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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. 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 LISF 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; and to establish frameworks for public-private sector partnerships to better utilise resources from both the public and private sector to meet health needs.
The LSIF has also 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 recently volunteered to fill out the implementation of the Checklist.
An APEC Anti-counterfeiting Health Products Seminar was held in Singapore on January 13-15, 2008. Over 120 experts from 17 APEC economies, including 11 developing economies met to examine ways to combat the skyrocketing increase in counterfeit medical products in the region and around the world. This seminar provided regulatory authorities and industry professionals with best practices in the detection and prevention of counterfeits. Participants were expected to take these tools back to their local economies to perform additional training exercises, building capacity in the region to combat this emerging threat. Resulting from the seminar is a draft action plan for combating counterfeit medical products.
Regional Seminars for Government Regulators: Harmonisation of Medical Device Regulation were held in Kuala Lumpur, Malaysia in March 2008 and in Toronto, Canada in May 2009. 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.
In order to strengthen drug regulatory authorities' capacity to harmonise regulatory practices a Workshop on Review of Drug Development in Clinical Trials was held in March 2008, To implement the capacity building program, advanced workshops on the Review of Drug Development in Clinical Trials and Good Clinical Practice /Clinical Research Inspection were held in Bangkok in February and March 2009 respectively.
The APEC Harmonization Center (AHC) was launched in in Seoul, Korea in June 2009. The AHC is an important step towards the harmonisation of regional regulatory priorities, An LSIF Regulatory Steering Committee has also been created to advance the harmonization agenda.
Current Activities
An APEC Harmonization Center Biosimilar Workshop will be held in Seoul in September 2009. The workshop will focus on the opportunities and challenges of biological medicines, regulatory issues for biosimilars and the regulatory landscape for biosimilars.
An Asian medical device regulatory harmonisation delegation will visit Australia, also in September. The visit is 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. The focus of the visit will be 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 GHTFs founding members - the Australian Therapeutic Goods Administration - implements their regulatory regime including auditing, quality systems and surveillance issues. A Latin America delegation will visit the U.S. and Canada for the same purpose in May 2010.
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
Mr Vincent Liu
Director (Program)
E-mail: jyl@apec.org
Reviewed on: 20 August 2009