Omegalabs (Pty) Ltd v Medicines Control Council and Others (32570/2015)  ZAGPPHC 1157 (7 December 2016)
T his case concerns judicial deference on matters that fall outside their area of proficiency. It posits that the determination of whether a product fits the definition of a “medicine” or a “medical device” is not simply an exercise in interpretation of a statute but rather entails a decision which involves a highly technical and evidence-laden evaluation of deeply contested medical and scientific matters.
The MCC is best equipped to perform that exercise, not a Court of law. In so finding, the case parts ways with 2 previous judgments of the Pretoria High Court which held in 2014 and 2015 that because similar products are classified as “medical devices” in other so-called “benchmark” countries, they must be taken as being similarly classified in South Africa too.”