Presented by: Maureen Kirkman & Jim Ringer (Chairperson) 5 August 2008

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

2. PTG – Pharmaceutical Industry Marketing Code Steering Committee 2007-2008 • IMSA Innovative Medicines South Africa • NAPM National Association of Pharmaceutical Manufacturers • PHARMISA Pharmaceuticals made in South Africa • PIASA Pharmaceutical Industry Association of South Africa • SMASA Self Medication Association of South Africa • Supported by: • NAPW National Association of Pharmaceutical Wholesalers • IHD International Healthcare Distributors • PHD Pharmaceutical Healthcare Distributors • PSSA Pharmaceutical Society of SA This initiative to eliminate perversities is supported by the entire medicines supply chain

3. 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

4. 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

5. 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

6. 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

7. 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

8. Contacts • IMSA Val Beaumont 011 880 4644 • NAPM Raseela Inderlall 012 323 7529 • PHARMISA Stavros Nicolau 011 239 6798 • PIASA Maureen Kirkman 011 805 5100 • SMASA Allison Vienings 012 803 4444 • NAPW Trevor Phillips 083 378 3260 • IHD Murray Clark 011 458 2222 • PSSA Ivan Kotze 012 301 0833

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

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