Publications by authors named "Abdallah S Daar"

117 Publications

Nanotechnology, equity and global health.

Nat Nanotechnol 2021 04;16(4):358-361

Department of Surgery, Temerty Faculty of Medicine, Toronto, Ontario (Emeritus), Canada.

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http://dx.doi.org/10.1038/s41565-021-00899-zDOI Listing
April 2021

The ethical, social, and cultural dimensions of screening for mental health in children and adolescents of the developing world.

PLoS One 2020 24;15(8):e0237853. Epub 2020 Aug 24.

Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.

Despite their burden and high prevalence, mental health disorders of children and adolescents remain neglected in many parts of the world. In developing countries, where half of the population is younger than 18 years old, one of every five children and adolescents is estimated to suffer from a mental health disorder. It is then essential to detect these conditions through screening in a timely and accurate manner. But such screening is fraught with considerable ethical, social, and cultural challenges. This study systematically identifies, for the first time, these challenges, along with potential solutions to address them. We report on the results of an international multi- and inter-disciplinary three-round Delphi survey completed by 135 mental health experts from 37 countries. We asked these experts to identify and rank the main ethical, social, and cultural challenges of screening for child and adolescent mental health problems in developing nations, and to propose solutions for each challenge. Thirty-nine significant challenges emerged around eight themes, along with 32 potential solutions organized into seven themes. There was a high degree of consensus among the experts, but a few interesting disagreements arose between members of the panel from high-income countries and those from low- and middle-income nations. The panelists overwhelmingly supported mental health screening for children and adolescents. They recommended ensuring local acceptance and support for screening prior to program initiation, along with careful and comprehensive protection of human rights; integrating screening procedures into primary care; designing and implementing culturally appropriate screening tools, programs, and follow-up; securing long-term funding; expanding capacity building; and task-shifting screening to local non-specialists. These recommendations can serve as a guide for policy and decision-making, resource allocation, and international cooperation. They also offer a novel approach to reduce the burden of these disorders by encouraging their timely and context-sensitive prevention and management.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237853PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7446846PMC
October 2020

Developmental origins of health and disease in Africa-influencing early life.

Lancet Glob Health 2018 03;6(3):e244-e245

Stellenbosch Institute for Advanced Study, Wallenberg Research Centre at Stellenbosch University, Stellenbosch 7600, South Africa; Dalla Lana School of Public Health and Department of Surgery, University of Toronto, ON, Canada.

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http://dx.doi.org/10.1016/S2214-109X(18)30036-6DOI Listing
March 2018

The World's Youngest Cadaveric Kidney Transplant: Medical, Surgical and Ethical Issues.

Transplant Direct 2016 Dec 16;2(12):e117. Epub 2016 Nov 16.

Department of Medicine, Sultan Qaboos University, Muscat, Oman, Al Khoudh, Muscat, Sultanate of Oman.

Background: We report here the first successful transplant from a preterm cadaveric donor. This was performed in November 1994. The donor, who had been born at about 33 weeks of gestation, was diagnosed as having agenesis of the corpus callosum. The transplant was carried out 10 days after the donor's birth. The recipient was a 17-month-old boy with a diagnosis of Denys-Drash syndrome (WT1 mutation).

Method: We describe and analyze the ethical, social, cultural, medical and surgical issues encountered and how these were addressed. The major issue of determining death in a beating heart, very young donor was dealt with in the absence of worldwide experience and guidelines.

Results: The transplanted recipient has lived with the grafted pair of kidneys for more then 22 years. He has led a relatively normal life.

Conclusions: It is possible for immature preterm deceased donor kidneys to be transplanted into a 17-month-old recipient and for the grafted kidneys to grow with the recipient and function for 22 years. There were challenges in ethically determining the death of the donor, in surgical techniques to obviate potential surgical complications, and in postoperative care of the recipient, but these were managed successfully.
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http://dx.doi.org/10.1097/TXD.0000000000000631DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142357PMC
December 2016

Progress in human embryonic stem cell research in the United States between 2001 and 2010.

PLoS One 2015 26;10(3):e0120052. Epub 2015 Mar 26.

