As the world scrambles to stay one step ahead of the pandemic, the Asia Pacific Medical Technology Association’s (APACMed) Chief Executive Officer (CEO), Harjit Gill shares lessons we can learn today, and the role of regulators in preparing the region for challenges in the future.
Social distancing, self-isolation and “flattening the curve” have slowly found a way into everyday conversations. Yet, nothing could have prepared the world for the pandemic we are facing, that has put a strain on our collective resources and way of life. While diagnostics is at the core of sustainable healthcare, its role, now more than ever, is critical in containing an outbreak. By helping identify infected patients early, testing can prevent community-wide transmission and ensure access to timely treatment. In a race to bring much needed equipment, testing technologies and treatments into countries, health authorities are working around the clock to ensure regulations can meet the needs in this constantly changing environment.
The sudden emergence and rapid transmission of COVID-19 has devolved into a global health crisis that current healthcare systems have not faced before.
The highly infectious nature of the novel coronavirus has led to countries taking drastic actions to prevent its widespread transmission. While the emergence of the Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and more recently Ebola have highlighted the gaps plaguing healthcare systems, not every outbreak has reached pandemic level. With two-thirds of the world’s healthcare systems ill-prepared for pandemicsaccording to the Global Health Security Index report,1 hospitals have been scrambling to manage the outbreak, while the medical technology industry has doubled its efforts to ramp up production.
As Harjit Gill explains, governments in Asia Pacific have taken steps to streamline regulatory processes to ensure the availability of important resources to fight the growing pandemic. This includes accelerating approvals for medical products such as personal protective equipment and diagnostic test kits and enabling emergency use authorizations (EUAs) of unapproved products when approved alternatives are not available.
“Countries recognise we are all in this together. There’s been a lot of effort on the regulatory front to improve access to COVID-19-related products, not just for domestic consumption but also for exports to support other economies,” Gill said.
Citing recent examples, she highlights South Korea’s efficient use of EUAs and China’s shortened approval time, India and Australia’s exemption of certain regulatory requirements for the use of some medical devices. Thailand and Taiwan are also finding creative ways to address hurdles given the lockdown environment – both are considering the acceptance of digital signatures or exempting notarisation requirements to allow easier patient access to essential medical products.
According to Gill, governments can accelerate regulatory approvals more effectively if they have a legal foundation in place to activate emergency approval pathways, as well as competent regulatory teams to swiftly review emergency-use products. “Countries with fewer resources could benefit from a regulatory reliance model to promote the sharing of knowledge and workload among regulators,” she says.
Representing Asia’s MedTech industry, the APACMed CEO offered a few lessons the industry can learn from this pandemic.
Taking advantage of digital technologies in healthcare
The first is to further unlock the potential of digital technologies in healthcare.
“We’ve seen both public and private sectors ramping up the adoption of digital technologies, such as telehealth, case tracking and contact tracing, AI-assisted diagnosis software, and remote trainings. If we could push for wider and deeper utilisation of digital technologies in the entire ecosystem, we would be much better prepared for the next crisis.”
“We hope that in the post COVID-19 era, regulators will be more convinced of measures that allow speed and agility without compromising safety and quality,” she adds. This could help to circumvent the unfolding tragedies that we are seeing in the current pandemic.
Expediting supply chain processes
Secondly, supply chains should be more robust to weather unforeseen disruptions. The industry can work with the public sector to formulate protocols for different scenarios and potential solutions, such as having alternative sources for raw materials and other essential supplies such as protective gear and test kits that are critical for frontline healthcare workers.
A multi-stakeholder approach
Finally, there should be better coordination within the healthcare ecosystem, including public-private partnerships, and much wider cross-boundary coordination mechanisms to cope with global crises. As Gill explains, these mechanisms need to cross national borders within the region and beyond, cross industry sector, be it pharmaceutical, devices, IVDs, or health technologies and cross the entire ecosystem to bring everyone on the same page.
There hasn’t been an ideal coordination mechanism in place to mobilise the ecosystem yet, but we see agencies like the World Health Organization and others working very hard to pull policy makers, scientists, doctors, innovators, academia, industry and donors together. I hope that we use learnings from this crisis to build greater trust, resilience and solidarity across nations.
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¹Global Health Security Index. 2019. https://www.ghsindex.org/wp-content/uploads/2019/10/2019-Global-Health-Security-Index.pdf