Regulation of Pharmaceutical Promotion:

assessment, analysis & advocacy

Lilia Ziganshina

20 May 2009 WHA

• 1988: WHO Ethical Criteria

• 2007: Resolution on the Rational Use of Medicines

• Country requests for assistance

• Calls from civil society, governments, donors and the WHO for action

Pharmaceutical Promotion: a major barrier to

the Rational Use of Medicines

The WHA Resolution on Rational Use of Medicines (WHA60.16) urges Member States…

“…to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor drug promotion, and to develop and implement programmes that will provide independent, non-promotional information on medicines.”

Regulation of Pharmaceutical Promotion: The way forward?

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Step 1: WHO/HAI Indicators on Promotion

Step 2: HAI Ethical Criteria Guidelines

Indicators on Promotion Methodology to assess Ethical Criteria in

MeTA* countries

* MeTA – Medicines Transparency Alliance

• WHO/HAI partnership

• International consultative group of experts

• Expansion and development of indicators

• Measure performance, perceptions, and outcomes of legislation and regulation

• Identify gaps in regulatory frameworks and policy implications

• Build capacity and advocacy efforts

• Model legislation - Country request

• International expert advisory panel

• Ethical Criteria and disguised promotion

• Implementing laws and regulations

• Financing mechanisms

• HAI core principles

Guidelines on Implementing the WHO Ethical Criteria

• 2009 - 2010

• Working with interested partners

• The way forward:

Looking ahead

Methodology to assess use of the Ethical Criteria in countries (Indicators)

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Model legislation on regulating pharmaceutical promotion

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Means to curb unethical promotion and advance public health