ERIC REURTS

Draft SA Marketing Code

Marketing Code Steering Committee

PIASA - Pharmaceutical Industry AssociationNAPM – National Association of Pharmaceutical

Manufacturers IMSA – Innovative Medicines of South AfricaSMASA – Self Medication Manufacturers Association of

South AfricaPHARMISA – Pharmaceuticals made in South Africa IHD – International Healthcare DistributorsLSPA – Logistics Service Providers Association (incl.

NAPW & PHD)Supported by PSSA – Pharmaceutical Society of SASAMED – South African Medical Devices AssociationSALDA – South African Laboratory and Diagnostics

Association

Recap - Legal context of the Code

Legal gaps identifiedCode 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

Scope of the Code

Revised Enforcement Model for the Code

no resolution 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

Timelines to implementation

A lot of work has been done alreadyProcess of implementation more complex

than anticipatedInitial timeline of June 2010 was setThis timeline will not be metCertainty is that Code will be implemented by

Q3 2010