Sandra Rotman Centre, University of Toronto and University Health Network, Toronto, Canada; Dalla Lana School of Public Health and Dept. of Surgery, University of Toronto, Toronto, Canada; Stellenbosch Institute for Advanced Study, Wallenberg Research Centre, University of Stellenbosch, Stellenbosch, South Africa.

On August 9th, 2001, the federal government of the United States announced a policy restricting federal funds available for research on human embryonic stem cell (hESCs) out of concern for the "vast ethical mine fields" associated with the creation of embryos for research purposes. Until the policy was repealed on March 9th, 2009, no U.S. federal funds were available for research on hESCs extracted after August 9, 2001, and only limited federal funds were available for research on a subset of hESC lines that had previously been extracted. This paper analyzes how the 2001 U.S. federal funding restrictions influenced the quantity and geography of peer-reviewed journal publications on hESC. The primary finding is that the 2001 policy did not have a significant aggregate effect on hESC research in the U.S. After a brief lag in early 2000s, U.S. hESC research maintained pace with other areas of stem cell and genetic research. The policy had several other consequences. First, it was tied to increased hESC research funding within the U.S. at the state level, leading to concentration of related activities in a relatively small number of states. Second, it stimulated increased collaborative research between US-based scientists and those in countries with flexible policies toward hESC research (including Canada, the U.K., Israel, China, Spain, and South Korea). Third, it encouraged independent hESC research in countries without restrictions.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0120052PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4374681PMC
March 2016

Declaration on mental health in Africa: moving to implementation.

Glob Health Action 2014 13;7:24589. Epub 2014 Jun 13.

Department of Psychiatry, University of Nairobi, Nairobi, Kenya; Africa Mental Health Foundation, Montreal, Canada.

Urgent action is needed to address mental health issues globally. In Africa, where mental health disorders account for a huge burden of disease and disability, and where in general less than 1% of the already small health budgets are spent on these disorders, the need for action is acute and urgent. Members of the World Health Organization, including African countries, have adopted a Comprehensive Mental Health Action Plan. Africa now has an historic opportunity to improve the mental health and wellbeing of its citizens, beginning with provision of basic mental health services and development of national mental health strategic plans (roadmaps). There is need to integrate mental health into primary health care and address stigma and violations of human rights. We advocate for inclusion of mental health into the post-2015 Sustainable Development Goals, and for the convening of a special UN General Assembly High Level Meeting on Mental Health within three years.
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http://dx.doi.org/10.3402/gha.v7.24589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4058779PMC
February 2015

A survey of international legal instruments to examine their effectiveness in improving global health and in realizing health rights.

J Law Med Ethics 2013 ;41(1):89-102

University of Toronto.

Many global health issues, almost by definition, do not recognize state borders and therefore require bi-lateral, or more often multi-lateral international solutions. These latter solutions are articulated in international instruments (declarations, conventions, treaties, constitutions of international bodies, etc). However, the gap between formal adoption of such instruments by signatory states and substantive implementation of the articulated solutions can be very wide. This paper surveys a selection of international legal instruments, including those where the sought after positive outcomes have been achieved, and those that have been ineffective, with little or no real progress being made. The paper looks for commonalities, both in the nature of the problems and the forms of the international legal instruments, to seek answers as to why some instruments ultimately succeeded where others failed. It also provides some guidance to law/ treaty makers to help ensure that they frame future instruments in such a way as to maximize the probability that those instruments will have a substantive positive impact on global health and health rights.
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http://dx.doi.org/10.1111/jlme.12007DOI Listing
March 2014

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Health Res Policy Syst 2012 Jun 6;10:18. Epub 2012 Jun 6.

Munk School of Global Affairs, University of Toronto, Toronto, Canada.

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.
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http://dx.doi.org/10.1186/1478-4505-10-18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424104PMC
June 2012

The use of race, ethnicity and ancestry in human genetic research.

Hugo J 2011 Dec 7;5(1-4):47-63. Epub 2011 Jul 7.

