PHM-Exch> Debate Erupts Over WHO Police Work Against ³ Counterfeit² Drugs Trade

[Claudio Schuftan]

From: Sangeeta ssangeetash at gmail.com

By Kaitlin Mara on 20 May 2010 @ 9:56 am
http://www.ip-watch.org/

A battle broke out yesterday at the World Health Organization over whether
it should continue its relationship with an in-house anti-counterfeiting law
enforcement and customs group, and what that decision might mean for the
role of the organisation in the fight against fake medicines.

Some countries seem to be ³trying to disguise trade and commercial interests
under public health,² the ambassador of Brazil told a committee on the
counterfeit issue at the annual World Health Assembly yesterday. ³This is
what is at stake in this negotiation.²

Brazil and India yesterday claimed that WHO¹s work against counterfeit and
substandard medicines is being influenced by brand-name drug producers with
an interest in undermining legitimate generic competition. The Brazilian
ambassador told Intellectual Property Watch there is a ³hidden agenda²
against generics from countries like Brazil.

³What is the mandate of the WHO? Is it a police organisation?² Or should it
be concentrating on matters of quality, safety and efficacy, she said to the
committee in an intervention that received a round of applause from many
governments.

At issue is the fate of the International Medical Products
Anti-Counterfeiting Taskforce [1] (IMPACT), which opponents say has led the
WHO ­ perhaps intentionally ­ to confuse the issue of substandard, falsified
or otherwise low quality or unsafe drugs with ³counterfeit² medicines. But
supporters of IMPACT, mainly developed countries with large brand-name
producers, argue that the group was intended to address public health and
not patents, and should remain involved with WHO.

More generally, WHO members are wrestling with how WHO should proceed with
work on fake medicines ­ including how to refer to such medicines.

No consensus appeared forthcoming on substantive issues late Wednesday
evening, though a proposed way forward may be addressed Thursday morning. A
way forward supported by some India and several South American countries
would tackle difficult substantive issues in a new intergovernmental
committee. These issues include effects of using different terms, the
relationship between WHO and IMPACT, and an examination of three draft
resolutions on fake medicines that have been submitted to the WHO (IPW, WHO,
18 May 2010 [2]).

WHO Director General Margaret Chan failed to directly address many of the
concerns brought up with regards to IMPACT during the meeting yesterday. The
call for intergovernmental processes in this issue and a new working group
on research and development financing (IPW, WHO, 14 May 2010 [3]) may
indicate a lack of trust on the part of some countries that the secretariat
will act on their best interests, some say.

The World Health Assembly is taking place from 17-21 May.

Time for WHO to ŒDivorce¹ IMPACT?

IMPACT ³functions outside the purview of WHO member states² and thus lacks
accountability to them or a mandate from them, said the delegate of Iraq, a
position that was supported by many other developing countries. But it has
been acting as though it represents WHO expertise in Africa, said Kenya.

Kenya¹s law on counterfeit products resulted from advice given by IMPACT,
said the delegate of the country. This law has been problematic for health
and access to medicine, he said.

When IMPACT approached Kenya on the issue of counterfeit, it went through
the ministry of trade, and the law was passed without consulting the
ministry of health. They presented model legislation, and used the trusted
letterhead of the WHO, he added. They have also been approaching other
countries in Africa, such as South Africa.

³Who is pushing this?² the delegate asked, later adding ³If you¹re not happy
in a marriage, you obviously get divorcedŠ [we are] seeking that this
marriage between WHO and IMPACT come to an end and we start proceedings on
the divorce.²

Venezuela asked for Chan¹s help in abolishing the group, and said WHO
support was needed to contribute to the interests of developing counties.
Brazil said it could have a life of its own if it found ³some other spouse²
but objected to its closeness with WHO.

India said it could not accept any IMPACT document becoming a WHO document
without express debate in a WHO governmental committee. The statement of
India will be posted here shortly.

Several developing countries brought up concerns that IMPACT had conflicts
of interest and was overly influenced by pharmaceutical companies and
developed countries.

Developed countries defended the work of IMPACT as doing essential work to
protect the public from dangerous products. IMPACT was established ³to
enable its broad range of partners to work towards common goals under WHO
leadership,² said Spain on behalf of the European Union, and Switzerland
acknowledged that the groups mandate needed clarifying but said it
appreciated its technical work.

The ³threats surrounding counterfeit, falsified or substandard medicine
require active engagement by a diverse range of all stakeholders,² said the
United States, recognising the leadership of IMPACT and as well as the
secretariat¹s ³actions to more carefully articulate the role of WHO within
IMPACT.² The US emphasised that ³WHO is the forum to address the public
health issues related to counterfeit, falsified or substandard medical
products,² and other issues could be addressed in other forums.

Chan said she would review ³WHO¹s engagement with other international
organisations,² but added that not every partnership is approved by the
World Health Assembly, citing the example of drug-purchasing mechanism
UNITAID and asking if governments also wanted that relationship reviewed.

She acknowledged that in IMPACT ³most of these countries are from the
developed world² but said participation of others is welcome.

Confusing Definition and Role of WHO

The only internationally agreed definition of ³counterfeits² is at the World
Trade Organization, where it is defined as a violation of trademarks, say
those who oppose the term. It is ³devoid of value² in the absence of a clear
understanding said India yesterday and as such is a ³nonstarter.² There is
further concern that the vague definition could interfere with trade of low
cost generic medicines. Brazil said falsification of medicines was a
critical issue, but it had a problem when ³private commercial interests wage
a war² within the WHO against generic medicines. Spain on behalf of the
European Union Wednesday acknowledged that the term counterfeit gives rise
to certain confusion, but said the term could be clarified.

The Brazilian ambassador told Intellectual Property Watch there are concerns
about both fake generics and fake brand-name medicines. But, ³if we want to
fight medicines that have intellectual property problems, let¹s go to the
WTO, WIPO [World Intellectual Property Organization].² At WHO, the focus
should remain on ³quality, safety, and efficacy.²

Michelle Childs and Tido von Schoen-Angerer from Médecins Sans Frontières
(MSF, Doctors Without Borders) told Intellectual Property Watch that the
experience of the organisation from its field work is that substandards are
the primary threat, not counterfeit. The credibility of the WHO needs to be
in addressing these concerns and helping to find a solution, they added,
saying the drive for intergovernmental processes indicated a lack of
certainty from some states that WHO would act in a way that protects their
interests.
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