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<blockquote style="BORDER-LEFT: #ccc 1px solid; MARGIN: 0px 0px 0px 0.8ex; PADDING-LEFT: 1ex" class="gmail_quote">from: Sangeeta <a href="mailto:ssangeeta@myjaring.net">ssangeeta@myjaring.net</a><br><br><br>Geneva, 12 May (Kanaga Raja) -- More than forty-five non-governmental<br>
organizations (NGOs) have voiced concern over the involvement of the World<br>Health Organization (WHO) in the issue of "counterfeit" medical products,<br>which they said will have adverse consequences for access to affordable<br>
medicines while also failing to address the very real problem of<br>proliferation of pharmaceuticals with compromised quality, safety and<br>efficacy.<br><br>The Open Letter is available at:<br><a href="http://www.twnside.org.sg/announcement/Open.Letter.to.WHO.DG.final.PDF" target="_blank">http://www.twnside.org.sg/announcement/Open.Letter.to.WHO.DG.final.PDF</a><br>
<br>In an open letter to WHO Director-General Dr Margaret Chan, the civil<br>society organizations were also troubled by WHO's engagement in the<br>International Medical Product Anti-Counterfeit Taskforce (IMPACT).<br>
<br>Among the concerns raised by the NGOs over WHO's role in IMPACT include its<br>links to entities that are engaged in matters pertaining to Intellectual<br>Property (IP) enforcement, the central role played by the International<br>
Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in IMPACT's<br>activities, the lack of transparency surrounding IMPACT's activities and the<br>lack of accountability, as IMPACT has operated outside the purview of WHO<br>
Member States.<br><br>(IMPACT was launched by the WHO in 2006, and according to the health agency,<br>it is aimed at building "coordinated networks across and between countries<br>in order to halt the production, trading and selling of fake medicines<br>
around the globe.")<br><br>(According to the WHO, IMPACT is "a partnership comprised of all the major<br>anti-counterfeiting players" including international organizations and<br>enforcement agencies such as Interpol, Organization for Economic Cooperation<br>
and Development, World Customs Organization, World Intellectual Property<br>Organization, World Trade Organization, pharmaceutical manufacturers'<br>associations such as IFPMA, as well as NGOs and drug and regulatory<br>
authorities.)<br><br>The open letter by the civil society groups comes just as the World Health<br>Assembly (WHA) of the World Health Organization begins its annual week-long<br>session on 17 May. The issue of "Counterfeit Medical Products" is on the<br>
agenda of the Assembly.<br><br>The open letter was signed by amongst others the Berne Declaration<br>(Switzerland), Centre for Trade and Development (CENTAD, India), the Delhi<br>Network of Positive People (DNP+, India), Edmonds Institute (US), Health<br>
Action International (HAI, global as well as regional branches), Health GAP<br>(US), Oxfam International, Peoples Health Movement - Global, Research<br>Foundation for Science Technology and Ecology (India), SEATINI (Uganda) and<br>
Third World Network.<br><br>The open letter was also accompanied by a separate joint NGO statement by<br>Third World Network and Health Action International - Global, voicing<br>serious concern over WHO's participation in, and endorsement of, IMPACT.<br>
(See details of the joint statement below.)<br><br>In the open letter to Director-General Dr Chan, the civil society groups<br>said that the term "Counterfeit" is defined by the WTO-TRIPS Agreement as<br>referring to a specific category of trademark violation and in some<br>
legislation to all other intellectual property (IP) violations as well.<br><br>Today, they said, it is widely known that business interests and governments<br>in OECD countries that represent them are making use of trade agreements,<br>
plurilateral government initiatives (e.g. the Anti-Counterfeit Trade<br>Agreement) and programmes in international agencies to set and enforce<br>higher IP standards under the heading of "Counterfeiting".<br><br>
It is against this background that WHO's use of the term "Counterfeit" to<br>refer to a range of pharmaceutical quality and safety problems is of most<br>concern, said the groups. They note that not only has this resulted in<br>
confusion but also offered a convenient route for proponents of an extended<br>IP agenda to press for inappropriate IP enforcement standards in developing<br>countries under the false premise that such standards will deliver quality<br>
assured pharmaceuticals to the people.<br><br>In this context, the letter cited as an example, the East African region<br>where several anti-counterfeiting legislation have been enacted or are in<br>the process of being enacted. "Whilst the proclaimed rationale for such<br>
legislation is to protect the public from unsafe products, these<br>legislations are in actual fact only about protecting the rights of IP<br>holders to the detriment of access to affordable generic pharmaceuticals."<br>
<br>Most of these legislations define "Counterfeit" products as being<br>substantially similar or identical to IP protected products, which<br>effectively makes every generic pharmaceutical a counterfeit. In Kenya,<br>
