Topic:- Medicines and Related Substances Amendment Bill [B6-2014]: adoption of NCOP amendments
Portfolio of health meeting held on 04 November 2015
Matters arising high level summary
I am constantly reminded that as people outside the parliamentary process, we do not always know how slowly the wheels of government can turn. This week, and the Portfolio of Health meeting, the Department of Health explained that the Medicines and Related Substances Amendment Bill [B6-2014] amended the Medicines and Related Substances Control Act 101 of 1965.
The Bill had been published on 20 February 2014 to establish a new South African Health Products Regulatory Authority (SAHPRA). The amendment of the Bill looked to provide for the establishment of a SAHPRA Board, address good governance structures for running the SAHPRA, and provide for transitional matters from the current Medicines Control Council (MCC) structure. The amended Bill also seeks to allow for the regulation of medical devices and in vitro diagnostics devices (IVDs), scheduled substances and complementary medicines.
The Committee asked questions relating to the removal of ‘scheduled substances’ in Section 35 of the Bill, and how the Bill should be adopted – clause by clause or as a blanket approval. A Member pointed out that the Bill had been tabled as a Section 76 Bill and not as a Section 75, as the Department had indicated in its presentation. Another Member expressed concerns that the amendments might open up spaces for corruption, and that there were not enough qualified, or skilled, people in the country to implement the Bill effectively.
Minutes of Committee meetings were adopted with a few minor changes. However, the Committee suggested that the Department should respond to concerns which had been previously raised by the Committee.