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.”
Read Full Judgement here
The judgment in Omegalabbs is brilliantly written and the intricate legal principles applicable are lucidly articulated. Thank you Sir for this resource.