THE Department of Health has set April 1 next year as the target date for establishing the South African Health Products Regulatory Authority (Sahpra), a development that will be closely watched by the pharmaceutical industry.
Sahpra will replace the overwhelmed Medicines Control Council (MCC), and will have a much wider mandate that includes the regulation of medical devices and complementary medicines.
The MCC cannot cope with the volume of applications it receives for new medicines and clinical trials, and takes up to three years to register new products, according to acting registrar Joey Gouws.
The MCC depends on a part-time team of expert reviewers, a model that was in line with international best practice in 1965, but is now hopelessly out of date, she said.
One of the key changes envisaged in replacing the MCC with Sahpra is that the new regulator will be a public entity with the power to retain the fees it generates from applications to register products and clinical trials. It will also be allowed to remunerate staff at rates higher than those typically paid in the public service, enhancing its ability to attract and retain staff, in a similar vein to the South African Revenue Service.
Improving the regulator’s human resource capacity would be vital to its success, said Aspen Pharmacare’s head of strategic trade Stavros Nicolaou. Aspen’s generic medicines typically took 18 months to get approval from the MCC, he said.
Adcock Ingram declined to specify how long it waited to get new products approved, but said there had recently been a slight improvement.
Two enabling acts for Sahpra have been assented to by President Jacob Zuma — the Medicines and Related Substances Amendment Act of 2008, and the Medicines and the Related Substances Amendment Act of 2015.
The 2008 act was amended after it was widely criticised for granting the health minister too much power: not only could the minister appoint the CEO of Sahpra, but the act also granted him the final say on whether or not to register products approved by the authority.
This governance structure was changed in the 2015 legislation, which made provision for a board chaired by a CEO who was given the power to appoint technical committees. The act also contains greater detail on the transition from the MCC to Sahpra.
Werksmans attorney Neil Kirby said the promulgation process would be legally complex, because the 2015 act says it comes into effect immediately after the commencement of the 2008 act — which will come into operation on a date that has yet to be proclaimed by the president in the Government Gazette. However, before the acts can be promulgated, the general regulations to the medicines act need to be amended.
Dr Gouws said extensive preparatory work was required before the launch of Sahpra, starting with the appointment of its board.
Another key step would be for the Treasury to formally approve Sahpra as a section 3a public entity so that it can retain revenue.
It would initially be funded by the fiscus, but was ultimately expected to secure 70% of its budget from fees, Dr Gouws said.