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 is pleased to see the new government’s commitment to maintaining a strong trade relationship with the United States and continuing to foster trust in the Taiwan-U.S. trade environment. Amid global political and economic changes, the government is actively striving toward enhancing bilateral investment, particularly in strategic industries such as pharmaceuticals.
The signing of the first agreement under the U.S.-Taiwan Initiative on 21st Century Trade framework, which includes a chapter on good regulatory practices (GRP), marks a significant step for Taiwan. The Executive Yuan has placed high importance on GRP, actively implementing regulatory adjustments. This commitment emphasizes the need for meticulous planning of regulations with significant impact on international trade and investment, signifying Taiwan’s determination to aligning with international legal standards and promoting trade cooperation with the United States.
The Committee commends the government’s recent healthcare investment and policy reform aimed at bolstering healthcare resilience. However, without comprehensive planning, there is a risk of diminishing willingness to introduce innovative new drugs, potentially even leading to the withdrawal of existing medications from the Taiwan market.
During the ongoing healthcare reform, we have noted challenges related to ambiguous new reimbursement processes, parallel reviews, and amendments to managed entry agreement (MEA) regulations. Additionally, the Committee notes issues with inadequate risk-sharing and unreasonable rebate percentages. These issues are compounded by drug policy reforms, such as price adjustment mechanisms that adversely affect new drugs.
Taiwan must swiftly enhance its investment appeal, ensuring reasonable drug pricing based on scientific evidence to maintain its market strength and prevent the negative effects of adopting international reference pricing. The Committee underscores that a predictable and stable healthcare environment is imperative to upholding the government’s dedication to advancing democracy, innovation, prosperity, and sustainability.
We call on the government to implement and reform healthcare policies aligned with GRP principles by facilitating effective stakeholder communication and consensus building. Only by thoroughly assessing the impact on international trade and investment can a stable business environment be ensured. The Committee suggest that government and industry work together to build a stable investment environment and promote a resilient, sustainable healthcare system, collectively enhancing Taiwan’s global competitiveness.
Suggestion 1: Utilize multiple funding channels to address funding issues and ensure sufficient reimbursement for new drugs.
The sustainability of Taiwan’s National Health Insurance (NHI) system is a paramount necessity, given its pivotal role in ensuring universal access to healthcare services for all citizens. The Committee acknowledges President Lai Ching-te’s prioritization of investment in health as a key policy objective during his presidential election campaign. We further applaud the government’s dedication to increasing healthcare expenditure and its establishment of an NT$10-billion New Drug Fund.
However, challenges persist due to insufficient resources, unalignment of reimbursement scopes with international standards, and prolonged review timelines for reimbursement, stemming from inadequate investment in healthcare. Injecting multiple funding sources, accompanied by clear implementation guidelines and timelines, into the healthcare system remains an important part of the solution.
1.1 Strengthen financial stability by aligning the growth rate of budgets for new drugs and new indications with the overall pharmaceutical expenditure growth. The Committee acknowledges recent efforts made by the National Health Insurance Administration (NHIA) to streamline the reimbursement process and timeline for new drugs and new indications, aiming to improve early access to innovative treatments. However, we stress that these measures alone are insufficient to facilitate early access to innovation.
The stagnant budget allocation for new drugs and new indications of around NT$2 billion has resulted in reimbursement challenges and has impeded investment in Taiwan, particularly after the pandemic. Addressing this issue is imperative to foster continued progress and enhance healthcare accessibility and innovation in Taiwan.
We strongly recommend that the government align the growth rate of budgets for new drugs and new indications with the overall pharmaceutical expenditure growth rate. This alignment would help sustain Taiwan’s attractiveness as an investment destination for multinational pharmaceutical companies.
1.2 Implement the NT$10 billion New Drug Fund with a clear timeline, execution guidelines, and reasonable funding allocation. The Committee looks forward to working with the NHIA to achieve significant milestones in improving patient access, particularly through the implementation of the NT$10 billion New Drug Fund, a key promise by President Lai to the public. As the operational details of the New Drug Fund, including its funding source(s), scope, timeline, and execution, remain unclear, the Committee offers its support and expertise in global best practices to ensure effective implementation of the fund.
We urge the government to collaborate with industry in preparing the New Drug Fund to ensure that the funding source and scope align with its intended coverage. Furthermore, we ask that the government establish a clear implementation timeline and develop comprehensive guidelines to facilitate the fund’s execution.
