PHM-Exch> New compromised medicines mechanism agreed, some concerns remain

[Claudio Schuftan]

From: Sangeeta <ssangeeta at myjaring.net>
Third World Network
www.twnside.org.sg

WHO: New compromised medicines mechanism agreed, some concerns remain.
(excerpts)

Heba Wanis* (Geneva): In its 130th session which ended this week the WHO
Executive Board agreed to the establishment of a inter-governmental
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 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. [see
http://www.twnside.org.sg/title2/intellectual_property/info.service/2011/ipr
.info.111103.htm].

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 reached 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.

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 IMPACT.

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.


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 added 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 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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