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 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

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 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

Structure of Code enforcement body

Marketing Code AuthorityBoard of Management

Adjudication panel

Appeal BoardAdmin 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