South Africa’s Health Director-General, Thami Mseleku, has defended recent attacks on the government’s draft Medicines and Related Substances Amendment Bill, which would give the country’s controversial Health Minister unprecedented powers over drug registration.

Under the bill, which seeks to replace the Medicines Control Council (MCC) with a new drug regulatory authority, Health Minister Manto Tshabalala-Msimang would be empowered to block the registration of new medicines if she felt that such a move was “in the public interest.” Supporters of the bill say that this provision will enable the government to negotiate lower prices with the drug’s manufacturer before its registration can go ahead but, according to critics such as the AIDS Law Project (ALP) and the Treatment Action Campaign (TAC), its passage would “signal the final death knell” of the scientific governance and evidence-based regulation of medicines and clinical trials in South Africa.

There are “numerous problems” with the bill, say the ALP and TAC, but the main issue is that it would give the Minister of Health the power 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”.

“In other words, a technical scientific task, determining the quality, efficacy and efficacy of medicines, will be subject to political interference,” they say, adding that the “meddling” by Dr Tshabalala-Msimang - who has infuriated patient advocates by telling HIV/AIDS patients to treat themselves with garlic and beetroot instead of antiretroviral drugs - would be given legislative force.

Pharmaceutical manufacturers also strongly oppose the bill’s attempts to regulate the industry in this way, and have said they will take it court if it should become law. However, Dr Mseleku denies that the government is attempting to fix drug prices, and says that intervening in the market is something that “every other country in the world is doing.” Health is not a commodity for the markets to determine – there are other issues to be considered, such as access to care, he added.

Dr Tshabalala-Msimang has said that the bill, which was introduced in Parliament on June 17, aims to create a health system that is efficient, equitable and accessible to all South Africans. The government is calling for submissions on its proposals by July 18, with public hearings set for August 5-6.