FAREWELL, FAIREST FRIEND

Renowned broadcaster, journalist and media personality, Monica Fairall-Morrell, died on the winter solstice of 21 June, 2009. She had been diagnosed with myeloma in late 2008 and finally succumbed to complications arising from pneumonia.

Despite the discomfort of her condition and the side-effects of aggressive treatment, Monica remained positive and optimistic to the end, sharing amusing anecdotes rather than complaints. Having worked closely with the Health Products Association of Southern Africa since the early 1980s, Monica edited the HPA Headlines since the newsletter’s inception – this issue was the last task that she completed before passing away.

A respected supporter and advocate of the South African health industry, Monica’s radio progammes disseminated well-researched information to a wide audience. Having worked closely with the Health Products Association since the early 1980s, her knowledge of the subject was impressive and her voice was a soothing balm that brought insight, joy and comfort into the lives of all who tuned in to listen.

Blessed with a razor-sharp wit, delightful sense of humour, formidable intellect, beautiful voice and radiant beauty, Monica was an inspiration to all. Her untimely death is a tremendous loss to not only our industry, but also to her husband and family, friends and colleagues. Monica was a person of integrity and serenity - to be a friend of hers was an enormous privilege.  She brought joy to the many long- standing relationships during her lifetime, while her recent marriage to Robert had ushered in a new and even more contented phase.
 
Our thoughts and sympathy go out to Robert, to Monica’s family and to all her many friends and colleagues in South Africa and around the world. Monica…we shall miss you so very much, but your spirit and legacy will remain with us always.

PLAYING BY THE RULES - but what are they?

INTERPRETING the law pertaining to CAMS products is proving to be confusing and difficult for a number of players in the health industry, so much so that a number of health product companies have recently been investigated by the DoH Inspectorate.

These developments have serious implications for the industry as a whole so an urgent meeting took place at the end of last month between HPA chairman Dr Alan Tomlinson, executive director Mathabo Mashiane and head of the DoH Inspectorate, Griffiths Molewa.

“Mr Molewa indicated that their activities did not represent an industry wide 'witch hunt' but rather a concern about certain  products being sold and claims made by some companies on the South African market,” reports Tomlinson. “He also told us that one of his priorities was to assess products and their claims on the basis of potential risk.  He does not wish to have products distributed or claims made which may endanger the general public.

"Mr Molewa encouraged us to continue with the work of the SMTC and said he was looking forward to the finalisation of the Regulations, particularly pertaining to CAMS," Tomlinson adds. He and Mashiane felt that the meeting was useful and co-operative. "Provided we act responsibly in the marketplace, there should be no difficulty for member companies,” Tomlinson says.

TRADITIONAL MEDICINE: GROWTH
& OPPORTUNITY

WITH more than 28 million consumers of traditional medicine in South Africa and approximately 185 500 traditional medicine practitioners, African Traditional Medicine (TM) is one of the major service industries in this country. It also contributes extensively to the overall economy.

Raw medicinal plants, healers' prescriptions and herbal medicines add up to an industry worth R2,9bn. Guest speaker at the HPA's March meeting, Professor Nceba Gqaleni, Chair of Indigenous Health Care Systems Research at UKZN, put members very thoroughly in the picture about current developments in TM and its importance for national healthcare.  He pointed out that the Traditional Health Practitioners Act No. 22 of 2007 had been signed into law and that a national policy on TM was at its final stages of development.

ANC Health policy calls for the integration of TM into the national health care system and the establishment of an African pharmaceutical industry so it was important for the DoH to develop a policy framework for TM, Gqaleni emphasised.

South Africa is one of 17 megadiverse countries that collectively contain about two-thirds of the global biodiversity. Along with its biodiversity, SA has a rich history of indigenous knowledge and manufacturing capacity, has access to biotechnology and is a growing site for clinical research. Gqaleni pointed out that these factors positioned the country strategically for the development of pharmaceuticals, agrochemicals, cosmeceuticals and nutraceuticals

He also touched on clinical evidence for TM, focusing on Sutherlandia and Hypoxis studies, the export of local medicinal plants and the history and purpose of bioprospecting. The majority of TM care providers are rural African women, one of the most marginalised groups in SA society. Bioprospecting for new products would empower them significantly.

THE ASA & PRODUCT CLAIMS

UNCERTAINTY about what one can and cannot say when advertising a health product is leading not only to confusion but controversy.
And provisions in the ASA code have not always been that clear or helpful either.

