This opinion was written in order to clarify the current status of complementary medicines. The matter of the Alliance of Natural Health Products (South Africa) v The Minister of Health and Another (case number 11203/2018) (ANHP case) and the following appeal by the Minister of Health and Another v Alliance of Natural Health Products (South Africa) (case no 256/2021) (Appeal) as well as other publications and the concerns of clients resulted in the opinion and also informed it.
Are all complementary medicines really medicines?
During the ANHP case, the court had to decide whether the Minister acted beyond his powers (ultra vires) when he regulated complementary medicines. It was argued that the definitions of complementary medicines and health supplements provided for in the 2017 General Regulations are so broad that it included a range of products and substances that are not medicines or scheduled substances if measured against the definition of a medicine in the Medicines and Related Substances Act, 101 of 1965 (Medicines Act).
It seems discipline-specific medicines were not relevant for the purposes of this judgement. The judgement thus only pertains to complementary medicines which are health supplements and specifically those not falling within the ambit of the definition of a medicine in the Medicines Act.
The parties agreed that the definition of a medicine in the Medicines Act is wide enough to include certain complementary medicines and that the Medicines Act empowers the Minister to regulate these complementary medicines. However, the parties disagreed that all complementary medicines are medicines and may therefore be regulated. The position was thus one of partial invalidity pertaining to only certain complementary medicines.
As said, the Alliance of Natural Health Products (ANHP) conceded that there are health supplements that are medicines as defined in the Medicines Act and which are subjected to the regulations. However, health supplements falling outside the ambit of the definition of medicines were not evaluated on a case-to-case basis because that would have only assisted in assessing the validity of the regulations regarding the particular product. Assessing whether separate products fall within the ambit of the definition of a medicine has thus been left open.
In this regard ANHP argued that products which only claims promotion of well-being and good health or which promotes relaxation, which make no therapeutic claims and contains no scheduled substances do not fall within the ambit of definition of medicine. Its regulation will be ultra vires.
The case clearly revolved around whether all complementary medicines are in actual fact medicines to be regulated under the 2017 General Regulations, or not.
The consequences of all complementary medicines being regulated as medicines
The ANHP case was brought by the alliance in its own interest and in public interest. It was argued that the application of the regulations to complementary medicines have certain consequences associated with significant effort and cost. ANHP wished to avoid these.
The consequences were listed as: registration of medicines before sale, labelling restrictions, advertising complying with requirements, prohibition on bonus or rebate systems and incentive schemes, prohibition of free samples, marketing regulations and Codes of Practice, prohibition of sale of medicines unless it complies with prescribed requirements, prohibition of publication of false or misleading advertisements, and prohibition of publication or distribution of advertisements that claims that a registered medicine has an effect other than what is stated in its registration notice.
It was argued that adherence to these provisions will cause complementary medicines to become expensive resulting in restriction of the public’s access.
However, currently complementary medicines have not been called up for registration and may therefore be sold unregistered. Adherence to labelling and requirements pertaining to quality, safety and efficacy is essential. For example, labelling serves to inform the public of the content of the medicine and how to store it. Stability requirements are essential to determine the expiry date of a product whereafter it may be become ineffective or even toxic. Surely these requirements are in the interest of the public and should not be avoided.
Unpacking these requirements and the practicalities of its implementation could be more important than determining which complementary medicines should be regulated. Unfortunately, this was not attempted.
It was suggested by ANHP that products only claiming promotion of well-being and good health or promoting relaxation whilst making no therapeutic claims and containing no scheduled substances may not fall within the ambit of definition of medicine. If so, it will be prudent to avoid making therapeutic claims in any publications including labels. Such claims will cause the product to fall within the ambit of the Medicines Act, including its provisions regarding advertising.
In terms of advertising, it is questionable whether the avoidance of the consequences regarding the publication of false or misleading advertisements will serve the public or even the industry. Even if the consequences regarding false and misleading advertisements provided for in the Medicines Act could be avoided, other legislation, codes and authorities prohibiting false and misleading advertisements may come into play.
