World Health Assembly: Groups Seek To Return Focus To ‘Broken’ Medical R&D System

The issue of access to medicines is on the agenda at this week’s World Health Assembly (WHA) and public health advocates are seeking greater clarity and detail about the latest member state effort to address failings in the global system of research and development for medical products.

The World Health Organization has been working for years to come up with solutions for the lack of private sector incentive to invest in research for treatments of neglected diseases occurring in developing countries, and the high prices that patent monopolies bring to medical products. This week, members are considering a watered-down resolution to analyse the issue for 3 more years.

The World Health Assembly is taking place from 20-28 May. The resolution (A66/23) on the work of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) will be taken up as soon as later today (24 May).

‘Fire in the Blood’

On 21 May, alongside the WHA, the Médecins Sans Frontières Access Campaign (MSF Access) sponsored a screening of ‘Fire in the Blood’, a documentary whose subject matter was the issue of access to antiretroviral (ARV) therapy drugs during the HIV/AIDS pandemic of the 1990s. There was also a panel discussion with the film’s director, Dylan Gray, James Love of Knowledge Ecology International (KEI), Mohga Kamal-Yanni of Oxfam, and Rohit Malpani, director of policy and analysis at MSF Access.

The goal of the event and documentary was to raise awareness of the access to medicines issue beyond public health circles. “The film is there to be a conversation starter, to engage general audiences to think about issue and all the different players involved … to help prevent a sequel,” said Gray. ‘Fire in the Blood’ tells the story of ARV pricing, access and availability, as well as the politics that influenced these matters.

Though many scenes from the film took place almost two decades ago, the film’s core issues are relevant today, perhaps more than ever. As explained in the film, the price of ARVs in South Africa and many other developing countries was successfully negotiated down to levels affordable to poor populations after tremendous efforts to bring in generic forms of AIDS drugs. However, Love said that regarding cancer treatments and technologies now, “we are kind of like 1999 as far as cancer is concerned,” and that the “scarcity of these medical technologies” is policy induced, having a particularly harsh impact in developing countries.

Two days before the draft resolution of CEWG report on research and development was to be addressed at the World Health Assembly, an agenda item at the heart of which is the issue of access to medicines, audiences and panellists alike were eager to discuss the implications of the draft resolution at this year’s WHA.

Love explained that there is a need to de-link the cost of R&D from the price of the drug. “You will never have universal access until you decide that tying the cost of R&D to the price of the drug has predictable, lethal consequences that are extremely unfair and unequally distributed throughout the world,” he said.

Love cautioned not to perpetuate a system of “apartheid of access to medical technologies,” saying that the CEWG is a small step but could be a “momentous” shift in policy to reconcile both access and innovation, so they are not seen as separate and conflicting objectives. He explained there is a need for a “system where universal access is part of the story … but not to give up on innovation either.”

Kamal-Yanni had tough words for industry regarding access and innovation, saying drug companies are blocking “anything that challenges the idea of intellectual property rights and the way of stimulating R&D.” In light of current talks at the World Trade Organization regarding an extension of the period of compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for least-developed countries (LDC), Kamal-Yanni also questioned the seemingly fixed nature of the TRIPS agreement by comparing it to the Quran as a document that cannot be changed. “TRIPS is not the Quran. Why can’t we change it?” he said.

When asked about the option of compulsory licences, Kamal-Yanni said such a course of action would not be feasible or sustainable for every disease in every country, and further, does not address the fundamental issue of R&D and monopoly prices.

Progress was a unifying message from the panellists, regarding access to medicines in general and the CEWG process in particular.

“We are disappointed with the lack of ambition in the draft resolution, but we also want the process to move forward,” said Malpani. “Member states should not lose an opportunity this week to provide greater clarity and detail to the draft resolution, especially with respect to the pilot projects and the proposed observatory.”

He also mentioned the four draft working papers published by WHO’s Public Health Innovation and Intellectual Property department that potentially “set out a clear process going forward” for the draft resolution but “will require feedback and engagement by member states.”

These papers describe in greater detail the main elements of the CEWG report or the global health R&D observatory, coordination and priority-setting in developing countries, financing mechanisms for health R&D, and the health R&D demonstration projects.

Links to WHO working papers [all pdf]:
Global observatory
Coordination
Financing mechanisms
Demonstration projects

Love emphasized the need to “come up with something different” in order to have innovation but not at the expense of access. “We need to change the system, break the system, engage,” he said. “We hope this debate moves forward from here.”

Urging Governments to Do the Right Thing

At a press briefing held for UN journalists on 23 May, Kathy Athersuch of MSF said, “We are very concerned,” and called the situation “very frustrating.” There have been no new antibiotics since the early 1980s and the pipeline is dry, she said. Current medicines are difficult to use and have “horrific” side effects.

“It is unacceptable to us that the research pharmaceutical community is not doing better,” Athersuch said. WHO has been trying to address this for years, and yet, “still here in 2013 member states are trying to come up with something piecemeal.” The further delay of years indicated in the current draft resolution is “unacceptable,” she said, adding the hope that “member states will wake up to the fact that this conversation cannot be delayed” as patients cannot wait.

Love pointed out in the briefing that the conversation has been going on for some 10 years. He distinguished two issues: gaps in research on diseases from which people in poor countries suffer, and tying the price of drugs to the high cost of R&D. He said the concept of de-linking those two issues is “threatening” to companies.

Love said it may not be coincidence that the proposed delay to 2016 for the CEWG work coincides with the end of WHO Director General Margaret Chan’s term of office. A senior WHO official denied any link between these but declined to discuss it further.

He also said that the Gates Foundation, which has become a top donor of the WHO along with the United States government, has aligned itself with the drug companies on these issues. A Gates Foundation official could not be found to comment.

Ultimately, he said, “You will never have universal access to medicines as long as you don’t have delinkage.” Instead of having the states regulate the drug companies, it has been the other way around, he added. Love’s suggestion is to pursue other models such as a pool to fund R&D that would still reward the companies, just not by high prices.

Brittany Ngo is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues. She is a summer intern at Intellectual Property Watch.