A presentation by marketing regulations advisor Stefan Vos at the last HPA general meeting aimed to assist members decipher the ASA codes. He explained that not only had there never been specific provisions for CAMS in the ASA codes but the MCC still did not have a basis on to regulateCAMS products. But he did stress that only products registered with the MCC may refer to any disease when making claims to the public.

In addition to elaborating on the complications associated with compliance and the consequences if non-compliance is reported, Vos provided clarification on the procedures required to adhere to the ASA Appendices. He also suggested that an HPA expert panel be set up to assist the ASA in matters pertaining to CAMS.

CAMS REGULATIONS: Still being drafted...

THE publication date of the CAMS Draft Regulations is still unknown so HPA members and CAMS stakeholders have to keep treading water. It’s thought that the draft documents are still to be work-shopped by the DoH and that the new draft regulations will contain a mixture of those published in 2004 together with clauses from regulations published in 2008.

“We believe that the Department has completed the necessary work and we anticipate that the latest draft regulations are to be published in the near future,” says HPA chair Dr Alan Tomlinson. "There will apparently be a month to comment before they are finally published. The HPA plans to request a meeting with the new Minister of Health, Dr Aaron Motsoaledi, to inform him of CAMS issues."

CAMS MUST BE IN THE HEALTHCARE SYSTEM

CAMS and Traditional Medicine (TM) must be integrated into the South African national health care system - and consumers and consumer advocates have important roles to play in ensuring the public has access to traditional and complementary medicine.

Talking at the HPA media breakfasts in Cape Town and Johannesburg last month, respected healthcare and health financing expert Professor Heather McLeod dealt informatively with a range of aspects relating to TM and CAMS - including their widespread global usage, WHO policy and the Beijing Declaration of November 2008 which recognised the progress of governments integrating traditional medicine into their national health systems.

In a presentation titled Consumers Driving Change, she stressed the importance of including TM/CAMS in our health system and highlighted the lack of medical insurance for complementary and alternative health treatments in Africa. This was out of step with supportive insurance schemes in other countries. She told the audience that integrating TM and CAMS into our national health insurance structure would enable consumers to choose according to their cultural heritage and belief systems.

McLeod's strong views coupled with her wealth of knowledge made her one of the most well-received speakers to address an HPA breakfast. An actuary by profession, she is a visiting associate professor in the Department of Public Health and Family Medicine at UCT and extraordinary professor in the Department of Statistics and Actuarial Science at the University of Stellenbosch. McLeod has also studied homeopathy and naturopathy and is registered as an Ayurvedic primary healthcare advisor with the AHPCSA. Her company, Integrated Healing, provides consulting services in health care financing. 
Prof McLeod’s power point presentation can be downloaded from the HPA website: www.hpasa.co.za

IRMA - WE SHALL MISS YOU...

IRMA Schutte, a founder and director of SA Natural Products, died on Good Friday after being diagnosed late last year with a rare and advanced cancer. 

A recipient of the HPA Personality of the Year Award during the 1990s, she was well-known and respected in the industry - and through her teaching, public speaking and media profile did much to promote public awareness of natural health and complementary medicine. Her lively personality, ready good humour and blend of personal experience with a wealth of information meant that her message was always accessible - if occasionally controversial! Dr Alan Tomlinson confirmed this in his tribute to her from the HPA. “Irma has been a doyenne in the health industry of South Africa for many years.

She had such enthusiasm for her subject and because she was knowledgeable about so many things, she always created an impact and gained respect. Irma was passionate about teaching the correct principles of health and nature and we are going to miss her contribution. Thank you, Irma, for the difference that you made.”

Two of her daughters, Estie Schreiber and Naomi Fraser, are active on the staff of SANP. Said Estie, who is marketing director: "We miss my Mom terribly. She inspired us all with her knowledge and her passion. All we can hope to do is honour her memory by carrying on the work that she loved so much.”    

ADVERTISING OPPORTUNITY IN MEDICAL PUBLICATION

THE Medical Chronicle, a leading publication to the medical profession, is to publish a supplement featuring the HPA. This will be supported by advertisements from member companies and provides a great opportunity to present the health products industry in a positive light to the medical profession.

"We need to be seen as responsible, informative and serious about what we do," says HPA executive secretary Deirdre Allen, "so we're asking members who take advertisement or advertorials to bear this in mind and to avoid making irresponsible claims or coming across as too esoteric."

Contact the publication at: (011) 787-4969
info@wilbury.co.za

PRODUCTS FOR TRADITIONAL HEALERS?

