English
Despite the widespread effects of the COVID-19 pandemic, Taiwan’s economy increased at a 6.28% annual rate in 2021, its highest growth rate in 11 years. But even during a period of robust economic growth and positive outlook, the Committee observes that Taiwan’s past momentum in investing in biopharmaceutical innovation – a critical factor in international competitiveness recognized by advanced countries – has stagnated. The state of Taiwan’s competitiveness at a time of global supply chain shifts is even more concerning. While neighboring countries have continued to invest boldly in biopharmaceutical innovation to firm up their international connections, Taiwan’s investment in new drugs and indications was at its lowest in recent years, as were its policy measures to ensure Taiwanese patients’ access to innovative treatments.
The Committee is deeply concerned about these developments, and urges Taiwan to take bolder steps to secure its place in the international innovative biopharmaceutical value chain. We also call on the government to set a clear and forward-looking policy objective to strengthen international connections and cooperation between the public and private sectors, increase public health resources, and invest further in innovative biopharmaceuticals within its excellent single- payer health insurance system to benefit people, patients, the medical communities, and the industry.
Suggestion 1: Improve Taiwan’s competitiveness in the international innovative biopharmaceutical value chain through Public-Private Partnerships (PPPs).
The COVID-19 pandemic has demonstrated the importance of ensuring ready access to critical innovative biopharmaceuticals in response to an emerging pandemic. The optimal course of action is to consistently play an active role in the global innovative biopharmaceutical value chain, from research and development to patient access. It is therefore essential to identify Taiwan’s weaknesses and opportunities and work to gain a competitive position in the international innovative biopharmaceutical value chain.
Taiwan is home to some of the world’s most prolific researchers and health professionals, and there are ample opportunities to capitalize on this domestic ability. It is critical for Taiwan to ensure that its talent stays connected and competitive internationally, both in practice and in research capacity, for a treatment population that is on par with that of high-income countries. This can be accomplished by ensuring that Taiwan’s clinical and treatment settings are aligned with international guidelines.
Taiwan is experiencing a widening disparity between local and international treatment environments. The inconsistent increase of budgets in Taiwan for new drugs and indications has slowed the medical community’s ability to access innovative treatment options. Meanwhile, South Korea and Singapore have made rapid progress in ensuring that their medical communities have access to innovative treatment options on par with international treatment guidelines, which has helped create a treatment setting conducive to innovative biopharmaceutical research and development.
Over the years, the Committee has advocated for Taiwan to make international connectivity in the innovative biopharmaceutical value chain a top priority. The Committee urges Taiwan to work to ensure the continuity of its competitive advantage in talent and close the gaps between clinical settings and populations to create a clinical and research environment aligned with international standards.
The Committee commends Taiwan for taking measured steps toward regulatory reform, such as by adopting the Regenerative Medicine Development Law. We urge the government to take bold actions to align patient populations and treatment options with international treatment guidelines in key areas, including precision medicine, oncology, gene and cell therapies, and other innovative treatments. Members of the Committee stand ready to collaborate with and support Taiwan through PPPs, with a focus on improving Taiwan’s competitiveness in the global biopharmaceutical value chain.
Recommendations
- Establish an Executive Yuan-level inter-ministerial task force with the international biopharmaceutical industry to draw up an acceleration policy roadmap and cross- ministerial funding sources for Taiwan’s international biopharmaceuticals. This will close the gap in key focus areas in the international biopharmaceutical value chain. Government stakeholders may include the Ministry of Health and Welfare, National Development Council, Ministry of Economic Affairs, and Ministry of Digital Affairs, among others.
- Consider openness, security, and reliability in establishing public-private partnerships to foster public consensus and support for critical areas of Taiwan’s public health agenda, such as precision medicine, digital health, and big data utilization.
Suggestion 2: Expand the annual healthcare budget by improving the horizon-scanning approach and securing multiple funding flows.
