[Ip-health] TWN Info: New compromised medicines mechanism agreed, some concerns remain

Sangeeta ssangeeta at myjaring.net
Thu Jan 26 08:49:25 PST 2012

Title : TWN IP Info: New compromised medicines mechanism agreed, some
concerns remain
 Date : 26 January 2012


TWN Info Service on Intellectual Property Issues (Jan12/05)
26 January 2012
Third World Network

WHO: New compromised medicines mechanism agreed, some concerns remain

Heba Wanis* (Geneva): In its 130th session which ended this week the WHO
Executive Board agreed to the establishment of a intergovernmental mechanism
on substandard/spurious/falsely-labelled/falsified/counterfeit medical
products², though concerns over WHO¹s relationship with IMPACT as well as
modalities of the mechanism remain unresolved. 

Decision to establish a new Member State (MS) mechanism was taken by the
Open Ended Working Group (OEWG) in its meeting in October 2011 as a
compromise over continuing differences on WHO's operations in dealing with
compromised medical products. The MS mechanism will have a broad mandate on
the prevention and control of compromised medical products that includes
addressing access to affordable medical products, including the supply and
use of generic medical products. [For information on the outcomes of the
OEWG see 

With some amendment, the EB approved the outcomes achieved by the OEWG.
These outcomes (i.e. the draft resolution, an annex containing the agreed
goals, objectives and terms of reference of the MS mechanism and a report on
the outcome of the OEWG) will now be transmitted to the 2012 World Health
Assembly (WHA) for adoption.

While the establishment of a MS mechanism was agreed to by the OEWG, the
Report of the OEWG noted that divergent views were expressed with regard to
WHO's involvement with International Medical Products Anti-Counterfeiting
Taskforce (IMPACT). [WHO¹s relationship with IMPACT has been a sticking
point in OEWG discussions. Many member states and civil society have called
for WHO to disengage from IMPACT on the basis it is an IP enforcement
initiative, lacks credibility and legitimacy. But a handful of countries
continue to support the initiative.]

No resolution was reach on this matter at the EB although some countries
called for a decision to be taken on the matter at the WHA.

Member states¹ intervention at the EB also highlighted some concerns over
modalities on the convening of the member state mechanism.

Draft resolution

China in its intervention proposed addition of a clause ³in a voluntary
manner² to operational paragraph 6 of the draft resolution, saying that MS
must be allowed to work in a voluntary manner and build up progressively. 

The agreed text of paragraph 6 of the draft resolution now reads ³6. URGES
Members States to: (1) on a voluntary basis, participate in and collaborate
with the Member State mechanism referred to in operative paragraph 4; (2)
provide sufficient financial resources to strengthen the work of the
Secretariat in this area².

Estonia, on behalf of the EU, supported by Norway initially did not favour
reopening the text agreed by the OEWG, however the legal counsel clarified
that participation in the OEWG was indeed voluntary.

Uncertain Modalities

On modalities of the MS mechanism, Chile, on behalf of UNASUR announced that
Argentina will host the first conference on SSFFC. Following this, Argentina
invited all Member States to the meeting in Buenos Aires in October.

However this proposal met with some reluctance with several countries
suggesting that a preparatory meeting be held in Geneva prior to Buenos
Aires meeting.  This proposal is likely to be finalised at the WHA in May

Disassociation from IMPACT stressed

Interventions on the topic also revealed clear positions on the MS mechanism
and on  IMPACT.

India said that IP enforcement should remain outside discussions on quality,
safety and efficacy (QSE) at the WHO, and called for severing any links with

India attributed the problem of compromised medicines to weak drug
regulatory structures adding that WHO¹s focus should be on strengthening of
drug regulatory authorities (DRA) to ensure QSE of medicines including
pharmacovigilance processes; and promotion of generics.

Nigeria, on behalf of the members of the African regional office (AFRO)
noted that  SSFFC medicines was a major public health challenge to the
region and encouraged WHO¹s work on medicines supply chain, local
production, capacity building, and multisectoral collaboration to ensure
access to QSE medicines. It proposed creating a sub-committee to work on the
definitions of SSFFC.

Barbados called on WHO to strengthen DRAs, including drug inspection,
pharmacovigilance and pre-qualification programmes.

Brazil said that ³activities carried out by IMPACT and the attempts to
redefine the term ³counterfeit², already defined in the TRIPS Agreement,
were examples of the lack of clarity between intellectual property aspects
and public health collective interests within WHO². 

Brazil also mentioned the emergence of anti-counterfeiting measures linked
to TRIPS-plus standards and IP enforcement, giving the example of the
Anti-Counterfeiting Trade Agreement (ACTA), and the 19 detentions by customs
authorities of medicines in transit through the EU. Brazil said that these
confirmed their concerns.

On the issue of SSFFC definitions, Brazil said that it was more relevant to
focus discussions on characterising the actions or behaviours, which should
be prevented.

On IMPACT, Brazil noted that it was an issue that cannot be left unresolved
in the proposed mechanism. ³We must be strive to find a solution to this one
issue that still set us apart², Brazil said, adding that it trusts that MS
will be able to decide on this matter during the WHA in May.

Bangladesh noted that the OEWG had not been in a position to come with
specific recommendations on the WHO¹s relationship with IMPACT, and called
for bridging the divergent views of MS by the WHA in May adding that there
is legitimate grounds for WHO to dissociate from IMPACT.

Thailand aligned itself with India and Bangladesh regarding IMPACT.

USA noted the sensitivity around IMPACT, and mentioned that once the MS
mechanism is in place, the USA will transfer their support from IMPACT to
the mechanism. The intervention also focused on securing global supply
chains of medicines, DRA strengthening and implementation of border

Iran expressed its ³deep concern² regarding the lack of finances in the area
of QSE at WHO, drawing the attention of EB Members to the fact that in spite
of this, MS still expect the WHO to play an active role in this regard. Iran
expected collaboration between MS and the Secretariat to secure the
necessary funds.

The necessity of allocating resources to the work of QSE at the WHO
Secretariat was also highlighted by Switzerland. 

Canada highlighted its support for the new MS-driven mechanism and noted
that all relevant stakeholders should be involved.

Japan mentioned their concerns are not only on QSE of medicines, but also
the violation of trademark and design rights. Japan called for cooperation
with all relevant stakeholders such as the private sector, and expressed its
willingness to support activities of countries in need.

The WHO Secretariat responded to queries and concerns by MS, particularly on
limited finances directed to QSE work, saying that it would be difficult to
mobilise extrabudgetary resources for what is considered core work of the
WHO. The Secretariat requested ³greater clarity² from MS on the exact nature
of the MS mechanism in order to assess the costs. 

*Heba Wanis is the Project Coordinator of Global Health Governance, Peoples'
Health Movement (PHM). This article has benefited from the valuable
contributions of PHM's WHO Watchers: Natalie Eggermont and Iboro Ekpo Nta

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