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Draft SA Marketing Code

Draft SA Marketing Code. Eric reurts. Marketing Code Steering Committee. PIASA - Pharmaceutical Industry Association NAPM – National Association of Pharmaceutical Manufacturers IMSA – Innovative Medicines of South Africa SMASA – Self Medication Manufacturers Association of South Africa

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Draft SA Marketing Code

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  1. Draft SA Marketing Code Eric reurts

  2. Marketing Code Steering Committee • PIASA - Pharmaceutical Industry Association • NAPM – National Association of Pharmaceutical Manufacturers • IMSA – Innovative Medicines of South Africa • SMASA – Self Medication Manufacturers Association of South Africa • PHARMISA – Pharmaceuticals made in South Africa • IHD – International Healthcare Distributors • LSPA – Logistics Service Providers Association (incl. NAPW & PHD) • Supported by PSSA – Pharmaceutical Society of SA • SAMED – South African Medical Devices Association • SALDA – South African Laboratory and Diagnostics Association

  3. Recap - Legal context of the Code Makes provision for a Marketing Code Legal gaps identified Code will not resolve or eliminate issues around perversities in the market

  4. 2009 Code snapshot • Major shift in enforcement model: • From being regulated by DoH to more self regulatory model • Industry tasked with setting up MCA • Independent board with broad representation • Collaboration with ASA • Outsourcing of code administration to ASA • DoH involvement • Adherence to the Code still a condition of registration • Breach of the Code is still a breach of the Act • Interim Board appointed • Function is drive to implementation of the Code • Needed for governance purposes • Steering Committee • Interim board delegates tasks to steering committee

  5. Code Steering Committee Restructure

  6. Scope of the Code

  7. Revised Enforcement Model for the Code no resolution no resolution Legal mechanisms

  8. Some important questions • Will the Code have ‘teeth’? • YES! • Section 18 C makes provision for a Code/s • Regulations to Section 18 C will be published by DoH • Adherence to the Code will be a condition of registration • When self regulatory mechanisms fail, complaints can be referred to DoH • Breach of the Code will be a breach of the Act • Most severe sanction will be cancellation of registration of a product • What about complementary medicines? • Out of scope of the current SA Marketing Code • HPA are developing their own Code

  9. Progress & Next Steps ≈      ≈ ≈ ≈

  10. Timelines to implementation • A lot of work has been done already • Process of implementation more complex than anticipated • Initial timeline of June 2010 was set • This timeline will not be met • Certainty is that Code will be implemented by Q3 2010

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