Global health experts today published a landmark collection of papers that together provide a unique microscope on the experience of countries, companies and organizations in sub-Saharan Africa addressing neglected health problems with homegrown drugs, vaccines, diagnostics and other creative scientific and business solutions.
The first-of-its kind study chronicles the triumphs and troubles of entrepreneurs, institutes and firms in Africa creating innovative, affordable technologies that bring hope to many sufferers of local diseases. While some have yet to succeed, several organizations cleared major hurdles to finance and create products, some of which may expand into global markets one day.
It is the first research offering a broad range of evidence and concrete examples of African innovation to address local health concerns. The papers draw on the experiences of authorities, researchers and entrepreneurs in Ghana, Kenya, Madagascar, Nigeria, Rwanda, South Africa, Tanzania, and Uganda. In addition to efforts involving health products, the experiences of health venture capital funds in African and other developed countries are profiled.
The papers were produced by Canada's McLaughlin-Rotman Center for Global Health (MRC), at the University Health Network and University of Toronto, and published as a special supplement in the UK-based open-access journal publisher BioMed Central Dec. 12 (with full public access at www.biomedcentral.com/bmcinthealthhumrights/10?issue=S1). One of the papers was published earlier in the journal Science.
The authors hope their work helps scale up and sustain work underway, while inspiring other organizations and countries to follow suit with the benefit of lessons learned by these African pioneers.
Says MRC Director Peter Singer: "If Africans are to prevail over diseases that kill and maim millions each year, they must do so by unleashing the formidable talents of their own African scientists and entrepreneurs. In the long term, the sustainable solutions to Africa's health problems rest with the home team."
"The large firms of the developed world producing drugs, vaccines, diagnostics and other health products are a great resource and partner. But many people will die if we wait for scientists from elsewhere to invent and market the health products Africa needs. These studies demonstrate that, with the right partners and incentives along with support from governments at home and abroad, Africans have the scientific creativity and entrepreneurial talent to improve local health and prosper at the same time."
"Our message to international agencies, donors and African governments: support these enterprises and nurture their potential, because they can make a major contribution to better health in developing countries - and to their own health. At the end of the day, this is about enabling people to solve their own problems, not only using science but also combining it with entrepreneurship."
Since it began in 2004, the MRC has focused extensively on how low-income countries themselves can remedy diseases of poverty. With relatively little profit incentive, firms in rich, developed countries largely neglect such diseases. The MRC has documented the benefits of the homegrown science approach to health problems, which include, beyond affordable products, less dependency on international donor programs and much-needed new economic opportunities and job creation. This collection represents the MRC's largest contribution to date on product commercialization for improving health in Africa.
Examples of African innovation:
"Concern over access to essential medicines have dominated international health policy debates over the last two decades," Harvard professor Calestous Juma says in a preface to the work. The debates, centered on intellectual property rights, wrongly assume that Africa will remain "a marginal player in the world of health innovation and will continue to rely on imported solutions.
"This collection of original papers provides a different prognosis. They reveal an emergent 'health innovation system' in Africa that is driven by a combination of local research, entrepreneurship and institutional adaptations."
The research complements a related MRC paper, published Dec. 10 in Science, about so-called "stagnant technologies" in sub-Saharan Africa - products with the potential to save many lives, but which exist only in a lab due to a failure of commercialization or support.
Led by researcher Ken Simiyu, some 25 such products were identified languishing in health research institutions in Africa, some already validated but not yet converted to a product or service. Of the 25 stagnant technologies found, 16 involved traditional plant products; the rest were new drug molecules, diagnostics, vaccines and medical devices.
Meanwhile, at the International Centre for Insect Physiology and Ecology in Kenya, researchers have patented human odors that effectively repel mosquitoes. While there is a need to determine formulations through further research, negotiations are underway with a multinational company.
Among conclusions of the MRC research teams:
"Driven largely by entrepreneurs, innovative and affordable technologies to improve health in Africa are under development throughout the continent, with firms using a variety of business models in a range of political environments," says MRC researcher Ken Simiyu.
"Clearly, many Africans have the needed talent and know-how. However, the seeds of their efforts need careful nurturing by both donors and African governments at all levels. Required are creative institutions and coherent policies that reduce risk, build on local strengths, and promote the effective use of local health research."
Says Abdallah S. Daar, MRC Senior Scientist and Director of Ethics and Commercialization: "We are all affected in one way or another by the health and well-being of everyone else on Earth. What we present is a look at many African companies and countries striving to create local health products for local needs. Understanding all aspects of their experiences - what worked, what didn't, and what could have been done better - is a huge leg up for other firms and governments who wish to stand on the shoulders of these pioneers."
