AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
Committee Events & Luncheons
The Committee supports the government’s healthy Taiwan policy, which reaffirms Taiwan’s strong commitment to the spirit of the World Health Organization’s (WHO) goal of achieving “Health For All.”
Taiwan boasts a well-established healthcare market. The National Health Insurance (NHI) system covers essential medical devices within constrained budgets, while also fostering a free-market environment conducive to the introduction of novel medical technologies and products. This approach aligns with the WHO’s emphasis on patient-centered healthcare.
Still, Taiwan’s healthcare spending as a percentage of GDP falls below that of Japan, South Korea, and other developed nations. As Taiwan becomes a super-aged society, with over 20% of the population aged 65 and above, the use of age-related operations, treatments, and long-term care will increase, leading to surging healthcare costs. It is therefore imperative that the government elevate healthcare expenditure from the current 6.6% to over 8% of GDP, aligning itself closer to the OECD average.
A sufficient healthcare budget will facilitate the rapid incorporation of new medical technologies and products, boost investment in public health, and bolster the resilience of the healthcare system. To sustain the wellbeing of its population, Taiwan must persist in integrating innovative medical technology products and services. In view of this need, the Committee puts forth the following recommendations:
Suggestion 1: Simplify medical device registration requirements to minimize the gap between international launch and Taiwan approval.
For a company to obtain a Certificate to Foreign Government/Certificate of Free Sale (CFG/CFS), the product must first have been marketed in its country of origin or in a prominent market such as the United States or Europe. This requirement impedes the timely introduction of new medical technologies in Taiwan. In contrast, most Asia-Pacific markets have eliminated the CFG/CFS prerequisite, allowing for simultaneous market entry alongside the United States and Europe. Consequently, Japan, Singapore, and South Korea are progressively emerging as centers of new medical technology development within the region, while Taiwan is lagging behind.
Although the Taiwan Food and Drug Administration (TFDA) responded to last year’s White Paper by stating it offers several alternatives to the CFG/CFS requirement, these alternatives are often time-consuming and burdensome for companies. Moreover, the CFG/CFS regulatory framework diminishes Taiwan’s international competitiveness. For instance, if the TFDA takes 10 months to approve a product, a CFG can only be issued after this approval is secured, and only then can registration in Taiwan commence. With Taiwan’s registration process taking an additional 9-12 months, there is a nearly two-year delay in product launch compared to global standards. This delay places Taiwan outside the scope of priority launches in Asia. The de-prioritization of Taiwan delays product introductions and affects the international stature of Taiwan’s medical professionals.
The Committee continues to urge the TFDA to remove the CFG/CFS requirements. Eliminating these conditions would enhance Taiwan’s regulatory attractiveness, reduce the interval between the global launch of new medical technologies and their domestic approval, and reinforce Taiwan’s position as a hub for medical advancements and a center of excellence in the Asia-Pacific region.
Suggestion 2: Simplify product scope change requirements for quality system documentation conformity assessments for foreign manufacturers.
Under current regulations, changes to product scopes within the existing quality system documentation (QSD) process require manufacturers to resubmit all documents provided through the initial QSD application. This requirement not only entails repetitive reviews of the same quality management system established by the manufacturer but also contributes to approval delays for new product registrations. To streamline this process, the Committee recommends that the TFDA’s Division of Quality Compliance and Management revise the application procedure for amending or extending product scopes in the QSD and simplify the documentation requirements.
Specifically, if no significant changes have occurred based on a manufacturer’s previously assessed medical device quality management system documents and the QSD remains valid within a three-year time frame, the submission should be limited to the ISO 13485 certificate, the manufacturing process document, and the device master record for the new product score only. This approach would prevent redundant reviews, enhance the efficiency of the review system, and accelerate the approval process for the benefit of patients and physicians.
Suggestion 3: Streamline the reimbursement application process to improve access to new medical technologies.
3.1 Implement parallel reviews for product registration and National Health Insurance Administration reimbursement. To expedite the introduction of new medical technologies and streamline their reimbursement approval, we suggest that applicants for medical technologies addressing clinical gaps, representing breakthrough innovations, or offering substitutable alternatives should be eligible to submit reimbursement applications to the National Health Insurance Administration (NHIA) concurrently with the licensing review process by the TFDA. Parallel processing will accelerate the market launch of new technologies and the approval of their reimbursement, enhancing the accessibility of novel medical technologies.
