THE WELLNESS INDUSTRY OF SOUTH AFRICA: A PATH TO APPROPRIATE REGULATION

Executive Summary

Wellness is a growing trend, both locally and internationally. People seek to take responsibility for their health, diet and state of mind. One of the ways they are doing this is through the many wellness products and services, health and dietary supplements and age-old traditional medicines from China, India and others.

The industries supplying these products and services have, since the 1980’s, been subjected to attempts by the medical regulatory authorities, and the medical industry, to comply with a range of pharmaceutically oriented regulations. In the majority of cases, these are highly inappropriate, costly and sometimes not even possible to implement for products in the wellness paradigm.

In many countries across the world, these wellness products are seen as food supplements, dietary supplements or natural health products. South African companies importing wellness products are forced to carry unnecessary additional costs, as these natural health products need to comply with pharmaceutically oriented medicine regulations before they can be sold locally. Local manufacturers who export products must first comply with these costly pharmaceutical regulations, before sending to countries with far more appropriate requirements.

Many of these wellness companies are small to medium businesses. These high costs are impacting their ability to survive, resulting shrinking businesses, job losses and less consumer choice.

The South African Government should not only support this once thriving business sector, but also make it both easy and affordable for consumers to access these products, to maintain good health – thereby reducing the already high load on the medical sector of the country.

Introduction

The Medicines Act 101 of 19651 was adopted to regulate the use, distribution, and manufacture of medicines and medical devices in South Africa.

In the 1980s it was acknowledged that Wellness products – named “Complementary Medicines (CMs)” by the various regulatory bodies – were different to Allopathic Medicines (e.g. they come from different paradigms, belief systems and energy systems and traditional practice) and therefore needed different criteria to Allopathic Medicines for regulation. Until 2013, many attempts were made to create a regulatory framework for Wellness products, both separate to and as part of the conventional / allopathic medicines framework.

This period up to 2013 featured many attempts by the Wellness industry to provide the various regulatory bodies of the time (such as Medical Control Council and South African Health Products Regulatory Authority) with a framework and set of processes that was appropriate to this category of products. The case for a different set of rules for Wellness was motivated by, amongst others

1. Many countries from around the world view these products as food supplements, dietary supplements or natural health products. They are not seen as medicines.
2. The relatively low risk levels of Wellness products aligns them far more with foods than Allopathic Medicines.
3. The wellness market consists of “consumers”, usually healthy individuals seeking to maintain their health and wellness, as opposed to the target market for pharmaceutical products, who are considered “patients”, usually seeking a remedy for an illness or other form of health disorder.
4. Many ingredients used in Wellness products are derived from natural sources. Some of these products are simple combinations of ingredients for convenient consumption and health benefits. In many cases, these ingredients are also used in household food preparations.
5. Wellness products often include multiple health supporting / promoting ingredients combined for a range of benefits – as opposed to the allopathic medicine approach of mostly single “active pharmaceutical ingredients” (APIs) used for preventing, diagnosing, treating, or relieving a disease or abnormal condition, or affecting the body’s function.

In 2013, amendments to the General Regulations of the Medicines Act2 established a category of medicines, Complementary Medicines (Category D) – referred to as CMs. These “medicines” which fall under this definition, included Health Supplements (e.g. vitamins, minerals, oils, proteins, probiotics, prebiotics, carotenoids, polyphenols, amino acids, saccharides, enzymes and others) along with other ingredients used in six major traditional healing disciplines namely Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine, as described in the Guideline for Complementary Medicines (Quality, Safety and Efficacy)3. It is worth noting that African Traditional Medicines are specifically excluded.

These regulations brought upon the wellness industry the need to licence their premises with South African Health Products Regulatory Authority (SAHPRA), the National Department of Health (NDoH) and with South African Pharmacy Council (SAPC).

The introduction of the need to register with SAPC requires these wellness companies to register as a Pharmacy and employ a registered pharmacist to act as the company’s Responsible Pharmacist. Some of the problems with this approach have been:

1. Some wellness companies do not handle or store product. There is therefore no need for them to register their premises as a pharmacy. Their premises are essentially an administrative office coordinating service providers and logistics. Moreover, these companies do not have any role for a pharmacist. This is an entirely unnecessary overhead.
2. Pharmacists are trained in allopathic medicines and have had limited to no training on any of the wellness / CMs paradigms. The role of Responsible Pharmacist is therefore in many cases wholly unsuited to a wellness company.

