Life Sciences Innovation Forum
The applied life sciences are critical to growth and socioeconomic development because healthy people produce healthy economies—innovations to make patient-focused products and services efficient, effective, and easily available, for example, 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. The LSIF 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.
These are its three main objectives:
- Harmonization with international standards and health services
- To promote economic and technical cooperation, including capacity building
- To explore avenues to promote public-private sector collaboration in life sciences innovation.
To serve the first objective, there is a subsidiary forum under the LSIF, the Regulatory Harmonization Steering Committee (RHSC), which was formed in 2008 under the chairmanship of Health Canada. The steering committee developed a multiyear strategic framework for achieving regulatory convergence for the approval processes of medical products by 2020. This was approved by APEC Ministers in 2011.
As to the second objective, there are two APEC centers established under the LSIF Planning Group: the APEC Harmonization Center (AHC) in Seoul, Korea, and APEC Bio-Medical Technology Commercialization Training Center (TCTC) in Bangkok, Thailand. The two centers engage in a series of capacity building activities across the APEC region, and the summary reports are presented to the second LSIF Planning Group Meeting every year.
The LSIF Executive Board meets annually right before the APEC High Level Meeting on Health and the Economy. The board members are the representatives of government, industries and academia from APEC member economies. The chair of the LSIF Executive Board is Mr. Shih-Chung Chen, the Minister of Health and Welfare, Chinese Taipei.
Selected Highlights of Current Projects
Important Notice on the First Life Sciences Innovation Forum (LSIF1) 2020
The Life Sciences Innovation Forum (LSIF) recognizes that participants of the LSIF and Regulatory Harmonization Steering Committee meetings are key officials stationed in health ministries, medical product regulatory agencies and important industries.
In consideration of the World Health Organization’s declaration of a global public health emergency as well as the responsibilities of these officials, who are obligated to assist with domestic outbreak-management efforts with regard the novel coronavirus (or COVID-19) the LSIF Regulatory Harmonization Steering Committee (RHSC) meeting on 7-8 February, and the LSIF Planning Group meeting on 9 February have been postponed and tentatively moved to the APEC SOM-2 timeframe in mid-April 2020.
The confirmed meeting date and venue will be informed whenever they are available.
- The LSIF held a suite of meetings during 2019’s Third Senior Officials Meeting in Puerto Varas, Chile:
- LSIF Regulatory Harmonization Steering Committee (15–16 August)
- LSIF Planning Group (17 August)
- LISF Policy Dialogue on Innovation, Regulatory Systems, and Regulatory Convergence (18 August)
- Health Working Group (HWG) – LSIF: 9th APEC High-Level Meeting on Health & the Economy (HLM9, 20–21 August)
Policy Dialogue on Enabling Investment in the Innovative Life Sciences
To explore how to foster and accelerate innovation, the APEC Life Sciences Innovation Forum (LSIF) convened a Policy Dialogue on Enabling Investment in the Innovative Life Sciences on 15–16 May 2019 in Chile on the sidelines of the Ministers Responsible for Trade Meeting (MRT). Participants included officials from government, startups, investment firms, global businesses, think tanks and academia. The event featured panels and presentations exploring challenges and opportunities for unlocking investment and how APEC economies can foster vibrant life sciences ecosystems through trade, investment, innovation and other policies and initiatives.
Key themes of the policy dialogue included:
- The vital role that trade, investment and innovation policies play in incentivizing private sector investment in the innovative life sciences. Economies must remove policy barriers and create a pathway for a return on investment, including through intellectual property rights, to unlock capital for life sciences innovation.
- The opportunity for greater cross-ministerial collaboration to advance innovation. Trade ministries as well as other government ministries such as finance and science have important roles to play with health ministries to develop and advance coordinated strategies for life sciences innovation. Public consultation is also important to support these efforts.
