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Regulatory Problems

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

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  1. Regulatory Problems The South African Medicines Control Council : a case study Dr M. Roy Jobson

  2. 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.

  3. Some participants! Pharma WHO industry Health care Regulators National Centres Medical media M. Lindquist

  4. M. Lindquist

  5. 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

  6. Act 101 of 1965 MCC DOH MRA

  7. + 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

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