These regulations also introduced the registration of product requirements, and in the future, wellness products will need to comply with the ICH CTD (Common Technical Document) format. This is an electronic documentation structure that was developed for allopathic medicines which is overkill for wellness products and in many instances, either impossible to comply with or wholly unaffordable for these companies.

It is also important to note that many companies in the wellness industry are small to medium businesses. Therefore, the costs of unnecessarily and overly pharmaceutical standards will eventually result in many of these businesses either closing or scaling down in size and product range. This is negative not only for the country’s economy and job market, but also for the consumer, whose personal health choices will become both more limited, as well as more expensive.

The HPA’s collaborative approach

The HPA (Health Products Association) has, since it was founded in 1976, worked with the various authorities and acted as a voice for its members. Since the HPA is certainly the largest representative body for wellness companies, it justifiably claims to represent the broader wellness industry.

Through this collaboration, the HPA has provided extensive comment on all legislation that, over the years, was published for comment. The Association has also attended meetings, workshops, webinars with the various authorities and representatives of these bodies. In many instances the HPA has received feedback from its members on matters which it has then presented to SAHPRA, SAPC, the Minister of Health in an attempt to give input to regulation.

At all times, the HPA has called for appropriate regulations for the wellness industry. It does not believe that regulations designed for an allopathic paradigm, and their requirements, are suitable for Wellness and has worked extensively to provide alternatives that will appropriately regulate the industry for the quality, safety and efficacy needed to protect its customers.

International precedent

Although in South Africa, wellness products are called “Complementary Medicines” (CMs) by SAHPRA and consistently being treated as if they are medicines, they are more appropriately named in many other countries and dealt with as foods. (see some examples below – there are many more)

1. Europe (including UK): “Food Supplements”, governed under food law
2. USA: “Dietary Supplements”, governed under food law
3. Canada: “Natural Health Products”, governed under its own directorate
4. Japan: “Dietary Supplements”, governed under food law
5. Singapore: “complementary health products”
6. Asean Region (10 countries): “Health Supplements” under Food Legislation
7. India: “Food Supplements”, governed under food law
8. China: “Health Foods”, governed under food law
9. Mexico: “Food Supplements”, governed under food law
10. New Zealand: “Food Supplements”, governed under food law

By forcing these products into the allopathic medicine regime, the South African authorities have created a disconnect with many of these important trading partners. The practice of importing a dietary supplement that needs to comply with medicine-like requirements adds enormous costs to the product and hence, to the consumer.

In the same manner, local manufacturers of health supplements need to comply with inappropriate and costly regulations which cause them to be uncompetitive on the international market – where they are competing with businesses producing the same products, but having to comply with more appropriate, in many cases food regulations.

Both the above result in loss of business opportunity, reduced income for both businesses and the state as well as higher costs to the consumer.

Court case: are health supplements medicines?

In April 2022 the Alliance of Natural Health Products (ANHP) won their case against SAHPRA in the Supreme Court of Appeal (SCA). The judge ruled products that do not make therapeutic claims are not “medicines”. Since SAHPRA had been attempting to regulate these products under a medicine-like framework, this created hope amongst the wellness industry that an appropriate regulatory environment would be the result.
The judgement specified that the Minister of Health had 12 months to remedy this situation. This could be in the form of adjusted regulations or a change to the Medicines Act. That 12 month period ended in April 2023 and, to date, the industry still awaits this remedy. In the interim, SAHPRA have applied the pre-existing regulations and guidelines as “business as usual” until the publication of the amended Regulations. However, due to the lack of clarity as to what Regulations and Guidelines actually do apply, the industry has been subjected to varying interpretations of the rules, causing confusion and frustration.

