Healthy People, Healthy Economies
Everybody's talking about the life sciences and biotechnology as the Next Big Thing. Policy makers in APEC consider life sciences innovation as an investment.
When Severe Acute Respiratory Syndrome, or SARS, circled the globe two years ago, doctors, research scientists and virologists worked around the clock to understand the biology of the virus and to develop innovative treatments for the disease. Scientists collaborated with clinicians in hospitals and partners in the private sector to develop diagnostic kits to detect the virus.
Much of that ground-breaking work took place within the 21 Member Economies of APEC. The Genome Institute of Singapore carried out sequencing to determine the genetic code of the virus and to study mutations while researchers at the University of Hong Kong and the Shenzhen Centre for Disease Control and Prevention isolated SARS-like viruses from civet cats and a raccoon dog at a wild animal market in Shenzhen.
Research on SARS, of course, is not the only important or innovative work emerging from the Asia-Pacific region. Life sciences research is an area that is fast becoming a hotbed for innovation across APEC economies and governments are taking it seriously. The Korean government is aiming to join the world's top seven biotechnology powers by 2010 and already has the highest per-capita biotech startup ratio in Asia, while Chinese Taipei is earmarking at least 3% of its GDP for life-sciences development.
Singapore officials, meanwhile, aspire to make their island state an international centre for biomedical research. Singapore is already a pioneer in the exciting new field of embryonic stem cell research and one of the few countries in the world with stem-cell lines. The cells contain genetic instructions and can be coaxed into becoming any of the 210 tissue types found in the human body. Also on Singapore's wish-list: To be the regional centre for clinical trials and drug development.
Across Asia, China; Hong Kong, China; Chinese Taipei; Thailand and Japan are all looking at nurturing the life and biomedical sciences. In China, the government's current five-year plan (2001-2005) lists the development of biotechnology and the modernization of traditional Chinese medicine as priority areas.
Now APEC is poised to take a leadership role in developing a model for regional cooperation to promote biomedical life sciences innovation that will stimulate economic growth and improve the quality of life for its people. At the October 27, 2002 meeting in Los Cabos, APEC Economic Leaders called for the establishment of a tripartite Life Sciences Innovation Forum (LSIF) to develop a strategic plan for life sciences innovation in the region and address the challenges of risk detection and prevention, as well as the treatment and cure of communicable and lifestyle diseases.
The way APEC leaders see it, life sciences innovation can be an important new driver of economic growth and a potent contributor to socioeconomic wellbeing. Investing in health will benefit economic growth, worker performance and productivity, and poverty alleviation.
APEC leaders identified common themes in the basic principles governing life sciences innovation at the August 2003 inaugural Life Sciences Innovation Forum in Phuket, Thailand. The September 2004 2nd Life Sciences Innovation Forum in Penang, Malaysia, developed recommendations for collective action going forward.
A readiness assessment template to assess the strengths and capacity building needs of economies was developed, and in June 2004, APEC Trade Ministers broadened the mandate of the forum in acknowledging the potential of the strategic plan to promote global trade and investment in innovative life sciences products and services. Two APEC economies, Chinese Taipei and Thailand were assessed as part of the readiness assessment pilot in 2004.
The strategic plan, endorsed at the recent APEC leaders' meeting in Santiago Chile in November 2004, is a landmark document. It provides guidance on how to maximize the return on investment in health innovation and turn activities in the sector to the benefit of people in APEC. In a nutshell, it aims to improve the health and well-being of citizens by encouraging investment and innovation across four key areas of the life sciences: research, development, manufacturing and marketing, and health services. As part of the plan, Thailand will host a Life Sciences Ministerial Meeting in 2005 to examine holistic approaches towards life sciences innovation to better meet the needs of the region.
"The plan sets a priority of addressing the challenges of risk detection and prevention as well as the treatment and cure of the communicable and life-style diseases in the region," noted Thai Minister Suwit Khunkitti, the chairman of the Life Sciences Innovation Forum, at the Santiago meeting. "The APEC region is poised to take a leadership role in the Life Sciences sector and the implementation of this strategic plan will provide a model for a global approach to life sciences innovation."
The plan includes a number of groundbreaking initiatives for APEC economies including proposals to explore the feasibility of establishing a Regional Venture Capital facility to accelerate research and development, devices, diagnostics, medicines and other treatments for diseases affecting developing economies. (Access to capital is a critical factor in determining the viability of life sciences innovation. Venture capital, seed funding, public-private partnerships, government funding and multilateral development banks and foundations should all be considered as potential sources of financing.)