Post-Human Genome Project progress has enabled a new wave of population genetic research, and intensified controversy over the use of race/ethnicity in this work. At the same time, the development of methods for inferring genetic ancestry offers more empirical means of assigning group labels. Here, we provide a systematic analysis of the use of race/ethnicity and ancestry in current genetic research. We base our analysis on key published recommendations for the use and reporting of race/ethnicity which advise that researchers: explain why the terms/categories were used and how they were measured, carefully define them, and apply them consistently. We studied 170 population genetic research articles from high impact journals, published 2008-2009. A comparative perspective was obtained by aligning study metrics with similar research from articles published 2001-2004. Our analysis indicates a marked improvement in compliance with some of the recommendations/guidelines for the use of race/ethnicity over time, while showing that important shortfalls still remain: no article using 'race', 'ethnicity' or 'ancestry' defined or discussed the meaning of these concepts in context; a third of articles still do not provide a rationale for their use, with those using 'ancestry' being the least likely to do so. Further, no article discussed potential socio-ethical implications of the reported research. As such, there remains a clear imperative for highlighting the importance of consistent and comprehensive reporting on human populations to the genetics/genomics community globally, to generate explicit guidelines for the uses of ancestry and genetic ancestry, and importantly, to ensure that guidelines are followed.
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http://dx.doi.org/10.1007/s11568-011-9154-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3237839PMC
December 2011

Stakeholder involvement in expensive drug recommendation decisions: an international perspective.

Health Policy 2012 May 5;105(2-3):226-35. Epub 2012 Jan 5.

Department of Pediatrics, McMaster University, Canada.

Objectives: To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees.

Methods: We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives.

Results: Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process.

Conclusions: A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process.
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http://dx.doi.org/10.1016/j.healthpol.2011.12.002DOI Listing
May 2012

Incentives for organ donation: proposed standards for an internationally acceptable system.

Am J Transplant 2012 Feb 17;12(2):306-12. Epub 2011 Dec 17.

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today's conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered.
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http://dx.doi.org/10.1111/j.1600-6143.2011.03881.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3350332PMC
February 2012

The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries.

BMC Public Health 2011 Oct 18;11:811. Epub 2011 Oct 18.

Department of Health Aging and Society, McMaster University, Hamilton, Ontario, L8S 4M4, Canada.

Background: Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries.

Discussion: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials.

Summary: While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.
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http://dx.doi.org/10.1186/1471-2458-11-811DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3339411PMC
October 2011

Chronic Non-communicable Diseases as a Threat for All: Recent Global Initiatives.

Authors:
Abdallah S Daar

Sultan Qaboos Univ Med J 2010 Dec 14;10(3):306-9. Epub 2010 Nov 14.

Dalla Lana School of Public Health Sciences and Department of Surgery, University of Toronto, Canada; McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Canada; Global Alliance for Chronic DIseases. Email:

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074726PMC
December 2010

Admixture mapping: from paradigms of race and ethnicity to population history.

Hugo J 2010 Dec 26;4(1-4):23-34. Epub 2010 Sep 26.

Admixture mapping is a whole genome association strategy that takes advantage of population history-or genetic ancestry-to map genes for complex diseases. However, because it uses racial/ethnic groupings to examine differential disease risk, admixture mapping raises ethical and social concerns. While there has been much theoretical commentary regarding the ethical and social implications of population-based genetic research, empirical data from stakeholders most closely involved with these studies is limited. One of the first admixture mapping studies carried out was a scan for Multiple Sclerosis (MS) risk factors in an African-American population. Applying qualitative research methods, we used this example to explore developing views, experiences and perceptions of the ethical and social implications of admixture mapping and other population-based research-their value, risks and benefits, and the future prospects of the field. Additionally, we sought to understand how social and ethical risks might be mitigated, and the benefits of this research optimized. We draw on in-depth, one-on-one interviews with leading population geneticists, genome scientists, bioethicists, and African-Americans with MS. Here we present our findings from this unique group of key informants and stakeholders.
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http://dx.doi.org/10.1007/s11568-010-9145-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051047PMC
December 2010

Health biotechnology innovation on a global stage.

Nat Rev Microbiol 2011 02;9(2):137-43

Halla Thorsteinsdóttir is at the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario M5T 3M7, Canada.

