WHO takes first step towards de-linking drug prices from access and innovation issues

A resolution adopted on 28 May that outlines WHO’s engagement on health R&D norms, including its financing, was subject of intense negotiations during the 69th session of the World Health Assembly (WHA) in meetings chaired by India.

The resolution states that the expert research committee would not only provide technical advise for Type II and Type III diseases but also for Type I diseases, and on anti-microbial resistance (AMR), emerging infectious diseases and emergency health responses.

According to WHO classification, Type I diseases are ones that do not discriminate between the rich and the poor countries and have large vulnerable populations in both — for instance, cancer. Type II are diseases with incidence in both rich and poor countries but with more proportion of patients in the poor countries — for instance, tuberculosis and HIV. While Type III are diseases that are specific to the poor countries — for instance, infectious tropical diseases such as leishmaniasis or malaria.

The committee’s mandate would also include diseases that face a market failure for drugs on account of shortage of medicines, the unavailability of older drugs, the lack of interest by companies to research such drugs because of its non-profitability, or for other reasons.

In earlier open-ended meetings of the member states on the R&D negotiations, there were attempts to narrow the scope of the resolution only to include neglected tropical diseases (NTDs). However, the scope in the adopted text remains broad.

“Something that we were very concerned in this WHA — it (the scope of the resolution) could have been narrowed down,” said Judit Rius Sanjuan, Manager of MSF’s Access Campaign.

WHO will also frame an operational plan for a voluntary pooled fund to support research and development for Type III and Type II diseases and specific research and development needs of developing countries in relation to Type I diseases which will be submitted to the next WHA.

“The plan shall describe how the WHO Global Observatory on Health Research and Development, the WHO Expert Committee on Health Research and Development and the Scientific Working Group of a pooled fund will work together, with specific disease examples, and in line with the core principles of affordability, effectiveness, efficiency, equity and the principle of delinkage,” the resolution states.

"The adoption of the resolution is an important step forward for innovation and access. We welcome the recognition of affordability, effectiveness, efficiency and equity as core principles to guide this work,” Esteban Burrone, Policy Advisor at Medicines Patent Pool (MPP), told Firstpost.

Experts see this as a potential first step towards de-linking drug prices from access issues and innovation of new medicines.

“Delinkage is moving forward, one step at a time, at the WHO,” said James Love, Director of Knowledge Ecology International, an organization that works on access issues, among other things.

The Indian delegation described the negotiations as “long”, “protracted”, “difficult at times” but “thrilled” at the outcome.

In 2012, the WHO established a Consultative Expert Working Group (CEWG) that recommended an internationally binding instrument on health R&D that included, establishing a global observatory for research, coordination functions for health R&D and finance for R&D. The CEWG had also recommended to set-aside a certain percentage of national GDPs for financing the health needs of developing countries.

But the recommendations of the CEWG have only been cherry-picked up until now.

An Open-Ended Working Group (OEWG) by member states in 2012 only agreed to certain elements recommended by the CEWG — the establishment of six demonstration projects to examine the implementation of CEWG principles and also, the establishment of a global observatory.

The six demonstration projects are aimed at developing products and include, an initiative on R&D for visceral leishmaniasis; development of a vaccine against schistosomiasis; a single-dose cure for malaria; development of affordable biomarkers as diagnostics; open-source drug development for diseases of poverty and a multiplexed point-of-care test for acute febrile illness.

However, the demonstration projects failed because of the need for voluntary funding of the projects. Money was slow to trickle in with a current funding gap of about $72 million.

“The entire CEWG process is very critical for meeting the needs of medicines, vaccines and diagnostics for the poorer sections of the world,” Anshu Prakash, Joint Secretary at the Ministry of Health and Family Welfare, and chair of the CEWG meetings told Firstpost.

“One of the areas where this resolution stands out is that it conveys policy coherence. It links seemingly unrelated actions and initiatives of WHO,” Prakash said.

The document also has a strong reference to SDGs and the UN Secretary-General’s initiative of the High-Level Panel (HLP) on Access to Medicines – the HLP reference had emerged as a sticking point in the negotiations as the US frowned upon the mention of the HLP in the document.

“It was not easy getting that (reference to UNHLP) in there,” a source familiar with the negotiations said.

The UNHLP that has a global mandate to explore the policy incoherence between the current system to finance R&D that is based on high price and monopolies and the outcomes that is, basically, the lack of innovation and affordability. The CEWG resolution, in its present form, mimics the UNHLP in the sense of not discriminating between the diseases of the rich and the poor nations — thus, “globalising” the issue of health needs—and exploring questions of drug price and access.

“It (CEWG resolution) connects the different agenda within the different frameworks and different strategies that are being considered within WHO and is asking to be coherent with CEWG and delinkage (priniciples),” Sanjuan said.

However, some health activists were less enthusiastic about the CEWG resolution stating that the core issue is clinching a global R&D treaty which has not happened till now.

“Clearly, we have not moved forward on that. And this has now been put on the backburner in the form of further discussions,” said Dr. Amit Sengupta of the People’s Health Movement. The global observatory is being used as a “smokescreen” to postpone substantial work on a global treaty on R&D that can actually address the “needs of rejigging the R&D system because the supply line is broken today”.

“In the absence of a research treaty that separates cost of innovation from the price of the medicine, we will encounter larger and larger problem between health needs and the availability of new medicines,” he added.

The most controversial concern remains the question of footing the bill for global health R&D. The text starts a conversation on financing and WHO’s role within financing but references the matter for further discussion in 2017.

The text mentions “options for sustainable funding”.

“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,” Love said.

“The fundamental mistake which was, perhaps, made was that the demonstration projects were kept outside the budget of WHO. That was a cardinal mistake. The global observatory is within the budget,” Prakash said responding to a question by Firstpost on why he thinks that financing the demonstration projects would be easier now when it has not been easy in the past.

“We have also tried that the funding for the entire strategic work plan should not be solely dependent on voluntary contribution. It should come from both—assessed contribution and voluntary contribution,” he added.

The delegates urged WHO's member states to increase funding for the observatory, and to strengthen their own national R&D observatories.

“Without money, and lots of it, it will not be important. All de-linkage efforts depend upon governments finding ways to fund R&D outside of the framework of high drug prices,” Love said.

Source: Firstpost