[Ip-health] OPEN Letter to the Chairperson of WHO Working Group on Substandard /Spurious/Falsified/Falsely-Labelled/Counterfeit(SSFFC)

Gopa Kumar kumargopakm at gmail.com
Mon Oct 24 09:36:15 PDT 2011

*OPEN Letter to the Chairperson of WHO Working Group on Substandard
/Spurious/Falsified/Falsely-Labelled/Counterfeit(SSFFC) Medical Products ,
Ambassador H E Darlington*

* *

We the undersigned would like to highlight some key concerns and
recommendations for the consideration of the Working Group in its upcoming
session on 25-28th October 2011.

We are of the view that the upcoming meeting is an opportunity for Member
states to reenergise WHO’s work-programme on medicines particularly in
refocusing WHO’s attention to facilitate availability of quality, safe and
efficacious medicine at an affordable price and on building regulatory
capacity of developing countries. We believe that these are critical pillars
to tackling the proliferation of medical products of compromised quality,
safety and efficacy (QSE).

Thus we are deeply concerned with the lack of human and financial resources
allocated to WHO’s programme on medicines. Secretariat’s paper
(A/SSFFC/WG/2/2) highlights budgetary constraints, the worrying dependence
of WHO’s work program on QSE on extra budgetary resources and the risk of
loss of independence, adversely affecting the capacity to address priorities
set by member States. This situation has crippled the ability of WHO to show
leadership from a public health perspective. It has also enabled other
entities (e.g. Interpol, World Customs Organization (WCO) to appropriate a
public health matter and to instead advance an agenda on enforcement of
intellectual property.

*As such we urgently call on WHO member states to restore WHO’s independence
and to reassert its leadership by ensuring that WHO’s medicines programme
receives the funds it needs particularly from WHO’s regular budget to fulfil
its responsibilities to Member States. *

One of the important objectives of the Working Group is to bring clarity
with regard to the terminologies and definitions pertaining to medical
products with compromised QSE.

On this matter, several of the undersigned organizations have on previous
occasions highlighted concerns with WHO’s continued use of the term
“Counterfeit” to also refer to medical products of compromised QSE.

The term “Counterfeit” 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.
Against this background WHO’s use of the term “Counterfeit” to refer to
compromised medical products would result in confusion and also offer 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.

The Secretariat has also recently agreed that the term “counterfeit” is
“perceived as associated with intellectual property rights” rather than with
“public health”.[2] <#_ftn2> *Thus we urge Member States to agree in the
upcoming Working Group to the discontinue using the term “counterfeit” to
refer to medical products of compromised QSE. *

Further from a public health perspective, circulation of any medical product
of compromised QSE is problematic and therefore needs to be withdrawn from
the market. Thus WHO should focus on tackling all aspects of medical
products of compromised QSE and should not limit itself to only dealing with
a select category of compromised products to the exclusion of others.
Moreover *determination of what terminologies should be used is a process
deliberated and guided by Member states. It is not a decision to be taken
alone by technical committees of WHO. *

On WHO’s relationship with IMPACT, we reiterate that WHO should
disassociated itself from IMPACT. Significant 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, the lack of transparency
surrounding IMPACT’s activities, and lack of accountability as IMPACT has
operated outside the purview of WHO member states.[3] <#_ftn3>

Concerns have also been raised about IMPACT’s link to entities (e.g. OECD,
MNCs, WCO, Interpol) which are very much engaged on matters pertaining to IP
enforcement under the banner of “anti-counterfeiting activities. This
further raises concern about conflicts of interests, about which WHO by its
own admission, has taken no measures to address.[4] <#_ftn4> It is also
particularly noteworthy that IMPACT has been identified as an initiative
involved in IP enforcement[5] <#_ftn5>.

Another key concern pertains to outputs of IMPACT particularly its
Principles & Elements for National Legislation Against Counterfeit Medical
Products which 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
promotemeasures 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.[6] <#_ftn6>

*Noting these concerns and the wide recognition that IMPACT lacks
credibility and legitimacy, we strongly urge WHO Member States to agree that
WHO disassociates itself from IMPACT and  to stop hosting IMPACT’s website
or rely on the documents produced by IMPACT as a basis for its work on QSE.*

*·**We also strongly urge the Working Group to** reorient WHO’s programme
towards addressing the real causes and solutions to medical products with
compromised QSE in particular focusing its attention to dealing with high
prices of pharmaceuticals, ensuring timely availability of affordable
pharmaceuticals, as well as strengthening the capacity drug regulatory
authorities. *

