[Ip-health] TWN Info: WHO proposes to join Global Fund's IP enforcement initiative

K.M. Gopakumar kumargopakm at gmail.com
Thu Nov 19 14:18:30 PST 2015


*Title :* TWN Info: WHO proposes to join Global Fund's IP enforcement
initiative
*Date :* 19 November 2015

*Contents:*

TWN Info Service on IP Issues, Health and Trade Issues

www.twn.my

*WHO proposes to join Global Fund's IP enforcement initiative*

Geneva, 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
products.

Astonishingly, the report is silent on the risk of participation in the GSC.

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 industry.

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
n_Global_Fund_Replenishment/).

[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 property rights."

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
organizations". (
http://www.woodsinternationalllc.com/--fighting_falsified_and_substandard_medicines
).

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
Harmonization.

* February 4, 2013, Woods International supports US Pharmacopeia's Spectral
Library Consortium meeting at the USP Headquarters in Rockville, MD.

* 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 opening
session.

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 unit
(http://www.interpol.int/News-and-media/News/2013/PR031).

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 groups.

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
bodies.

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
website.

The MSM is expected to consider the participation of WHO in the GSC on 20
November.




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