[Ip-health] WHO: Medicines access study absent from proposed prioritised activities on Substandard and Falsified Medical Products

K.M. Gopakumar kumargopakm at gmail.com
Thu Nov 30 11:21:05 PST 2017


*Title :* TWN Health Info: WHO: Medicines access study absent from proposed
prioritised activities on substandard and falsified medical products
*Date :* 2017-11-30

*Contents:*

TWN Info Service on Health Issues (17/11)
30 November 2017
Third World Network
www.twn.my

*__________________________________________________________________*

*WHO: Medicines access study absent from proposed prioritised activities on
**Substandard and Falsified**  Medical Products *

Geneva, 30 November (Third World Network) – Proposed prioritised activities
on substandard and falsified medical products at the World Health
Organization (WHO) do not refer to an on-going study on access to medicines.

The 6th meeting of the Steering Committee of the WHO Member State Mechanism
(MSM) on Substandard and Falsified Medical Products that is taking place
from 30 November to 1 December in Geneva will finalise the list of
prioritised activities to implement the MSM work plan for the 2018/19
biennium.

At its 5th meeting in November 2016 the Steering Committee mandated a study
on “Understanding the links between access to quality, safe, efficacious
and affordable medical products and the emergence of substandard, spurious,
falsely-labelled, falsified, counterfeit (SSFFC) medical products”.

 [The title of the MSM originally referred to SSFFC medical products. Since
the inclusion of the word “counterfeit” conflates intellectual property
with quality and safety issues, and creates confusion regarding generic
medicines, the World Health Assembly in 2017 amended the title to MSM on
Substandard and Falsified Medical Products.]

The new list of proposed activities for consideration this week contains 8
activities with actions corresponding to each activity. Of these 8 proposed
activities, 5 are from the prioritised activities for the 2015-2017
biennium and 3 are new activities. However, the proposed list of activities
changes the corresponding actions in activity D, which is currently under
implementation.

Activity D under the current prioritised list (2014-2015 biennium) is
to “*Identify
WHO areas: working on the issue of access to quality, safe, efficacious and
affordable medical products and request a report on the current state of
affairs.*”  There is only one action listed under this activity which is to
“*Engage experts to review and report on all WHO activities on access, from
an SSFFC medical products approach*”.  (http://apps.who.int/gb/sf/
pdf_files/MSM3/A_MSM3_2-en.pdf)

[According to available literature, including WHO’s own publications, one
of the main reasons for the circulation of quality compromised medicines is
the lack of access to of affordable medicines. In the absence of access to
affordable medicines people are forced to buy medicines from the informal
market at a lower price, which often bears the risk of compromised quality.
Therefore from a public health perspective, policies to enhance affordable
medicines can drastically reduce, if not eliminate, the circulation of
quality compromised products (especially falsified medicines) rather than
following a police approach of medicines regulation. Recognising this link
between access to affordable medicines and circulation of compromised
quality medicine, the MSM identified one of the actions as “*Increase the
knowledge and understanding about the links between the lack of
accessibility/affordability and its impact on the emergence of SSFFC
medical products and recommend strategies to minimize that impact”*.] (
http://apps.who.int/gb/sf/pdf_files/A_MSM2_6-en.pdf)

The 5th MSM meeting in November 2016 provided the following research
questions for the access to medicines study (http://apps.who.int/gb/sf/
pdf_files/MSM5/A_MSM5_2-en.pdf):

·      Is there evidence of an increased risk of circulation of SSFFC
medical products in the absence of access to affordable products?

·      Is there verifiable evidence that SSFFC medical products are
circulating in the public sector?

·      To what extent can increased public provisioning of medicines
contribute to reducing the circulation of SSFFC medical products in the
local markets?

·      What are the emerging best practices for increasing the access to
affordable medicines?

The cost of the Secretariat carrying out the study was estimated at CHF
56,695.  In the absence of adequate funding it was agreed that the
Secretariat would carry out the following three activities in a stepwise
manner:

·      Complete preliminary survey of the literature;

·      Complete review of cases reported to the WHO Global Surveillance and
Monitoring System; and

·      Complete WHO Secretariat report to be published.

The 5th MSM meeting also decided that the Secretariat start the work on the
study as contained in document A/MSM/5/2 and requested an update on Phase 1
of the work at the next Steering Committee meeting (the on-going meeting
this week).

While this activity is part of the implementation work plan, the proposed
prioritised action under activity D is silent on the study and vaguely
states: “*WHO Secretariat to review and report on future WHO activities on
access to quality, safe, efficacious and affordable medical products from
the angle of links with substandard and falsified medical products*”. (
http://apps.who.int/gb/sf/pdf_files/MSM6/A_MSM6_2-en.pdf)

Thus the scope of action does not refer specifically to the study mandated
by the last MSM meeting, and the Secretariat would  instead review and
report on future activities of WHO on access to medicines from the angle of
links with substandard and falsified medical products.  This generality is
not the intention of activity D.

>From the notes on the record of the Steering Committee meetings of March
and September 2017, the Secretariat appears to be soft-pedalling on the
study. The notes of the March Steering Committee state:

 “*The Secretariat provided an update on its work on the proposed study on
deepening the understanding of the link between access to quality, safe,
efficacious and affordable medical products and the emergence of SSFFC
medical products. The preliminary assessment of literature and data (Phase
1) had been completed and it was agreed that the Secretariat would move to
a more in-depth review (Phase 2) and provide an interim report at the next
SC meeting.”*  Thus the Secretariat only updated the Steering Committee and
did not share the substance of the literature review.

The notes of record of the September Steering Committee meeting show that
prior to the meeting, the Secretariat circulated information on the
literature review on the links between restricted access to medical
products and the emergence of substandard and falsified medical products in
the market.

The Secretariat also “noted that there were other papers and discussions in
development on this issue, notably the broader paper on access to medicines
and vaccines that would be presented to the Executive Board in January
2018, which would inform this work.  Steering Committee members agreed to
revisit this activity at its meeting in March 2018 at which the Secretariat
will be able to provide an update on these contributing efforts.”

There was no discussion on the next step, i.e. complete review of cases
reported to the WHO global surveillance and monitoring system. Further, the
notes of record do not reveal whether the resource constraints forced the
Secretariat to carry out the literature review without looking at the
research questions as set out by the 5th MSM Steering Committee decision.

The delay in carrying out the study may result in enhancing regulatory
policing without policy measures to promoting access to medicines, which
are crucial for access to quality medicines and to restrict the scope for
pervasive incentives for the circulation of quality compromised medicines.


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