[Ip-health] NGO Letter to WHO DG on "Counterfeits" & IMPACT

Sangeeta ssangeeta at myjaring.net
Thu May 13 00:51:58 PDT 2010

We, the undersigned organizations are very concerned about the nature and
extent of WHO¹s involvement in issues pertaining to counterfeit medical
products. We recognize that work must be undertaken under WHO¹s leadership
to ensure availability of quality, safe and efficacious pharmaceuticals but
we fear that WHO¹s involvement in the issue of ³Counterfeits² will have
adverse consequences for access to affordable medicines while failing to
address the very real problem of proliferation of pharmaceuticals with
compromised quality, safety and efficacy.
The term ³Counterfeit² is defined by the WTO-TRIPS Agreement as referring to
a specific category of trademark violation[1] <#_ftn1> 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"[2] <#_ftn2> .
It is against this background that WHO¹s use of the term ³Counterfeit² 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.
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 ³Counterfeit² 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.
Equating ³Counterfeit² (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 confusion over the use of the term ³Counterfeit² 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 ³Counterfeit² would also refer to situations involving IP
infringements. We would also point out that empirical, reliable and
transparent statistics about ³counterfeit drugs² 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.[3] <#_ftn3>
In addition, we are troubled by WHO¹s 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.[4]
<#_ftn4> In particular concerns have been raised about participation in
IMPACT¹s activities especially the central role played by the International
Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in
IMPACT¹s activities, lack of transparency surrounding IMPACT¹s activities,
and lack of accountability as IMPACT has operated outside the purview of WHO
member states.[5] <#_ftn5>
Concerns have also been raised about IMPACT¹s link to entities which are
very much engaged on matters pertaining to IP enforcement under the banner
of ³anti-counterfeiting activities² 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.[6]
<#_ftn6> It is also particularly noteworthy that IMPACT has been identified
as an initiative involved in IP enforcement[7] <#_ftn7> .
Another key concern is IMPACT¹s 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.
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.[8] <#_ftn8>
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
The above mentioned concerns raised by Member states have been largely
ignored with the WHO continuing to promote use of the term ³Counterfeit²,
and to endorse IMPACT including by allowing IMPACT to use WHO¹s logo on its
documents, even where such documents are prepared by the pharmaceutical
industry.[9] <#_ftn9> 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[10] <#_ftn10> .
We are of the view that WHO¹s continued involvement in IMPACT threatens to
undermine WHO¹s credibility as an organisation that is impartial and that
upholds the interests of public health.
In view of the above we urge 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 ³Counterfeit² which is already defined in
the TRIPS Agreement[11] <#_ftn11> ;
·       to distance itself from IMPACT, its activities and its Draft
Principles & Elements and to stop functioning as the Secretariat of IMPACT;
·       to withdraw WHO¹s logo from all IMPACT documents and to ensure that
WHO does not endorse any other activities that promotes the IP enforcement
·       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 drug regulatory authorities.
1. Asian Community Health Action Network (ACHAN), Sri Lanka
2. All India Drug Action Network (AIDAN)
3. Asia Pacific Network of People Living with HIV/AIDS (APN+).
4. Berne Declaration, Switzerland
5. Brazilian Interdisciplinary AIDS Association (ABIA), Brazil
6. Butere Focused Women in Development (BUFOWODE), Kenya
7. Centre for Trade and Development (CENTAD), India
8. Coalition for Health Promotion and Social Development (HEPS-Uganda)
9. The Cut the Cost Cut the Pain Network, Philippines
10. Damien Foundation, Belgium
11. Delhi Network of Positive People (DNP+)
12. Diverse Women for Diversity, India
13. Drug Action Forum - Karnataka, India
14. Economic Governance for Health, UK
15. Ecumenical Pharmaceutical Network, Kenya
16. Edmonds Institute, US
17. EMPOWER, India 
18. Egyptian Initiative for Personal Rights (EIPR), Egypt
19. Health Action International Africa (HAIA)
20. Health Action International Asia Pacific (HAIAP)
21. Health Action International Europe
22. Health Action International Global
23. Health Action International Latin American & Caribbean (HAI LAC)
24. Health GAP, USA
25. Healthy Skepticism Inc
26. HealthWrights (Workgroup for People¹s Health and Rights), US
27. IP Justice, USA
28. Intal, Belgium 
29. International Baby Food Action Network (IBFAN)
30. International Peoples Health Council (South Asia), India
31. Initiative for Health Equity and Society, India
32. Low Cost Standard Therapeutics (LOCOST), India
33. Lokoj Institute, Bangladesh
35. Medical Action Group, Philippines
36. Medico International, Germany
37. National Association of People Living with HIV/AIDS in Nepal
38. Oxfam International
39. Peoples Health Movement Global
40. Policy Research for Development Alternative, (UBINIG), Bangladesh
41. Research Foundation for Science Technology and Ecology, India
42. Southern and Eastern African Trade, Information and Negotiations
Institute (SEATINI), Uganda
43. Third World Network
44. Third World Relief Fund, Belgium
45. Kevin Outterson, Associate Professor of Law & Co-Director of the Health
Law Program 
Boston University School of Law,
Faculty Advisor - American Journal of Law & Medicine,
Editor in Chief - Journal of Law, Medicine & Ethics
46. Sean Flynn, Associate Director, Program on Information Justice and
Intellectual Property
Washington College of Law, American University
47. Ska Keller, Green MEP, Germany

