Info Service on Health Issues (May15/13)
WHO public health, innovation and IP programme to be reviewed
Geneva, 31 May (K M Gopakumar) – Member States of the World Health Organization agreed to the programme review process for the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA).
This was done through a resolution adopted on 25May at the 68th World Health Assembly (WHA) that took place on 18 to 26 May in Geneva.
There was considerable debate over an evaluation of the GSPOA and a review of the implementation of the GSPOA. While the developed country Member States and the Secretariat were advocating a comprehensive evaluation under the WHO Evaluation Policy, developing country Member States preferred an over all programme review as mandated under WHA Resolution 62.16. The comprehensive evaluation is a technical exercise to be carried out by firms without examining the policy issues and without much involvement of Member States. Developing country Member States view a programme review as being able to focus on policy issues along with technical aspects. Further, a programme review can be carried out by a panel of experts familiar with the GSPOA instead of a management consultancy firm that has little understanding of the issue. (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_BCONF1Rev1-en.pdf).
[The GSPOA was adopted at the 61st WHA in May 2008 (WHA 61.21) (see SUNS #6482 dated 27 May 2008). The GSPOA aims to promote new thinking on innovation and access to medicines, and was based on the recommendations of the 2006 report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health. It provides a medium-term framework for securing an enhanced and sustainable basis for needs driven essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for R&D, and estimating funding needs in this area. See http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf
The resolution proposed by the delegations of Bolivia, Brazil, Ecuador, India and South Africa was adopted with certain amendments after informal consultations on 22 May.
According to the adopted Resolution the review is staggered in two parts lasting three years from June 2015 to May 2018. The first phase is a comprehensive evaluation of GSPOA and will be initiated in June 2015. The “final comprehensive evaluation report would be submitted for the consideration of the Seventieth World Health Assembly in 2017, through the Executive Board”. (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_BCONF1Rev1-en.pdf)
In the second phase, the GSPOA evaluation will be followed by an overall programme review. An 18-member expert panel is to be appointed by the WHO Director-General by February 2017 and this panel of experts is to carry out the review. The evaluation report would be submitted to the 71st WHA in 2018. The original resolution requested the Director-General to submit the progress report to the 70th WHA in 2017.
Further, the resolution extends the time frames of the implementation of the plan of action from 2015 until 2022. The GSPOA consists of two parts viz. a Global Strategy and Plan of Action. The time frame for the implementation of plan of action is between 2008-15. The resolution extended this time frame for implementation to 2015-2022.
The resolution also extends “the deadline of the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property on its achievements, remaining challenges and recommendations on the way forward to 2018, recognizing that it was not presented in 2015, as requested by resolution WHA62.16”.
The reason for the two-phase review process and the extension of deadline is a confusion created by a proposal by the Secretariat at the 133rd session of the Executive Board in 2013.
[The Executive Board comprises 34 individuals technically qualified in the field of health; each one designated by a Member State elected to do so by the WHA. Member States are elected for three-year terms. The main functions of the Board are to give effect to the decisions and policies of the Health Assembly, to advise it and generally to facilitate its work: http://www.who.int/governance/eb/en/]
WHA resolution 62.16 had set a deadline for submission of the report of the overall programme review at the 2015 WHA. It states: “in addition to continued monitoring, to conduct an overall programme review of the global strategy and plan of action in 2014 on its achievements, remaining challenges and recommendations on the way forward to the Health Assembly in 2015 through the Executive Board”. (See page 30 of http://apps.who.int/gb/ebwha/pdf_files/WHA62-REC1/WHA62_REC1-en-P2.pdf)
However, the Secretariat ignored this requirement and proposed an evaluation of GSPOA at the 133rd Session of Executive Board (EB) in May 2013. The Board noted the proposal from the Secretariat without any formal decision, ignoring the doubts raised by Brazil and South Africa about the requirement under WHA resolution 62.16. The EB’s oral decision also extended the time line set by WHA 62.16 from 2015 to 2017.
