Medical devices will now be regulated in South Africa, with the newly established regulatory body, the South African Health Products Regulatory Authority (SAHPRA), replacing the Medicines Control Council (MCC) with effect from 1st June.
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.
As far as the regulation of medicine is concerned, the local pharmaceutical industry has been long-suffering, waiting anything from two to seven years to register new medicines and clinical trials. Among the new regulator’s first tasks will be clearing a backlog of more than 2,000 applications awaiting registration by the MCC.
Generic medicines are up to 80% cheaper than brand name equivalents and is currently only used by 56% of the population. Therefore, the savings could be massive if more generics are brought to market.
Pharma Dynamics CEO Erik Roos believes that 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.”