NEW REGULATORY AUTHORITY
Health minister Motsoaledi appoints board of medical body
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).
The 15-member board will be chaired by respected scientist Prof Helen Rees, who heads the board of the MCC.
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.
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 AfricansKonji Sebati
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," said Ipasa CEO Konji Sebati.
"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 board was appointed for a three-year term, expiring on September 30 2020.