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Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements

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Abstract

This article compares and contrasts the pressures of both open access data sharing and commercialization policies in the context of publicly funded embryonic stem cell research (SCR). First, normative guidelines of international SCR organizations were examined. We then examined SCR funding guidelines and the project evaluation criteria of major funding organizations in the EU, the United Kingdom (UK), Spain, Canada and the United States. Our survey of policies revealed subtle pressures to commercialize research that include: increased funding availability for commercialization opportunities, assistance for obtaining intellectual property rights (IPRs) and legislation mandating commercialization. In lieu of open access models, funders are increasingly opting for limited sharing models or "protected commons" models that make the research available to researchers within the same region or those receiving the same funding. Meanwhile, there still is need for funding agencies to clarify and standardize terms such as "non-profit organizations" and "for-profit research," as more universities are pursuing for-profit or commercial opportunities.
Stem Cell Research Funding Policies and Dynamic Innovation:
A Survey of Open Access and Commercialization Requirements
Maroussia Lévesque &Jihyun Rosel Kim &Rosario Isasi &
Bartha Maria Knoppers &Aurora Plomer &Ya n n J o l y
#The Author(s) 2014. This article is published with open access at Springerlink.com
Abstract This article compares and contrasts the pressures of
both open access data sharing and commercialization policies
in the context of publicly funded embryonic stem cell research
(SCR). First, normative guidelines of international SCR orga-
nizations were examined. We then examined SCR funding
guidelines and the project evaluation criteria of major funding
organizations in the EU, the United Kingdom (UK), Spain,
Canada and the United States. Our survey of policies revealed
subtle pressures to commercialize research that include: in-
creased funding availability for commercialization opportuni-
ties, assistance for obtaining intellectual property rights (IPRs)
and legislation mandating commercialization. In lieu of open
access models, funders are increasingly opting for limited
sharing models or protected commonsmodels that make
the research available to researchers within the same region or
those receiving the same funding. Meanwhile, there still is
need for funding agencies to clarify and standardize terms
such as non-profit organizationsand for-profit research,
as more universities are pursuing for-profit or commercial
opportunities.
Keywords Stem cellresearch(SCR) .Humanembryonic stem
cells (hESC) .Induced pluripotent stem cells (iPSC) .Open
access .Data sharing .Commercialization
Abbreviations
hESC human embryonic stem cells
iPSC induced pluripotent stem cells
IPRs intellectual property rights
MTA material transfer agreement
SCR stem cell research
SLA simple letter agreement
TTO technology transfer office
Introduction
Researchers have noted a potential conflict between open
access and commercialization requirements in the field of
biomedical research. Indeed, a recent overview of the data
access policies of the principal science funding bodies in the
United Kingdom reveals differences concerning monitoring
and financial support for the implementation of open access
policies [1]. Likewise, a summary review of the Canadian,
British and American literature suggests a possible conflict
between open access and commercialization in genomic aca-
demic research [2]. Using bibliometrics to visualize the effect
of patenting on collaborative research in Canada as measured
in co-authorship, another study reveals that commercial activ-
ity could have a negative impact on research collaboration [3].
There is also growing evidence that commercialization
M. Lévesque :J. R. Kim :R. Isasi :B. M. Knoppers :Y. Joly (*)
Centre of Genomics and Policy, McGill University, 740 Avenue du
Docteur-Penfield, Montreal, Quebec, Canada H3A 1A5
e-mail: yann.joly@mcgill.ca
M. Lévesque
e-mail: maroussia.levesque@gmail.com
J. R. Kim
e-mail: jihyun.r.kim@mail.mcgill.ca
R. Isasi
e-mail: rosario.isasi@mcgill.ca
B. M. Knoppers
e-mail: bartha.knoppers@mcgill.ca
A. Plomer
School of Law, Bartolome House, The University of Sheffield,
Winter Street, Sheffield S3 7ND, UK
e-mail: A.Plomer@sheffield.ac.uk
Stem Cell Rev and Rep
DOI 10.1007/s12015-014-9504-5
pressures are increasing and becoming more institutionalized
through funding policies [4].
This article analyzes how commercialization and open
pressures are represented in public funding documents and
stem cell innovation frameworks in international, national and
regional contexts. How complex are the current knowledge
technology transfer requirements? Are there any visible con-
tradictions between the various policies? Are there other pol-
icy issues that could create innovation bottlenecks? To explore
these questions, we briefly introduce the international policy
framework governing embryonic SCR, before turning to an
analysis of specific funding bodies and organizations.
Research and Methodology
We conducted a review of open access and commercialization
policiesas established by publicly funded bodiesto inves-
tigate commercialization and open access pressures in the
underlying innovation framework, and the level of policy
integration between selected jurisdictions. While our study
focuses specifically on hESC research, our analysis and con-
clusions are likely generalizable to other sources of pluripotent
stem cell lines, such as iPSCs. We chose to focus in the EU,
United Kingdom, Spain, Canada, and the United States be-
cause those jurisdictions met the following criteria: (1) high
level of public (national/regional) funding, (2) leading science
with regards to the stem cell field, (3) establishment of a
national stem cell biobank and (4) documentation publicly
available in English, Spanish and/or French.
Amongst our research questions were: are there clear pro-
prietary or open science requirements embedded in funding
policies and guidelines, including requirements for the trans-
lation of stem cell research? Are dissemination requirements
or additional funding support for intellectual property rights
(IPRs) used as pressures or incentives to promote one inno-
vation approach over another? At the level of international
organizations, countries, and specific regions, we studied the
policy requirements of funding bodies, stem cell banks, and
non-profit SCR research organizations as embodied in laws,
guidelines, information documents and material transfer
agreements (MTAs). Policies applicable to the translation of
SCR into downstream research and clinical use were classified
into two broad categories: open science requirements and
intellectual property (patent) requirements.
Using the keywords open accessand/or commercializa-
tioninthesearchengineofeachsurveyedorganization,we
examined SCR funding guidelines and project evaluation
criteria. We performed additional searches on the websites of
funding bodies using the following terms: access agreement,
access license, commercialization, data sharing, intellectual
property policy, intellectual property, IP, material deposit
agreement, material transfer agreement, patent, research
translation policy, research use license, research tool, royalty,
and stem cell. Where the context warranted, we supplemented
our general queries with institution-specific technical terms,
such as foreground IPfor the FP7 program financed by the
EU. Our search returned 94 documents.
Where available, we also used specialized briefs outlining
the funding landscape for a particular jurisdiction. For the UK,
we consulted the UK policy excerpts from the Hinxton Group
(2006), the UK Stem Cell InitiativesdocumentEstimated
UK Investment in Stem Cell Research[5]andaworkshop
summary on regenerative medicine [5]. For Canada, we re-
ferred to the Canadian Asset Map for Stem Cell and Regen-
erative Medicine [6]. For Spain, we consulted a paper pub-
lished by Genome España [7]. For international sources, we
relied on existing academic resources [810]. Finally, we also
consulted centralized grant query portals [11] to confirm the
thoroughness of our list of surveyed organizations. We con-
firmed the accuracy and completeness of the information
reflected on organizationswebsites with the guidance of an
expert team of advisors [12].
Our inclusion criteria were:
&International organizations. International organizations
with a critical mass of researchers that seek to harmonize
SCR practices and set global policy standards were in-
cluded because of their possible normative influence on
national SCR funding policies.
