NEW LOOK FOR HPA
The HPA has repositioned its image to support its new strategic objective of becoming the country’s key innovative, reliable, and trusted industry body. In conjunction with Saige Business Consulting, the HPA’s repositioning includes a revitalised logo and website.
The interactive and informative website is to be launched in June 2016. It contains HPA and CAMS-related material useful to members and consumers. While some aspects of the site are available to the general public, HPA members will have a log-in code to access useful research documents and links that are of value to CAMS-industry stakeholders. These include Parliamentary Acts, documentation on: production, manufacturing, distribution, along with a comprehensive library of links to numerous related organizations, and a credible database of members.
Future projects include a marketing strategy to increase consumer trust, plans to improve product safety and efficacy, and strategies to improve working relations and trust with the Department of Health (DoH), media, consumer groups and associated bodies.
LEGISLATION
REGISTRAR OF MEDICINES MEETS WITH HPA
On 7 April 2016 Dr Joey Gouws the Registrar of Medicines at the South African Medicines Control Council (MCC) gave a presentation to the HPA Executive Committee. The salient points are documented below.
Entitled ‘Medicines Control Council & Update on SA Health Products Regulatory Authority & CAMS’, the presentation included an explanation of the structure of the Department of Health (DoH), the MCC, along with the structure and future role of the South African Health Products Regulatory Authority (SAHPRA), and relevant Complimentary Alternative Medicines (CAMS) topics.
She extended a sincere and personal invitation to members of the HPA and CAMS industry to interact with her.
Dr Gouws stated that CAMS is considered to be a new industry in terms of regulated medicines. According to her figures the lack of an appropriate CAMS regulation is stifling industry growth. She revealed that there are approximately 120 000 CAMS products on record.
She added that whilst the MCC includes a Complementary Medicines Committee (CMC) chaired by Dr Neil Gouwer, the CMC (which comprises of 30 CAMS evaluators) have yet to approve any of the 120 CAMS applications received since November 2013.
Furthermore there are usually approximately 1 800 applications a year, but only 10 are on record for the period May 2014 to November 2015.
The following specific regulations relating to CAMS-status was clarified by Gouws:
1. Health Supplement: A product, whether vitamin, mineral or nutritional supplement with ingredient levels below the published registration levels and with a “soft” claim, will be deemed a health supplement. GMP quality is the main criterion on which these products will be assessed. Any products above the registration levels will be deemed a medicine.
2. Pharma Format: Any product whether it be a capsule, powder, tablet, etc., will be deemed a CAMS product if in a pharmaceutical format. The assessing of these products will depend on the claim and the intention of the product.
3. Responsible Pharmacist: Companies will be required to apply to the Pharmacy Council for an exemption should they not make use of a pharmacist. The Pharmacy Council and not the MCC has this ruling in the Pharmacy Act 29.4. The MCC deems the person who has submitted the dossier as the “owner” of that product and responsible for its efficacy and safety.
4. CTD: The completion of a CTD application for CAMS will have its own guideline replacing the existing one. Once again, emphasis will be on quality. Gouws informed the HPA Executive Committee that health supplements fall under the MCC and not food law. This despite the fact that Codex has deemed all nutritional/health supplements to be foods.
She also stated that the MCC does interact with other countries regarding these matters – in particular the European Union, Singapore, Australia and Canada, amongst others.
Finally she commented that the MCC has decided to forego the idea of utilising the listing system in South Africa due to its lack of success in some countries.
INDUSTRY TRENDS
REGULATIONS IMPACT SURVEY
Despite the austere regulations gazetted in November 2013, the industry continues to grow. According to an impact survey recently commissioned by the HPA and conducted by Health Eye, the current market value is approximately R8 billion, with a growth rate of 13.5 percent in 2015.
In order to understand the impact of regulations, Health Eye obtained evidence from HPA member companies on: human resources, manufacturing, import and export, current product availability, registration status, and financial aspects.
Health Eye commented as follows: “HPA membership was categorized into raw materials and finished product contract manufacturers, CAMS products companies and ‘other’ companies not falling into any of the aforementioned categories. With 67.4 percent of the members either completing or partially completing the questionnaires, the results of this survey are considered representative of the HPA membership.”
