INDUSTRY OVERHAUL
Bitter pill for drug makers as fees hike nears under new regulator
Drug manufacturers will soon face a significant increase in the fees charged by SA’s new medicines regulator, as it moves to end an era in which firms enjoyed rates far below those levied in other countries. "We need to re-evaluate the fees, which are too low and in some cases non-existent," the South African Health Products Regulatory Agency (Sahpra) board chairwoman, Helen Rees, said on Wednesday. Sahpra needs to overhaul its fee structure not only to bring its rates in line with other regulators but also to ensure it generates a significant portion of its own operational budget. Unlike the Medicines Control Council (MCC), which it replaced in February, Sahpra will be only partially funded by the state. The government anticipates that allowing Sahpra to retain the revenue it generates will provide the resources to improve its in-house capacity, which is vital if it is to speed up the approval of new products. Consultation was under way with the pharmaceutical industry to ensure th...
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