Specific issues impacting Wellness industry companies

1. Annexure B: Guideline 7.04 lists the approved health supplements. The only way for companies to request that SAHPRA add new ingredients and products to this list is by submitting via an Annexure B application. The following are the current issues with this process:
   • SAHPRA is not processing, or is extremely slow to process, these Annexure B applications, severely limiting companies wanting to release new products, or import certain ingredients not on the list into South Africa (even though they are available in many other countries around the world).
   • SAHPRA has refused to permit access to the status or the nature of the Annexure Bs in their system. They are therefore not being accountable for their commitment to process these applications, with some having been submitted as far back as early 2022.
   • In addition, without making the substances for which Annexure Bs have been submitted publicly available, companies are unable to determine whether they should submit for their own purpose or not – creating duplication of work due to multiple companies having to submit Annexure Bs for the same substances.
   • Without Annexure Bs being processed, Guideline 7.04 is fast becoming an out of date list.
2. Port Health – Virtually all products and raw materials for the wellness industry being imported into South Africa are now subjected to inspection by Port Health. The following lists a few examples of the problems experienced
   • Different interpretations by different inspectors – meaning that one company will have a product approved and another company will have the same product detained
   • Recent change by SAHPRA whereby an Annexure B application must be approved before a product or ingredient may be released
   • As a result of Guideline 7.04 not having been updated since March 2022 and Annexure B applications not being processed timeously, companies struggle to import any relatively new product or ingredient as Port Health has no way to approve them.
   • Port Health’s processes are not geared to split shipments, meaning that if a shipment consisting of multiple products or ingredients have one item that is not approved by the inspector, companies are subjected to the entire shipment being detained and, in many cases, either have to be sent back to their source or be destroyed. Companies are losing millions of Rands due to this.
   • Ingredients that are actually foodstuffs are being stopped – these are not on the Guideline 7.04 and no Annexure B exists. Since these ingredients do not need to be listed on either as SAHPRA does not regulate Foods, there is no clear way for companies to address this situation.
3. Certificate of Free Sale – Companies exporting products to certain countries require a Free Sale Certificate that confirms their regulatory status in South Africa. Without this certificate, they are cannot export and since this certificate needs to be renewed from time to time, it becomes an important requirement for them to do business. Current challenges are
   • Currently SAHPRA is extremely slow to issue these certificates, with many of the HPA’s members having applied months and some even years ago and still have not received a response.
   • SAHPRA do not give feedback, or are extremely slow and limited in the feedback they provide to companies on the status of their Certificates. With this being an important document to enable them to do business, this lack of response has a negative impact on their business.
4. SAHPRA Licences – The experience from members who have applied for a SAHPRA licence ranges vastly. These include:
   • Some members submitted their application in February 2022 and have still not heard anything back from SAHPRA or have had one or two requests for additional information, to which they have responded and still have no idea as to when they will receive their licence
   • The HPA has been asked by members to intervene in instances where they do not understand what SAHPRA has requested and are not able to discuss their question with a SAHPRA representative who will explain what is needed – ie, SAHPRA staff are often not helpful.
   • In many cases members have received a final approval for their licence application from SAHPRA but have not received their actual licence. In most cases, they also receive no response to their follow ups requesting status their licence. These companies, after having complied with all requirements for a licence are still left without one and no feedback as to when they will receive it.
5. SARS tariffs – SARS has recently also effectively begun to “regulate” wellness products through amendments to the Customs and Excise Act of 1964. Their definition is different to that of SAHPRA.
   • This additional amendment appears not to fully take into account SAHPRA’s regulations and so companies find the combination of SAHPRA and SARS requirements even more restrictive.
6. African Traditional Medicine
   • This sector is currently unregulated in South Africa. The topic is highly political, including issues of cultural sensitivity, intellectual property rights over traditional knowledge, power, identity, and social justice specifically in the context of the South African historical landscapes.
   • In some cases, practitioners package products that make them appear to be wellness products and sell them through similar mechanisms. This discriminatory practice places an unfair advantage to these operators, as they have no cost to licence their business, no burdensome administrative requirements, no need to employ a pharmacist, no GMP (Good Manufacturing Practice) monitoring or requirements and they do not need to register their products.

Supporting Wellness in South Africa

As the above has shown, the HPA has consistently engaged with the various authorities over time. In most cases the HPA’s input and feedback has been either ignored or only partially taken into consideration.
The HPA has proposed solutions to the Regulator and the Authority several times. Specifically, the HPA presented a comprehensive solution to the MCC in 2013, in which it detailed a separate directorate, a simplified screening system for low risk CMs and appropriate requirements for all discipline specific healing modalities, including African Traditional Medicines.