&International and national public funding organizations
substantially promoting SCR activities. In order to deter-
mine the level of SCR activity, we considered the number
of grant opportunities specifically applicable to SCR or
with an explicit mention of SCR in a funding application,
as well as the amount of funding. Our research focuses on
public funding organizations because our hypothesis is
that these organizations face heightened pressure to make
their research open, whether by making their research
results available for free (Wellcome Trust) [13]orpub-
lishing their results online in a peer-reviewed academic
journal [14]. They also face increasing pressure to trans-
late results to the clinic, for which commercialization via
restrictive IP practices can be instrumental. SCR activity
also includes stem cell banks that facilitate the procure-
ment of SCR material.
&SCR regional and national policy and data results from
2010. Some jurisdictions, particularly the United States,
lack SCR-specific access policies and legislations. Thus,
we relied on the general laws and guidelines that impact
the translation of SCR. Moreover, given the scarcity of
material at the international level, we extended our search
to 2006 in order to capture some key international docu-
mentation. We excluded most state or provincial laws and
focused primarily on federal legislation, with the excep-
tion of California in the U.S. section to highlight its role as
Stem Cell Rev and Rep
a forerunner in SCR [15,16]. We also surveyed the
autonomous community of Andalusia, as its legal frame-
work, funding policies and institutional strategy provide a
singular innovation model because of the adoption of the
policy set forward by the Andalusian Initiative for Ad-
vance Therapy (AIAT). This flexible framework provides
an interesting contrast to that applicable in California, the
other region analyzed in our study.
&Data available in English, French or Spanish.
Our exclusion criteria were:
&Private, for-profit organizations. While many private
funding bodies [17] have provided significant funding
for SCR, they were excluded from our research because
we wanted to examine how the public funding sector is
affected by open access and commercialization pressures.
&Lack of public data available. Although some jurisdictions
have high levels of SCR activity, the available literature does
not allow an informed analysis of their innovation frame-
works. We focused on the organizations located in the five
jurisdictions with the most available information rich data
(detailed policies, legal documents, and guidelines) for a
clear picture of their national innovation framework.
Definitions
In the context of this paper, we define commercialization as
the process of extracting economic value from new products,
processes, and knowledge through the use of IPRs, licensing
agreements, and the creation of spin-off companies [18]. For
the purpose of our research, rather than to enter the termino-
logical debate that is often associated with open access move-
ments and strategies, we chose to adopt a broad perspective on
this notion to be as inclusive as possible [19]. Thus, we
considered open access as the open sharing of scientific
knowledge and research materials with minimum restrictions,
with the international scientific community, to forge a model
of open scientific collaboration. These models are intended to
stimulate downstream investigations and analyses and to im-
prove research translation [2].
Results and Discussion
International Organizations
International professional organizations such as the Interna-
tional Society for Stem Cell Research (ISSCR) and the
Hinxton Group provide an institutional foundation for the
development and dissemination of best practices [20]. These
institutions have an important role in fostering scientific
progress, policy development and influencing funding sup-
port. However, it is also important to acknowledge that their
power is limited to that of legitimacy pressures[21]in
other words, proposing new, non-binding, policies and acting
as a mediator between jurisdictions.
The International Society for Stem Cell Research (ISSCR)
The ISSCR is a non-profit organization for stem cell re-
searchers. It fosters exchange and dissemination of informa-
tion pertaining to stem cell research [22] and advocates open
access.
The ISSCR Guidelines for the Conduct of Human Embry-
onic Stem Cell Research [23]weredesignedasaninterna-
tional ethical and professional guidance standard that could be
incorporated in SCR grant requirements. The guidelines ad-
dress all scientists, clinicians and institutions engaging in
SCR, regardless of affiliation. ISSCR influences the ethics
and policy recommendations of national organizations.
Their guidelines endorse in the strongest possible terms
the principle that research with human materials is valuable to
all, and that the proper practice of science requires unhindered
distribution of research materials to all qualified investigators
engaged in non-commercial research and the dissemination of
its benefits to humanity at large on just and reasonable terms
(s. 7.1) [23]. Further, as a prerequisite for being granted the
privilege of engaging in human stem cell research, researchers
must agree to make the materials readily accessible to the
biomedical research community for non-commercial re-
search(s. 7.2) [23]. The sample hESC-related MTA defines
commercial purposesas the sale, lease, license, or other
transfer of the material or modifications to a for-profit orga-
nization(s. I. 10) [24].
The ISSCRs sample MTA also provides a template agree-
ment for sharing SC, wherein the user must adhere to open
access practices. This agreement is not to be interpreted to
prevent or delay publication of research findings(s. II.11)
[24], and recipients must preserve reasonable public and
scientific accesswhen distributing material derived from
the sample (s. II.5(c)) [24]. They must also ensure the rights
for the non-exclusive transfer of their material to academic
and governmental research institutions for internal research
purposes (s. II.5) [24]. In other words, they cannot use exclu-
sive licenses to privatize downstream inventions building on
open access material, without expressly written consent from
the providerand after negotiating in good faith (s. II.67) [24].
In its Guidelines for the Clinical Translation of Stem Cells
[25], the ISSCR encourages development and assessment of
alternative models of intellectual property, licensing, product
development, and public funding to promote fair and broad
access to stem cell-based diagnostics and therapies(s.
38(c)(ii)) [25]. This invites researchers to consider novel IPR
Stem Cell Rev and Rep
regimes that give wider access to therapeutic products arising
from their SCR.
Most importantly, the ISSCR invites funding institutions
and researchers to adopt the principles of open science. It
explicitly endorses open access as a scientific obligation,
provides a model MTA to facilitate material sharing and
promotes wide access to both research tools and therapeutic
products [25].
The Hinxton Group
Funded by non-profit organizations such as the Wellcome
Trust and the Greenwall Foundation as well as governmental
bodies (e.g. UK Foreign and Commonwealth Office), the
Hinxton Group is an institution born from an interdisciplin-
ary group to explore the ethical and policy challenges of
transnational scientific collaboration raised by variations in
regulations governing embryo research and stem cell science
[26]. While its role is advisory [27], the Hinxton Groups
recommendations may influence the scope of public funding
policies due to its advocacy role in promoting open access and
encouraging funders to maintain the accessibility of funda-
mental research tools.
The Hinxton Group has highlighted the dangers associated
with current SCR patenting practices, pointing out that the
tree-like shape of cellular differentiation makes the field espe-
cially prone to IPR holdings that can function as tollbooths to
access broad areas of work, creating a drag on investment and
slowing down basic research[27]. It therefore proposes
alternative IPR arrangements that would limit exclusivity in
two ways. First, the Hinxton Group encourages patent owners
to facilitate access to their material by non-profit institutions
[27]. Second, it prompts researchers to prioritize data sharing
by using patent pools or formally constructed semi-commons
to prevent exclusive licensing and overcome the patent thicket
issue [27]. This point is related to technologies needed to
advance the stakes of the field [27], not downstream develop-
ment of commercial (or therapeutic) applications.
The Hinxton Group also takes the position that cordoning
off fundamental research like novel cell lines, reagents and
related technologies [that] function as platforms for broad
areas of follow-on work[27] is particularly deleterious to
the advancement of SCR. It invites decision makers to compel
SC researchers to implement open access measures and de-
velop a consistent policy for sharing data and materials post
publication.[27].
