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Regulatory Problems. The South African Medicines Control Council : a case study Dr M. Roy Jobson. A national responsibility. Statutory independent body (1965) Members appointed by Minister of Health

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regulatory problems

Regulatory Problems

The South African

Medicines Control Council :

a case study

Dr M. Roy Jobson

a national responsibility
A national responsibility
  • Statutory independent body (1965)
  • Members appointed by Minister of Health
  • Mandate is to ensure that the availability of medicines is in the public interest, and meets criteria of safety, efficacy and quality.
some participants
Some participants!

Pharma

WHO

industry

Health care

Regulators

National

Centres

Medical

media

M. Lindquist

slide5

CONSTITUTION

Administrative Justice

Pharma

WHO

industry

Health care

Act 101 of 1965

Freedom of Access to Information Act

Activists

MCC

MRA

(Medical)

Media

PFMA

S A D C

benefit harm analysis of being a regulator
+

Responsibility

Stature

Exposure to bigger picture

Constant learning

Contribution to country’s health

Some payment

Can raise issues

Maligned by media/ public

Speed reading skills

“Volunteer” (payment low)

Vulnerability

Time lines

Availability

Exhaustion

Secrecy

Benefit-Harm Analysis of being a regulator