Study reveals developing countries with recipe for thriving health biotech industries

Cuba, South Africa, India, China, Brazil among nations showing the way

Study co-authors are available for advance interviews Friday Dec. 3. Please call to schedule a time. The study will be published as a special supplement Mon. Dec 6 in Nature Biotechnology. The embargoed study can be previewed by media online at http://www.utoronto.ca/jcb/home/news_nature.htm

Cuba, South Korea, and India make and export their own biotech vaccines, Egypt manufactures recombinant insulin, and South Africa is developing a novel vaccine for HIV/AIDS.

Health biotechnology is no longer the sole preserve of high-level research institutions of North America and Europe, according to a ground-breaking three-year study by 15 researchers of health biotechnology innovation systems in seven countries: Brazil, China, Cuba, Egypt, India, South Africa and South Korea. “Nowhere is the need for science and technology as a tool for development more relevant than in addressing the health needs of the world’s poor,” says co author Peter Singer, MD, Director of the University of Toronto Joint Centre for Bioethics, a world–leading think tank on medical ethics.

“Vaccines, diagnostic tools and other products of biotechnology which can be produced relatively easily and cheaply by developing countries have the potential to save millions of people who die each year from diseases. This study helps to reveal and understand the recipe used by developing countries to create thriving health biotech industries.”

Results of the study, funded by Genome Canada and others and published Dec. 6 in a supplement to Nature Biotechnology, documents the development of successful health biotechnology sectors in detailed case studies of seven countries. It identifies factors that led to their success and the challenges that remain.

The key findings underline the importance in developing countries of 1) focusing on local health needs (“necessity becomes opportunity”), 2) the role of the private sector in commercialization, 3) widespread collaboration, 4) specializing in a niche, and 5) long-term government support. “The study offers a variety of ’lessons learned’ that can help other countries build a local biotech sector that brings local health benefits. They may also be of relevance to industrially advanced nations,” says Dr. Singer.

Development of biotech industries in developing countries is essential, he added. Because markets for drugs in industrialized countries are much more lucrative, the creation of health products for people in the poorer parts of the world has lagged badly behind. Of 1,393 new drugs marketed between 1975 and 1999, only 16 were for tropical and other diseases predominantly affecting developing countries — and three of the 16, were for tuberculosis, which affects countries worldwide. More than 175 new drugs were developed for cardiovascular disease in the same period.

Necessity becomes opportunity in Cuba

Not only did Cuba represent a small market, the collapse of the Soviet Union and the U.S. trade embargo forced it to develop its home-grown solutions to local health problems. After Cuban scientists trained in labs around the world in the early 1980s, Cuban research and development programs led to the first and only vaccine for a strain of meningitis and stemmed a local outbreak in the mid 1980s.

More recently, Cuba produced the world’s first human vaccine with a synthetic antigen that protects against Haemophilus influenzae type b infection, which often leads to pneumonia and meningitis in children under the age of five.

Despite being relatively poor, Cuba’s biotech sector is among the most successful in the developing world today. Cuba exports biotechnology products to more than 50 countries, mainly in Latin America, Eastern Europe and Asia.

Cuba’s long-standing investment in education and science, Fidel Castro’s keen interest in biotechnology, and knowledge sharing within institutions are among the factors that led to this success, the study found. Cuba has applied for or holds at least 400 patents in the biotechnology field.

Although Cuba has had success, limited access to foreign investment in the capitalistic world of biotechnology, the U.S. trade embargo and the inability of Cuban scientists to enter the U.S. have been significant hurdles, the study reports.

Private Sector Powers Products and Services

“Countries with strong scientific foundations are well placed to succeed, but economic benefits will likely be linked to how well they can engage and sustain private sector growth and commercialize scientific discoveries as products,” says Abdallah Daar, MD, Director for Ethics and Policy of the McLaughlin Centre for Molecular Medicine and a program director at the JCB.

The private sector was found by researchers to be essential for integrating various sources of knowledge in health biotechnology and turning them into products and services. While countries differed greatly in how far they were able to build up private sector involvement, South Korea is undoubtedly furthest advanced.

Although a late starter in biotechnology when compared to Cuba, the South Korean government has played a critical leadership role and will invest about $4.4 billion in the field from 2000 to 2007. Equally important, government policies encourage technology transfer and allow university professors to set up private firms or spin-off companies.