A new connection with the Traditional Healers Association (THO) and Phepsile Maseko has been established for the HPA by executive director Mathabo Mashiane. “We shall be working with them on issues that affect both associations,” she says. It's also hoped that THO can help with access to decision makers within the DoH. Adds Mathiane: "The THO is holding primary care courses for their members and have requested products to give to delegates from HPA members." 

COMPANY PROFILE

COLOURFUL HEALTH AT A CELLULAR LEVEL

TISSUE salts were formulated way back in the 1870s by Dr W.H. Schuessler. Now, more than 120 years later, a Cape Town based natural health practitioner has taken them to a new level.

Radiographer Allison Effting became enamoured with Biochemic Tissue Salts when, in 1993, they were a healing catalyst for a personal health crisis that had not responded to conventional treatment. “It seemed too simple that supplementation with these fundamental mineral energies could make such a difference to my health,” Effting reflects. "Given that I was allopathically trained, this came as a huge revelation to me.”

She went on to study the Schuessler Biochemic System of Health that's based on his view that 12 tissue salts are the basic minerals essential to life. Following her subsequent training as an Aura-Soma colour consultant and teacher, Effting began exploring the colour resonance of tissue salts and finally developed a link between the two therapies.

In 2002, her international associates became interested in the project and asked to distribute her tissue salts. This culminated in the creation of AllisOne Products. AllisOne Colour-Astro Biochemic Tissue Salts are now manufactured in Cape Town to Effting’s formulation. “They are lactose free and larger in size, so a maintenance dose is a one daily tablet rather than multiple doses. They are manufactured under stringent energetic protocols so that they achieve a biochemic rather than homoeopathic effect. They also have a balancing effect on the bio-energetic field,” says Effting.

She believes that tissue salts are vital supplements for health and well-being. “They are minerals in an energy form, held in a suitable base and released into the bloodstream via the mucous membranes when dissolved in the mouth. They thus become available to cells and tissues in a very short time and are not dependent on digestive processes to release the beneficial nutrients,” she says.
As well as being the CEO of AllisOne Products, Effting founded the Biochemic Institute of South Africa and chairs the Association of Aura-Soma Practitioners of Southern Africa. She has served on the executive of COCHASA (Confederation of Complementary Health Associations of South Africa) for the past eight years.
Her innovative tissue salts have been available overseas under the Aura-Soma label since 2005. They were introduced locally at last year's Natural & Organics expo and will be in Johannesburg with agents, Absolute Organix, at this month's expo. They are available at some health shops, from selected practitioners and can also be purchased from the AllisOne online shop.

PHARMACISTS CRITICISE
COMPLEMENTARY MEDICINES

COMPLEMENTARY medicines came under fire recently from the Pharmaceutical Society of South Africa (PSSA). In their March newsletter, the PSSA published an open letter to the Medicines Control Council outlining their dissatisfaction with the management of complementary medicines.

The PSSA felt that complementary products were “freely marketed without any regulatory oversight" and that this was "an unfortunate and regrettable failure of the MCC’s statutory obligation to ensure that the availability of medicine and related substances are in the public interest”.

Responding to the comments on behalf of the HPA, Dr Alan Tomlinson pointed out - among other things - that the HPA was "equally supportive of responsible regulation to control medicines and to appropriately control substances known as complementary medicines”.
The full PSSA letter and HPA response can be viewed in the news section of the HPA website: www.hpasa.co.za

TRAINING ...
EARN CPD POINTS WITH
NATURAL HEALTH COURSE

A comprehensive correspondence course as well as workshops in natural health and complementary medicine are available to healthcare professionals as well as health industry personnel as part of the Natural Health Continued Education Program (NHCEP).

Run by Dunamis Nutrition International, the self-study course comprises 30-plus modules drawn up by experts in their respective fields. The modules are in three groups: western herbals and plant extracts, nutritional supplements and wider complementary health issues and subjects. Pharmacists, general practitioners and healthcare practitioners who complete the training will receive 2 clinical points per module towards the continued education system.

Seven clinical points (1 CPD per workshop) in the following topics are also available: the effects of nutrition/nutritional supplements on sport performance, HIV/AIDS, cancer, diabetes, CVD, arthritis, and chronic fatigue syndrome/fibromyalgia.
Selected modules may be completed by frontshop assistants, marketers of pharmaceutical and cosmetic products, and personal trainers.
The correspondence course costs R4 500.00.
Workshops are R150 each (includes CPD certificate).

