrey Serebrennikov (Amway Government Affairs Manager, Legal) led the organising committee of the Conference for more than 6 months.
There was a strong Amway presence of speakers:
Audra Davies– Vice President, Product Development – Health, Beauty & Home, Nutrilite Health Institute (Audra’s presentation was highly engaging and well-researched and received a warm welcome from the audience);
Wei Qian – European Regulatory Policy Manager: Regulatory officials were impressed by Wei’s excellent presentation on EU regulatory outlook and kindly asked to provide them with the presentation copy;
Vasiliy Isakov –Head of the Department of Gastroenterology and Hepatology Clinic of the Institute of Nutrition.
All regulatory stakeholders’ representatives were in attendance, including Head of Russia’s Federal Office of Surveillance of Consumer Right Protection and Wellbeing (Rospotrebnadzor), Federal antimonopoly service, State Duma and Russian Union of Industrialists and Entrepreneurs.
Science was supported by Department of Dietetics and Clinical Nutrition of Peoples’ Friendship University of Russia (RUDN). Over 20 scientists had an opportunity to discuss BAFS role in optimising day-to-day nutrition and to share the latest results in studies of the clinical efficiency of BAFS.
A round table on biologically active food supplements (BAFS) focused for the first time on specific BAFS problematics as a part of a bigger food industry. There was a vivid discussion over BAFS regulations in Europe, BAFS distant and itinerary trade legalisation, advertisement rules in the industry.
The full event coverage on YouTube attracted more than 6000 viewers in two days.
“We hope that the conference that has already proved to be a noticeable event, will contribute to BAFS industry development and fuel long-awaited change in regulatory landscape, including technical regulation and BAFS distant and itinerary trade legalisation,” says South African Amway Pharmacist, Allen Frank.
All available editions of the HPA headlines currently in our archive are listed below. To view any of them, simply click on the edition's title and it will open in a new window.