PHM-Exch> NGOs concerned over WHO's role in "counterfeit" drugs, IMPACT

[Claudio Schuftan]

> from: Sangeeta ssangeeta at myjaring.net
>
>
> Geneva, 12 May (Kanaga Raja) -- More than forty-five non-governmental
> organizations (NGOs) have voiced concern over the involvement of the World
> Health Organization (WHO) in the issue of "counterfeit" medical products,
> which they said will have adverse consequences for access to affordable
> medicines while also failing to address the very real problem of
> proliferation of pharmaceuticals with compromised quality, safety and
> efficacy.
>
> The Open Letter is available at:
> http://www.twnside.org.sg/announcement/Open.Letter.to.WHO.DG.final.PDF
>
> In an open letter to WHO Director-General Dr Margaret Chan, the civil
> society organizations were also troubled by WHO's engagement in the
> International Medical Product Anti-Counterfeit Taskforce (IMPACT).
>
> Among the concerns raised by the NGOs over WHO's role in IMPACT include its
> links to entities that are engaged in matters pertaining to Intellectual
> Property (IP) enforcement, the central role played by the International
> Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in
> IMPACT's
> activities, the lack of transparency surrounding IMPACT's activities and
> the
> lack of accountability, as IMPACT has operated outside the purview of WHO
> Member States.
>
> (IMPACT was launched by the WHO in 2006, and according to the health
> agency,
> it is aimed at building "coordinated networks across and between countries
> in order to halt the production, trading and selling of fake medicines
> around the globe.")
>
> (According to the WHO, IMPACT is "a partnership comprised of all the major
> anti-counterfeiting players" including international organizations and
> enforcement agencies such as Interpol, Organization for Economic
> Cooperation
> and Development, World Customs Organization, World Intellectual Property
> Organization, World Trade Organization, pharmaceutical manufacturers'
> associations such as IFPMA, as well as NGOs and drug and regulatory
> authorities.)
>
> The open letter by the civil society groups comes just as the World Health
> Assembly (WHA) of the World Health Organization begins its annual week-long
> session on 17 May. The issue of "Counterfeit Medical Products" is on the
> agenda of the Assembly.
>
> The open letter was signed by amongst others the Berne Declaration
> (Switzerland), Centre for Trade and Development (CENTAD, India), the Delhi
> Network of Positive People (DNP+, India), Edmonds Institute (US), Health
> Action International (HAI, global as well as regional branches), Health GAP
> (US), Oxfam International, Peoples Health Movement - Global, Research
> Foundation for Science Technology and Ecology (India), SEATINI (Uganda) and
> Third World Network.
>
> The open letter was also accompanied by a separate joint NGO statement by
> Third World Network and Health Action International - Global, voicing
> serious concern over WHO's participation in, and endorsement of, IMPACT.
> (See details of the joint statement below.)
>
> In the open letter to Director-General Dr Chan, the civil society groups
> said that the term "Counterfeit" is defined by the WTO-TRIPS Agreement as
> referring to a specific category of trademark violation and in some
> legislation to all other intellectual property (IP) violations as well.
>
> Today, they said, 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".
>
> 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 of most
> concern, said the groups. They note that 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.
>
> In this context, the letter cited as an example, the East African region
> where 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.
>
> The open letter said: "Equating 'Counterfeit' (a term defined in the TRIPS
> Agreement) to spurious  (i.e. products with no or insufficient or toxic
> active ingredients) and falsely labelled pharmaceutical products 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 and falsely labelled pharmaceuticals,
> which arise irrespective of whether there is an IP violation."
>
> Moreover, said the groups, 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."
>
> In addition, the civil society groups said that they are troubled by WHO's
> engagement in IMPACT and share the concerns of the many Member States that
> have questioned the legitimacy of IMPACT. In particular, concerns have been
> raised about participation in IMPACT's activities especially the central
> role played by 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.
>
> Concerns have also been raised by the groups 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 the Interpol, OECD,
> the World Customs Organisation (WCO), the World Intellectual Property
> Organization (WIPO), the European Commission and 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. It is also
> particularly noteworthy that IMPACT has been identified as an initiative
> involved in IP enforcement."
>
> The groups cited another key concern in respect of IMPACT's Principles &
> Elements for National Legislation Against Counterfeit Medical Products,
> which they said 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.