One weakness of the Hinxton Groups statement is the lack
of acknowledgement of the blurred lines between non-profit
and for-profitinstitutions. This is particularly evident in
their recommendation pertaining to the licensing of
government-funded SCR inventions, which state that they
must reserve research rights for non-profit institutionsand
[e]nsure that data and materials are available to government
and academic researchers with a minimum of delay[27].
From their statement, it remains unclear whether non-profit
institutionsexclude universities when they pursue partner-
ships with private companies, as is often the case. Further-
more, the Hinxton Groups recent attempt to apply their rec-
ommendations to the specific Asian regional context may
have resulted in an over emphasis of cultural differences
[28] which in turn did not provide concrete guidelines to
ensure open access.
Several funding bodies have adopted granting policies that
fulfill certain aspects of the Hinxton Groups recommenda-
tions. Notable examples (further discussed) are: Canadas
Stem Cell Networks IP Protection Fund and Impact Grant
and the UKs Biotechnology and Biological Sciences Re-
search Councils Data Sharing Plan Compliance Monitoring.
SummaryInternational Groups
International Groups involved in scientific research have been
among the first and more active supporters of open access
[29]. Given the mandates of ISSCR and the Hinxton Group to
promote collaborative international SCR, it is no surprise that
their policies seem to favor open access over commercializa-
tion, though they do also recognize the necessity to commer-
cialize stem cell products and have included some accommo-
dation to that effect. The rest of this paper however demon-
strates that these policies have only had a moderate impact on
stem cells innovation strategies at the national level.
Since more traditionally non-profitinstitutions (e.g. uni-
versities) increasingly partner with for-profitones, policies
need to accurately reflect this new reality. International SCR
organizations must address this challenge in order for their
open access policies to provide truly meaningful guidance to
the global stem cell research community.
European Union
Concerns over the moral (and a fortiori the legal) status of the
human embryo have potentially limited the downstream com-
mercialization of hESC-based SCR (and their clinical transla-
tion) in the European Union (EU). This is best exemplified in
the landmark case of Oliver Brüstle v Greenpeace [30]in
which the European Court of Justice ruledbased on the
interpretation of the European Directive on the legal protec-
tion of biotechnological inventions (98/44/EU)that proce-
dures involving hESCs are unpatentable if they derive from
the destruction of human embryos [31,32]. In this decision,
the Court adopted a broad definition of the term embryo
despite the absence of consensus among the EU member
states on the term, effectively replacing existing definitions
of embryoin various national patent laws of the member
states [32]. While an analysis of the patentability of SCR-
based procedures and products is beyond the scope of this
Stem Cell Rev and Rep
article, the impact of this recent EU ruling on stem cell
innovation policies in the European Union should not be
neglected.
The 7th Framework Programme (FP7) (until 2013)
The FP7 was established by the EU in 2007 for a period of
7 years. It established the notion ofEuropean added valueor
transnational qualityas qualification criterion for funding
[33]. Since inception, the FP7 has funded over 30 SCR pro-
jects organized in large-scale consortia [34]. Grant require-
ments address how results should be shared with consortium
members, affiliates and third parties [35].
The FP7 regime allows its project participants (partici-
pants) to set their own guidelines and rules for sharing data,
which can set discretionary limits on data sharing. Core con-
sortium members of FP7 benefit from a patent pool; more
remote actors may enjoy certain access rights and even subli-
censes, if the participant consents to granting sublicenses in
writing (s. II.32.5; see Figure 2) [35,36]. The Guide to
Intellectual Property Rules for FP7 Projects (Guide)recom-
mends the participant allow other participants in the project
access to his or her backgroundinformation [35]. However,
the definition of background specifies that it relates only to
information relevant to the project (i.e. needed to implement
the project or needed to use the foreground generated)[35]
Accessing the background of another participant can only
occur during the projects duration, or within 1 year of the
projects completion [35]. Moreover, the Guide states that
foreground IP (IP created during the FP7 project) should be
protected[35] by patents, when it has industrial or commer-
cial potential. Such arrangements for ownership and IPR can
restrict access, since the participants have an opportunity to
decide how opentheir research will be, unless they are
receiving specific grants that have their own particular open
access requirements [35].
The default IP regime by FP7 allows participants to retain
exclusive rights and licensing, which encourages commercial-
ization. Joint participants must agree among themselves to the
allocation of ownership for the foreground IP (s. II.26.2) [36].
When no joint agreements exist, the FP7 Commission has a
default IPR regime, where each joint owner is entitled to grant
non-exclusive licenses to third parties without any right to
sublicense (s. 40.2) [3537]. As a report sponsored by the
European Commission notes, exclusive licensing is a potent
commercialization enabler: [exclusivity] increases the ()
potential strength and value of their IPR and the likelihood
that the results will be exploited[38]. Therefore, the exclu-
sive rights established by the default IPR regime can be seen
as favoring commercialization.
The Commission retains the right to object to the grant of
an exclusive license to parties outside the EU [35]. Regional
economic considerations can therefore trump the translation of
scientific research into products and services [39]. If the
Commission objects to a certain project, it requests the partic-
ipant to immediately suspend the granting of the license. The
Commission will then communicate safeguards it considers
appropriate to alleviate the objectionable grounds [35].
Finally, it should be noted that IPR protection mitigates the
obligation to disseminate results to the research community at
large. Under FP7, dissemination activities shall be compati-
ble with the protection of intellectual property rights, confi-
dentiality obligations and the legitimate interests of the
owner(s) of the foreground(s. II.30.2) [36]. IP protection
can therefore delay dissemination of research findings until a
patent application is filed, as prior disclosure would
invalidate the application [35]. Disproportionate harm
to the IP of other project participants is also a legiti-
mate reason to limit dissemination of the research re-
sults. The Guide to IP Rules confirms that dissemination
of data is subsidiary to IPR protection: [w]here dis-
semination of foreground does not adversely affect its
protection and use, there is an obligation to disseminate
it swiftly(emphasis added) [35].
Despite these limitations on data sharing, certain initiatives
under the FP7where SCR projects may take placedo
provide concrete obligations to openly disseminate research
results. For example, a 2008 Open Access Pilotproject
required researchers to deposit their articles or manu-
scripts in a relevant repository immediately upon accep-
tance for publication, to be made open access within
6monthsif the research falls under the area of Health,
and within 12 months if the research falls under Science
in Society [33].
SummaryEU
The FP7 program innovation framework reveals a restricted
access model (protected commons) that only allows limited
access to promote economic benefits within Europe. The grant
criterion of European added valuenecessarily requires re-
searchers within Europe to share information freely, but also
constrains the ambit of that access within the parameters of the
EU. Although the FP7 program appears to favor a protected
commons approach, SCR grant applicants may also face
obligations to disseminate research more openly from specific
initiatives like the Open Access Pilot Project. However, the
definition of dissemination in these open access requirements
displays enough flexibility to accommodate commercializa-
tion priorities.
The various nuances and exceptions present in their poli-
cies could be challenging to navigate for scientists with lim-
ited business experience. Given the current patent conundrum,
it would also be worthwhile to empirically assess how relevant
these rules are for current grantees and how frequently they
are being used.