With increasing globalization, infectious diseases are spreading faster than ever before, creating an urgent need for international collaboration. The rise of emerging economies has changed the traditional collaborative landscape and provided opportunities for more diverse models of collaboration involving developing countries, including North-South, South-South and North-South-South partnerships. Here, we discuss how developing countries can partner with other nations to address their shared health problems and to promote innovation. We look specifically at what drives collaborations and at the challenges that exist for them, and we propose actions that can strengthen these partnerships.
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http://dx.doi.org/10.1038/nrmicro2492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096843PMC
February 2011

Global health. Stagnant health technologies in Africa.

Science 2010 Dec;330(6010):1483-4

McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Toronto ON, M5G 1L7, Canada.

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http://dx.doi.org/10.1126/science.1195401DOI Listing
December 2010

Africa's largest long-lasting insecticide-treated net producer: lessons from A to Z Textiles.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S6. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto ON, M5G 1L7, Canada.

Background: Field trials have demonstrated the efficacy of insecticide-treated nets, and the WHO has recently endorsed a shift toward Long-Lasting Insecticide Treated nets (LLINs) due to factors such as reduced distribution costs. However, the need for LLINs poses several challenges. Is it possible to manufacture LLINs in large quantities in the African continent, where malaria is most endemic? When production is located in low-income countries, what role is played by local funding and employment, scaling up manufacturing, and partnerships? What factors influence availability and pricing?

Discussion: A case study of A to Z Textiles was undertaken to answer the question of how large-scale production of LLINs can occur in a low income setting. One of the largest sources of bed nets for Africa, A to Z Textiles is Africa-based, and its Tanzanian operations have a production capacity of 30 million LLINs per year, along with full WHO recommendation for its nets. Our analysis is based on semi-structured interviews with key informants familiar with A to Z, site visits in Tanzania, and literature reviews.This paper discusses the history and current status of A to Z Textiles, identifies the factors that led to its success, and suggests policy considerations that could support similar initiatives in the future. Local funding, scaling up manufacturing, technology transfer, and partnerships all played important roles in A to Z's ascent, as did perceived benefits of local employment and capacity-building. Regulatory issues and procurement rules acted as barriers. A to Z cost-effectively manufactures high-quality LLINs where malaria is most endemic.

Summary: With a production capacity of 30 million LLINs per year, and full WHOPES (WHO Pesticide Evaluation Scheme) certification, A to Z Textiles demonstrates how key health goods can be successfully produced in the low-income countries that use them. Its example may be instructive and of high interest to readers in the malaria community, especially in developing countries, and to those who wish to support or partner with efforts by developing countries to build their health innovation capacity.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001614PMC
December 2010

Science-based health innovation in Uganda: creative strategies for applying research to development.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S5. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, at the University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario, M5G 1L7, Canada.

Background: Uganda has a long history of health research, but still faces critical health problems. It has made a number of recent moves towards building science and technology capacity which could have an impact on local health, if innovation can be fostered and harnessed.

Methods: Qualitative case study research methodology was used. Data were collected through reviews of academic literature and policy documents and through open-ended, face-to-face interviews with 30 people from across the science-based health innovation system, including government officials, researchers in research institutes and universities, entrepreneurs, international donors, and non-governmental organization representatives.

Results: Uganda has a range of institutions influencing science-based health innovation, with varying degrees of success. However, the country still lacks a coherent mechanism for effectively coordinating STI policy among all the stakeholders. Classified as a least developed country, Uganda has opted for exemptions from the TRIPS intellectual property protection regime that include permitting parallel importation and providing for compulsory licenses for pharmaceuticals. Uganda is unique in Africa in taking part in the Millennium Science Initiative (MSI), an ambitious though early-stage $30m project, funded jointly by the World Bank and Government of Uganda, to build science capacity and encourage entrepreneurship through funding industry-research collaboration. Two universities - Makerere and Mbarara - stand out in terms of health research, though as yet technology development and commercialization is weak. Uganda has several incubators which are producing low-tech products, and is beginning to move into higher-tech ones like diagnostics. Its pharmaceutical industry has started to create partnerships which encourage innovation.

