WHO technical working group on good governance in pharmaceutical systems: meeting report, Geneva, December 2017

WHO/EMP/2018.03 WHO technical working group on good governance in pharmaceutical systems Meeting report Geneva December 2017 1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. WHO technical working group on good governance in pharmaceutical systems. Meeting report. Geneva December 2017. Geneva: World Health Organization; 2018. Licence: CC BY- NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. This publication contains the report of the report of the Bi-Regional Consultation on Good Governance for Improved Access to Medicines and does not necessarily represent the decisions or policies of the World Health Organization. 2 Background Good governance is essential for the attainment of universal health coverage. The World Health Organization’s Good Governance for Medicines (GGM) programme has, since its inception in 2004, worked with more than 35 countries to assess and address governance gaps and vulnerabilities to corruption. Feedback from countries on the transparency assessment instrument1 used in Phase 1 of the GGM programme showed that the assessment was useful in raising awareness on the need for good governance and in designing interventions to address gaps. Nevertheless, countries reported that the assessment instrument was lengthy and resource-heavy. This feedback catalysed the revision process of the transparency assessment instrument. A series of consultations took place with countries as well as technical experts to identify areas for revision. The major modifications incorporated were a change from qualitative interviews to desk research as the basis for assessing transparency, a refinement of the scope of the assessment to include components of accountability and a simplification of the methodology to analyze the results. In addition, efforts were made to reduce duplication with any other pharmaceutical system assessment tool. A first draft of the revised tool was alpha tested in Canada and the Netherlands. Following the alpha test, further revisions were made to produce the Field test version of the Pharmaceutical system transparency and accountability assessment tool (Annex 1). The field test version was conducted in Kosovo, Malawi, Malaysia, Mongolia and Fiji. Assessors involved in the field test were invited to a meeting to share experiences with the revised tool with the aim of finalizing the pharmaceutical system transparency and accountability assessment tool and to review experiences with translating the results into actions. Pharmaceutical System Transparency and Accountability Assessment Tool (Field Test Version) The revised tool is a desk research assessment of the key information that should be in the public domain in order to facilitate accountability. 2 The tool is organized into 4 cross-cutting areas and 8 functional areas. Cross-cutting areas include: access to information and participation; medicines policy; code of conduct and anti-corruption; and managing conflicts of interest. Functional areas include: registration and marketing authorization of pharmaceutical products; licensing premises of manufacturers, wholesalers and retailers; regulatory inspections of manufacturers, wholesalers, retailers and clinical research organizations; pharmaceutical promotion; independent information; clinical trials oversight; medicine selection and reimbursement lists; and public procurement and distribution. The key information is assessed to determine whether it is in the public domain or not. Sub-questions are included to allow for more in-depth analysis of particular questions. A traffic light system is used to score the results: green for if the information is in the public domain; yellow if the information is incomplete, under revision or publication pending; or red if the document is not in the public 1 World Health Organization. Measuring transparency in the public pharmaceutical sector, assessment instrument. 2009. http://www.who.int/medicines/areas/policy/goodgovernance/measuring_transparency/en/ (accessed 4 April 2018). 2 Paschke, et al, under review. 3 domain. An overall transparency score is calculated for each cross-cutting or functional area as per the following formula: (Number of questions answered “Yes”) + 0, 5(Number of questions answered “Partial”) Score= ------------------------------------------------------------------------------------------------------- ---------*100 Total number questions in that section The overall transparency and accountability score is then assigned as: High if the score is: >=67% Moderate if the score is: <67 and >=33% Low if the score is: <33% Detailed results can be reviewed within the different cross-cutting and functional areas. Consolidated results of field tests Overall transparency scores for cross-cutting and functional areas were consolidated by WHO for 6 out of 7 of the field test sites to test the usefulness of the assessment tool for providing a global view of transparency and accountability in pharmaceutical systems. Figure 1 shows the overall transparency and accountability score by cross-cutting and functional areas for the 6 field test sites. Figure 1. Field test assessment results Site 1 Site 2 Site 3 Site 4 Site 5 Site 6 Access and participation Code of conduct CoI Registration Licensing Regulation Promotion Clinical trial oversight Selection Procurement Distribution High = >= 67% questions answered 'Yes' Moderate: <67 and >=33% questions answered 'Yes' Low: <33% questions answered 'Yes' Analysis of the consolidated results from the six field tests showed that:  The areas where transparency and accountability are strongest are: codes of conduct, and the licensing of pharmaceutical establishments.  