No Place for Minister in Medicine Registration Process

September 19, 2008

No Place for Minister in Medicine Registration Process

Opposition parties and the pharmaceutical industry have welcomed the decision saying it should be seen as a victory of science over political interest.

Stakeholders have warned that the independence of the new SA Health Products Regulatory Authority (SAHPRA) would be seriously jeopardized if the minister could halt the registration of medicines on the basis of political and economic considerations. The new body, which will be replacing the overburdened and dysfunctional Medicines Control Council, will also be responsible for the approval and registration of medical devices and complementary medicines.

IFP spokesperson on health, Dr Ruth Rabinowitz, said while there was still concern that the new authority did not have a clear enough structure and was not sufficiently independent, the scrapping of the two-tier process should be seen as a victory for science.

“What we’ve achieved is that the authority that is going to register health products, including medicines, complementary medicines, vitamins and traditional and western herbal medicines will now decide on the basis of science whether those medicines should be registered or not,� she said.

“We hope that this decision will finally put an end to a proposal from the health ministry that would have delayed or denied access to life-saving drugs to South Africans by politicising the approvals process,” DA health spokesperson Mike Waters said in a statement.
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