>
> According to the open letter, these elements also promote measures that
> have
> led to seizures/detainment of good quality pharmaceuticals in transit at
> European ports on request of MNCs (multinational corporations) on suspicion
> of IP violations, which resulted in delayed treatment for developing
> country
> patients.
>
> "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.
>
> "The above-mentioned 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. 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," says
> the
> open letter to Dr Chan.
>
> "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," the groups stressed.
>
> In view of the above, the civil society groups urged the WHO Secretariat:
>
> -- to explore use of other terminologies through Member-driven process to
> capture the problem of pharmaceuticals with compromised quality, safety and
> efficacy, substituting the term "Counterfeit" which is already defined in
> the TRIPS Agreement;
>
> -- to distance itself from IMPACT, its activities and its Draft Principles
> &
> Elements and to stop functioning as the Secretariat of IMPACT;
>
> -- 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; and
>
> -- to reorient its programme towards addressing the real causes and
> solutions to pharmaceuticals with compromised quality, safety and efficacy,
> in particular focus its attention to dealing with high prices of
> pharmaceuticals, ensuring timely availability of affordable
> pharmaceuticals,
> as well as strengthening the capacity of drug regulatory authorities.
>
> In a separate joint statement voicing concerns on WHO's participation and
> endorsement of IMPACT, Third World Network and Health Action International
> said that IMPACT has been identified as an intellectual property (IP)
> enforcement initiative, operating outside the purview of WHO Member States
> and it fails to address the root causes of the proliferation of medicines
> with compromised quality and safety, such as high medicines prices.
>
> "WHO's involvement in IMPACT legitimises the TRIPS-plus-plus IP enforcement
> agenda pushed by OECD governments and businesses and undermines public
> health. It threatens WHO's credibility as an institution charged with
> protecting the Right to Health," said Sangeeta Shashikant, from Third World
> Network.
>
> Sophie Bloemen from Health Action International commented: "governments and
> intergovernmental bodies should not spend time advancing and strengthening
> the IP rights of pharmaceutical companies, who are free to protect their
> private rights at their own expense, and instead should focus on tackling
> the key issues that affect public health."
>
> "At a time when millions of people still go without the medicines they need
> due to high prices, ongoing WHO participation in IMPACT is a major step in
> the wrong direction. Enabling the pharmaceutical industry to aggressively
> enforce intellectual property rights in developing countries does nothing
> to
> lower medicine prices or improve the quality of medicines" added Rohit
> Malpani of Oxfam.
>
> According to the joint TWN-HAI statement, despite the many pressing issues
> of quality, safety, and efficacy of medicines, there is still a narrow
> focus
> on intellectual property in relation to medicines and the focus on
> so-called
> "counterfeit" medicines means that even fewer resources are available to
> address real public health threats from compromised quality and safety.
>
> Dr. Gopal Debade, Co-Convener of the All India Drug Action Network (AIDAN),
> said that "high prices and unethical promotion of drugs are the basic
> factors responsible for the circulation of medicines with compromised
> quality. WHO should focus on these fundamental issues and not on the
> enforcement of IP rights."
>
> Kevin Outterson, Associate Professor and Director of the Health Law Program
> at Boston University, reinforced this point by stating that "counterfeiting
> is the intentional violation of trademark law - and nothing more. The
> patent-based drug industry has tried for years to confuse the issue,
> tricking policy makers into distrusting and blocking genuine generic drugs
> through patent laws and border enforcement. Generic drugs save lives and
> should be promoted."
>
> Loon Gangte of the Delhi Network of Positive People (DNP+) in India said:
> "WHO's primary concern should be public health and not the enforcement of
> intellectual property rights. As a public health organisation, it should
> not
> pursue an agenda that puts patients' lives in danger".
>
> According to the TWN-HAI statement, the WHO should refocus its efforts on
> addressing the wider public health threats by: promoting intergovernmental
> discourse on medicines quality, safety and efficacy; strengthening the
> capacity of drug regulatory authorities; addressing high medicine prices
> and
> other barriers to access; and preventing the unethical promotion and
> marketing of medicines that divert already limited health resources toward
> high-priced medicines instead of affordable essential medicines.
>
> Meanwhile, according to some sources, seventeen NGOs have also written to
> Mr
> Anand Grover, the UN Special Rapporteur on the right of everyone to the
> enjoyment of the highest attainable standard of physical and mental health,
> requesting his intervention on anti-counterfeiting initiatives in WHO to
> safeguard the Right to Health. +
>
>
>
>
>
>
>
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