The papers in full, to be published (with open public access) will be published Sunday Dec. 12 as a special open-access BMC supplement at www.biomedcentral.com/bmcinthealthhumrights/10?issue=S1
A 25-minute interview on this topic with MRC Director Peter Singer and researcher Ken Simiyu is available online from Dec. 12 at www.mrcglobal.org/projects/african_innovation
Company studies in brief
Africa's largest long-lasting insecticide-treated net producer:
Lessons from A to Z Textiles
Authors Hassan Masum, Ronak Shah, Karl Schroeder, Abdallah S. Daar and Peter A. Singer say A to Z Textiles exemplifies how large-scale production of an important health product, Long-Lasting Insecticide Treated Nets (LLINs), can succeed in a low income setting.
One of the largest sources of bed nets for Africa, and the largest manufacturer in Africa itself, A to Z Textiles of Tanzania cost-effectively produces tens of millions high-quality LLINs where malaria is most endemic, and the World Health Organization certifies its product.
Local funding, economies of scale, technology transfer, and partnerships all played important roles in A to Z's success, as did perceived benefits of local employment and capacity-building. Regulatory issues and procurement rules were barriers.
The company's success was achieved without tariffs or other protectionist measures. Many such opportunities have been documented in the African context, such as manufacturing common medical supplies.
"Ultimately, success is enabled by responsiveness to opportunities, willingness to invest and take risks, ability to execute, and strong leadership," the authors say. "A to Z and its partners have not only successfully created an African source for public health goods, but have demonstrated tremendous commitment to the endeavor."
Continued success is not assured, they add, due to the looming plateau in demand for LLINs, competition from LLINs from Asia, and the entry of more African LLIN manufacturers. "All suggest the need for continued innovation to stay in business."
Can incubators work in Africa?
Acorn Technologies and the entrepreneur-centric model
Authors Justin Chakma, Hassan Masum and Peter A. Singer define business "incubators" as organizations that support the growth of new and typically technology-based enterprises, and the confluence of human and financial capital.
Although traditionally incubators have been used for economic development, they can also help improve global health by fostering the development and delivery of local innovation in developing countries.
The study describes the success of South Africa's Acorn Technologies in establishing Real World Diagnostics, a biomedical device firm that developed rapid strip tests for local diseases, including schistosomiasis and HIV, and reported $2 million (USD) in revenue in 2009.
Acorn achieved this while operating as a non-profit and with little physical infrastructure. A virtual business model effectively reduced fixed costs and Acorn focused on mentoring entrepreneurship, offering training, and networking.
Key to Acorn's achievement: identify entrepreneurs with technologies offering both health and economic impact, and provide them flexible support from an early stage. Where needed experience did not exist locally, they sought out international networking and mentorship.
"With the right policies and business models, incubators have the potential to generate economic and health benefits for Africa."
Among other recommendations: Pool the resources of African countries with scientific strengths to create regional innovation centers and communities, which bring together science, networks of practice, entrepreneurship, and capital.
Venture capital on a shoestring: Bioventures' pioneering life sciences fund in South Africa
Authors Hassan Masum and Peter A. Singer examined the modest but promising success of Cape Town's Bioventures, a rare life sciences venture capital firm in sub-Saharan Africa, operating on a relative "shoestring" of US$12 million.
It has supported eight innovative South African firms since 2002, notably Disa Vascular, a creator of stents for heart patients.
Beyond providing funds, Bioventures' support to investees included board participation, contacts, and strategic services.
"Bioventures had to be proactive in finding and supporting good R&D, and not merely wait for the ideal company to walk through the door," the authors say.
"Providing hands-on support to early-stage health ventures posed problems - due to the fund's relatively small size, overhead and management expenses were tightly constrained. Bioventures sometimes wasn't able to make follow-on investments, being forced instead to give up equity to raise follow-on investment capital."
The firm nonetheless "represents a significant accomplishment: creating a life sciences investment fund in Africa," the authors say. It has shown how a small African venture capital firm can successfully help create research and development-based health technology companies.
Among hurdles to be overcome by Disa Vascular: finding local people experienced in taking a new biomedical device through the European regulatory process, as well as breaking into international markets.
Partnering with a larger fund is among the recommendations, with local venture capital firms perhaps acting "as a sort of technology scout and early stage developer, with the larger fund being available for follow-on investments as successful investees grow."
The Bioventures experience also suggests that future health care technology funds targeting ailments of the poor might require investors to accept health benefits as part of their overall "return."