Stem Cell Rev and Rep
National Organizations
United Kingdom
hESC Research in the UK is governed by the Human Fertil-
ization and Embryology Act 2008 (HFEA). The administra-
tive rules of the HFEA contained in their Code of Practice
require that the cell line be deposited in the UK Stem Cell
Bank (UK SCB) as a condition of the grant of a license for
newly derived hESC lines, whether they are supernumerary
from in vitro fertility treatments or created specifically for
research purposes [40].
UK Stem Cell Bank
The UK SCB is the regulator mandated to be a repository for
all embryonic stem cell lines derived in the UK. The SCB
operates in accordance with the principles of governance laid
down in its Code of Practice [41] and employs an IPRs
management model tailored to the commercial potential of
different types of SC lines.
The UK SCB mandates open access to laboratory-grade
stem cells useful to fundamental research. While laboratory-
grade lines may contain impurities limiting therapeutic appli-
cations, they are nevertheless valuable for fundamental re-
search. The UK SCB requires sharing of these lines through
a non-exclusive royalty-free license (s. 3.3) [42].
The UK SCBs approach preserves the commercial poten-
tial of valuable clinical-grade stem cells, conducive to thera-
peutic in vivo applications in humans. Strict quality standards
established by the European UnionsTiss ue an d C ells
Directives from 2004 to 2006 (EU) govern these lines. Parties
can negotiate access to clinical-grade lines for commercial
purposes without restrictions from the Steering Committee
(s. 6.4) [41] (ss. 1.1(m); 2.5. 2.8) [43]. This hands-off ap-
proach from the UK SCB is an incentive to commercialize, as
it removes encumbrances from the IPRs. Furthermore, IPRs
resulting from research by users on clinical-grade lines do not
have to be licensed back to the Depositor, thereby providing
private investors with a more attractive IPR portfolio.
The UK SCBs two-track policy addresses the specific
market potential of research and laboratory grade stem cells.
It promotes open access to the former, while preserving the
commercial value of the latter.
Biotechnology and Biological Sciences Research Council
The Biotechnology and Biological Sciences Research Council
(BBSRC) is part of the Research Councils UK, funded by the
Department for Business, Innovation and Skills. The BBSRC
invested £12.3 M in SCR in 200708 [44]. It prioritizes the
replacement of animal models with cardiomyocyte stem cell
models [45]. It has also identified regenerative medicine as a
priority in its Strategic Plan [44]. The Strategic Plan states that
[p]ublicly-funded research data are a public good, produced
in the public interestand should be openly available to the
maximum extent possible[44].
The knowledge exchange and commercialization policy
encourages researchers to pursue open access by stating that
there are circumstances where the publication of research
outcomes or free dissemination to business might be the most
effective approach[46]. Those values are reflected in the
Grants guide, which requires all applications to have a data
sharing policy or justify why sharing would not be appropriate
(s. 4.20) [47]. The implementation of this plan must be sum-
marized in the final report, which counts towards the grantees
track record for future applications [47], thus ensuring
accountability.
On the other hand, the BBRSCs IP policy encourages
commercialization to some extent by identifying the securing
of IPRs through funded research as a way to strengthen the
UK economy. Its Policy on Maximizing Impact of Research
aims to encourage an entrepreneurial culture within the aca-
demic bioscience research base[48]. The BBRSCs data
sharing policy allows a delay in publication if securing IPRs
requires periods of exclusive use of data[49]. This is not
pressure to commercialize per se, but rather the assurance that
those interested in commercialization will have the necessary
room to secure the protection of valuable innovations. The IP
policy does not impose rules on the ownership of IP [50],
recognizing that the varying spectrum of private sector in-
volvement can require different patenting and licensing
strategies.
Overall, the BBRSC has a strong stance on open access, as
reflected in its strict requirement for grant applications to have
a built-in data sharing policy. Where appropriate, it also in-
vites researchers to commercialize via protective IPRs and
provide them the necessary latitude to be successful at it.
Medical Research Council
The Medical Research Council (MRC) funds several research
centers, including the Centre for Regenerative Medicine,
which focuses on SCR. It also funds SCR projects at different
stages of research through specific grants. The Royal Charter
of the MRC identifies the objective of contributing to ()
the economic competitiveness of Our United Kingdom(s.
2(1)(b)) [51], as well as generating public awareness and
communicating research outcomes, thus recognizing both
open access and commercialization. Its data sharing policy
states that valuable scientific data from MRC-funded research
should be made available to the scientific community with as
few restrictions as possible[52]. However, the policy also
makes clear that it is not intended to discourage filing of
patent applications in advance of publication[52] and allows
ashort periodof delay in publication if necessary.
Stem Cell Rev and Rep
The UK-China stem cell partnership development initiative
focuses on fundamental research. It seeks to develop collabo-
rative links in stem cell research between the two countries
[53]. It offers a maximum of £400,000 per collaborative
project (for up to 12 projects) that aims to foster SCR at a
small-scale that would eventually lead to future and joint
activity. While this collaboration cannot be equated with open
access because it is restricted to a finite group of scientists, it
nevertheless fosters a protected environment conducive to the
exchange of scientific data without the barriers of IP
protection.
In addition, the Translational Stem Cell Research Commit-
tee funds research aiming to advance technological develop-
ments in preclinical SCR or early phase clinical trials. Its aim
was to provide up to £10 million per year for all of its projects
by 2010/11 [54]. This type of grant encourages protective IP
practices in order to attract private investment. Industrial
partners in translational grants can pre-negotiate the distribu-
tion of academically generated foreground project IP[55].
The orientation and conditions of these two SCR grants
enables the MRC to offer flexible data sharing modalities.
While the existence of two modes of funding allows re-
searchers to tailor their data sharing or commercialization
preference, the difference in funding amounts suggests that
the MRC incentivizes commercialization more. Data shar-
ingrestricted to research partnersmay be better suited
for fundamental research under the China-UK grant, while
IPR strategies can secure return on investment for translational
grantees working on SCR further down the developmental
timeline. In sum, the MRC innovation policy seems to gener-
ally favor commercialization over open access through its
general policies and funding Schemes.
Technology Strategy Board
The Technology Strategy Board (TSB) is the UKs innovation
agency. Its remit is to accelerate economic growth by stimu-
lating and supporting business-led innovation[56]. Original-
ly established in 2004 with an advisory role only, it became a
Non Departmental Public Body with a wider remit and exec-
utive functions in 2007. It is sponsored by the Department of
Business, Innovation and Skills. The TSB has funded ten SCR
projects since 2010 via its Knowledge Transfer Partnerships
[56] and committed over £2 million to SCR within its Re-
generative medicinestem cells for safer medicineprogram
[57]. The TSB also offers £1 million in grants to study bipolar
affective disorder using iPS cells [58]. Several grants
encompassing SCR, including two regenerative medicine
funds, seek to speed up the market-readiness of SC innova-
tion. Grant applications must include a route to market and
long-term commercialization plan [59].
The funding rules, adopted by the TSB, do not directly
mandate open access. Instead, they distinguish between
projects involving economic activitiesin which Catapults,
Public Sector Research Establishments, Research Council
Institutes, charities, public sector organizations, others take
part and non-economic research activities. It is envisaged
that those involved in economic activitieswill adopt similar
practices as industrial partners in normal market conditions,
including decisions not to disseminate results [60]. By con-
trast, there is an expectation that non-economic activities
will be disseminated. Dissemination through open access
repositories is one of the means envisaged. Other means
extend to [] producing a case study, speaking at a confer-
ence, publishing academic papers, open access repositories
(databases where raw research data can be accessed by any-
one), or through free or open source software and so on[60].
