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 of the role of investment in health innovations that address health and related economic and fiscal challenges facing the region, and of the return on investment for economies.
The Forum was also mandated to establish frameworks for public-private sector partnerships to better utilize 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 Checklist in 2009.
The LSIF 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 from 27-28 September 2011.
In 2014 the LSIF commended and approved Peking University’s proposal to establish a Health Sciences Academy (HeSAy) for the APEC region to help provide the intellectual underpinning for and advance the knowledge of health and health sciences innovations and related policies.
In 2015, the LSIF worked with the Health Working Group (HWG) on a number of projects and initiatives, including the Fifth APEC High-Level Meeting on Health & the Economy held on 30-31 August in Cebu, Philippines.
This meeting’s joint statement charts a new course for bringing innovations and partnerships into programs for strengthening health systems.
The Healthy Asia Pacific 2020 Roadmap was developed jointly by the HWG and LSIF to guide the implementation of the Healthy Asia Pacific 2020 initiative which was endorsed by APEC Ministers and welcomed by APEC Leaders in 2014.
To advance the harmonization agenda, the LSIF Regulatory Harmonization Steering Committee (RHSC) was created and an APEC Harmonization Center (AHC) was established.
Launched in Seoul in June 2009, the AHC is considered an important step towards harmonizing regional regulatory priorities.
The AHC has since organized 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. Come 2016, the AHC serves as the coordinator of Centers of Excellence (CoEs).
The AHC website provides information for and about CoEs, including open-source training material and annual training schedules. The AHC conducts accreditation assessments in collaboration with the RHSC and champion economies and convene CoE executive directors annually.
Starting 2008, the RHSC has organized a series of regional seminars for government regulators on the issue of harmonization of medical device regulation, with the objective of helping regulators of medical devices in APEC economies develop robust regulatory systems. Industry representatives were also invited to participate.
The seminars highlighted the benefits to patients, regulators, the industry and to global and regional trade when economies implement a medical device regulatory system based on harmonized standards and procedures. The training programs were developed in coordination with the Global Harmonization Task Force and two regional working parties: The Asian Harmonization Working Party and the Latin American Harmonization Working Party.
The 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 towards 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.
In 2016, the RHSC’s mandate was to promote a more strategic, effective and sustainable approach to harmonization of medical product regulations by:
- Proactively identifying and prioritizing projects seen to be of greatest value
- Strengthening linkages with harmonization initiatives, training organizations and other key players to promote complementary actions and most effective use of resources
- Leveraging work with other harmonization initiatives, avoiding duplication of work
The RHSC’s priority work areas by economy are:
- Multi-Regional Clinical Trails (Japan)
- Good Clinical Practices Inspections (Thailand)
- Pharmacovigilance & Medical Device Vigilance (Korea)
- Biotechnological Products (Korea)
- Cellular Therapies (Singapore)
- Good Registration Management (Chinese Taipei; Japan)
- Global Supply Chain Integrity (United States)
When the RHSC met during the 2016 First Senior Officials’ Meeting, they accomplished the following:
- Securing agreement on a Center of Excellence (CoE) Memorandum of Understanding (MOU) Template between the LSIF and host institutions
- The contents of the Steps to Formalize a CoE draft document were endorsed by the RHSC
- Annual Performance Report template was endorsed as a mechanism to assess/evaluate CoEs
The RHSC also endorsed the following institutions to serve as CoE host institutions on a pilot basis:
- Seoul National University (for biotherapeutics)
- Northeastern University (for biotherapeutics)
- Peking University (for MRCT/GCP)
- Duke/NUS Singapore (for MRCT/GCP)
- Pharmaceuticals and Medical Device Agency, Japan (for MRCT/GCP and pharmacovigilance & medical device vigilance)
- Regulatory Affairs Professionals Society (RAPS) (for good registration management)
- Korea Institute of Drug Safety and Risk Management (KIDS) (for pharmacovigilance & medical device vigilance)
- University of Tennessee Health Science Center (for supply chain integrity).