The Committee thanks the government for its adoption last year of a horizon-scanning approach to budgeting for new drugs and new indications to accelerate the launch of new pharmaceutical products and improve patient access to innovative treatments. However, the new drug/new indication budget for 2022 is the lowest in recent years. The Committee is concerned that such a small budget will affect the competitiveness of Taiwan’s pharmaceutical market as well as patients’ access to new medicine, which is a much broader concern within Taiwan’s population.
During this period of high economic growth, we strongly urge the government not to underestimate the importance of its investment in healthcare and remind it of its duty to safeguard the new drug/new indication budget. Although Taiwan’s National Health Insurance (NHI) system faces financial challenges, long-term investment in new drugs is vital to establish a sustainable healthcare system and protect people’s health.
2.1 Prioritize patients’ unmet needs under the horizon-scanning approach and regularly communicate with the industry to improve budgeting methods. Due to limited resources, the horizon-scanning approach adopted by the National Health Insurance Administration (NHIA) includes a uniform NT$200 million cap for individual products and is thus inadequate for satisfying the unmet medical needs of many patients, particularly in the fields of oncology and rare diseases. To improve this approach, the Committee suggests consulting the industry and prioritizing the allocation of sufficient resources to fully address patient needs. Moreover, the budget- preparation method should be continuously discussed and improved. We therefore urge the government to regularly communicate with the Committee, preferably every January and March during the budget determination period, to collect our feedback and suggestions on setting the annual budget.
2.2 Secure multiple funding flows for the new drug/new indication budget. The spirit of the NHI is to harness the collective power of the government, enterprises, and individuals to ease the economic burden associated with seeking medical treatment and to improve citizens’ wellbeing. As Taiwan’s population ages and new medical technologies are developed, medical expenditures in Taiwan continue to grow. Given the limits on the NHI Global Budget, the budget for new drugs and new indications has stagnated. This insufficient budgetary allocation leads to cost-oriented reimbursement decisions and a lengthier review process. The widening gap between the scope of reimbursement and approved indications has also failed to meet patients’ medical needs by hindering their timely access to innovative medicines.
Patient groups and the industry have continued to raise proposals on how to expedite access to new drugs and improve their affordability. We suggest that the government learn from the experience of advanced countries in establishing multiple funding flows. In the short term, those sources could be allocated from the government budget and new-drug copayment scheme. Longer-term, we recommend establishing funds and creating supplementary insurance schemes for new drugs. Such an initiative could also help resolve the NHI’s financial predicament.
Suggestion 3: Continue the DET pilot program and work with industry to explore improvements to the drug-price adjustment mechanism.
The Committee has appreciated the government’s implementation of the Drug Expenditure Target (DET) pilot program as a way to address the shortcomings of the previous Price-Volume Survey (PVS) through improved predictability. Eight years have passed since the program’s introduction in 2013. In light of the rapid changes taking place in medical innovation and technology, a holistic evaluation of the program’s implementation and support for future adjustments to drug-price policy is necessary.
3.1 Maintain the DET pilot program. We believe that the DET should continue to be implemented on a pilot basis, and that the government should continue to communicate and coordinate with pharmaceutical companies and industry associations to seek ways to ensure the stability of drug supplies, foster the industry’s sustainable development, and safeguard the public’s right to drugs.
3.2 Schedule only one DET price adjustment per year. Frequent drug price adjustments can seriously complicate the business-planning activities of the pharmaceutical industry and impact the stable supply of drugs. In
addition, given the current scope of NHI coverage, the complicated procurement negotiation process that follows such adjustments has resulted in a heavy burden on hospital operations. The Committee therefore recommends that drug-price adjustments be conducted only once per year.
3.3 Include industry voices early in the process of adjusting drug prices and ensure that the process adheres to principles of predictability, stability, and fairness. Policy formulation or revisions inevitably impact the business operations of drug providers, who are a cornerstone of the medical ecosystem. The Committee hopes to cooperate with the government in its drug-price policy planning (for example, in reforming reimbursement standards, establishing a mechanism for addressing price gaps, and other ways) by joining the discussion early in the process and helping reduce any unnecessary adverse impact. Price adjustments that are based on market fairness, stability, and predictability will encourage long-term investment by multinationals in Taiwan, and the continuous introduction of innovative drugs will benefit the Taiwanese people.