The areas where transparency and accountability are weakest are: selection and clinical trial oversight.  The detailed analysis of the consolidated results shows that this tool is useful to identify common areas of weakness in cross-cutting and functional areas. 4 Country experiences with the revised assessment tool The following feedback was provided on countries’ experience using the revised tool: Strengths of the tool  The scoring of the main questions was straightforward and allowed for the development of a “traffic light” summary that is easy to understand and that facilitates the quick identification of strengths and weaknesses within countries’ pharmaceutical systems. It is also a powerful way of engaging policy makers and other stakeholders in the improvement of good governance in the pharmaceutical sector.  For some countries, making information publicly available is a new concept. This tool is therefore useful for introducing the concept of transparency and raising awareness of its importance. It also facilitates the identification of information should be in the public domain among governments as well as other stakeholders involved in the pharmaceutical sector.  The assessment tool helped countries generate evidence that can be used for policymaking. Challenges  Given the level of comprehensiveness of the assessment tool, it is necessary to have a country assessor that is familiar with the pharmaceutical system.  Due to the high degree of fragmentation of where information is located, finding the information for the assessment was challenging and time consuming. The 18 day timeframe outlined in the assessment guide was not realistic, as countries reported taking a month and a half to conduct the assessment.  Questions were raised regarding the ‘partial’ answers and the scoring of information that does exist but is not publicly available, and what would be considered a justifiable reasons for not having such information in the public domain. Suggestions  A list of websites where information can be found would be helpful for country assessors.  Some of the questions require clarification.  Given the high level of fragmentation of where information is located, opportunities exist to begin a process of centralizing information so that it can be more easily accessible to the public.  More questions could be added on the sections on whether standards and commitments have been met and on follow up for each of the core functions.  Governments should be made aware that the assessment is being carried out to begin the dialogue on governance and catalyse political buy-in.  The results from the assessment should be validated. Options to do this were discussed: o Key informant interviews with the stakeholders involved in each of the core functions of the pharmaceutical sector could facilitate tracking down of information. o The assessment findings could be presented to government officials to ensure no information was accidentally missed.  Key informant interviews could also serve as a capacity building tool to make stakeholders aware about transparency and accountability and their importance. 5 Discussion on the scoring methodology “Partial” scores The scoring methodology of the assessment tool, as well as its functionality was reviewed. Experience from the field test of the revised assessment tool highlighted that the meaning of “partial” answers varied depending on the country and therefore required clarification. While the use of a “partial” score provided some flexibility in the scoring to account for documents that exist but require an access request, or documents that do not exist but are currently under development, it was concluded that in either case, the information is not in the public domain and those questions should be scored as “no”. For that reason, it was concluded that the partial score should be deleted. Scoring of sub questions It was concluded that, because these sub-questions are related to the content of the information that is publicly available, they should be included in the scoring of each of the main questions. Key informant interviews Political will is crucial for the success of the GGM programme. However, in countries where political will is not strong or is absent, conducting the assessment can help catalyse dialogue on good governance and raise awareness of its importance for the pharmaceutical sector. Participants discussed the role of key informant interviews as a means to increase awareness among key informants of the importance of transparency and accountability in the pharmaceutical sector. Conducting interviews can be challenging in countries where there are only a limited number of potential key informants that are knowledgeable on the topic. In addition, the sensitivity of the topic can create issues of anonymity, which limit the ability to conduct focus groups, or record interviews for transcription and analysis. Nevertheless, there was consensus among participants that interviews should be an element of the assessment tool. Interview questions should be kept open ended, and could be adapted from the original version of the assessment tool. Translating assessment results into a Framework for Action Zimbabwe’s experience Zimbabwe carried out an