Replaced – Medicines Control Council

November 25, 2011

he SA Health Products Regulatory Authority, a medicines control body, is likely to be set up in two or three years as government tries to speed up the pharmaceutical approval process, according to health department director-general Precious Matsoso.

The SA Health Products Regulatory Authority, a medicines control body, is likely to be set up in two or three years as government tries to speed up the pharmaceutical approval process.

Sahpra, as it is to be known, has been a work in progress for more than 10 years. It is intended to replace the Medicines Control Council (MCC), which the pharmaceutical industry claims has consistently failed to meet its mandate of testing and accrediting pharmaceuticals for the SA market.

According to health department director-general Precious Matsoso, Sahpra will be run as an independent body and will manage its own budget. But it will report to her department and parliament.

Its intended organisational structure can be compared with that of the Council for Medical Schemes, which has a backlog of 1500 drugs waiting to be registered.

Parliamentary health portfolio committee chairman Bevan Goqwana says: “Something should have been done to address drug registrations a long time ago. You cannot apply health programmes without making medicines available to treat diseases. With more drug options available, pricing becomes competitive. Another worrying issue is that the MCC collects millions from the pharmaceutical industry, but that money goes to treasury.”

This means the MCC relies heavily on the health department for its funding rather than using the money paid by the industry. And the MCC seems under-resourced with an annual budget of R43m and a skeleton staff of 24 permanent workers who oversee drug registrations for a population of 50,5m .

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