[1] <#_ftnref1>  Footnote 14(a) to Article 51 defines ³counterfeit trademark
goods² shall mean any goods, including packaging, bearing without
authorization a trademark which is identical to the trademark validly
registered in respect of such goods, or which cannot be distinguished in its
essential aspects from such a trademark, and which thereby infringes the
rights of the owner of the trademark in question under the law of the
country of importation²

[2] <#_ftnref2>  For an overview of anti-counterfeiting initiatives see
Susan Sell (2008), ³The Global IP Upward Ratchet, Anti-counterfeiting and
piracy enforcement efforts: The State of Play² available at
ay-OPs_1_June_2008.pdf> . See also Ermias Tekeste Biadleng and Viviana Munoz
Tellez (2008) ³The Changing Structure and Governance of Intellectual
Property Enforcement² Research Paper 15, South Centre, p. 25 available at
www.southcentre.org <http://www.southcentre.org>

[3] <#_ftnref3>  See Kevin Outterson and Ryan Smith (2006)., ³Counterfeit
Drugs: the Good, the Bad and the Ugly² 16 Albany Law Journal of Science and
Technology 525

[4] <#_ftnref4>  See ³Concerns voiced over IMPACT, Secretariat's role on
"counterfeits" available at
n.ipr.info.090201.htm> ;

[5] <#_ftnref5> See South Centre & CIEL IP Quaterly Update, Third Quarter
2008, available at 

[6] <#_ftnref6>  See FAQ with Answers prepared by WHO & IMPACT, distributed
at an Open Forum on IMPACT on 26th March 2010 wherein it is states that ³To
date, participation in task force meetings has not required any declaration
of interests.²

[7] <#_ftnref7>  See G8 Summit Declaration on ³Growth & Responsibility in
the World Economy² (2007) available at
> ; See OECD report on ³The Economic Impact of Counterfeiting and Piracy²,
available at 
03_OECD_Study_on_Counterfeiting_and_Piracy.pdf>  ; See also

[8] <#_ftnref8>  For example IMPACT¹s 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.

[9] <#_ftnref9> G Power, ³Anti counterfeiting Technologies for the
Protection of Medicine² , p.2,

[10] <#_ftnref10>  See FAQ with Answers prepared by WHO & IMPACT,
distributed at an Open Forum on IMPACT on 26th March 2010 wherein it is
states that ³IMPACT documents could become a WHO document if they undergo
WHO procedures including review by the relevant WHO Expert Committee
processes². See also WHO¹s website at http://www.who.int/impact/news/en/
<http://www.who.int/impact/news/en/>  wherein comments are being sought on
IMPACT¹s Draft Principles & Elements for National Legislation Against
Counterfeit Medical Products²

[11] <#_ftnref11>  Other terminology mentioned in WHA resolution 41.61 to
refer to the problem of pharmaceuticals with compromised quality, safety and
efficacy are: ³falsely labeled², ³spurious² and ³substandard². 

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