Service on Health Issues (Nov15/05)
19 November 2015
Third World Network
proposes to join Global Fund's IP enforcement initiative
19 Nov (K M Gopakumar) – The World Health Organization has proposed
to join the intellectual property enforcement initiative of the Global
Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund).
This intellectual property (IP) enforcement initiative, known as the
Global Steering Committee (GSC) for the quality of medical products,
raises concerns over the health body's role in IP enforcement. The
Global Fund established the GSC as a multi-stakeholder platform.
According to a press release issued by the Global Fund on 23 March
2015, "The Global Steering Committee is harnessing the collective
capabilities and innovations of major health development institutions
to combat falsified, substandard, stolen and diverted medicines and
other health products".
Norbert Hauser, former Inspector-General of the Global Fund, currently
heads the GSC. According to the press release, "Representatives
from regulatory and law enforcement agencies, non-governmental organizations
and the pharmaceutical industry, including innovators and generic
manufacturers, will be invited to join the GSC to contribute to an
enhanced drug quality assurance framework, supply chain integrity,
and expanded public awareness".
The fourth meeting of WHO's Member State Mechanism (MSM) on Substandard/Spurious/Falsely
Labelled/ Falsified/Counterfeit Medical Products (SSFFC) is to take
a decision on WHO's participation in the GSC.
The MSM Steering Committee in March allowed WHO to participate as
an observer in the GSC. The MSM meeting is taking place at the WHO
headquarters in Geneva on 19-20 November.
[The MSM was established through a World Health Assembly resolution
to guide WHO's activities on quality, safety and efficacy of medicines
without conflating it with intellectual property enforcement.]
The MSM Steering Committee, in its September meeting, asked the WHO
Secretariat to critically review the potential benefits of their participation
in the GSC, as well as any potential risks/obligations.
The Secretariat has come out with a report titled "WHO's participation
in the global steering committee for quality assurance of health products".
In this report, the Secretariat states: "The risk of failing
to collaborate in these areas of overlap may lead to the wastage of
resources and the overburdening of Member States with a growing number
of initiatives that may also be in competition with one another -
generating confusion rather than clarity".
Further, it states that there may be merit in certain well-targeted
and aligned initiatives. Three examples are listed covering each of
the overlapping areas: regulatory strengthening, communication education
and awareness- raising, and surveillance and monitoring of SSFFC medical
Astonishingly, the report is silent on the risk of participation in
According to the Secretariat's paper, the current core members are
the World Bank, the GAVI Alliance, United Nations Development Programme
(UNDP), United States President's Malaria Initiative, USAID, United
States Food and Drug Administration, UNITAID, The New Partnership
for Africa's Development and INTERPOL.
The Secretariat's paper is silent on the non-core members which concerned
observers suspect to be private sector actors, especially the pharmaceutical
In an article in the America Journal of Tropical Medicine, authors
Martin Cinnamond and Tom Woods, working with the Global Funds Inter
Agency Task Force, wrote: "The GSC for quality assurance of health
products will harness the collective efforts of multilateral and bilateral
organizations, regional authorities, NGOs, manufacturers, and technical
partners to facilitate an enhanced framework for both quality and
supply chain integrity of medicines and health products" (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455089/).
However, the Secretariat's paper does not name any private sector
participation. It carefully names only core members. Nevertheless,
the Global Fund has a Memorandum of Association with the International
Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
"to fight fake medicines" (http://www.theglobalfund.org/en/news/2013-12-02_Private_Sector_Engages_i
[The abovementioned article states that the Joint Interagency Task
Force (JIATF) "is an initiative that offers a new, proactive,
and intelligence-led approach to safeguarding the delivery of quality
medicines for major donor organizations and protecting public health
by identifying falsified medicines in countries where they appear.
By also focusing on the issue of stolen and diverted medicines, JIATF
provides an important assurance mechanism".]
The GSC initiative is another instance of intellectual property (IP)
enforcement initiatives that conflate quality, safety and efficacy
of medicines with IP enforcement. Neither GSC nor the Global Fund
provide any definition of the term "falsified" medical products.