The TSB supports patent filing costs up to £5,000 [61],
making protective IPR practices an attractive option. Re-
searchers are thus encouraged to share their innovation in a
way that is conducive to commercialization. For example, the
CRACKIT grant IP scheme is designed to offer industry
sponsors early access to new technology. Furthermore, access
can be extended beyond the project duration through
granting of royalty-free licenses or through favorable pricing
foranagreedperiod[58]. The invitation to tender also
requires thatSC scientists ensure the availability of their work:
through publication and dissemination, or by appropriate
licenses, royalty-free or royalty-bearing on fair and reasonable
terms[58]. Because sharing this material entails administra-
tive costs and uncertainty relative to the extent of the rights
conceded, researchers may be tempted to adhere to a minimal
open access standard through the dissemination of publica-
tions rather than sharing the patented material or the process
itself.
Finally, public funding of stem cell research in the UK is
driven by a wider strategic goal to strengthen public-private
partnerships and collaborations between universities and in-
dustry initiated under the Blair and Brown governments and
exemplified by the UCL-Pfizer collaboration to develop
pioneering stem cell sight therapies in 2009 [62]. In its 2011
report to Parliament, David Willetts, the Secretary of State for
Business, Innovation and Skills announced the Coalitions
commitment to the UK knowledge base by maintaining the
annual £4.6 billion budget for science and research
programmes, with £150 million each year supporting
university-business interaction which in turn benefits clusters,
through Higher Education Innovation Funding[63]. This
strategy prompted the creation of the Cell Therapy Catapults
established by the Technology Strategy Board in 2012 to grow
the UK cell therapy industry, increasing health and wealth for
all [64].
In addition, in April 2012, a report from the UK Medical
Research Council (MRC) setting out A UK Strategy for UK
Regenerative Medicine[65] signaled the intention of the
leading funders (BBSRC, Engineering and Physical Sciences
Stem Cell Rev and Rep
Research Council (EPSRC), Economic and Social Research
Council (ESRC), MRC & Technology Strategy Board (TSB))
to support cell based research through response mode
funding, and continued strategic investment in centres of
excellence and partnerships with industry.ACell Therapy
Catapulthas been launched at the end of 2013 [64,66]. Like
all the six catapults funded by the TSB, the Cell Therapy
Catapult is intended to bridge the gap between business,
academia, research and government[67].
In its 2011 report on Innovation and Research Strategy, the
Coalition government announced its intention to promote
open access to publications of publicly funded research along-
side a commitment to strengthen support for public-private
partnerships. A working group was appointed to make strate-
gic recommendations on the implementation of open access
policies. The report was endorsed by the government [68,69].
SummaryUK
Public funding of SCR in the UK is taking place within a
strategic framework aimed at accelerating the translation of
basic research into innovative therapeutic products through
close collaborations and partnerships between academic re-
searchers and industry. The funding models and policies seek
to integrate traditional modes of IP protection into public
research institutions rather than displace or disrupt the com-
mercial interests of for-profit partners through the classic
divide between economicand non-economicresearch ac-
tivities. Whilst the model envisages that the latter will still be
undertaken by non-for profit organizations and universities
who are also required to disseminatetheir research, open
access is currently not mandated in this environment.
Spain
Akin to the UK approach, Spain has adopted a comprehensive
framework regulating SCR and its clinical translation [70,71].
With regards to commercialization, the Royal Decree 55/2002
of 18 January on the Use and Assignment of Inventions in
Public Research Bodies establishes the framework for the use
and assignment of inventions in public research bodies, regu-
lating IP from public research centers such as the Spanish
National Research Council (Consejo Superior de
Investigaciones Cientificas, CSIC) and the Carlos III Health
Institute (ISCIII), both of which are involved in SCR. The
CSIC is a public institution whose primary objective is to
develop and promote multidisciplinary scientific and techno-
logical research and is attached to the Ministry of Economy
and Competitiveness [72]. The Carlos III Health Institute is
the main research organization for biomedical research in
Spain. It is also attached to the same Ministry [73]. National
Organizationsof the Royal Decree assigns IPRs to the insti-
tution, butgrants the inventor a third of thebenefits. If the IP is
assigned to a party other than the public institution where the
research took place, the public research institution will have
the right to a non-exclusive, non-transferable free exploitation
licence(s. 3). Further, [w]hen researchers perform an in-
vention as a result of a contract with a private or public
institution, the contract must stipulate who owns IPRs(s.
5). These broad provisions allow the necessary flexibility to
structure IPRs according to the specific needs of each public-
private partnership and provide a predictable IPR distribution
framework.
Some federal laws appear to pressure researchers to com-
mercialize. The 11/1986 Law on Patents [74]requiresuniver-
sity researchers to report patentable inventions. The 14/2011
Law on Science, Technology and Innovation [75]setsouta
knowledge transfer policy for public R&D funders. Pursuant
to this law, the [v]alorisation of the knowledge obtained
through research applies to all processes allowing publicly-
financed research to reach all sectors of society. Its objectives
are () to facilitate an adequate protection of the research
results with a view to transferring such results(s. 35(2)(b))
[75]. The law also states that the transfer of research results to
third parties (via patent or licenses) are governed by contract
law, where each party can establish its own protective mea-
sures (s.36) [75]. These laws set the normative background to
which institutional funding policies containing indications of
substantial pressures to commercialize academic SCR are
developed.
Spanish National Stem Cell Bank (SNSCB)
The Carlos III Health Institute is responsible for the Spanish
National Stem Cell Bank (SNSCB), a decentralized network
of hESC and iPSC repositories ensuring nation-wide access
for non-commercial research. It combines intervention to en-
sure access to basic science material with a hands-off ap-
proach to commercial transactions. Public and private institu-
tions deriving SC lines must deposit a sample in the SNSCB
(Order SCO/393/20). Licenses governing access to these lines
are available only to researchers operating in non-profit set-
tings (s. 3) [76]. This excludes any private involvement:
material shall not be used in a research program where rights
(either actual or contingent) have already been granted to a
research sponsor who does not have a separate written agree-
ment with provider permitting such use of material(s. 3)
[76]. However, the bank refrains from intervening in negoti-
ations with potential commercial buyers.
The autonomous community of Andalusia
The community of Andalusia provides a distinct setting, with-
in the Spanish national jurisdiction, for SCR to develop. The
Law 16/2007 on Science and Knowledge governs the man-
agement of science in Andalusia [77]. Its provisions
Stem Cell Rev and Rep
emphasize commercial potential (s. 53 (a)(b)), and it sets out
incentives such that: [a]chieving an invention susceptible of
protected exploitation through intellectual property rights ()
shall be meritorious in the evaluation criteria of calls, employ-
ee selection and professional development in the Andalusian
public sector(s. 60). Researchers can receive a percentage of
the royalties their inventions earn for public entities.
The Andalusian Public Health Systems Technology Trans-
fer Office (TTO-APHS) has MTAs applicable to the sharing of
SCR. It proposes two agreements for the exchange of research
material between public institutions. The first model of MTA
postpones determination of IP ownership of subsequent dis-
coveries: [i]f research results related to the material are sus-
ceptible of legal protection, the parties shall meet with their
legal representatives to determine invention authorship and the
contribution of each party(s. 7) [78]. This delay in determin-
ing ownership creates uncertainty over who owns the rights to
inventions arising from shared cell lines. Researchers may be
more reluctant to collaborate under this MTA if they wish to
preemptively secure IP ownership over their future inventions.
