1. “Empowering doctors to bring health to the nation” COMMENTS BY THE SOUTH AFRICAN MEDICAL ASSOCIATION (SAMA) on THE MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL, 2008

2. The South African Medical Association (“SAMA”) is the professional association for doctors in South Africa and welcomes the opportunity to comment on the Bill. “Empowering doctors to bring health to the nation”

3. We invited comment from our standing committees as well as from other interested parties in our membership. SAMA supports all legislative measures aimed at accentuating the protection and promotion of public interest and public health. Further SAMA supports all measures designed at promoting access to healthcare. “Empowering doctors to bring health to the nation”

4. Technical Issues SAMA’s written submission includes a number of technical issues which we wish to draw to the Committee’s attention. We refer the Committee to that submission for greater detail. SAMA will, in this presentation focus emphasise certain critical matters raised in this Bill. “Empowering doctors to bring health to the nation”

5. The Bill seeks to introduce an Authority which will deal with the certification and registration of “medicines” This Authority represents a significant improvement on the current MCC and will reduce delays in the registration of medicines and in approving trials significantly without decreasing the high standards required for approval SAMA strongly supports this aspect of the Bill.

6. “Empowering doctors to bring health to the nation” The Authority is headed by a Chief Executive Officer (CEO) and is accountable and reports to the Minister of Health. The CEO is appointed by the Minister. SAMA supports this.

7. “Empowering doctors to bring health to the nation” The Minister has direct control over the Authority and has the final say whether a product is registered or certified.

8. “Empowering doctors to bring health to the nation” SAMA is concerned with the direct control that will now be conferred upon the Minister in respect of the registration and certification of medicines, cosmetics, medical devices and foodstuffs. We are of the view that the authority will more than adequately fulfil this function in respect of medicines and to confer this responsibility effectively on the Minister is imprudent.

9. SAMA would respectfully submit that: The Minister is already putting a process in place which is both authoritative and safe The Minister will appoint the CEO on the basis of her/his knowledge, experience, expertise and capacity to represent the minister. The Bill does not preclude the CEO from consulting with the minister if required. The Minister does not and indeed need not have any particular expertise in the field “Empowering doctors to bring health to the nation” The Minister should provide generic advice via the CEO but should not micromanage the process The Minister is already fully occupied and the need for authorisation will delay the process and may impact negatively on the efficiency of the process

10. The South African Medical Association expresses our gratitude for being afforded an opportunity to present our concerns regarding this Bill to the Parliamentary Portfolio Committee. “Empowering doctors to bring health to the nation”