WHO says “no thanks” to the private sector
meeting, the World Health Organization (WHO) Executive Board (EB) discussed precisely who would be allowed in the room in the future under the proposed new Framework for Engagement with Non-State Actors (FENSA), which, if passed by the World Health Assembly (WHA), would set strict new rules and processes for WHO to follow in engaging with non-state actors (NSA)—including nongovernmental organizations (NGOs), civil society organizations (CSOs), the private sector, and philanthropic foundations. These new policies impact everything from who is allowed to participate in governance meetings to the ways WHO can collaborate with local NGOs. To provide some context for the proposed changes, below is an overview of the current rules, the proposed new regulations, and some of the implications of particular concern for the global health research and development (R&D) world.There’s an old adage about political negotiating: “You need to be in the room when things are happening if you want to have an impact.” At its recent
Current rules governing engagement with NSAs
The current rules governing WHO’s collaboration with NSAs derive from “Principles Governing Relations Between the World Health Organization and Nongovernmental Organizations.” The Principles recognize three levels of relations between WHO and NSAs: informal, working, and official. Informal relations consist of “…exchanges of information and reciprocal participation in technical meetings” and are designed to build a platform of shared priorities. They can continue on an ad-hoc basis for as long as necessary without any written agreement.
If the relationship elevates to the level of specific joint programming and activities, WHO and the NSA can enter into a 2-year period of working relations. The two organizations exchange formal letters of commitment and agree to evaluate the outcome of the collaboration at the end of the joint activities. These types of collaboration do not require any decisions by the EB and can occur with WHO Secretariat staff approval; they do not grant any formal participation rights at the EB or WHA.
To receive formal recognition and participation rights at the EB and WHA, an NSA must complete a successful period of working relations and submit an application to the EB. If admitted into formal relations, the NSA’s relationship with WHO is then subject to review every three years. If the application is rejected, the NSA cannot reapply until it has completed another period of working relations.
Proposed new regulations
The new proposed FENSA rules take a far different approach. Rather than recognizing three different categories of relations, it features only two: official relations and “engagement.” Unlike the current regulations, however, it does specify different rules of engagement depending on the type of NSA; NGOs/nonprofits are treated differently than philanthropic foundations, which are treated differently than academic institutions, which are in turn treated differently than the private sector. Of particular note for the R&D community, private-sector entities would be barred from official relations, as would any entities not “at arm’s length” from commercial sponsors or members. This could be interpreted to include some product development partnerships.
Under FENSA, WHO would be required to create a publicly-available online register of every NSA it engages with at the global, regional, or country level. A pilot version of this register is currently available here. Each NSA that wished to engage with WHO would be required to populate all of the information shown in the link above as well as a to-be-determined section detailing the precise nature and funding of the engagement. For the purpose of registration requirements, engagements are defined as: participation in meetings, donation of resources, information/evidence sharing, advocacy efforts, and technical or programmatic collaboration. Essentially, as currently written, this category requires registration for almost any type of collaboration.
When an organization proposes engagement(s), WHO Secretariat staff would be required to review both the organization’s information and the proposed activity in the register, as well as conduct a full due diligence assessment on risk management and potential conflicts of interest. Only after these processes have completed would the activity move forward. The staff burden of these processes is hard to overstate; the European WHO region had over 5,000 individual engagements with over 1,500 NSAs in 2014 alone.
As shocking as it sounds, all of the above scrutiny would be required for simple “engagement,” not for official relations. In order to guarantee the right of representation at EB and WHA meetings, an organization would still need to submit a separate application with even more extensive documentation.
Implications for the health R&D community
Ultimately, FENSA, if implemented as it currently stands, does not seem likely to fix any problems, while it would likely create additional hurdles for the R&D community by:
- Greatly hindering the ability of WHO to collaborate with outside organizations by imposing a burdensome registration and review process for every type of engagement (no matter how small or informal).
- Potentially disenfranchising significant sectors of the global health R&D community by imposing stricter requirements that might redefine some product development partnerships as private-sector organizations that are not entitled to representation.
The WHO working group revising FENSA will meet again in early April to attempt to reach an agreement so that they can present a consensus resolution to the WHA in May. We will be following the process very closely, and will provide further updates on this blog as they happen.