Institute 'a boost' for medicines council

The Department of Health is to launch a specialised institute of regulatory medicine in April as one of the measures to improve the capacity of the Medicines Control Council (MCC) to approve new drugs and clinical trials, according to health director-general Precious Matsoso. The pharmaceutical industry has consistently complained that it takes far longer to register new medicines in SA than in countries such as the UK and US.

Tamar Kahn: Business Day, 19 February 2014

The council's slow approval process, which can take up to four years, affects the earnings of pharmaceutical companies and limits patients' access to new treatments, and hampers medical research. Last year, Litha Healthcare said delays at the MCC were delaying the launch of its first locally made vaccine.

A year earlier, local drug maker Adcock Ingram said registration backlogs at the council were the single biggest impediment to growth. The institute is expected to fill an important gap in local training - at present no South African universities offer qualifications in the science behind regulating medicines. Matsoso said the institute would be a joint initiative by the universities of Pretoria, North West and Rhodes. Thirty-five students who held Masters of Science qualifications would be enrolled in April, and would be trained to work at the council or in the industry. Retired regulators from authorities such as the US Food and Drug Administration (FDA) have been recruited to train students. Matsoso said the EU had granted about R10 million to kick-start the project, and the Bill & Melinda Gates Foundation was also expected to invest.

The Health Department is also exploring the scope for mutual recognition agreements between the council and other regulatory authorities, such as the European Medicines Agency, and the UK's Medicines and Health products Regulatory Agency, to speed up the MCC's registration process. Officials have visited Switzerland to study how its medicines regulator used this approach. Matsoso said the capacity building was an important aspect of preparing for the launch of the South African Health Products Regulatory Agency, which would replace the MCC. The new body will have a wider ambit, and will introduce regulation of medical devices for the first time. Draft legislation to bring the body into being was submitted to Parliament late last year, but has yet to be processed.

The Innovative Pharmaceutical Association SA, which represents research-based drug makers, welcomed news of the institute. Spokeswoman Val Beaumont said there had been acknowledgement for some time of the problems the MCC faced, noting that the MCC was regarded as operating at a high standard despite its slowness. She said an institute dedicated to training medicine regulators was "very exciting" and would be supported by the pharmaceutical industry. Beaumont said it was important that the MCC retain some sovereignty if it entered into mutual recognition agreements.

Aspen Pharmacare's head of strategic trade, Stavros Nicolaou, said the institute was "a great initiative, and something the private sector would embrace", and that a more highly skilled pool of medicine regulators would help the council attract and retain talent. He said capacity constraints at the MCC did not just affect the registration of new products, but also held up post-registration changes that companies needed to make, such as switching suppliers or moving factories. These kinds of processes could take upwards of 18 months.