[Ip-health] UAEMers, Jim Kim in the Chronicle of Higher Education on Uni Role in Global Access to Medicines

[Ethan Guillen]

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Two very dedicated members of Universities Allied for Essential Medicines
(www.essentialmedicine.org) and Jim Kim teamed up to write this commentary
in the Chronicle of Higher Education on the role of universities in global
access to medicines.

Ethan
Executive Director
Universities Allied for Essential Medicines
955 Massachusetts Ave, #110
Cambridge, MA 02139
T: 775-287-2553

http://chronicle.com/weekly/v54/i24/24a03201.htm

>From the issue dated February 22, 2008POINT OF VIEW
Universities Have a Key Role in Global Access to Medicines
By RAJESH PANJABI, RAHUL RAJKUMAR, and JIM YONG KIM

Around the world, the fight for affordable medical treatment is
intensifying. Headline-grabbing battles are being waged in India, where the
Chennai High Court recently decided a major constitutional case over access
to lifesaving cancer medication. In Thailand, Abbott Laboratories, a
multinational pharmaceutical giant, has withdrawn registration of all its
new medicines as leverage in a prolonged battle with the government over
drug prices and patent recognition.

Huge pharmaceutical companies and foreign governments, however, are not the
only players in the struggle for affordable treatment =8B universities, too=
,
are at the heart of it. Universities play a critical role in medical
innovation and must start using their clout to help make lifesaving
medicines more affordable to poor countries. After all, universities are
heavily involved in the research and development of many of those
treatments.

In India, for example, the drug at the center of the lawsuit is Gleevec
(imatinib mesylate), a cancer treatment based on research by scientists at
the Oregon Health and Science University and the Dana-Farber Cancer
Institute. And in Thailand, at least one of the drugs that Abbott is
withholding, Zemplar (paricalcitol), is based on a patent licensed out of
the University of Wisconsin at Madison. These examples are no anomaly: In
2000 a study by Congress's Joint Economic Committee concluded that
university and publicly financed research helped develop 15 of the 21 drugs
considered by experts to have had the highest therapeutic impact.

In 2006 Universities Allied for Essential Medicines, a student organization
with chapters at nearly 40 universities, issued a statement calling for
universities to "promote equal access to research, promote research and
development for neglected diseases, and measure research success according
to impact on human welfare." That document, called the Philadelphia
Consensus Statement (http://www.essentialmedicine.org/cs), was signed by
thousands of students and by scientists, prominent public-health officials,
and several Nobel laureates.

One of the central recommendations of the statement was that universities
adopt humanitarian licensing policies to ensure low-cost access to drugs
developed at universities. In key instances, universities hold patent right=
s
in the innovations discovered in their labs. In addition to the examples
mentioned above, universities hold U.S. patent rights in other critical
cancer drugs, an anemia treatment, and AIDS medicines. Perhaps the most
widely discussed new drug of the past year, the new cervical-cancer vaccine=
,
is based on intellectual property held by Georgetown University.

When universities hold patents, their licensing decisions determine whether
the fruits of their research will be accessible in poor nations.
Universities, dedicated to the creation and dissemination of knowledge in
the public interest, thus have a crucial and obvious role in promoting
innovation and access to health-related technologies. What is a more vital
component of the public interest than global public health?

Last year, 13 prominent research universities, the American Association of
Medical Colleges, and the Association of University Technology Managers
committed to principles that may make their medical breakthroughs more
available in poor countries (The Chronicle,
<http://chronicle.com.libproxy.lib.unc.edu/daily/2007/03/2007030705n.htm>
March 7). Their pledge publicly recognizes for the first time that
"universities should strive to construct licensing arrangements in ways tha=
t
ensure that =8A underprivileged populations have low- or no-cost access to
adequate quantities of [university-developed] medical innovations."

Although their groundbreaking statement is laudable, the group's
recommendations failed to offer specifics on how universities might build
such provisions into their licensing agreements =8B despite making
recommendations on a number of other issues. Universities should commit to
more than principle; they should commit to concrete licensing terms in
exclusive technology-transfer agreements. And this is where they have so fa=
r
failed to act.

