Health Minister Aaron Motsoaledi has appointed the board of the South African Health Products Regulatory Authority (Sahpra), marking an important step towards setting up the agency to replace the Medicines Control Council (MCC).
Business Day reports that the 15-member board will be chaired by respected scientist Professor Helen Rees, who heads the board of the MCC.
The report says Sahpra has been anxiously anticipated by the pharmaceutical manufacturing industry, as it is expected to be more efficient than the MCC at processing applications to register medicines and clinical trials. Sahpra is also expected to improve protection for consumers, as it will have a wider mandate than the MCC and will for the first time bring oversight to the medical device sector.
Since the MCC would cease to exist on the night before the first meeting of the Sahpra board, the board would need to ensure a smooth handover between the two agencies, said the Department of Health’s deputy director-general for regulation and compliance Anban Pillay. Staff at the MCC would be offered positions at Sahpra, and a CEO would have to be recruited, he said.
It typically takes between three and five years for a new chemical entity to be approved by the MCC, according to the Innovative Pharmaceutical Association of SA (Ipasa), a trade body representing multinational drug firms that hold the patents on brand-name products. Even medicines prioritised by the MCC, which include those for HIV and tuberculosis, can take up to two years to get the green light.
"We hope that the new Sahpra will realise that the kinds of delays we experience in registering medicines in SA are in fact impacting on access to medicines for South Africans – access to old and new medicines and devices," Ipasa CEO Konji Sebati is quoted in the report as saying. "We have heard a whole host of reasons for the delays, none have made much sense frankly."
Aspen Pharmacare’s head of strategy trade Stavros Nicolaou said pharmaceutical manufacturers were not expecting a short-term fix from Sahpra. "The backlogs are worse than ever. It needs to be refinanced, and build capacity, which is a medium-to long-term project," he said. One of the factors that delayed approvals was that the MCC did not employ full-time reviewers, he said.
The report says the board was appointed for a three-year term, expiring on 30 September, 2020.
The new members appointed on account of their expertise in the fields of medicine, medical devices, in vitro diagnostic medical devices (IVDs), vigilance, clinical trials, good manufacturing practice, public health or epidemiology are Professor Helen Rees, Dr Ushma Mehta, Professor Shabir Banoo, Dr Edith Nonhlanhla Madela-Mntla, Dr Henry Leng, Dr Thapelo Motshudi, Professor Kelly Chibale, Prof. Amaboo Dhai, Professor Maphahlaganye Mphahlele, and Dr Mphane Molefe.
The other members are Adv Hasina Cassim (appointed on account of her knowledge of the law), Mandisa Hela (good governance), Lesibana Fosu (financial matters and accounting), Tinyiko Baloyi (information technology) and Professor Craig Househam (human resource management).
[link url="https://www.businesslive.co.za/bd/national/health/2017-10-19-health-minister-motsoaledi-appoints-board-of-medical-body/"]Business Day report[/link]
[link url="http://www.mccza.com/documents/34c37bdb10.15_Media_Release_SAHPRA_Board_Oct17_v1.pdf"]MCC material[/link]