Conclusions: Science-based health product innovation is in its early stages in Uganda, as are policies for guiding its development. Nevertheless, there is political will for the development of STI in Uganda, demonstrated through personal initiatives of the President and the government's willingness to invest heavily for the long term in support of STI through the Millennium Science Initiative. Activities to support technology transfer and private-public collaboration have been put in motion; these need to be monitored, coordinated, and learned from. In the private sector, there are examples of incremental innovation to address neglected diseases driven by entrepreneurial individuals and South-South collaboration. Lessons can be learned from their experience that will help support Ugandan health innovation.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001613PMC
December 2010

Science-based health innovation in Tanzania: bednets and a base for invention.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S4. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, at the University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario, M5G 1L7, Canada.

Background: Tanzania is East Africa's largest country. Although it is socially diverse, it has experienced general political stability since independence in 1964. Despite gradual economic development and Tanzania's status as one of the biggest recipients of aid in Africa, health status remains poor. This paper explores Tanzania's science-based health innovation system, and highlights areas which can be strengthened.

Methods: Qualitative case study research methodology was used. Data were collected through reviews of academic literature and policy documents, and through open-ended, face-to-face interviews with 52 people from across the science-based health innovation system over two visits to Tanzania from July to October 2007.

Results And Discussion: Tanzania has a rich but complex S&T governance landscape, with the public sector driving the innovation agenda through a series of different bodies which are not well-coordinated. It has some of the leading health research on the continent at the University of Dar es Salaam, Muhimbili University of Health and Applied Sciences, the National Institute for Medical Research and the Ifakara Medical Institute, with strong donor support. Tanzania has found developing an entrepreneurial culture difficult; nevertheless projects such as the clusters initiative at the University of Dar es Salaam are encouraging low-tech innovation and overcoming knowledge-sharing barriers. In the private sector, one generics company has developed a South-South collaboration to enable technology transfer and hence the local production of anti-retrovirals. Local textile company A to Z Textiles is now manufacturing 30 million insecticide impregnated bednets a year.

Conclusions: To have a coherent vision for innovation, Tanzania may wish to address some key issues: coordination across stakeholders involved with health research, increasing graduates in health-related disciplines, and building capabilities in biological testing, preclinical testing, formulation and standardization, and related areas important to moving from basic research to applications. The private sector can be encouraged to innovate through improved access to financing, and incentives for R&D. The diaspora community represents an untapped source for partnerships and access to other developing world markets and technology. The government may wish to set up mechanisms to encourage south-south collaborations, and to bring the public and private sector together around specific projects to help realize the country's innovation potential.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001612PMC
December 2010

Science-based health innovation in Rwanda: unlocking the potential of a late bloomer.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S3. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, at the University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario, M5G 1L7, Canada.

Background: This paper describes and analyses Rwanda's science-based health product 'innovation system', highlighting examples of indigenous innovation and good practice. We use an innovation systems framework, which takes into account the wide variety of stakeholders and knowledge flows contributing to the innovation process. The study takes into account the destruction of the country's scientific infrastructure and human capital that occurred during the 1994 genocide, and describes government policy, research institutes and universities, the private sector, and NGOs that are involved in health product innovation in Rwanda.

Methods: Case study research methodology was used. Data were collected through reviews of academic literature and policy documents and through open-ended, face-to-face interviews with 38 people from across the science-based health innovation system. Data was collected over two visits to Rwanda between November - December 2007 and in May 2008. A workshop was held in Kigali on May 23rd and May 24th 2009 to validate the findings. A business plan was then developed to operationalize the findings.

Results And Discussion: The results of the study show that Rwanda has strong government will to support health innovation both through its political leadership and through government policy documents. However, it has a very weak scientific base as most of its scientific infrastructure as well as human capital were destroyed during the 1994 genocide. The regulatory agency is weak and its nascent private sector is ill-equipped to drive health innovation. In addition, there are no linkages between the various actors in the country's health innovation system i.e between research institutions, universities, the private sector, and government bureaucrats.