We understand that proposals on various mechanisms including
multi-stakeholder and coordination mechanism may be considered by the
Working Group. We caution against these mechanisms particularly as  WHO’s
work on QSE must be driven by its Member states and not by other
organizations or entities. Further we are also concerned about WHO’s
cooperation with other organizations such as Interpol and the World Customs
Organization particularly as these organizations are known to continue using
“counterfeit” to refer to medical products of compromised QSE and promote IP

*We stress that any mechanism that is developed should be intergovernmental
in nature, open to all member states and to observers in official relations,
with decision-making powers remaining with WHO Member states. Member States
should work to empower and guide WHO’s work on QSE particularly in enhancing
its ability to take specific measures to facilitate availability of quality
affordable medicines and to build regulatory capacity. *


Dr. Margaret Chan, Director General, WHO

* *

*List of Signatories*

1.     Act Up-Paris

2.     Affordable Medicines for Africa

3.     AI The Thai Network of People living with HIV/AIDS (TNP+)

4.     AIDS ACCESS Foundation, Thailand

5.     All India Drug Action Network (AIDAN)

6.     Asha Kiran Samudayak Samiti (CBO), India

7.     Asia pacific network of people living with HIV (APN+)

8.     Balance from Mexico.

9.     Bern declaration, Switzerland

10.  Brazilian Interdisciplinary AIDS Association (ABIA) Brazil

11.  Center for Health, Human Rights and Development (CEHURD),Uganda

12.  Center for Trade and Development (Centad), India

13.  Centre for Global Health Policy and Innovation (Global)

14.  Centre for Safety and Rational Use of Indian Systems of Medicine, India

15.  Consumer and Civic Action Group, India

16.  DAN

17.  Diverse Women for Diversity, India

18.  Drug Study Group, Thailand

19.  Drug System Monitoring and Development Program, Thailand

20.  Foundation for AIDS Rights, Thailand

21.  Foundation for Consumers, Thailand

22.  Foundation for Health Action

23.  FTA Watch, Thailand

24.  Fundacion Arcoiris por el respeto a la diversidad sexual. Mexico.

25.   GTPI , Brazil

26.  Health Action International (Asia –Pacific)

27.  Health Action International (Europe)

28.  Health Action International (Global)

29.  Health and Development Foundation, Thailand

30.  Health Consumers Protection Program, Thailand

31.  Health Gap, USA

32.  HEPS-Uganda (Coalition for Health Promotion and Social Development).

33.  IFARMA Foundation, Columbia

34.  Initiative for Health & Equity in Society, India

35.  International Baby Fodd Action Network (IBFAN)

36.  International Treatment Preparedness Coalition (ITPC)

37.  Jefa de la Oficina de América Latina AIDS Healthcare Foundation, Mexico

38.  Kenya Pharmaceuticals Distributors Association

39.  Knowledge Ecology International  (KEI)

40.  LOCOST, India

41.  National Association of People living with HIV/AIDS in Nepal ( NAP+N)

42.  NEPHAK, Kenya

43.  OXFAM

44.  Peoples’ Health Movement

45.  Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)

46.  Programa de Soporte a la Autoayuda de Personas Seropositivas – (PROSA),

47.  Research Foundation for Science Technology & Ecology , Delhi

48.  Rural Pharmacists Foundation, Thailand

49.  SATHI, India

50.  SEATINI (Southern and East African Trade Institute) - South Africa

51.  Sí, da Vida, Peru

52.  Social Pharmacy Research Unit, Chulalongkorn University

53.  Thai Holistic Health Foundation

54.  Thai NGO Coalition on AIDS

55.  Third World Network

Individual signatories

1.     Wim De Ceukelaire, Belgium

2.     Beth Elpern Burrows,

3.     Edmonds, Washington USA

4.     Francesco Nicoli , PHD Student, Italay

5.     Signe Hermann, M.Sc., Copenhagen, Denmark

6.     Indro Mattei, public Health pharmacist, Switzerland

7.     Malini Aosola , Student, London School of Hygiene and Tropical


[1] <#_ftnref> Footnote 14(a) to Article 51 defines “counterfeit trademark
goods” 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 importation”


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

[4] <#_ftnref> 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.”

[5] <#_ftnref> See G8 Summit Declaration on “Growth & Responsibility in the
World Economy” (2007) available at
report on “The Economic Impact of Counterfeiting and Piracy”, available at
See also

[6] <#_ftnref> 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.

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