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Appendix F
Commissioned PaPer
Sharing Knowledge for Global Health
Anthony D. So, MD, MPA, and Evan Stewart, BA*
The U.S. Commitment to Global Health identifies technological innovation
and diffusion as the main drivers for improving health for all people by reducing
avoidable disease, disabilities, and deaths. The sharing of knowledge is central
to that vision, but involves far more than making a journal article open access,
posting a database publicly to the web, or licensing a technology. These are all
important building blocks to transferring technology effectively.
Sharing, as opposed to transferring, implies a two-way street. This is not
to say that such exchanges are not asymmetric. Such exchanges slope along the
steep gradients of disparities that separate industrialized and developing coun -
tries. Though only one-fifth of the world’s population, the developed world is
home to over two-thirds of the world’s researchers, commands three-quarters of
the gross expenditure on R&D, and originates over ninety percent of the patents
granted by the patent offices in Europe, the United States, and Japan. The United
States alone generates nearly twice the number of scientific publications (32.7%
of the world total) than the whole of the developing world (17.3%). 1
These asymmetries, of course, run in the other direction when examining
*Anthony D. So, MD, MPA, is with the Program on Global Health and Technology Access and the
Center for Strategic Philanthropy and Civil Society, Terry Sanford Institute of Public Policy, Duke
University and the Duke Global Health Institute, Durham, North Carolina. Evan Stewart, BA, is with
the Program on Global Health and Technology Access, Terry Sanford Institute of Public Policy, Duke
University, Durham, North Carolina.
This paper is made available as an open-access document distributed under the terms of the Cre -
ative Commons Attribution License, which permits unrestricted use, distribution, and reproduction
in any medium, provided the original authors and source are credited.
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THE U.S. COMMITMENT TO GLOBAL HEALTH
where the global burden of disease falls. Increasingly, biomedicine is turning
to the growing pools of talent in the developing world. The conduct of clinical
trials is burgeoning in the developing world—no doubt lured, in part, by reports
that a top-notch academic center in India charges a tenth per case report of what
a second-tier medical center in the United States would in mounting a clinical
trial.2 Pharmaceutical firms in the developing world may face different opportu -
nity costs than large multinational corporations, and this may lead to gap-filling
R&D investments, such as in more cost-effective processes for producing drugs.
Shin Poong, a Korean firm that significantly lowered the costs of producing
praziquantel, a drug to treat schistosomiasis, is a case in point. 3 Some of these
asymmetries are eroding away. From 2000 to 2006, the average annual growth
rate in the number of patent filings originating from countries such as China and
India outstripped that of all reported countries in Europe and North America. 4
But the vibrancy of the scientific enterprise is only captured, in part, by tradi-
tional measures of innovation. Scientists trained, publications, patent filings, and
revenues from health technologies highlight the disparities, but not the potential
of research collaboration. Combination drugs effective for treating malaria may
be produced by Northern pharmaceutical companies, but a core component is
artemisinin, a Chinese traditional medicine. Without the collaboration of research
centers in countries where SARS was endemic, the race to contain the threatening
pandemic would have been crippled. Without the wild virus samples of avian flu
from developing countries, steps to preparing a vaccine stockpile would slow.
The interdependency of global health is clear from such examples. But these
examples also underscore the importance of sharing knowledge for global health
and of shaping effectively the enabling environment for doing so.
What should be the focus of the U.S. commitment to global health—level-
ing the slope or ensuring the flow of knowledge on that two-way street? Perhaps
solutions need to address both. In a globalizing world, both knowledge and the
human resources capable of applying that knowledge flow readily across borders.
If the process of sharing knowledge only lures away the most talented to U.S.
research laboratories, would it only exacerbate the brain drain from developing
countries? If those from developing countries train here in the United States,
will they return to settings where they can apply those skills? If the governance
of product development partnerships represents the voices of donors but not
those they purport to serve in developing countries, will the fruits of their work
be effectively disseminated? As a recent study observed, U.S.-based companies
increasingly have sponsored clinical trials in developing countries, but of the cur-
rent Phase III clinical trials in these settings, not one in their sample focused on a
disease endemic largely in developing nations.5 Is it really ethical or sustainable
to mount clinical trials in developing countries that yield new treatments, but to
fail to make these therapies affordable or more targeted to the public health needs
of the populations in which they were tested?
Sharing knowledge in the context of the U.S. commitment to global health
often emphasizes the North-South axis of collaboration. From the vantage point
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APPENDIX F
of the United States, the potential for collaboration and capacity building to
improve global health is greatest along this axis. Of course, there are lessons
from years of North-North collaborations across countries that might cross-apply.
Not to overlook other axes though, South-South collaborations deserve particular
note. The INDEPTH Network consists of 34 demographic surveillance sites in
18 countries, all in the developing world.6 Facilitating cross-site studies of longi-
tudinal health and social studies in resource-limited settings, the network draws
support from a range of Northern donors, including private foundations such as
Gates, Rockefeller, the Wellcome Trust, and Hewlett; bilateral aid agencies such
as CIDA, DFID, and Sida; and government research agencies such as IDRC and
the U.S. National Institutes of Health (NIH). With its Secretariat based in Accra,
Ghana, the network’s governance remains largely in the hands of researchers
from developing countries. Partnerships though are welcomed with Northern
institutions, from product development partnerships such as the Malaria Vaccine
Initiative to universities such as the London School of Hygiene and Tropical
Medicine and the Swiss Tropical Institute.
