The definition of a counterfeit medicine is not well established. In 1992, the WHO defined a counterfeit medicine as: “a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source." Under this definition, it is the deliberate mislabeling of a drug or medicine which makes it a counterfeit. The US FDA uses a similar definition,
(2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.
There are concerns, however, that some are attempting to expand the definition of counterfeit to include low-quality medications and substandard ingredients, or to use the word "counterfeit" to describe any infringement of intellectual property, including cases where products do not infringe on trademarks, but where there are disputes over patent claims (including cases where medications are manufactured under legitimate limitations and exceptions to patent rights, or where issues concerning patent validity and relevance are quite difficult, or where the relationship between rights and exceptions to rights are complex). For more on this issue, see "What is a Counterfeit?" KEI Policy Blogs, May 21, 2008.
In general, be wary of reported figures that combine counterfeit and substandard drugs into the same category. Substandard products, including those from disreputable firms, are a serious problem, but one that is primarily a regulatory rather than an intellectual property right issue. The WHO recently has issued a number of estimates of the extent of the marketing of counterfeiting and substandard drugs. Most of the dollar value reported in these estimates are for substandard drugs, not for counterfeits as the term is normally understood.
Health Risks of Counterfeit Medicines
Health authorities are appropriately concerned about actual counterfeits products. A counterfeit manufacturer operates outside of the regulatory frameworks that protect consumers, and they can sell products of low quality that harm consumers without being held accountable. In some cases patients are killed by medicines with fake, poor quality or the wrong ingredients Not all counterfeit drugs are of poor quality, however, and some WHO experts have estimated that a significant amount of high quality counterfeits are sold to consumers.IMPACT (International Medical Products Anti-Counterfeiting Taskforce)
IMPACT was formed in Rome at the WHO International Conference on Combating Counterfeit Drugs in February 2006 by the major players in pharmaceutical anti-counterfeiting. Among the groups represented are INTERPOL, the Organization for Economic Co-operation and Development (OECD), World Customs Organization (WCO), World Intellectual Property Organization (WIPO), World Trade Organization (WTO), International Federation of Pharmaceutical and Manufacturers' Associations (IFPMA), International Generic Pharmaceuticals Alliance (IGPA), World Bank, European Commission (EC), and others. Its aim is "to build coordinated networks across and between countries in order to halt the production, trading and selling of fake medicines around the globe" and is composed of working groups on legislative and regulatory infrastructure; regulatory implementation; enforcement; technology; and communication.
Government and Industry Documents and Meetings
30 March - 1 April 2008. 2nd Anti-Counterfeiting Health Products Seminar (referred to on the IMPACT website as the 2nd IMPACT Global Forum), "Building International Cooperation to Protect Patients," sponsored by the Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum, the U.S. Food and Drug Administration, the U.S. Department of Commerce, Singapore’s Health Sciences Authority and the U.S.–ASEAN Business Council.
13-15 February 2008. 1st IMPACT Global Forum, "Using Technology to Combat Counterfeit Medical Products."
13-15 January 2008. 1st Anti-Counterfeiting Health Products Seminar, sponsored by the APEC Life Sciences Innovation Forum, the U.S. Food and Drug Administration, the U.S. Department of Commerce, Singapore’s Health Sciences Authority and the U.S.–ASEAN Business Council.
10-14 December 2007. IMPACT General Meeting 2007, Lisbon, Portugal: Summary Report,
13 March 2007. "First Anti-Counterfeiting Technologies Meeting," Prague, Czech Republic.
13-16 November 2007. "First ASEAN-China Conference on Combating Counterfeit Medical Products," Jakarta, Indonesia.
14-16 November 2006. "First IMPACT General Meeting, Summary of Conclusions."
September 2006. William Burns, "WHO launches taskforce to fight counterfeit drugs," Bulletin of the World Health Organization, vol.84 no.9.
18 February 2006. "Declaration of Rome," Conclusions and Recommendations of the WHO International Conference on Combating Counterfeit Medicines.
1999. World Health Organization, "Guidelines for the development of measures to combat counterfeit medicines," WHO/EDM/QSM/99.1
Related News Stories
26 June 2008. Phil Taylor, "Counterfeiting conference to hear of burden in developing world," In-PharmaTechnologist.com.
24 June 2008. Phil Taylor, "Repackaging ban 'most powerful tool to prevent counterfeiting in Europe,'" In-PharmaTechnologist.com.
01 May 2008. Philip Payne, "The counterfeit problem," Pharmaceutical Technology Europe.
General News Stories and Academic Papers on Pharmaceutical Counterfeits
30 June 2008. Nick Taylor, "Parallel traders EU counterfeiting response," In-PharmaTechnologist.com
29 June 2008. Oliver Morgan, "Parallel trade in drugs puts EU patients at risk," The Guardian.
23 June 2008. Nick Taylor, "EU counterfeiting response is far from generic," In-PharmaTechnologist.com.
4 June 2008. Jonna Dagliden, "Parallel Trade of Pharmaceutical Tops European Commission Agenda, says New Report," PRLog.
20 May 2008. Nick Taylor, "40% of EU counterfeit drug seizures of Swiss origin," In-PharmaTechnologist.com
21 January 2008. Ed Silverman, "‘Black Propaganda?’ Parallel Trade And Counterfeits," Pharmalot.
1 February 2007. LTC Harms, "Shared Challenges, Common Goals," Address, 3rd Global Congress on Combating Counterfeiting and Piracy.
2006. Kevin Outterson and Ryan Smith, "Counterfeit Drugs: The Good, the Bad and the Ugly," Albany Law Journal of Science and Technology, Vol. 15, 2006.
19 June 2006. Jonathan Harper, Julian Morris, Graham Satchwell, Philip Stevens, David Taylor, Michael Tremblay, "Coincidence or Crisis? Prescription Medicine Counterfeiting," The Stockholm Network.
14 March 2005. Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White, "The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers," Public Library of Science (PLoS).
1 March 2005. "No security issue from parallel trade, says Pfizer VP," In-PharmaTechnologist.com
2005. Anil K. Deisingh, "Pharmaceutical counterfeiting," The Analyst, 130, 271 - 279.