E-DRUG: Please sign on: Civil Society Letter to WHO Working Group on SSFC
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[Send any response to Gopakumar at kumargopakm@gmail.com by 24th
October 2011 ]
Dear Friends,
Next week the SSFFC Working Group (i.e. The working group established
to discuss the terminology of "counterfeit" and WHO's relation with
IMPACT) will be meeting from 25th -28th Oct.
We are concerned with the direction it is taking. In particular there
is some talk about handing over the job of deciding on terminology to
the WHO Expert Committee, and setting up a multi- stakeholder forum as
well as a high-level coordination among the different UN and other
agencies.
This is simply another way for continuing with status quo in WHO as
well as in Interpol and other agencies and bypassing Member states
scrutiny.
This letter builds on the previous CSO letter sent to WHO DG in May
2010 See http://www.twnside.org.sg/announcement/Open.Letter.to.WHO.DG.final.PDF
Thus we have drafted a civil society letter to be send to the
Chairperson of the Inter governmental Working Group and we hope that
you are able to sign on to it. See below for the letter.
If you are able to pls give the name or organization, country as well
as contact email to Gopakumar at kumargopakm@gmail.com by 24th
October 2011.
We also welcome individual signatures.
Thank you
Shailly Gupta
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
C 236 Defence Colony, New Delhi, India
Tel: +91 11 46573731, +91 11 46573730
M: 9899976108
"Shailly" <shailly.17@gmail.com>
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OPEN Letter to the Chairperson of WHO Working Group on Substandard
/Spurious/Falsified/Falsely-Labelled/Counterfeit(SSFFC) Medical
Products ,
Ambassador
Permanent Representative
Permanent Mission of the Republic of Zambia to the United Nations
Office and other international organizations in Geneva
Director General
World Health Organization
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 hijack 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 constitutes
medical products of compromised QSE and terminologies should be
deliberated and guided by Member states. It is not a decision to be
taken 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
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 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.[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 enforcement.
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.
Signatories
....
[1] 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”
[2] See A/SSFFC/WG/3 Rev.1
[3] See South Centre & CIEL IP Quaterly Update, Third Quarter 2008, available at
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
[4] See FAQ with Answers prepared by WHO & IMPACT, distributed at an Open Forum on IMPACT on 26th March 2010 wherein it is stated that “To date, participation in task force meetings has not
required any declaration of interests.”
[5]See G8 Summit Declaration on “Growth & Responsibility in the World Economy” (2007) available at
http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html; See OECD report on “The Economic Impact of Counterfeiting and Piracy”, available at
http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_03_OECD_Study_on_Counterfeiting_and_Piracy.pdf; See also http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm#what
[6] 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.