• rossouw1@telkomsa.net.
• (012) 347-6476/083-457-7480
• www.sportdynamic.co.za

LEARN ABOUT EVIDENCE-BASED SUPPLEMENTS

THE growing need within the health industry for evidence-based support of nutritional substances prompted Cape Town pharmacist Tanya Templeton to establish a training and information service called NatPharm Consulting.
She believes this support is vital when dealing with critical questioning from the allopathic industry and regulating authorities. It also helps company representatives to communicate confidently with suppliers and end-users about the merit, safety and efficacy of the complementary medicines they are handling.
Templeton's services provide product education and familiarisation with conditions that may be managed with CAMS, their mechanisms of action and place in therapy. Included is an introduction to nutrition, the holistic model of healthcare, the role of vitamins and minerals, bulk nutrients, foods and food classes, bowel flora and maintenance of health.
NatPharm Consulting also carries out research, evaluation and critical appraisal of scientific literature for product development, package inserts, outer cartons and labels, claims and marketing material, ASA complaints and MCC/DOH enquiries.
Templeton - who also has a diploma in Nutrition - directed and was an information specialist at the Medicines Information Centre in UCT's Department of Pharmacology for eight years. For the last five years she has worked as a pharmacist in the complementary medicines industry.
(021) 674 6103 / 082 655 2625 tanya@natpharmconsulting.co.za

HARD MEDICINE TO SWALLOW?

THE DoH recently passed a bill relating to a transparent pricing system for medicines and scheduled substances. The previous Minister of Health, Barbara Hogan had, on the recommendation of the Pricing Committee, made adjustments to the schedule in terms of which the dispensing fee for doctors has now been set (inclusive of VAT) as follows:

• Where the single exit price of a medicine or scheduled substance is less than R65, the dispensing fee must not exceed 30% of the single exit price.
• Where the single exit price of a medicine or scheduled substance is greater than or equal to R65 the dispensing fee shall not exceed R20.

FORTHCOMING EVENTS ...

GET YOUR HEAD AROUND
THE COMPANIES ACT

The new Companies Act - which will have a major impact on all companies in South Africa - is to be implemented in the near future. The Companies Act 2008 has modernised the Companies Act of 1973 by promoting transparency and corporate governance and aligning it with international best practice. Furthermore, it's completely revamped the way companies are formed and the way company officers will be expected to conduct their affairs.
The new act will entirely replace the existing Companies and Close Corporation regulatory regime. Signed into law on 8 April this year, it will take effect some time in mid-2010 to enable companies to bring their administration into line. It is vital therefore that local companies familiarise themselves with the contents and implications of the Act.

To ensure that HPA members are up to speed on what the Act means, the HPA, in conjunction with Sonnenberg's solicitors, is hosting a breakfast seminar on Tuesday July 7.  Michael Katz, one of the drafters of the bill, will present the two hour seminar entitled The Ramifications of the Companies Act 2008. This will be followed by a short lecture from the Sonnenberg’s team on the health care regulatory environment, BEE and/or the Protection of Personal Information Bill. The venue is EAS/Sonnenberg’s, 150 West Street, Sandton. Cost is R150 which includes a continental breakfast.

Contact: Deirdre Allen - hpasa@hpasa.co.za - (011) 789 4464

WIN WITH THE APPLETISER
HEALTHY LIVING EXPO

TIME is running out to stake your place at the Appletiser Healthy Living Expo. Set to take place from 4 to 6 September, space is limited so it is wise to book a stand as soon as possible. And ask if you're still in time to catch the early bird bonus! Some exciting new companies have signed up this year, so make sure you take advantage of this opportunity to showcase your products and services directly to the public. The exhibition is held in the Fountain Court at Sandton with a good volume of people traffic.

Contact: Heather Hook
(021) 713 3360 -heather@fairconsultants.com.

NATURAL & ORGANIC PRODUCTS
– ON SHOW AGAIN

THE increasingly popular Natural & Organic Products Exhibition will be hosted alongside a sister event this year, The Women’s Show. This will ensure an increased number of visitors and a cross-pollination of markets that have a natural synergy. Taking place from 26 to 28 June at the Coca-Cola Dome in Johannesburg, the show is set to attract between 15 000 and 20 000 visitors.

As the largest green industry platform in South Africa, the exhibition provides a wide range of natural and organic products, sustainable technologies, services, information and practical advice under one roof.  It might be too late to be an exhibitor, but diarise the date and place to take a look at how the green revolution is taking shape in South Africa. It's our future.

