Key Messages

 

●During the COVID-19 pandemic the LSIF remains steadfast in our commitment to foster partnerships between government, industry, and academia aimed at enhancing the development of and access to the life sciences innovations that save and improve lives.

●The LSIF remains committed to supporting APEC economies with fostering an enabling environment that allows industry to make bold investments in the research and development of new products, including safe and effective COVID-19 vaccines and treatments.

●The LSIF commits to supporting APEC as a whole and members individually in reducing and eliminating unnecessary barriers to trade in medical products and in promoting resilient supply chains for medical products.

●During this time of crisis the LSIF commits to continuing to protect the medical product supply chain – and ultimately people and patients – by promoting trade in safe and quality drug products and ingredients, including through wide dissemination of the APEC Supply Chain Security Toolkit and the adoption of best practices.

●The LSIF reaffirms its commitment to advancing the convergence of the regulatory review and approval processes for medical products, especially those essential to the COVID-19 response, so safe and effective products are readily available to those who need them.

●The LSIF intends to expand policy and regulatory cooperation for enabling the adoption and deployment of alternative financing mechanisms to help maintain and expand healthcare coverage.

●The LSIF encourages APEC economies to harness the digital economy and apply digital technologies in healthcare services to combat COVID-19 and other public health challenges.

 

The members of the APEC Life Sciences Innovation Forum (LSIF) express our condolences to the families of those who have lost their lives to COVID-19 and express our sympathy to those who have seen their livelihoods affected by the economic fallout of this pandemic. We also express our support and appreciation for the health workers, scientists, and other personnel on the front lines for their contribution and sacrifice in protecting public health.

 

The APEC LSIF, established by APEC Economic Leaders in 2002, is APEC's leading initiative on health sciences innovation. It is a tripartite forum that engages representatives from government, industry and academia to foster an enabling policy environment for innovation in the medical life sciences sector. We are committed to supporting APEC economies with: enabling life sciences innovation; promoting resilient trade in medical products; ensuring the safety and quality of the medical products; accelerating regulatory convergence; facilitating innovative healthcare financing; and harnessing the digital economy and digital technology to enable the future of life sciences innovation. The LSIF reaffirms its commitments to fostering life science innovation cooperation in support of health for all and the shared prosperity of the Asia-Pacific community.

 

As APEC Economic Leaders have stated, “investing in health will benefit economic growth, worker performance and productivity, and poverty alleviation”.  Our success in working together – as public officials, private sector research and manufacturing representatives, and academic representatives -- to develop diagnostics and to begin to treat patients with existing medicines while conducting trials with new medicines has been supported by the connections we have developed in APEC since we began to work together on other health challenges, and by the public-private-academic cooperation that APEC has fostered for almost two decades. The LSIF recognizes that addressing the unprecedented challenges posed by the COVID-19 pandemic requires coordination and a collective response in the spirit of solidarity and partnership. During the COVID-19 crisis, the LSIF remains steadfast in our commitment to continue to foster these partnerships between government, industry, and academia aimed at enhancing the development of and access to life sciences innovations.  Now more than ever it is imperative to collaborate on the design of clinical trials to ensure each participant’s experience results in regulatory grade data, and that we work together to enable and facilitate the availability of existing and novel vaccines and treatments that could safely be used to save and improve lives. We are also determined to contribute to APEC economies’ efforts in stimulating economic recovery and preparing for future pandemics. 

 

Enabling Life Sciences Innovation 

 

APEC members recognize that trade, investment, and innovation policies play a vital role in enabling the life sciences industry to make bold investments in the research and development of new products, including those to treat and prevent COVID-19. Such policies have enabled the unprecedented number of collaborations currently underway between government, industry, and academia across the APEC region and around the world, and have allowed clinical trials for potential treatments and vaccines to start in record time following the initial sequencing of the viral genome that causes COVID-19. Most of the clinical trials underway for potential COVID-19 treatment and vaccine candidates are currently taking place in the APEC region. Ongoing collaboration will ensure these trials produce the type of information our regulators need to ensure the safety, quality and efficacy of diagnostics, medicines and treatments entering the market.

 

Policy environments that foster the growth of life sciences innovation are critical for not only controlling this pandemic but also preparing for future ones. The LSIF recognizes the importance of flexible approaches and innovative public-private partnerships during global public health emergencies, but also cautions that changing innovation-enabling policies could undermine the development of safe and effective new treatments and vaccines.

 

The LSIF remains committed to supporting APEC economies with fostering an enabling environment to grow their innovative life sciences sector during and after the COVID-19 pandemic. The LSIF will work to update the LSIF Enablers of Investment Checklist to reflect the knowledge, lessons, and experiences learned from the COVID-19 pandemic and the evolving requirements to attract investment in the sector. 

 

Promoting Resilient Trade in Medical Products

 

Resilient trade is necessary to ensure that people are able to access the medical products they need to combat pandemics. Many life science and medical technology companies have ramped up manufacturing capacity and output of essential medicines, research, and testing of potential vaccines, and diagnostic kits to meet the increase in demand. Collaboration between governments and industry remains vital to ensure the availability and accessibility of safe and effective medical products.

 

The LSIF acknowledges the importance of ensuring open, secure, stable, and efficient global supply chains and keeping markets open and trade flowing in response to COVID-19. We support APEC as a whole and members individually in reducing and eliminating unnecessary barriers to trade in medical products and in promoting resilient supply chains for medical products. We plan to present our recommendations for promoting resilient trade in medical products to the APEC Committee on Trade & Investment in 2020.