The rise of modern medicine has introduced another important dimension of
knowledge sharing—the bidirectional exchange between industry and publicly
funded institutions such as universities and government laboratories. Dispropor-
tionate to the level of corporate funding, the norms governing this exchange have
reshaped the way universities share their inventions. Some have suggested that
the commercialization of university research has corrupted the mission of higher
education.7,8 Many of these concerns trace to the nature of the agreements struck
between universities and corporations. These contracts affect the publishing of
research, the sharing of data and research tools, and the licensing of patented
inventions. Corporations bring complementary expertise, an ability to scale up
products for delivery, and additional research resources. While such collabora -
tions may bring value to university research efforts, the conditions under which
they operate deserve greater scrutiny and transparency. Society has relied on the
academy to contribute to knowledge in the public domain, to maintain the inde -
pendence of inquiry with safeguards against conflict of interest, and to engage in
“blue-sky” research and high-risk experimentation.
The market has failed to deliver diagnostics, drugs, and vaccines that meet
the disproportionate burden of disease afflicting those in developing countries.
Public-private partnerships have emerged over the past decade to fill this gap.
Using public sector monies, product development partnerships have embarked
on drug discovery programs for neglected diseases. Half of these partnerships
involved multinational corporations that conducted these projects on a “no profit-
no loss” basis. Of note though, the other half of these projects were conducted
by small firms doing so on a commercial basis.9 The opportunity costs for these
smaller firms may be different. There can be an important North-South dimension
to these collaborations as well. A recent survey found that over half of private
sector firms in health biotechnology in developing countries had ongoing col -
laborations with partners in developed countries.10
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0 THE U.S. COMMITMENT TO GLOBAL HEALTH
STEPS TO SHARING KNOWLEDGE FOR GLOBAL HEALTH
Sharing knowledge for global health involves generating knowledge relevant
to the context of low- and middle-income countries, effectively transferring such
knowledge and technologies to these settings, and ensuring that its intended ben -
eficiaries can apply it on a sustained basis. Each of these steps presents its own
set of challenges, but also affords new opportunities.
Knowledge must either be relevant or adapted to the context of low- and
middle-income countries. Some of this knowledge will be relevant because the
health problems are shared ones between North and South. Often thought to be
diseases of affluence, noncommunicable diseases, in fact, comprise a growing
share and already account for nearly half of the burden of disease in developing
countries.11 Put in perspective, cardiovascular diseases, cancers, and diabetes
comprise 16% of the burden of disease in low- and middle-income countries. By
comparison, malaria is responsible for 4% of the disability-adjusted life years
lost in these countries.12
As the 10/90 gap suggests though, the investment in global health R&D does
not prioritize efforts focused on the burden of disease that disproportionately
afflicts those in low- and middle-income countries. With the paying market being
relatively small, some treatments rely on the spillovers from dual markets. The
availability of eflornithine, the “resurrection drug” for treating sleeping sickness,
has at times depended on its dual use as a treatment for the removal of facial
hair in women. For those engaged in biodefense research, substantive review
usually focuses on the dual use of such technologies for biodefense against
emerging infections as well as for potentially nefarious purposes.13 Some of
this research, including the platform technologies applied, might be evaluated
for a third use—humanitarian applications to neglected diseases in developing
countries. Not relying on the serendipity of finding incidental applications for
neglected diseases, government and philanthropic funders have also invested in
product development partnerships.
Sharing knowledge requires an enabling environment. The investment
required to transfer information is a measure of the “stickiness” of that informa -
tion.14 Stickiness is a function of the attributes of the information itself as well
as that of the information seekers and providers. Intellectual property rights
might make such knowledge costly to acquire while information technology has
changed the speed and marginal cost of disseminating knowledge. Sometimes the
skills are local to where that knowledge is being used. For example, laboratory
apprenticeships may afford the firsthand experience necessary for performing
certain procedures.
Several factors affect the sharing of knowledge: (1) the nature of the knowl-
edge to be shared; (2) the norms for scientific exchange; and (3) its role in the
innovation process. Today’s science has many ways of codifying knowledge, from
study methods described in journal articles to patents disclosed. Tacit knowledge,
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APPENDIX F
on the other hand, is not well codified. A technology new to developing country
firms—such as conjugation technology for vaccine production—may not easily
transfer without technical assistance. Norms over the ownership of knowledge
also influence the sharing of knowledge. These norms are rooted in statutes and
regulations such as the Bayh-Dole Act, prevailing practices among research
institutions, and guidance provided by funding agencies as well as competition
among scientists.
The sharing of knowledge matters most if innovation and scientific progress
are cumulative. By cumulative innovation, one might envision several types
of arrangements of research inputs and outputs (see Figure F-1).15 A single
innovation might spawn multiple, second-generation innovations. For example,
a receptor target might lead to several promising new drugs. Alternatively a
second-generation output might require the input of multiple first-generation
inputs. Some of these inputs may eventually be incorporated into the second-
generation product, but other needed inputs—research tools—will not be. Finally,
the process of innovation may be a quality ladder, where successively better
products build on the model of the previous one. Process innovations of drugs can
lower the marginal cost of production, extend its shelf life outside the cold chain,
or improve its bioavailability. Each pattern of cumulative innovation responds
differently to the ways in which knowledge is shared or inventions are licensed.
For example, a product patent on a drug effectively may block others who might
otherwise pursue process innovations in the manufacture of that drug.
