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Ethics, Society, Culture: - Develop public engagement strategies to inform and educate the
public about developments in genomics and biotechnology
- Develop capacity to address ethical, social and cultural issues
- Improve accessibility and equity
Politics: - Strengthen understanding, leadership and support at the political level for biotechnology
- Develop policies outlining national biotechnology strategy
These recommendations provide guidance for all those interested in supporting science,
technology, and innovation to improve health in the developing world. Applying these
recommendations broadly across sectors and regions will empower developing countries
themselves to harness the benefits of biotechnology and genomics for billions who have long been
excluded.
Background technology to improve health in their regions. We
Genomics and biotechnology hold great potential to fight define'genomics' as the powerful new wave of health-
diseases that disproportionately affect the world's poorest related life sciences (biotechnologies) energized by the
people. However, the benefits of biotechnology, driven by Human Genome Project and the knowledge and tools it is
market incentives of the industrialized world, have spawning (including proteomics, transcriptomics, metab-
accrued primarily to rich countries, with billions in the olomics, etc). Our operational definition encompasses
developing world largely excluded from these advances. the ethical, legal, social and cultural dimensions of devel-
Developing nations are now taking steps to build long- oping the science and technologies and taking them to
term plans to benefit from biotechnology innovation [1]. where they were needed: from the lab to the village, as it
In Africa, the African Union Commission President devel- were. In this paper we use the terms 'biotechnology' and
oped a High-Level Panel on Modern Biotechnology to 'genomics' interchangeably. We first explored ways to har-
"generate a critical mass of technological expertise in tar- ness biotechnology to improve the health in the develop-
geted areas that offer high growth potential" from bio- ing world in 2001, followed by a study that identified the
technology and "harness biotechnology in order to top ten biotechnologies for improving health in develop-
develop Africa's rich biodiversity...improv [e] agricultural ing countries in 2002 [5,6]. Between 2002 and 2004, the
productivity and [develop] pharmaceutical products [2]." MRCGH planned, developed, and executed five Executive
In January 2007, the African Ministerial Council on Sci- Courses on Genomics and Public Health Policy in five
ence and Technology received the Panel report and com- regions in the developing world. In this endeavor we col-
mitted themselves to a "20 year African Biotechnology laborated with local experts and institutions to bring
Strategy" to promote that vision. The Federation of Asian together 232 developing world experts and key stakehold-
Biotech Associations offers another Southern-based exam- ers from multiple sectors to determine the best way to har-
ple of "collaboration between industry and academia" ness genomics and health biotechnology to improve the
that seeks to "boost investment in biotechnology, interna- health of people in the developing world. Previous recom-
tional trade in biotechnology products, and outsourcing mendations on how to bring the benefits of biotechnol-
of services [3]." The need for developing countries to ogy to the poor have not focused on generating broadly
develop and benefit from biotechnology is clear – as a dis- applicable guidelines for improving health, but rather on
cussion paper from the World Bank's recent Global Forum enhancing particular technologies, such as agricultural
on Science, Technology, and Innovation (STI) states, there biotech [7,8] and nanotechnology [9], or providing action
is no longer a question of whether countries should build steps for particular nations [10] or stakeholders (e.g. civil
science and technology capacity that promotes biotech- society or research institutes) involved in promoting bio-
nology innovation, "but what type of capacity to build, technology [11]. Moreover, rather than employing wide-
given their economic constraints, and how best to imple- spread consultation with developing world experts to gen-
ment these capacity building action plans [4]." erate recommendations, existing proposals have come
from small-scale workshops without a developing world
Driven by a mission to harness the advances of innovative focus [12,13], forums emphasizing development as
technology for global health equity, the McLaughlin-Rot- opposed to health, or publications by lone developing
man Centre for Global Health (MRC), formerly the Cana- world voices [9]. To our knowledge, never before has such
dian Program on Genomics and Global Health, sought to a large, multi-sectoral, Southern-based group of experts
ask how developing countries can best harness health bio- been consulted on these issues. This paper offers a cross-
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comparison of their recommendations. The similitude of The 232 participants from 58 countries (see Figure 1) were
these independently generated recommendations sup- chosen based on contacts identified through our previous
ports their robustness as answers to the five courses' over- work related to this area including recommendations
arching question: how can the developing world best from field experts leading to a subsequent snowball effect.
