The registration of health products in the country should be the sole prerogative of the health minister, MPs heard on Tuesday.
Briefing the National Assembly's health committee on the Medicines and Related Substances Amendment Bill currently before parliament, the department's Director General Thami Mseleku said the minister will have the final say on what medicines could be registered in the country.
Concerns were raised earlier in a joint submission by the Aids Law Project (ALP) and the Treatment Action Campaign (TAC) on the draft medicines and related substances amendment bill, 2008.
According to the submission the amendments would "allow the Minister of Health to block the registration of medicines of proven quality, safety and efficacy, as well as to allow the sale and provision of untested “treatments” and “cures”."
Essentially this will give the minister the power to veto the registration of certain medicines, Jonathan Berger, of the ALP, told Health24.
"Our primary concern regarding the proposed amendment to section 36 of the Medicines Act is that it appears to have been drafted with the express purpose of enabling the Minister to allow, amongst other things, the widespread use of unproven medicines for the treatment of HIV infection," the submission read.
"Our well-founded suspicion is based on the Cabinet's actions during the Virodene scandal, the inappropriate actions of the current Minister and director general regarding the conduct of Matthias Rath and the provision of his untested products, and the Ministry of Health’s support for other untested AIDS “treatments” and “cures” sold by people such as Zeblon Gwala and Tine van der Maas," the submission continued.
The minister has also been quoted as saying that traditional treatments should not be judged by "Western" criteria. What exactly she meant by "Western" criteria, and what alternatives she proposes, remains unclear. Her department has not as yet responded to inquiries in this regard.
Politics vs science
"The registration of medicines should be a political process, it should not be a science issue alone," he said.
While medicines would be subjected to an intensive screening process to establish their efficacy and safety, products which pass the test could still be rejected by the minister.
"Once medicines have been certified as being safe, of good quality and efficacious... the Minister will only register such medicines if it is the public interest to do so," Mseleku said.
In deciding whether to grant a registration licence, the Minister would also have to take the country's economic interests into account.
MPs query decision
However, MPs were not convinced that the minister should be directly involved in matters relating to the registration of medicines.
ANC MP and the committee's chairperson James Ngculu said the department had so far failed to explain why it was necessary for the minister to be granted powers to make important decisions on scientific matters.
"I'm not convinced that you need a minister to approve a medicine," he said.
MPs were also sceptical about the department's proposal that the new agency soon to replace the Medicines Control Council (MCC) - the African Health Products Authority - as envisaged in the measure, would fall under direct control of the department.
Democratic Alliance MP Mike Waters said the agency has to be "viciously independent" and free from political interference.
Public hearings on the measure would begin next week.
(SAPA, July 2008)