[Ip-health] JAMA: Leveraging University Research to Advance Global Health
Ethan Guillen
ethan.guillen@essentialmedicine.org
Wed Oct 24 10:08:19 2007
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Hello All,
JAMA this week published an article written by two UAEM members which
expands upon the policy proposals of the Philadelphia Consensus Statement.
A link to our press release is here: http://www.essentialmedicine.org/155/
Best,
Ethan
http://jama.ama-assn.org/cgi/content/full/298/16/1934
Leveraging University Research to Advance Global Health
Dave A. Chokshi, MSc; Rahul Rajkumar, MD, JD
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#AUTHINFO>
JAMA. 2007;298:1934-1936.
The world's destitute sick face a perilous disadvantage in accessing
essential medicines. The crisis stems from 2 related problems. First, for
the billion people affected by neglected diseases such as trypanosomiasis
and cholera, few safe and effective treatment options exist. Because these
neglected diseases predominantly affect the poor, they attract little
research and development funding, leading to a paucity of therapies.1
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-1>
Second, for other diseases, several interlinked factors impede access to
medicines that do exist: high prices, underfunded and uncoordinated health
care systems, and drug formulations ill-suited to resource-poor settings.
Generic competition has lowered the price of antiretroviral therapy for
human immunodeficiency virus (HIV) from more than $15 000 per patient-year =
6
years ago to $99 today. 2
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-2>
Concomitant with this decrease in prices has been an increase in funding an=
d
political will to address the HIV/AIDS pandemic. This has shifted the debat=
e
from whether antiretroviral therapy is possible in resource-poor settings t=
o
how to strengthen health infrastructure to provide comprehensive care.3
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-3>
Despite the progress demonstrated for antiretroviral therapy in poor
countries, there is, as yet, neither a comprehensive nor a lasting solution
to ensure that patients in poor countries pay less for medicines than
patients in rich countries. Even antiretrovirals, generally heralded as a
success story for differential pricing, show the evanescence of any progres=
s
that has been made. Implementing new first-line HIV treatment guidelines
from the World Health Organization would cost 5 times more per patient-year
than the older, first-line treatment regimen; second-line therapies are
even more expensive.2
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-2>
Meanwhile, major generic-producing countries like India must now enforce
product patents to comply with the World Trade Organization's Trade-Relate=
d
Aspects of Intellectual Property Rights (TRIPS) agreement. 4
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-4> The
US government is pushing further still for expanded intellectual property
protection by systematically negotiating so-called TRIPS-plus provisions
into bilateral free-trade agreements. 5
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-5>
Taken together, these developments threaten to undermine gains for the
health of the underserved that have been made by reforms to the
international intellectual property system.
The Role of Universities
Research universities have an opportunity to intervene in the
access-to-medicines crisis in poor countries. By virtue of their upstream
contribution to the drug development pipeline=8Bestimated at $19.6 billion =
in
2002 for the United States alone=8Buniversities have considerable untapped
influence. 6
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-6> Bot=
h
the number of patents held and the number of license agreements executed by
universities more than doubled between 1991 and 2005. 7
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-7> The
case for university action becomes more tangible when considering actual
medicines. For instance, the patent rights contributing to several currentl=
y
marketed HIV drugs are held by universities: stavudine (Yale University),
abacavir (University of Minnesota), lamivudine (Emory University),
emtricitabine (Emory University), and enfuvirtide (Duke University).
Overall, university patents are associated with 10 of the 30 HIV drugs
approved by the US Food and Drug Administration between 1987 and 2007. 8
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-8>
Several institutions=8Bboth private and public=8Bhave demonstrated that it =
is
possible to leverage ownership of intellectual property to improve access t=
o
medicines. For example, in 2001, Yale University negotiated price
concessions from Bristol-Myers Squibb for stavudine in South Africa. 9
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-9>
Similarly, the Bill and Melinda Gates Foundation, through its Grand
Challenges in Global Health initiative, requires grantees to ensure that an=
y
health products created with Grand Challenges funds will be available at
affordable prices in poor countries.10
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-10> Th=
e
grants call for principal investigators to outline ex ante intellectual
property ownership issues, licensing strategies, and potential commercial
partners. The US National Institutes of Health (NIH) has also pioneered
proactive management of its intellectual property to benefit the developin=
g
world. For technologies with a worldwide market (such as new
antiretrovirals), the NIH has adopted license terms that require companies
in North America or Europe to provide a marketing plan for making products
available in developing countries.11
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-11>
Public-sector research and licensing practices have implications extending
beyond HIV medicines. Of the 35 million deaths from chronic disease that
occurred in 2005, 80% occurred in low- and middle-income countries.12
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-12>
Expanding access to primary care treatments for chronic illnesses like
diabetes and cardiovascular disease could have an immediate effect, both
for patients and for the structure of limited or unstable health care
systems. Vaccine-preventable diseases also exemplify the magnitude of the
opportunity. Human papillomavirus vaccine was originally developed at the
University of Rochester, Georgetown University, Queensland University, and
the US National Cancer Institute. Research on rotavirus vaccine was
originally conducted at the Wistar Institute and the Children's Hospital of
Philadelphia. Both of these vaccines were recently licensed for use in the
industrialized world without a clear strategy for access to the vaccines in
poor countries, where the vast majority of deaths due to cervical cancer an=
d
diarrhea occur.