Those who benefit from this sharing of knowledge must have the absorptive
capacity to apply and sustain its use. The transfer of technology depends on the
absorptive capacity of the setting where it would be used. Technology has both
hardware and software aspects. Hardware is the tool as embodied as a physical
object while software is the information base for the tool.16 The capital costs
for purchasing hardware may be out of reach, but so might be the maintenance
costs. Variable costs such as reagents for diagnostic tests can be prohibitively
expensive. The software side consists not just of the knowledge to use the tool,
but also may require the human resource expertise to apply it.
ACCESS TO THE BUILDING BLOCKS FOR RESEARCH
From bench to bedside, the value chain of R&D consists of inputs and out -
puts at every stage, each dependent on the sharing of knowledge. Three stages in
this value chain warrant closer scrutiny because decisions at these points signifi -
cantly shape what knowledge is shared within the scientific community. These
building blocks for research include access to scientific publications, the norms
for data and material sharing, and patenting and licensing practices. Character-
izing the obstacles and opportunities at each stage can help point the way to solu -
tion paths that lower the barriers to sharing knowledge and improve the scientific
community’s ability to respond to the challenges of global health.
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THE U.S. COMMITMENT TO GLOBAL HEALTH
Cumulative Innovation
Generation 1 Generation 2
A)
Tiering Pooling
B) C)
FIGURE F-1 A) Innovation may occur in several ways. One input may lead to a higher
quality output, with each generation of F-1.eps bringing a successively better product.
innovation
Alternatively, a single input may spawn several outputs, as one target receptor may lead
to several new drugs. Finally, several inputs may be required to produce one output;
these inputs may be innovations themselves or simply research tools (adapted from
Scotchmer, 2004).15 B) Tiering may segment the marketplace between a paying market
and a resource-limited one that may receive a discounted price or other preferential access.
C) Inputs may also be pooled, thereby reducing transaction costs to innovation and more
readily enabling socially useful bundles. Such pooling—particularly when strategically
done by the public and/or philanthropic sectors—may be structured to influence positively
the norms and the licensing by which other inputs are also made available for innovation.
Such an arrangement characterizes a technology trust.
Access to Scientific Publications
The challenges to sharing knowledge through scientific publication come
both from the supply and the demand side. On the supply side, studies suggest
that industry funding may not only occasionally introduce potential bias into the
conduct of research, but also possible delays in its publication. Of those respond -
ing to a survey of life science faculties at universities receiving the most NIH
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APPENDIX F
funding, nearly a third of the investigators that benefited from corporate research-
related gifts indicated that their industry sponsor wanted pre-publication review
of journal articles resulting from the gift.17 A majority of the contracts struck
between these scientists and life science companies also mandated a six-month
period of confidentiality to give time for patenting of resulting inventions.18 By
contrast, the NIH has provided guidance that such delays should not exceed a
30- to 60-day window.
On the demand side, subscription prices to journals may place access to
some research out of reach. This problem not only faces some institutions in the
developing world, but also among patients in the developed world. For many
patients, especially those with rare diseases, the high cost of accessing individual
journal articles can pose an obstacle to learning about one’s condition or treat -
ment options. As a result, patient advocacy groups have recently joined the call
on the U.S. government to embrace open access policies.19,20
To ensure greater access to scientific publications, several strategies have
been deployed. One has involved tiered pricing, and the other, the pooling of pub-
lished research in open-access journals or repositories. Particularly in developing
countries, mailing hard copies of journals would be prohibitively costly. With
the advent of the Internet, however, much of this access can now be provided
electronically.
Launched in January 2002, the WHO-led Health InterNetwork Access to
Research Initiative (HINARI) seeks to provide tiered access to more than 6,200
major journals in biomedicine and related social sciences. In collaboration with
participating publishers, HINARI divides low- and middle-income countries into
two groups: countries with a GNI per capita from US$1250-3500/year whose
institutions can receive access for $1000/year and those below that cutpoint
whose institutions receive free access via an online research portal.21 The pub-
lishing company Elsevier, whose journals are made available through HINARI,
claimed in 2006 that the initiative contributed to raising the rates of publication
by researchers in the 105 HINARI-eligible countries. In their analysis, research -
ers in HINARI countries increased their rates of publication by 63% while those
in non-HINARI nations saw only a 38% increase.22 However, some problems
have surfaced in gaining online access to these journals. In order to be eligible
for HINARI access, researchers in developing nations must have an institutional
affiliation, prohibiting nonaffiliated scientists, doctors, and government officials
from accessing HINARI articles.23 Even for those with the correct institutional
affiliation, investigators from a Peruvian university noted in 2007 that many of
the highest impact journals were not available there.24 Those journals that were
accessible via HINARI were often either open-access journals or those which
already provided free access to low-income countries.
