The Challenges of Regulatory Convergence in APAC Medtech

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Regulatory harmonisation for medical devices between countries in Asia-Pacific has long been a challenging issue, predominantly due to the extreme variation in cultures, economic development, governmental models, and healthcare systems in the region.

 

Greater harmonisation would allow solutions introduced in APAC’s most developed markets to filter down to its emerging economies, but unified regulation may be a mere pipe dream. However, smaller collaborations have already borne fruit and companies are finding other ways to leverage the expertise in markets like Singapore to benefit patients across the region, spurred on by the COVID-19 pandemic.

 

Do we want perfect harmonisation under one regulatory code or do we really want broader, clearly defined common standards that ultimately allow things to move faster?

Andrew Frye, Baxter

 

For Andrew Frye, SVP & President for APAC at Baxter, the question of harmonisation needs to be unpacked and examined.ASEAN has made some progress towards achieving a number of harmonisation goals,” he states. “However, we need to think about the overarching aim of harmonisation and convergence. Do we want perfect harmonisation under one regulatory code or do we really want broader, clearly defined common standards that ultimately allow things to move faster? All stakeholders basically agree that greater convergence and standard-setting is the best direction in which to head.”

 

Sanjay Prabhakaran, himself a Baxter alumnus and now head of women’s health specialist Hologic, is in agreement. “Harmonisation is linked to the question of establishing what “good” looks like. What good looks like in one country may not be replicable in another where the circumstances are different,” he notes. “Attempting to replicate something one-for-one in a developing country that works in a developed country with higher GDP spend will probably not be a good solution. However, there is a stakeholder willingness to establish what a good outcome looks like and how it can work in a developing country context. There is a greater opportunity to simplify the regulations in several of the ASEAN countries which will allow for faster access to the latest technology benefiting the patients.

 

COVID-19 may provide the push for greater convergence as Harjit Gill, CEO of regional medtech association APACMed points out. “Many governments are using the pandemic to revisit outdated regulatory and capacity building models,” she states. “Our efforts with the “regulatory reliance” program, for example, are driving greater harmonisation for medtech across the ASEAN region, thereby reducing timelines, complexities, costs and improving access.” While full harmonisation is not realistic, pilot projects like that between the Thai FDA and Singaporean HSA show that progress is being made.

 

What good looks like in one country may not be replicable in another where the circumstances are different

Sanjay Prabhakaran, Hologic

 

Baxter’s Frye, who is also the current chairman of the APACMed Board of Directors, agrees that the pandemic has created an inflection point. “[The need for greater harmonisation and convergence in the region] has become even more apparent under COVID-19, where new technologies have become available,” he proclaims. “The fact that countries lack the resources to evaluate these new technologies gives us an opportunity to think about leveraging existing approvals from Singapore’s HSA, for example, as opposed to letting countries try to go it alone. Indeed, Singapore is leading regionally, creating credible standards and use cases that other countries can leverage. APACMed has been pushing this for several years and has hosted a number of conferences on the topic. As an industry, we know that speed of access to innovation and reduced workload for regulators must go hand in hand.”

 

Siemens Healthineers is a good example of a company leveraging its footprint in Singapore to serve the wider region. The company’s Asia Reference Centre is, in the words of MD Ai Li Siow, “a ‘hub and spoke’ model for clinical and educational excellence. This includes exploring new protocols in certain disease treatments by collaborating with industry partners who have specific healthcare or medical expertise.”

 

Siow continues, “The Center also serves as a hub to support the needs of other countries in our region. Our Asia Reference Center can provide remote scanning assistance wherein medical specialists are able to access our radiological systems from any location to provide support to the personnel using the system, particularly for complicated clinical examinations. For instance, if there is the need for a specific examination to take place in a remote location, which does not have access to qualified medical professionals, our team of qualified experts can step in and provide remote access support to drive various clinical examinations in that healthcare institution. This is now possible thanks to the digital infrastructure we have built here. The objective for setting up the Siemens Healthineers Asia Reference Centre is to combine our technological know-how with the local medical specialist expertise here to support other countries in the region.”

 

The objective for setting up the Siemens Healthineers Asia Reference Centre is to combine our technological know-how with the local medical specialist expertise here to support other countries in the region

Ai Li Siow, Siemens Healthineers

 

Lance Little, APAC MD for Roche Diagnostics, adds that individual companies have a responsibility to help build ecosystems between different players to foster greater access to innovation. He notes that “I see organizations like Roche Diagnostics increasingly developing more of an ecosystem mindset. The days of seeing ourselves as just a piece within the ecosystem, sitting independently of other players and interacting only with the people we see a direct connection with, are coming to an end. The role of a diagnostics or pharma or medtech company needs to become more interactive. How can we partner with different players to improve overall healthcare outcomes and overall healthcare efficiency? This will become an increasingly important conversation because public and private health providers are looking to do more with each dollar.”

 

Hologic’s Prabhakaran also bangs the drum for more collaboration. “The toughest job in healthcare belongs to the Ministry of Health,” he opines. “It is truly a challenging task and therefore industry stakeholders need to put themselves in the MOHs shoes. We need to understand that they are trying to keep costs down so that a larger part of the country’s GDP can be spent on more revenue-generating growth drivers while at the same time ensuring that the population is healthy and has access to good healthcare. Bringing these two diametrically opposed views together takes a considerable effort, so by working in partnership with the payers and providers we can come up with solutions that can be beneficial for all.”


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