Suggestion 4: Improve MEA practices to enhance the renewal negotiation process and protect confidentiality.
The Committee appreciates the government’s adoption in 2018 of Managed Entry Agreements (MEAs) as one of its methods for NHI reimbursement. Adoption of the practice, when it adheres to principles of mutuality and due process, puts Taiwan in sync with international drug reimbursement trends, helps accelerate the introduction of new drugs and improves the accessibility of new treatments for patients. MEAs are in essence risk-sharing mechanisms that allow the government and the pharmaceutical industry to reach agreement on the preservation of confidentiality and other mutually beneficial terms.
From 2021, member companies started to experience issues when renewing and terminating MEAs. At the termination or renewal of an MEA, principles of scientific evidence, patient needs reflected in actual demand and usage of the drugs, and confidentiality of the existing MEA terms should continue to be observed. In the course of implementation, the Committee urges the government to address any issues in the MEA procedure related to breach of confidentiality and lack of mutuality, and to meaningfully engage with industry and make improvements on the issues based on the Committee’s recommendations.
4.1 Ensure the transparency and predictability of the procedure for MEA renewal and termination negotiations and provide a reasonable amount of time for such negotiations to be completed. The current system does not clearly define the terms and procedures for MEA termination or renewal and negotiations, which makes
it difficult for member companies to effectively evaluate the proposed renewal terms and make counter-proposals. Given the complexity and product-specificity of MEAs, sufficient time and flexibility should be provided, and mutuality ensured, so that parties can prepare, propose, and respond to terms.
