Regulatory Process for Traditional and Natural Health Products in South Africa

Regulatory process for traditional and natural health products in South Africa. The main objective of the Alliance for Natural Health Products South Africa is to ensure that consumers receive quality and safe products. Universities have a role to play in regulating traditional and natural health products.

Regulatory process in South Africa

Until recently, the Natural Health Products (NHP) sector of the health industry in South Africa was not regulated. In fact, the Medicines Control Council (MCC) had a backlog of more than 14,000 applications to register products. This resulted in a situation where consumers faced a lack of choice and a monopoly in the market for these products. The Minister of Health appointed a Ministerial Task Team to review the MCC and recommend a new regulatory authority. The new authority would be a public entity and be funded by the industry on a cost-recovery basis.

However, the proposed new regulatory system is expensive and complex. It also has the disadvantage of being a barrier for small and medium-sized manufacturers. In addition, it is also discriminatory in terms of race, tradition, social origin, belief, etc. It is also not transparent and does not respect constitutional obligations. There is a need for a more rational regulatory system to balance consumer choice and the public safety.

The World Health Organisation's Traditional Medicines Strategy was published in 2013. In addition, the Department of Health has been working with universities in South Africa to regulate the quality of products. The University of North West has been at the forefront of regulating the quality of products, while the University of Cape Town has a Drug Information Unit.

A plethora of plant species are found in South Africa. There are approximately 24,000 plant species in the country, ranging from indigenous African traditional medicines to western and Chinese medicinal plants. These plants are generally regarded as safe as a whole and offer synergistic effects. Many of these products have been used for years without serious reports of toxicity. It is imperative to repeal existing NHP regulations and establish a new regulatory framework that protects the consumer and the product.

A similar regulatory process has been successfully implemented in Australia and Canada. In this case, an Electronic Listing System (ELS) was set up. This system was designed to allow for quick control of Traditional & Natural Health Products. ELS committees were expert working groups that assessed the novel health products. The committee approved the inclusion of Natural Health Products in the ELS database, as well as African Traditional Medicines. The ELS has been accepted by the MCC. It is anticipated that the system will be up and running within a few months.

The new regulatory process for natural health products in South Africa should be based on the 'presumption of safety' principle. There is no reason for consumers to be forced to prove the safety of a health product. Instead, the state should provide compelling reasons for current discriminatory regimes. It should also ensure that the product's safety is guaranteed and the user has access to the product.

In addition, the current regulatory process discriminates on the belief behind the product. It is also difficult for small companies to obtain registration. For example, the application fee for evaluation of a single product costs R12,400. This is excessively expensive for small companies. crinière de lion

Regulatory process for traditional and natural health products in South Africa

Until recently the parallel health sector in South Africa was not regulated. The Medicines and Related Substances Act (MRSA) was intended to control new synthetic molecules such as thalidomide, but was not intended to control African Traditional Medicines (ATMS). However, the industry has grown from about 30 million people in 2006 to over three billion dollars today, with about 24,000 plant species being used in ATMs. These ATMs are sold in pharmacies, informal Spaza shops and are now being sold in formal retail stores.

In 2008 the Minister of Health announced the separation of Non-Indigenous Traditional Medicines from Indigenous African Traditional Medicines. This was done after the World Health Organization's Traditional Medicines Strategy was published. A similar system has been implemented successfully in Australia and Canada. The Department of Health is now working with universities in South Africa to regulate products.

The regulatory process for traditional and natural health products in South Africa needs to be rethought and redirected in order to protect the public and guarantee consumer access. The current regulations discriminate against a number of factors, including social origin, belief and culture. They also place an unfair burden of proof on manufacturers. These burdens of proof are unconstitutional. The current regulations are excessively onerous for small and medium sized companies. In addition, the fees for registration and evaluation are too expensive. This will mean that the vast majority of products will not be registered or evaluated, and the consumers will be left with limited options.

The Medicines and Related Substances Act should be reformulated to include traditional and natural health products, and the products listed under the Act must be regulated under equal terms. The current Regulations for NHPs have resulted in confusion, with some herbal products being marketed without being assessed for safety. The Health Products Association of South Africa has challenged the regulations in court.

The regulatory process for Traditional & Natural Health Products in South Africa should not only be reformed, but a separate Directorate should be set up to oversee the regulation of these products. The 'presumption of safety' principle should be employed in order to avoid the burden of proof on manufacturers.

An Electronic Listing System should be implemented to allow for rapid control of Traditional & Natural Health Products. The ELS can be set up within months at a very minimal cost. The ELS can run a positive list of pre-authorised Traditional African medicines and other natural health substances. These substances can then be vetted by expert working groups. The ELS committee will approve inclusion of Natural Health Products in the ELS database. The committee will then collate data from various sources, and make recommendations to the relevant Category Sub-Committees. These decisions will then be forwarded to the Department of Health for implementation.

Regulation of traditional and natural health products in South Africa by universities

Until recently, the parallel health sector in South Africa was relatively unregulated. However, the Medicines and Related Substances Act of 2002 was enacted to regulate novel synthetic molecules. It was intended to include pharmaceutical drugs and novel substances that may have the potential to affect public safety. While the Act does not explicitly mention Natural Health Products, it outlines the characteristics of each category. For example, a substance is considered to be a 'health supplement' if it contains vitamins and minerals.

The Allied Health Professions Council of South Africa is not the voice of Traditional & Natural Health Products, but it has been a major player in regulating the health industry. It is therefore important that it is part of the dialogue around the regulation of African Traditional Medicines. The Committee should be made up of registered African Traditional Practitioners and other experts in the field. It should steer policy away from a 'doctor prescribes' approach towards an 'integrative' approach.

There are over 24,000 species of plants growing in South Africa, many of which are used in Traditional & Natural Health Products. Some indigenous plants are being marketed singly, while others are being marketed in mixtures. It is estimated that there are over thirty million people who use African Traditional Medicines annually. Most of these products have been used for years without serious reports of toxicity. But these are not regulated by the Medicines Control Council.

The Complementary Medicines Committee is non-representative and lacks transparency in decision-making. It has also been accused of selectively inviting a single stakeholder group to participate. The Department of Health has noted that the regulation of traditional medicines will be implemented using a digital listing system. This will result in a fast registration process. However, the current fees for evaluation are R12,400 per product application. This will result in small and medium sized companies being prevented from registering.

It is clear that the Medicines Control Council is not suited to the regulation of Traditional & Natural Health Products. It discriminates against indigenous African Traditional Medicines. It is also discriminatory against Non-indigenous traditional medicines.

The current regulatory model is also too expensive and too difficult for small and medium sized companies to comply with. This is a major barrier for many of the small and medium sized companies that manufacture natural health products. This is not a fair burden of proof to place on manufacturers.

A rational regulatory system that balances consumer choice and public safety should be enacted. A similar system has been successfully introduced in Canada and Australia. It is therefore important that the Medicines and Related Substances Act be amended to include Traditional & Natural Health Products. This should be done through amendments to the principal Act, and should involve broad stakeholder consultation.