According to the summary records of the 133rd EB meeting, “The Director-General said that it was important to be mindful of reporting requirements given to the Secretariat in resolutions adopted at previous governing body meetings. However, coherence was crucial. Paragraph 6 of resolution WHA62.16 requested the Director-General, in addition to continued monitoring, to conduct an overall programme review of the global strategy and plan of action in 2014 on its achievements, remaining challenges and recommendations on the way forward to the Health Assembly in 2015. The Secretariat was now being requested to perform an independent evaluation and produce the report in 2015. The Secretariat could do what was asked of it only if the financial resources were available. She suggested that a progress report might be produced in 2015, paving the way for a later report of the comprehensive, independent evaluation” (emphasis added). (See http://apps.who.int/gb/ebwha/pdf_files/EB133-REC1/B133_REC1-en.pdf)
The situation raised an interesting legal issue of the overruling of the decision of the WHO’s highest decision making body, i.e. WHA, through a decision of the EB. This question was never directly asked to the Secretariat at the EB meetings. However, the summary records show that both Brazil and South Africa made an attempt to raise this issue (http://www.twn.my/title2/health.info/2015/hi150105.htm).
[Third World Network (TWN) learned from a developing country delegate that the WHO legal advisor was asked at the drafting group on GSPOA extension and review at the 136th EB on whether it is possible to overrule a WHA decision though an EB decision. According to the delegate, surprisingly the legal advisor gave a vague answer that under certain circumstances the EB can overrule WHA decisions without giving any legal reasoning. When TWN asked the legal advisor the same question just after the decision of the formation of the drafting group at 133rd EB last week, the legal advisor expressed his inability to answer the question without referring to documents.]
To resolve the issues around the timeline and the evaluation versus implementation review the 136th EB adopted a decision in January 2015.
Regarding the timeline the EB decision “decided to recommend to the Sixty-eighth World Health Assembly to extend the deadline of the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property on its achievements, remaining challenges and recommendations on the way forward to 2018, recognizing it was not presented in 2015, as requested by resolution WHA62.16”.
However, there was no consensus with regard to the question on evaluation versus implementation review. Therefore the decision requested the Director-General: “to provide a report for the Sixty-eighth World Health Assembly on options, in consultation with Member States, for the conduct of the comprehensive evaluation and the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, on its achievements, remaining challenges and recommendations on the way forward, including whether to combine the two instruments, sequencing, terms of reference, timing and options for establishing an evaluation management group with the goal of completing this exercise by 2018”. (See page 11 of http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_DIV3-en.pdf)
The report of the Secretariat (A 68/35) tabled for the recently concluded WHA proposed the undertaking of a comprehensive evaluation and overall review in a staggered manner. The Resolution accepted the recommendation on the staggered approach along with the time line mentioned in the Secretariat report.
Further, the Secretariat’s report also provided the Terms of Reference of the comprehensive evaluation, role and composition of the ad hoc evaluation management group as well as some suggestions on terms of review for the overall programme review.
According to the Resolution that was adopted on 25 May, the terms of reference of the comprehensive evaluation is as per the proposed terms of reference in the Secretariat’s report. The comprehensive evaluation is to assess the status of implementation of the eight elements of the global strategy and 108 specific actions defined in the plan of action for 2008-15. The evaluation would document achievements, gaps and remaining challenges and make recommendations on the way forward. The evaluation would look at implementation by all stakeholders listed n the action plan at the global, regional and national level. The stakeholders listed in the action plan include government, WHO Secretariat and other relevant stakeholders. Other relevant stakeholders are: International and national research institutions; academia; national and regional regulatory agencies; relevant health-related industries, including both public and private; public–private partnerships; public-private and product deve lopment partnerships; nongovernmental organizations; concerned communities; development partners; charitable foundations; publishers; research and development groups; and regional bodies; and regional organizations.
[The 8 elements of the Global Strategy are: prioritising research and development needs, promoting research and development, building and improving innovative capacity, transfer of technology, application and management of intellectual property to contribute to innovation and promote pubic health, improving delivery and access, promoting sustainable financing mechanisms and establishing monitoring and reporting systems.]
The terms of reference of the implementation review are yet to be finalised. According to the Resolution the Terms of Reference would be finalised by the EB at its 140th session in January 2017.
The Resolution does not accept the suggestions of the Secretariat report with regard the composition of the ad hoc evaluation management group. The resolution requests the Director-General “to convene an ad-hoc Evaluation Management Group to assist the comprehensive evaluation composed of 6 independent external subject matter experts, and two evaluation experts from the United Nations Evaluation Group”.
