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  • Change in South Africa medicines approval 'unscientific'

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[CAPE TOWN] The South African government is poised to change its regulations for medications, allowing appeals against approvals on unscientific grounds and giving the health minister final say on new treatments.

Opponents say the amendment will strike a blow to evidence-based scientific evaluation of medicines, giving political views precedence over safety and necessity.

The Parliamentary Portfolio Committee on Health approved the Medicines and Related Substances Amendment Bill this week (25 August), which will create a new regulatory authority to replace the 43-year-old Medicines Control Council that currently oversees new medicines entering the market.

The legislation will allow the health minister to make a final decision on all new medicines and potentially pass treatments that have not undergone full scientific testing.

The minister can decline to register products which have passed clinical trials, says Ruth Rabinowitz, an opposition health committee member, calling the legislation ''counterfeit".

The amendment will also introduce an appeals process, whereby any person can oppose the approval of a medicine.

Announcing the bill, James Ngculu, chairperson of the portfolio committee, argued that though some medications might work for individuals, they might be bad for communities, and people had the right to object to medicines on unscientific grounds.

Thami Mseleku, director-general of South Africa's health department, claimed the measure would empower members of public to challenge medical decisions on political and economic grounds.

But Mike Waters, health spokesman for opposition party the Democratic Alliance, says the legislation has "opened a can of worms," and created a "bureaucratic nightmare".

Vicki Ehrich, chief operating officer of the Pharmaceutical Industry Association told SciDev.Net that they "strongly advocated" to the portfolio committee that the registration of medicines should be based only on safety, quality and effectiveness and are now "greatly concerned" that this has been replaced by an appeals process.

"This is contrary to our stance that registration should be separate from such considerations," she told SciDev.Net.

"A further concern is that the appeals process itself could be abused and used to delay entry of products to market, for example by competitors." 

Abieda Williams, of the Pharmaceutical Industry Association and who testified against the proposals, says the amendment is modelled on a Brazilian system, which led to "significant delays" in medicine approval. As a result, she says, citizens in urgent need of medications that lack approval are suing the Brazilian government.

The bill is expected to be passed into law by the full parliament when it reconvenes in September.

Nongovernmental organisations the Treatment Action Campaign and the AIDS Law Project, acting on behalf of South African HIV patients, say they will take legal action if it is passed. They argue that antiretroviral medications — which the government has opposed in the past — could be blocked.

Link to proposed Medicines and Related Substances Amendment Bill [270kB]

Link to AIDS Law Project and Treatment Action Campaign submission on the Medicines and Related Substances Amendment Bill [342kB]

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