The Committee thus recommends that the government provide a clear procedure for MEA termination and renewal negotiations in which mutuality between parties is observed. In the process of negotiation and evaluation, recommendations arising from negotiations should be scientific and empirical, and the industry should be informed of the evaluation in advance, so that both parties can reach a mutually acceptable consensus.
4.2 Review regulations to ensure the preservation of confidentiality and protect trade secrets of the industry. Currently, there is no standard procedure for exiting MEA renewal negotiations when consensus on terms is not reached. Regardless, the government should fulfill its duty of maintaining confidentiality in such cases. It is essential that the MEA terms are treated as confidential and not leveraged to secure further discounts during renegotiations. Companies should thus be allowed to include confidentiality and termination clauses in MEAs and renewals.
Chinese
近年全球在COVID-19疫情衝擊下經濟衰退，反觀台灣，防疫成效有目共睹，經濟成長率亦高達6.28%，為11年來之最。儘管在經濟成長強勁與前景樂觀的時期，委員會觀察到台灣在創新生醫產業的投資似停滯未有進展，然生醫產業為全球先進國家公認評估國際競爭力的重要因素。在全球供應鏈轉移之際，台灣的國際競爭力令人擔憂。許多鄰近國家持續投資生醫產業並積極與國際交流，但台灣在新藥的投資及確保台灣患者獲得創新醫療的政策，均處於近年來的最低水平。
委員會為此感到擔憂，提醒政府應採取更大膽的步驟，確保台灣在國際創新生醫製藥價值鏈中的地位。同時，委員會也呼籲政府制定明確且具前瞻性的政策目標，強化國際連結，與公私部門合作，投入資源在民眾健康，持續改革單一給付之健保體系，嘉惠民眾、病患、醫療社群與產業。
建議一：建立公私協力模式，提升台灣在全球生醫創新價值鏈的競爭力
COVID-19疫情顯示，即時取得創新藥品對台灣因應新興流行傳染病極具重要性，達到此目標最佳的方式即為台灣持續積極參與全球創新生醫價值鏈，從新藥研發到提供病患創新藥品。因此，了解台灣生醫產業的優勢與劣勢並努力提高產業競爭力，至關重要。
台灣孕育許多全球極具研究能量的學者專家與醫療專業人才，也有充足的機會運用國內優秀的人才庫。確保醫藥專業人才在臨床醫療與研發能量上維持全球競爭力，使醫療資源與創新藥品可近性先進國家水準一致，對於台灣極其重要。如此，將可使臨床治療決策與國際治療指引充分接軌，打造符合國際趨勢的臨床試驗環境，有助於達成上述目標。
另一方面，台灣創新藥品可近性與國際間的差距，正以令人警惕的速度持續擴大。近年來，鄰近的韓國與新加坡無不設法加速，使醫療體系與病人盡速取得符合國際治療指引的創新藥品，同時建立有利生醫創新研發的環境。然而，台灣卻因為健保新藥與新適應症預算無法穩定成長，使新藥引進速度受到相當大的阻礙。
過去數年，委員會持續呼籲台灣應優先強化與國際生醫創新價值鏈的連結。委員會敦促台灣應延續既有的生醫人才競爭優勢，縮短在地臨床醫療及新藥資源與國際標準的差距，以創造符合國際標準且有利世界級創新研發的環境。
委員會肯定政府持續改革，積極推動再生醫療三法等有利於生醫創新的法案，但也呼籲台灣採取更具雄心與魄力的行動，強化並加速新藥可近性與國際接軌，特別是在精準醫療、癌症、基因與細胞療法及其他創新療法等關鍵領域。委員會成員將全力透過公私協作的模式支持政府，提升台灣在全球生醫價值鏈的競爭力。
我們的建議
1. 建立行政院層級的跨部會工作小組，與國際藥廠合作，共同規劃政策藍圖及跨部會預算投入，弭平台灣與國際生醫價值鏈的差距。工作小組成員應包含衛生福利部、經濟部、數位發展部與國家發展委員會等。
2. 以開放、安全、互信為原則，建立公私部門協力模式並凝聚共識，支持台灣推動精準醫療、數位醫療、大數據資料應用等國家核心戰略產業目標。
建議二：透過前瞻性掃描編列預算與確保多元財源，擴大年度醫療保健預算