The available definition is from the European Union Directive on Falsified
Medicines that defines 'falsified' as: "Any medicinal product
with a false representation of: (a) its identity, including its packaging
and labelling, its name or its composition as regards any of the ingredients
including excipients and the strength of those ingredients; (b) its
source, including its manufacturer, its country of manufacturing,
its country of origin or its marketing authorisation holder; or (c)
its history, including the records and documents relating to the distribution
channels used. This definition does not include unintentional quality
defects and is without prejudice to infringements of intellectual
Thus, the false representation of packaging and labelling provides
amble scope for converting a trademark infringement or alleged infringement
into a case of a falsified medicine.
According to the March press release, GSC is also harnessing the collective
capabilities and innovations of major health development institutions
to combat stolen and diverted medicines and other health products.
Observers point out that combating the diversion of medicines is in
effect a combat on parallel importation, one of the flexibilities
guaranteed under the TRIPS Agreement.
(Parallel importation allows the legal importation of medicines from
a country, where the product is legally introduced and available at
a lower price to another country where the originator's product is
available at a higher price, without the permission of the IP owner.)
Further, stealing of medicines does not necessarily compromise the
quality of medicines. Often the quality link of stolen medicines is
established through a farfetched way that these medicines can be repackaged
as some other medicine and pushed into the supply chain, which poses
a threat to the safety of the patient.
The IP enforcement orientation of GSC is very clear from the involvement
of Tom Woods, who co-authored the above-mentioned article in the American
Journal of Tropical Medicine. Tom Woods is a Senior Advisor to the
Global Fund and represents the Global Fund in the GSC. Tom Woods is
also instrumental in the setting up of the JIATF.
However, neither the Global Fund nor the WHO Secretariat have disclosed
the fact that Tom Woods is the President of Woods International LLC,
a Washington-based private sector consulting firm.
According to the website of Woods International, both the firm and
Tom Woods are involved in many activities related to anti-counterfeit
medicines. The website discloses that one of their projects is to
"provide advisory and representational services for one of the
largest multilateral aid agencies focused on safe medicines in the
developing world". This representation project makes him represent
the Global Fund in the GSC and JIATF.
According to the firm's website, "Woods International raises
public awareness through policy dialogue and advocacy. We also create
partnerships for the deployment of programs and technology aimed at
eradicating harmful fake drugs".
Further, Woods International claims that: "These public and private
collaborations help equip and train regulatory and enforcement bodies
with the tools and know-how they need. Woods International is building
a global coalition made up of Leading Policy Institutions, International
donor agencies and governments, Health, regulatory, and enforcement
bodies within the developing world, private sector providers of technology,
the pharmaceutical industry, public policy institutions and non-governmental
Further, the website clearly claims that Woods International is responsible
for setting up of JIATF and the GSC. It states: "Building international
coalition of multilateral development agencies to tackle the challenge
of falsified, substandard, diverted and stolen medicines known as
the Global Steering Committee for Quality Assurance of Health Products."
In other words, Woods International appears to use the Global Fund
as a camouflage to host the JIATF and the GSC to serve its commercial
interest of IP enforcement. The Woods International website
provides a number of events including on counterfeit medicines either
organised or participated by Tom Woods. Some of these events are:
* June 24-25, 2015 - Global Steering Committee, Global Fund, and KPMG
host workshop on access to safe medicines in developing countries.
London, UK. Tom Woods to Chair.
* June 22, 2015 - Global Steering Committee on Quality Assurance of
Medicines, Geneva, Switzerland.
* September 18, 2014 - Innovations at the Global Fund, PMI, and PEPFAR,
Washington, DC Capitol Hill. Tom Woods chairs discussion.
* In June 2013, Tom Woods directed the senior policy conference on
Access to Safe Medicines at the prestigious Wilton Park conference
facility in Sussex, England. The meeting was broadly described as
the most diverse gathering of regulators, manufacturers, technology
providers, non-governmental organizations, and academics ever assembled
on the topic.
* May 2013, Tom Woods visits China to meet with SFDA officials in
Beijing as well as provincial level regulators in southern China.
