CHAIRPERSON’S REPORT 2018
2018 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.
The HPA and the DSA will work together in 2019 to engage with the Pharmacy Council to obtain an Exemption from 14, 19 & 22C of the Pharmacy Act.
PROBIOTICS – HPA APPLICATION FOR INCLUSION OF SUBSTANCES TO BE ADDED TO HEALTH SUPPLEMENT LUST AND MOTIVATION FOR THE EXPANSION OF ALLOWABLE CLAIMS OF PROBIOTICS
The HPA submitted a comprehensive motivation on 20th August 2018 to SAHPRA’s PEEU for inclusion of more probiotic substances to be added onto the Health Supplement List and further motivation for the expansion of allowable claims of probiotics classified as health supplements.
The (HPA) formally submitted its applications for the following
- 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;
OTHER DOWN-SCHEDULING APPLICATIONS SUBMISSIONS BY THE HPA (2013 AND 2018)
The HPA has submitted several applications for downscheduling of substances over the years, these have influenced the following outcomes;
- 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].
THE NATIONAL HEALTH INSURANCE (NHI) BILL AND THE MEDICAL SCHEMES AMENDMENT BILL
July 2018: The HPA submitted a comprehensive comment on the recently published NHI Bill and the Medical Schemes Amendment Bill presented by Health Minister, Dr Aaron Motsoaledi
The HPA welcomed the draft amendment Bill to the end that it aims to make healthcare more accessible and in principle, applauds the government for taking proactive measures to improve the quality of national healthcare in South Africa for all South Africans.
However, we confirmed the reservations and concerns around some of the proposed amendments that look set to impact on the Complementary Medicine paradigm incorporating African Traditional Medicines, Chinese Traditional Medicine, Ayurveda Traditional Medicine, Unani Tibb Traditional Medicine, European traditional Herbals, Nutritional Dietary supplements, Homeopathy, Energy Medicine, Vitamins and Minerals, Sports Nutrition, Natural Health products.
the HPA is not disputing that a comprehensive and viable healthcare system is needed in South Africa and is long overdue. However, there are a number of questions which the HPA seeks to fully comprehend and for which is needs answers:
- 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.
HPA: Application for timeline extension for comment by the HPA and its members companies:
The HPA applied for an additional two (2) months, to therefore have an overall five (5) months period in which to provide extensive, substantive comment of value to all parties and with the intention to constructively collaborate to improve the quality of national healthcare in South Africa for all South Africans.
COMMENTS BY THE HEALTH PRODUCTS ASSOCIATION OF SOUTH AFRICA (HPA) ON: THE IMPLEMENTATION OF FEES PAYABLE IN TERMS OF THE PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 as published in the STAATSKOERANT, 31 AUGUSTUS 2018 No. 41871 GG No R 912
10TH DECEMBER 2018 SUBMISSION TO SAHPRA: SIGNIFICANT CONCERNS REGARDING THE FEE STRUCTURE INCLUDE: As was the case in 2016, the HPA contends that to apply the published fees structure to the CMs industry will be prohibitive to industry and as such the HPA recommends the following be considered:
- 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.
The HPA further requested that the newly formed CMs broad based working group address all of the issues as stated above including the concerns relating to CTD, Fees, definitions, guidelines, time frames, roll-out and other related items.
CONCLUDING ARGUMENT: As South Africa is a progressive country when it comes to freedom of speech, regulations and rights of its people, is it also not our responsibility to acknowledge and protect the traditions and practices as well as the right to exist of all medical paradigms and in doing so supporting all groups equally (majority and minority) with respect to their preferred health care practices and the right to Freedom of Choice as set out in the Constitution of South Africa? In our view, this can be done without any compromise in relation to quality, safety and efficacy of CMs.
COMMON TECHNICAL DOCUMNT (CTD) DOSSIER
The HPA has significant concern as it relates to the current ZA-CTD system being the ONLY registration format for CMs and in the absence of any simplified screening / notification system, the HPA contends that it may be very difficult for the DOH / SAHPRA to manage, control and implement the many thousands of products on the market. Whilst the HPA recognizes that the ZA-CTD is specifically designed to deal with the control and registration of Orthodox medicines and not CMs, the HPA contends that if one only applies the CTD to CMs, it is anticipated that it will significantly reduce the number of products on the market as it is not designed to provide for or grasp the foundation and principles of CMs.
THE HPA HAS ENGAGED WITH SAHPRA AND CONTINUES TO COMMUNICATE THE FOLLOWING CONCERNS RELATED TO THE CURRENT CTD FORMAT:
- 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
HPA SOLUTION PROPOSALS
- 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
CTD DOSSIER ALTERNATIVE: A specialist overview: Peter Kreft document
Peter Kreft independently prepared a document outlining the difficulties of completing a CTD format for a multiple substance product. It is an excellent and well thought through document and includes a solution-based proposal for collaboration with SAHPRA.