The Malagasy Institute of Applied Research (IMRA)
Biopiracy - the use of a people's long-established medical knowledge without acknowledgement or compensation - has been a disturbing historical reality and exacerbates the global rich-poor divide.
Bioprospecting, however, describes the commercialization of indigenous medicines in a manner acceptable to the local people. Bioprospectors seeking to develop traditional medicines in a quality-controlled manner face several challenges, however: a lack of skilled labor and high-tech infrastructure, adapting developed world R&D protocols to developing world settings, keeping products affordable locally, and managing the threat of biopiracy.
The Malagasy Institute of Applied Research (IMRA) has employed bioprospecting to develop new health treatments for conditions such as diabetes and burns. It has found a balance between Western science and Malagasy cultural traditions and offers a useful example for African and other organizations interested in bioprospecting.
IMRA follows four guiding principles:
Using these principles, IMRA developed products like Madeglucyl, a treatment for diabetes management based on a traditional remedy.
Say the authors: "Stoked by identity politics and a broader debate about the degree to which traditional knowledge should be protected, a number of local actors have called for increased protection. In reality, the middle ground as represented by organizations like IMRA between complete protectionism and unfettered access to ethno-medical knowledge may represent the best hope of pushing forward the boundaries of medical research."
Turning science into health solutions: KEMRI's challenges as Kenya's health product pathfinder
According to authors Ken Simiyu, Hassan Masum, Justin Chakma and Peter A. Singer, the private sector in sub-Saharan Africa is ill-prepared to commercialize ideas emerging from public research institutes. The institutes, therefore, often take up the tricky task themselves.
The Kenya Medical Research Institute (KEMRI), for example, constructed a full-scale manufacturing facility to produce HIV and Hepatitis B diagnostic kits.
The researchers detail a slew of problems that eventually left KEMRI's factory idled.
A limited product line -- diagnostics -- proved dangerous as it relied on government purchasing. Shortly after construction of a production unit, an abrupt change occurred in Kenyan regulatory requirements and the government stopped purchasing KEMRI's products.
Others among the challenges KEMRI faced in trying to develop products: lack of infrastructure, inadequate financing, and little experience with respect to innovation.
However, the institute overcame them through diversification, partnerships and changes in culture.
KEMRI diversified its product line to include a disinfectant as well as modified rapid HIV and Hepatitis B test kits. It adopted an open innovation business model, which linked it with investors, research partnerships, licensing opportunities, and revenue from contract manufacturing. It has established a marketing division, developed an institutional IP policy, and trained its scientists on innovation management.
KEMRI has shown how research institutes in Africa "can turn science into health solutions for local health problems, thus reducing Africa's health burden," the authors say. "The findings could have implications for other research institutes in Sub-Saharan Africa seeking to develop health products."
Among the lessons learned:
The road to commercialization in Africa:
Lessons from developing the sickle-cell drug Niprisan
One of the few low-toxicity drugs available anywhere to treat sickle-cell anemia -- a debilitating chronic blood disorder -- is derived from medicinal plants in Nigeria. Authors Kumar Perampaladas, Hassan Masum, Andrew Kapoor, Ronak Shah, Abdallah S. Daar and Peter A. Singer looked at barriers faced by Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) while bringing this important product to market. They also chronicle many significant achievements in this drug's development process, even though it ultimately failed.
Nigeria alone has more than 4 million sickle-cell anemia patients, and every year an estimated 150,000 children are born with the condition, which also afflicts many North Americans and Europeans of African descent.
NIPRD developed the herbal medicine Niprisan from a combination of certain seeds, stems, fruit and leaves. Formal agreements entitled the traditional practitioners whose knowledge was used in the development program to product sale royalties.
The drug developers won regulatory approval in Nigeria, partnered with US-based firm XeChem, demonstrated clinical efficacy and safety, and were awarded valuable "orphan" drug status by the US Food and Drug Administration.
Niprisan failed to achieve mainstream success, however, due to a number of problems, such as insufficient manufacturing capacity, quality control issues, pricing and distribution, and lack of financing. Today, NIPRD is considering options for another commercial partner to take the drug forward.
The paper cites five key lessons learned for policy-makers and entrepreneurs:
Venture funding for science-based African health innovation
Authors Hassan Masum, Justin Chakma, Ken Simiyu, Wesley Ronoh, Abdallah S Daar and Peter A. Singer describe case studies of five health venture funds based in the developing world, and suggest lessons.
The five funds included publicly-owned organizations, corporations, social enterprises, and subsidiaries of foreign venture firms. Three funds aimed primarily for financial returns, one for social and health returns, and one had mixed aims. (One of the funds, Bioventures, is discussed above.)