The TTO-APHS is a signatory to the UBMTA of the Asso-
ciation of University Technology Managers [79], dealing with
the transfer of unpatented material between non-profit entities.
Users deriving a patentable process or product own the rights to
their inventions and can share them for non-commercial pur-
poses (s. 8) [79]. This research can be commercialized if the
derived product is sufficiently different from the original mate-
rial (s. 5(a)) [79]. Otherwise, the commercialization of inven-
tions that incorporate the original material is subject to negoti-
ations with the provider of the material (s. 7) [79]. The UBMTA
allows providers and users of SC material more certainty about
the ownership and use of subsequent innovations, and could
significantly reduce barriers to open access sharing of non-
commercial research. The fact that the UBMTA is a well recog-
nized international standard should also facilitate negotiations
and potentially speed up the transfer process.
Andalusian Initiative for Advanced Therapies (AIAT)
The AIAT is funded by the government of the Autonomous
Community of Andalusias government, through its Ministry of
Health and the Regional Ministry of Economy [80]. This public
agency seeks to translate SCR into therapies without private
involvement. Instead of relying on private commercialization to
achieve translation, the AIAT extends state support to later-stage
research. It sponsors clinical trials driven by public local insti-
tutions and hospitals. In doing so, it aims to translate discoveries
that have therapeutic potential but few commercial prospects.
SummarySpain
Federal laws in Spain encourage commercialization by pro-
viding the flexibility necessary to accommodate the needs of
those who wish to take the commercialization route. Similar to
several other surveyed jurisdictions, Spains approach incen-
tivizes research with commercial potential by providing public
researchers with a margin of the benefits from IPR exploita-
tion. Regional laws in Andalusia reveal a similar stance.
Broad legislative statements about knowledge transfer
through IPR protection are made at both levels of government
and some limited initiatives exist at the regional/institutional
levels to support open access and non-commercial research.
Canada
hESC research is permitted in Canada, as long as it takes place
within a specified ethical and legal framework as
circumscribed by a patchwork of federal and provincial legis-
lation, in compliance with a Supreme Court ruling that chal-
lenged the constitutionality of the federal Assisted Human
Reproduction Act [81]. SCR is also subject to various research
guidelines [82,83].
Canadian Institutes of Health Research (CIHR)
CIHR has a mandate to foster collaboration and facilitate
commercialization [84]. In 2012, the CIHR, in partnership
with Genome Canada, assigned $67.5 million for the Geno-
mics and Personalized Health program [85], and $10 million
for a Program Grant in Transplantation Research [86]and$6
million for Canada-Japan Teams in Epigenetics of Stem Cells
[87].
CIHRs grant guidelines contain broad statements and a
few non-specific requirements on open access [88]orcom-
mercialization. According to the updated 20102012 Guide-
lines for Human Pluripotent Stem Cell Research, all hESCs
derived with CIHR funding must be listed with the registry
[established by CIHR] and made available by the researcher to
other researchers(s. 6) [89]. Grants require a knowledge
dissemination and exchange strategy [90] and evaluation
criteria include [a]ppropriateness of the proposed strategies
for Knowledge Translation[91]. The grants awards guide
further states that [t]he research process is not complete until
the results are validated and openly transmitted to the appro-
priate audience(s. 2-A21.2) [92].
Commercialization incentives are equally sparse and indi-
rect in the CIHR guidelines, which do not provide any guid-
ance or facilitation on IPRs. The Tri-Agency policy, applica-
ble to the three major federal life science funders including the
CIHR, delegates IP management to the researchers institution
[93]. The hands-off approach regarding commercialization is
also apparent in its statement: [t]he Agencies () do not pass
judgment on the eventual commercial success of the research
[93]. Despite this attitude towards commercialization, certain
CIHR grant applications seem to put an emphasis on com-
mercialization potential and plans as criteria for funding [94].
Stem Cell Rev and Rep
Stem Cell Network
The Stem Cell Network (SCN) is a Networks Centre of
Excellence, whose activities consist of R&D and transla-
tion-commercialization[95]. Organized in large-scale,
academically-led virtual research networks that bring together
partners from academia, industry, government and not-for-
profit organizations[96], it recently decided to fund SCR
through the valley of deathstage, i.e. too late for traditional
academic grants but too early for industry sponsorship[97].
Its budget amounts to over $82 million for the 20012015
period [95].
The SCN prioritizes commercialization by providing an
optional IPR management model and separate grants for mar-
ket translation. These grants do not necessarily conflict with
open access because the aforementioned strategies are option-
al and separate from open access requirements. It also offers
incentives to commercialize SCR with market potential, while
remaining alert to the importance of open access to fundamen-
tal research. Although the SCNsgoalistoaccelerate pro-
jects with commercial and therapeutic potential[98], this pull
is achieved through soft incentives. Its IP Protection Fund [99]
and Commercialization Impact Grants [100] offer $5,000 and
$75,000 respectively to initiate and refine IP assets developed
with SCN funding. In the core grants, the researcher must
detail a long-term clinical translation plan, but this can take the
form of a protective IPR strategy or open-access data sharing.
Scientists are simply asked to [p]rovide a brief and clear
description of [their] long-term clinical translational plan for
the proposed research including how the proposed grant will
further the long-term goals[101]. The message sent to the
researcher is that the SCN will use additional funding to
promote commercialization as the best route to translation,
but open access to the research remains an option. Thus, the
SCN exerts a soft pressure on its researchers to commercialize
via additional strategic grant opportunities, training seminars
[102] and the disseminations of commercialization tools [103]
without proscribing open access.
The SCN provides a set of boilerplate IP agreements [103]
to assist academic and industrial partners wishing to collabo-
rate on commercializing SCR. By providing a comprehensive
IPR framework, this toolkit could save significantly on trans-
action costs associated with IP management. The toolkit also
pre-empts possible IPR ownership conflicts, thus reducing
costs associated with potential litigation. Echoing the UK
SCBs provisions for downstream inventions, these agree-
ments give privileged access to scientists who derive a stem
cell [104].
SCNs attempt in 2005 to promote the commercialization
of stem cell research via the creation of a spinoff company,
Aggregate Therapeutics, was unsuccessful. Aggregate Thera-
peutics was incorporated with the goal of managing and
leveraging the intellectual property of interested researchers
from the SCN. However, the company did not gain enough
private sector investment due to a host of reasons, including
the early stage of research and uncertainty about IPRs [3]. The
early-stage nature of IPRs owned by Aggregate Therapeutics
also did not fit with the fundraising model of venture capital
investors who required shorter timeframes than the IP allowed
[105]. Interestingly, Aggregate Therapeutics kept a clause in
its model licensing agreement that allowed SCN researchers to
be able to use the technology for non-commercial purposes
[106]. After the demise of Aggregate Therapeutics, the drive
for commercialization of SCR has continued with the emer-
gence of the Centre for Commercialization of Regenerative
Medicine (CCRM) in 2011. The Centre explicitly aims to
accelerate the commercialization of stem cell- and
biomaterials-based technologies and therapies[107].