委員會感謝政府於2021年開始採取前瞻性掃描（Horizon Scanning）方式編列新藥及新適應症預算，加速新藥給付及改善病患對創新治療之可近性。然而，2022年健保總額
所編列之新藥及新適應預算卻為近年來新低，委員會擔憂低預算將衝擊台灣市場的競爭力與病患獲得新藥之可近性。
委員會鄭重呼籲，在高經濟成長動能的帶動下，政府不可忽略或輕視醫療保健產業之投資，更應保障及捍衛新藥及新適應症預算。面對健保財務挑戰，委員會呼籲政府注重長遠目標並加速新藥引進及給付，建立永續健保體系，保障人民健康。
2.1 前瞻性方式編列之新藥與新適應症預算，應優先挹注資源於未滿足之病患需求部分，並與業界定期溝通，改善預算編利方式
政府在運用前瞻性掃描方式編列新藥及新適應症預算，考量資源有限，在預算編列上統一設定2億元上限，忽略「未滿足之病患需求」（unmet medical need），特別是在癌症與特殊疾病之領域。委員會建議透過與業界溝通及優先分配足夠的資源，以滿足病患需求。此外，在預算編列方法學上，政府也應持續討論及改善。委員會呼籲政府應在年度預算編列之際，定期與本委員會溝通討論，建議於每年1月及3月定期討論，以實質提供年度預算編列之建議。
2.2 多元機制補強新藥資源 加速新藥引進
全民健保施行之精神本以集結政府、企業及個人等群體力量，解決民眾就醫經濟困難，增進民眾健康福祉。隨著台灣人口老化及新醫療科技發展，醫療支出持續上升。在現有健保預算增幅有限下，新藥與新適應症預算呈現停滯，不僅讓藥品給付審議以財務為導向，更導致給付審議時程拉長，給付範圍與核准適應症差距顯著變大，民眾與創新治療可近性呈現缺口，無法滿足病友對使用創新藥品之迫切期待。
近年來，病友團體及業界持續就前述給付時程及範圍提出建言，期能及時治療並減輕經濟負擔。委員會建議政府借鏡先進國家增設多元財源，改善新藥給付之困境，短期可從公務預算編列支應、實施新藥部分負擔，中長期則朝增設基金財源或補充式新藥保險等方式規畫。
建議三：與產業共同研議精進藥價調整制度，持續試辦藥費支出目標制（DET）
委員會感謝政府試行DET制度，以改革原有藥價調查制度之不足。惟自2013年試辦至今已屆8年，有鑑於創新科技及醫療環境日新月異，實有整體評估執行經驗並配合未來藥品政策調整之必要。
3.1 維持試辦 DET藥價調整制度
委員會認為應持續試辦DET，且政府應持續與藥界公、協會溝通協調，尋求兼顧藥品穩定且能維繫產業永續的方式，保障民眾用藥品質與權益。
3.2 DET藥價調整應以每年一次為原則
藥價調整涉及藥品製造、供應等營運規劃，且牽動上下游產業鏈，頻繁調整將嚴重影響產業鏈之規劃，進而衝擊藥品穩定供應；此外，以目前健保收載規模，藥價調整後之繁複採購議約程序，實對醫院經營造成沉重負擔。因此，委員會建議藥價調整應以每年一次為原則。
3.3 藥價調整制度之變動應與業界及早溝通合作，變革方向應以「可預測性」、「穩定性」及「公平性」為原則
藥品提供者實為醫療生態體系之基礎，政策制定或異動勢必衝擊商業營運，委員會期盼與政府合作規劃藥價政策（如過去政府提出之改革藥品支付標準、建立藥價差處理機制等），提早加入研議並充分提供產業意見，以完善新政策制度之規劃，降低不必要之衝擊。價格調整若能本於市場之公平性、穩定性與可預測性，將有助於外商長期在台灣投資
布局，持續引進創新藥品，創造台灣民眾之福祉。
建議四：改善藥品給付協議，落實保密原則
委員會對於政府在2018年將藥品給付協議（Managed Entry Agreement）納入健保給付方式，以符合國際藥品給付趨勢並加速新藥引進，提高病患對新治療可近性之美意，表達肯定。然藥品給付協議係以風險分攤為基礎，讓政府與製藥業者雙方，在保密及合意達成約定，於續約時應就當下之實際使用情況與科學實證再次協商，且確保雙方保密約定。
從去年開始，許多委員會成員在更新與終止藥品給付協議時遇到問題。當中止或更新協議時，應持續遵循實證原則、病患需求反映在藥物的實際需求和使用情況，以及現有條款的保密原則。本委員會對於執行上有違反保密之虞及在合約協議程序上不透明之處，呼籲政府應正視此問題，並立即就本委員會之建議與業界溝通，著手改善。
4.1 確保給付協議協商程序及時程的透明度與可預測性，合理協商時間亦有助達成共識
現行制度並未明確制定續約程序及時間，造成企業續約評估及與取得總公司核准之挑戰。考量程序複雜性及產品特殊性，協商給付協議應有合理的時間、彈性與相互性，以便雙方能準備、提案及回應相應條款。委員會建議政府應給予合理時間及明確程序，任何新增加之協商建議應具備科學及實證性，並提前知會製藥業者評估，以利雙方達成共識。
4.2 檢視法規以改善現行藥品給付協議的保密性，保障製藥產業之商業秘密
目前藥品給付協議對於續約無法達成共識需有退場機制的規範未臻完善。不論在續約或是退場機制，政府對於業界提供之營業秘密應盡保密義務。 至關重要的是，給付協議條款應被視為機密，而非在重新談判期間作為協商之籌碼。製藥產業應被允許在給付協議協商及續約時，加入保密和終止條款。