For greater market predictability, we also suggest increasing the transparency of the Expert Advisory Meetings and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee. Making the minutes of these meetings publicly available would provide stakeholders with clearer insights into decision-making processes and criteria, thereby facilitating better planning and strategy development in the medical technology sector.
3.2 Relax the regulations governing non-reimbursed medical devices. Many innovative non-implantable medical devices fall outside the scope of specific procedure fees, while innovative implantable devices face challenges in securing non-reimbursed codes. This issue is compounded by uncertain timelines for completing the review process once manufacturers submit applications to the NHIA. We urge the NHIA to facilitate quicker access to the market for these innovative medical devices by streamlining the review process. The Committee further recommends the concurrent gathering of market price data to provide valuable reference for future pricing decisions.
3.2.1 Revise Article 2 of the regulations governing non-reimbursement. Once license holders seeking reimbursement for medical devices submit an application through the online system, the products pending reimbursement approval should be listed on the non-reimbursed medical device list available on the NHIA website. Revising Article 2 to permit this change would ensure transparency and allow for the proper regulation and tracking of medical devices awaiting reimbursement status, thereby returning non-reimbursed devices to the free market.
After a reimbursement code has been assigned, medical institutions should be permitted to pay a self-payment fee for the use of these devices in clinical practice, as stipulated in Article 21 of the Medical Care Act.
3.2.2 Revise Article 4, Section 3 of the regulations to ensure a sufficient notice period. The review of the NHIA’s Z code list, which includes items that have been self-paid for over three years, aims to determine whether these items should qualify for reimbursement. However, current practices at the NHIA do not include providing notice before a decision is made, and the reimbursement prices proposed are often low. Consequently, companies may face significant revenue losses and insufficient time to plan and communicate internally regarding the NHIA decision.
We urge the NHIA to complete the review process for functional medical devices that has been underway since 2013. The Committee also strongly suggests that decisions taking effect in the upcoming year be disclosed in July of the preceding year and that the NHIA fully communicate its decisions with license holders, medical institutions, medical associations, and relevant units. With a sufficient budget and consensus on the reimbursement points, the listed medical devices should be approved for reimbursement to comply with current clinical use.
3.3 Establish a self-pay procedure platform and simplify the application process. Article 21 of the Medical Care Act stipulates that hospitals must secure approval from the appropriate city or county government department of health to levy charges for non-reimbursed medical services. For each hospital to have to individually submit an application is unnecessarily cumbersome and time-consuming. To streamline the procedure, we urge the Department of Medical Affairs and the NHIA to collaborate with local health departments to create a unified self-pay procedure platform.
We further recommend that once a city’s department of health authorizes self-pay procedures, other cities should be able to adopt these procedures without additional approvals, provided that the extra fee being charged does not exceed 15% of the initially approved fee. Such a policy would significantly reduce the processing time and facilitate quicker access to new medical technologies, thereby enhancing patient care and driving the adoption of innovative medical solutions across cities and counties.
Suggestion 4: Adopt additional payment methods to improve the financial sustainability of the National Health Insurance system.
New health technologies and products continue to bring improvements to healthcare quality. However, reimbursement prices often fail to accurately reflect the value of these products. In view of Taiwan’s limited NHI budget and the increasing risks of global supply chain shortages, the Committee suggests adopting additional payment methods to encourage the continuous entry of new health technologies into the market. Doing so will help Taiwan avoid being excluded from priority supply markets.
4.1 Prioritize balance billing for new medical devices not included in the reimbursement scheme. The approved prices for balance billing, as outlined in Article 52-4 of the PBRS, should prioritize the use of the median or higher value of the “domestic market selling price, or the self-pay price charged by medical institutions at all levels.” A more sophisticated product categorization is needed to reflect product value and encourage the continuous introduction of new technological products into Taiwan.
