THE YEAR IN REVIEW
HPA Chairperson, Maria Ascencao, at the HPA Annual General Meeting on 9 July 2020 – conducted via Zoom in order to adhere to Covid-19 regulations – presented a comprehensive and enlightening annual overview of the HPA’s achievements, projects and regulatory concerns. “July 2019 to July 2020 was another period of high-level and high-speed activity, advocacy, achievements, disappointments, challenges and advancement for the HPA – on many fronts,” she said. “There have been a significant number of changes within the industry, primarily related to the South African Health Products Regulatory Authority (SAHPRA), over-regulation, strikes, political chaos, the economy…and COVID-19, which has forever changed the world. What has not changed, however, is the unique ability of this organization 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.”
According to Ascencao, despite COVID-19 – or because of it – the CAMs/Health supplement and functional food industry remains sustainable, regardless of the regulatory challenges and economic environment, and remains robust, resilient and respected. “HPA member companies can pause and reflect on their invaluable contribution to health and wellness in South Africa, as well as how this has positively contributed to the trade, professional and consumer support for the industry as a whole,” she states.
Her presentation included information from the Global Nutraceuticals Market Report 2020-2024, various highlights, meetings and media updates, the IADSA 2019 grant awarded to the HPA and how it is to be utilised, applications to SAHPRA regarding supplement adjustments and down-scheduling, HPA interactions with international and local partners and alliances, the proposed CAMs marketing code, the global economic outlook during the COVID-19 pandemic, the recently published SAHPRA regulations, and more.
“The HPA is fully engaged to promote the benefits of the industry and to work tirelessly to resolve the current regulatory challenges, and is also fully committed to ensuring that the industry it represents is protected from inappropriate legislation. Our aim is to see onerous regulations amended so as to facilitate access to safe and efficacious health products for all South Africans. That the industry continues to thrive in the face of adversity is because of each individual member-company’s commitment to a strong code of ethics and a willingness to raise the bar by effectively self-regulating within a confusing regulatory environment towards responsible, appropriate GMP and operating standards, product integrity and a focus on safety and best business practice.”
The full presentation is available to HPA members on the HPA website.
REGULATIONS – THE WORK CONTINUES
CAMs regulations continue to be an ongoing concern that the HPA has worked on tirelessly for decades. HPA Vice Chairperson, Leigh Gunkel-Keuler, is the key committee member working extensively within the political, business and regulatory sectors for the advancement of the industry. She has initiated several milestone-achievements and her work has been extremely valuable to the HPA and industry. Gunkel-Keuler attended several high-level meetings with both government and private-sector players, and gave a concise report on her extensive work in her ‘Government Affairs Update’ presentation at the July HPA AGM.
An HPA interpretation and summary of the recently published SAHPRA Guidelines for CAMs, dated 6 July, in which SAHPRA revealed the application forms and guideline documents relevant for the registration of complementary medicines, was delivered by Maria Ascencao who reports that: “The recently published SAHPRA roadmap and transitional process for the regulation of complementary medicines has been a cause of great concern to many stakeholders in the industry. It has, however, also provided some much-needed insight as to what the foreseeable regulatory future for these products holds. In general, the guidelines appear to have taken many industry concerns into consideration, and as such allow for obtaining licences through a process of attestation (or testimony to comply) and for standardisation of labels, while unfortunately also reinforcing apprehensions about compliance-associated costs.
Both presentations are available to HPA members on the HPA website.
CBD CATEGORISED AS SCHEDULE 0 COMPLEMENTARY MEDICINE
Cannibidiol (CBD) is now used in healthcare products, food, skincare products and even pet treats. Just over a year ago, CBD was considered a scheduled substance, available only on prescription. This changed on 23 May 2019 when a maximum daily dose of 20 mg of CBD was exempted from the operation of the schedules to the Medicines Act for one year. On 24 April 2020, shortly before the exemption lapsed, the HPA submitted a comprehensive down-scheduling application to SAHPRA for motivation of CBD as a Category D Complementary Medicine Health Supplement. On 8 May 2020, Health Minister Zweli Mkhize signed into law the new scheduling status for certain CBD products. This was published in Government Gazette 43347, dated 22 May 2020. CBD is now considered a Category D, Schedule O Complementary Medicine, with relevant low-risk claims. HPA Technical and Regulatory Director, Wayne Robinson, gave a CBD-update presentation at the HPA AGM.
Robinson discussed the legal status of cannabis, the cultivation of medicinal cannabis, new cannabis and CBD schedules, CBD as a S0 CAMs requirement, cannabinoid testing, common testing requirements, cannabis test results and the importance of testing, quality assurance, product registration, and CBD as a cosmetic.
On 5 August 2020, Auntony Mukhwanazi wrote in EWN that the cannabis industry can help reignite the SA economy: “The negative impact of the COVID-19 pandemic on our economy can be reversed if government, business and society work collectively to establish a sustainable cannabis industry as one of the interventions.
REMEMBERING BRUCE DENNISON
Bruce Dennison arrived in this world as unexpectedly as he left. He was born on 4 April 1943 in Cape Town due to the unforeseen diversion of the ship on which his mother was returning to Nigeria. He passed away very suddenly on 13 April 2020, shortly after being diagnosed with a brain tumour. Committed to and passionate about the natural health industry – which he served from the time he entered the field in 1974 – he made an invaluable contribution to the sector both locally and internationally, and the world is a little emptier without his presence. Considered by many to be a ‘legend’, Bruce was Chairman of the HPA for 19 years and was elected Honorary President following his role as Chairman. He was also a founding member of the International Alliance of Dietary/Food Supplement Associations (IADSA), and Vice Chairman of IADSA for nine years.
