Medicines and Related Substances Amendment Bill 2008 Pharmaceutical Task Group: Industry Marketing Code Steering Committee Presented by: Maureen Kirkman & Jim Ringer (Chairperson) 5 August 2008

PTG – Pharmaceutical Industry Marketing Code Steering Committee IMSA Innovative Medicines South Africa NAPMNational Association of Pharmaceutical Manufacturers PHARMISAPharmaceuticals made in South Africa PIASAPharmaceutical Industry Association of South Africa SMASASelf Medication Association of South Africa Supported by: NAPWNational Association of Pharmaceutical Wholesalers IHDInternational Healthcare Distributors PHDPharmaceutical Healthcare Distributors PSSAPharmaceutical Society of SA This initiative to eliminate perversities is supported by the entire medicines supply chain

Medicines and Related Substances Amendment Bill 2008 Background Many perversities in the marketplace related to the marketing of medicines and other health products In 1998 attempt to remove these for medicines by amendments [Sec 18A] banning incentives and required the Minister of Health to make Regulations for the marketing of medicines and to provide for an enforceable Code of Practice [Sec 18C] We welcome the application of these measures to the marketing of all health products to eliminate perversities

Legal Gaps and Marketing Code There is no provision for regulations to support S18A and this is creating loopholes and opportunities to get around the ban on incentives No direct legal link between the Medicine Pricing Regulations and marketing incentives Marketing Code for Medicines not published in an enforceable form by DoH No enforcement Perversities continue in the marketing of medicines and other health products – undermines the intent of the Medicines Pricing Regulations

Amendment Bill 2008 Industry supports the elimination of perversities in the system [ Section 18A and 18C ] Publication of a code/s is essential – but The Bill changes wording from ‘the MoH “shall” to “may” make Regulations’ relating to a Code of Practice for marketing of health products. This change should not be made in the Bill Reason: Compliance must be mandatory for all companies and for all products to protect patients Compliance must be enforced through the legislation and registration processes

Recommendation Empowering provision needed for Regulations [Sec 35] to enforce compliance with the legislation [18A] and Marketing Codes [18C] Code to be based on self-regulation by industry and supported by ultimate enforcement via the SAHPRA Compliance with the code to be a condition for registration of a medicine or a health product Publish SA Marketing Code for Medicines without delay and follow with relevant Codes of Marketing Practice for other health products

Conclusion Our request: Provide for regulations to S18A and S18C Finalise and publish SA Marketing Codes Step wise implementation of Code – medicines first Objective is to ensure ethical marketing practices and eliminate perversity in the marketing of health products to protect patients

Contacts IMSA Val Beaumont NAPM Raseela Inderlall PHARMISAStavros Nicolau PIASA Maureen Kirkman SMASA Allison Vienings NAPW Trevor Phillips IHD Murray Clark PSSA Ivan Kotze

Self Regulatory Code Authority Industry to establish, manage and fund an independent Marketing Code Authority to administer complaints made under the SA Marketing Codes for health products Limited resource needed by DoH Needs endorsement from DoH Precedents in United Kingdom and Australia Responsible for: – providing Guidance – training – updates and revisions of the Code – handling complaints in transparent manner – providing regular reports – working with DoH to ensure compliance

Structure of Code enforcement body Marketing Code Authority Board of Management Adjudication panel Appeal Board Admin assistant Adjudicator / Director

Composition of Board Industry representatives – from companies and trade associations supporting the Codes Dept of Health Health professionals from HPCSA / SAPC Consumer representative