The Resolution also requests the Director-General to “select the 6 independent external subject matter experts in line with guidelines for selection of members for ad hoc evaluation management groups included in the WHO Evaluation Practice Handbook, including through consultation with the Regional Directors”.
The original version of the resolution proposed 12 independent external experts and two evaluation experts from the UN Evaluation Group. Further, according to the original draft resolution, 12 independent experts should be subject experts, identified from a pool of experts proposed by Member States and representing all six regions of the WHO.
However, the evaluation is to be conducted by an international consultancy firm. According to Secretariat report, “The evaluation would be conducted by an external independent evaluator, selected through an open tender. The evaluator would be an independent external organization or team with appropriate knowledge of the subject of the evaluation and skill mix, as well as relevant experience in performing evaluations involving innovation strategies in public health and access to medical products and technologies”.
Unlike the evaluation, a panel of 18 experts would conduct the implementation review. This panel of experts would be drawn “respecting gender balance, equal regional representation, and diversity of technical competence and expertise to conduct the overall programme review, with a broad and balanced mix of expertise, practical experience and backgrounds covering the eight elements of the global strategy and plan of action on public health, innovation and intellectual property, and including from developed and developing countries”. The Director-General will select from the roster of names forwarded by Member States immediately after the 139th EB in 2016. The Director-General is requested to appoint the panel of experts by February 2017.
According to the original draft, the Director-General is requested “to establish a panel of experts to conduct the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property with a broad mix of expertise, practical experience and backgrounds covering the eight elements of the global strategy and plan of action on the public health , innovation and intellectual property, and including experts from developed and developing countries identified by the Director-General from a pool of experts proposed by Member States”.
The staggered process is a compromise worked out after a series of informal negotiations between the 136th EB and 68th WHA. Developed countries preferred an evaluation to a programme implementation review. On the other hand, developing countries like Brazil, Bolivia, India and others preferred an implementation review because these countries view the evaluation exercise as a technical exercise lacking the policy flavour in it especially when it is carried out by an international consultancy firm. Further, the evaluation is guided by the WHO evaluation policy and handbook. This would lack the policy orientation of the assessment of implementation.
Further, developing country Member States, especially from developing countries that constitute the majority, would have a say in the selection of experts to carry out the evaluation under the Resolution. Under the WHO evaluation policy there is little scope for that. Therefore, a compromise was worked out to include six experts in the evaluation management group.
According to an observer, the trust deficit regarding the Secretariat is reflected in the provision in the selection of panel. It does allow the Director-General to set up the panel of experts but puts various conditions including the selection of experts from a roster of names forwarded by Member States, including through the Regional Directors.
Therefore the compromise is worked out to carry out a staggered process consisting of both the GSPOA evaluation and implementation review.
According to the Secretariat’s report, “in the current context, this evaluation is envisaged as a formative evaluation i.e. an evaluation conducted during the implementation phase of the global strategy and plan of action, with the intention of documenting achievements, gap and remaining challenges and of making recommendations on the way forward”.
Regarding the scope of the programme review it states:
“The overall programme review will be a more policy-oriented, forward -looking exercise. Using specific terms of reference, the programme review will consider the findings of the comprehensive evaluation, together with other technical and managerial aspects of the programme, with a view to identifying what needs to be improved and modified in the next stages of the global strategy and plan of action. The programme review will add a broader policy perspective to the assessment, but it will not apply the methodology of an evaluation. Furthermore, while it will also seek to undertake an assessment of implementation of the global strategy and plan of action (both success factors and challenges), it also offers possibilities for broader engagement of different stakeholders at various stages of the process”.
The estimated financial cost for the extension of implementation of the plan of action is USD 100 million (staff at USD 60 million and activities at USD 40 million). The estimated cost for the comprehensive evaluation is USD 470,000 (USD 70,000 for staff cost). The overall programme review cost is USD 1.6 million (staff at USD 1.1 million and activities at USD 500,000).
The estimated number of staffers is: “nine additional full-time equivalent staff members in the professional and higher categories and three full -time equivalent staff members in the general service category will be required at headquarters, and two full-time equivalent staff members in the professional and higher categories and one full-time equivalent staff member in the general service category will be required in each regional office. For the programme review, two full -time equivalent staff members in the professional and higher categories and one full -time equivalent staff member in the general service category will be required for 18 months at headquarters”.+