[Ip-health] SUNS: NGOs concerned over WHO's role in "counterfeit" drugs, IMPACT

Sangeeta ssangeeta at myjaring.net
Thu May 13 00:39:09 PDT 2010


NGOs concerned over WHO's role in "counterfeit" drugs, IMPACT
SUNS #6924 Monday 17 May 2010

Geneva, 12 May (Kanaga Raja) -- More than forty-five non-governmental
organizations (NGOs) have voiced concern over the involvement of the World
Health Organization (WHO) in the issue of "counterfeit" medical products,
which they said will have adverse consequences for access to affordable
medicines while also failing to address the very real problem of
proliferation of pharmaceuticals with compromised quality, safety and
efficacy.

In an open letter to WHO Director-General Dr Margaret Chan, the civil
society organizations were also troubled by WHO's engagement in the
International Medical Product Anti-Counterfeit Taskforce (IMPACT).

Among the concerns raised by the NGOs over WHO's role in IMPACT include its
links to entities that are engaged in matters pertaining to Intellectual
Property (IP) enforcement, the central role played by the International
Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in IMPACT's
activities, the lack of transparency surrounding IMPACT's activities and the
lack of accountability, as IMPACT has operated outside the purview of WHO
Member States.

(IMPACT was launched by the WHO in 2006, and according to the health agency,
it is aimed at building "coordinated networks across and between countries
in order to halt the production, trading and selling of fake medicines
around the globe.")

(According to the WHO, IMPACT is "a partnership comprised of all the major
anti-counterfeiting players" including international organizations and
enforcement agencies such as Interpol, Organization for Economic Cooperation
and Development, World Customs Organization, World Intellectual Property
Organization, World Trade Organization, pharmaceutical manufacturers'
associations such as IFPMA, as well as NGOs and drug and regulatory
authorities.)

The open letter by the civil society groups comes just as the World Health
Assembly (WHA) of the World Health Organization begins its annual week-long
session on 17 May. The issue of "Counterfeit Medical Products" is on the
agenda of the Assembly.

The open letter was signed by amongst others the Berne Declaration
(Switzerland), Centre for Trade and Development (CENTAD, India), the Delhi
Network of Positive People (DNP+, India), Edmonds Institute (US), Health
Action International (HAI, global as well as regional branches), Health GAP
(US), Oxfam International, Peoples Health Movement - Global, Research
Foundation for Science Technology and Ecology (India), SEATINI (Uganda) and
Third World Network.

The open letter was also accompanied by a separate joint NGO statement by
Third World Network and Health Action International - Global, voicing
serious concern over WHO's participation in, and endorsement of, IMPACT.
(See details of the joint statement below.)

In the open letter to Director-General Dr Chan, the civil society groups
said that the term "Counterfeit" is defined by the WTO-TRIPS Agreement as
referring to a specific category of trademark violation and in some
legislation to all other intellectual property (IP) violations as well.

Today, they said, 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".

It is against this background that WHO's use of the term "Counterfeit" to
refer to a range of pharmaceutical quality and safety problems is of most
concern, said the groups. They note that 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.

In this context, the letter cited as an example, the East African region
where 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 "Counterfeit" 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.

The open letter said: "Equating 'Counterfeit' (a term defined in the TRIPS
Agreement) to spurious  (i.e. products with no or insufficient or toxic
active ingredients) and falsely labelled pharmaceutical products 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 and falsely labelled pharmaceuticals,
which arise irrespective of whether there is an IP violation."

Moreover, said the groups, confusion over the use of the term "Counterfeit"
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 "Counterfeit" would also refer to situations involving
IP infringements.

"We would also point out that empirical, reliable and transparent statistics
about 'counterfeit drugs' 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."

In addition, the civil society groups said that they are troubled by WHO's
engagement in IMPACT and share the concerns of the many Member States that
have questioned the legitimacy of IMPACT. In particular, concerns have been
raised about participation in IMPACT's activities especially the central
role played by IFPMA in IMPACT's activities, lack of transparency
surrounding IMPACT's activities, and lack of accountability, as IMPACT has
operated outside the purview of WHO Member States.

Concerns have also been raised by the groups about IMPACT's link to entities
which are very much engaged on matters pertaining to IP enforcement under
the banner of "anti-counterfeiting activities", such as the Interpol, OECD,
the World Customs Organisation (WCO), the World Intellectual Property
Organization (WIPO), the European Commission and 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. It is also
particularly noteworthy that IMPACT has been identified as an initiative
involved in IP enforcement."