Across disciplines ranging from electrical engineering to mathematics, the
free, online access of journal articles corresponded to higher mean citation rates. 25
Several studies suggest that open access articles have a higher citation rate than
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THE U.S. COMMITMENT TO GLOBAL HEALTH
closed-access articles.26,27 This held true even when comparing open-access
articles compared to non-open-access articles in the same journal.28 Importantly,
the impact of open-access publication on citations in journal publications was
twice as strong in the developing world.29
Open access can take several forms. By retaining copyright or nonexclusive
license, authors can self-archive their work, oftentimes on their own websites
or in a university repository. This is also known as the “green” road. In early
2008, Harvard University adopted its own open-access mandate through which
members of the Faculty of Arts and Sciences will submit electronic copies of all
completed articles to an institutional repository that will eventually be accessible
worldwide via the Internet.30 Faculty members may opt out of the system if they
choose, but it is expected that most will grant a nonexclusive license to the uni -
versity to make use of their work. The approach of an institutional open-access
repository has also spread: Harvard Law School and Harvard’s Kennedy School
of Government recently adopted their own open-access initiatives as have the
Stanford University School of Education, Boston University, and the Massachu-
setts Institute of Technology.31,32,33,34
Breaking with the approach to supporting journal access through subscrip -
tions, open-access journals have offered an alternative model to scientific pub -
lishing, also known as the “gold” road. Open-access journals raise revenues
from a variety of sources—endowments, institutional subsidies, membership
dues, fundraising, advertising, or upfront submission or publication fees—or just
depend on voluntarism. Of note, most open-access journals do not charge any
publication fees.35 Open-access journals make published articles more broadly
available online without subscriber fees. In so doing, open-access journals enable
wider distribution of the research published in these outlets, and at the same time,
the copyright licensing of these works allow greater potential of “remix.” For
example, if a developing country research institution sought to pull together a
compendium of key articles on schistosomiasis and to share such a resource with
sister institutions, the transaction costs of assembling an open-access collection
of journal articles are far lower than doing so with non-open-access articles,
where reprint rights would have to be negotiated with each journal holding the
copyright.
Open-access publishing has benefited from Creative Commons licensing.
Such licensing enables artists, writers, and researchers to lift voluntarily some
or all of the copyright restrictions upon their work. The family of Creative Com-
mons licenses allows for different permutations of the conditions under which
the work might be distributed, displayed, performed, or become the basis of a
derivative work. These conditions may require attribution, limit subsequent use
to noncommercial purposes, not allow derivative works, or allow sharing under
condition that derivative works carry the same licensing.
In the biomedical sciences, much research is funded by governments, and
given this support, the public understandably expects access to the findings
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APPENDIX F
from such research. The NIH estimates that 80,000 publications grew out of
NIH-supported research in 2003.36 Initially making a nonbinding request of its
researchers, NIH asked that all publications resulting, in whole or in part, from
its funding to be deposited in PubMed Central, a publicly accessible archive of
scientific publications, within 12 months after the study’s publication.37 How-
ever, the yield from voluntary compliance with this policy was very low: fewer
than 5% of NIH-funded researchers submitted their articles.38 The failure of this
policy prompted U.S. congressional action that mandated it as a requirement of
NIH funding beginning in April 2008.39 The NIH Public Access Policy requires
investigators to submit final, peer-reviewed journal manuscripts arising from NIH
funding to PubMed Central upon acceptance for publication. Such papers must
be available to the public through PubMed Central no later than 12 months after
publication. Taking a green path, this approach mandates deposit of government
funded research in an online archive broadly available to the public. By allowing
grantees to use NIH funding for publication fees though, the NIH also supports,
in part, the gold road.
Several prominent medical research funders have made open access a condi -
tion of grant support. The European Research Council (ERC), a funding body
set up by the European Union (EU) to promote research in the region, has also
put forward an open-access policy requiring its grantees to post all publications
to a research repository within six months of publication.40 This marked the first
EU-wide open-access policy and ERC has stated that it has interest in shorten -
ing the six-month window period in the future.41,42 The Wellcome Trust requires
submission of scientific publications resulting from its grants into U.K. PubMed
Central within six months of the publication date and even provides funding
for the upfront fees associated with publishing in such outlets. 43,44 Grantees of
the Howard Hughes Medical Institute also face a similar requirement to deposit
publications in PubMed within six months of the publication date. 45 By contrast,
NIH’s Public Access Policy remains at 12 months, twice the embargo period
accepted by other leading funding agencies.
Access to Research Data and Materials
The sharing of research data and materials enables the scientific community
to confirm study findings and also to build upon the work of others. Access to
these building blocks of research, however, may also be encumbered for reasons
similar to those encountered over scientific publications. The difference is that
access to data and materials enriches immensely the pursuit of new hypotheses
that derive or go substantially beyond its original research use.
Competing public policy concerns set some limits on the sharing of research
data and materials. For example, some data may risk the personal privacy of
human subjects, and the disclosure of other data may compromise the confiden -
tiality of privileged proprietary information. Unlike the electronic distribution of
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THE U.S. COMMITMENT TO GLOBAL HEALTH
journal articles or data, the marginal cost of disseminating research materials may
not be negligible, and these transaction costs also may pose barriers to sharing.
Dual use of technologies have the potential both to advance scientific knowl -
edge and to pose threats to public health or the environment, and such research
activities as well as resulting data and materials require governmental oversight. 46
However, denying data access not only imposes additional costs and barriers to
research along these lines, but also can place patients at risk of redundant or
unnecessary clinical trials.
Slow responses to material transfer requests resulted in project delays of
greater than a month among one out of six biomedical researchers surveyed in
universities, government or nonprofit institutions.47 Noncompliance with these
material transfer requests resulted in 1 out of 14 scientists giving up a line of
research on at least one of their projects each year. While noncompliance with
these requests were not reported to relate to the patent status of the requested
material, key reasons given for noncompliance included the costs and effort
involved in providing the sample and protecting the ability to publish. Negotiating
MTAs with industry often came with conditions, such as reach-through claims,
royalties, and publication restrictions. This was particularly common for requests
for drugs.
