Wednesday, June 24, 2009

An open letter to the MCC

The Treatment Action Campaign (an AIDS activist NGO) recently published an important open letter by physicians and academics to the Medical Control Council (South Africa's equivalent of America's FDA) about its failure to adequately regulate quack remedies.

The summary:
"*The Complementary Medicines 2002 call up has resulted in an untenable regulatory hiatus where medicines of unknown quality have flooded the South African market.
*The South African public has been put at risk – not only health-wise but in terms of potentially fruitless expenditure of their disposable income on products which have not been independently assessed.
*This undermines citizens’ rights to bodily and psychological integrity as enshrined in the Constitution of our country.
*It is the Medicines Control Council’s responsibility to regulate all medicines available to the public.
*The Medicines Control Council has failed to ensure that as far as complementary medicines are concerned, their availability is in the public interest, and it has failed to consider “only” these products’ safety, quality and therapeutic efficacy in relation to their effects on the health of South African persons, because it has not required any evidence for these products’ safety, quality and efficacy.
*Based on the Zondi judgment, the Medicines Control Council must resume its statutory obligation to consider all medicinal claims made in the advertising of medicinal products.
*The 2002 call up should be rescinded, and replaced with a notice in terms of Section 19(2) of the Medicines Act – but with the additional provisos of submitting current certificates of analysis and all advertising claims made. A six month period should be stipulated for fulfilment of these requirements."

See also: a news piece on the open letter by Health-e and a blog post on the MCC's regulatory failure by Roy Jobson (one of the signatories).

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