In December 2016 the Pretoria High Court ruled that one cannot avoid regulatory oversight by the Medicines Control Council (MCC) by declaring that a health-related product is a medical device and not a medicine. That is a determination which the MCC must make.
In Omegalabs (Pty) Ltd v The Medicines Control Council and Others, the applicant was a healthcare company which applied for a declaratory order that their product (a skin preparation called Dermalex), was correctly to be classified as a medical device and therefore not currently subject to regulation by the MCC.
Section 22C(1)(b) of the Medicines and Related Substances Act, empowers the MCC to regulate and license the manufacture, import, export, wholesale and distribution of medicines and medical devices. However, unlike the case with medicines, regulations applicable to medical devices had not yet been passed, leaving medical devices effectively unregulated.
The primary question which the court had to answer was not whether Dermalex was a medical device, but rather whether that determination is best made by a court of law or by the statutorily-appointed MCC.
A decision to classify a product as either a medical device or a medicine requires technical knowledge and proficiency which a court of law lacks.
The Act indicates that the distinguishing characteristic of a medical device is that it does not achieve its purpose by ‘chemical, pharmacological, immunological or metabolic means in or on the human body’. The court found that such an assessment entails making a decision which involves a highly technical and evidence-laden evaluation of deeply contested medical and scientific matters. This was clearly demonstrated by the differing views of the parties’ respective experts in the case.
A decision to classify a product as either a medical device or a medicine requires technical knowledge and proficiency which a court of law lacks. The MCC is specifically established to regulate medicines and medical devices. It possesses the expertise necessary to make such a determination. Therefore, the court refused to make the determination and dismissed the application with costs.
This decision breaks away from earlier rulings in the Gauteng High Courts on the same issue (see for instance Gelderma Laboratories South Africa (Pty) Ltd v the MCC and Others).
New medical device regulations were published in December 2016 (Regulations relating to Medical Devices and in vitro diagnostic medical devices (IVDs)). Read our commentary on these regulations in the article ‘Long-awaited medical device regulations unpacked’.
Any prevailing ambiguity on the legal position pertaining to medical devices will hopefully now be resolved through the impending implementation of these regulations and further amendments to the Act.