WHO Performance Undermined By Inadequate EU Collaboration

By Daniele Dionisio

Though the WHO is among the recipients of EU contributions, support should be scaled up now that the WHO fears program cuts because of a persistent funding crisis. Revenues from a Financial Transaction Tax would be a resource for the EU to partly allocate for WHO needs.

Amidst a public funding shortfall, the World Health Organization (WHO)’s slimmer budget for 2014-2015 ($3.9 billion) foreshadows cuts to the programs for communicable diseases and outbreak and emergency responses.

As such, from 1 September 2013, the organization has begun charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components through the WHO Prequalification Programme, a move feared to discourage applications, with a negative impact on procurement and access to essential medicines.

The key to WHO functioning and success relies heavily on deep collaboration and sustainable financial support from Member States.

Unfortunately, this would not be the case with the European Union (EU). Indeed, while relying on established synergies with WHO, including contribution to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, the EU’s global plan for health development cooperation seemingly lacks adequate coordination and collaboration with WHO. Worse, a number of EU political choices run against WHO directions.

The EU succeeded in opposing any mention of the report and recommendations of the WHO-backed Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in the lame resolution EB132/R7 on poverty-related neglected diseases (NDs) passed at a January 2013 meeting of the WHO Executive Board.

Aside from innovative financing sources and the de-linkage of R&D cost from the price of health products, the core recommendation of CEWG report was for WHO Member States to begin formal negotiations towards a global framework – a medical R&D Treaty– that would enhance coordination and financing of medical innovation and set norms to ensure the cost of R&D is de-linked from the price of products and thereby attain the widest possible access.

Yet, the EU is keen on undermining any progress on the Treaty. Starting from the 65^th WHO World Health Assembly (WHA), where several European countries ran against and slowed down a proposal to negotiate a binding convention on financing R&D for NDs, the EU still remained opposed to the Treaty at the 66^th WHA last May.

Similar considerations apply to the models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines. There is seemingly poor attention by the EU, apart from product development partnerships and prizes, to the other models taken into consideration by WHO. This disregards evidence that any one model is not enough to ensure full availability of life-saving medicines, and would contradict the commitment of the EU’s plan for health development cooperation that high-quality medicines and care in the developing world be available without restrictions.

And there is more.

In the aftermath of adoption by the 65^th WHA of a Member State Mechanism (MSM) to fight poor-quality medicines internationally, the EU said it would consider shifting its relevant activities to the new mechanism should it prove successful. However, while there is wide frustration on the slow pace of the MSM until now, the reliability of EU openings is doubtful, mainly because an MSM would be entitled to call for a medical R&D Treaty as a binding convention, which the EU is fiercely opposed to.

Unfortunately, the EU looks like it would disregard WHO as the most accountable, overarching actor. As an example, while the latest WHO and EU plans to address medicine quality issues have raised criticism of inadequate coordination and collaboration with each other, the Directive 2011/62/EU against falsified medical products (applicable from January 2013) did not mention WHO as a partner body for field purposes, and did not align with WHO definition of “falsified medicines”.

The conflicting issues above run contrary to the EU’s engagement as the world’s largest aid donor, and raise doubts about EU’s real will and ability to address today’s overall challenges while pushing for sustainable development and inclusive access to care and treatments.

This couples with fear that terms threatening access to medicines by the worst-off people could be approved in negotiations for an EU-Thai agreement and an EU-India trade deal now on track to conclusion. As reported “…These trade agreements are designed to ensure that developing countries who sign these agreements adopt more stringent IP laws that go much beyond the requirements of the World Trade Organization’s TRIPS agreement. … Proposed EU Trade agreements seek to further consolidate and extend the monopolies of big pharmaceutical companies by blocking the production, registration and supply of affordable generic medicines…”

The concern is even greater now that a 12 June 2013 EU custom regulation has incurred criticism of allowing illicit seizing of in-transit goods (including legal generic medicines) “over a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit” and without “clear and convincing evidence of a substantial risk of diversion”. These terms would hamper TRIPS flexibility grants and run against EU commitments regarding access to treatments without restrictions. [TRIPS refers to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights]

And it comes as no surprise that all of this occurs at a time when the EU global plan for health development cooperation has reportedly fallen short of adequate coherence, innovative financing and collaboration with interested parties, while its commitment in R&D for neglected diseases is not spread evenly between EU member states.

As such, it is bad news that a slimmer EU budget for 2014 to 2020 period was endorsed by the EU Parliament in the 3 July plenary session.

Beyond Makeshift Solutions

Filling the gaps highlighted here is a matter of priority and a way for the EU to consolidate leadership in global health. To this aim, the EU should display better coherence between its policies, strategies and practices.

Relevantly, the EU should support stronger WHO leadership, secure the organization more financial support, and seek deep collaboration, coordination and alignment with the overall UN system and interested stakeholders. Inherently, the revenues from a Financial Transaction Tax, now on track to enforcement in Europe, would be a resource for the EU to partly allocate for WHO needs.

While helping identify shared priorities for global health, this strategy would avoid overlapping and ensure that global health products and initiatives are delivered without restrictions and in a fast, efficient manner.

Finally, this would put into practice what the EU Commission Communication and Council conclusions on the EU role in global health envisaged three years ago:

“At global level, the EU should endeavour to defend a single position within the UN agencies. The EU should work to … increase coordination and effectiveness of the UN system. It should support stronger leadership by the WHO in its normative and guidance functions to improve global health. The EU should seek synergies with WHO to address global health challenges…”

“The EU shall promote dialogue and joint action with key global players and stakeholders, including UN agencies concerned with global health, International Financing Institutions, regional organisations, regional health networks, and countries, in order to identify synergies, coordinate actions, advance in the achievement of commitments, and avoid duplication and fragmentation to increase effectiveness.”

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is Head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio@tiscali.it