‘Backlog fee’ would speed up registration of drugs in SA, industry body says
South African drug makers may be asked to pay a "backlog fee" to help clear a pipeline of medicines waiting years for approval, according to a proposal being considered by a new industry regulator. Delays for hundreds of medicines have kept the latest treatments off South African shelves and have hampered the fight against cancer, heart disease and other illnesses, in a country that also has more people receiving anti-retroviral (ARV) drugs than anywhere else in the world. Besides improving access to life-saving medication, analysts say the South African Health Products Regulatory Authority’s (Sahpra’s) proposal could help boost revenue streams for companies competing in the $3.8bn-a-year market. "It’s the first time SA offers this and we would support a backlog fee, provided it is performance-driven," said Stavros Nicolaou, senior executive for strategic trade at Aspen Pharmacare. Sahpra wants to cut the backlog and allow the regulatory assessment of all products in an "achievable ...
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