The proposal for the establishment of the South African Health Products Regulatory Authority is contained in the Medicines and Related Substances Amendment Bill.

The department's Director General Thami Mseleku briefed members of the Portfolio Committee on Health in Parliament on Tuesday, 29 July 2008.

The department would like to set up a new agency that will incorporate the work of the Medicines Control Council but have a broader mandate and be run on business principles.

It will be allowed to recruit skilled medical experts at market-related salaries, said Mseleku on Tuesday.

Review of MCC

Mseleku also briefed the Portfolio Committee on the review of the Medicines Control Council (MCC), which is nominally independent although its members are appointed by the Minister of Health Manto Tshabalala-Msimang and the Medicines Regulatory Affairs (MRA), which falls under the department.

The review was conducted following complaints about the efficiency and outputs of the MCC such as lengthy timeframes for approving drugs and the disjointed operational systems of both the MCC and the MRA.

The department conducted the review with a view to update the MCC too, which was conceived in 1965.

The new agency "by and large" incorporates recommendations made by the Parliamentary Committee, but deviates in certain respects. The body will largely fall under the control of the department, rather than be a state-owned company, said Mseleku.

SAHPRA in control

The South African Health Products Regulatory Authority (SAHPRA) will have the power and be mandated to evaluate all medicines, medical devices, and other health products with medicines or medical content for efficacy, safety and quality.

It will also evaluate all blood derived products used for medicinal purposes, certify all of the above, as well as authorise the conduct of clinical trials, be they human and animal.

Another role for the SAHPRA will be to conduct post-marketing surveillance of medicines, as well as, said Mseleku, to conduct "pharmacovigilance" - keeping a watch on pharmaceutical products.

Scientific focus

The body will not however be concerned with marketing issues, but will focus on the scientific side of medicines and be responsible for their approval, certification and regulation, the Director General said.

Rather, SAHPRA will be an overarching regulatory authority for all health products, be they for humans or animals and will be run as an agency with the goal of a 50% cost recovery in terms of its operations, and will retain revenue from fees.

While it will need money from the government to start up, it will be run on business principles, with good governance central to its daily operations, and be headed by a Chief Executive Officer and be accountable to the Ministry of Health.

Little controversy

Mseleku told MPs he believed that there was little that was controversial about the Bill, and that most of the new legislation establishing the agency was supported by previous work done by the Parliamentary Committee.

"At the end of the day, our belief is that there are not many controversial issues relating to this Bill," Mseleku told MPs.

Agency roles

Apart from being responsible for evaluating the safety, quality and efficacy of medicines, the proposed agency will also have the function of licensing manufacturers of drugs, wholesalers and distributors, and will have a "relationship" with the Patents Office, which is responsible for patenting new medicines.

According to the Medicines and Related Substances Amendment Bill, the new authority will also look at the safety of foodstuffs and cosmetics which have medicinal components, or which make medicinal claims.

The powers of the new authority will be broad, and will include the registration of veterinary medicines and other animal health products.

Article published courtesy of BuaNews