[Ip-health] SUNS: Countries question IMPACT's legitimacy and WHO's role in counterfeits

[Sangeeta]

WHO: Concerns voiced over IMPACT, Secretariat's role on "counterfeits"
SUNS #6627 Wednesday 28 January 2009

Geneva, 27 Jan (Sangeeta Shashikant) -- Many developing countries voiced
concerns at a meeting of the Executive Board of the World Health
Organization (WHO) over the Secretariat using the term "counterfeit" to
describe problems relating to the quality, safety and efficacy of medical
products, and addressing such problems through the International Medical
Products Anti-Counterfeit Taskforce (IMPACT).

At a meeting of the Executive Board on 23 January, Latin American (grouped
under GRULAC) and Southeast Asian countries (called SEARO) as well as Iran
and Egypt were concerned that the term "counterfeit", used in connection
with IP violations particularly trademark infringements, would result in th=
e
WHO addressing health concerns through IP enforcement measures.

Concerns were also raised over the WHO's anti-counterfeit taskforce IMPACT,
which many countries felt was unsuited to address the issue of quality,
safety and efficacy (QSE) of medical products because its establishment
lacked a mandate from the WHO's governing bodies; its emphasis on
"counterfeits"; the involvement of the private sector in its activities thu=
s
raising issues of conflicts of interest; and lack of transparency.

The Africa Group, recognizing alarm among some countries over the use of th=
e
term "counterfeit", recommended improving its definition.

Malawi spoke of the need perhaps to come out with another word to replace
=B3counterfeit=B2.  It also recognized concerns raised about IMPACT but str=
essed
the need to come up with measures to deal with substandard medicines.

Strong views were expressed against the Secretariat's report and draft
resolution attached to the report contained in EB124/14 entitled
"Counterfeit Medical Products". This resulted in the rejection of the
documents.

The documents presented by the Secretariat featured counterfeit as a severe
health problem distinct from IP issues and sought endorsement for IMPACT an=
d
its activities.

Analysis of the Secretariat's report and attached draft resolution suggests
that the documents may potentially become a problem for the prompt
availability of affordable generic medicines (See SUNS #6623 dated 22
January 2009 and SUNS #6618 dated 15 January 2009.)

The debate at the Executive Board resulted in significant convergence among
most developing countries present that more efforts need to be made to
strengthen the drug regulatory authorities - which tend to be weak in
developing countries =AD to address QSE through WHO with guidance from memb=
er
states.

Noting the unease and dissatisfaction with the approach taken by the report
and draft resolution, on the suggestion of WHO Director-General Dr. Margare=
t
Chan, it was agreed that WHO would prepare a new report (without a
resolution) for member states' consideration at the World Health Assembly
(WHA), which would address the public health dimension of the issues and
what WHO is doing to strengthen the DRA (Drug Regulatory Authorities). In
this regard, it would also look at the Global Strategy and Plan of Action
(GSPOA) on Public Health, Innovation and Intellectual Property.

At the request of Thailand, Dr Chan also agreed to prepare another report
that would investigate issues of conflicts of interest among members of
IMPACT.

However, the agreement was preceded by a push from the Chair of the meeting
(Sir Liam Donaldson of the UK), the EU and the Swiss delegation for either
an informal working group or some outcome on the issue of counterfeits,
despite the apparent dissatisfaction among Executive Board and non-Executiv=
e
Board members with document EB124/14 prepared by the Secretariat.

Sir Liam, on one occasion drew parallels with the draft resolution on "The
grave health situation caused by Israeli military operations in the occupie=
d
Palestinian territory, particularly in the occupied Gaza Strip", and said
that sometimes content did not matter and that agreement was needed more as
a symbolism so as not to give comfort to counterfeiters. He argued that it
might be possible to agree to a shorter resolution.

Hungary, on behalf of the EU, the UK and Switzerland showed strong support
for setting up an informal working group to work out an outcome for the
Executive Board. The US suggested the possibility of an intergovernmental
meeting prior to the WHA to take the issue forward.

However, such a push was resisted, and resulted in sharp responses from man=
y
of the developing countries participating in the meeting as Executive Board
members and observers.

Paraguay, on behalf of GRULAC, issued a declaration reiterating its
readiness to deal with the medicines policy as WHO is the appropriate forum
for QSE of medical products as long as it respects national legislation. It
added that adulteration of medicines, absence of objective measures and
non-compliance with good manufacturing practices are themes of concern and
must be dealt with to ensure QSE of medical products and should be based on
scientific and health evidence.

