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<TITLE>Counterfeit medicines: SIGN ON Letter to Margaret Chan</TITLE>
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<FONT FACE="Times New Roman"><SPAN STYLE='font-size:12.0px'>Dear All, <BR>
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Below is an open letter to Dr. Margaret Chan on the issue of WHO's involvement in anti-counterfeiting activities. <BR>
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The basic aim of this letter is to make clear that there is a confusion in relation to use of the counterfeit terminology and this confusion is being used to promote IP enforcement. Concerns about WHO's involvement in IMPACT are also highlighted. As you may well know, several developing countries, Thailand, Brazil, India, Chile, Bangladesh, Iran, Egypt objected to WHO's involvement in IMPACT as well as raised the problem of confusion in relation to the counterfeit terminology. They will be taking this issue up at the upcoming World health Assembly. <BR>
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Do let us know if your Organization is willing to sign on to the letter. Pls pass on the letters to other NGOs that you think may be interested in the issue and in supporting us. <BR>
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If you would like to sign-on to the letters pls send us an email with the name of your organization and country to sangeeta@thirdworldnetwork.net or to ssangeeta@myjaring.net<BR>
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Deadline for signing on to the letter is 3 May 2010. <BR>
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Regards<BR>
Sangeeta Shashikant<BR>
Third World Network<BR>
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OPEN LETTER TO DR. MARGARET CHAN<BR>
DIRECTOR GENERAL OF WORLD HEALTH ORGANISATION<BR>
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We, the undersigned organizations are very concerned about the nature and extent of WHO’s involvement in issues pertaining to counterfeit medical products. We recognize that work must be undertaken under WHO’s leadership to ensure availability of quality, safe and efficacious pharmaceuticals but we fear that WHO’s involvement in the issue of “Counterfeits” will have adverse consequences for access to affordable generic medicines while failing to address the very real problem of proliferation of pharmaceuticals with compromised quality and safety.<BR>
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The term “Counterfeit” is defined by the WTO-TRIPS Agreement as referring to a trademark violation and in some legislation to all other intellectual property (IP) violations as well. Today it is widely known that business interests and governments in OECD countries that represent them are making use of trade agreements, plurilateral government initiatives (e.g. the Anti-Counterfeit Trade Agreement) and programmes in international agencies to set and enforce higher IP standards under the heading of "Counterfeiting"[1] <#_ftn1> . <BR>
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It is against this background that WHO’s use of the term “Counterfeit” to refer to a range of pharmaceutical quality and safety problems is most concerning. Not only has this resulted in confusion but also offered a convenient route for proponents of an extended IP agenda to press for inappropriate IP enforcement standards in developing countries under the false premise that such standards will deliver quality assured pharmaceuticals to the people. <BR>
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For instance, in the East African region several anti-counterfeiting legislation have been enacted or are in the process of being enacted. Whilst the proclaimed rationale for such legislation is to protect the public from unsafe products, these legislations are in actual fact only about protecting the rights of IP holders to the detriment of access to affordable generic pharmaceuticals. Most of these legislations define “Counterfeit” products as being substantially similar or identical to IP protected products, which effectively makes every generic pharmaceutical a counterfeit. In Kenya, enactment of the Anti-Counterfeit Act 2008 has been challenged by people living with HIV/AIDS on the grounds that enforcement and application of the Act will deny them access to affordable essential medicines and thus deny their Right to Life. <BR>
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Equating “Counterfeit” (a term defined in the TRIPS Agreement as trademark violation) to spurious pharmaceuticals (i.e. falsely labeled products, products with no or insufficient or toxic active ingredients) not only undermines confidence in much-needed affordable quality generic products but also results in public health problems being addressed through an IP enforcement lens. Such an approach will not deliver the solutions needed to address the proliferation of spurious pharmaceuticals, which arise irrespective of whether there is an IP violation. <BR>