Note that the product cannot be used, manufactured or sold for therapeutic purposes whilst claiming non-therapeutic purposes on its label.
Regulation of complementary medicines which are not medicines
In the ANHP case the court declared that the definition of a medicine only applies to substances that are used or purported to be suitable for use, or manufactured or sold for use in the diagnosis, treatment, mitigation, modification or prevention of maladies, in order to achieve a medicinal or therapeutic purpose in human beings and animals.
However, the court of appeal held that this order cannot stand and it was set aside. The first reason was that there had been no dispute as to the proper interpretation of the definition of ‘medicine’ in the Medicines Act before the court a quo. Therefore, the previous court should not have issued a declarator in answer to a hypothetical or academic question. The second reason was that this part of the order impermissibly departed from the language of the Medicines Act. It not only introduced the word ‘maladies’, but failed to give due recognition to subparagraph (a)(ii) of the definition of ‘medicine’.
Because this issue was raised mero motu (of its own accord, without assistance of any party) by the appeal court itself, there was no successful party in this regard and no costs were awarded.
However, the court of appeal upheld the order that the 2017 General Regulations are declared unlawful to the extent they apply to complementary medicine and health supplements that are not medicines or scheduled substances as defined in section 1 of the Medicines Act. The appeal of the Minister and SAHPRA was thus dismissed with costs.
References were made to international best practices pertaining to the regulation of complementary practices. However, the ANHP argued that there is no benchmark regarding these practices that can be followed by South Africa.
The declaration of invalidity was suspended for twelve months to allow SAHPRA (actually the Minister) an opportunity to correct regulatory defects. Even though all parties agreed that the regulation of complementary medicine is vital, the ANHP prayed that the declaration of invalidity should not be suspended. This would have created a lacuna in the regulation of complementary medicines. The judge also loathed the idea of leaving the regulation of complementary medicines without a time frame within which the Minister must finalise the correction of the faulty regulations.
ANHP then launched a the cross-appeal against the suspension of the declaration of invalidity. The court held that it is widely accepted that there is a public interest need to also regulate complementary medicines and health supplements that are not medicines under the Act. Therefore, it is in the public interest to regulate these substances under the regulations during the interim period of consideration of the appropriate regulation thereof. The cross-appeal was therefore dismissed with costs.
In short both courts referred the regulation of complementary medicines back to the Minister for correction. In the meantime, even the complementary medicines which are not medicines under the Medicines Act will be regulated under the regulations by SAHPRA until another appropriate way of regulating them has been considered. Whatever decision is made going forward, all complementary medicine will ultimately be regulated.
Complementary medicines which are medicines will continue to be regulated by SAHPRA under the Medicines Act. Complementary medicines which are not medicines under the Medicines Act will also be regulated. By whom and how these products will be regulated is a question which is currently causing major confusion in the complementary medicine industry. If regulated by an alternative authority, the regulation of these products may differ from the current legislation being less or more advantageous to the industry.
What is known is that the decision on how the complementary medicines which are not medicines should be regulated was ultimately placed in the hands of the Minister of Health. Although proposals may be made by interested parties such as ANHP, drafting of the legislation will be under the direction of the Minister.
The way forward
It is important for the complementary medicine industry to determine the status of their products on a case-to-case basis. Complementary medicines which are manufactured, used or sold for therapeutic purposes will fall under the Medicines Act
and will be controlled by SAHPRA. Complementary medicines with no therapeutic use will also be controlled by SAHPRA until further notice. The industry will have to take commercial issues into consideration when deciding on the claims to be made since it is not limited to label claims.
The provisions of the Medicines Act and General Regulations as well as the content of Guidelines are known. However, should the complementary medicines without therapeutic effects be controlled under different legislation by another authority, the provisions are yet unknown. It is also unknown whether the rights acquired under the current regime will be upheld by a new authority.
Update received after publishing date: https://www.sahpra.org.za
Publishing date: 25 Apr 2022