The plan also provides a set of best practice guidelines and advocates greater information sharing among regulators in APEC Member Economies with regard to safety issues, counterfeit products and other risks. In addition, it recommends building support for a major molecular diagnostics initiative to help reveal the onset of chronic diseases and an associated large scale cohort and monitoring program to gather essential information for the assessment of risk and disease and prevention. A Molecular Biology Laboratory would draw on the model of the European Molecular Biology Laboratory.
Based on the output from the Forum and Expert Working Groups, the Forum also developed a Life Sciences Readiness Assessment template that can be used by economies to assess their strengths and capacity building needs in each area of the life sciences innovation chain. Through investigation and discussion, facilitators will help each economy determine the capacity building needs to reach the target.
On other fronts, the plan encourages each APEC economy to set up multidisciplinary taskforces that can make recommendations on life sciences policy and priorities across all areas health care. It encourages APEC Education, Health, and Science and Technology Ministers to give appropriate priority to life sciences education and continuing medical professional education and training. It advocates for instance that APEC members develop and implement life sciences curricula at all education levels including at the primary school level and encourage exchange programs on life sciences among APEC economies at the secondary and tertiary levels. Coordinated postdoctoral fellowship programs dedicated to life sciences are also recommended.
Collaboration and networking among APEC economies is important to assure efficiencies and that the region remains at the cutting edge of life sciences innovation. Human capital should be pursued through collaborative efforts between economies through public and private collaborations, the plan urges. At the same time, APEC economies should cooperate through shared educational programs, establish centers of excellence with critical mass around research priorities, provide adequate infrastructure to support research, encourage coordination between national research agencies, and align research projects with health priorities.
Under the plan, APEC economies would develop disease awareness programs and information on the full range of treatment and management options as well as in areas such as dietary and lifestyle advice. The plan also lobbies for the creation of a federation of regional life sciences professional societies that could be recognized by international professional societies.
"The plan is a huge accomplishment of great importance for the APEC Economies," says Barbara Norton, chair of the Life Sciences Planning Group and director of industry at the Office of United States Trade Representative in Washington, D.C. "It is the first time that this kind of plan has been put together for a region."
Norton notes that the plan should help individual economies and the region attract investment in burgeoning life-sciences industries, stimulate innovation and improve health. Norton argues that this kind of investment will make the latest health advances more readily accessible. "Life sciences innovation has the potential to open up entirely new vistas that we cannot even foresee or predict," she says.
From a patient's perspective, Norton adds, the plan advocates greater harmonization of regulatory regimes within APEC, which will result in improved patient access to the latest medical technologies. And with access to state-of-the-art medical technology, health problems will be diagnosed more quickly and accurately, more patients can be treated each day, recovery times will be shorter, patients can return to work earlier and diseases can be controlled more effectively.
To be sure, the plan will need strong leadership from the top within each economy but with the endorsement of APEC leaders, "we have that," says Norton. "Implementation will require a lot of hard work, but we have a clear message from APEC Ministers and Leaders and industry, academia and officials will work to respond."
One of the first activities is for economies to assess their own strengths and weaknesses to help target their efforts to aspects of the life sciences value chain where they may already have an advantage and to know where they will need to build capacity for others, Norton explains. Much of the plan "can be parsed out into individual chunks and it is expected that economies will work on the area of most interest to them or where they will make progress most quickly."
Cooperative projects are already underway to develop innovations that can address early detection and prevention of disease. An independently supported Pacific Health Summit will be held in June 2005 to focus on new technologies in early detection and prevention of diseases and policies to support emerging technologies. The APEC Health Task Force also is addressing health priorities, including health security threats in the region, and independent initiatives are being promoted by major research organizations in the region.
The LSIF encourages economies to identify and prioritize health needs. This includes the use of health surveys and needs assessment, which should also focus on inequalities within economies. Opportunities in Asia for the development of a clinical trials industry are also enormous write the plan's architects. Asia has a large patient base, with unique and unmet medical needs, a large pool of professionals and good IT infrastructure. The area of clinical trials has significant potential for further development given the rich diversity of the region.
Building partnerships to harmonize clinical trial regulations and practices according to international best practices will be critical to success, the plan notes. There is room for significant enhancement of research capabilities through collaboration, networking, pooling resources, and examining the prospect of cooperative funding initiatives. The plan also calls for an efficient and robust clinical trial regulatory regime focused on safety, efficacy and ethical standards. Member economies will work to establish clinical trials registries, accessible to all interested parties.
Protection of Intellectual Property and cooperation among economies to combat counterfeiting is also critical. The plan recommends that APEC economies should work to implement a legal framework that is TRIPS compliant. APEC Economies must also work to provide adequate infrastructure and resources for enforcing laws and regulations. Intellectual property cases should be reviewed by appropriate judicial bodies with IP trained judges, evidence discovery frameworks, as well as mature injunction and bonding mechanisms to allow effective adjudication.