 

Ensuring the Safety and Quality of Medical Products

 

During this time of crisis, the LSIF is committed to further enhancing coordination of efforts to protect the medical product supply chain – and ultimately people and patients – by promoting trade in safe and quality drug products and ingredients. Protecting the integrity of the medical product supply chain is complex and requires a global approach. The APEC LSIF Supply Chain Security Toolkit for Medical Products is a comprehensive resource that addresses areas of vulnerability in the medical product supply chain and the lifecycle of medical products - from raw materials to use by patients. It contains recommended best practices and tools to prevent and detect substandard and falsified medical products before they reach people and patients. The toolkit also provides tools to efficiently and effectively respond to incidents involving substandard and falsified medical products.

 

The LSIF commits to continuing to work with APEC members and its network of APEC Training Centers of Excellence for Regulatory Science to ensure the wide dissemination of the Supply Chain Security Toolkit and to promote the adoption of best practices by industry stakeholders and regulators throughout the region.

 

Accelerating Regulatory Convergence

 

The COVID-19 pandemic has called attention to the urgent need for streamlined market approval processes to enhance access and availability of new safe and effective medicines, including future COVID-19 vaccines and treatments.

 

In response to the pandemic, the LSIF is accelerating efforts to advance regulatory convergence - a voluntary process whereby the regulatory requirements across economies become more aligned over time as authorities adopt internationally recognized technical guidance, standards and scientific principles, and common or similar practices and procedures. Regulatory convergence helps APEC economies avoid unnecessary duplication of regulatory reviews thereby allowing products to be approved more quickly.  For instance, when multiple regulatory authorities accept the results of a multi-regional clinical trial or MRCT (clinical trials conducted in more than one region under a single protocol, designed to produce regulatory-grade data) then drug development is expedited.  With MRCTs there is no need to conduct individual clinical trials separately in each economy, unnecessarily putting additional trial participants at risk and extending the time it takes to get, in the case of COVID-19, a safe and effective vaccine or treatment to those who need them.

 

Regulatory convergence related to post-approval changes can increase access by reducing strains on the supply chain that occur when multiple versions of a product need to be produced to comply with different domestic regulatory review criteria. Regulatory convergence can also save precious public resources by tapping into the expertise and work of other high-performing regulators around the region. Finally, regulatory convergence can reduce uncertainty and delays so companies find it easier to do business, investing their capital and creating jobs. 

 

The LSIF reaffirms its commitment to advancing the convergence of the regulatory review and approval processes for safe and effective medical products, especially those essential to the COVID-19 response. We are currently updating and extending our strategic framework for accelerating regulatory convergence for medical products in the APEC region and commit to incorporating perspectives from the COVID-19 pandemic into our strategic framework. We will continue to promote economic and technical cooperation, including capacity building, and provide needed assistance to developing economies. We commit to leveraging our network of 26 Centers of Excellence across 9 APEC economies, providing training programs for hundreds of regulators annually, to build the skilled human capacity needed to enable the region’s regulators, especially those in developing economies, to effectively and efficiently respond to COVID-19 and future pandemics.

 

Facilitating Innovative Healthcare Financing

 

The economic case for increasing investment in health has never been stronger. Financial contributions from governments, civil society, and industry have proven vital in rapidly responding to the pandemic. Yet, sustainable healthcare financing is the long-term solution for establishing a baseline in health systems that enhances access to healthcare, which is especially important during public health crises. The work of the LSIF to increase access to healthcare by expanding the role of the business sector, improving health system efficiency, and exploring the use of innovative and alternative financing models will be more important than ever after the pandemic.

 

This year the LSIF will expand virtual cooperation to expand the use of the APEC Checklist of Enablers for Alternative Health Financing to help APEC economies improve their policy and regulatory environment for enabling the adoption and deployment of alternative financing mechanisms to help maintain and expand healthcare coverage. Health financing policies that strengthen health system resilience, health security, and expand universal health coverage will enable us respond to the current COVID-19 crisis as well as future challenges.

 

Harnessing the Digital Economy and Digital Technology to Enable the Future of Life Sciences Innovation

 

COVID-19 has brought to the forefront the importance of leveraging the digital economy and digital technology tools, sharing information across borders between academia, governments, civil society, and the business sector in order to monitor, understand, mitigate, and respond to the pandemic. Thanks to economies sharing the genetic code of the virus that causes COVID-19 across the globe, scientists, public health officials and healthcare providers are able to accurately diagnose infections and pull expertise to develop safe and effective treatments and search for a vaccine.  

 

The digital economy and digital technology tools have enabled healthcare services to be provided to a wider range of patients and the population at large than ever before and in ways that would have been unthinkable only a few years ago. This has provided continuity of services to patients with ongoing medical needs that may not otherwise have been met in a time of social distancing or as many traditional health care facilities were dealing with challenges of the pandemic. Moving forward, digital health can be expanded to minimize unnecessary patient visits to secondary and tertiary hospitals to further optimize resources at these hospitals for patients with the greatest needs. 

 

The LSIF commits to facilitating the sharing of information and best practices in harnessing the digital economy and digital technologies to enable the future of life sciences innovation and our ability to address COVID-19 and future health challenges.