The groups cited another key concern in respect of IMPACT's Principles &
Elements for National Legislation Against Counterfeit Medical Products,
which they said 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.

According to the open letter, these elements also promote measures that have
led to seizures/detainment of good quality pharmaceuticals in transit at
European ports on request of MNCs (multinational corporations) on suspicion
of IP violations, which resulted in delayed treatment for developing country
patients.

"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 above-mentioned concerns raised by Member States have been largely
ignored, with the WHO continuing to promote use of the term 'Counterfeit',
and to endorse IMPACT including by allowing IMPACT to use WHO's logo on its
documents, even where such documents are prepared by the pharmaceutical
industry. 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," says the
open letter to Dr Chan.

"We are of the view that WHO's continued involvement in IMPACT threatens to
undermine WHO's credibility as an organisation that is impartial and that
upholds the interests of public health," the groups stressed.

In view of the above, the civil society groups urged the WHO Secretariat:

-- to explore use of other terminologies through Member-driven process to
capture the problem of pharmaceuticals with compromised quality, safety and
efficacy, substituting the term "Counterfeit" 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 WHO's logo from all IMPACT documents and to ensure that WHO
does not endorse any other activities that promotes the IP enforcement
agenda; and

-- to reorient its programme towards addressing the real causes and
solutions to pharmaceuticals with compromised quality, safety and efficacy,
in particular focus its attention to dealing with high prices of
pharmaceuticals, ensuring timely availability of affordable pharmaceuticals,
as well as strengthening the capacity of drug regulatory authorities.

In a separate joint statement voicing concerns on WHO's participation and
endorsement of IMPACT, Third World Network and Health Action International
said that IMPACT has been identified as an intellectual property (IP)
enforcement initiative, operating outside the purview of WHO Member States
and it fails to address the root causes of the proliferation of medicines
with compromised quality and safety, such as high medicines prices.

"WHO's involvement in IMPACT legitimises the TRIPS-plus-plus IP enforcement
agenda pushed by OECD governments and businesses and undermines public
health. It threatens WHO's credibility as an institution charged with
protecting the Right to Health," said Sangeeta Shashikant, from Third World
Network.

Sophie Bloemen from Health Action International commented: "governments and
intergovernmental bodies should not spend time advancing and strengthening
the IP rights of pharmaceutical companies, who are free to protect their
private rights at their own expense, and instead should focus on tackling
the key issues that affect public health."

"At a time when millions of people still go without the medicines they need
due to high prices, ongoing WHO participation in IMPACT is a major step in
the wrong direction. Enabling the pharmaceutical industry to aggressively
enforce intellectual property rights in developing countries does nothing to
lower medicine prices or improve the quality of medicines" added Rohit
Malpani of Oxfam.

According to the joint TWN-HAI statement, despite the many pressing issues
of quality, safety, and efficacy of medicines, there is still a narrow focus
on intellectual property in relation to medicines and the focus on so-called
"counterfeit" medicines means that even fewer resources are available to
address real public health threats from compromised quality and safety.

Dr. Gopal Debade, Co-Convener of the All India Drug Action Network (AIDAN),
said that "high prices and unethical promotion of drugs are the basic
factors responsible for the circulation of medicines with compromised
quality. WHO should focus on these fundamental issues and not on the
enforcement of IP rights."

Kevin Outterson, Associate Professor and Director of the Health Law Program
at Boston University, reinforced this point by stating that "counterfeiting
is the intentional violation of trademark law - and nothing more. The
patent-based drug industry has tried for years to confuse the issue,
tricking policy makers into distrusting and blocking genuine generic drugs
through patent laws and border enforcement. Generic drugs save lives and
should be promoted."

Loon Gangte of the Delhi Network of Positive People (DNP+) in India said:
"WHO's primary concern should be public health and not the enforcement of
intellectual property rights. As a public health organisation, it should not
pursue an agenda that puts patients' lives in danger".

According to the TWN-HAI statement, the WHO should refocus its efforts on
addressing the wider public health threats by: promoting intergovernmental
discourse on medicines quality, safety and efficacy; strengthening the
capacity of drug regulatory authorities; addressing high medicine prices and
other barriers to access; and preventing the unethical promotion and
marketing of medicines that divert already limited health resources toward
high-priced medicines instead of affordable essential medicines.

Meanwhile, according to some sources, seventeen NGOs have also written to Mr
Anand Grover, the UN Special Rapporteur on the right of everyone to the
enjoyment of the highest attainable standard of physical and mental health,
requesting his intervention on anti-counterfeiting initiatives in WHO to
safeguard the Right to Health. +






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