harness genomics and biotechnology to improve health? Thorough in-depth literature review and internet-based
searches were also conducted to select and validate our
Discussion participant choices. The participants were carefully
Executive Courses on Genomics and Public Policy selected to represent a wide range of interests relevant to
The Executive Courses on Genomics and Public Health biotechnology, with special consideration given to appro-
Policy took place between 2002 and 2004 for experts in priately balancing geographical, gender and discipline/
five regions of the developing world: Nairobi, Kenya with specialty distribution. The sectors represented included:
the African Centre for Technology Studies for the African
continent; Kerala, India with Indian Council of Medical - government representatives, health ministry officials,
Research for the Indian subcontinent; Muscat, Oman with
the World Health Organization's Regional Office for the - regulatory officials, legal experts,
Eastern Mediterranean region (EMRO); Caracas, Vene-
zuela with the United Nations University's Biotechnology - scientists from academic institutions and industry,
for Latin America and the Caribbean (BIOLAC) and the including the director of a national institute of genomics
Pan American Health Organization for Latin America and in the developing world, and a member of the research
the Caribbean; and Hong Kong SAR China with the Uni- team that in 1997 cloned Dolly the sheep, the first animal
versity of Hong Kong for the Western Pacific and South- ever cloned from an adult mammalian cell,
east Asia region.
- industry executives, biotechnology company representa-
tives,
Figure 1breakdown of participants in the Executive Courses on Genomics and Public Health Policy
Regional
Regional breakdown of participants in the Executive Courses on Genomics and Public Health Policy.
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- members of non-governmental organizations (NGOs), 4. sharpening recommendation language; and
and media.
5. attaining general or widespread agreement among par-
The executive courses had three goals: ticipants.
1. To familiarize the participants with the current status Participants received evaluation forms at the end of each
and implications of health genomics and biotechnology, course. The general consensus reflected success in terms of
and to provide information relevant to public policy-mak- achieving the goals and objectives of the Courses, with sat-
ing in these fields. isfaction ratings by the participants ranging from 86%-
96%. The first three courses have been published individ-
2. To provide frameworks for analyzing and debating the ually without a synthesis of the recommendations as a
policy issues and related ethical questions in health whole [14-16]. This paper, however, compares and ana-
genomics and biotechnology, and to help people to lyzes recommendations from all five courses.
understand, anticipate and influence the legal and regula-
tory frameworks under which health biotechnology Recommendations from the Course Participants
industries will operate, both nationally and internation- In each course, working groups were asked for advice on
ally. developing genomics/biotechnology in the region to
improve public health as outlined above. One of the
3. To begin developing a leaders' network reaching across products from each course was a set of recommendations
different sectors (including industry, academic, govern- on how best to harness biotechnology to address local
ment and NGOs) by sharing perspectives and building health needs within their region. The recommendations
relationships. are intended for use by policy-makers, industry leaders,
scientists, health care providers, NGOs, and funding agen-
The courses, each lasting four, intensive, interactive days, cies. We applied these categories retrospectively to the
consisted of a series of presentations, primarily delivered Courses after developing them in consultation with devel-
by local experts, and discussions led by stakeholders from oping world key informants in 2006. We compared and
different countries and sectors, allowing for the opportu- analyzed the Courses' recommendations and synthesized
nity to express different viewpoints They provided oppor- them into four categories as presented below: 1) science,
tunities to share information about the research, ethics, 2) finance, 3) ethics, society, and culture, and 4) politics.
social context, infrastructure, media relations, business These categories, while not completely mutually exclu-
development, and regulations affecting the development sive, help to present the recommendations of the 5
of biotechnology, and gave the participants background groups.