1.3 Leverage commercial health insurance to expand long-term funding sources. The Committee continues to emphasize the importance of the NHI’s financial sustainability and has proposed supplementary insurance as an additional funding source. Given the NHI’s limited resources, many patients have turned to commercial health insurance to offset the high costs of medical care. However, a gap exists in that actual medical expenses are not fully covered by commercial insurance policies, often leading to disputes over claims. Aware of both the critical role and the challenges posed by current commercial insurance practices, the Ministry of Health and Welfare has initiated a comprehensive study through the National Health Research Institutes to create a model for supplemental health insurance that addresses this issue.
The Committee recognizes the government’s initiative in exploring supplemental health insurance to address the reimbursement gap in treatment. We recommend that the Executive Yuan establish a dedicated office or appoint a special committee to facilitate cross-departmental collaboration. The goal should be to develop a supplementary insurance model that leverages public-private partnerships and policy interventions, effectively bridging the treatment gap.
Suggestion 2: Ensure transparency and predictability within the regulatory framework to improve timely access to innovation.
The Committee expresses its deep appreciation for and support of the government’s dedication to expediting patient access to new drugs. Aware of the challenges inherent in such changes, we are eager to offer our insights and collaborate to achieve mutual benefits. This collaborative effort is expected to boost the investment of multinational pharmaceutical companies in Taiwan’s healthcare sector, thereby expediting the availability of new drugs for patients in need.
2.1 Establish a milestone review tracking system and organize regular biannual reviews and dialogues with industry and patient groups upon the implementation of a new policy. Taiwanese patients are facing prolonged waiting times for the reimbursement of new drugs and new indications. According to NHIA statistics, the average waiting time for new drugs to be approved is around 12.5 months. However, most member companies have reported that actual wait times often exceed this, with a noticeable trend toward longer durations in recent years. The variation arises from lack of agreement between industry and government on how to calculate the duration from submission to effective reimbursement. While the industry counts from the date of a company’s initial submission, the government begins its timing from the date of administrative review acceptance without factoring in any additional administrative processing time. This discrepancy impedes mutual understanding and complicates discussions about key milestones in the reimbursement process. To address this issue, we recommend that the government create a tracking system that discloses essential information for public scrutiny. This system should incorporate key milestones, allowing for transparent tracking by the public and patients in need.
To help facilitate timely access to innovative drugs, the NHIA has introduced such policies and initiatives as a parallel review process, establishment of the Center for Health Policy and Technology Assessment, conditional listing of new drugs, and an increase in the new drug budget funded by savings from price adjustments on off-patent products. To evaluate the effectiveness of these initiatives, the Committee requests that the government set clear indicators for the new implementations while establishing biannual reviews and meetings with industry and patient groups following the implementation of new policies.
2.2 Provide clear guidance on value assessment indicators. Discussions on reimbursement have predominantly centered around budgetary impacts rather than value-based pricing, causing a significant gap between the current pricing methodology and established pricing methodologies outlined in the National Health Insurance Drug Dispensing Items and the Fee Schedule. This discrepancy can obscure significant expenditures in MEAs and price-volume agreements, leading to pricing unpredictability.
Furthermore, the high clawback ratio required in MEAs for exceeding the cap does not align with the proportional principles of risk-sharing. These conditions not only lead to unpredictability in pricing but also risk demoting Taiwan in the launch sequence of multinational pharmaceutical companies. Moreover, when review meetings conclude that a drug “is not recommended to be reimbursed because of a lack of cost-effectiveness,” these judgments frequently fail to align with internationally recognized economic evaluation methods.
We recommend that the government reassess the role of healthcare economic evaluations used during case appraisals, increase the predictability of appraisals, and actively engage in transparent communication with industry regarding the assessment criteria.
Suggestion 3: Ensure the predictability of the pricing and price adjustment systems for new drugs and new indications to attract investment.
3.1 Continue the Drug Expenditure Target pilot program and adjust its base to reflect investment in health. The Committee welcomed the 2013 introduction of the Drug Expenditure Target (DET) pilot program, which aimed to enhance the predictability of drug price adjustments. A DET program sets an annual target for total drug expenditures, and if actual spending exceeds this target, pharmaceutical companies must pay rebates to offset the excess. The Committee supports the continued implementation of the DET program, emphasizing the need for regular communication and collaboration with pharmaceutical companies and industry associations through quarterly meetings to discuss potential policy changes.
Considering the rapid advancements in medical innovation and technology during the decade since the program’s introduction, the DET program’s effectiveness should be evaluated. Additionally, the DET baseline should be continuously adjusted to accurately reflect innovation levels. This approach is vital to maintaining a stable drug supply, fostering sustainable development within the industry, and ensuring public access to essential medications.
