PHM-Exch> Counterfeit medicines: SIGN ON Letter to Margaret Chan

Fri Apr 23 02:18:38 PDT 2010

Dear All, 

Below is an open letter to Dr. Margaret Chan on the issue of WHO's
involvement in anti-counterfeiting activities.

The basic aim of this letter is to make clear that there is a confusion in
relation to use of the counterfeit terminology and this confusion is being
used to promote IP enforcement. Concerns about WHO's involvement in IMPACT
are also highlighted. As you may well know, several developing countries,
Thailand, Brazil, India, Chile, Bangladesh, Iran, Egypt objected to WHO's
involvement in IMPACT as well as raised the problem of confusion in relation
to the counterfeit terminology. They will be taking this issue up at the
upcoming World health Assembly.

Do let us know if your Organization  is willing to sign on to the letter.
Pls pass on the letters to other NGOs that you think may be interested in
the issue and in supporting us.

If you would like to sign-on to the letters pls send us an email with the
name of your organization and country to sangeeta at thirdworldnetwork.net or
to ssangeeta at myjaring.net

Deadline for signing on to the letter is 3 May 2010.

Regards
Sangeeta Shashikant
Third World Network
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OPEN LETTER TO DR. MARGARET CHAN
DIRECTOR GENERAL OF WORLD HEALTH ORGANISATION

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 generic medicines while
failing to address the very real problem of proliferation of pharmaceuticals
with compromised quality and safety.

The term ³Counterfeit² is defined by the WTO-TRIPS Agreement as referring to
a trademark violation 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"[1] <#_ftn1> .

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 as trademark
violation) to spurious pharmaceuticals (i.e. falsely labeled products,
products with no or insufficient or toxic active ingredients) 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 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.[2] <#_ftn2>

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.[3]
<#_ftn3> 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.[4] <#_ftn4>

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 Interpol, OECD, the World
Customs Organisation (WCO), the World Intellectual Property Organization
(WIPO), the European Commission, 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.[5] <#_ftn5> It is also
particularly noteworthy that IMPACT has been identified as an initiative
involved in IP enforcement[6] <#_ftn6> .

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.[7] <#_ftn7>

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 abovementioned 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.[8] <#_ftn8> 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[9] <#_ftn9> .

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 WHO
Secretariat:

·       to explore use of other terminologies to capture the problem of
pharmaceuticals with compromised quality, safety and efficacy substituting
the term ³Counterfeit² 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 WHO¹s logo from all IMPACT documents and to ensure that
WHO does not endorse any other activities that promotes the IP enforcement
agenda;
·       to focus its attention on dealing with high prices of
pharmaceuticals, ensuring timely availability of affordable pharmaceuticals,
as well as strengthening the capacity drug regulatory authorities.

[1] <#_ftnref1>  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
http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Pla
y-OPs_1_June_2008.pdf
<http://www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Pl
ay-OPs_1_June_2008.pdf> . See also Ermias Tekeste Biadleng and Viviana Munon
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>

[2] <#_ftnref2>  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

[3] <#_ftnref3>  See ³Concerns voiced over IMPACT, Secretariat's role on
"counterfeits" available at
http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn
.ipr.info.090201.htm
<http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/tw
n.ipr.info.090201.htm> ;

[4] <#_ftnref4> 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-qua
rterly-update&Itemid=102&lang=en
<http://www.southcentre.org/index.php?option=com_content&view=article&am
p;id=955%3A2008-3rd-quarter-ip-quarterly-update-&catid=50%3Aintellectual
-property-quarterly-update&Itemid=102&lang=en>

[5] <#_ftnref5>  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

[6] <#_ftnref6>  See G8 Summit Declaration on ³Growth & Responsibility in
the World Economy² (2007) available at
http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html
<http://www.g-8.de/Webs/G8/EN/G8Summit/SummitDocuments/summit-documents.html
> ; See OECD report on ³The Economic Impact of Counterfeiting and Piracy²,
available at 
http://www.oepm.es/cs/OEPMSite/contenidos/ponen/InformeOCDE26feb09/2009_03_0
3_OECD_Study_on_Counterfeiting_and_Piracy.pdf
<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 
<http://ec.europa.eu/internal_market/iprenforcement/observatory/index_en.htm
#what> 

[7] <#_ftnref7>  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.

[8] <#_ftnref8> G Power, ³Anti counterfeiting Technologies for the
Protection of Medicine² , p.2,
http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf
<http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf>

[9] <#_ftnref9>  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

SIGNATORIES

All India Drug action Network
Diverse Women for Diversity .
Egyptian Initiative for Personal Rights
Health Action International Asia Pacific
Health Action International Europe
Health Action International Global
International Peoples Health Council ( South Asia )
Initiative  for Health Equity and Society ,
Research Foundation for Science Technology and Ecology
Third World Network

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