(021) 671 0935 - amy@specialised.com

AUGUST WORKSHOP IN OTC MARKETING

PHARMACEUTICAL marketers have a chance to attend an OTC Pharmaceutical Marketing Workshop scheduled for 12 August at Johanneburg's Indaba Hotel. Seven workshops will be presented that day including an all-important one on the new Marketing Code which is supported by all the pharmaceutical associations and will profoundly influence marketing practices. The new code will shortly be officially announced and will become an essential reference for OTC marketers. A panel of speakers – including the HPA's Mathabo Mashiane – will focus on key issues and answer questions. The objective of the workshop is to communicate best practices in marketing at retail by focusing on case study examples and highlighting success factors. The workshop is organised by Marketing Mix in association with POPAI SA (Marketing at Retail), and cost per delegate is R2 850 (plus VAT). Three or more delegates, R2 500 (plus VAT).

Enquiries: Daisy Mulenga - daisym@systems.co.za
(011) 234 7008

RESEARCH & REGULATION NEWS FROM AROUND THE WORLD (Supplied by IADSA)

AMERICAN SUPPLEMENT LAW
UNDER ATTACK

IN the wake of a number of recent recalls of harmful products in the USA, a massive attack has been launched against the Diet Supplement Health and Education Act (DSHEA) by the American media and public. There is a rising tide of calls to change the DSHEA claiming that it is bad law, that it has de-regulated the industry and should therefore be changed.

However, the Act has its defenders. The Council for Responsible Nutrition (CRN) says that it was the failure to enforce the law that caused most of the problems. CRN points to powers within the DSHEA which the FDA and other agencies have consistently failed to apply. Food lawyers Ivan Wasserman and Svetelana Walker argue that to carve up the regulations would be to turn a blind eye to all that is good in the Act and what it has achieved since being enacted in 1994.

Also in defense of the DSHEA, Michael Sawnor of the All American Pharmaceutical and Natural Foods Corporation, declares: ”Without DSHEA, it is very likely that herbs, enzymes and anything other than a basic low-dose multivitamin would have been removed from the market. We cannot return to those dark ages.” He too believes that the FDA has failed to implement or enforce even the most basic parts of the law.

“The fact that some rogue individuals are selling products intentionally laced with prescription drugs, which is and always has been illegal, is now ‘evidence’ that the FDA lacks regulatory authority,” writes Sawnor. “FDA does not lack authority. It is the dishonest anti-supplement coalition that lacks authority…moral authority.”

And from the IADSA Newsflash ...

HERBS: MEDICINE OR FOOD SUPPLMENT?

SPAIN: The European Court of Justice recently judged against Spain for its practice of considering products that contain herbs as medicinal. This is despite the fact that they are marketed legally in other EU states as food supplements. The Court saw this practice as incompatible with the principle of the free movement of goods. The ECJ decision was that substances which, while having a physiological effect on the body but one that is not significant, should not automatically be classified as medicinal products by function.

THUMBS UP FOR HIGH SELENIUM YEAST

USA: The FDA has approved a ‘generally recognised as safe’ (GRAS) status for a type of high selenium yeast. The l00% organically bound high selenium yeast is standardised with the US National Cancer Institute, and is intended for use to reduce cancer of the lung, colon and prostate. 

NEW GREEN RESEARCH AGENCY

UK: A new Food & Environment Research Agency (FERA) has been launched that aims to support and develop a sustainable food chain and healthy natural environment and to protect the global community from biological and chemical risks. The new agency brings together expertise in: the understanding of relevant policy and regulation issues; inspection services to protect seeds, crops, etc; the science necessary to horizon scan for issues, diagnose threats, trace contaminants, evaluate risk and inform policy; response to and recovery from contamination.

WEIGHT LOSS PRODUCTS DOWN UNDER

AUSTRALIA: The Australian Department of Health and Ageing has developed a Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss. This has been produced to assist sponsors of listed complementary medicines evaluate the evidence around indications and claims for weight loss. If consistency in the type and level of evidence required for these indications and claims is achieved, it will give consumers confidence in the medicines they choose for self-care.

GETTING TOUGH ON FOOD IMPORTS

USA: The Food and Drug Administration (FDA) and US Customs and Border Protection have published a notice of rules pertaining to imported food - and a draft guide outlining the agencies’ enforcement policies. The types of food affected include dietary supplements, dietary ingredients and infant formula.

NANOTECHNOLOGY & FOOD SAFETY

USA: Concerns raised by member countries on the safety implications of the application of nanotechnology to food and agriculture have prompted the Food and Agriculture Organisation  and the World Health Organisation to hold an expert meeting to explore the issue. Their aims are to:

• summarise actual and anticipated nanotechnology applications in the food and agriculture sectors, and what their implications for food safety might be
• review current risk assessment procedures for their suitability to assess nano-particles in relation to foods
• consider questions of communication with all stakeholders and research priorities to fill information gaps around food safety issues.