3.2 Ensure that new price adjustment methodologies follow the principle of predictability and align with international norms. Considering the diversity in healthcare environments, reimbursement policies, and price adjustment methods globally, Taiwan’s practice of referencing drug prices to those in 10 advanced countries could impact fairness and pose a risk of supply shortages. We recommend retaining the use of local market transaction prices for regular price adjustments. Specifically, for DET Class 3 (drugs with a patent that expired less than five years ago), the pricing strategy should acknowledge mono-source new products, offering a standalone pricing protection period of at least 10 years to ensure that innovative drugs are launched in Taiwan, safeguarding access and encouraging investment in the pharmaceutical sector.
Moreover, the implementation of the new pricing adjustment mechanism should adhere to international norms to avoid creating incentives that disproportionately suppress originator drugs. Additionally, it is crucial to address the unique price gap between the reimbursement price and hospital transaction price in Taiwan. Resolving this issue calls for careful consideration and comprehensive evaluation of pricing policies to ensure fairness.
3.3 Adhere to pricing rules to ensure the predictability of pricing results. To improve the predictability of review processes and recognize the value of new drugs, the Committee urges the government to shift focus from budget constraints and follow the NHI Pharmaceutical Benefit and Reimbursement Scheme for the pricing of new drugs with solid safety and efficacy evidence. This approach will enhance people’s timely access to innovative drugs in Taiwan. The pricing principle for new indications should be modeled on the pricing of new drugs or be clearly stipulated in relevant laws and regulations to provide a legal basis for decisions.
Suggestion 4: Ensure fair implementation of MEA regulations that promote voluntary and mutually beneficial agreements.
Collaborative dialogue between government and key stakeholders is integral to the success and sustainability of Taiwan’s NHI system. The Committee appreciates the government’s efforts to foster regular communications with the pharmaceutical industry. However, recent proposed revisions to MEA regulations have been a source of concern. In January, the Committee addressed these issues and submitted specific suggestions to the NHIA through an official letter, but no clear consensus was reached during NHIA’s communication meeting in March. We ask that the NHIA seriously consider the perspectives put forth by the Committee.
