ERIC REURTS Draft SA Marketing Code

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

Recap - Legal context of the Code Act 101 of 1965 Section 22G Section 18C Section 18B Section 18A Legal gaps identified Code will not resolve or eliminate issues around perversities in the market Legal gaps identified Code will not resolve or eliminate issues around perversities in the market Makes provision for a Marketing Code

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

Code Steering Committee Restructure Marketing Code Steering Committee MCA Interim Board Code Steering Committee Working Groups

Scope of the Code Marketing & promotion of medicines to healthcare professionals Will replace Appendix A of ASA Code Part A Marketing & promotion of medicines to consumers Will replace Appendix A of ASA Code Part B Enforcement of the Code Part C Medical Devices? Part D?

Revised Enforcement Model for the Code Company to company Refer to MCA Refer to DoH Final Sanction no resolution Legal mechanisms

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

Progress & Next Steps Finalize Code (Part A & B) Code Alignment discussions SAMED & SALDA Rewrite & finalize Part C Sanctions document developed Guidelines to Code written Request for proposal sent to training providers Outsourcing proposal ASA (administration function only) Agreement between ASA, DoH and CSC on publishing of Code MCA established as a legal entity SLA with ASA or alternative Appoint Executive Director of MCA Inform DoH on final MCA functioning and agreements DoH to publish regulations Code is enforced and applicable to all medicines

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