The role of government in facilitating access to data and research materials
is bounded, in part, by statute and regulations. For example, the U.S. Copyright
Act of 1976 prevents the federal government from claiming copyright protection
of its publications, and OMB Circular A-130 mandates that government-produced
data should be made available at the marginal cost of disseminating it. OMB Cir-
cular A-76 prohibits the government from entering into direct competition with
the private sector in providing information products and services. Tensions exist
between treating scientific data as a public good as opposed to a private one, and
there are important implications for the research commons.48
As with publications, open access may also multiply the impact of research
data. For example, in a 2007 study of 85 cancer microarray clinical trial publica -
tions, the public sharing of available data contributed to a 69% increase in cita -
tions.49 While half the trials in the study made their data publicly available, they
comprised 85% of the total citations.
As suggested by findings in the genetics research community, there are the
familiar reasons for denying access to data and research materials. When making
requests for information, data, or materials related to published research, nearly
half of geneticists reported that at least one of their requests had been declined
over the previous three years.50 Consequently, investigators said they could not
confirm research that had been published. Among the reasons most frequently
given for denying such requests, geneticists cited the high costs of producing
materials or information, the need to protect their own or their colleagues’ ability
to publish, and the commercial value of the data or material.
In the setting of emerging infectious diseases, the need for rapid and freer
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APPENDIX F
exchange of information and materials has become most clearly evident. The
WHO’s Global Influenza Surveillance Network played a key role in linking the
world’s leading laboratories and experts with real-time information during the
SARS outbreak in 2003.51 In the race to identify the coronavirus as the cause of
SARS, 11 laboratories recruited by the WHO regularly and voluntarily shared
samples of the unknown virus and held conference calls to discuss their results. 52
Without this level of collaboration and sharing, the transmission of SARS might
not have been halted within four months. For other diseases that might not unfold
as infectious disease outbreaks, would not freer exchange norms also help speed
the race to a cure?
Funding agencies again have played an important role in setting norms for
sharing data and materials. Providing guidance to its grantees in 2003, the NIH
requires applicants for grants greater than $500,000 to provide a plan for “timely
release and sharing of final research data from NIH-supported studies for use by
other researchers.”53 The ERC requires that “primary data” such as nucleotide
or protein sequences or epidemiological data must be submitted to a database
within six months.54
Led by the Wellcome Trust and the NIH, leading sequence centers involved
in the Human Genome Project pledged to deposit completed gene sequences of
every 1,000 base pairs within 24 hours of completion into a publicly available
database, GenBank. Called the “Bermuda Rules,” these rules were created to pre-
vent the patenting of DNA sequences through defensive publishing.55 Providing
further incentive to follow the Bermuda Rules, the NIH subsequently suggested
that the patenting of work emerging from the publicly funded Human Genome
Project would negatively impact the likelihood of receiving future grants.56
Data sharing has also been supported by other initiatives since the adoption
of the Bermuda Rules—by the Merck Gene Index,57 the International Nucleo-
tide Sequence Database Collaboration,58 and the Worldwide Protein Data Bank
among others.59
Traditionally, the sharing of data and materials involves both informal and
formal norms. Informally researchers sometimes bypass negotiation over mate-
rial transfer agreements (MTAs), but such practices may place the institution at
some risks that would otherwise be lessened by use of MTAs. Informal transfers
of materials among investigators circumvent institutional management of the
intellectual property and give advantage to some researchers better connected
than others.60 Increasingly though, informal sharing has given way to formal
agreements on data or material sharing that cover concerns such as attribution,
protection of patient confidentiality, the right to publish resulting research find -
ings, and intellectual property rights (IPRs).
Various groups have sought to lower the costs of such transactions. The first
strategy involves harmonizing the formal agreement form used among institu -
tions. The Uniform Biological Material Transfer Agreement (UBMTA) offers a
standard approach for transferring materials for noncommercial, research pur-
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THE U.S. COMMITMENT TO GLOBAL HEALTH
In the region, countries range from large middle-income country markets like
Brazil to smaller, least developed country markets like Haiti. Tiered pricing avail-
able to Haiti may not be so for Brazil. Under the Accelerating Access Initiative,
five pharmaceutical manufacturers offered lower prices for HIV medicines by
brokering agreements on a drug-by-drug, country-by-country basis. With only
five countries in Latin America and the Caribbean initially participating in this
Initiative, the countries of the Caribbean started a subregional negotiation with
Accelerating Access Initiative partners. Central American countries soon fol -
lowed suit en bloc, and then ten other Latin American countries started collective
negotiations.107 Each subregional negotiation improved upon the country-by-
country negotiations with the Accelerating Access Initiative. The important les -
son from this experience is the monopsony power of collective negotiation—or
pooling—for tiered pricing.
Apart from organizing demand, pooling can facilitate access to the supply
side by constructing a research commons. Such a step can lower the transaction
costs of assembling these research inputs. Pools can come together by various
means. Upstream in the R&D pipeline, pooling can build upon a more robust
public domain of research tools and other inputs. The entanglements of IPRs
might be fewer over the building blocks of knowledge. Downstream in the R&D
pipeline, commercializable inventions will play a more important role in the pool,
so the mix of incentives to contribute and disincentives to leave the pool may be
more complicated to structure than in upstream pools.
By applying the Creative Commons Attribution License, open access publi -
cations create pools of journal articles that permit “unrestricted use, distribution,
and reproduction in any medium, provided the original author and source are
credited.” Open-access repositories for data and journal articles posted online at
universities similarly pool research resources for broad, public availability. Norm-
setting approaches like the adoption of the UBMTA have the same potential, but
when universities substitute their own more restrictive MTAs in lieu of following
the UBMTA, the fragility of such pooling arrangements becomes clear.