The fundamental purpose of MEAs should be to expedite patient access to new drugs, prioritize patient needs, and encourage long-term investment in innovation. The Committee urges the government to regularly communicate with industry until consensus is reached on how to amend the MEA regulations. Our recommendation is that any amendments be based on the following principles:
Including confidentiality provisions in MEAs is also vital to protect the commercial proprietary rights of pharmaceutical companies. MEAs should be consistent with the spirit of contractual mutual consent and equal consultation.
By embracing these recommendations, Taiwan’s healthcare system can become a collaborative environment that effectively balances the interests of all stakeholders, ensuring equitable access to innovative treatments that benefit patients.
本委員會欣見新政府致力於維持台美深厚貿易關係、承諾將肩負使命促進台美間可互信的貿易環境,並在全球政經環境更迭中積極增進尤以醫藥等戰略產業方向的雙邊投資。而關於已簽署之「台美21世紀貿易倡議」第一階段中的良好法制作業(Good Regulatory Practices, GRP)備受行政院重視,且已積極採取法規調和措施,要求謹慎規劃對國際貿易或投資造成重大影響的法規,展現出臺灣與國際法規標準看齊以促進與美國合作的決心。
本委員會進一步肯定政府近期為健保永續及韌性推動健保改革與投資,然若缺乏完整規劃,將導致創新性新藥引進意願低,甚至驅使現有藥物退出市場。本委員會在改革的過程中注意到許多挑戰,例如:為推動平行審查而改變的健保給付審查流程並不具體明確,藥品給付協議法規修正草案內容缺乏適當的風險分擔及合理返還額度、藥品政策改革包含調價機制衝擊新藥等。本委員會認為台灣需儘速強化對外資之吸引力,藉由確保藥品合理核價是根據科學實證結果,藉以維持市場優勢,避免採取十大醫藥先進國藥價而帶來負面影響等,並強調唯有營造可預測及穩定的健保環境,對於政府達成承諾打造臺灣成為更民主、創新、繁榮及永續的目標至關重要。
本委員會呼籲政府改革或施行健保法規時應遵循GRP原則,促進與利害關係人的有效溝通並凝聚共識,完善評估對國際貿易投資的影響,始能確保穩健的投資環境;期盼政府持續與產業協力推動韌性、永續的健保體系,共同努力增進臺灣全球競爭力。
建議一:運用多元管道處理財源問題,確保新藥獲得充分給付
有鑒於台灣全民健康保險(NHI)確保所有公民皆能獲得醫療服務上扮演著關鍵角色,其永續性可謂至關重要。本委員會肯定賴清德總統在競選期間將醫療投資視為優先政策目標,並讚揚政府致力於增加醫療支出並將成立百億新藥基金,以癌症優先辦理。然而,由於資源不足、醫療費用給付範圍與國際標準不一致、給付審查時間過長,以及從根本上對於健保投資的缺乏,都使得改革仍具挑戰,也突顯出為健保系統挹注多元資金,並提供清楚的執行準則與時程,仍然是問題的重要解方。
1.1 新藥與新適應症的預算成長率應與整體藥品支出的成長率一致以強化財務穩定性
委員會認可健保署近期精簡健保給付審查流程及時間以改善民眾對創新藥品的可近性,然而我們認為這些措施並不足以促進其可近性。對於新藥及新適應症預算分配的停滯才是導致健保給付挑戰的原因,特別在新冠肺炎大流行後,阻礙對台灣的投資,由於此議題對提升台灣醫療保健可近性和創新極為關鍵,我們強烈建議政府將新藥和新適應症的預算成長率應與整體藥品支出成長率一致,此舉將有助於維持台灣對跨國製藥公司投資的吸引力。
1.2 以明確的時程、執行準則,與合理資金分配來設立百億新藥基金
本委員會期盼與健保署攜手合作,以達成改善民眾對於創新藥品可近性之重要里程碑,特別是透過落實賴總統允諾公眾之百億新藥基金政策。有鑒於新藥基金的實務運作上,包含基金來源、範圍、時程及執行細節等尚未明確,委員會樂意提供支持並分享國際實務經驗以確保基金有效運作。
我們呼籲政府與產業合作來共同籌備新藥基金,確保資金來源和範圍能夠符合其預期給付目標,我們更進一步的希冀政府能夠有明確的執行時間與建立廣泛的指引來加速新藥基金的落實。
1.3 運用商業保險作為健保擴大財源之長期目標
委員會不斷重申健保財務永續的重要性,並建議政府應以商業保險來增加健保財源。相關利害關係人已意識到當前商業保險扮演關鍵作用和其實務帶來的挑戰,衛生福利部已委由國家衛生研究院進行全面研究並建立一個補充健康保險費模式來解決當前之問題。