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Moreover confusion over the use of the term “Counterfeit” makes it impossible to obtain data on the true extent of the proliferation of medicines which do not meet quality, safety and efficacy standards because the data on “Counterfeit” would also refer to situations involving IP infringements. We would also point out that empirical, reliable and transparent statistics about “counterfeit drugs” is non-existent and that the only comprehensive global collection of data on drug counterfeiting is held by the Pharmaceutical Security Institute (PSI), an industry body that fails to make information available for public scrutiny.[2] <#_ftn2> <BR>
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In addition, we are troubled by WHO’s engagement in the International Medical Product Anti-Counterfeit Taskforce (IMPACT) and share concerns of the many member states that have questioned the legitimacy of IMPACT.[3] <#_ftn3> In particular concerns have been raised about participation in IMPACT’s activities especially the central role played by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in IMPACT’s activities, lack of transparency surrounding IMPACT’s activities, and lack of accountability as IMPACT has operated outside the purview of WHO member states.[4] <#_ftn4> <BR>
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Concerns have also been raised about IMPACT’s link to entities which are very much engaged on matters pertaining to IP enforcement under the banner of “anti-counterfeiting activities” such as Interpol, OECD, the World Customs Organisation (WCO), the World Intellectual Property Organization (WIPO), the European Commission, the multinational pharmaceutical industry. This further raises concern about conflicts of interests, about which WHO by its own admission, has taken no measures to address.[5] <#_ftn5> It is also particularly noteworthy that IMPACT has been identified as an initiative involved in IP enforcement[6] <#_ftn6> . <BR>
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Another key concern is IMPACT’s Principles & Elements for National Legislation Against Counterfeit Medical Products which are not only problematic because they emerge from an initiative whose legitimacy is in question but also because - it includes a call for addressing counterfeit medical products inter alia by establishing or enhancing intellectual property legislation; contains provisions that could result in TRIPS plus implementation as well as non-tariff barriers for trade in medical products, which could undermine access to affordable medicines, become entry barriers for generic industries particularly of developing countries and affect use of flexibilities such as parallel importation of good quality medicines. <BR>
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These elements also promote measures that have led to seizures/detainment of good quality pharmaceuticals in transit at European ports on request of MNCs on suspicion of IP violations, which resulted in delayed treatment for developing country patients.[7] <#_ftn7> <BR>
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Moreover the approach adopted by IMPACT is faulty as it fails to address the root causes for the proliferation of pharmaceuticals with compromised quality and safety in particular the high price of pharmaceutical products which results in inequitable access and the problem of weak regulatory capacity in developing countries in terms of facilities, financial and human resources.<BR>
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The abovementioned concerns raised by Member states have been largely ignored with the WHO continuing to promote use of the term “Counterfeit”, and to endorse IMPACT including by allowing IMPACT to use WHO’s logo on its documents, even where such documents are prepared by the pharmaceutical industry.[8] <#_ftn8> Moreover despite repeated objections to IMPACT and its Principles & Elements, WHO also appears to be pushing for the adoption of such elements as a WHO document bypassing scrutiny of the World Health Assembly[9] <#_ftn9> . <BR>
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We are of the view that WHO’s continued involvement in IMPACT threatens to undermine WHO’s credibility as an organisation that is impartial and that upholds the interests of public health. In view of the above we urge WHO Secretariat:<BR>
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· to explore use of other terminologies to capture the problem of pharmaceuticals with compromised quality, safety and efficacy substituting the term “Counterfeit” which is already defined in the TRIPS Agreement; <BR>
· to distance itself from IMPACT, its activities and its Draft Principles & Elements and to stop functioning as the Secretariat of IMPACT; <BR>
· to withdraw WHO’s logo from all IMPACT documents and to ensure that WHO does not endorse any other activities that promotes the IP enforcement agenda;<BR>
· to focus its attention on dealing with high prices of pharmaceuticals, ensuring timely availability of affordable pharmaceuticals, as well as strengthening the capacity drug regulatory authorities. <BR>
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[1] <#_ftnref1> For an overview of anti-counterfeiting initiatives see Susan Sell (2008), “The Global IP Upward Ratchet, Anti-counterfeiting and piracy enforcement efforts: The State of Play” available at <a href="http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf">http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf</a> <a href="http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf"><http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf></a> . See also Ermias Tekeste Biadleng and Viviana Munon Tellez (2008) “The Changing Structure and Governance of Intellectual Property Enforcement” Research Paper 15, South Centre, p. 25 available at www.southcentre.org <a href="http://www.southcentre.org"><http://www.southcentre.org></a> <BR>
