Info Service on Health Issues (Nov17/11)
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.