WHO Fine-Tunes Work On Epidemics In Debates On IHRs, R&D Blueprint

The Ebola outbreak spurred actions from the World Health Organization in terms of how to deal with emergencies and also getting medicines and vaccines to patients in emergency situations. The secretariat presented an implementation plan for the International Health Regulations, and a report on its recent blueprint on research and development for potentially epidemic diseases at its Executive Board meeting this week. The United States sought to limit the scope of WHO’s work on R&D in this context.

Some countries called for a more substantive implementation plan, while some others voiced concerns about external evaluations of national implementation of the International Health Regulations (IHR) (2005).

On the blueprint, some developing countries remarked that its financial strategy does not include the de-linkage between research and development (R&D) costs and the price of medical products.

The IHR (2005) is an agreement between 196 countries, including all WHO member states, by which countries have agreed to build their capacities to detect, assess and report public health events, according to the WHO.

In the wake of the Ebola outbreak, a Review Committee on the Role of the IHR (2005) in the Ebola Outbreak and Response was convened and presented its recommendations [pdf] to the World Health Assembly in May 2016.

Following the 2016 WHA, the WHO director general was asked to submit a draft global implementation plan for the recommendations of the Review Committee, including immediate planning to improve delivery of the IHR (2005), according to the EB meeting document [pdf].

Six Areas for Action

The director general was also asked to submit a final version of the global implementation plan to the EB, the meeting document stated. The plan includes six proposed areas of action, four of which can be implemented immediately, and two to be further considered by member countries.

The four first areas are : (1) Accelerating States Parties’ implementation of the IHR (2005); (2) Strengthening WHO’s capacity to implement the IHR (2005); (3) Improving the monitoring and evaluation of and reporting on core capacities under the IHR (2005); and (4) Improving event management, including risk assessment and risk communication.

The two last areas are: (5) Additional health measures and enhancing compliance with the Temporary Recommendations under the IHR (2005); and (6) Rapid sharing of scientific information.

Some developing countries, such as Vietnam, Bahrain and Bangladesh called for WHO’s support to develop national master plans to implement the IHR (2005). Japan called for more coordination between WHO and the World Bank to help countries to increase their core capacities.

Malta for the European Union and the United Kingdom said they expected more substance and ambition in the proposed plan, while the Netherlands said the plan although going in the right direction, “is a little step when giant steps are necessary,” he said. There is a need for “less nice and politically correct words, but action.”

Action 3 includes a reference on a “joint external evaluation tool developed by the WHO secretariat and partners,” and the annex to the document mentions a “Joint external evaluations of core capacities required under the Regulations” to be “conducted in 30 more countries by end-2017.”

Russia Questions Plan, Others Insist On Voluntary Evaluations

Russia voiced reservations about the plan and said it is more a list of aims and targets rather than a clear picture of measures to be undertaken, responsibilities, expected results and indicators.

Despite the fact that the document was discussed in regional committees, the Russian delegate said, not all of the concerns and proposals have been taken into account in the plan. Russia, as well as a number of other countries, expressed concerns such as the central and coordinating role of the WHO in implementing the plan, improving, monitoring and evaluation, and the funding involved, he said.

Further, Russia asked what “is behind” paragraph 8 of the plan, which indicates that WHO “would also work with partners to mobilize technical and financial assistance” to countries for the assessment of their core capacities and the development and implementation of national action plans. The paragraph also states that the WHO would work with both countries “and partners on preparing guidance for cross-border collaboration and coordination in public health matters.”

If partners have resources, “surely it is better that they support WHO rather than trying to create some kind of parallel global initiative,” which would be counterproductive, he said.

Countries Call for Broad-Based Discussions

Russia called for broad-based discussions and that there be approval by the governing bodies of WHO for any new instrument for monitoring, evaluation and accountability, and this to be done before any such instrument enters into force.

India remarked on the fact that the IHR (2005) is the only globally binding instrument on health. Different countries are at different levels of development and may not have the resources to meet the diverse health challenges, the delegate said.

India also said that “Any move which makes external evaluation as a pre-condition for receiving financial support and technical assistance would go against the developmental paradigm.”

Brazil also called for a full-fledged discussion on the proposal. There are issues of compliance, the delegate said, asking what happens if countries are not in a position to comply. There are a lot of unanswered questions, he added.

Monitoring and evaluation is a delicate issue because countries will be submitted to external evaluations of their national implementation, said the Brazilian delegate.

Zimbabwe asked for more clarity on area 6, on the rapid sharing of scientific information, and how WHO policies and mechanisms will ensure affordability and accessibility of vaccines and medicines developed through the sharing of data.

The EB decided the secretariat should take into account the discussions, comments and suggestions and come up with a final draft strategic plan, which is expected to be submitted for discussion at the May World Health Assembly.

WHO Capacity Issues Raised on Blueprint

Also after the Ebola outbreak, the WHO secretariat started work on the development of a blueprint for research and development preparedness and responds for potentially epidemic diseases.

The secretariat produced a report [pdf] which was noted by EB members on 25 January.

The United Kingdom, which said it is in discussions with WHO to fund the blueprint, asked how the WHO is trying to get additional funding and remarked that the WHO blueprint is not the only coordination mechanism for global R&D. What is the WHO doing to ensure smooth collaboration, effective competition, and no unnecessary duplication? she asked.

The United States, although supportive of the WHO’s effort at coordination of research, said it is concerned about extending the role of WHO beyond its capacity. WHO should coordinate and provide information that facilitate the research agenda settings by stakeholders and work with member states and their appropriate research entities in particular in the design and execution of clinical trials, the delegate said.

“We would be concerned about the WHO taking on a role defining the R&D agenda itself,” the US delegate said. WHO should bring research partners together to design, manage, and facilitate the conduct of research rather than seeking to undertake these activities itself, he added.

IP Issues Ignored Say Some

India said there should be policy coherence between the R&D blueprint and the broader WHO R&D agenda. Health R&D should be needs-driven and evidence-based and be guided by the core principle of affordability, effectiveness, efficiency and equity, said the Indian delegate.

More clarity and detail are needed about the public health financial model proposed by the WHO, he said, voicing concern about the lack of recognition by the secretariat’s report of the principle of de-linkage between the price of the products and the cost of research as an essential component of this model.

Brazil concurred with India and said the blueprint would benefit from a broader perspective, including intellectual property issues “as they relate to access, pricing, and affordability of medicines.”

Brazil said the issue of the blueprint is one of the items on the EB agenda for which an analysis of the recent recommendations of the United Nations Secretary-General’s High-Level Panel on Access to Medicines would be “quite relevant.” He called for considering those recommendations in the further elaboration of the blueprint.

The WHO secretariat said the blueprint is “firmly positioned” and will remain under the oversight of member states, like all other programmes. The secretariat, he said, commits to report on results and seek guidance on priorities.

Civil Society Calls on Board to Consider High-Level Panel Recommendations

In a letter dated 25 January, a coalition of civil society groups called the WHO to address the recommendations included in the report of the High-Level Panel.

They underlined some of the key recommendations of the panel: a biomedical R&D Agreement or Convention and the implementation of incentives that de-link R&D costs from prices of health technologies.

The groups urged the WHO “to convene an Open-Ended Meeting in 2017 aiming to discuss and start negotiations for an R&D Agreement or Convention and help Member States and other stakeholders implement the rest of recommendations” in the report.

Signatories include the European AIDS Treatment Group, Health Poverty Action (UK), Oxfam, Medicus Mundi International, Public Eye, Third World Network, Universities Allied for Essential Medicines, and the Working Group on Intellectual Property (Brazil).

 

Image Credits: Flickr – ibbl