Lessons learned include
The authors suggest that those looking to design venture funding for African science-based health innovation with significant impact should structure funds for long-term sustainability and attract for-profit private sector funds.
The proposed venture approach can complement existing initiatives to encourage local scientific and economic development while tapping new funding sources.
The authors conclude that 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.
Country studies in brief
Science-based health innovation in Uganda: creative strategies for applying research to development
According to authors Sheila Kamunyori, Nelson Sewankambo, Abdallah S. Daar, and Peter A. Singer, Uganda has a long history of health research. And it has moved recently to build its science and technology capacity.
They detail Uganda's capacity in health and biotechnology innovation and highlight examples of indigenous innovation, challenges for the future, and areas of strength on which to build.
Uganda has a range of institutions influencing science-based health innovation, with varying degrees of success. It has developed biosafety regulations and intellectual property policies, and has put before Parliament a coherent science and technology policy to coordinate efforts.
Uganda is unique in Africa by establishing its own Millennium Science Initiative - an ambitious $30 million project 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 is weak. Nevertheless, Uganda has several incubators producing low-tech products and moving into higher-tech product like diagnostics. Uganda's pharmaceutical industry has started creating partnerships to encourage health product innovation.
The authors say the personal initiatives of the President (the annual Presidential Science Awards and the Presidential Support Fund, for example), and his government's willingness to fund participation in the Millennium Science Initiative clearly demonstrate political will in Uganda to develop science and technology innovation. As well, activities to support technology transfer and private-public collaboration have been put in motion. In the private sector of Uganda are examples of innovation driven by entrepreneurs and South-South collaboration, to address neglected disease. Lessons can be drawn from their pioneering efforts.
The authors urge the government to put more focus on development of biotechnology, disseminate lessons from innovative initiatives, and support human resource development in health innovation.
Science-based health innovation in Tanzania: bednets and a base for invention
Authors Ronak Shah, Abdallah S. Daar and Peter A. Singer note that Tanzania has gradually undertaken economic reforms that have increased private sector activity and opened the economy to global competition.
However, despite Tanzania's economic growth and its status as one of Africa's biggest aid recipients, health in the country remains poor.
The public sector drives Tanzania's science and technology innovation agenda through a myriad of institutions and organizations dedicated to various aspects of health and other sciences.
It has some of the leading health research on the continent, with strong donor support, such as the University of Dar es Salaam, Muhimbili University of Health and Applied Sciences and the Ifakara Medical Institute. All are involved with international projects on infectious disease, though none with substantial technological spin-offs.
Perhaps more than the other countries studied, Tanzania - politically socialist until recently - has found developing an entrepreneurial culture difficult.
Nevertheless, one private generics company has developed a South-South collaboration to enable technology transfer and local production of anti-retrovirals. And a long-established textile company, A to Z Textiles described earlier, manufactures 25 million bed nets a year - a fascinating example of local innovation.
To achieve greater innovation in general and for health in particular, the authors urge the government to coordinate different stakeholders involved with health research, increase graduates in health-related disciplines, and build technological capabilities in such areas as biological testing, preclinical testing, formulation and standardization - the absence of which hinders the transition from basic research to product development.
Other recommended reforms: Encourage the private sector to move towards innovation through improved access to financing, and incentives for R&D. And a mechanism to bring the public and private sector together around specific projects could help unblock some of the country's innovative potential.
At a December, 2007 national life sciences workshop in Dar es Salaam, co-hosted by the McLaughlin Rotman Center, local stakeholders - including government, private sector, and research community representatives - strongly supported the need to increase knowledge flow and other recommendations. The group also formed a local steering committee to plan development of a life sciences innovation center. Since then, the local steering committee, MRC and partners have developed business and operational plans, land has been obtained, and next steps are being considered by the Tanzanian cabinet.
The proposed center would offer tenant space and serve as a business incubator and collaboration office. It will network with research institutions across Tanzania and operate a specialized seed fund to support promising, pre-commercial ideas.
"This innovation centre embodies a new approach," the authors say, "and involves bringing together for the first time in Tanzania science, business and capital under one roof to create a dynamic environment where scientific knowledge, the demands of the marketplace, and the realities of funders exist together."
Science-based health innovation in Rwanda: unlocking the potential of a late bloomer
Authors Kenneth Simiyu, Peter A. Singer, Abdallah S. Daar and Mike Hughes say Rwanda's indigenous science-based health product innovation system is under-developed due to the destruction of the country's scientific infrastructure and human capital during the 1994 genocide. What it has, though, offers examples of good practice.
