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Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation
Rationale
Methodology
Irrational prescribing and use of medicines
often results in inappropriate or harmful
treatment, a waste of valuable health
resources and increased drug resistance.
Literature
review
The single most important stimulus behind
irrational medicines use is the unethical
promotional of medicines
Many countries have introduced a
legislative framework to regulate the
promotional activities of the
pharmaceutical industry; these vary widely
regarding content, implementation and
enforcement.
Key Informants
Interview
Field analysis
Background
Whilst the pharmaceutical industry plays a key
role in developing and producing medicines,
there is a tension between industry’s need to
expand product sales and a country’s public
health needs.
“ There is an inherent conflict of interest between
the legitimate business goals of manufacturers
and the social, medical and economic needs of
providers and the public to select and use drugs
in the most rational way.” 1
Promotional material is often the main or only
source of information about medicines for health
professionals and consumers. The sheer volume
of promotion al activities including industry
involvement in continuing medical education,
clinical research, patient groups and other areas,
make persuasive promotional messages difficult
to avoid.
Comprehensive tools for the systematic collection and
analysis of relevant laws, guidelines or codes related to
the promotion of medicines. Additional tools to assess
existing mechanisms that implement and/or enforce
restrictions on promotional activity.
Interview schedules for data collection from representatives
from the drug regulatory authorities, WHO, health care
professionals, civil society, pharmaceutical industry
representatives, insurers and media. Qualitative analysis of
insights into the current promotion situation, and
observations on best practice.
Monitoring specific promotion outcomes (such as directto-consumer advertisements, the impact of sales
representatives and the uptake of generic medicines),
thus allowing measurement of progress against
legislative or code of practice intervention
Regulation of Promotion: milestones
1988 : WHO Ethical Criteria for Medicinal Drug Promotion.
This document remains the
gold standard against which
promotional activities, and
national and regional efforts to
regulate promotion, are judged.
2007: Resolution WHA 60.16 on rational use
of medicines 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.” 2
Next steps
Objectives
The project aims to determine:
The scope of regulation and/or restrictions on
pharmaceutical promotion in countries
The impact and effectiveness of regulatory
frameworks and/or codes of practice aimed at
restricting promotional activities
This will help countries to identify:
1) National legal provisions on promotion as well as
existing mechanisms to implement and enforce them
2) Existing forms of unethical promotion and best
practice
3) Any gaps in the regulatory framework that need to
be addressed
Results
This research will provide a detailed profile of how
promotion is managed within a country’s, including
• Strengths and weaknesses of the regulatory
framework
• Any outstanding enforcement issues
• A clearer picture of the political context and
stakeholder positions on regulation
The research findings will provide valuable insight into the
efficacy of pharmaceutical promotion regulation; highlight
areas that need strengthening; and inform
recommendations to improve policies on medicines
promotion. National surveys carried out using the HAI
methodology will provide an evidence base, which
countries can then use to make policy choices that
contribute to the rational use of medicines.
The methodology now needs to be pilot tested: by assessing a number of countries representing
various levels of economic development; these countries will benefit from a comprehensive
assessment and will be involved in the finalisation of the methodology.
It will then be released as an open access tool.
Further information: [email protected]
1 World Health Organization. Clinical Pharmacological Evaluation of Drug Control. WHO, 1993
2 Resolution 60.16 on Rational Use of Medicines. 60th World Health Assembly, 2007