Conclusions: Despite the fact that the 1994 genocide destroyed most of the scientific infrastructure and human capital, the country has made remarkable progress towards developing its health innovation system, mainly due to political goodwill. The areas of greatest potential for Rwanda are in traditional plant technologies. However, there is need for investments in domestic skill development as well as infrastructure that will enhance innovation. Of foremost importance is the establishment of a platform to link the various actors in the health innovation system.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001611PMC
December 2010

Science-based health innovation in Ghana: health entrepreneurs point the way to a new development path.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S2. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, at the University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario, M5G 1L7, Canada.

Background: Science, technology and innovation have long played a role in Ghana's vision for development, including in improving its health outcomes. However, so far little research has been conducted on Ghana's capacity for health innovation to address local diseases. This research aims to fill that gap, mapping out the key actors involved, highlighting examples of indigenous innovation, setting out the challenges ahead and outlining recommendations for strengthening Ghana's health innovation system.

Methods: Case study research methodology was used. Data were collected through reviews of academic literature and policy documents and through open-ended, face-to-face interviews with 48 people from across the science-based health innovation system. Data was collected over three visits to Ghana from February 2007 to August 2008, and stakeholders engaged subsequently.

Results: Ghana has strengths which could underpin science-based health innovation in the future, including health and biosciences research institutions with strong foreign linkages and donor support; a relatively strong regulatory system which is building capacity in other West African countries; the beginnings of new funding forms such as venture capital; and the return of professionals from the diaspora, bringing expertise and contacts. Some health products and services are already being developed in Ghana by individual entrepreneurs, which are innovative in the sense of being new to the country and, in some cases, the continent. They include essential medicines, raw pharmaceutical materials, new formulations for pediatric use and plant medicines at various stages of development.

Conclusions: While Ghana has many institutions concerned with health research and its commercialization, their ability to work together to address clear health goals is low. If Ghana is to capitalize on its assets, including political and macroeconomic stability which underpin investment in health enterprises, it needs to improve the health innovation environment through increasing support for its small firms; coordinating policies; and beginning a dialogue with donors on how health research can create locally-owned knowledge and be more demand-driven. Mobilizing stakeholders around health product development areas, such as traditional medicines and diagnostics, would help to create trust between groups and build a stronger health innovation system.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001610PMC
December 2010

Venture funding for science-based African health innovation.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S12. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto ON, M5G 1L7, Canada.

Background: While venture funding has been applied to biotechnology and health in high-income countries, it is still nascent in these fields in developing countries, and particularly in Africa. Yet the need for implementing innovative solutions to health challenges is greatest in Africa, with its enormous burden of communicable disease. Issues such as risk, investment opportunities, return on investment requirements, and quantifying health impact are critical in assessing venture capital's potential for supporting health innovation. This paper uses lessons learned from five venture capital firms from Kenya, South Africa, China, India, and the US to suggest design principles for African health venture funds.

Discussion: The case study method was used to explore relevant funds, and lessons for the African context. The health venture funds in this study included publicly-owned organizations, corporations, social enterprises, and subsidiaries of foreign venture firms. The size and type of investments varied widely. The primary investor in four funds was the International Finance Corporation. Three of the funds aimed primarily for financial returns, one aimed primarily for social and health returns, and one had mixed aims. Lessons learned include the importance of measuring and supporting both social and financial returns; the need to engage both upstream capital such as government risk-funding and downstream capital from the private sector; and the existence of many challenges including difficulty of raising capital, low human resource capacity, regulatory barriers, and risky business environments. Based on these lessons, design principles for appropriate venture funding are suggested.

Summary: Based on the cases studied and relevant experiences elsewhere, there is a case for venture funding as one support mechanism for science-based African health innovation, with opportunities for risk-tolerant investors to make financial as well as social returns. Such funds should be structured to overcome the challenges identified, be sustainable in the long run, attract for-profit private sector funds, and have measurable and significant health impact. If this is done, the proposed venture approach may have complementary benefits to existing initiatives and encourage local scientific and economic development while tapping new sources of funding.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S12DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001609PMC
December 2010

The road to commercialization in Africa: lessons from developing the sickle-cell drug Niprisan.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S11. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto ON, M5G 1L7, Canada.