Ensuring access to university-derived medicines in poor countries would hav=
e
a demonstrable effect on global health only if pro-access policies are
adopted collectively by major research universities. An important step
toward consensus was taken recently when the Association of American Medica=
l
Colleges (AAMC) and 18 research institutions called for ensuring access to
university innovations in the developing world.13
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-13> Th=
e
AAMC and collaborating universities joined committees of the World Health
Organization 14
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-14> an=
d
the American Association of Arts and Sciences 15
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-15>
that previously espoused this same principle. What follows are policy
recommendations for operationalizing that principle.
Promoting Equal Access to Research
When university-owned intellectual property is necessary for the developmen=
t
of a potential health-related product such as a drug, a vaccine, or a
diagnostic test, universities could either require the inclusion of
licensing terms in exclusive technology transfer agreements that ensure
low-cost access to health-related innovations in the developing world; or
develop a transparent, case-by-case global access strategy to ensure access
when licensing provisions will not serve access objectives.
The licensing transaction between a university, and, for example, a
biotechnology company represents an important point of leverage for access
considerations. A critical lesson learned from the first round of price
reductions for antiretroviral agents was that generic competition is the
most effective mechanism for lowering prices. 4
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-4> An
effective licensing policy would engender such generic competition. One
example of this type of policy is the equitable access license (EAL),
developed by Universities Allied for Essential Medicines. The EAL is a
nonexclusive, open licensing arrangement that provides a means to capture
any downstream licensee improvements for the purpose of supplying
developing-country markets. 16
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-16> -17
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-17> Th=
e
EAL applies to countries classified as low- or middle-income by the World
Bank and permits multiple producers to compete in these countries simply b=
y
notifying the university and its licensee.
An advantage of the EAL is that, by relying on the market for generic
production, the administrative burden on the university is minimized.
However, this parsimony may not be well-suited to certain situations. For
example, biologics (eg, vaccines and macromolecules such as monoclonal
antibodies) and medical devices are subject to different scientific and
technical constraints than are synthetic small molecules (eg,
antiretrovirals such as stavudine) and may require different methods to
ensure access. Universities ought to implement open licensing solutions lik=
e
the EAL where possible but could pursue alternative global access strategie=
s
for predefined situations in which open licensing may not be the best
solution. While intellectual property ownership is an important and
tangible point of influence, it is not the only leverage available to publi=
c
institutions such as universities.
The term "global access strategy" derives directly from the Gates
Foundation's guidance on intellectual property management for the Grand
Challenges in Global Health.10
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-10>
Among other provisions, the guidance requires that the grantee's
intellectual property revert to the Gates Foundation if the patented
innovation is found to be inaccessible in poor countries. The purpose of th=
e
global access strategy, however, is to prevent this situation from arising
in the first place by negotiating in advance a feasible plan to ensure
access to innovations where they are needed most. Potential components of a
global access strategy include: (1) stipulations for voluntary licenses to
generic manufacturers and mandatory sublicensing requirements to alternativ=
e
manufacturers when access objectives are not being met; (2) clauses
requiring the licensee to make products developed from a university
innovation available at a reduced cost in developing countries; (3) activel=
y
seeking third-party organizations to participate in development and
distribution for the developing-world market; and (4) participating in
patent pools (ie, joining with other institutions and companies to
cross-license patents) that are organized in the interest of public
health.15
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-15>
Promoting Research and Development for Neglected Diseases
Neglected diseases are those for which treatment options are inadequate or
do not exist and for which drug-market potential is insufficient to attract
a private-sector response. To promote research and development in treatment=
s
for neglected diseases, universities could adopt needs-based medical
research policies, such as promoting in-house neglected-disease research;
engaging with nontraditional partners to create new opportunities for
neglected-disease drug development; and carving out a neglected-disease
research exemption for any patents held or licenses executed.
Internally, university decision makers setting the research agenda could
purposefully include work on neglected diseases in their deliberations.
While funding sources and faculty interests govern the research agenda to
some degree, steps can be taken to cultivate neglected-disease research.
