1/12/2019 Amendment Bill 6D of 2014 Briefing to the Portfolio Committee of Health 04 November 2015

Outline and Context The presentation outlines the history on the Medicines and Related Substances Amendment Bill, 2014 (Bill 6 of 2014) Discussion on 20 October 2015 in the National Council of Provinces (NCOP) on Bill 6D of 2014

History Bill 6 amends the Medicines and Related Substances Control Act 101 of 1965 and Act 72 of 2008. Published, 20 Feb 2014, GG no. 37361: Establish a new South African Medicines Regulatory Authority (SAHPRA) provide for establishment of a Board the so called SAHPRA board address good governance structures for running of SAHPRA provide for certain transitional matters from the current MCC structure to SAHPRA

History …cont allow for the regulatory oversight of Medical Devices and IVDs allow for the regulatory oversight of Scheduled Substances allow for the regulatory oversight of Complementary Medicines delete and insert certain words in certain definitions; effect certain technical corrections

History …cont Portfolio Committee, Health: Public hearings 29 Oct 2014, 31 Oct 2014, 5 Nov 2014 (18 stakeholders) Portfolio Committee finalised discussion: 25 Febr 2015 National Assembly: Minister tabled Bill as Bill6B of 2014 for its second reading on 13 August 2015 Bill 6B was tagged as a Section 75 Bill and referred to the National Council of Provinces (NCOP)

History …cont NCOP discussion: 25 Aug 2015 Provincial Legislator : 28 Aug-12 Sept 2015 (9 Provinces) Provincial Public hearings: 28 Aug- 21 Sept2015 (38 hearings) NCOP: 22 Sept 2015 - Provincial negotiated mandates Select Committee Social Services (NCOP): 20 Oct 2015, 9 Provinces- Final Mandate Amendments outlined in Bill 6C of 2014 Unanimous vote in favour of Bill 6D of 2014 [combined Bill 6, 6B, 6C]

NCOP Amendments Amendments as per Bill 6C of 2014: technical amendment to allow insertion of “ ’ ” Technical amendment to Section 28 to correct sub section 3 Technical amendment to omit the wording “Scheduled substance” from Section 35(e)(xxxi) Technical amendment to omit the wording “Medical Devices” and replace with “Scheduled substances, medical devices” in Section 35(e)(xxxxvii) Editing of the numbering to refer to both sub section (5) and (6)

NCOP Amendments…cont Amendments as per Bill 6C of 2014: Technical correction to insert “5” Editing to omit “6” and insert “6” Editing to correct numbering and to delete 2 and replace with 3 Editing to correct numbering and to delete 3 and replace with 4 Technical correction to omit reference to “food control” Editing to correct numbering and to delete 4 and replace with 5 Editing to correct numbering and to delete 5 and replace with 6 Editing to correct numbering and to delete 6 and replace with 7 Editing to correct numbering and to delete 7 and replace with 8

Bill 6D of 2014 Bill 6D of 2014 intends to consolidate: Bill 6B Bill 6C

I thank you Director-General: Health