SummaryCanada
In the context of SCR, CIHR favors a hands-off approach to
commercialization as illustrated by the broad requirements for
open access in its policies and the absence of commercializa-
tion requirements or guidelines. The CIHR Program in Trans-
plantation Research, a notable exception to this approach,
reveals a certain preference towards commercialization by
inviting grant applicants to identify previous patents or IPRs.
The SCN exerts soft pressure on its researchers to commer-
cialize their work through additional funding opportunities
and its extensive commercialization/IP reference documents.
Yet ultimately, there is no conflict between open access and
commercialization requirements, since these components are
optional.
United States
In contrast with the other jurisdictions under study, the United
States does not have a comprehensive legislative scheme
addressing stem cell research. Instead, it controls hESC re-
search through restrictions on federal science funding. The
1996 Dickey-Wicker amendment limited Congressability to
fund embryo research, curtailing HESC line derivation with
federal funding [108]. From 2001 to 2009, President Bushs
Executive Order 13435 (2007) limited federal funding for
stem cell research by prohibiting research using HESC lines
derived after 2001. However, President Obama lifted this
restriction with Executive Order 13505 in 2009, which was
later implemented via the National Institutes of Health Guide-
lines for Human Stem Cell Research [109]. Interestingly, the
above restrictions are not applicable to privately funded hESC
research.
The Bayh-Dole Act (1980) [110] amended federal patent
law by changing the allocation of intellectual property for
federally funded research. It encourages commercialization
by allowing non-profit organizations (including universities)
Stem Cell Rev and Rep
to retain ownership of their inventions when they conduct
research with federal funding. These organizations are expect-
ed to prioritize commercialization and give preference to small
US-based businesses. Any open access requirements by
funding bodies must be compatible with the Act.
National Institutes of Health
The NIH invested over $1 billion in stem cell-related research
in 2011 [111]. It conducts research through in-house institutes
such as the Center of Regenerative Medicine, and outsources
funding to universities and research institutions. 80 % of its
budget goes towards outsourced research for which the NIH
only acts as a funder [112]. It imposes dual obligations on
researchers; they must disseminate unique research resources
to develop science, and commercialize their inventions to
demonstrate the economic benefits to taxpayers [113].
The Policy on Sharing of Model Organisms for Biomedical
Research [114] lays out open access modalities for NIH-
funded research in a model MTA. Noting that the NIH is
able to support more investigators than if these useful models
had to be generated in duplicate by more than one NIH funded
investigator[114]. It encourages free dissemination of
unpatented research materials such as subclones of unmodi-
fied cell lines and genetically modified organisms among
NIH-funded researchers.
The Principles and Guidelines for Recipients of NIH Re-
search Grants and Contracts on Obtaining and Disseminating
Biomedical Research Resources [113] present various access
policies, depending on two factors. The first concerns the
position of the material along the development timeline:
whether it is a research tool or a product with commercial
potential. The second factor is the identity of the accessing
party: whether they are an NIH-funded colleague, an external
non-profit researcher or a for-profit entity.
For fundamental research, scientists receiving NIH funding
can access material through a Simple Letter of Agreement
(SLA). External non-profit researchers benefit from a royalty-
free non-sublicenseable research license governed by the
UBMTA, which details how an accessing researcher can share
modifications to the providers unpatented material. Commer-
cial users must obtain a non-exclusive license. Access is
gradually restricted as the product moves through develop-
ment, from a quasi-informal SLA to a binding license. Tech-
nology closer to commercial application, particularly that in
need of private investment to move forward, can be shared
with a free or paying royalty scheme, depending on whether
access is sought for academic purposes of conducting further
research or profit purposes of commercialization. According
to the Principles and Guidelines for Recipients of NIH Re-
search Grants and Contracts on Obtaining and Disseminating
Biomedical Research Resources, even exclusive licenses are
acceptable [113]. Under this model, stem cell researchers
would be required to share their research tools and products
if their research is related to public health.
More recently, the NIHsBest Practices for the Licensing
of Genomic Inventions recommended licensing policies and
strategies that maximize access, as well as commercial and
research utilization of the technology to benefit the public
health[115]. These guidelines are likely relevant for SCR,
as they apply to full-length genes and their expression prod-
ucts[115].
Each grant project seeking over $500,000 per year must
submit a data-sharing plan. The Data Sharing Policy and
Implementation Guidance [116] suggests several methods of
sharing: researchers can manage access requests themselves,
or deposit data in an archive or enclave. If researchers do not
plan to share the data, they must justify their refusal. In cases
of non-compliance, the NIH may make data sharing an
explicit term and condition of subsequent awards[116].
However, the Policy does not stipulate specific content, for-
matting, modes, or timeframes for data sharing and simply
states: what is sensible in one fieldmay not work at all for
others[116]. Moreover, within the NIH there are numerous
data sharing policies stipulating different requirements for
data sharing from its subdivisions such as National Institute
of Allergy and Infectious Diseases (NIAID) [117]. Some of
these data sharing policies stipulate that research data must be
available within one year of publication [118] while others
sharing plans are more open-ended.
In sum, the NIH recognizes the importance of open access
by facilitating a protected commons model for sharing re-
search between NIH-funded researchers, and by mandating a
data-sharing plan for substantial science research funding.
National Stem Cell Bank at the WiCell Research Institute
(until 2011)
From 2005 to 2011, the NIH funded the National Stem Cell
Bank (NSCB) at the WiCell Research Institute in Wisconsin.
While the NSCB ceased is operations in 2011 due to the end
of its agreement with the NIH, it is important to analyze it as it
provides an illustration of a protected commons approach
used to alleviate the tension between open access and com-
mercialization requirements. Because researchers procuring
SC lines from WiCell for NIH-funded research were granted
a non-commercial license, it imposed several access obliga-
tions on derived material, inventions or products the users
created, thereby creating an arrangement that can be qualified
as a limited sharing model.
The Memorandum of Understanding between the federal
government and WiCell precluded users from commercializ-
ing hESC lines from WiCell and the patents belonging to the
Wisconsin Alumni Research Foundation, but allowed the
commercialization of materials or processes derived from the
users work. Users were able to commercialize their own
Stem Cell Rev and Rep
work, but the IP was subject to a non-commercial research
license benefiting the NSBC, the provider of the line, and
certain non-profit and academic institutions [119121]. In
both cases, non-commercial licenses to userswork on the
stem cell lines were considered a quid pro quo for allowing
initial access to the material.
California Institute of Regenerative Medicine (CIRM)
The CIRM was created as a result of Proposition 71 (also
known as the California Stem Cell Research and Cures Act)
[122]. Similar to Canadas SCN, CIRMs objective is to fund
projects in the Valley of Deathstage, where research in early
stages does not have enough federal funding to reach the
clinical trial stage that is often funded by private industries
[123,124].
As the goal of Proposition 71 was to benefit Californians
with rapid advancementof stem cell research (s. 2) [122],
CIRM prioritizes access to materials within the state. In this
sense, its sharing policy is akin to a protected commons
limited to California. CIRM-funded researchers must share
newly derived lines with other researchers after publication, as
per the California Code of Regulations:[a] Grantee shall
share Publication-related Biomedical Material, for bona fide
purposes of research in California[125]. Since its definition
of research encompasses commercial activities like research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge(s. 100020 (i)) [125],
Californias private SCR companies have access to SC lines
related to CIRM-funded publications before foreign non-
profit SCR institutions.