While private sector pools provide access to patents comprising MPEG-2,
DVD and other standards in the electronics industry, the creation of pools in
biomedicine has been slower in coming. There certainly have been fledgling
efforts to create a SARS patent pool,108 to develop UNITAID’s proposed patent
pool for HIV/AIDS drug products,109 and to seed a technology trust for neglected
diseases.110 Recently though, GlaxoSmithKline stirred renewed interest in this
approach with its announced commitment to donate more than 800 patents to
a pool open to researchers working on developing treatments for neglected dis-
eases.111 Going beyond patent pools, the “technology trust” model explores the
potential for pooling across the value chain, from open-access databases to pool -
ing of patented inventions. Using various arrangements for collectively managing
intellectual property, it emphasizes the normative role that public sector pooling
and its strategic use of IPRs can play in encouraging greater scientific exchange
and innovation.112
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APPENDIX F
Significant start-up costs exist for creating a pool. Organizers have to con -
sider how to define what patents are essential to a pool or not; set valuation and
remuneration, if any, for patented inventions or copyrighted materials in the pool;
establish incentives for joining the pool and disincentives for leaving it; and seek
antitrust guidance to ensure the pool is pro-competitive. In agricultural biotech -
nology, the Rockefeller and McKnight Foundations along with 10 universities
created Public Sector Intellectual Property Resources in Agriculture (PIPRA) in
2003. Its stated goals were to “overcome the fragmentation of public-sector IP
rights and re-establish the necessary FTO [freedom to operate] in agricultural
biotechnology for the public good, while at the same time improving private-
sector interactions by more efficiently identifying collective commercial licensing
opportunities.”113 Acting more as a clearinghouse than a pool, its public database
comprised of patented inventions from member institutions makes it easier to
identify socially useful bundles of intellectual property for commercialization.
Public sector and philanthropic funders seldom foot these transaction costs
for pooling in biomedical R&D. NIH grantees cannot charge legal fees for pat -
enting or licensing as a direct cost to their project. However, it can be built into
the indirect facilities and administrative costs of a grant. This certainly limits the
means by which nonprofit research institutions might be willing to use IP strategi-
cally to protect the public domain. After all, patenting involves both legal, filing
and maintenance fees, and protecting IP for the public domain does not promise a
financial return on this investment. Nonetheless, the willingness of some funders
and even some universities to support upfront fees for publication in open-access
journals is a promising step in this direction, perhaps one that might be emulated
when patenting to protect public access is at stake.114,115
Not paying these transaction costs for pooling, however, can be problematic,
particularly for emerging infectious diseases. In these cases, the spread of the
epidemic may outpace the prosecution of patents at the Patent Office. As a result,
developers of diagnostics and treatments for the disease receive little certainty
from the patent system as the epidemic unfolds. The U.S. Centers for Disease
Control and Prevention and the British Columbia Cancer Agency argued that
the rationale for rushing to the Patent Office during the SARS outbreak was to
maintain the freedom to operate for potential innovators in this space. 116 This
example reveals the perceived need by public agencies to patent in order to pro -
tect researcher access and the public’s interest in areas of critical public health
concern. With patents still issuing years after the initial SARS epidemic has been
contained, pooling may help resolve the uncertainty faced by pharmaceutical
firms working on emerging infectious diseases during the outbreak.
Effectively used, tiering and pooling efforts can contribute to greater open -
ness in the sharing of knowledge. Open-source science focuses more on the way
in which the resulting collaboration is organized. Taking a page from the free
software movement, the philosophy is embodied in the General Public License
that allows a copyright owner to license a user to use his or her work, examine
the underlying source code, modify it, and redistribute modified or unmodified
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THE U.S. COMMITMENT TO GLOBAL HEALTH
versions of the work. The license provides this right without paying a fee in return
to the owner, but stipulates that the same conditions must be passed along to any
subsequent user of that work.
This open-source approach turns the traditional model of innovation on its
head. Open-source production empowers end users in the innovation of a technol-
ogy, and in so doing, emphasizes transparency as well as peer review and feed-
back.117 Attribution of contributions in such communities is more difficult to trace
than the authorship of scientific publications. With the successful experiences of
open source in software, would such an approach apply in biomedicine? Perhaps
bioinformatics might be, by analogy, a good starting point. The advent of the
Internet has certainly changed the costs of open-source production. Distributed
computing projects such as Folding@Home involve nonscientists and scientists
alike in contributing desktop computing power to solving computationally inten -
sive problems like protein folding. Moving from distributing computing projects
to peer-based production among scientists may be more challenging.
Still some have applied similar open-source principles to biomedical science.
Initially the Haplotype Map (HapMap) Project required users of its database to
agree to a license, whereby investigators committed “not to use the data in any
way that will restrict the access of others, and will only share the data obtained
with others who have accepted the same license.”118 While such a license reaches
virally through to subsequent users of the data, it may pose problems for those
seeking to commercialize inventions in a marketplace where secure IP holdings
can spell the difference between access to venture capital or not. Some have
proposed the possible application of open source to finding cures for tropical
diseases, where there is not a large paying market.119 The adoption of such an
approach among wet lab scientists has been slower in coming.