information. However, the main question, 'how best to
harness biotechnology to improve global health,' and the Science
regional recommendations were developed in small and Within the recommendations related to science, partici-
large group discussions of the participants. Topics pants focused on the potential of inter-sectoral, regional,
included scientific advances in biotechnology, innova- and international collaboration to build capacity, the
tions in business models, public sector perspectives, eth- need for surveys of current capacity, and the importance
ics, legal issues, and national innovation systems. This of looking to successful models elsewhere. Participants
information is critical for developing countries if they are specifically called for collaboration and capacity-building
to absorb and control research information and public as methods to improve science education and establish
policy issues affecting major technological breakthroughs regional and international networks – these networks pos-
in the life sciences and public health. sess the much needed capacity to increase dialogue
between biotechnology developers and end-users. India's
Participants drove the process of identifying and collect- lack of emphasis on regional collaboration is likely linked
ing these recommendations. Participants constructed the to the fact that it was the only Course whose participants
recommendations by: all came from one nation. Africa and Latin America,
whose biotechnology capacities are comparatively less
1. pre-drafting recommendations based on presentations; developed, both encouraged their regions to look to suc-
cessful models of biotechnology innovation elsewhere
2. deleting any recommendations which the group did ([17] see Table 1).
not support;
Finance
3. adding missing recommendations; Key issues that arose regarding finance included regula-
tory systems, intellectual property rights, and private sec-
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Table 1: Scientific Recommendations
Africa India Eastern Mediterranean Latin America and the Caribbean Western Pacific/Southeast Asia
-Establish a regional network to - Improve industry-academic - Provide coordination and - Conduct a study both to document - Seek development funds from
foster sustained inter-sectoral interface with appropriate networking among national system's strengths in genomics and national, regional and
dialogue incentives to improve public health biotechnology bodies and biotechnology and also to determine the international sources
- Commission African capacity and the nation's wealth coordinators to exchange information, needs which can be addressed by these - Perform foresight exercises,
survey in genomics-related R&D - Establish an internet-based opinion expertise, and training disciplines including prioritization, needs
to determine areas of strength leaders' network to foster cross- - Regional cooperation in - Educate and prepare the necessary assessment and action plan
- Undertake a detailed study of sectoral dialogue production and utilization of health human resources in genomics and - Facilitate linkages between
R&D models with demonstrated biotechnology biotechnology government, academia, NGO's, civil
success in the developing world - Coordinate a national survey/ - Seek help and advice from society, researchers, the health system
- Establish seven regional research inventory/situation analysis/needs institutions in other countries in the and industry
centres of excellence assessment of health region that have had a successful - Build capacity and share core
biotechnology innovation systems, experience in this endeavor facilities
including scientific and management -Develop mechanisms of regional - Develop joint training programs
capacity, government policies, cooperation to harness genomics and - Identify existing genomics/
legislation and regulations, intellectual biotechnology for both health and biotechnology capacity including
property policies, private sector economic development trained personnel, equipment, etc. in
activity, and strengths/weaknesses, - Harness the potential of Latin all public and private sectors
opportunities and threats America and the Caribbean in genomics - Build essential core research
- Encourage academic institutions to and biotechnology to improve health for facilities linked to local needs
include health biotechnology the population of the region - Develop training programs for
topics within their curricula and - Build on existing networks so as to different personnel categories
create specialized programs and avoid duplications and redundancies - Integrate genomics/
degrees where appropriate. There - Encourage the participation of biotechnology in curricula
should be particular emphasis on ICT researchers, government officials, beginning at a primary level to
and bioinformatics members of the private sector, members postgraduate levels
of civil society, and any other relevant
stakeholders
- Address local health needs
- Should not only pursue pure research but
also applied problem solving
investigation and product development
- Facilitate learning
- A strategy and a plan of action should
be built at the regional level in order to
promote the creation of international,
interdisciplinary, multidisciplinary, and
BMC Public Health 2007, 7:346
multi-institutional projects
6. BMC Public Health 2007, 7:346 http://www.biomedcentral.com/1471-2458/7/346
tor collaboration. Participants stressed the need to harness Indian-Pakistani tensions, his presentation received a
the power of biotechnology not only for health, but also "warm response" from Pakistani delegates that led not
for economic development. Several regions stressed the only to the bulk transfer of the hepatitis B vaccines from
need to identify appropriate entry points for biotechnol- India to Pakistan, but also the technology transfer that
ogy products and exploit domestic and regional markets facilitated their manufacture in Pakistan [19]. "Every
[6]. India's lack of emphasis on product entry may be due small cooperation matters," he said. "Science does not
to the fact that its private sector's affordable pharmaceuti- have borders." Beyond this example of collaboration, the
cals have already emerged competitively in domestic and EMRO Ministers of Health adopted the recommendations
global markets ([18] see Table 2). from that meeting and in the Latin America and Carib-
bean region, the Pan American Health Organization
Ethics, Society and Culture (PAHO) followed up with discussions of the recommen-
Courses commenting on ESC issues called for public dations from that event. The Courses have also stimulated
engagement programs that would inform and educate international academic exchange – both bringing partici-
their populations on biotechnology developments. pants to Canadian institutions as well as funding graduate
Another common theme included the need for capacity to study abroad. Following the courses, both participants
address ethical issues including legal, social, and environ- and the MRCGH staff have played advisory roles for one
mental concerns. Participants also underscored themes of another in subsequent research projects.
