Reactions To WHA Resolution On R&D Financing Generally Positive

Today, the annual World Health Assembly is poised to approve a new plan on research and development into medical products that are affordable to all. NGOs, industry and other observers welcomed the outcome.

The draft resolution is heading to the closing plenary session for final approval today. The World Health Assembly is taking place from 23-28 May.

The resolution was agreed in a drafting group last night and approved quickly this afternoon in committee (B).

The issue was WHA agenda item 16.2: Follow-up to the report of the Consultative Expert Working Group on Research and Development [CEWG]: Financing and Coordination.

The drafting group’s early completion of the draft resolution last night came as a surprise to some as a draft document for the WHA was almost entirely bracketed, representing lack of agreement. But participants said afterward there was a general willingness to keep the issue on the table at WHO and compromise was found.

The resolution bolsters efforts at WHO at finding ways to finance R&D resulting in affordable products for neglected diseases and other needs. It addresses funding for these efforts, and the activities carried forward from a 2012 resolution setting out a plan, including an observatory to collect and analyse data, sets up a new committee on R&D prioritisation, and promotes a pooled fund for R&D.

An IP-Watch look at the approved resolution is available here (IPW, WHO, 27 May 2016).

Below are various statements in reaction to the resolution.

IFPMA

Mario Ottiglio of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said, “Moving forward on this debate means focusing on practical and politically feasible actions, which build on what currently works in pharmaceutical innovation, recognise where improvements can be made, and leverage the different roles that different stakeholders can play.”

He added: “This resolution seems to provide a constructive approach to the CEWG follow up process as it brings it onto more concrete ground. We look forward to seeing WHO’s next report on these issues and stand ready to play our part.”

The IFPMA floor statement on the CEWG issue is available here.

UAEM

Universities Allied for Essential Medicines (UAEM) said:

“We are encouraged by the momentum that the CEWG discussions have gained and the leadership shown by several Member States in keeping this process alive. The outcomes have highlighted significant and essential steps in the right direction. However, we urge Member States to recognise the need for furthering discussions on new coordination and financing mechanisms for R&D at an open ended meeting which would take into account recent analyses and input from civil society actors. It continues to be our firm belief that a legally binding framework is urgently needed to ensure that R&D is coherent, sustainable and needs-driven.”

UAEM’s committee statement on the agenda item is available here [pdf].

PHM

Amit Sengupta, associate global co-ordinator, People’s Health Movement, said: “The resolution on CEWG represents the failure of the global community to be visionary and take effective measures that address the gross inadequacies of the research system for medicines. The resolution postpones discussions on a R&D treaty that is the core of the aspiration of the CIPH report and the entire process leading up to the setting up of the CEWG. Measures such as the global observatory are minor increments to the larger aspiration of a global R&D treaty and are being used as a smokescreen to obviate more focused attention on a R&D treaty.”

KEI

James Love, director of Knowledge Ecology International, issued a statement in KEI’s analysis of the resolution and broader goals:

“Delinkage is moving forward, one step at a time, at the WHO. The resolution [on] sustainable R&D funding does more than we expected, and sets the stage for a renewed debate in 2017, after the U.S. elections, and during the campaign for a new WHO DG. The fact that the Secretariat is asked to look at ‘options for sustainable funding’ for a pooled R&D funding model is important, since at the end of the day, this negotiation should focus on ‘sustainable funding’ mechanisms. Without money, and lots of it, it will not be important. All delinkage efforts depend upon governments finding ways to fund R&D outside of the framework of high drug prices. We have asked countries to focus on the incentives that will be needed to induce counties to collaborate on funding R&D as a public good. We also favor a system of multiple pooled funding mechanisms competing against each other for government funding. Neither of these proposals have moved forward, but when you look at what it takes to get sustainable funding, you have to ask why a country would want to be a donor, and then the questions of incentives, benefits to donors and the ability to choose managers of R&D funds, becomes more relevant.”

MSF

Judit Rius Sanjuan, US manager and legal policy adviser of the Access Campaign at Médecins Sans Frontières (MSF, Doctors Without Borders) said:

“The week’s outcome on the WHO CEWG negotiations is an important step in the right direction. Member States have not only agreed to expedite the development of a global observatory on health R&D and to create a WHO expert committee to better identify gaps and prioritize R&D efforts – both are important elements of a global framework on R&D – but have also ensured the scope of diseases is comprehensive and covers a variety of market failures.

Most importantly, governments have recognized the UN Secretary General’s High Level Panel on Access to Medicines and emphasized the key CEWG norms and principles that R&D needs to be needs-driven, affordable, effective, efficient and a shared responsibility, and further endorsed the guiding principle that R&D costs need to be de-linked from end product prices.

Member States have asked WHO to connect the dots and promote policy coherence within variety of ongoing R&D processes, including when implementing the Global Action Plan on AMR [antimicrobial resistance] and the R&D Blueprint for emerging pathogens.”

MSF continues to urge Member States and WHO to fully implement the CEWG recommendations and looks forward to the report at the Seventieth World Health Assembly next year and the follow up open-ended meeting that should fully embrace the need for reforms and for new approaches to research and development and access to medicines that we hope the UN Secretary General High Level Panel will recommend.”

DNDi

In a committee statement before the drafting group’s agreement, Michelle Childs, head of policy advocacy for the Drugs for Neglected Disease initiative (DNDi), said, “Innovation and access are on the political agenda like never before, but the response to these failures is fragmented.”

DNDi identified five core problems in the failure of R&D frameworks to address neglected diseases, emerging infectious diseases, antimicrobial resistance, and hepatitis C treatment. These are:

“1.     No global body to identify R&D needs,

2. No globally-agreed priority setting,
3. No coordination of R&D efforts to reduce duplication,
4. Lack of sustainable financing,
5. No globally-agreed norms that guide R&D initiatives to ensure affordability”

DNDi also called for member states to “ask WHO to organize an intergovernmental conference on policy coherence for R&D, to consider core common elements for development of global frameworks for R&D.”

 

Image Credits: Thiru Balasubramaniam