IOM aiding US government attempts to quash R&D Treaty, undermine access to medicines in developing countries

The Institute of Medicine (IOM), the health arm of the US National Academy of Sciences, appears to have worked with the US government to undermine efforts to establish an international R&D treaty to address health needs of developing countries.

In an email dated September 26, 2012, members of the IOM’s Global Health Interest Group were contacted by a representative of the IOM leadership to relay the opposition of the US government to the proposed treaty. They were also requested to help support this position before the 2013 January WHO Executive Board (EB).

The conclusions of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which included a strong recommendation for an international binding convention for “providing effective financing and coordination mechanisms to promote R&D”, (see http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.100121) have been subject to extensive deliberations by WHO Member States.

Dedicated open-ended consultations on the CEWG report were convened from 26-28 November 2012 where the issue of an R&D treaty was a focal point of negotiations. The resolution that emerged from these discussions omitted mention of a treaty and gave less ambitiously directions to establish a Global Health R&D Observatory and run health ‘demonstration’ projects. This resolution was bitterly debated at the meeting of the Executive Board in January  During this period, the US staunchly blocked any movements towards a binding agreement. For more background see here and here.

The IOM email from September 2012 describes a request from the Office of Global Health Affairs in the Department of Health and Human Services (HHS) at a time when it was preparing the official US government position on the CEWG recommendations. Noting that the recommendations of the working group had “generated reservations on the part of the US and other governments”, the email spells out the request from HHS and the process through which interest group members could get involved in the ‘fast track effort’:

HHS was hoping that an independent body such as the IOM could suggest
alternative ideas for consideration at the WHO.  Given that these
ideas need to be developed before the WHO Executive Board meeting in
January, there is insufficient time (and insufficient money) to employ
the usual IOM consensus committee study process.  Individual IOM
members and non-IOM member colleagues can provide independent views
though through a relatively new, low cost and lower key “discussion
paper” mechanism we have implemented at the IOM.  This would involve
one or more interested parties writing between mid-October and
mid-December several “white papers” that would be published on the IOM
website under our Perspectives banner.  If you are unfamiliar with the
IOM Perspectives format, there are now many posted on the IOM website
at: http://www.iom.edu/Global/Perspectives.aspx.

After further laying out the project guidelines developed  with HHS, the email concludes with this statement:

“The IOM is committed to being of service to the country and this is one of those times when we can pull together and make a special contribution.”

See the full email at the bottom of this post.

Indeed it appears that the IOM’s urgent appeal for supporting the HHS request was answered,  judging from the publication of the discussion paper “Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute R&D to Meet Health Needs in Developing Countries” by Peter Hotez, Rachel Cohen, Carol Mimura, Tadataka Yamada, and Stephen L. Hoffman, on January 16, 2013 just a few days prior to the WHO Executive Board.

In keeping with the IOM/HHS instructions, the report focuses on financing global health R&D; expresses doubts regarding the need for and feasibility of the most transformative recommendations of the CEWG in relation to a binding instrument and setting financial obligations; and highlights alternative or weaker approaches to priority setting, coordination and financing R&D.

On the subject of an R&D treaty, the paper states that not all of the co-authors were in agreement but fails to present any of the alternate viewpoints. The discussion from the report follows:

Based on information provided by representatives from the USG (the Department of Health and Human Service [HHS] and the National Institutes of Health [NIH]), we also recognize that the USG might disagree with some elements of the CEWG report. Some, but not all, of the co-authors of this discussion paper agreed with HHS and NIH in their assessment. Specifically,

  • It might not be appropriate or feasible to set a percentage of GDP as a financing goal. Financing programs work best when they begin with a rigorous, result-based framework that sets clear expectations, rather than simply starting with a financial goal. Moreover, it is not at all clear that 0.01 percent of GDP would provide appropriate funding after 10 years or decades into the future, particularly since the mix of low-, middle- and high-income countries is already evolving dynamically, with many lower- and middle-income countries moving into higher categories. LMIC research needs and incentives are likely to change significantly in the next generation. Finally, financing goals around health R&D needs for LMICs should be time-limited, reviewed periodically, and made on a voluntary basis.
  • It is doubtful that the USG is prepared to initiate negotiations for a binding international instrument on R&D. Treaty negotiation is both lengthy and expensive, and formal negotiations would consume policy makers and draw the resources of national governments and WHO away from steps that could be taken immediately. Moreover, enforcement mechanisms are difficult and might not avert a “free-rider” problem—most of the signatory states are currently not even close to approaching a soft norm.
  • Most of the estimated $1.4 billion in neglected disease R&D funds is managed through the National Institute of Allergy and Infectious Diseases (NIAID) at NIH. It seems unlikely that 20 to 50 percent of these funds could be ceded to an international funding pool or multilateral organization (as proposed in the CEWG report)—although a proportion of funds designated for specific diseases, such as NTDs, from the U.S. Agency for International Development (USAID) and other sources potentially could be committed for this purpose.
  • Overall, it is unlikely that the USG would be able to maintain its current level of investment if the funds and responsibility for their use were not connected to the organization or budget accountable for the request and results specified.

We emphasize that there was not consensus among the co-authors of this document about the statements above.

The email from IOM leadership to members of the IOM Global Health Interest Group follows:

From: [redacted]
Subject: Some news from the Board on Global Health about a special project
Date: September 26, 2012

Dear Members of the IOM Global Health Interest Group:

I am writing to inform the interest group of a fast track project that
would benefit from the involvement of interest group members.  Over
the last several weeks I have corresponded with several of you about
this recent request from the HHS Office of Global Health Affairs.
Given that the enthusiasm has been great and the need for diverse
talented advice rather acute, I want to give each of you the
opportunity to “throw your hat in the ring” for helping with some
aspect of this effort.