However, it stressed that WHO is not the appropriate forum for observance o=
f
IPRs and that "counterfeit" pertains to infringement of IP rights,
particularly trademarks and has nothing to do with health concerns. WHO
should guide discussions on health issues and not deal with issues that are
the purview of other fora. It further stated that actions should be adopted
after a process of negotiations among Member States that includes the
strengthening of the health authorities responsible for regulation of
medicines.

Brazil, in opposing the draft resolution, voiced deep concern over the QSE
of medical products, adding that it has been working to combat falsificatio=
n
and all forms of illegality. It emphasized that WHO is the forum for debate
of methodologies focused on QSE of medical products and should help Member
States to strengthen their DRA. It added that WHO is not a "forum for
discussions on enforcement of intellectual property rights". It said that
any norms or definitions set to deal with QSE of medical products have to b=
e
inclusive, evidence-based and done through a Member State-driven process.

Brazil highlighted the recent seizure by the Dutch port authorities of an
Indian shipment of generic drugs Losartan (for arterial hypertension), whil=
e
it was in transit to Brazil as a concrete example of the negative impacts o=
f
the relationship between health issues and enforcement of IPRs.

In relation to this case, Brazil also read a joint statement by its Ministe=
r
of Foreign Relations Celso Amorim and the Minister of Health, Dr. Jose Gome=
s
Temporao, which states: "The decision to retain the shipment - which was
not, at any moment, brought onto Dutch territory - was undertaken as a
result of an administrative request from a third company (therefore, withou=
t
the official endorsement of the local judiciary system) which allegedly own=
s
intellectual property rights over LOSARTAN in the Netherlands" and that thi=
s
"process imposes on the supplier, and not on the company which requested th=
e
intervention, the responsibility to prove the legality of the transaction,
essentially an inversion of the universally accepted juridical concept that
the accusatory party must present the evidence."

The statement said that "Irrespective of the value or volume involved, or o=
f
the fact that the shipment was returned to the country of origin (India),
the Brazilian Government considers that the decision by the Dutch
authorities to detain an input which is strategic to public health in a
developing country, and exported in conformity with the existing
international norms, represents a grave drawback in the treatment of the
issue of the universal access to medicines" and "represents a distorted use
of the international intellectual property system, supposedly upheld by
European Union legislation, and contrary to the spirit and provisions of th=
e
Doha Declaration on TRIPS and Public Health." The statement added that "thi=
s
is the sort of procedure that this Organization should oppose firmly".

Brazil said that the case must be seen in light of the direction which the
IMPACT initiative has taken, i.e. under the pretext of a fight against
counterfeit medicines, it attempts to impose a revision of WHO's position o=
n
the issue, with a view to inhibit the legitimate commerce of high quality,
competitively priced generic drugs. Brazil stressed its dissatisfaction wit=
h
the action undertaken in the port of Rotterdam, which it said raised doubts
with respect to the commitment of European countries to the issue of access
to medicines by developing countries. It added that the action may also be
taken up in the WTO.

Brazil also stressed the primacy of health over trade, as well as the right
of countries to fully use the flexibilities of the TRIPS Agreement to
guarantee universal access to medicines, as reaffirmed in WHO's GSPOA on
Public Health, Innovation and IP.

Indonesia, on behalf of SEARO countries, also could not accept document
EB124/14. While fully committing to combat drugs that do not conform to QSE=
,
Indonesia questioned the legitimacy of IMPACT, adding that "we are still
unclear if the Rome Declaration was subsequently discussed, recognized and
endorsed by the EB and WHA to frame the terms of reference or decide on the
establishment of IMPACT's function and membership".

Indonesia said that SEARO countries "do not accept" particularly the
Principles and Elements for National Legislation (Model Elements) produced
by IMPACT, since the process has not been inclusive, and it is the
"sovereign" right of countries. It also stressed that the focus should be o=
n
the strengthening of the DRA and any discussion on this should be
intergovernmental in nature.

Bangladesh also expressed concerns about treating "counterfeit", a term use=
d
in relation to IP violations particularly trademark violations, as a public
health issue. It added that there was a need for better understanding of th=
e
problems and its root causes. It also said that without independent verifie=
d
data, it may be premature to consider the issue. It further said that the
approach to the issue, i.e. taking authority away from the DRA and placing
it in the hands of the law enforcement agencies which have no idea or
capacity to evaluate QSE of medical products, may in fact affect drug
supply.