accessibility and equity in terms of disseminating biotech-
nology innovations (see Table 3). We recognize that the structure of the Courses limits the
rigor of the processes which generated these recommen-
Politics dations – although participants reached consensus
Political recommendations from participants highlighted through discussion, there was no formal consensus proc-
political leadership as a core factor in promoting biotech- ess. The Courses are rooted in opinions rather than eco-
nology research and development in their regions. Many nomic or scientific analysis. Theoretically, had the
participants stressed the need for national strategy and Courses involved a different set of participants, the results
public policy on genomics and biotechnology. African might have differed. However, compared to the alterna-
participants recommended using the established New tive of conducting surveys with 232 respondents from 58
Partnership for Africa's Development (NEPAD) as an countries, we feel the courses generated a more sustained
entry point onto the continent's political agenda. Several engagement with participants.
regions also stressed the need for government support in
funding and developing biotechnology (see Table 4). This study serves to offer a taxonomy of potential actions
for harnessing biotechnology to improve health; however,
Summary some countries are already attempting to deal with the
Although the recommendations from the five courses dis- challenges listed above. Ongoing studies at our Centre
play nuances linked to regional differences in biotechnol- indicate that the Brazilian government has been trying to
ogy capacity and development, financial conditions, stimulate interactions between the public and private sec-
political frameworks, and population needs, fundamental tor, specifically through the creation of an innovation law
lessons emerge from their insights. These lessons reinforce meant to facilitate interactions between academia and
the results of another study rooted in developing world industry – due to this intervention, more and more private
expert insights that highlighted the same four key forces: companies are tapping into services within universities for
science; finance; ethics, society, and culture; and politics. research and product development. With regard to the
The similitude of the Courses' recommendations, despite challenge of intellectual property management, a recent
their independent generation in five different regions by report from Médecins sans Frontières calls for developing
over 200 participants, affirms the robustness of our countries to look to the success of Brazil and Thailand in
answer to how genomics and biotechnology can best issuing compulsory licenses [20].
serve the health of the world's poorest people. Below is a
summary of their recommendations based on those These recommendations will be useful to all those inter-
groupings (see Table 5). ested in supporting science, technology, and innovation
to improve health in the developing world – both for
Already, the courses have spurred development of bio- industrialized nations interested in supporting knowl-
technology capacity in the developing world. Beyond the edge-based approaches to science and developing nations
generation of recommendations, the Courses produced a looking to foster biotechnology innovation. Across the
network for future collaboration. For example, an Indian sectors of academia, government, industry, and civil soci-
participant invited to speak at the EMRO Course ety, scientists, policymakers, regulators, venture capital
explained that although the Course occurred amidst
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Table 2: Financial Recommendations
Africa India Eastern Mediterranean Latin America and the Caribbean Western Pacific/Southeast Asia
- Create sustainable financing - Develop independent, - Coordinate a national survey/ - Develop mechanisms of regional - Identification of cheaper alternative
mechanisms accountable, transparent inventory/situation analysis/needs cooperation to harness genomics and sources of energy
regulatory systems [...] for a single assessment of health biotechnology biotechnology for both health and - Develop and harmonize regulatory
entry, smart and effective system innovation systems, regulations, economic development. The policies including IP, biodiversity
- Improve industry-academic intellectual property policies, networks should not only pursue pure management, biosafety, movement of
interface with appropriate incentives private sector activity, and research but also applied problem solving genetic material, protection of
to improve public health and the strengths/weaknesses, opportunities investigation and product indigenous knowledge
nation's wealth and threats development - Create innovative business models
- Increase [government] funding for - Develop a proposal for a Regional - Facilitate the development of guidelines for economic and health care
healthcare research with appropriate Genomics and Health Research on intellectual property, biosafety, development and to support research
emphasis on genomics Fund emphasizing both peer-reviewed bioethics, regulation, and public - Identify appropriate entry points for
research and capacity strengthening awareness genomics/biotechnology (e.g. various
- The National Commission on - Adopt a strategic point of entry into forms of agriculture, genetic screening,
Biotechnology, in collaboration with genomics and biotechnology. traditional medicine, bioinformatics,
