Observations, comments and questions from the Government of Mexico to document A67/6 “Framework of engagement with non-State actors", discussed at the 67th World Health Assembly Follow-up to decision WHA67(14) Mexico City, 17 June 2014 General observations: Mexico believes that continuous, transparent and open relations between non-State actors and the World Health Organization (WHO) can enrich the Organization's work. These relations should go hand in hand with constructive dialogue and a creative approach to new global challenges in the field of health. Relations with non-State actors should respect WHO's intergovernmental, independent and objective character, and should focus on the promotion of WHO policies, strategies and programmes, in full coordination and consultation with member States. It is necessary to minimize or avoid risks which could undermine the value and integrity of the work of WHO, such as those relating to conflicts of interest. Bearing all of the above in mind, the key factors in such relations are: 1. Transparency in the nature, characteristics, scope and duration of all standing engagements, and those that will be established in the future, and 2. An efficient accountability mechanism which allows evaluation, monitoring and correction, if necessary, of the outcomes of each engagement. We would like to thank the secretariat in advance for its efforts in producing a thorough report on the contributions made during the debates which took place during the Sixty-seventh World Health Assembly in relation to the framework for engagement with non-State actors, as well as on policies for engagement with the different groups of non-State actors. Specific comments, questions and requests for additional information 1. Please specify which activities and forms of engagement proposed throughout the general framework document for non-State actors and in the four proposed policies and operational procedures for engagement with nongovernmental organizations, private sector entities, philanthropic foundations and academic institutions are already being carried out by WHO. 1 2. Following on from the above request, please specify what information is available regarding the activities and forms of engagement with non-State agents (regardless of type) which are already being carried out by WHO. 3. We believe that the establishment of risks of engagement (paragraphs 21-24) should be more clearly and specifically linked to the forms of participation of non-State actors, in particular regarding Resources (paragraph 17), Evidence (paragraph 18) and Technical Collaboration (paragraph 20). 4. In relation to the section on due diligence and risk assessment and management (paragraphs 25 to 28), it is necessary to specify: - Which actors will be responsible for validating this process and how the Executive Board will perform risk assessments; - The criteria to be taken into account in risk assessment; - The criteria to be taken into account when considering the feasibility of initiating relations with WHO; - The relationship between the section on oversight of engagement and the terms on which the Board will support the review of relations with non-State actors. This should be done with the objective of harmonizing and not segmenting information. 5. What criteria are applied in WHO’s internal due diligence process in order to exclude all undue external influence? (Page 7, paragraph 25 and footnote). 6. Why are WHO assessments not being publicized? (Page 7, footnote). 7. We believe that the section on transparency should be strengthened (paragraphs 29 and 30) and expanded. Furthermore, the presentation of this information should begin with existing relations between WHO and non-State actors. We reiterate that the information gathered so far regarding the situation at WHO has key significance in the agenda of engagement with any non-State actor. We also request that the footnotes on pages 1 and 2 be incorporated into the body of the document, given the importance of their content. 8. With respect to the relationship between the framework and the four specific policies on engagement (paragraph 34), it is necessary to clarify whether a minimum or some percentage of funding will be taken into account. The purpose of this would be to determine whether or not a private sector entity making financial contributions could be considered independent, as well as the nature and purpose of the engagement. 9. In relation to other WHO policies, paragraph 36, part e) should make reference to instances which will determine whether or not financial contributions from non-State actors are accepted. Although the document states: “…the decision on accepting such a financial contribution is regulated by this framework”, it is not clear under what circumstances this would happen or which governing body would make such a decision. We therefore recommend that this information be clarified and that it not refer solely to regulation by the framework. 2 10. The section on the Process of Management of Engagement (paragraphs 37-42) should include a specific procedure for periodic reporting to Member States with general and specific information on the decision-making process. 11. Regarding specific operational procedures for the initiation, continuation or discontinuation of engagements (page 10, paragraph 39), we request more information to be included on the Senior Management Committee on Engagement, especially with regard to their integration. 12. Regarding the mandate of the Committee on non-State actors of the Executive Board, the document should specify how the chosen Member State from each region will be elected, as paragraph 43 states that the Committee will be composed of six members (one from each region) but does not specify the criteria for choosing the member from each region. 13. We request clarification on the criteria used to establish the two-year period of relations in the section on Official Relations (page 12, paragraph 48, footnote). 14. In the draft WHO policy and operational procedures for engagement with nongovernmental organizations, we believe it would be appropriate to specify in paragraph 8 what kind of resources WHO could provide to a nongovernmental organization to carry out specified work, and the policies and procedures for this purpose, as the document refers merely to what WHO receives and not what it provides. 15. Paragraph 19 of the draft WHO policy and operational procedures on engagement with private sector entities requires clarification as to what is meant by "in principle", because it says that, in principle, secondments from the private sector will not be accepted. It is therefore necessary to highlight the circumstances in which this could happen, emphasizing that secondments from the private sector will not be accepted. 16. It would be useful to specify the nature of the guidelines through which collaborative relations will be initiated; i.e. through an agreement, a letter of intent or a kind of contract aiming to define boundaries, rights and benefits. 17. We again request that references to secondments be more precisely defined in respect of the role of the seconded staff, through a clear and concise statement from the budgeting and human resources departments. 18. Greater clarity is required in the definition of the parameters to be used by WHO when considering a systematic relationship with non-State actors. 19. We reiterate the need to define which mechanisms will be applied to initiate official relations with private sector entities. 20. With respect to kinds of interaction, the document states that international business associations with which WHO maintains official relations will participate in governing 3 bodies’ meetings in compliance with the corresponding procedures and practices. We request more details on how these procedures and practices actually work in order to clearly define their role and the degree of intervention. 21. The paragraph stating that international business associations participating in WHO meetings would designate a head of delegation and declare their delegates' affiliations does not go into enough detail. In particular, we request more details on how this declaration would be made. 22. We reiterate that the paragraph referring to donations of medicines should specify the criteria which will be taken into account for the selection of countries, communities and patients receiving them. 23. It is important to continue to emphasize that the contribution of resources through nonState actors can promote better health practices, as long as there are controls in place to assure that ethical and legal standards are being met at national and international level. The possibility of any conflict of interest arising should be minimized and the protection of participants in research should be ensured. 24. We reiterate that transparency and accountability are key elements in all relations with non-State actors, particularly regarding contribution of resources. 25. We believe that donations earmarked for clinical trials and product development are matters that still require further clarification in terms of specific operational policies and procedures. We suggest going further and setting out in this document the procedure to be considered for the management of conflicts of interest. 4