Manto to get undue powers?
Last updated: Wednesday, May 21, 2008 PrintThe concerns were raised 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.
The fall of the MCC?
Legislative reform of the Medicines Control Council (MCC) and the regulation of medicines have been called for from various quarters – including the ALP and the TAC - for a number of years.
According to the submission though, the bill represents the wrong kind of reform. "Its enactment would signal the final death knell of the scientific governance of medicines and clinical trials in South Africa," the submission said.
"In our view, this is the latest attack on the evidence-based regulation of medicines and clinical trials, which began in early 1997 when the then independent and internationally respected MCC intervened to stop unauthorised and unethical trials on the industrial solvent Virodene," the submission said.
According to Berger, the MCC, as it stands, is only semi-independent. "Much of its independence has been undermined already. It must be independent (reporting to parliament in terms of empowering legislation, not floating freely without any lines of accountability) to protect it from political and commercial pressure. Its mandate on quality, safety and efficacy cannot and should not be compromised to satisfy political or commercial considerations," he said.
According to Berger, the proposed amendment bill threatens the remaining independence of the MCC in the following ways:
- Locates the drug regulatory authority wholly within the department of health, which does not have the capacity nor the political will to ensure that it operates independently.
- Removes the council, leaving the drug regulatory authority without any governance structure.
- Gives the minister the power to exclude products from the operation of the act, and to refuse to register certified products.
The department of health has also been accused of not consulting with civil society in the development of the bill and not allowing for sufficient time for its discussion.
The department has been contacted for comment, but has not yet responded at the time of writing. – (Marcus Low, Health24)
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