the relevant ministries, should Bioinformatics is one such potential point diagnostics for infectious diseases, etc)
develop a plan to integrate of entry; others should be identified - Explore formation of public-private
genetic and genomics products through foresight exercises conducted in partnerships to address regional and
(including diagnostics, vaccines, the region national health needs
therapies, and other genomic - Domestic small and medium
priorities), within the health system and enterprises in the region should form
public health programs strategic alliances and joint ventures,
with special emphasis on bringing
together organizations from different
countries in the region
Table 3: ESC Recommendations
Africa India Eastern Mediterranean Latin America and the Caribbean Western Pacific/Southeast Asia
BMC Public Health 2007, 7:346
N/A - Engage the public and ensure - The National Commission on - The population of the countries in - Engage their publics in ways that
broad-based input into policy setting Biotechnology should develop the region should be informed and inform, seek feedback and use the
- Ensure equitable access of poor to programs of public awareness and educated about the developments in feedback to inform policy
genomics products and services engagement. Important "publics" genomics and biotechnology, and in the - Increase capacity for research and
- Develop independent, accountable, here include media and religious impact of these disciplines in addressing development on ethical, legal,
transparent regulatory systems... based leaders as well as the public at large. local health needs environmental and social
on ethics to ensure that ethical, The discussion should include ethical implications
legal and social issues are issues
addressed - The emphasis should be on
accessibility and equity to improve
the health of the poor
8. Table 4: Political Recommendations
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Africa India Eastern Mediterranean Latin America and the Caribbean Western Pacific/Southeast Asia
- Identify champions among - Increase [government] funding for - Create National Commission on - Create, at the local and regional -Coordinate/undertake/conduct
politicians healthcare research with appropriate Genomics, Biotechnology and Health, levels, a strategy to strengthen strategic planning aimed at achieving
- Use the New Plan for African emphasis on genomics multisectoral membership include capacity in science, in technology, and sustainability of programs using
Development (NEPAD) as entry youth, women, and civil society. The in management measurable benchmarks for desired
point onto political agenda focus should include ethical issues -Establish a concrete genomics regional and national outcomes
- Based on evidence from the national and biotechnology public policy, a - Encourage proactive government
survey described above, governments strategy, and a plan of action to support
of member states should develop and develop and use these disciplines to - Advocate for public and private
adopt, at the highest level, a national address the country's most pressing support
biotechnology strategy health problems
- Regional Director EMRO may be - Build strategy at the regional
requested to address the level in order to promote the creation
governments at the highest level of international, interdisciplinary,
for actively considering the proposals multidisciplinary, and multi-institutional
of this workshop and for giving priority projects
attention to genomics for health and
health biotechnology. The political
leadership may be provided
effective advocacy material, with
special reference to its link with
poverty alleviation, public health
objectives, and need for transfer (and
internalization) of technology
Table 5: Summary Table of Recommendations from the Executive Courses on Genomics and Public Health Policy
Recommendations to Harness Genomics for Health in Developing Countries
SCIENCE
• Collaborate through national, regional, and international networks
• Survey and build capacity based on proven models through education, training, and needs assessments
FINANCE
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• Develop regulatory and intellectual property frameworks for commercialization of biotechnology
• Enhance funding and affordability of biotechnology
• Improve the academic-industry interface and the role of small and medium enterprise
ETHICS, SOCIETY, CULTURE
• Develop public engagement strategies to inform and educate the public about developments in genomics and biotechnology
• Develop capacity to address ethical, social and cultural issues
• Improve accessibility and equity
POLITICS
• Strengthen understanding, leadership and support at the political level for biotechnology
• Develop policies outlining national biotechnology strategy
9. BMC Public Health 2007, 7:346 http://www.biomedcentral.com/1471-2458/7/346
firms, industry representatives, and donor communities 10. Cohen JI: Harnessing Biotechnology for the Poor: challenges
ahead for capacity, safety and public investment. Journal of
will benefit from the applications of these insights. Human Development 2(2):239-263. 2001 Jul 1
11. Morris ML, Hoisington D: Bringing the benefits of biotechnol-
Biotechnology can act both as a catalyst to foster overall ogy to the poor:the role of the CGIAR centers. In Agricultural
Biotechnology in Developing Countries: Towards Optimizing the Benefits for
development of science and technology as well as the the Poor Edited by: Qaim M, Krattiger AF, von Braun J. Boston, Kluwer
development of practical solutions to local health needs. Academic Publishers; 2000:327-356.