4.2 Expand the value-based pricing model to reflect the value of products and increase the add-on factors for medical devices with functional improvement. According to Article 52-2, Paragraph 3, Section 1 of the NHI Drug Reimbursement Items and Payment Standards, only seven add-on factors are available for functional improvement medical devices. Given the rapid advancement of health technology, these seven add-on factors are increasingly inadequate to properly capture the value of new medical solutions.
Moreover, the existing pricing method for medical devices with functional improvements typically allows for less than a 15% price increase, which also does not sufficiently capture the value of these innovations. To more accurately reflect their worth, we suggest that additional factors be incorporated into the pricing mechanism to ensure that pricing aligns more closely with the advancements and benefits being offered.
The Committee recommends the inclusion of four additional add-on factors:
Suggestion 5: Adopt more precise classifications and pricing for medical devices used for diagnosis or treatment without additional reimbursement.
Article 3 of the PBRS stipulates that payment points for surgical materials, procedures, anesthesia, or diagnostic fees should include general medical devices. Consequently, such devices are not reimbursed individually.
However, advancements in health technology have resulted in the introduction of new and innovative general materials for surgical use, significantly reducing surgical risks and enhancing the quality of medical care. The benefits of these innovative products include minimizing tissue damage from cutting and hemostasis, reducing surgery time, lowering surgical infection rates, and improving surgical efficiency or clinical outcomes. To increase access to such products, the Committee makes the following recommendations:
5.1 Reevaluate the pricing methodology for novel general materials included in the procedure fee. General materials with special functionalities and clinical benefits should undergo more precise classification and product differentiation. If the general materials demonstrate specific functions, they should be categorized as special materials and charged separately. For instance, sutures could be further categorized into general sutures, antibacterial sutures, and knot-free sutures to protect the public’s right to use innovative materials, while highlighting the value of innovative devices.