Bangladesh also raised concerns over IMPACT and its activities, and said
these are not sufficiently member-driven and has a high involvement of the
private sector, raising concerns about conflicts of interest, especially
since organisations participating in IMPACT are also engaged in IP
protection and enforcement.

Bangladesh also raised apprehension with regard to the new definition that
emanated from the recent IMPACT meeting in Tunisia, adding that the
definition lacks precision and may well have serious adverse impacts on the
access to drugs since it may include legally produced generic drugs.

It further stated that any definition should exclude all IP infringements.
It referred to Secretariat=B9s report which states that the proposed
definition =B3will serve as a model text for national legislation=B2, addin=
g
that if so it has to be a definition by member states and not by IMPACT
since an inaccurate or misleading definition could have impact on developin=
g
countries and its industries.

It stressed the importance for developing countries to retain as much polic=
y
space as possible, and concluded stating that it could not support WHO's
report and the draft resolution as it focuses on combating counterfeits as
an end in itself rather than as a public health effort.

Niger, on behalf of African member states, expressed difficulty in getting
the right information about the magnitude and extent of the "counterfeit"
problem. It added that most low-income countries do not have DRA. It also
stressed the need for a better definition and exchange of information.

[Several African country delegates participating in the Executive Board
meetings have privately pointed out that in using the term "counterfeit",
they intend to protect against medicines with no or wrong active ingredient=
s
(spurious medicines) and medicines of low quality (substandard medicines)
and that their intention on this issue is not to protect or enforce IP
rights - see SUNS #6623 dated 22 January 2009].

Hungary, on behalf of the EU, said that this issue was a "priority" for the
EU, adding that the new EU draft legislation is based on IMPACT's Model
Elements and that the fight against counterfeit required international
action based on clear principles and cooperation between the police, banks
and customs. In this regard, WHO has the coordinating role.

The US showed strong support for IMPACT.

UAE spoke in favor of the Report and draft resolution while Oman sought
clarification as to whether one of the causes for the increase in
counterfeits was the patent system which allows patents to be valid for 20
years.

Switzerland said that while it was better to change the term "counterfeit"
it wondered whether this was politically feasible. It stressed that one mus=
t
use "counterfeit medical products" which is not the same as "counterfeits".
It further said that it did not hear criticisms on the quality of technical
work of IMPACT.

Sir Liam, the chair of the Executive Board, picked up the possibility of a
small informal drafting group and sought to push it forward. However, the
Chair's push for a small drafting group and a short resolution was resisted=
,
and in fact resulted in sharp responses from many of the developing
countries participating in the meeting as Executive Board members and
observers.

India, aligning itself with the SEARO statement, reiterated concerns of how
non-tariff barriers are used to obstruct access to cheap good quality and
affordable medicines. It opposed the formation of any group to discuss the
issue until WHO came out with documentation with regard to medicines which
are "substandard", "falsely labeled" and "spurious".

Iran also voiced strong concerns over document EB124/14, i.e. if considered=
,
it will result in a strong mandate on "counterfeit" in relation to IP and a=
n
endorsement of IMPACT. It added that it could not accept either outcome.

It also reiterated that =B3counterfeit=B2 which pertains IP violations are =
not
per se quality problems and not an issue for WHO. It stressed on the need t=
o
focus on the issues of false labeling, substandard and spurious medicines
and avoid issues of IP enforcement.

Iran also asserted that IMPACT definition of =B3counterfeit=B2 in Secretari=
at=B9s
report opens the possibility of using health concerns as a means for IP
protection and enforcement and that IMPACT=B9s Model Elements would hamper
access to medicines and achieving self sufficiency in manufacturing.

Iran further raised issue about the highly unbalanced participation in
IMPACT and the lack of full transparency, stressing that members need to
avoid hasty action amounting to endorsement of IMPACT and its views on
counterfeit.

Venezuela voiced objection to the use of the term "counterfeit" on the basi=
s
that its connotation can be misleading. It added that IMPACT's definition
and proposals can be used as a front for protectionism and might amount to =
a
barrier to countries wishing to develop self-sufficiency in manufacturing.
It expressed the view that direct financing by special interests and the
stress on law enforcement interfered with sovereign matters. It rejected
outright IMPACT's policies.

Thailand also said that it could not support EB124/14 and especially
IMPACT's Model Elements. It however added that it could support
strengthening DRA and having a discussion on this issue.