However, the Open Source Drug Discovery (OSDD) project, launched by
India’s Council of Scientific and Industrial Research in 2008, is a promising
model to watch. The online platform allows a community of scientists to share
and collaborate on projects, from gene sequencing to new drug development, on
Mycobacterium tuberculosis. Backed by US$38 million in commitments from
the Indian government, this open-source website has already engaged 700 par-
ticipants from 130 cities across 56 active projects.120 OSDD differs from previ-
ous open-source drug discovery projects in that it has the support of a leading
research institution in a major developing country, promises to adopt 30 colleges
throughout India where students will have the opportunity to contribute research
to this initiative, and importantly, has substantial financial resources to leverage
research collaborations. Public financing may be the key to applying open-source
production in biomedicine, both paying for what cannot be volunteered and sup -
porting the open exchange important for collaboration.
By reengineering the value chain of R&D, alternative models for innovation
may emerge and potentially better meet the needs of global public health. The
approaches of tiering, pooling, and open source point to potential ways in which
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APPENDIX F
the sharing of knowledge might be improved. While some of these efforts will
emerge spontaneously from the scientific community, others will require targeted
and strategic public and philanthropic investment. Unlike the private sector, the
public and philanthropic sector does relatively little to manage collectively or
strategically its IPRs to seek fair returns from its investment.
Yet arguably if publicly funded research were not freely available, the tax-
payers would have paid for the results several times over—grants for the aca -
demic research, salaries for those academics giving their time for peer review, and
subscriptions for such journals.121 For drugs, diagnostics, and vaccines, taxpayers
pay for much of the basic science and some of the clinical research, the academic
training of research scientists, and of course, for the final product. Some have
argued for the federal government to pay for clinical trials, so that the results
would be treated as a public good.122
This calculus of “pay now or pay more later” might guide where the public
ought to direct its investments to maximize the returns to the health care system.
For example, in the value chain of scientific journal publication, paying the pub -
lication fees for open-access journals is one way of supporting a business model
that encourages the sharing of knowledge. Going further, the U.S. government
could develop a system of supporting open-access journals that publish peer-
reviewed, publicly funded research. For those open-access journals that charge
publication fees, it could build support into the direct or indirect cost structure of
grants. For those open-access journals that do not charge fees, it could provide
direct or indirect subsidies. Either way, it could support journals that provide open
access rather than impose subscription fees on patients, providers, and universi -
ties. This support could factor in transition costs, the citation impact factor of the
journal in that field, the rejection rate, and the number of publicly funded research
articles published by the journal.
For clinical trials, greater public funding could also reap significant benefits.
If structured appropriately, such support might result in improved data transpar-
ency and access, the sharing of clinical trial information on shelved products, the
removal of financial conflict of interest in the conduct of clinical trials, priority
placed on trials addressing major public health concerns, and transparency of
R&D costs that might allow policy makers to assess reasonable pricing of the
resulting products. The recently approved NIH funding for comparative effective-
ness trials is a useful first step in this direction.123
Reengineering the value chain might also involve investing in alternative
business models, one that might lower the cost of R&D for neglected diseases.
The Gates Foundation grant to the Institute for One World Health, the University
of California, Berkeley, and Amyris Biotechnologies to produce artemisinin at
no profit for the developing world is one such example. Another example comes
from the work of Global Vaccines, Inc., a nonprofit firm that seeks to develop
affordable products for developing country markets with the support of public
funding and then to disseminate this technology through commercial sublicenses
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0 THE U.S. COMMITMENT TO GLOBAL HEALTH
for markets in industrialized countries. With Wellcome Trust and UK govern -
ment funding, investigators from Imperial College and the London School of
Pharmacy reengineered not only the existing version of hepatitis C treatment,
pegylated interferon, but also the approach to help ensure its scale-up as a product
affordable to the many afflicted with this disease in the developing world.124,125
Through a university spin-off, they licensed the drug to Shantha Biotechnics,
bypassing the more customary route of licensing it to a multinational pharma -
ceutical firm. Facing different clinical trial costs, Shantha Biotechnics will try to
produce a more affordable treatment than the one currently available.
Sharing knowledge from bench to bedside is critical to bringing about inno -
vation the world—and particularly its poor—need from the biomedical sec -
tor. Overcoming the disparities between industrialized and developing countries
sometimes seems like a Sisyphean challenge, but strategic steps taken by the
public and philanthropic sector can help create an environment that enables
both North and South to work together towards improved innovation and greater
access to health technologies.
ACKNOWLEDGMENTS
The authors gratefully acknowledge the support of the Institute of Medi -
cine and a grant from the National Human Genome Research Institute (Grant
5R01HG003763, Building a Technology Trust in Genomics) as well as insightful
feedback from Sarah Scheening on the IOM Program staff, the IOM Committee,
and several experts, including Professor Peter Suber, Professor Arti Rai, Shaoyu
Chang, MD, MPH, and Joseph S. Ross, MD, MHS.
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Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: A
Final Notice. Federal Register 64(246): 72090. Available at: http://grants.nih.gov/grants/intell-
property_64FR72090.pdf.
97 Doris Duke Charitable Foundation. 2004. Medical Research Program Bulletin. Available at: http://
www.ddcf.org/doris_duke_files/download_files/MRPBulletinOct04.pdf.
98 Ferguson, S. 2005. Presentation at Duke Conference on “Collective Action and Proprietary Rights:
Promoting Innovation and Access in Health Care.”
99 Sanjit, B. 2004. New meningitis vaccine in the pipeline. Science in Africa. Available at http://www.
scienceinafrica.co.za/2004/july/meningitis.htm.
100 Institute for OneWorld Health Licenses Potent Therapy from Yale and University of Washington to
Treat Chagas, One of the Largest Parasitic Diseases in the World. 2003. Institute for OneWorld
Health Press Release. Available at: http://www.oneworldhealth.org/media/details.php?prID=9.