That support for the private sector has in turn given birth to a nascent South Korea venture capital sector, something that is almost nonexistent in other countries. As a result a surprising 450 and 600 Korean companies are using some aspect of biotechnology in their business.

Successful Innovation Requires Collaboration

The case studies confirmed that successful innovation requires widespread collaboration. China’s lack of collaboration prevented its scientists from being the first in the world to sequence the severe acquired respiratory syndrome (SARS) virus.

Brazil and Egypt have also been hindered by a lack of linkages, especially between universities and industry. Those countries’ success to date has been the result of strong individuals playing pioneering roles in their health biotechnology development. Despite the value of strong individual leadership, a systemic approach is likely to be more sustainable in the long run, says Halla Thorsteinsdóttir, D.Phil, Assistant Professor at the University of Toronto and the study’s co-ordinator.

To overcome this, most countries have or are promoting clusters in health biotechnology to support collaboration. Examples include South Korea’s Daeduk Science Town, India’s Genome Valley, and Cuba’s West Havana Scientific Pole.

“Countries that encourage close linkages of research, business, policy, health institutions and other actors in the field and ensure an active knowledge flow among them have been the most successful,” says Dr. Thorsteinsdóttir.

Specialization Produces Cost-effective Results

Focusing on a niche area is yet another successful strategy the study found. Recombinant vaccines are relatively easy to reproduce and can be much more cost-effective way to deal with infectious diseases than drugs. India, for example, is developing vaccines for hepatitis B and C as well as South Africa HIV/AIDS.

“With limited resources and underdeveloped private sectors, targeting specific areas that fit both their needs and existing strengths is an effective strategy employed by some developing nations,” says Dr. Thorsteinsdóttir.

In such circumstances political will was also found to be a crucial factor in the seven countries studied. India, for example, emphasized health biotechnology in its sixth five-year plan, 1980–1987, as a tool to tackle India’s underdevelopment and to improve the health of its population.

“Health biotechnology is a science-intensive field requiring considerable investments of time and money before it is likely to generate benefits,” she says.

Long Term, Creative Government Support Essential

Governments can encourage the biotech sector by providing incentives to overcome difficult economic conditions. For example Brazilian authorities dealt with high inflation rates and Cuban authorities revised foreign investment laws. In fact, political will and a strong government role have been essential for all countries with strengths in biotechnology, the report says.

This is the same model the U.S. government adopted many years ago. America’s world-leading biotech industry has been strongly supported by government in nearly every stage of its evolution, says Dr. Daar.

The loss of the best and brightest researchers to developed countries like the U.S. is a serious and ongoing challenge the study notes, and governments can play an important role in stemming this ’brain drain’. Since the late 1990s China has made concerted efforts to encourage expatriate professionals to return. Incentives include the provision of funding for the establishment of laboratories in China and schemes to enable returning scientists to establish firms.

How the Study Was Conducted

The study used a broad definition of biotechnology as “the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services.”

Case studies relied on multiple sources of information. As many as 30 to 40 key people in the health biotech sector including government, private and public research institutions, educational institutions, the private-sector and non-governmental organizations in each country sources were interviewed. Published papers and books, background and policy documents, and patent data were also analyzed.

The findings were subsequently validated through verification of the case studies with interview participants and presentation at the Canadian Program on Genomics and Global Health’s (CPGGH) Genomic Policy Executive Courses, including meetings held for the Eastern Mediterranean, Latin America and Caribbean, East Asia, and India. Finally, the CPGGH held a 2-day workshop from May 31 to June 1, 2004, with the collaborators, researchers and invited external experts to discuss and exchange ideas on the case studies.

Says Keith Stewart, Director of McLaughlin Centre for Molecular Medicine: “The McLaughlin-Rotman Centre for Global Health – an initiative of the McLaughlin Center for Molecular Medicine – has a mission to accelerate the introduction of molecular discovery into clinical care. This by its nature requires that scientific and clinical programs based on biotechnology are deployable and economically viable not only in the industrialized world but also in resource-poor settings – studying the impact of biotechnology in developing countries is then of high importance to us and we are pleased to have supported this important effort.”