5.2 Allow patients to use innovative devices at their own expense. In the realm of medical device innovation, when manufacturers introduce advancements that enhance product functionality, there is a natural expectation for these products to fetch a higher price point. However, the NHIA initially includes these advanced devices under the pre-existing reimbursement structures. This practice mandates that manufacturers must subsequently submit evidence of clinical benefits to justify any proposed price adjustments.
Pertinent legislation, namely Article 48 of the PBRS and Article 21 of the Medical Care Act, addresses this scenario. These articles specify that if innovative medical devices do not demonstrate an economic benefit and other reimbursed alternatives exist, patients should still have the opportunity to use these devices at their own expense. As the new products have yet to meet the requirements, we strongly urge the government to allow patients to freely choose these medical devices at their own expense. Doing so would not only support innovation within the industry but also respect patient autonomy in choosing their preferred medical solutions.
委員會支持政府的「健康台灣」政策,此政策再次體現了台灣對於世界衛生組織(WHO)為達成全民均健(Health for All)目標的堅定承諾。
台灣擁有成熟的醫療市場,在醫療預算有限的情況下,全民健康保險能夠給付基本醫材,且為新醫療科技及產品提供友善的自由市場環境,此制度呼應了WHO以病人為中心之醫療照護的主張。然而,台灣的醫療支出占國內生產總值(GDP)的比例低於日本、韓國和其他發達國家。隨著台灣逐漸成為65歲以上人口佔超過20%的超高齡社會,與年齡相關的手術、治療和長期護理的醫療業務將增加,並導致相關支出急遽上升。是故,將醫療支出從目前的國內生產總值6.6%提高到超過8%為政府當務之急,以與經濟合作暨發展組織(OECD)的平均一致。
充足的醫療預算將有助於新興醫療技術和產品的快速整合、增加公共衛生投資,並強化醫療系統韌性。為了維護人民的福祉,台灣必須持續整合創新的醫療技術產品和服務。鑒於這一需求,委員會提出以下建議:
建議一:簡化醫療器材查驗登記審查要求以縮短國內核准與國際上市之時間
免除醫療器材註冊對美國製售證明(CFG)及歐盟自由銷售證明(CFS)之要求。
取得製售證明之前提在於原產國或其他國家(如美歐)必須先上市,此舉導致新醫療科技產品在國內上市之時間遭延遲,相比之下,目前亞太區大部分市場皆已免除製售證明之要求,因而可與美歐同步上市,以至於日韓及新加坡逐漸成為亞太區新醫療科技產品之發展中心,而台灣則位居落後。
儘管食品藥物管理署(TFDA)已針對去年的白皮書回應表示有提供了許多製售證明之替代方案,但這些方案往往耗時費力並對公司造成負擔,此外,由於查驗仍需檢附製售證明,削弱了台灣的國際競爭力。舉例來說,如果美國食品藥物管理局(FDA)需要10個月才能批准一個產品,那麼只有在獲得批准後,製售證明才能發放,而後方能開始在台灣進行產品登記。考量到台灣的登錄流程需要額外9至12個月,產品上市的時程與全球標準相比幾乎要延遲了兩年,使得台灣被排除在亞洲產品優先上市地位,推遲了產品引進時程並影響台灣醫療專業人士之國際地位。
委員會持續敦促食藥署免除製售證明之要求以增加台灣之競爭力,並縮短國內新醫療技術核准與國際上市的時程差距,強化台灣在亞太區醫療發展中心及卓越中心之國際地位。
建議二:簡化外國醫療器材製造廠,對於醫療器材品質系統文件審查( QSD )申請認可登陸品項的變更
根據目前的規定,如要申請變更現有品項,需重新檢附最初申請時的所有文件,此舉不僅對製造商建立的相同品質系統文件進行重複審查,亦會延後新產品登記核准的時間。委員會建請食藥署品質監督管理組研擬QSD認可登錄品項的變更方法,以簡化文件要求。具體來說,新增之登錄品項在QSD三年之有效期限內,基於前次已審查之品質系統文件無重大變更下,僅須提供 ISO 13485證書、製造流程文件,與新增品項之醫材檔案清單,以避重複審查、加速核准時效、創造高效審查制度以提升法規競爭力,造福患者和醫事人員。