Capital investments by universities such as the $30 million committed to
found the Duke Global Health Institute=8Ban interdisciplinary initiative
combining education, research, and service missions=8Bare too few and far
between. 18
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-18>
Even simple structural changes, such as the creation of a Center for
Neglected Diseases, and marketing of neglected-disease research capacity ca=
n
help attract talented researchers and new sources of funding, as seen in th=
e
cases of the George Washington University and the University of California
at Berkeley.19
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-19> -20
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-20> On=
e
way that all universities could start is by formalizing annual review
practices aimed at identifying new or currently shelved technologies with
promising potential for application to neglected diseases.
University policy makers might also take note of the external developments
that have changed the landscape of neglected-disease drug development.
Product-development partnerships like the Medicines for Malaria Venture an=
d
the Drugs for Neglected Diseases Initiative have attracted hundreds of
millions of dollars in funding, the majority of which is contributed by the
Gates Foundation. 21
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-21>
Universities could actively seek privately funded but targeted
partnerships=8Bas well as partnerships with developing-country companies a=
nd
research institutions=8Bto develop technologies applicable to neglected
diseases.
In addition, when patented innovations have not yet been licensed for
further development, universities could allow, as a matter of policy, other
nonprofit institutions to use them in research for neglected diseases. One
way to operationalize this research freedom could be to contribute to a
comprehensive molecular screening library for neglected diseases. 22
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-22>
When innovations have been externally licensed, universities could include
an exemption for neglected-disease research in their licensing agreements.
These agreements can be structured as a "dual-market" opportunity,
permitting the universities to partner with companies for markets in
industrialized countries while a nonprofit entity retains the rights to
develop the compounds for patients in developing countries.23
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-23>
Measuring Research Success According to Effect on Global Public Health
University technology transfer operations are usually evaluated using
simple, quantifiable criteria such as patents applied for and received,
licenses granted, and licensing revenue generated. The focus on these types
of statistics may partly explain why technology transfer objectives are
often misaligned with the broader public mission of universities. 24
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-24> Ye=
t
perhaps surprisingly, licensing revenue from academic research is, in the
majority of cases, not a lucrative investment. For example, among US
institutions, the ratio of licensing income to sponsored research funding
was reported to be 5% or less in 2005. 25
<http://jama.ama-assn.org/cgi/content/full/298/16/1934#REF-JCO70068-25>
Thus, the positive social effect of university innovations=8Bparticularly i=
n
poor countries=8Bwould go largely unnoticed if the success of technology
transfer were measured in dollars alone. To rectify this situation,
universities could collect and report data on university intellectual
property practices related to global health access. Furthermore,
universities could collaborate to develop more robust technology transfer
metrics that better gauge access to public health goods and innovation in
neglected-disease research.
Even though perfectly sound technology transfer metrics may not yet exist,
universities can make the nonmonetary benefits of technologies for global
health more transparent. For example, universities could disclose all
health care=ADrelated products in which they hold intellectual property
rights. Universities could also publish information on patents applied for
or granted in all developing countries, the number and nature of licensing
agreements that include access-minded provisions, and reports of
nontraditional partnerships for neglected-disease research and development=
.
University mission statements typically include the noble idea of creating
and disseminating knowledge in the public interest. Holding universities to
these standards is a critical means to fulfilling an even loftier
principle, codified in the Universal Declaration of Human Rights: providing
access to medical care and treatment as a basic human right.
AUTHOR INFORMATION
Corresponding Author: Dave A. Chokshi, MSc, University of Pennsylvania
School of Medicine, 3434 Sansom St, Floor 2, Philadelphia, PA 19104 (
daveash@med.upenn.edu <mailto:daveash@med.upenn.edu> ).
Financial Disclosures: None reported.
Funding/Support: Universities Allied for Essential Medicines is funded by
the Ford Foundation, Rockefeller Foundation, Oxfam America, and the Moriah
Fund.
Role of the Sponsors: Ford Foundation, Rockefeller Foundation, Oxfam
America, and the Moriah Fund did not have any involvement in the research o=
r
writing of this article.
Additional Contributions: We are indebted to the nonprofit organization
Universities Allied for Essential Medicines for its work on the Philadelphi=
a
Consensus Statement on University Policies for Health-Related Innovations
(http://consensus.essentialmedicine.org
<http://consensus.essentialmedicine.org/> ). Mr Chokshi wrote the initial
draft of the Philadelphia Consensus Statement and helped organize
subsequent revisions as a member of Universities Allied for Essential
Medicines. We thank Howard Hiatt, MD, of Harvard Medical School for his
thoughtful insights during the preparation of this article. Dr Hiatt
received no compensation for his contribution.
Author Affiliations: University of Pennsylvania School of Medicine,
Philadelphia (Mr Chokshi); and Department of Medicine, Brigham and Women's
Hospital, Boston, Massachusetts (Dr Rajkumar).
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