Access To Medicines Project

Briefing Note: Recommendations for World Health Assembly Pharmaceutical Counterfeiting Resolution

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The nations of the world are considering a resolution on Counterfeiting at this week’s World Health Assembly in Geneva. Essential Action has produced a briefing note urging three specific changes to the resolution as pre-conditions for its adoption.

Essential Action recommends:

1. The Counterfeiting Draft Resolution should cite the role of high medicine prices in promoting pharmaceutical counterfeiting.

2. The Counterfeiting Draft Resolution should emphasize the need for companies to disclose information they have concerning counterfeits.

3. The Counterfeiting Draft Resolution should address counterfeiting as a public health problem. Anti-counterfeiting measures requiring the cooperation of health agencies should focus specifically and exclusively on the dangers and harms posed to the public by counterfeit goods. The WHO’s anti-counterfeiting work should be driven by the need to protect
public health, not intellectual property.

The full text of the briefing note is available following continuation of the post in html, and here as an rtf document: EA_Note_WHA_counterfeit_resn.rtf
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Essential Action Note on WHA Counterfeiting Draft Resolution (A61/A/Conf. Paper No.1)

The Counterfeiting Draft Resolution does not identify an important incentive for pharmaceutical counterfeiting: high medicine prices. According to WHO, “When the prices of medicines become excessively high and unaffordable, patients tend to look for cheaper sources. Such [a] situation encourages counterfeiters to produce cheaper counterfeit drugs. … When price differences exist between identical products, patients and consumers go for the cheaper ones. This creates a greater incentive for counterfeiters to supply cheap counterfeit medicines.”[1] The Counterfeiting Draft Resolution should cite the role of high medicine prices in promoting counterfeiting.

The Draft Resolution should add two paragraphs:
o [Introduction:] Recognizing that when prices of medicines become excessively high and unaffordable, patients tend to look for cheaper sources. This situation gives counterfeiters an incentive to supply cheaper counterfeit drugs;

o [2. REQUESTS the Director General:] (6) To further investigate the role of high medicine prices in promoting counterfeiting and suggest paths of action, to address the issue.

The Counterfeiting Draft Resolution should emphasize the need for companies to disclose information they have concerning counterfeits. Although pharmaceutical companies depend on law enforcement and public resources to locate counterfeits and maintain consumer confidence in their brands, companies do not always disclose what they know about counterfeits in the market.[2] The Counterfeiting Draft Resolution should recommend Member States require private companies to disclose any information they obtain about the existence of potentially dangerous counterfeit products.[3]


The Counterfeiting Draft Resolution should add the following:

o [Introduction] Recognizing that health authorities obtaining timely, complete and comprehensive information about potentially dangerous counterfeits in the market is essential to protecting public health;

o [1. URGES Member States:] (4) to establish appropriate mechanisms enabling international cooperation and exchange of information among relevant authorities involved in detecting and combating counterfeit medical products, including requiring companies to timely disclose any information they obtain concerning the existence of potentially dangerous counterfeits;

o [2. REQUESTS the Director General:] (1) to support Member States in their efforts to develop and implement policies and programmes aimed at combating counterfeit medical products, including facilitating the exchange of information at the international level, for example through establishing guidelines for the mandatory disclosure of information concerning potentially dangerous counterfeit products; and the development of tools, guidelines, training and awareness initiatives,
and methodology for evaluation and monitoring;

The Counterfeiting Draft Resolution should address counterfeiting as a public health problem. Anti-counterfeiting measures requiring the cooperation of health agencies should focus specifically and exclusively on the dangers and harms posed to the public by counterfeit goods. The WHO’s anti-counterfeiting work should be driven by the need to protect public health, not intellectual property. From a public health perspective, medicine counterfeiting is a subset of a larger drug quality problem. The Counterfeiting Draft Resolution should make clear WHO’s interest in combating counterfeiting is to protect public health rather than intellectual property.

The Counterfeiting Draft Resolution should add the following:
o [Introduction:] Cognizant that counterfeit medicines are a subset of a larger drug quality problem, that WHO should address counterfeiting specifically and exclusively as a public health concern, and not as a means to address intellectual property rights controversies;

May 2008
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For More Information, Contact:
Sarah Rimmington
(Geneva until May 29) +41 (0)78 847 0562
srimmington@essentialinformation.org

Peter Maybarduk
(Washington, DC) (+1) 202-387-8030
peter.maybarduk@essentialinformation.org

Essential Action
PO Box 19405, Washington, DC USA 20036
www.essentialaction.org/access

[1] “What encourages counterfeiting of drugs?” World Health Organization Counterfeits FAQ, available at:
http://www.who.int/medicines/services/counterfeit/faqs/16/en/index.html.

[2] Reportedly, the Pharmaceutical Security Institute (PSI), formed by fourteen pharmaceutical companies in 2002, recorded 76 cases of counterfeiting in 2004. The FDA only knew of 58. “Counterfeit medicines – What are the problems?” Pharma-Brief Special, BUKO Pharma-Kampagne, a member of Health Action International (2007) at 5. PSI’s counterfeiting
database is considered the world’s best, yet it reportedly “is not accessible to the WHO, health authorities or the public.” “The global threat of counterfeit drugs: why industry and governments must communicate the dangers.” Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White, Public Library of Science (PLoS) Medicine, April 2005, Volume 2, Issue 4, at 305.

[3] The Secretariat’s Report cites “ineffective collaboration and exchange of information between public and private sector” as contributing to an environment in which counterfeits can thrive. IMPACT’s Working Group on Legislative and Regulatory Infrastructure recommends the “mandatory reporting of [counterfeiting] information to competent authorities.” by manufacturers. IMPACT Working Group on Legislative and Regulatory Infrastructure, “Principles and Elements for
National Legislation against Counterfeit Medical Products.”

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May 19th, 2008 at 10:03 am

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