Introduction
Facts
Decision
Comment
It is no secret that the courts have held on various occasions that if a person says that a product is used for the purpose of treating or preventing disease, it will fall within the definition of a "medicine" under the Medicines and Related Substances Act 101 1965 (Medicines Act). The oft-quoted judgment in this respect is Treatment Action Campaign v Rath [[2008] 4 All SA 380 (C)], which provides as follows:
It is not the intention of the Legislature to control substances which are ordinarily drunk by man such as Rooibos Tea as long as such substances are ordinarily used and there are no claims of their medicinal efficacy. In my view the use of a particular substance is the determining factor in deciding whether or not it is a medicine. If one adopts this approach one is able to limit the seemingly overbroad definition of "medicine". To use Mr Ntsebeza's Rooibos Tea example in order to emphasise the purpose of the Act, if a person were to sell Rooibos Tea and to hold out to the public that it could cure arthritis Rooibos Tea could fall under the definition of "medicine". The reason for such finding would not be difficult to fathom: a number of people are likely to start using Rooibos Tea in the hope that it would treat or prevent or cure arthritis. The only logical way to protect the public against such claims would be to bring Rooibos Tea within the definition of "medicine" so that its quality, safety and efficacy could be controlled and regulated.
Accordingly, a product that claims to have a "medicinal purpose" (ie, the capability to diagnose, treat or prevent diseases) will be treated as a medicine for the purposes of the Medicines Act.
In the recent case of Alliance of Natural Health Products in South Africa v South African Health Products Regulatory Authority, which was handed down by the High Court of South Africa, Gauteng Division Pretoria, on 1 October 2020 and which is subject to an appeal, the Court implicitly confirmed that the distinction between complementary medicines that fall within the scope of a medicine and those that do not depends on whether therapeutic claims are made in relation to the product in question.
A "therapeutic claim" includes any claim that a product can or should be used for a therapeutic purpose, which includes "the prevention and treatment of malady" as well as the prevention, diagnosis, treatment, mitigation or modification of physical or mental diseases.
In a recent decision, the Directorate of the Advertising Regulatory Board (ARB) was asked to determine the boundary between medicinal and cosmetic claims. Although this decision is subject to appeal, it raises interesting questions about when a claim is considered medicinal or not.
The claim that was in issue before the directorate read "protection from skin infection causing germs", when used in relation to a hygiene soap bar. Within the industry, hygiene soap bars are ordinarily treated as cosmetic products and not as medicines. However, not only is it recognised by the courts that only medicines can make therapeutic claims, this too is recognised by the Code of Advertising Practice administered by the ARB, which expressly permits "[p]rimary cosmetics [to] have secondary germ protection functions" and to make "claims for such a secondary functions" but prohibits the use of claims in relation to cosmetics that:
convey the impression, through their overall execution and/or the use of symbols, that the cosmetic product provides medicinal benefits (such as healing or curative properties).
Whether a claim is conveyed as a secondary claim and in a cosmetic sense will largely depend on the context in which the claim is portrayed.
The complainant in the matter before the directorate opined that the use of the term "infection" in the claim conveyed the impression that the cosmetic product possessed medicinal properties. In support of this assertion, the complainant relied on the definition of the term "infection" in the online Collins Dictionary – namely, "disease caused by germs or bacteria". According to the complainant, this definition therefore:
conveys an impression that the use of the hygiene soap protects from germs which cause skin diseases, and as such, that the product possesses medicinal properties in contravention of the [Code].
The directorate dismissed the complaint and instead took the view that the claim in question did not convey medicinal properties and was cosmetic in nature. The basis of the directorate's argument was as follows:
The current advertising does not incorporate the word "illness", makes no reference to preventing illness, does not suggest any healing or curative properties or that this soap would offer "relief of a disease condition". At worst, it claims to "protect" (a permissible cosmetic function in terms of Appendix B) against "germs" (a permissible secondary cosmetic claim in terms of Appendix B) that could cause "skin infection" and/or "infection" (which is typically not regarded as a disease or illness, but as a potential precursor thereto if left unchecked). Pertinently, it does not claim to heal a skin infection once it is established.
Although this decision raised difficult issues and could have gone either way, there is merit in the stance taken by the directorate. This is because although the term "infection" on its own may be capable of having a medical connotation, the context in which it is used is relevant to determining whether such use conveys that a product has medicinal properties. Arguably, in some cases, the use of the term "infection" may be seen as conveying that the product has a primary medicinal purpose. However, in the context of the claim in question, the use of the term "infection" arguably did not suggest that the hygiene soap bar would cure or treat an infection, as would be required to convey a medicinal purpose. Instead, the claim could be described as a permitted secondary germ-protection claim that served to describe the kinds of germ (namely, germs that caused skin infections) that the cosmetic product could protect against.
In this case, it was important to distinguish between the claims "prevention of infection" and "protection against infection-causing germs". The former would be medicinal, whereas the latter would not. Although protection against germs that cause skin infections has the consequence of preventing infection, this was not what was being claimed. In the context of a hygiene soap product, a germ-protection claim conveys the secondary function of the product – namely, to protect against the entry of germs into the user's system. In making the claim "protection against infection-causing germs", this same secondary function of soap was recognised in the context of infection-causing germs (ie, germs that lead to infection). By using the term "infection" in this secondary function claim, there was no prima facie elevation of the claim from a secondary claim to a primary claim because the claim neither implied nor suggested that the product was effective in preventing, curing or treating infections. The claim implied that the product protected against the entry of infection-causing germs into the user's system and was aligned with the ambit of general germ-protection claims.
Further, although the term "illness" has been acknowledged by the ARB in the past as conveying a medicinal purpose, this implication arguably cannot be imputed to the term "infection", which is distinct from the term "illness". "Illnesses" or "diseases" are broad terms used to describe damaged cells in the body that result from an infection and include non-communicable conditions such as heart disease. In other words, infection caused by germs and bacteria is only a starting point on a continuum that may or may not ultimately lead to an illness or disease. It is therefore debatable that the use of the term "infection" implies or would be viewed or understood by a consumer as denoting or being synonymous with the term "illness".
The directorate's decision makes sound logical sense and aligns with the current case law on medicinal claims, which recognises that "medicinal claims" are those that imply to the user that the product will "prevent", "cure" or "treat" a malady. However, as is evident by the fact that the claim in question has been challenged, whether a claim (particularly a germ protection claim) is medicinal or cosmetic in nature is not always clear. In line with this, it is difficult to assess whether the ARB Appeals Committee, currently seized with this matter on appeal, will rule with or against the directorate on this issue.
Because the simple act of making a therapeutic claim in relation to a product puts the product at risk of being a medicine, there is certainly a lot of careful thought that must be put into the shaping of claims used to describe the purpose of a cosmetic product, particularly if that product is not intended to be a medicine.
For further information on this topic please contact Alexandra Wood at ENSafrica by telephone (+27 11 269 7600) or email ([email protected]). The ENSafrica website can be accessed at www.ensafrica.com.