These recommendations align holistically and act as 12. Proceedings of The Way Forward to Strengthen National
Plant Breeding and Biotechnology Capacity. Food and Agricul-
forces that will affect the development and adoption of ture Organization of the UN. Headquarters, Agriculture Department,
health biotechnology in the developing world [21]. Plant Production and Protection Division, Crop and Grassland Serv-
ice. 2005 Feb 9–11
Applying these recommendations broadly across sectors 13. Proceedings of the Biotechnology and Rural Livelihood –
and regions will empower developing countries them- Enhancing the Benefits Conference. The Hague, the Nether-
selves to harness the benefits of biotechnology and lands. International Service for National Agricultural Research Con-
sultation. 2001 June 25–28
genomics for billions who have long been excluded. 14. Smith AC, Mugabe J, Singer PA, Daar AS: Harnessing genomics to
improve health in Africa – an executive course to support
genomics policy. Bio-Med Central 2005, 3:2 [http://www.health-pol
Competing interests icy-systems.com/content/3/1/2].
The author(s) declare that they have no competing inter- 15. Acharya T, Kumar NK, Muthuswamy V, Daar AS, Singer PA: Har-
ests. nessing genomics to improve health in India – an executive
course to support genomics policy. Bio-Med Central 2004, 2:1
[http://www.health-policy-systems.com/content/2/1/1].
Authors' contributions 16. Acharya T, Abdur Rab M, Singer PA, Daar AS: Harnessing genom-
ASD and PAS designed and participated in all of the ics to improve health in the Eastern Mediterranean Region -
an executive course in genomics policy. BioMed Central 2005,
courses in addition to participating in the writing of this 3:1 [http://www.health-policy-systems.com/content/3/1/1].
paper. DLP led in the Western Pacific and Southeast Asia 17. Thorsteinsdóttir H, Quach U, Daar AS, Singer PAS: Promoting Bio-
technology Innovation in Developing Countries. Nature Bio-
Course and did the initial analysis of the recommenda- technology 2004, 22:DC48-DC52.
tions. KB analyzed the recommendations and drafted the 18. Kumar NK, Quach U, Thorsteinsdóttir H, Somsekhar H, Daar AS,
paper. All authors read and approved the final manu- Singer PA: Indian biotechnology--rapidly evolving and industry
led. Nat Biotechnol 22 Suppl():DC31-DC36.
script. 19. India, Pakistan establish closer cooperation in Biotechnol-
ogy. Pakistan Times, Business & Commerce Desk . 2004 Feb 29
20. Albano I, Padma TV: Learn from Brazil and Thai drug licenses,
Acknowledgements say MSF. Sci Dev Net . 25 July 2007
The authors would like to acknowledge our colleagues who led the individ- 21. Singer PA, Berndtson K, Tracy CS, Cohen ERM, Masum H, Daar AS:
ual Courses: Tara Acharya, Nandini Kumar, Mohammed Abdur Rab, Fabio A Tough Transition. Nature 449:160-163.
Salamanca-Buentello, Deepa L. Persad, Alyna Smith, and John Mugabe.
Funding for the Executive Courses came from Genome Canada, through Pre-publication history
the Ontario Genomics Institute, Canada's International Development The pre-publication history for this paper can be accessed
Research Centre, and the Ontario Research Fund. In the case of the East- here:
ern Mediterranean Region, partial funding came from the WHO EMRO
office. The Norwegian government provided some funding for the African
Course.
http://www.biomedcentral.com/1471-2458/7/346/pre
pub
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