* February 14, 2013 in Washington, DC, Woods International participates
in the Institute of Medicine Workshop on International Regulatory
* February 4, 2013, Woods International supports US Pharmacopeia's
Spectral Library Consortium meeting at the USP Headquarters in Rockville,
* November 28-29, 2012 in Washington, DC, Woods International co-convened
the 7th Global Forum on Pharmaceutical Anti-counterfeiting in partnership
with UK-based Reconnaissance International. Tom Woods chaired the
It is really surprising that the WHO Secretariat, currently engaging
in the process of enhanced safeguards through due diligence and risk
assessment prior to taking decisions on engagement, did not put out
this information related to the GSC and JIATF in the public domain.
The participation of INTERPOL is clear evidence of the IP enforcement
agenda by conflating quality issues of medicines with IP issues.
INTERPOL has taken USD 4.5 million for the creation of INTERPOL's
Pharmaceutical Crime Programme to further build on the work of its
pharmaceutical Medical Product Counterfeiting and Pharmaceutical Crime
The close association of INTERPOL with pharmaceutical companies including
the acceptance of financial resources raises serious issues of conflict
of interest in the GSC process.
The cooperation between INTERPOL and the Global Fund already resulted
in the conflation of quality issues with IP.
The Global Fund website carries a photograph of INTERPOL operations
on counterfeit medicines as an activity of seizure of diverted medicines
or counterfeit involvement with INTERPOL.
The Global Fund claims that "As part of Interpol's coordinated
effort known as Operation Porcupine, 2,000 police and officials took
part in raids across West Africa at the end of May, seizing almost
200 tons of fake or illicit medicines. In partnership with the Global
Fund, The UN Operation Cote d'Ivoire (UNOCI) and the World Health
Organization, the raids targeted markets, shops, storage facilities,
pharmacies and private homes in order to seize diverted, stolen, or
counterfeit medicines. During the raid in Lome, police discovered
malaria drugs (ACTs) which had been diverted from their intended markets
as well as counterfeit ACTs" (http://www.theglobalfund.org/en/blog/2014-06-26_Combatting_Theft_and_Counterfeiting_of_Medicines_in_West_Africa/).
This clearly shows that the Global Fund engagement is not confined
to quality of medicines but even includes prevention of parallel importation,
an important flexibility in the TRIPS Agreement.
The WHO Secretariat's paper mentions five Working Groups without naming
the members of the working groups.
These Working Groups are: (1) supporting NMRA (national medical regulatory
agencies), drug quality and supply chain authority; (2) data gathering,
reporting, sharing, and analysis; (3) information dissemination and
public awareness; (4) enforcement; and (5) public-private financing.
Some of the working groups are similar to the International Medical
Product Anti-Counterfeit Taskforce (IMPACT), a multi-stakeholder platform
for IP enforcement hosted by WHO till 2011.
The IMPACT secretariat was shifted out of WHO due to opposition from
many Member States. IMPACT also worked in the same format of working
These working groups are: Communications Working Group, Legislative
and Regulatory Infrastructure Working Group, Regulatory Implementation
Working Group, Enforcement Working Group and Technology Working Group.
It is not very clear if the IMPACT working groups are still functioning.
However, even though the Secretariat of IMPACT was shifted out of
WHO, the latter continues to host IMPACT website (http://www.who.int/impact/en/).
One developing country delegate told Third World Network (TWN) that
the Secretariat is trying to avoid the mistake they committed in the
case of IMPACT where an initiative was launched without obtaining
the permission of Member States.
Many Member States objected to hosting the IMPACT Secretariat in WHO
as well as WHO's participation in IMPACT without the approval of governing
The same delegate also said that the Secretariat is trying to obtain
Member State consent with "half-cooked information" and
not disclosing vital information necessary to make an informed decision.
Several observers point to the lack of transparency in the activities
of GSC. The Global Fund website provides little information.
There is little information regarding the composition of the working
groups, and the financing mechanism of the GSC is not available on
The MSM is expected to consider the participation of WHO in the GSC
on 20 November.