It concluded that potential problems include the cost of compliance with regulations; as this may force many companies to retrench staff and some may even have to close business, as well as drastically reducing the number of new products entering the market, whilst current product ranges are being reduced and consolidated.
According to Health Eye, “The CAMS industry is currently facing a period of change and uncertainty, and although market figures indicate a strong growing market, initial quantification of the potential risks signal possible adverse effects, particularly on the smaller companies.”
WHAT’S ON – FEEDBACK
THE ECONOMIC IMPACT OF FOOD SUPPLEMENTS ON GLOBAL HEALTH
HPA President Bruce Dennison was one of many esteemed speakers at the IADSA General Assembly held on 27 April 2016 in Prague. “It was fantastic,” enthuses Dennison. “The main theme was the role of dietary supplements in global health. The insights presented prove that proper nutrition and dietary supplements have a positive impact on health worldwide. It is important that South Africa benefits from this knowledge and takes cognisance of the vital role that our industry can play in this country.”
Presentations were provided by representatives from key countries including New Zealand, Turkey, the Pacific Alliance, China, India, Japan, Indonesia, South Africa and the USA. IADSA gave comprehensive reports on the following topics: “The Evolution of Nutrition”, “From Science to Economics: The potential value of supplementation” (which included discussion on the Challenges and Opportunities for Micronutrients and Phytonutrients), “The Economic Burden of Non-Communicable Diseases and the Role of Nutrition”, and the “Global Heath and Economic Impact of the Use of Food Supplements”.
INTERNATIONAL
CRN CONNECTION
The Council for Responsible Nutrition (CRN) is a trade association that represents dietary supplement manufacturers and marketers in the United States. While the organization focusses primarily on US domestic regulatory issues, it also hosts global symposia, meetings, and publishes various scientific documents beneficial to CAMS industry associations worldwide.
”As we observe the increasing interconnectivity of our interests around the globe to protect and cultivate the environment for our respective members and their nutritional products, we appreciate the need for regular communication among the associations who defend these interests,” explains CRN President & CEO, Steve Mister.
As CRN develops content that is of global interest, so the organization will share this with HPA members. CRN press releases and announcements of legislation or regulations that may impact on companies exporting products to the US, as well as other items. To this end, CRN now offers for review the recent CRN-I scientific symposium proceedings article that appeared in the European Journal of Nutrition. This is freely available on the CRN-I website, and freely cite-able and shareable. The abstract has been translated into a number of languages, also posted on this website.
INDIGENOUS CORNER
BE AWARE OF BIOPROSPECTING
South Africa is a megadiverse country. One of 17 nations that collectively account for 70 percent of global biodiversity. The lack of appropriate bioprospecting legislation has over the years, resulted in many valuable materials being excessively harvested and exported. This to the detriment of local communities and the economy. Fortunately, along with many other countries, South Africa is now regulating bioprospecting. The Department of Environmental Affairs (DEA) has been meeting with the CAMS industry to ensure that they are aware of the various regulations surrounding the marketing of African indigenous plants.
Companies that market indigenous South African herbs must ensure that they have the correct licences and permission to use a natural resource. To gain insight into the necessary requirements and ramifications of indigenous material use, the HPA is to be included in a Forum currently being formed by the DEA. Be aware that the DEA is empowered to arrest and fine those who do not adhere to bioprospecting regulations: one company has already been charged with non-compliance and the option of a 10-year jail sentence or R10-million fine.
The DEA Bioprospecting Regulatory Guidelines can be downloaded by clicking here
For a list of indigenous plants go to: http://redlist.sanbi.org/ or https://www.cites.org/
HELPFUL HINTS
ADVICE ON USING A CONTRACT MANUFACTURER
Employing a contract manufacturer requires thoughtful and thorough research before making a final decision. The final decision depends on whether you prefer to sell, market or manufacture. If you want to focus on selling your brand it makes sense to consider using a contract manufacturer that specialises in manufacturing and can provide a valuable service to a CAMS business.
Most importantly, when it comes to choosing a contract manufacturer, do your homework. Ask questions. Research the options. Find out which are the best and most reliable contract manufacturers in your area, those that will give the best service, rates and value for money. And box at your fighting weight – go for a company that fits your requirements, can benefit your business and respects your product. A very small company may turn out to be too reliant on your business, while one too big may consider you small fry and not worthy of too much attention.