Argentina also mentioned that WHO is not the appropriate forum for
enforcement of IP rights, adding that the TRIPS Agreement contains a
definition on "counterfeit" and that it was not appropriate for WHO to draw
up an additional definition. It also said that it did not support
harmonization on this issue and urged the Executive Board not to recommend
to the WHA the adoption of the resolution.

Ecuador raised similar concerns adding that WHO should direct its work
toward QSE within the context of public health and respecting national
legislation, as it was not the appropriate forum for enforcement of IP
rights.

Egypt said that recently there has been a lack of clarity as to what WHO's
activities have been and should be in relation to QSE of medical products,
adding that there is a growing sense of unease about IMPACT, an initiative
not enjoying a mandate from WHO's governing bodies.

It asked Executive Board members: "Are we discussing public health problems=
,
or are we, as has recently been witnessed in other intergovernmental fora i=
n
specialized agencies of the United Nations and other IGOs, witnessing an
importation of a specific IP enforcement agenda into the WHO?"

Ensuring quality of drugs requires utmost attention and should be handled
through DRA and WHO has a role to play in supporting DRA, but on the other
hand, counterfeit is a trademark violation, which should be dealt with unde=
r
relevant IP laws, it added. It further stated that WHO should pay attention
to finding solutions, not through the lens of IP, but health.

It also said that substandard products represent a far larger risk and thes=
e
classes (i.e. counterfeit and substandard) must not be confused particularl=
y
at the WHO.

Egypt also highlighted concerns over IMPACT, i.e questions of
representation, and on the quality and objectivity of data including
statistics used. It added that IMPACT has no mandate to pronounce on issues
prerogative of national legislation and that neither the draft resolution
nor the report is a positive way forward.

Egypt also responded to Chair=B9s remarks on the Gaza draft resolution stat=
ing
that the resolution is a valid contribution that it expects WHO to work on.

Chile said that on substance this is not an IP problem but one of poor
quality, substandard, falsely labeled and unapproved products not in
compliance with QSE.

As to form, it alluded to the problem of transparency, insufficient
documents, and unclear funding as well as IMPACT meetings held everywhere
except in Geneva, adding that to give legitimacy to the issue it has to be
dealt with in WHO or at least a group established by EB or WHA.

It referred to a definition that emerged in 1992 but not adopted by member
states and spoke of the need for a definition which would be to everyone=B9=
s
satisfaction, recognize the problem, adding that this issue cannot be
resolved in a working group in an EB session.

Bahamas added there were many assumptions made about regulatory capacity in
EB 124/14, stressing that it was important to know what WHO was doing to
focus on public health aspects particularly as it relates to member states=
=B9
countries regulatory capacities. Neither criminal nor trade activities are
managed by health it added and that there was a need to remove all
references to criminal and trade aspects from the report.

Dr. Carissa F. Etienne, Assistant Director General of Health System and
Services attempted to reiterate the same old arguments of WHO found in the
Secretariat=B9s report in response to many of the interventions made i.e. t=
hat
counterfeiting is a public health problem and that there were statistics on
it, adding that counterfeit in WHO referred to patients that were the
victims.

Dr. Etienne also said that IMPACT=B9s secretariat lies in WHO and attempts =
to
bring stakeholders together and that the Secretariat will make IMPACT more
transparent.

However countries simply could not accept Dr. Etienne=B9s explanation.

Bahamas said that it expected a more specific response as to what WHO itsel=
f
has been doing to provide technical support to countries in the region.

Bangladesh responding to the suggestion of the Chair on an informal draftin=
g
group and to WHO Secretariat said that since it does not accept the
underlying premise of EB 124/14, there cannot be an effective discussion on
the matter, and urged the Chair to recognize its unease and dissatisfaction
with EB 124/14.

In response to Switzerland, Bangladesh said it was questioning the
legitimacy of IMPACT and thus how was it able to critique IMPACT=B9s work.

Brazil also expressed its dissatisfaction with EB 124/14, adding that the
issue was not about whether the resolution was big or small, but it was not
clear what was meant by =B3counterfeit=B2 in the context of WHO=B9s mandate=
.

It also said that the Secretariat=B9s report builds on the technical work d=
one
by a group which is not a member driven group and that member states don=B9=
t
know whether IMPACT when it deliberates takes into consideration the
relevant guidelines and issue such as high prices, and its impact on
counterfeits.

It also cautioned the Secretariat that it would not like too see WHO being
taken over by the Interpol or the police.