There is much goodwill in Industry and many companies would gladly collaborate with SAHPRA and open their facilities for the training of Inspectors etc. A positive, joint approach is possible. It requires management and leadership skills without the loss of Regulatory control. On the contrary, because the suggested approach is simpler and fairer, it will supply the public of South Africa with safer, better medicines that are available at a reasonable price.
CAMS MARKETING CODE
The HPA worked extensively with the Marketing Code Authority (MCA) between September 2017 and October 2018 to ensure the incorporation of CAMS/HS related direct to consumer marketing model and update of their original code thereby providing a mechanism for our Members to comply with the new MCA code should they choose to sign up with the MCA.
We stand by our original request of a separate Code for Complementary Medicines. The HPA acknowledges the MCA willingness to further improve the code and the HPA is committed to collaborate further in order to constantly improve a code that is best suitable for Complementary Medicines. The HPA is aware that during this period HPA Members were not able to comply with the old MCA code, as many of their products were (and still are) not registered and as such it caused a delay in HPA Members signing up to the MCA code.
The HPA recognizes that many of its’ Members have many different types of products which include Complementary Medicines, Foods, Beverages and Cosmetics and as such these companies may opt to be affiliated with MCA or the newly established Advertising Regulatory Body (ARB) or both.
The HPA Scientific and Advisory Committee continues to work towards updating the original HPA 2012 CAMS Marketing Code in early 2019, and seeks to establish a self-regulatory model as also to continue to collaborate with the MCA and the newly established, Advertising Regulatory Body (ARB) for an independent CAMS Marketing Ethics Code.
We will also ensure that the HPA Scientific and 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 LISTING/SCREENING SYSTEM
The HPA’s Broad based reference group developed the LISTING system incorporating a list of safe substances inclusive of dosage levels and safety profile references etc. between 1997 and 2012. This includes all the various paradigms that make up the CAMS/HS industry.
The HPA has a resolution and framework ready to provide to SAHPRA i.e. the “screening/listing” to be converted to 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 SAHPRA/DOH as is currently the case .
The HPA continues to engage on the suggestion to SAHPRAs that a simplified screening / listing / notification system be introduced for all Health Supplements (HS) CMs and simple Discipline Specific (DS) CMs prior to a fee structure being introduced.
HPA SCIENTIFIC ADVISORY COMMITTEE
The HPA Scientific Advisory Committee, headed by Wayne Robinson, continues to provide members with assistance regarding advertising and labelling concerns via the HPA Advisory Committee and providing Certificates of Free sale.
This Committee continues to work tirelessly to advise and provide support to HPA members and to overall protect consumers and a responsible industry.
Engagement with Alliances to preserve the industry:
The HPA Exco worked 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.
HPA has collaborated with IADSA, CRN and the American Botanical Council on an international level, and with DSA, SMASA, PHARMISA, GBMSA and other associations in South Africa with the objective of creating a strong and united drive for a workable regulatory framework for CAMS/HS.
On December 6th, 2018, the HPA EXCO voted to form a “Broad Based CAMS and Health Supplements Working Group” in alliance with the DSA (Direct Selling Association) and the (HAS) Health Shops Association, and OTHERS with the following key Goal and Objective:
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.
- 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
This Committee with be actively engaged in 2019 to influence government policy on CAMS/ Health Supplements, functional food and other nutritional and nutraceutical products with the goal to build and maintain a positive regulatory and legislative environment for the industry as a whole to foster consumer confidence and industry growth.
BUILDING HPA MEMBERSHIP: NEW MEMBERS IN 2018
The HPA worked effectively to increase membership efforts this year, thanks to our enthusiastically engaged Executive Committee and we warmly welcomed the following new members in 2018:
Feel Pharmaceuticals – Afrigetics
JJ Pharma Stability
RA Pharma Solutions
STRATEGIC MARKETING & COMMUNICATIONS PLAN 2019
Year 2019 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:
HPA HAS LAUNCHED A FRESH NEW APPROACH TO SHOWCASING THE INDUSTRY BENEFITS
A KEY DRIVER FROM 2018 & WILL BE FURTHER UPSCALED IN 2019 TO:
- 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.
In addition, there will be other business networking opportunities, seminars and workshops organised 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 do contact me or any of the committee to discuss your ideas and any other issues you would like to bring to our attention
INTERNATIONAL ALLIANCE OF DIETARY SUPPLEMENTS ASSOCIATION (IADSA):
HPA President, Bruce Dennison has confirmed the exciting news that IADSA are considering having their 2020 Annual Conference in South Africa. IADSA also wish to put together a SADC regional conference to discuss the formalisation of supplements. IADSA will work with the HPA on these projects in early 2019. We hope to receive confirmation on the South African City selected to host the IADSA 2020 conference within the next couple of months.
The HPA has this year had to increase its annual subscription by 7.5% 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 thank you, our members, for your support throughout 2018, and I thank the HPA Executive Council for their hard work and commitment to the Association.
The HPA EXCO and I pledge to work even more strenuously for you in the year ahead with vigour and determination.
May you be active, happy, healthy, successful and true to yourself, your family and your friends in 2019
Health Products Association of Southern Africa
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