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[2] <#_ftnref2> See Kevin Outterson and Ryan Smith (2006)., “Counterfeit Drugs: the Good, the Bad and the Ugly” 16 Albany Law Journal of Science and Technology 525<BR>
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[3] <#_ftnref3> See “Concerns voiced over IMPACT, Secretariat's role on "counterfeits" available at <a href="http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090201.htm">http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090201.htm</a> <a href="http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090201.htm"><http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090201.htm></a> ;<BR>
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[4] <#_ftnref4> See South Centre & CIEL IP Quaterly Update, Third Quarter 2008, available at <a href="http://www.southcentre.org/index.php?option=com_content&view=article&id=955%3A2008-3rd-quarter-ip-quarterly-update-&catid=50%3Aintellectual-property-quarterly-update&Itemid=102&lang=en">http://www.southcentre.org/index.php?option=com_content&view=article&id=955%3A2008-3rd-quarter-ip-quarterly-update-&catid=50%3Aintellectual-property-quarterly-update&Itemid=102&lang=en</a> <a href="http://www.southcentre.org/index.php?option=com_content&view=article&id=955%3A2008-3rd-quarter-ip-quarterly-update-&catid=50%3Aintellectual-property-quarterly-update&Itemid=102&lang=en"><http://www.southcentre.org/index.php?option=com_content&view=article&id=955%3A2008-3rd-quarter-ip-quarterly-update-&catid=50%3Aintellectual-property-quarterly-update&Itemid=102&lang=en></a> <BR>
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[5] <#_ftnref5> See FAQ with Answers prepared by WHO & IMPACT, distributed at an Open Forum on IMPACT on 26th March 2010 wherein it is states that “To date, participation in task force meetings has not required any declaration of interests.”<BR>
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[6] <#_ftnref6> See G8 Summit Declaration on “Growth & Responsibility in the World Economy” (2007) available at <a href="http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html">http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html</a> <a href="http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html"><http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html></a> ; See OECD report on “The Economic Impact of Counterfeiting and Piracy”, available at <a href="http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_03_OECD_Study_on_Counterfeiting_and_Piracy.pdf">http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_03_OECD_Study_on_Counterfeiting_and_Piracy.pdf</a> <a href="http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_03_OECD_Study_on_Counterfeiting_and_Piracy.pdf"><http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_03_OECD_Study_on_Counterfeiting_and_Piracy.pdf></a> ; See also <a href="http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm#what">http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm#what</a> <a href="http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm#what"><http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm#what></a> <BR>
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[7] <#_ftnref7> For example IMPACT’s Principles & Elements propose that Governments should apply legal basis to all medical products in transit/trans-shipment, bounded warehouses, free trade zones and all situations of the international trade. <BR>
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[8] <#_ftnref8> G Power, “Anti counterfeiting Technologies for the Protection of Medicine” , p.2, <a href="http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf">http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf</a> <a href="http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf"><http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf></a> <BR>
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[9] <#_ftnref9> See FAQ with Answers prepared by WHO & IMPACT, distributed at an Open Forum on IMPACT on 26th March 2010 wherein it is states that “IMPACT documents could become a WHO document if they undergo WHO procedures including review by the relevant WHO Expert Committee processes”. See also WHO’s website at <a href="http://www.who.int/impact/news/en/">http://www.who.int/impact/news/en/</a> <http://www.who.int/impact/news/en/> wherein comments are being sought on IMPACT’s Draft Principles & Elements for National Legislation Against Counterfeit Medical Products”<BR>
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SIGNATORIES<BR>
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All India Drug action Network <BR>
Diverse Women for Diversity .<BR>
Egyptian Initiative for Personal Rights<BR>
Health Action International Asia Pacific<BR>
Health Action International Europe<BR>
Health Action International Global<BR>
International Peoples Health Council ( South Asia ) <BR>
Initiative for Health Equity and Society , <BR>
Research Foundation for Science Technology and Ecology <BR>
Third World Network<BR>
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