委員會認可政府就補充醫療保險以解決健保給付缺口的措施進行評估。我們建議行政院設立專門辦公室或專責委員會以促進跨部門合作,以發展一個利用公私夥伴關係和政策干預的補充保險模式為目標,有效縮小醫療給付差距。
建議二:確保藥物給付規範之透明性及可預測性,以強化及時取得創新藥物之可近性
委員會對於政府致力於加速患者取得新藥的努力表達最深切的認同與支持,考量到改革對現況帶來的挑戰,我們渴望提出見解,與政府合作以達成雙贏局面。我們期待通過雙方合作,提升跨國藥廠投資台灣醫療保健領域之意願,進而加速台灣患者對於新藥的可近性。
2.1 建立透明化給付進度追蹤系統,並於新政策實施後籌畫每年兩次與產業界及病友團體的定期審查及溝通機制
台灣患者正面臨新藥與新適應症給付等待時間延長的問題。根據健保署統計資料,新藥生效的平均等待時間僅12.5個月,然而絕大多數會員公司反映實際經驗皆超過12.5個月,且近幾年時間有延長趨勢。這種差異源自於業界及政府針對藥品給付從送件到生效等待時間之計算並無共識,例如:產業界是從送件日期開始計算,而政府則是從案件行政審查受理日開始計算,忽略了前端行政審查流程,雙方對於給付等待時間的理解差異,使得彼此無法針對各重要環節進行有效討論。因此,我們建議政府應建立追蹤系統,公開必要訊息以供各界審視流程。這個系統中應包括給付審議流程的重要事件時間點,讓大眾及有需求之病患能夠透明追蹤。
為加速新藥收載,健保署近期推動平行送審措施、設立健康政策與醫療科技評估辦公室為專責單位、實施暫時性健保支付制度、並計畫將逾專利期藥品藥價調整金額挹注新藥預算。為評估上述新政策之成效,本委員會建議政府應設定針對新政策之評估指標,並於新政策實施後建立與產業界及病友團體每年兩次的審查與溝通會議。
2.2 對於價值評估之方法提供明確指引
多數藥品給付案件的討論著重於財務影響而非價值導向,使得最終核定之藥品價格與藥品給付項目及支付標準之原則存在顯著落差;此外,在藥品給付協議(MEA)所要求超過限量額度之高還款比例,亦未符合風險分攤之比例原則。上述情況不僅造成價格之不可預測性外,更導致跨國公司在部分藥物上市時間排序上將台灣優先順序往後移。值得注意的是,當審查會議結論指稱「藥物不具成本效益故不建議納入給付」,多數所指的成本效益並非遵照國際認可之標準方法學所定義的分析方式。
委員會建議政府重新檢視在案件審理中經濟評估方法學的應用並重視其結果,使審議決策過程與結果更符合國際標準且具可預測性,並積極且透明地與業界溝通審查要點。
建議三:確保新藥和新適應症定價和價格調整系統的可預測性,以吸引投資
3.1 持續推行藥品費用支出目標(Drug Expenditure Target,DET)試辦計畫,並調整DET基準以反映對健康的投資。委員會樂見為增強藥價調整的可預測性,於2013年所引入的DET試辦計劃,該計劃旨在增強藥價調整的可預測性。委員會支持繼續實施DET計劃外,強調在執行之前需要與製藥公司和行業協會進行定期溝通和合作。而考量到自DET計劃引入以來在醫療創新和技術的快速發展,也應評估計劃的有效性,並應持續調整DET基準以確切反映創新程度。此做法對於維持藥品穩定供應、促進行業永續發展,以及確保大眾對於基本藥物的取得至關重要。
3.2 確保新的價格調整方法遵循可預測性原則並符合國際規範。考慮到全球醫療環境、給付政策和價格調整方法的多樣性,台灣採用十大醫藥先進國參考定價可能會影響公平性並導致供應短缺風險。我們建議維持本土市場交易價格進行定期價格調整。而對於DET第三類藥品,定價策略應認可單一來源新產品,並提供至少10年的獨立定價保護期,以確保創新藥物在台灣上市能獲得保障,並藉此鼓勵製藥行業在台投資。實施新的價格調整機制應遵守國際規範,以避免相關獎勵機制對原開發藥物的市場競爭造成不成比例地阻礙。此外,由於台灣的藥品健保價與醫院交易價格存在落差,若要提供價格獎勵機制應通盤評估其公平性。
3.3 遵守定價規則以確保定價結果的可預測性。為了提高審查流程的可預測性並認識到新藥物的價值,委員會敦促政府遵循全民健康保險給付項目與支付標準對新藥物進行定價,不應僅因考量財務衝擊而改變核價方式,並應基於充足證據。此將幫助提升台灣民眾取得創新藥物之即時性。對於新適應症的定價原則應以新藥的定價方式為範本,或明確規定於相關法律法規中以作為決策的法律依據。
建議四:確保公平執行藥品給付協議(MEA)法規,促進自願和互利之協議精神
政府和主要利害關係人間的合作與對話對台灣健保體系的成功和永續發展至關重要,委員會感謝政府在促進與製藥產業定期溝通上所做的努力。然而,最近健保署所提出的 MEA 法規修訂版本引起了產業的擔憂;今年1月,委員會透過正式公文向健保署提出了具體建議,但在今年3月的溝通會議上仍未能達成明確共識。委員會建議政府應認真審視產業端所提出的觀點。
MEA 當初設立的初衷是為加速患者取得創新藥品,優先考慮患者的需求,並鼓勵長期投資於創新研發。委員會敦促政府定期與業界溝通,直至對於MEA法規修法達成共識。委員會誠摯建議,任何政策變更都應遵循下列原則:
MEA應堅持公平互惠原則、合理風險分擔、科學實證協商及保密原則。儘管討論仍在進行,但委員會必須重申健保署於2023年12月的提案草案不僅背離了上述原則,並違反了普遍公認的合約法原則。委員會敦促政府尊重公平互惠原則,在基於科學證據下進行藥品給付協議談判,並透過合理的方法設定公平的還款比率來分擔風險。此外,MEA應僅在契約期間內對雙方具有拘束力,不應任意因為政府與其他第三方之間的契約變動而受影響,而為了保護製藥公司的商業所有權,在MEA中納入保密條款也至關重要。同時,MEA應符合合約雙方同意和平等協商的精神。
透過採納這些建議,相信台灣的醫療體系可創造一個有效平衡所有利害關係人權益且互相協作的環境,以確保病患能公平獲得創新治療,嘉惠更多病友。