“We are privileged to have had a person of Bruce Dennison’s calibre, intelligence and passionate dedication representing the HPA in its pursuit to ensure that the natural health industry thrived in Southern Africa. He was highly revered within the dietary supplement industry, well-regarded in international circles and strongly respected for his tenacious spirit and good humour,” says Maria Ascencao. “With 45 years of unrivalled experience and a broad knowledge of dietary supplements, health supplements and complementary medicines, Bruce was one of South Africa’s leading health and wellness pioneers, and also a true expert in the field of natural products, health foods and dietary supplements. It’s been a wonderful privilege and a great honour to serve alongside him and to work with him since 1997. Bruce was a great force for good, as well as a ‘Force of Nature’ who leaves a lasting imprint on the HPA and the South African and global industry.”
Dennison is survived by his wife, Maryke, sons Robert and Andrew, daughter-in-law Alison, and grandchildren Annabel and Tom.
IADSA LEADS THE WAY
The HPA was very pleased to welcome IADSA Executive Director, Simon Pettman, to the 9 July 2020 HPA AGM. Pettman, who joined the meeting from London via Zoom, made a presentation entitled “Our work and our future direction” which outlined IADSA’s commitment and five-year plan. He also discussed the success of the new communication initiative, called ‘Mind the Gap’.
IADSA – of which the HPA is a founder member – was created in 1998 as the global alliance of dietary supplement associations and companies to shape policy and regulation. The association has invaluable experience and expertise gained from working in more than 80 countries worldwide, often partnering with governments. Examples of the work undertaken by this prestigious organization include:
• Helping to protect the status of botanicals and build a scientific/regulatory rationale for botanical supplements
• Finalisation and implementation of the notification system for certain categories of supplements in China
• Helping rescue the Turkish market from the cliff’s edge, and then building with the regulatory bodies a new, viable system
• Developing a Health Supplement and Nutraceutical Resource Centre with the Food Safety Standards Authority of India
• Launching the first ‘Mind the Gap’ series to communicate in a simple way complex information about the role and value of supplementation
Some of IADSA’s primary goals are to continue with long-standing activities to build understanding of the supplement category, its value and its needs, to increase recognition of the role of food supplements in helping people achieve healthier lives, and to maintain the momentum for improved regulations.
The HPA expressed its appreciation to IADSA for continued support and assistance to the HPA in its endeavours to establish an appropriate regulatory system.
The full presentation is available to HPA members on the HPA website.
HERBAL HELP FOR COVID-19?
As the search for a Covid-19 cure or vaccine continues, the herb Artemesia annua is showing some potentially positive assistance from the plant kingdom. In June 2020, German scientists from the Max Planck Institute of Colloids and Interfaces released laboratory-test data showing that extracts of the Artemisia plant are active against the virus causing Covid-19. “The results are very promising,” said Peter Seeberger, head of the study and Managing Director the Max Planck Institute.
The Max Planck Institute scientists and Interfaces in Potsdam are among a group of researchers from Germany and Denmark collaborating with the US company, ArtemiLife, to explore whether the Artemisia plant can be used against the novel coronavirus. This research is the latest contribution to several initiatives to use the Artemisia annua in the treatment of Covid-19.
South African scientist, Frank van der Kooy at North-West University, has launched an effort to conduct clinical trials on Artemisia, teaming up with Jerome Munyangi, a Congolese doctor from the faculty of medicine at the University of Kolweri-Lualaba. Algerian researchers had tested the effectiveness of Artemesia-based malaria drugs against SARS-CoV-2 in April. Their study demonstrated that artemisinin was more effective than hydroxychloroquine.
Artemesia was first touted as a ‘miracle cure’ for Covid-19 at the end of April by Madagascar’s President Andry Rajoelina, who promoted a potion containing Artemesia extract and other herbs. At that time, the WHO warned that there were no scientific studies or data to prove its effectiveness. The plant is now undergoing numerous studies and South Africa is collaborating on research with Madagascar on research which is apparently also pursuing clinical trials of two injectable medications.
Artemisia is long-known to have uses for the treatment of malaria, and drugs have been developed using artemisinin, which is a derivative of one of the plant’s compounds. Research has also been conducted into using Artemisia in combating HIV, as well as its effectiveness against another type of coronavirus, SARS.
Kerry Gilmore, who is an organic chemist at the Max Planck Institute, said there are at least 10 active compounds within the Artemisia extracts. Further research will help determine whether individual compounds or a combination of them are responsible for the activity against Covid-19.
The HPA is currently engaging with the South African Pharmacy Council (SACP) on how to resolve the issue of the Responsible Pharmacists requirement in health supplement businesses. ”Regulation 23 of the August 2017 and Related Substances Act No 101 of 1965 as amended, as relates to licensing requirements, are of overall concern to the HPA, and in particular as regards the ‘responsible person’ having to be a Pharmacist,” states Maria Ascencao. “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 the issue. This involves 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
“The HPA and the DSA will in 2020 seek to work together with SAHPRA to engage with the Pharmacy Council to obtain an Exemption from 14, 19 and 22C of the Pharmacy Act. The HPA is motivating that the Responsible Person could be sourced from an Allied Health Professions Council of South Africa (AHPCSA) registered member – as an example – or that a new classification under the South African National Accreditation system could be worked on.”