[Ip-health] WHO EB130-Brazil's statement on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products: report of the Working Group of Member States

thiru at keionline.org thiru at keionline.org
Sat Jan 21 06:58:34 PST 2012

130ª Sessão do Conselho Executivo da OMS

Minuta de intervenção


Align with statement of UNASUR

To begin with, we would like to congratulate former Ambassador of Zambia
in Geneva, Darlington Mwape, for his competent work as Chair of the
Open-Ended Working Group on
substandard/spurious/falsely-labelled/falsifeid/counterfeit medical
products. His ability to listen and lead the negotiations created a
constructive and fruitful environment for the deliberations of the Working
Group which resulted in a consensual outcome.

I also would like to acknowledge the important role of the Secretariat in
providing Member States with the necessary tools and information for the

Mr. Chairman,

Following intensive discussions at the World Health Assembly in 2010, WHO
Member States decided to set up an intergovernmental working group to
address, from a public health perspective, the issue of medical products
with compromised quality, safety and efficacy, as well as the relationship
of the Organization with the International Medical Products
Anti-Counterfeiting-Taskforce - IMPACT. In doing so, Member-States
acknowledged the importance of taking this debate to a proper
intergovernmental setting.

Among the reasons that led to the establishment of the Working Group were
the serious concerns that WHO and public health objectives were being used
as a front to strengthen the IP enforcement agenda and to support
commercial interests. The activities carried out by IMPACT and the
attempts to redefine the term “counterfeit” -  already defined in the
TRIPS Agreement - were examples of the lack of clarity between
intellectual property aspects and public health collective interests
within WHO.  These concerns were confirmed by the emergence of numerous
anti-counterfeiting measures linked to TRIPS-plus standards and IP
enforcement, such as the Anti-Counterfeiting Trade Agreement (ACTA) and
the 19 detentions by customs authorities of medicines in transit through
the EU.

After two rounds of negotiations, the Working Group agreed to set up a
mechanism of Member States to address the issue of falsified medicines.
This mechanism will be technically oriented and will operate in a fully
transparent and inclusive manner. The goal, objectives and terms of
reference of the future Mechanism were also clearly defined so as to
ensure that its work will focus on  addressing the scourge of SSFFC
medical products from a public health perspective.

In this context, we welcome the offer made by Argentina to host the first
meeting of the Member-States mechanism.

Allow me to make some preliminary comments on the guidelines for the
technical work of the future Mechanism.

On definitions, Brazil believes it is more efficient and relevant to
concentrate discussions on characterizing the actions or behaviors that
should be prevented, instead of looking for concepts to define products
that might be irregular. The identification of behaviors and actions to be
prevented would provide a descriptive and objective approach to the

On the relationship between this Organization and IMPACT, while we
acknowledge the divergent views with regard to this particular point, we
strongly believe that this essential aspect of the deliberations cannot be
left unresolved. Despite our differences, we have been able to agree on a
way forward that will hopefully unite us in the prevention and control of
falsified medicines. However, in order to achieve this goal and truly
start a new beginning, we must be strive to find a solution to this one
issue that still set us apart. We trust that Member States will be ready
to take a decision on this matter during the next World Health Assembly.

Last but not least, to efficiently prevent SSFFC medical products, WHO and
its Member States must address the root causes of the problem, namely the
unequal access of the world population to essential medicines. Trade of
falsified medicines will not thrive where quality, affordable medicines
are available to the population. From a public health standpoint, which
must always guide WHO’s work, access to QSE affordable medicines must be
an essential part of any policy directed to fight falsified medical

Thank you


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org

More information about the Ip-health mailing list