- Government, industry and academia must strengthen partnerships to develop strong innovation ecosystems that promote commercialization. Vibrant ecosystems are essential to transforming research into new products that can be commercialized and improve health outcomes. But such ecosystems will not develop without the right policies, best practices, access to capital and other essential elements.
- The importance of other enablers such as human capital, regulation and standards. These other factors include developing a strong base of human capital for the life sciences and leveraging standards and regulations that promote the development and commercialization of life sciences innovations.
The final report of this Policy Dialogue can be found here.
Policy Dialogue on Innovation, Regulatory Systems, and Regulatory Convergence: “A Decade of Regulatory Convergence in APEC: Learning from the Past, Looking to the Future”
The project built upon the LSIF’s long-standing recognition of the critical role that the life sciences sector plays in promoting public and economic health and the role that strong and efficient regulatory systems play in enabling life sciences innovation.
The policy dialogue convened the leaders of drug and medical device regulatory authorities and representatives from industry and academia to reflect on a decade of progress towards regulatory convergence in APEC and to envision the next iteration of a regional vision for how regulatory systems and regulatory convergence may accelerate life sciences innovation and make new medical products available to populations across APEC economies.
One of the most important outcomes of the policy dialogue is the release of research results on the Regulatory Harmonization Steering Committee’s (RHSC) key performance indicators (KPIs) tracking regulatory convergence over the last decade and now on an annual basis (conducted as an LSIF – APEC Harmonization Center project). The project acknowledged that the KPIs endorsed by the RHSC to date are focused on regulatory convergence of drug and vaccine approvals, and welcomed KPIs to monitor and evaluate regulatory convergence of medical device approvals as well. The research result encouraged the RHSC to not only continue tracking the KPIs on an annual basis, but also to develop more specific KPIs to track progress within each priority work area. Please find the result illustration here.
The final report of this Policy Dialogue can be accessed here.
Expected outcomes/deliverables for 2019 – 2020
- The statement of the 9th APEC High-Level Meeting on Health & the Economy: Aging Society
- Policy Dialogue on Enabling Investment in the Innovative Life Sciences
- Policy Dialogue on Innovation, Regulatory Systems, and Regulatory Convergence
- Continuing implementation of the APEC Action Plan on Rare Diseases through activities led by the LSIF Rare Disease Network
- 2019 APEC Center of Excellence Pilot Training on Supply Chain Security for Medical Products
- Blood Screening & Processing Centralization and Regulatory Harmonization Discussion
- Blood Screening & Processing Centralization through Development of a Center of Excellence – a workshop to be conducted on February 2020 in Yogyakarta, Indonesia
The LSIF also welcomes the continuing project implementation of:
- Tropical Health Workforce Hub
- Rare Disease Network
- APEC Health Sciences Academy
- Innovative Healthcare Financing
- APEC Digital Hub for Mental Health
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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.
9th APEC High-Level Meeting on Health and the Economy Joint Statement(341.29 KB, docx)
Joint Activities of the HWG and LSIF that Support Health Across the Life Course(336.76 KB, docx)
APEC LSIF Letter to Ministers and Leaders (Including Action Plan)
The APEC Life Sciences Innovation Forum Terms of Reference
APEC Life Sciences Strategic Plan
Roadmap to Promote Prospective Regulatory Convergence in Cell- and Tissue-based Therapeutic Products
APEC Concept Note - Roadmap to Promote Regulatory Convergence for Medical Device Vigilance
APEC Biotherapeutic Products Roadmap to reach a high level of regulatory convergence by 2020
Roadmap to Promote Multi Regional Clinical Trials and Good Clinical Practice Inspection (GCP Inspection)
Roadmap to Promote Regulatory Convergence for PV ver2
Draft Roadmap to Promote Good Registration Management (GRM)
Roadmap to Promote Global Medical Product Quality and Supply Chain Integrity
Ms Erika Elvander
Office of Global Affairs
US Department of Health and Human Services
Mr Johnny LIN