Transcript Pharmaceutical Task Group Marketing

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
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IMSA
NAPM
PHARMISA
PIASA
SMASA
Innovative Medicines South Africa
National Association of Pharmaceutical Manufacturers
Pharmaceuticals made in South Africa
Pharmaceutical Industry Association of South Africa
Self Medication Association of South Africa
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Supported by:
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NAPW
IHD
PHD
PSSA
National Association of Pharmaceutical Wholesalers
International Healthcare Distributors
Pharmaceutical Healthcare Distributors
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
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IMSA
NAPM
PHARMISA
PIASA
SMASA
NAPW
IHD
PSSA
Val Beaumont
Raseela Inderlall
Stavros Nicolau
Maureen Kirkman
Allison Vienings
Trevor Phillips
Murray Clark
Ivan Kotze
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880
323
239
805
803
378
458
301
4644
7529
6798
5100
4444
3260
2222
0833
Structure of Code enforcement body
Marketing Code Authority
Board of Management
Adjudicator / Director
Admin assistant
Adjudication panel
Appeal Board
Composition of Board
• Industry representatives – from
companies and trade associations
supporting the Codes
• Dept of Health
• Health professionals from HPCSA / SAPC
• Consumer representative