Government policy, research institutes and universities, the private sector and NGOs are involved in health product innovation in Rwanda. And they say the country shows strong political will to support health innovation through both leadership and government policy. However, Rwanda has a weak scientific base and regulatory agency, and its nascent private sector is ill equipped to drive health innovation.
In addition, there are few linkages between the various actors in the country's health innovation system i.e. between research institutions, universities, the private sector, and government bureaucrats.
For a country with limited natural resources, transformation into a knowledge-based economy is the only route to economic development for Rwanda, the authors say. This requires further appropriate investments in domestic knowledge as acquisition of knowledge from abroad is very expensive. Of foremost importance is the establishment of a platform to link the various actors in the health innovation system.
Since the study's completion, the researchers have continued work with the Ministry of Science and Technology and the Ministry of Education to address key challenges. Stakeholders agreed with the study's results and recommendations, including the life sciences innovation center concept. A local steering committee was created to lead planning and business and operational plans have been initiated with the help of the MRC and others.
The virtual platform will network the center to various research institutions across the nation, and a product development fund will nourish promising pre-commercial ideas. The innovation centre embodies a new approach, convening Rwanda's science, business and capital under one roof -- a one-stop shop for investors in technology opportunities.
Science-based health innovation in Ghana: health entrepreneurs point the way to a new development path
Authors Sara Al-Bader, Abdallah S. Daar and Peter A. Singer say Ghana has well-recognized growth potential, It has plentiful natural resources (cocoa, gold, timber, and recently-discovered oil), a stable governance situation, long-standing universities and research institutions, and improving communications infrastructure.
Little research has been conducted on Ghana's capacity for health innovation to address local diseases, however. The research maps out key actors, highlights examples of indigenous innovation, sets out future challenges and outlines recommendations.
The fundamentals for a science-based health innovation system in Ghana already exist, according to the study: research organizations, regulatory bodies, health delivery systems and a well-established pharmaceutical industry, for example.
And Ghana can boast of examples of knowledge translation by public institutions that have made a major impact on local diseases such as river blindness.
However, links within the public sector are poor, as is knowledge sharing between the public and private sectors.
Low-tech technology transfer from research groups into local communities has occurred for decades, but these initiatives rarely if ever involve the private sector. As such, they are not scaled up, and have had limited economic effect.
Some small, entrepreneurial firms, largely focused on producing essential medicines such as affordable anti-retrovirals, appear to be shaping the science-based health innovation landscape most strongly.
The firms address undersupplied markets, tackling new parts of the value chain, or creating easy-to-use formulations. Plant medicine also plays a vital part in the health sector in Ghana, and increasing attention and resources are being directed towards the standardization and ultimately the scientific testing of the efficacy of these medicines.
Producing pediatric, one-dose formulations of generic drugs, as the company DanAdams has done, is an important step in building capacity and reaching new customers. In general, these pharmaceutical firms are accessing foreign knowledge - through licensing, technology transfer or tacit knowledge acquired overseas - and adapting it locally.
Among recommendations: Ghana should increase science and technology funding to the 1% of GDP suggested by the African Union; improve morale and remain linked to the international science community; create, publicize and implement a plan which coordinates across government and sets realistic targets for applying science and technology innovation to improve health; continue efforts to attract students to biomedical and health degrees; better link courses with opportunities for practical experience within the health system and private sector (which would help prevent brain drain); and remove barriers, such as outdated investment policy, to the entrepreneurial health sector.
As well, it should address intellectual property protection and access to international markets.
After their initial fieldwork in Ghana, MRC researchers helped create a working group on health and biotechnology innovation, with representation from government, the research community and the private sector, to consider how to build a sustainable hub in Ghana that would link stakeholders, overcome barriers to collaboration, and stimulate locally-relevant health innovation.
The group identified some key activities like setting up a virtual network to convene stakeholders through the Internet and regular meetings, a technology road show to showcase Ghanaian technologies to financiers and others, and creating a database of technologies, infrastructure and equipment within Ghana that could be accessed easily and help identify potential areas of cooperation.
McLaughlin-Rotman Centre for Global Health is based at the University Health Network and the University of Toronto. We envision a world where everyone benefits from new diagnostics, vaccines, drugs and other life science solutions. For more information, please visit us at: www.mrcglobal.org. The study was funded by the Bill & Melinda Gates Foundation through the Grand Challenges in Global Health Initiative, and by Genome Canada through the Ontario Genomics Institute and the International Development Research Centre. For more information: www.mrcglobal.org
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