Universities Allied for Essential Medicines has offered one set of model
licensing terms of its own: the equitable-access license, which is one way
of structuring a licensing agreement to ensure that drugs developed in
campus laboratories are made available in poor countries. These licensing
terms use a particular legal mechanism =8B so-called grant-back provisions =
=8B
to empower all generic manufacturers to cheaply supply university-developed
drugs to low- and middle-income countries. Competition would keep prices
low.

But Universities Allied for Essential Medicines has also sought to work wit=
h
universities that might prefer other ways of structuring such licenses, for
the underlying goal =8B a concrete, transparent, and effective mechanism fo=
r
access at the lowest possible cost in impoverished countries =8B is more
important than any particular set of terms.

The danger of missed opportunities is clearly illustrated by a 2005
licensing deal that Emory University struck with Gilead Sciences and Royalt=
y
Pharma. The university sold its royalty stake in anti-AIDS medicines,
Emtriva (emtricitabine) and Truvada (emtricitabine and tenofovir), for an
upfront fee of $525-million. At first glance, the deal seemed like a boon
for Emory, which no doubt benefited from such a generous infusion of
unrestricted funds. The half-billion-dollar price the drugs fetched suggest=
s
that Emory had a great deal of bargaining power in the negotiations and
probably could have insisted on humanitarian licensing terms and still
gotten a huge payoff. By failing to do so, the institution neglected its
central mission as a world-class research institution: to develop and
disseminate knowledge for the public good.

The Emory-Gilead story drives home the need for universities, when measurin=
g
technology-transfer "success," to stay consistent with their core mission.
What you measure matters, and most universities measure success purely in
financial terms. For example, the Association of University Technology
Managers' annual report on the success of university technology transfer
focuses almost exclusively on traditional indicators, including revenue
generation, the number of patents filed, and the number of licenses
executed.

Instead, technology-transfer officers must measure success not only in term=
s
of revenue, but also by impact on global human welfare. As institutional
mission statements reflect, that is what it means to be a great research
university. Such "access metrics" might consider whether the deal is
transparent, ensures access to university innovations in poor countries, or
facilitates research on treatments for neglected diseases. This simple
change would encourage universities to act in the public interest.

Pharmaceutical companies will no doubt resist when universities adopt
humanitarian terms in their licensing deals. But their most commonly cited
reasons =8B the risk of illegal rerouting of cheaper medicines to wealthier
countries and the dampening of incentives for innovation =8B are weak.
Although some pharmaceutical companies express concern about cheaper generi=
c
products overcoming regulatory barriers and entering high-income markets
illegally, there is no empirical evidence of any substantial flows of
medicine from poorer countries to high-income countries. Moreover, companie=
s
can easily alleviate any such concerns in the same manner that the World
Trade Organization has: by requiring use of different packaging, pill color=
,
and shape in different countries to help identify illegal imports.

Pharmaceutical companies (as well as universities) may also question whethe=
r
humanitarian licensing terms like those we propose would be financially
viable. In fact, humanitarian licensing terms would encourage the
introduction of reduced-price drugs only into markets too poor to afford
them otherwise. Brand-name pharmaceuticals garner minimal profits in
impoverished countries: The entire continent of Africa accounts for less
than 1 percent of all pharmaceutical revenue. In fact, humanitarian
licensing terms could mean that a university and its private-sector partner=
s
could actually reap royalties by distributing drugs in markets that would
otherwise be neglected.

It is past time for higher education to claim moral leadership for the
biomedical enterprise. We live in an era when decades elapse before advance=
s
discovered in the academic laboratories of rich countries reach the world's
destitute sick. Our universities must act collectively and definitively to
expand global access to medicines.

Rajesh Panjabi is an M.D. candidate at the University of North Carolina at
Chapel Hill School of Medicine; Rahul Rajkumar is a physician at Brigham an=
d
Women's Hospital; and Jim Yong Kim is chief of the division of social
medicine and health inequalities at Brigham and Women's Hospital, chair of
the department of social medicine at Harvard Medical School, and director o=
f
the Francois-Xavier Bagnoud Center for Health and Human Rights at Harvard
School of Public Health. Michael Steffen and Robynn Sturm, executive
directors of Universities Allied for Essential Medicines, contributed to
this article.
http://chronicle.com <http://chronicle.com/>
Section: Commentary
Volume 54, Issue 24, Page A32



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