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Life Sciences Innovation Forum |
Life sciences innovation is critical to growth and socio-economic development as healthy people produce healthy economies. Efficient and effective delivery of patient focused products and services can improve a population's longevity, wellness, productivity and economic potential.
Established by APEC Leaders in 2002, the Life Sciences Innovation Forum (LSIF) has since grown to become APEC's leading initiative on health and health sciences innovation.
It is a tripartite forum that engages representatives from the highest levels of government, industry and academia to create the right policy environment for life sciences innovation. The LSIF brings together scientific, health, trade, economic and financial considerations to address the challenges of infectious and chronic disease and ageing populations. Guiding principles include transparency, meaningful dialogue with stakeholders and recognition of due process. The LSIF forum also acknowledges that capacity building is critical to successful implementation.
Achievements
An APEC Life Sciences Strategic Plan was approved by APEC Ministers in 2004 and it includes recommendations for collective action and an implementation schedule. The Strategic Plan also provides recommendations for strengthening the innovative life sciences sector in the APEC region, placing particular emphasis on boosting region-wide levels of investment in research and development for health innovation.
In 2007 the LSIF was tasked to undertake a multidisciplinary study on the role of and returns to economies from investment in health innovations that address health and related economic and fiscal challenges facing the region. It was also mandated to establish frameworks for public-private sector partnerships to better utilise resources to meet health needs.
The LSIF has developed an Enablers of Investment Checklist, a voluntary guidance tool for policy makers in each APEC economy to assess their investment environment for life sciences innovation. Singapore volunteered to fill out the implementation of the Checklist in 2009.
Based on a series of seminars held in 2008-2009 that dealt with ways to combat the increase in counterfeit medical products, the LSIF has developed an Anti-counterfeit Medical Product Action Plan. The objective is to share best practices in the detection and prevention of counterfeits to both regulatory authorities and industry professionals, and to build capacity at the economy level to combat the threat.
A series of regional seminars for government regulators on the issue of harmonisation of medical device regulation were held in 2008 and 2009 (Malaysia and Canada). The objective was to help regulators of medical devices in APEC economies develop robust regulatory systems. The seminars highlighted the benefits to patients, regulators and industry and to global and regional trade when economies implement a medical device regulatory system based on harmonised standards and procedures. Industry representatives were invited to participate. The training programs were closely coordinated with the medical devices Global Harmonisation Task Force and two regional working parties: The Asian Harmonisation Working Party and the Latin American Harmonisation Working Party.
Workshops aimed at strengthening drug regulatory authorities' capacity to harmonise regulatory practices relating to drug development in clinical trials, and to good clinical practice/clinical research, were also held in Thailand in 2009.
The APEC Harmonization Center (AHC) was launched in Seoul, Korea in June 2009. The AHC is an important step towards harmonising regional regulatory priorities. An LSIF Regulatory Steering Committee has also been created to advance the harmonisation agenda. The AHC has since organised a series of events, including an "APEC Harmonization Center Biosimilar Workshop" in September 2009. The workshop was focused on the opportunities and challenges of biological medicines, regulatory issues for biosimilars and the regulatory landscape for biosimilars. A "Good Manufacturing Practice Pharmaceutical Validation Workshop," was also held by the AHC in December, 2009 and drew over 450 participants
Current Activities
A medical device regulatory harmonisation delegation from various APEC economies in Asia visited Australia in September, 2009. Subject to the Budget and Management Committee's (BMC) approval, an expanded delegation from other APEC economies in Latin America and Asia will visit the United States and Canada for the same purpose in August 2010. These visits are part of an APEC project to educate regulators on global harmonisation of medical device regulation. The objective is to help regulators better understand global medical device regulations and the emerging similarities between them. Focus is placed on laboratory visits and training conducted by government and industry regulatory experts involved in the Global Harmonization Task Force (GHTF). It will concentrate on how one of the GHTF's founding members - the Australian Therapeutic Goods Administration - implements their regulatory regime including auditing, quality systems and surveillance issues.
Based on deliberations at the LSIF's Planning Group meeting in March 2010 in Hiroshima, Japan, the work plan for 2010 includes the following:
- Extending the 2008 LSIF Framework Study to include infectious disease and metrics that show the dynamic effects on economic growth of investment in health innovations;
- Reviewing and expanding the application of the LSIF Enablers of Investment Checklist and ensuring that metrics are included for enabler of biologics development and deployment; ways of supporting and promoting innovation, including the role of Health IT;
- Developing a multi-year strategic plan for regulatory harmonisation;
- Convening a small multi-disciplinary group of experts to examine options for extension of the 2008 APEC LSIF Framework Study;
- Exploring the role of health-related productivity indicators;
- Reviewing the Enablers of Investment Checklist to assure metrics are included for enablers of biologics development and deployment;
- Establishing a small group to discuss and coordinate the role of information and communications technologies in health systems.
The next LSIF Planning Group meeting will be held on 29 May 2010 in Sapporo, Japan on the margins of the Second Senior Officials' Meeting.
Life Sciences Innovation Forum - Key Contacts
LSIF Planning Group Chair
Ms Barbara Norton
Director, Industry
Office of United States Trade Representative (USTR)
600 17th Street NW
Washington DC 20508
Tel: (1 202) 395 6160
Fax: (1 202) 395 9674
E-mail: bnorton@ustr.gov
APEC Secretariat
Steve Chen (Mr)
Director (Program)
E-mail: sc@apec.org
Reviewed on: 28 May 2010