assessment using the previous version of the transparency assessment instrument and participated in the meeting to share their experience with analysing results and developing a framework for action. The assessment included a desk review as well as key informant interviews. Key informants reported the existence of information necessary to ensure transparency and accountability. A “patient perspective study” was conducted to collect further insight on vulnerability to corruption. The results from that study helped support the findings from key informant interviews. In order to develop an action plan, Zimbabwe conducted a series of consultative meetings with stakeholders to ensure the framework was clear, concise, and to help push policy makers uptake the 6 framework. Zimbabwe set up a Steering Committee and Task Force comprised of key stakeholders and consumer representatives. Goal setting was one of the priorities during the development of the framework and implementation plan. A prioritizing exercise was conducted that involved analysing the amount of time needed to implement an activity, its level of complexity, as well as its potential impact on the improvement of transparency and accountability. Prioritization was also guided by the results from the patient perspective study. Linking the GGM programme was another of the focus areas to ensure continuity. Zimbabwe integrated good governance practices into education curricula for medical and pharmacy students. The three greatest challenges for the development of a framework were the prioritization process, soliciting of written feedback from key stakeholders, and stakeholder’s perceptions of the term ‘corruption’. Other challenges include changes in the political environment and ensuring continuity in political commitment for the GGM Programme. Way forward The feedback received during the meeting will be incorporated into the assessment tool for the final revision. 7 Meeting Agenda 18 December Time Agenda Item Presenter/Facilitator 9:00 Introduction and opening of meeting  Welcome and opening remarks  Review of agenda and objectives Gilles Forte, WHO 9:15 Transparency and accountability in pharmaceutical systems: Where we have been and where we are going Deirdre Dimancesco, WHO 9:45 Experience with the GGM assessment tool  Malaysia  Fiji Leona Tan Sze Ping, Malaysia Vasit Nawadra, Fiji 10:15 Break 10:45 Experience with the GGM assessment tool  Malawi  Mongolia Nettie Dzabala, Malawi Purevsuren Sodnomtseren, Mongolia 11:15 Pilot feedback and assessment results Gabriela Martinez, WHO Consultant 11:45 Breakout session  Strengths and weaknesses of the assessment tool  Strengths and weakness of the approach 12:30 Lunch 13:30 Breakout session  Cross cutting areas  Registration, licensing, inspection 15:00 Break 16:00 Breakout session  Promotion, clinical trial oversight, selection  Procurement, distribution 17:30 Wrap up Deirdre Dimancesco, WHO 8 19 December Time Agenda Item Presenter/Facilitator 9:00 Review of day 1 and introduction to day 2 Deirdre Dimancesco, WHO 9:15 Breakout session  Data collection and recording  Scoring methodology  Report templates 10:30 Experience with developing an action plan  Experience in Zimbabwe Chiedza Maponga, Zimbabwe 10:45 Break 11:15 Breakout session  Interpreting results  Translating results into meaningful actions 12:30 Lunch 13:30 Breakout session  Prioritizing actions  Developing a logframe 15:00 Break 15:30 Breakout session  Developing a qualitative component 17:00 Group discussion:  What is needed to move from transparency to accountability 17:30 Wrap up Deirdre Dimancesco, WHO 20 December Time Agenda Item Presenter/Facilitator 9:00 Review of day 2 and introduction to day 3 9:15 Breakout session  Marketing to the health care professional  Undue influence from the private sector 10:30 Break 11:00 Breakout session  Targeting the consumer (awareness campaigns, internet activities, support to patient groups) 12:00 Group discussion  Priority actions for future work on governance 12:30 Final wrap up Deirdre Dimancesco, WHO 9 List of participants NAME INSTITUTION COUNTRY Chiedza Maponga School of Pharmacy, College of Health Sciences, University of Zimbabwe, Zimbabwe Renata Slaveska- Raichki Ss. Cyril and Methodius University Macedonia Nettie Dzabala College of Medicine, Main Campus, Pharmacy Department Mahatma Gandhi Road, Blantyre Malawi Purevsuren Sodnomtseren Health Sciences University of Mongolia Mongolia Leona Tan Sze Ping Pharmacy Policy and Strategic planning, National Medicine policy Section, Pharmaceutical Services Division, Ministry of Health, Malaysia Malaysia Paul Grootendorst University of Toronto Drug Insurance and Reimbursement Canada Vasit Nawadra Ministry of Health Fiji Anne Pashke University of Hamburg Germany Sophie Harris Transparency Internationale United Kingdom Helena Walkoviak Management Sciences for Health United States Gilles Forte Office of the Director, Department of Essential Medicines and Health Products, World Health Organization Switzerland Deirdre Dimancesco Office of the Director, Department of Essential Medicines and Health Products, World Health Organization Switzerland Gabriela Martinez Office of the Director, Department of Essential Medicines and Health Products, World Health Organization Switzerland Adi Nuseirat WHO Regional Office for the Easter Mediterranean Region Egypt Wilfred Dodoli WHO Country Office Malawi Malawi Chimgee Enkhee WHO Country Office Mongolia Mongolia Stann Midzi WHO Country Office Zimbabwe Zimbabwe