enactment of the Anti-Counterfeit Act 2008 has been challenged by people<br>living with HIV/AIDS on the grounds that enforcement and application of the<br>Act will deny them access to affordable essential medicines and thus deny<br>
their Right to Life.<br><br>The open letter said: "Equating 'Counterfeit' (a term defined in the TRIPS<br>Agreement) to spurious (i.e. products with no or insufficient or toxic<br>active ingredients) and falsely labelled pharmaceutical products not only<br>
undermines confidence in much-needed affordable quality generic products but<br>also results in public health problems being addressed through an IP<br>enforcement lens. Such an approach will not deliver the solutions needed to<br>
address the proliferation of spurious and falsely labelled pharmaceuticals,<br>which arise irrespective of whether there is an IP violation."<br><br>Moreover, said the groups, confusion over the use of the term "Counterfeit"<br>
makes it impossible to obtain data on the true extent of the proliferation<br>of medicines which do not meet quality, safety and efficacy standards<br>because the data on "Counterfeit" would also refer to situations involving<br>
IP infringements.<br><br>"We would also point out that empirical, reliable and transparent statistics<br>about 'counterfeit drugs' is non-existent and that the only comprehensive<br>global collection of data on drug counterfeiting is held by the<br>
Pharmaceutical Security Institute (PSI), an industry body that fails to make<br>information available for public scrutiny."<br><br>In addition, the civil society groups said that they are troubled by WHO's<br>engagement in IMPACT and share the concerns of the many Member States that<br>
have questioned the legitimacy of IMPACT. In particular, concerns have been<br>raised about participation in IMPACT's activities especially the central<br>role played by IFPMA in IMPACT's activities, lack of transparency<br>
surrounding IMPACT's activities, and lack of accountability, as IMPACT has<br>operated outside the purview of WHO Member States.<br><br>Concerns have also been raised by the groups about IMPACT's link to entities<br>
which are very much engaged on matters pertaining to IP enforcement under<br>the banner of "anti-counterfeiting activities", such as the Interpol, OECD,<br>the World Customs Organisation (WCO), the World Intellectual Property<br>
Organization (WIPO), the European Commission and the multinational<br>pharmaceutical industry.<br><br>"This further raises concern about conflicts of interests, about which WHO<br>by its own admission, has taken no measures to address. It is also<br>
particularly noteworthy that IMPACT has been identified as an initiative<br>involved in IP enforcement."<br><br>The groups cited another key concern in respect of IMPACT's Principles &<br>Elements for National Legislation Against Counterfeit Medical Products,<br>
which they said are not only problematic because they emerge from an<br>initiative whose legitimacy is in question but also because it includes a<br>call for addressing counterfeit medical products inter alia by establishing<br>
or enhancing intellectual property legislation, contains provisions that<br>could result in TRIPS-plus implementation as well as non-tariff barriers for<br>trade in medical products which could undermine access to affordable<br>
medicines, become entry barriers for generic industries, particularly of<br>developing countries, and affect use of flexibilities such as parallel<br>importation of good quality medicines.<br><br>According to the open letter, these elements also promote measures that have<br>
led to seizures/detainment of good quality pharmaceuticals in transit at<br>European ports on request of MNCs (multinational corporations) on suspicion<br>of IP violations, which resulted in delayed treatment for developing country<br>
patients.<br><br>"Moreover, the approach adopted by IMPACT is faulty as it fails to address<br>the root causes for the proliferation of pharmaceuticals with compromised<br>quality and safety, in particular the high price of pharmaceutical products<br>
which results in inequitable access and the problem of weak regulatory<br>capacity in developing countries in terms of facilities, financial and human<br>resources.<br><br>"The above-mentioned concerns raised by Member States have been largely<br>
ignored, with the WHO continuing to promote use of the term 'Counterfeit',<br>and to endorse IMPACT including by allowing IMPACT to use WHO's logo on its<br>documents, even where such documents are prepared by the pharmaceutical<br>
industry. Moreover, despite repeated objections to IMPACT and its Principles<br>& Elements, WHO also appears to be pushing for the adoption of such elements<br>as a WHO document bypassing scrutiny of the World Health Assembly," says the<br>
open letter to Dr Chan.<br><br>"We are of the view that WHO's continued involvement in IMPACT threatens to<br>undermine WHO's credibility as an organisation that is impartial and that<br>upholds the interests of public health," the groups stressed.<br>
