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“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
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”
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”
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”
“Empowering doctors to bring health to the nation”
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.
“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.
“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.
“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.
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