The Life Sciences Innovation Forum (LSIF) continues to attract significant high level attention from scientists, health economists, senior government policymakers, industry experts and representatives of international organizations, including the World Health Organization (WHO), UNICEF, and the Asian Development Bank. In June 2012, the LSIF collaborated with the Health Working Group to organize the APEC High-Level Meeting (HLM) on Health & the Economy which attracted 150 senior level participants from 15 APEC Member Economies. The outcomes of the HLM demonstrated the importance of investment in health as a key plank of economic development. An overarching recommendation from LSIF was that given the importance of health to economic development, APEC should ensure that a health component features in the work of all APEC groups. The High-Level Meeting on Health and the Economy will be held in Bali on 20-21 September 2013.
The LSIF worked collaboratively with the Health Working Group this year to encourage APEC Member Economies to implement the APEC Non-Communicable Diseases (NCD) Action Plan, which was endorsed by APEC Ministers during their November 2011 meeting in Honolulu. The Action Plan aims to reduce the economic impact of chronic diseases in the region through the sharing of best practices and the establishment of innovative public-private partnerships.
Illustrative of APEC’s regulatory convergence and cooperation priorities, and in accordance with APEC Ministers’ direction, the LSIF Regulatory Harmonization Steering Committee (RHSC) began implementation of its multi-year strategic framework for achieving regulatory convergence for medical products (both devices and medicines) by 2020. The RHSC has developed a Multi-Year Project to support the work of the Global Drug Integrity and Supply Chain initiative. The LSIF RHSC has continued its program of largely self-funded advanced training projects in areas that support the achievement of regulatory convergence, including on Global Drug Integrity and Supply Chain, Good Review Practices, Cellular Therapies, Multi-regional Clinical Trials, Good Clinical Practice Inspection, Combination Products, Pharmacovigilance, and Biotechnological Products. The RHSC also approved a restructuring to include all APEC economies and a regulatory network inclusive of industry experts.
The LSIF also discussed on-going work programs, which include a robust research cooperation agenda, addressing the growing problem of the safety and efficacy of medical products; a re-emerging focus on enhancing research cooperation and collaboration in the region; and continued efforts to examine policies that enable investment in life sciences, and the importance of policies to ensure that medical innovations are diffused throughout health systems.
In the LSIF meeting in Medan this June 2013, the LSIF Research Committee introduced the “Roadmap for Innovation and possible Capacity Building Initiatives.” Members agreed to cooperate with the Association of University Technology Managers (AUTM) on establishing the APEC-AUTM Biotechnology Commercialization Training Centre.
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 investment in health innovations that address health and related economic and fiscal challenges facing the region, and the return on investment for economies. 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.
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 with both regulatory authorities and industry professionals, and to build capacity at the economy level to combat the threat. A workshop on anti-counterfeit medicines was held in Beijing, China from September 27-28, 2011. A series of regional seminars for government regulators on the issue of harmonisation of medical device regulation were organized by the Regulatory Harmonization Steering Committee (RHSC) since 2008. 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.
RHSC continues to break new ground in developing innovative approaches to address regulatory priorities and to serve as a global catalyst for change. Significant progress has been made toward promoting regulatory convergence in the medical products sector by 2020, in partnership with key international bodies and initiatives, and according to the strategic framework and roadmap.
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 Harmonization Steering Committee (RHSC) 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 2009. The workshop was focused on the opportunities and challenges of biological medicines, regulatory issues for biosimilars and the regulatory landscape for biosimilars. A follow up workshop on Biosimilars was held in April 2012.
Barbara NORTON (Ms)
LSIF Planning Group Chair
Office of United States Trade Representative (USTR)
600 17th Street NW
Washington DC 20508
Tel: +1 202 395 6160
Fax: +1 202 395 9674
Steve CHEN (Mr)