Review of Legislation
This article was originally published in RAJ Devices
Executive Summary
South Africa committee backs science-based approvals
South Africa committee backs science-based approvals
A parliamentary committee in South Africa has approved draft healthcare reform legislation, but only after a controversial proposal that would have given the health minister final control over the registration of medicines and medical devices was eliminated1. Participants at public hearings in August and most recently on 2-3 September said that the Parliamentary Portfolio Committee on Health accepted the draft Medicines and Related Substances Amendment Bill 2008, which would create a new independent health products regulatory agency within the Department of Health and introduce new registration procedures, among other things.
A copy of the bill as approved by the committee has not yet been made available to the public. The bill will now be submitted to the National Council of Provinces for approval by the health committees in each province. It will then be returned to the parliament for final approval, which is expected to happen by the end of this year.
The original version of the bill would have set up a two-tier approval process under which the health minister would have had the power to approve or deny a registration based on whether the product was “in the public interest” - after the product had already been certified as meeting the prescribed standards of safety, quality and efficacy. Virtually all comments received by the committee had opposed this two-tier approval process.
After deliberations with the Department of Health, the committee decided that all reference to an approval or appeal on the basis of “public interest” should be removed from the registration process. Participants at the September hearing have confirmed that, as the draft legislation stands, the only grounds for approval or appeal against a registration would be on the basis of safety, quality or efficacy.
Members of the portfolio committee also succeeded in adding more detail to the draft legislation regarding the composition and function of the new regulatory agency, participants said. Furthermore, the committee removed medical devices from the definition of “health product”, instead listing devices separately in clauses where appropriate. For example, some medicines are limited to sale by pharmacists only, whereas this would not apply to medical devices.
MAUREEN KIRKMAN
References
1. The Regulatory Affairs Journal - Devices, 2008, 16(4), 281-282