New laws are about to give the Minister of Health, Manto Tshabalala-Msimang enormous control over the regulation of drugs in South Africa. The Medicines and Related Substances Emendment (sic) Bill will abolish the Medicines Control Council (MCC) and replace it with the South Arfican Health Products Regulatory Authority (Sahpra). The remit of this new body will include the sale of medical devices, certain foods and cosmetics and pharmaceuticals. All well and good - but - and this is a very large but - the powers that this new bill gives to the minister will undermine not only the independence of the new authority, but its international standing as well. Under the proposed legislation, drugs will be 'certified' after meeting the usual criteria of safety and efficacy, but will then have to be 'registered'. And it is this 'registration' that is in the hands of the health minister. She will, apparently, base this on 'national interest'. Only once a product has gone through this double process can it be sold in South Africa. According to experts, the basis on which registration can be denied is equivocal. Final decision making rests with the minister and the criteria on which these decisions are made are vague. Jonathan Berger of the AIDS Law Project, see the process as one that undermines the independence of the MCC - dating back to the Virodene debacle. The minister's powers could allow her to refuse registration of drugs that she didn't want government to be forced to use - such as antiretrovirals. Given her and the government's record on the provision of antiretroviral medication - generally only doing so when forced by court action - this new bill is scary stuff indeed. Could we land up in the situation where the only 'registered' medication in South Africa is indiginous and of questionable value? Hopefully not, but any challenge to the new legislation will be welcomed by rational people.
Bridget Farham Editor https://www.bizcommunity.com