建議三:簡化給付申請流程以提升新醫療科技之可近性
3.1 推動查驗登記及健保給付平行審查。
為加速新醫療科技市場准入並簡化其給付流程,我們建議將符合臨床缺口、具突破性、或具替代性之醫療科技,可於向食藥署申請許可證審查時,同步向健保署提出健保給付建議,以加速新科技的上市和健保給付的批准,從而提高新醫療科技的可近性。而為提升市場可預測性,我們也建議提升專家諮詢會議之透明度,藉由公開會議紀錄的方式以幫助利害關係人進行決策和設定準則,從而促進醫療技術領域的規劃和策略發展。
3.2 鬆綁「全民健保尚未納入給付特材管理作業要點」。
許多非植入式創新醫療器材超出給付費用範圍,而植入式創新器材在獲得全民健保尚未納入給付特材品項代碼(Z碼,暫時自費碼)則面臨困難,且在製造商提交申請給健保署後,也無法確定完成審查的時程,因此,我們敦促健保署通過簡化查驗程序來加快創新醫療器材進入市場的速度,並同時收集市場價格數據以做為未來定價的參考。
3.2.1 修正作業要點第二點
當醫療器材許可證持有者透過線上系統提交給付申請,審查中之產品,醫療機構應被允許按照《醫療法》第21條的規定,依臨床情況判定自費使用相關醫材。可列於健保署全球資訊網「全民健保尚未納入給付特材品項表」。透過修改第二點作業要點將確保醫材管理變更透明性,並允許對其醫療器材進行適當監管及追蹤,從而使非給付醫材重返自由市場。
3.2.2 修正作業要點第四點之(三)以確保足夠的通知期
健保署所審查之Z碼清單包含自費超過三年的品項,旨在確定這些項目是否有資格獲得給付,然而政府在做出給付決定前並無事前告知業者,且給付報價往往偏低,從而導致企業恐面臨重大的收入損失並缺乏內部溝通和規劃的時間。
我們敦促健保署將自一百零二年起經完成審議程序之功能類別品項,於前一年七月預告,並充分和醫材許可證持有者、保險醫事服務機構,專業醫學會等相關單位溝通,在預算充足及給付點值有共識下,將表中特材納入健保給付,以符合臨床使用現況。
3.3 建立自費診療項目整合平台並簡化申請流程。
對於尚未納入給付之診療項目,醫療院所可依《醫療法》第21條向地方衛生主管機關申請核定醫療服務項目及費用,但目前仍需由各醫院個別向衛生局提出申請,流程冗長且重複。委員會建議由醫事司及健保署協調縣市衛生局意見,建立自費診療項目整合平台,並簡化申請流程,若已有縣市核准之自費診療項目,其他縣市在收取費用不超過第一件核准費用15%內,可直接比照通過,以縮短時程並提升新醫療科技可近性。
建議四:擴大採用多元化的給付方式以促進健保財務永續
新醫療科技及產品持續為醫療技術及品質帶來提升,然而健保給付之價格,往往無法準確反應產品價值,在現行全民健保預算有限及全球供應鏈缺貨風險提升的情勢下,委員會建議擴大採用多元化的給付方式,以鼓勵新醫療科技持續進入市場,避免台灣因市場規模小而被排除於優先供貨國家。本委員會建議如下:
4.1 尚未納入給付之新特材均優先採用自付差額制度。並根據藥物給付項目及支付標準第52條之4之自付差額產品,應採用「各層級醫療院所收取自費價格」中位數以上來核定費用。產品功能分類應更細緻,以反映產品價值,鼓勵新科技產品持續引進台灣。
4.2 擴大以產品價值為基礎的核價模式,並增加新功能類別特材的加成因素。依現行藥物給付項目及支付標準(以下稱支付標準)第52-2條第一項第三款,針對功能改善特材,只有7項核價加算因素符合標準。
惟醫療科技日新月異,現有的7項加算因素已無法反映產品價值,又依現行核價規定,分類為功能改善的新特材,每項只能得到不多於15%的加算,實無法反映新醫療科技之臨床價值。故本委員會建議增修4項因素於支付標準,以確保功能改善新特材,其產品價值能如實反應在核價:(1)產品功能性的改善:如透過結構設計等,可提高固定強度、生物相容性、耐久性及使用時間等;(2)可改善患者生活品質之治療方法:如提升患者使用方便性及獨立生活的能力、緩解疼痛及不適感、提升患者滿意度等;(3)有來自醫院更具臨床實用性的證據;(4)提高病人或醫療從業人員的操作便利性。
建議五:針對內含於診斷或治療而不另外支付之醫材,採更精準分類定價
現行各項健保手術所需之「手術一般材料費」,依「藥物給付項目及支付標準」第3條規定,「本標準未列項目之支付價格已包含於醫療服務給付項目及支付標準相關手術材料費、處置費、麻醉費或檢查費項目支付點數內,不另支付」。然隨著醫療科技進步,許多手術執行時使用的一般材料(含過程面特殊材料)品項,已有更加新穎的產品能進一步降低手術風險並提升醫療品質,這些創新產品的好處包括:減少組織切割及止血引起的損傷、縮短手術時間、減少手術感染等,並可提升手術效率或帶來更好的臨床效果。但此類產品,若不論創新與否僅以同品項一概而論,均包含於醫療服務給付項目內,不另支付,則無法反映創新醫材之價值。為增加此類創新產品之可取得性,本委員會建議:
5.1 重新審視過程面之新穎醫療器材計價方式。
具特殊功能及醫療效益者,應進行更細緻的分類及產品差異性評估,如:縫線產品可再細分為一般縫線、特殊功能的抗菌縫線、與免打結縫線等。若屬特殊材料者應獨立計價,以反映創新產品在同品項醫材間的差異及價值,保障民眾使用新科技產品權利。
5.2 新穎醫材儘速開放於醫療市場,提供民眾自費選擇。
在醫療器材創新領域,當廠商引進具新功能和先進技術的產品時,自然期望這些產品能夠獲得更高的價格。然而,健保署都先將這些新穎醫材以現有給付條件納入健保,要求廠商未來可提交臨床效益證據,再考慮評估價格調整,此舉與普世產業商業運作模式不符。依據「全民健康保險藥物給付項目及支付標準」第48條規定,如果創新醫療器材已有其他可替代之健保產品,而對於健保屬缺乏經濟效益者,我們強烈建議政府應儘速讓這些無法納入健保的新穎醫材回到市場,依《醫療法》第21條相關規定,使病人有選擇自費使用的機會,不僅能支持產業創新,亦能尊重病人的醫療自主決定權。