101 UBC Global Access Agreement with iCo Therapeutics Offers Oral Drug to Help Millions in Devel-
oping World. 2008. University-Industry Liaison Office Press Release. Available at: http://www.
publicaffairs.ubc.ca/media/releases/2008/mr-08-054.html.
102 SNP (Single-Nucleotide Polymorphism) Consortium. Full Genome Representative SNP Map
Program Summary. Available at: http://snp.cshl.org/about/program.shtml.
103 Walsh, J.P., C. Cho and W.M. Cohen. 2005. View from the Bench: Patents and Material Transfers.
Science 309: 2002-2003.
104 $. Million, Five-Year Grant from Gates Foundation for Antimalarial Drugs Brings Together
Unique Collaboration of Biotech, Academia, and Nonprofit Pharma. 2004. Institute for One-
World Health Press Release. Available at: http://www.oneworldhealth.org/documents/DP_%20
Malaria%20Release%20121304.pdf.
105 Eligibility. HINARI Web Site. Available at: http://www.who.int/hinari/eligibility/en/.
106 Johnston, R.E. 2005. Academic science and the business of vaccines. Arch Virol Suppl. (19):
203-206.
107 Fitzgerald, J., and B. Gomez. 2003. An Open Competition Model for Regional Price Negotiations
Yields Lowest ARV Prices in the Americas. Presentation to the 8th World STI/AIDS Congress,
Punta del Este, Uruguay.
108 Simon, J.H.M., E. Claassen, C.E. Correa, and A.D.M.E. Osterhaus. 2005. Managing severe acute
respiratory syndrome (SARS) intellectual property rights: the possible role of patent pooling.
Bulletin of the World Health Organization 83: 707-710.
109 UNITAID moves towards a patent pool for medicines. 2008. UNITAID Press Release. Available
at: http://www.unitaid.eu/index.php/en/NEWS/UNITAID-moves-towards-a-patent-pool-for-
medicines.html.
110 So, A. 2008. Creating an Enabling IP Environment for Neglected and Rare Diseases. IOM
Workshop presentation. Available at: http://www.iom.edu/?id=54295 as cited in Wizeman,
T., S. Robinson, and R. Giffin. 2008. Breakthrough Business Models: Drug Development for
Rare and Neglected Diseases and Individualized Therapies: Workshop Summary. Washing-
ton, DC: The National Academies Press, p. 63. Available at: http://books.nap.edu/openbook.
php?record_id=12219&page=63.
111 Whalen, J. 2009. Glaxo Offers Patents to Aid Research. Wall Street Journal.
112 So, A.D. 2004. Enabling Conditions for the Scientific Commons. Presentation at Innovation in the
Life Sciences: Intellectual Property and Public Investment for Pharmaceuticals and Agriculture
at the Earth Institute, Columbia University. Available at: http://www.earth.columbia.edu/cgsd/
events/life_sciences_agenda.html.
113 Atkinson, R.C., R.N. Beachy, G. Conway, F.A. Cordova, M.A. Fox, K.A. Holbrook, D.F. Klessig,
R.L. McCormick, P.M. McPherson, H.R. Rawlings, R.Rapson, L.N. Vanderhoef, J.D. Wiley,
and C.E. Young. 2003. Public Sector Collaboration for Agricultural IP Management. Science
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THE U.S. COMMITMENT TO GLOBAL HEALTH
114 Wellcome Trust. 2008. Position statement in support of open and unrestricted access to published
research. Available at: http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Open-
access/Policy/index.htm.
115 Berkeley steps forward with bold initiative to pay authors’ open-access charges. 2008. SPARC en-
ews. Available at: http://www.arl.org/sparc/publications/articles/memberprofile-berkeley.shtml.
116 Brickley, P. 2003. Preemptive SARS patents. New Scientist 4(1): 20030509-02.
117 Hope, J. 2008. Biobazaar: The Open Source Revolution and Biotechnology. Cambridge, Mas-
sachusetts: Harvard University Press.
118 Cukier, K.N. 2003. Open source biotech: can a non-proprietary approach to intellectual property
work in the life sciences? Acumen J of Life Sciences 1(1). Available in abridged form at: http://
www.cukier.com/writings/opensourcebiotech.html.
119 Maurer, S.M., A.K. Rai and A. Sali. 2004. Finding Cures for Tropical Diseases: Is Open Source
an Answer? PLoS Medicine 1(3): 183-186.
120 Menon, S., 2009. Sreelatha Menon: Researchers sans borders. Business Standard. New Delhi.
Available at: http://www.business-standard.com/india/news/sreelatha-menon-researchers-sans-
borders/04/50/350429/.
121 Alliance for Taxpayer Access. Enhanced Access to the Published Results of NIH Research Will
Benefit Science, the Economy and Human Health. Available at http://www.taxpayeraccess.
org/resources/Benefits_of_Access.pdf.
122 Lewis, T.R., J.H. Reichman, and A.D. So. The Case for Public Funding and Public Oversight of
Clinical Trials. Economists’ Voice January 2007.
123 Loftus, P. 2009. Coming Soon: Comparative Effectiveness Research for Biotech, Wall Street Journal
Health Blog. Available at: http://blogs.wsj.com/health/2009/03/27/coming-soon-comparative-
effectiveness-research-for-biotech/.
124 Careers and Recruitment. 2007. Entrepreneurial experience. Nature Reviews Drug Discovery 6,
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125 Heilemann, J. 2007. A biotech pioneer takes on Big Pharma. CNNMoney.com.
