New regulator will also oversee medical devices
The new authority replacing the Medicines Control Council is expected to clear a backlog of more than 2,000 applications
Medical devices will now be regulated in SA, with the newly established regulatory body, the South African Health Products Regulatory Authority (Sahpra), replacing the Medicines Control Council (MCC) with effect from June 1.
Until now, medical devices and complementary medicines have gone unregulated as the MCC could only deal with medicines. This gap was laid bare a few years ago when the Tara Klamp, a device used for medical circumcisions, split medical opinion following its application in KwaZulu-Natal.
SA has the largest medical device market and manufactures a range of devices, although it is primarily reliant on imports from Germany and the US.
Sahpra’s official existence comes as the government has finally signed the Medicines and Related Substances Amendment Act of 2008. However, the body is not yet operational as Health Minister Aaron Motsoaledi has yet to appoint a board.
The Health Department wants Sahpra to be the solution to the extensive delays that beset the MCC, which took much longer compared to US or European regulators to approve new medicines and clinical trials. Sahpra will also be responsible for regulating foodstuffs, cosmetics, disinfectants and diagnostics.
Stavros Nicolaou, who is head of industry association Pharmaceuticals Made in SA (Pharmisa) said the new structure will be able to generate its own income, allowing the body to use modern systems and retain staff that were often overwhelmed with volumes of work and prone to being snatched by the private sector. "The workload of the MCC quadrupled but the funding didn’t match," Nicolaou said.
The drug industry often criticised the MCC’s long approval times, which could stretch to more than three or four years, holding back business. Based on industry figures, registering new products with the MCC took an average of three to five years, but could exceed seven.
Among the new regulator’s first tasks will be clearing a backlog of more than 2,000 applications awaiting registration by the MCC.
Pharma Dynamics CEO Erik Roos said Sahpra could usher in a new and much more effective era for the local pharmaceutical sector. "Sahpra’s new structure will follow a similar model to the US Food and Drug Administration in that it will be more independent than the MCC," he said. "It will only be partly funded by the government with approximately 70% of funds coming from industry bodies, which will not only enhance the entity’s ability to attract and retain the necessary skills and resources it requires to function optimally, but is critical to its success."
Nicolaou said that in the medium to long term, Pharmisa is hoping that the body will become an efficient, modernised, IT-driven system that is self-sustaining. However, a report in March said sub-Saharan Africa ranked the least attractive region to commercialise medical devices.
BMI Research medical device analyst Ethel Kuntambila said although African markets are responsive to investment in medical equipment, the region’s poor operational environment and meagre access to healthcare, coupled with limited manufacturing capabilities, gives it poor rankings in comparison to other regions.