Background: Developing novel drugs from traditional medicinal knowledge can serve as a means to improve public health. Yet countries in sub-Saharan Africa face barriers in translating traditional medicinal knowledge into commercially viable health products. Barriers in moving along the road towards making a new drug available include insufficient manufacturing capacity; knowledge sharing between scientists and medical healers; regulatory hurdles; quality control issues; pricing and distribution; and lack of financing. The case study method was used to illustrate efforts to overcome these barriers during the development in Nigeria of Niprisan - a novel drug for the treatment of sickle cell anemia, a chronic blood disorder with few effective therapies.

Discussion: Building on the knowledge of a traditional medicine practitioner, Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) developed the traditional herbal medicine Niprisan. The commercialization of Niprisan reached a number of commercial milestones, including regulatory approval in Nigeria; securing US-based commercial partner XeChem; demonstrating clinical efficacy and safety; being awarded orphan drug status by the US Food and Drug Administration; and striking important relationships with domestic and international groups. Despite these successes, however, XeChem did not achieve mainstream success for Niprisan in Nigeria or in the United States. A number of reasons, including inconsistent funding and manufacturing and management challenges, have been put forth to explain Niprisan's commercial demise. As of this writing, NIPRD is considering options for another commercial partner to take the drug forward.

Summary: Evidence from the Niprisan experience suggests that establishing benefit-sharing agreements, fostering partnerships with established research institutions, improving standardization and quality control, ensuring financial and managerial due diligence, and recruiting entrepreneurial leaders capable of holding dual scientific and business responsibilities should be incorporated into future drug development initiatives based on traditional medicines. Country-level supporting policies and conditions are also important. With more experience and support, and an improved environment for innovation, developing new drugs from traditional medicines may be an attractive approach to addressing diseases in sub-Saharan Africa and other regions.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001608PMC
December 2010

Science-based health innovation in sub-Saharan Africa.

BMC Int Health Hum Rights 2010 Dec 13;10 Suppl 1:S1. Epub 2010 Dec 13.

McLaughlin-Rotman Centre for Global Health, at the University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario, M5G 1L7, Canada.

In recent years emerging markets such as India, China, and Brazil have developed appropriate business models and lower-cost technological innovations to address health challenges locally and internationally. But it is not well understood what capabilities African countries, with their high disease burden, have in science-based health innovation.This gap in knowledge is addressed by this series in BMC International Health and Human Rights. The series presents the results of extensive on-the-ground research in the form of four country case studies of health and biotechnology innovation, six studies of institutions within Africa involved in health product development, and one study of health venture funds in Africa. To the best of our knowledge it is the first extensive collection of empirical work on African science-based health innovation.The four country cases are Ghana, Rwanda, Tanzania and Uganda. The six case studies of institutions are A to Z Textiles (Tanzania), Acorn Technologies (South Africa), Bioventures venture capital fund (South Africa), the Malagasy Institute of Applied Research (IMRA; Madagascar), the Kenyan Medical Research Institute (KEMRI; Kenya), and Niprisan's development by Nigeria's National Institute for Pharmaceutical Research and Development and Xechem (Nigeria).All of the examples highlight pioneering attempts to build technological capacity, create economic opportunities, and retain talent on a continent significantly affected by brain drain. They point to the practical challenges for innovators on the ground, and suggest potentially helpful policies, funding streams, and other support systems.For African nations, health innovation represents an opportunity to increase domestic capacity to solve health challenges; for international funders, it is an opportunity to move beyond foreign aid and dependency. The shared goal is creating self-sustaining innovation that has both health and development impacts. While this is a long-term strategy, this series shows the potential of African-led innovation, and indicates how it might balance realism against opportunity. There is ample scope to learn lessons more systematically from cases like those we discuss; to link entrepreneurs, scientists, funders, and policy-makers into a network to share opportunities and challenges; and ultimately to better support and stimulate African-led health innovation.
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http://dx.doi.org/10.1186/1472-698X-10-S1-S1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001606PMC
December 2010
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