<br>In view of the above, the civil society groups urged the WHO Secretariat:<br><br>-- to explore use of other terminologies through Member-driven process to<br>capture the problem of pharmaceuticals with compromised quality, safety and<br>
efficacy, substituting the term "Counterfeit" which is already defined in<br>the TRIPS Agreement;<br><br>-- to distance itself from IMPACT, its activities and its Draft Principles &<br>Elements and to stop functioning as the Secretariat of IMPACT;<br>
<br>-- to withdraw WHO's logo from all IMPACT documents and to ensure that WHO<br>does not endorse any other activities that promotes the IP enforcement<br>agenda; and<br><br>-- to reorient its programme towards addressing the real causes and<br>
solutions to pharmaceuticals with compromised quality, safety and efficacy,<br>in particular focus its attention to dealing with high prices of<br>pharmaceuticals, ensuring timely availability of affordable pharmaceuticals,<br>
as well as strengthening the capacity of drug regulatory authorities.<br><br>In a separate joint statement voicing concerns on WHO's participation and<br>endorsement of IMPACT, Third World Network and Health Action International<br>
said that IMPACT has been identified as an intellectual property (IP)<br>enforcement initiative, operating outside the purview of WHO Member States<br>and it fails to address the root causes of the proliferation of medicines<br>
with compromised quality and safety, such as high medicines prices.<br><br>"WHO's involvement in IMPACT legitimises the TRIPS-plus-plus IP enforcement<br>agenda pushed by OECD governments and businesses and undermines public<br>
health. It threatens WHO's credibility as an institution charged with<br>protecting the Right to Health," said Sangeeta Shashikant, from Third World<br>Network.<br><br>Sophie Bloemen from Health Action International commented: "governments and<br>
intergovernmental bodies should not spend time advancing and strengthening<br>the IP rights of pharmaceutical companies, who are free to protect their<br>private rights at their own expense, and instead should focus on tackling<br>
the key issues that affect public health."<br><br>"At a time when millions of people still go without the medicines they need<br>due to high prices, ongoing WHO participation in IMPACT is a major step in<br>the wrong direction. Enabling the pharmaceutical industry to aggressively<br>
enforce intellectual property rights in developing countries does nothing to<br>lower medicine prices or improve the quality of medicines" added Rohit<br>Malpani of Oxfam.<br><br>According to the joint TWN-HAI statement, despite the many pressing issues<br>
of quality, safety, and efficacy of medicines, there is still a narrow focus<br>on intellectual property in relation to medicines and the focus on so-called<br>"counterfeit" medicines means that even fewer resources are available to<br>
address real public health threats from compromised quality and safety.<br><br>Dr. Gopal Debade, Co-Convener of the All India Drug Action Network (AIDAN),<br>said that "high prices and unethical promotion of drugs are the basic<br>
factors responsible for the circulation of medicines with compromised<br>quality. WHO should focus on these fundamental issues and not on the<br>enforcement of IP rights."<br><br>Kevin Outterson, Associate Professor and Director of the Health Law Program<br>
at Boston University, reinforced this point by stating that "counterfeiting<br>is the intentional violation of trademark law - and nothing more. The<br>patent-based drug industry has tried for years to confuse the issue,<br>
tricking policy makers into distrusting and blocking genuine generic drugs<br>through patent laws and border enforcement. Generic drugs save lives and<br>should be promoted."<br><br>Loon Gangte of the Delhi Network of Positive People (DNP+) in India said:<br>
"WHO's primary concern should be public health and not the enforcement of<br>intellectual property rights. As a public health organisation, it should not<br>pursue an agenda that puts patients' lives in danger".<br>
<br>According to the TWN-HAI statement, the WHO should refocus its efforts on<br>addressing the wider public health threats by: promoting intergovernmental<br>discourse on medicines quality, safety and efficacy; strengthening the<br>
capacity of drug regulatory authorities; addressing high medicine prices and<br>other barriers to access; and preventing the unethical promotion and<br>marketing of medicines that divert already limited health resources toward<br>
high-priced medicines instead of affordable essential medicines.<br><br>Meanwhile, according to some sources, seventeen NGOs have also written to Mr<br>Anand Grover, the UN Special Rapporteur on the right of everyone to the<br>
enjoyment of the highest attainable standard of physical and mental health,<br>requesting his intervention on anti-counterfeiting initiatives in WHO to<br>safeguard the Right to Health. +<br><br><br><br><br><br><br></blockquote>
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