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Advancing Innovative Healthcare in Asia Pacific

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Country Highlights

ASEAN

Singapore – Charting the Path for Value-Based Market Access

Amidst pressures of balancing healthcare costs and maintaining patient access to medical devices, it is important payers recognise the unique value added services that the MedTech industry provides to physicians, providers and patients.

With the aim of serving as a catalyst for greater collaboration within Singapore and as a valuable resource for other governments and stakeholders across the region facing similar challenges, APACMed, in partnership with the Singapore Manufacturing Federation’s Medical Technology Industry Group (SMF’s MTIG) and Vista Health, published a white paper: “Value-Based Pricing for MedTech: A Collaborative Path for Singapore” in 2023.

Malaysia & Thailand – Enhancing Regulatory Reliance with Thai FDA and MDA – Capability & Capacity Building

Thailand:

An APACMed-led delegation engaged with Thai FDA over a two-day workshop in Bangkok, Thailand in 2023 with discussions aimed at further enhancing the Regulatory Reliance programme between Singapore HSA & Thai FDA to make it one of the most comprehensive programmes and a role model in the region.

23 Thai FDA officers were trained on topics such as Good Regulatory Practices leading to Agility, Software as a Medical Device (SaMD), Fit-for-purpose Change Management and Biocompability.

Malaysia:

APACMed’s RA Committee organised a Training Workshop for Malaysia Medical Device Authority (MDA) in conjunction with Global Harmonization Working Party (GHWP) in 2023. 

The training workshop focused on emerging regulatory topics such as AI and Machine Learning, Cybersecurity, Risk-Based Change Management, and Innovative Medical Devices.

Guest speakers from GMDN Agency presented on Global Medical Device Nomenclature standards. 

Industry participants also received insights from Mdm Salbiah, Director of Policy, Industry and International Affairs at Medical Device Authority on the guidance document on Medical Gas System (EPSP) – Standards for Demonstrating Compliance developed by GHWP. 

Indonesia – Advocating for a Balanced Approach towards Localisation

APACMed in collaboration with Indonesian Health Economics Association (inaHEA) held a closed-door policy dialogue on Building Healthcare Resilience in Jakarta on 30 May 2023.

The keynote address was delivered by the General Secretary of the Ministry of Health of the Republic of Indonesia, Pak Kunta Wibawa Dasa Nugraha. The forum was well attended by senior government officials, various clinical associations, and the industry. As an outcome of this series of discussions, a policy brief document (members-only access) was developed and released at a policy session as a part of the 8th Biannual Scientific Meeting of Indonesian Health Economics Association on 27 October 2023. The document emphasises a balanced approach towards localisation – through collaboration between industry, government and other healthcare stakeholders. 

The launch was attended by over 350 attendees including Vice Minister of Finance Suahasil Nazara, senior officials from the Ministry of Health of the Republic of Indonesia, The House of Representatives, Republic of Indonesia (DPR RI) and the Social Security Agency of the Republic of Indonesia.

The discussion emphasised the need for collaboration between government, industry and other healthcare stakeholders towards the common goal of striking the right balance between innovation, domestic resilience, and quality healthcare for Indonesia. One of the key areas of collaboration highlighted was the Pharmaceutical and Medical Device Dictionary as an instrument for fair procurement.

Vietnam – Sharing Value-Based Procurement Best Practices

APACMed, in partnership with US-ASEAN Business Council (US-ABC) and EuroCham Vietnam Medical Devices & Diagnostics Sector Committee, jointly organised the Amended Law on Tender and Value-Based Procurement Best Practices Sharing Workshop on 18 October 2023 in Hanoi, Vietnam. 

The workshop was attended by over 60 attendees from industry, hospitals and policymakers from the Ministry of Planning and Investment (MPI), Ministry of Health (MOH), Vietnam Social Security.  

The workshop covered the importance of adopting a value-based approach for healthcare procurement to deliver better patient outcomes and meet government objectives, and the challenges faced as Vietnam moves into its new model of value-based healthcare procurement while continuing to improve patient outcomes. There was insight sharing and frank discussion on the Amended Law on Tender, value-based procurement best practices and how they could be adapted for application in Vietnam to benefit patients, providers and achieve the goals of improved access to care and reduced healthcare costs. 

Philippines – Advocating for Regulatory Reliance and a Risk-Based Approach for Access to Innovative IVD Solutions

APACMed partnered with the Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) to advocate for the adoption of a risk-based approach and regulatory reliance in order to reduce the burden to the system and ensure access to safe, quality, and innovative in-vitro diagnostic solutions by engaging with the Department of Health-Office for Health Laboratories.

Adopting a risk-based approach will free up resources used for lower risk IVDs hence enabling a shift in focus to high risk products. Likewise, the application of regulatory reliance will allow the OHL to leverage on the previous work done by other regulatory agencies.

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Australia, Japan and South Korea– Paving the Way For Digital Health Reimbursement

Digital health technologies are gaining traction across APAC. However, reimbursement pathways remain complex and unclear.

The APACMed Policy Forum on Digital Health Reimbursement was held on 23 May 2023, with participants from Australia, Japan, Singapore, South Korea, Germany, France, and the UK. Several digital health policymakers, academicians, and experts from the respective countries, along with the APACMed Digital Health Reimbursement Alliance (DHRA) core committee, local trade associations, and EVERSANA members participated in the event.

Through the APACMed DHRA Policy Forum, APACMed, with the support of EVERSANA, aimed to create a baseline understanding of the reimbursement status for digital health technologies in Australia, Japan, Singapore, and Korea.

Policymakers from the four markets were invited to discuss the progress made in deciphering the complex reimbursement pathway for digital health and the outstanding challenges that make it hard to bring new innovations swiftly into the market and increase access to patients via reimbursement.

The forum fostered meaningful discussions, addressed critical challenges, and explored innovative solutions.

Read more about how we are making an impact in:

china

China – Championing the Out-of-Hospital Care Model

Through collaboration with central and local policymakers and key opinion leaders, our collective efforts are geared towards charting a path for a robust and impactful out-of-hospital care model in China. During our “Out-of-hospital Care Forum – Exploring ‘Internet + Healthcare’: Innovations in China” held in Beijing in 2023, the APACMed China office presented our meticulously curated research report to esteemed Chinese policymakers, prominent experts, and thought leaders. Facilitating cross-country sharing of best practices, Mr. Lai Yi Feng from the Singapore Ministry of Health’s Office for Healthcare Transformation presented the latest pilot on Mobile Inpatient Care @ Home during the event.

india

India – From Volume to Value: Unlocking India's Medical Device Innovation Potential Through Collaboration

APACMed and KPMG India launched a report titled ‘Volume to Value: Fostering Research and Innovation in India’s  Medical Device Industry’ at an event attended by Dr. Vinod Paul, NITI Aayog, Government of India, along with distinguished guests and industry leaders.

The session themed ‘Collaboration across the ecosystem: Innovation acceleration in India’s Medical Devices Sector’ explored key topics such as the role of the government, private sector and academia in fostering innovation, strengthening collaborations and the sharing of best practices from global markets.

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