The HHS Office of Global Health Affairs is preparing the US government
response to the WHO Expert Working Group on Research and Development:
Coordination and Financing (CEWG).  The recommendations from this
working group, as enumerated in the attachment, have generated
reservations on the part of the US and other governments.  The CEWG
recognized that funding to meet R&D requirements for the prevention,
control, and treatment of diseases of developing countries is
insufficient.  The CEWG report states the following as conclusions:

“All countries should commit to spend at least 0.01% of GDP on government-funded R&D devoted to meeting the health needs of developing countries in relation to the types of R&D defined in our mandate.

 In addition we propose that countries should consider these targets:

 Developing countries with a potential research capacity should aim to commit 0.05-0.1% of GDP to government-funded health research of all kinds

 Developed countries should aim to commit 0.15-0.2% of GDP to government funded health research of all kinds.”

 The CEWG called for a binding treaty to mobilize these funds. Though it appears that the US does quite well against the global health research R&D targets, the US government is not supportive of a binding treaty for a number of reasons to include the length of time needed to negotiate such an agreement, the difficulty enforcing such a treaty, and the fact that treaties are best for agreements with terms that logically should be relatively fixed for years.  The US government sees the R&D enterprise as needing a type of dynamic management that is not well-suited to the treaty mechanism.  There is also some feeling that the 0.01% financing goal is not well-grounded in a bottom-up goal-oriented R&D strategic plan.

 HHS was hoping that an independent body such as the IOM could suggest alternative ideas for consideration at the WHO.  Given that these ideas need to be developed before the WHO Executive Board meeting in January, there is insufficient time (and insufficient money) to employ the usual IOM consensus committee study process.  Individual IOM members and non-IOM member colleagues can provide independent views though through a relatively new, low cost and lower key “discussion paper” mechanism we have implemented at the IOM.  This would involve one or more interested parties writing between mid-October and mid-December several “white papers” that would be published on the IOM website under our Perspectives banner.  If you are unfamiliar with the IOM Perspectives format, there are now many posted on the IOM website at:  http://www.iom.edu/Global/Perspectives.aspx.

Below is the statement of task worked out with HHS to guide this effort.

“The HHS Office of Global Health requests that the IOM Board on Global
Health to plan a half-day meeting on “Strengthening the Mechanisms to
Plan, Coordinate, Finance, and Execute Research and Development to
Meet Health Needs in Developing Countries.” To plan the meeting, an
ad hoc committee of approximately six US and foreign experts would
meet electronically during the month of October 2012.   The planners
will include individuals with public and private sector expertise in
the milestone-based planning and management of medical research
programs across the continuum from basic science to implementation.
They should also include persons with broad global health experience,
experience in innovative financing of the global health enterprise,
and experience in international health leadership.

The planning group will develop a framework for the workshop that will
foster discussion of about four key issues relevant to planning,
coordinating, financing, and executing research and development to
meet the needs of developing countries.  These issues could include
approaches to research priority setting, an enumeration of leading
gaps in global health R&D, R&D planning and costing, the private
sector role in global health R&D, the creation of effective global
health research networks, the building of R&D capacity in developing
countries, innovations in financing the global health R&D enterprise,
and principles of global health R&D management.

The planning group will identify and recruit individuals or small
groups of individuals to prepare IOM-published Perspectives white
papers on the chosen topics to serve as a starting point for the
workshop.  It is understood that Perspectives are not reports of the
IOM or the National Research Council and therefore are not subject to
their review processes. They reflect the observations and opinions of
the authors who are recognized as leading experts.  Four to five
Perspectives papers will be discussed in preliminary form at the
workshop with minor revisions by the authors to follow.  Acceptable
final versions will be posted on the IOM website and printed for hard
copy distribution.

The meeting will be held at the US National Academies with local
participants physically present and some presenters and others
participating through a suitable electronic media such as webinar or
audio/video conferencing technologies.  Other than the Perspectives
papers and an informal staff-written summary of the meeting, there
will be no formal written products.  The above work will take place
over a four month period of performance.  The workshop will place
approximately three months after project initiation (before the end of
calendar year 2012) and the final Perspectives electronic papers
posted no more than a month later.”

 I will be working with my Board on Global Health colleague, [redacted], to orchestrate this fast track effort.  We are forming a roughly six person planning committee to help to further frame this series of papers. The plan will be discussed at the Board on Global Health meeting on Wednesday, October 17th.   We will need to help to recruit author teams for the five or so papers.   As you can see from the statement of task, these teams would likely need to include thought leaders in burden of disease, research management and coordination, research financing, research networks, research capacity-building, etc. The leaders could be supplemented by junior faculty and graduate students.  This would be a great opportunity to contribute in a very visible way to key discussions at WHO.

 Beyond planners of the paper series and writers for the writing teams, we will need volunteer reviewers.  So, please let [redacted] and me know of your thoughts. The IOM is committed to being of service to the country and this is one of those times when we can pull together and make a special contribution.

 All the best,

[redacted]

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This entry was posted in access to medicines, Institute of Medicine, R&D, WHO and tagged . Bookmark the permalink.

One Response to IOM aiding US government attempts to quash R&D Treaty, undermine access to medicines in developing countries

  1. Pingback: How Drug Companies Keep Medicine Out of Reach | Don't trade our lives away

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