Latest Articles

The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step towards realising improved turnaround times on new registration applications, which will benefit the public and healthcare economy. SAHPRA has a…
The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step towards realising improved turnaround times on new registration applications, which will benefit the public and healthcare economy. SAHPRA has a…
The South African Pharmacy Council has published revised competency standards for pharmacists for public comment. As the statutory body responsible for regulating the pharmacy profession in South Africa, the Pharmacy Council first developed a competency framework for pharmacists in 2006. Following a review process, those competency standards are now being revised to bring them in line with current practice, having regard to changes to formal qualifications and global competency standards and trends in pharmacy practice.…
Our law does not recognise a claim for constitutional damages for loss of a parent’s right to rear a child who was stillborn as a result of medical negligence. In Mbhele v MEC Health for the Gauteng Province, an expectant mother was admitted to Chris Hani Baragwanath Hospital with signs of foetal distress – an emergency medical condition. When she arrived, she was not treated as an emergency case but only seen to by…
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),…
The ‘Procedural regulations pertaining to the functioning of the office of health standards compliance and handling of complaints by the ombud’ (the procedural regulations) were brought into force on 13 October 2016. The Office of Health Standards Compliance (The OHSC), was established by the National Health Act. It is responsible for the monitoring and enforcement of compliance by health establishments, including private hospitals, with norms and standards prescribed by the Minister of Health…
A UK High Court has decided that settlement of a claim for injuries sustained by a sub-contractor on a construction project would only extinguish a further claim against a hospital for alleged negligent treatment received following the work accident if the settlement satisfied the whole claim. The defendant hospital brought an application to declare the further civil claim against it an abuse of process on account of the fact that the plaintiff had already accepted…