The raison dêtre of Proposition 71 was to make medical
treatments and cures more available for uninsured California
residents (s. 100607) [125]. The language of the regulations
and requirements provide a flexible framework where open
access principles are dynamically balanced with commercial-
ization imperatives. However, the regime does advantage
California residents over foreigners.
The CIRMs IPR policies are embedded in the health
regulations of the California Code of Regulations,ensuring
clout and uniformity. There is a general obligation to make
reasonable efforts to develop, commercialize or otherwise
bring to practical application CIRM-Funded Technology or
CIRM-Funded Inventions( s. 100606(a)) [125]. A third party
can implement this requirement by licensing the patented
technology (s. 100606(b)) [125], but the CIRM-funded re-
searchers remain responsible for ensuring that their technolo-
gy become publicly available. In the case of exclusive licens-
ing, CIRM retains reach-through rights to appoint other li-
censees to carry the research forward (s. 100610) [125].
CIRMs IPR regime also sets out a series of rewards to the
State depending on the volume of licensing revenue and the
value of the CIRMs initial investment, creating a quasi joint
venture between the State and the grantee. (s. 100608 (a)(2);
(b)(1)) [125]. These policies appear to have resulted in eco-
nomic growth in California, as illustrated in one study that
found a 30 % increase in venture capital investments of life
sciences from the 20062011 period (the first 5 years of
CIRM) as compared to the period between 2000 and 2005
[16].
SummaryUnited States
An examination of US policies reveals that federal public
funding bodies most commonly mandate limited access to
materials and data (i.e. protected commons limited to state
or national borders). This may be due to the fact that much of
the commercialization pressures come from federal or state
laws. Certain organizations, like the CIRM, have developed
their own regulations into a framework where strong research
commercialization requirements do not seem to jeopardize
accessibility due to a sharing model similar to a protected
commons. In addition, the move towards a greater focus on
stem cell research and regenerative medicine in California will
certainly have some impact on the future of geographic distri-
bution of universities, biotechnology and pharmaceutical in-
frastructures and investments of venture capital in the United
States [124].
Because philanthropic organizations also contribute signif-
icantly to SCR and its clinical translation in the U.S., their
funding requirements will also shape commercialization and
open access pressures. This is an area where further research is
needed. In sum, in the US the pressure to commercialize
arguably remains strong because commercialization require-
ments are embedded in federal legislation and certain state
regulations.
Discussion
The purpose of our research was to investigate and lay out
access and commercialization pressures that exist in public
funding policies and documents from SCR organizations. We
also investigated the level of integration between the various
requirements contained in policies governing embryonic
SCR.
Except for the international level which clearly favored
openness, the policy framework of all surveyed jurisdictions
proved flexible enough to permit both open access and com-
mercial approaches to technology translation in the field of
stem cell research. While some countries, such as the United
States, seemed to exert stronger pressure towards commer-
cialization; the actual differences were just a matter of degree,
rather than a case of completely distinct or opposing policy
positioning. The latter, coupled with the fact that the studied
frameworks were formulated in broad policy strokes (as
Stem Cell Rev and Rep
opposed to extensive legal regulations), renders impos-
sible a micro level comparative assessment of the vari-
ous national approaches. However, we can still glean
some interesting trends emerging when looking at the
broad lens of our research objective, this is, to compare
and contrast the pressures of both open access data
sharing and commercialization in public funding policies
and stem cell innovation frameworks.
Our survey of policies by public funding bodies reveals subtle
pressures to commercialize research that include increased
funding availability for commercialization opportunities, assis-
tance for obtaining IPRs and federal legislation directly mandat-
ing commercialization. A substantial amount of the pressure to
commercialize could also originate from normative documents
generally applicable to public research, not directly related to
SCR. Although international groups like the ISSCR and the
Hinxton Group have been advocating open access models, their
limited political sway and the lack of associated financial incen-
tive limit the impact of their recommendations.
Another thread emerging from our analysis is the appear-
ance of a protected commons model (i.e. access limited to
researchers residing within the country) as a compromise
between open and proprietary SCR. Some institutions grant
priority access to a limited set of actors based on a common
funder (NIH) or jurisdictional belonging (CIRM). Others re-
strict access through bilateral funding arrangements such as
the UK-China stem cell partnership development initiative at
the MRC. This protected commons model could be consid-
ered a compromise when innovations are too advanced to be
shared openly like basic research, but not sufficiently mature
to sustain a proprietary model designed for market-ready
products. Nevertheless, we also see it applied to basic research
(NIH, MRC UK-China partnership), suggesting a withdrawal
from the completely open access innovation model. These
more restrictive IPR practices must be situated within the
policy framework governing hESC in each country, since
some regions such as the EU forbid patenting procedures
involving human embryonic stem cells. It should be clearly
understood that these controlled access national schemes do
not equate to open sharing. Sooner or later, the international
research community will need to position itself on the neces-
sity of these more protectionist requirements.
Our research also sheds substantial light on the technology
transfer grey zoneof policies, identifying a protected com-
mons approach between open access and commercialization
that is emerging in SCR. This grey zone is further complicated
by the evolution of universities from being non-profit organi-
zationsto also playing a significant entrepreneurial role [126].
Potential confusion might arise because general data shar-
ing policy for health research or national innovation frame-
works may differ from specific requirements in grants
pertaining to SCR. For example, the innovation framework
of the FP7 funding body strongly prefers commercialization
and allows researchers to delay publication if necessary, yet
their Open Access Pilot Project requires immediate deposit of
research findings in a public repository.
There is also a need for more standardized definitions of terms
such as academic research(sometimes assimilated with not
for profit research)andcommercial purposes(sometimes
assimilated with for profit research) to alleviate confusion
and uncertainty for researchers. With increasing partnerships
between universities and for-profit organizations to foster com-
mercialization, universities are straddling the boundary of not-
for-profit research and commercialization [127]. It is not always
clear how funding bodies distinguish a non-profit researcher
from for-profit researchers, who would be subject to different
requirements for sharing modifications to a providersmaterial.
In conclusion, stem cell researchers are usually guided
through various push and pull mechanisms to make one of the
three choices: 1) open their research to the international commu-
nity; 2) deposit their research in a protected common that will be
made accessible for a specific class of research or to a specific
type or researchers; 3) commercialize their research through
intellectual property, licensing and public private partnerships.
Preferred strategies and outcomes, as well as the degree of
complexity of this stem cell innovation maze vary greatly ac-
cording to each investigated jurisdiction. Integrating these poli-
cies to promote international collaborative stem cell research will
no doubt be a daunting task. Yet, given the current difficulties
translating stem cell science from bench to bedside, the SCR
community should move towards aligning policies, in order to
prevent further negative impacts to an already complex process.
Acknowledgments This paper was written with financial support from
the Stem Cell Network and the Centre for Commercialization of Regen-
erative Medicine.
The authors would like to thank Javier Arias-Diaz (Carlos III Health
Institute), Carol George (University of Edinburgh) and Geoffrey Lomax
(California Institute for Regenerative Medicine) for providing guidance
on the national SCR organizations. The authors would also like to express
their gratitude to Timothy Caulfield (University of Alberta) for providing
insightful comments on earlier drafts of this paper.
Conflicts of Interest The authors indicate no potential conflicts of
interest.
Open Access This article is distributed under the terms of the Creative
Commons Attribution License which permits any use, distribution, and
reproduction in any medium, provided the original author(s) and the
source are credited.
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