[Ip-health] Intervention by the US at the WHO Executive Board on Counterfeit Medical Products

[Thiru Balasubramaniam]

U.S. Statement

Counterfeit Medical Products
Agenda item 4.11

Mr. Chair,

The counterfeiting of medical products affects all countries, and puts
people at the risk of harm from medical products that may contain too
much, too little, or the wrong active ingredient, and/or contains
toxic ingredients. A coordinated, international approach to address
this crime is essential. The WHO International Medical Products Anti-
Counterfeiting Task Force (IMPACT) has filled that role exceptionally,
and we recognize its expert work to address the public-health aspects
of the counterfeiting of medical products.

The U.S. Government takes all reports of suspect counterfeit medical
products seriously, and puts the necessary resources into
expeditiously investigating and following up on these reports, and
into putting in place any actions (e.g., recalls) and public-awareness
campaigns appropriate to protect U.S. citizens. This includes outreach
and coordination with international regulators and law enforcement.

We also assist countries in strengthening their capacity to produce
high-quality medicines, detect counterfeit products, track responsible
parties, respond to toxicity cases, and raise public awareness.

Given the long and difficult negotiation over the definition of a
=93counterfeit medical product=94 at the Third General Meeting of IMPACT,
in Tunisia, in December of last year, we are disturbed the WHO
Secretariat originally circulated Document EB124/14 with a draft
resolution that with language that significantly widened the scope of
the =93patent=94 exclusion to an exclusion for all intellectual property.
Such a broad exclusion is technically incorrect, and we ask the
Secretariat to explain how such a mistake occurred, given the
importance of this issue to Member States.

As the largest market globally for both branded and generic medical
products, the United States understands the importance of the WHO
Secretariat's work on counterfeit medical products for multiple
interests, particularly patients.

For us, a resolution under this agenda item is important to help
ensure the safety and well being of patients globally. We have a
number of changes to the Secretariat's proposed resolution text. We
note from discussion a divergence of opinions among Board Members on
this agenda item, and are interested in hearing the perspectives of
Board Members and other Member States so the Board can develop a
consensus way forward that all can support.

Thank you.

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997