his year marks a century since the deadly Spanish flu epidemic in 1918, which led to the deaths of an estimated 50 million people. Today, we remain vulnerable to the ever-present threat of pandemics arising from emerging and re-emerging infectious diseases.

Aiming to provide a platform for discussions on pandemic preparedness in Asia, the Duke-NUS Centre of Regulatory Excellence (CoRE) and DIA worked together to bring the first joint DIA-CoRE conference to Singapore and the wider South-East Asia region. This inaugural event, Accelerating Access to Innovative Products – Improving Responses to Pandemic Diseases, held in January 2018, focused on approaches to expedite research and development of health products (including vaccines and diagnostics), and ensure timely patient access to such products during pandemic situations.  The panel of speakers featured public health and healthcare leaders, infectious disease experts, regulators, and industry players, which enabled multi-stakeholder dialogue and networking.

Not “If” but “When”

Speakers repeatedly emphasized the unavoidable certainty of a pandemic event in the near future, highlighting that today’s highly globalized and interconnected environment promotes rapid global spread of a highly infectious disease. Moreover, widespread antimicrobial resistance and a decline in new antibiotics research complicate eradication efforts against antibiotic-resistant infectious diseases such as malaria and tuberculosis.

In addition to the global threat, Southeast Asia faces health challenges from endemic infectious diseases, including malaria and dengue, which thrive in tropical climates. Heterogeneity across the region with regard to economic growth, health systems, and regulatory structure also contribute to regulatory, business, and operational challenges for healthcare stakeholders looking to address the pandemic threat.

Multifaceted Systems: Effective, Responsive, Coordinated

A pandemic situation is often unpredictable and calls for rapid responses to prevent further spread, treat the infected, and protect the healthy. Conference sessions described pandemic preparedness, touching on key components of an effective, responsive, and coordinated system that must respond quickly and facilitate timely access to an adequate supply of vaccines. Such a system is multifaceted, requiring effective coordination of multiple components:
 

1. Regulatory mechanisms include early access or accelerated approval schemes, provision of scientific advice or consultation, and a robust system for long-term post-market safety monitoring of vaccines.
2. The antimicrobial R&D pipeline must be supported by both upstream (i.e., promoting research) and downstream (i.e., post-development “reward”) incentives to foster steady innovation.

3. Robust operations supported with adequate resources are vital to ensure timely distribution of sufficient health products to the people.


A Global Win against a Global Threat

The conference highlighted a poignant reminder that infectious diseases do not recognize borders, underlining that a global multi-stakeholder effort is necessary to combat the threat effectively.

Within Southeast Asia, regional heterogeneity and limited resources highlight the need for partnerships and collaboration among policy makers, regulatory stakeholders, industry, healthcare providers, technical partners, and funders. Taking into account the regulatory capability and capacity of the national regulatory authority, implementation of Good Reliance Practice (under the World Health Organization’s Good Regulatory Practice guidelines) could help regulators prioritize and allocate limited resources in a way that best contributes to public health.

A grand panel at the end of the conference discussed developing a cross-cutting framework for pandemic responses, raising the suggestion of an Asia-Pacific coalition that would provide a platform for information-sharing and coordinate mechanisms necessary to accelerate access to health products during pandemic situations.

The Time to Act is Now

Given the reality and potential impact of pandemic threats, actions to build pandemic preparedness must be undertaken with a sense of urgency. We anticipate continued conversations with key partners and stakeholders through future planned activities.

References available upon request.

Accelerating Access to Innovative Products – Improving Responses to Pandemic Diseases