WHY SUPPORT THE TNHA?
The TNHA is inviting any person, company or organization with an interest in protecting access to Natural Health Products (NHPs) and Dietary Supplements to support the TNHA. By limiting its purpose to protecting access to Traditional & Natural Health Products, the TNHA will focus on identifying and responding to threats facing the traditional & natural health product sector. In essence, the TNHA will act as an industry watchdog and as a social catalyst to bring about fair, transparent and appropriate regulaions for Traditional & Natural Health Products.
The Natural Health Product (NHP) Industry in South Africa is under immediate threat. For example:
- the majority of NHP registration applications to the Medicines Control Council (MCC) are being denied under Regulations that that are pharmaceutical styled and wholly inappropriate to the natural health product industry. In the three years since the gazetting of the regulations for NHPs (2013), the Medicines Control Council have only given the ‘right of sale’ to 6 (six) NHPs for which applications for registration as ‘Complementary Medicines’ were made. The MCC conducted an audit on the NHP sector between February 2002 and late 2013. In that period they found there to be over 120 000 NHPs on the local market. The slow page of registration is due to the MCCs historical capacity crisis, the inability for NHP manufacturers to comply with the regulations and the industry’s mass action campaign to boycott the regulations which are considered unconstitutional, unlawful and irrational.
- the regulatory requirement that all NHP manufacturers be licensed as pharmaceutical companies and to upgrade their manufacturing facilities to a cost exceeding R20 million (for a small scale facility) is unaffordable for most manufacturers. Companies can either not raise the capital required to comply, or see no cost recovery model. The vast majority of ingredients used in NHPs are Generally Regarded as Safe (GRAS) and are regulated as foods in various developed countries (i.e the USA). The regulatory requirement that Pharmaceutical Good Manufacturing Practice (PGMP) be applied to all HHPs is both irrational and an excessive cost burden. Because NHPs are low risk substances, less onerous and less costly Food Good Manufacturing Practice (FGMP) should be adopted as the minimum standard required. We concede that there are a few NHPs which may have a higher risk profile (based on substance, dose or method or dosage form) which can have their GMP scaled up accordingly.
- the manufacturers of NHPs will have to employ full-time pharmacists in their manufacturing facilities and distribution offices. A starting salary of a production pharmacist begins at R45 000 a month. South Africa has a critical shortage of qualified pharmacists, with a shortage of 600 urgently required to fill posts in just the state healthcare system. Pharmacists are not trained in natural health principles and philosophy, and no longer study pharmacognosy in university, therefore rendering them unsuitable for this industry.
- the new NHP Regulations are driving small and medium sized manufacturers out of business due to the excessive costs to comply. It is the small and medium size companies which produce most of the innovative products which are beneficial for health and wellness. Manufacturers are being forced to continue to drop low selling Natural Health Products due to the high cost of compliance. or to reformulate them out of efficacy (lowering the amounts of certain substances of substituting them). The net result of this will be large companies (pharmaceutical companies) choosing the ‘safe’ path ahead and producing mainly synthetic, low potency multivitamin type products to exploit the vacuum created by the loss of thousands of real natural health products. The public will be left with false choices when seeking out non-drug therapies and wellness products.
- the NHP Regulations will unduly increase the cost of products;
- the NHP Regulations drive products from the market that South Africans depend upon for their health;
- innovation on new products is grinding to a halt as it becomes clear that novel multi-ingredient products will not pass the MCC’s scrutiny without drug-style evidence in the form of clinical trials;
- natural health products that consumers, retailers and distributors depend upon are stopped at the border due to non-compliance with the Regulations.
The TNHA is ideally suited to deal with this immediate threat.
There is a pressing need for an organization that is positioned to take a leading role in uniting both the stakeholders and the other interest groups in the industry. The leading consumer groups have already expressed a desire to work with the TNHA in forming a coalition. The TNHA may be the only organization capable of creating the coalition necessary to address the immediate regulatory crisis.
- The TNHA will be able to include those stakeholders that for whatever reasons are unwilling to work with the other industry groups.
- The TNHA will seek to work with all other industry groups to bring about regulatory change and in this way can act as a bridge between those groups and stakeholders and consumer groups currently unwilling to work with them.
- The changes required to bring about an appropriate regulatory scheme for NHPs may require legal action to be instituted against the Ministry of Health, National Department of Health and the Medicines Control Council. The TNHA have already appointed a legal team to prepare for this eventuality should other means of negotiation and lobbying fail.
The current regulatory crisis is not the only issue threatening the NHP industry. Although the Natural Health Product industry is facing an immediate threat with the imposition of the drug-style NHP Regulations, there are other threats lurking in the background. These threats include:
- international treaties and harmonisation schemes South Africa are participating in which threaten our sector such as CODEX, The International Coalition of Medicines Regulatory Authorities (ICMRA) and the Pan-African Medicines Regulatory Authority (AMRA).
- the imposition of ever stricter standards (regulatory creep) upon the industry by the MCC.
- the arbitrary seizure of NHPs at our border by the Port Health Authority, following unlawful instructions by the Department of Health and MCC.
Stakeholders are currently not being kept up to date on these issues. The TNHA keeps up to date on these issues and will be working with our members and alliance partners to protect them from these threats.