建立一個評估創新醫療科技是否具價值的機制，並將評估結果作為公共政策制定或管理的依據，牽涉的範圍包括產業、科技、醫學、管理、經濟、民眾等面向，影響的層面不僅只政府及人民的需求，還可能涉及產業界龐大的商業利益與競爭壓力，甚至影響未來的科技進展走向，不同面向之利害關係人及各參與群體的立場或理念往往不同，甚至敏感對立，各種可控制及不可控制的因果關聯也極為複雜。除相關的利害關係人群體間因立場不一致，可能產生衝突而影響政策之可行性外，還面臨各方對醫療科技評估角色、相關制度規劃及執行模式等制度建立之要素是否有共識、研究能力及科學基礎是否足夠、基礎環境是否已完備等，都是制度能否建立及有效運作之影響變因。 本研究針對我國建立醫療科技評估之政策可行性，及連帶牽動之制度架構規劃與執行運作設計等面向之相關影響變數，進行不同利害關係人群體間之意見分析，以深入訪談政府單位、學者專家及產業界代表的方式，探討我國發展HTA制度之最主要的爭議點，並參酌國際經驗，提出我國如何平順進行醫療科技評估之建議。 自訪談中發現台灣發展HTA最可能面對的問題為產業界對此政策的疑慮和反彈壓力；各利害團體間對HTA角色、定位、評估方法、判斷標準及研究報告如何使用之認知與共識；制度面的完整規劃及運作；HTA對中小型企業可能造成的衝擊；本土資料缺乏、人才不足、及使用者對HTA報告沒有信心等。 因此本研究將依據研究發現與討論，嘗試自我國建立HTA之政策可行性、發展HTA之法規環境、HTA執行模式及相關運作規劃等面向，提出研究結論與可行建議： 研究結論 壹、針對我國建立HTA之政策可行性的探討： 由國際各區域的HTA發展情形可知HTA已為國際趨勢，雖然產業界與政府及學者專家對我國是否有必要發展HTA機制有二極的看法，本研究經研討後認為政府有義務介入新醫療科技的發展和使用，以確保民眾獲得及使用醫療資源的可近性與可靠性，再加上HTA方法學可協助提供充分且可靠的資訊，協助並增進決策制定的品質，因此國內有建立HTA機制的必要性與需要性，目前亦為國內開始推動HTA的適合時機。 貳、針對我國發展HTA之法規環境及HTA執行模式之探討： 推動HTA機制須否設立法源及明確的法規，本研究經研討後認為初始的推動過程中，以行政命令的方式推動會較有效率，但當最後社會共識形成，國內環境成熟後，建立法源依據對推動及落實仍有其需要性，因為包括相關研究如何公開及如何使用，都會涉及到權利義務，一旦研究內容有所爭議，也才較具裁量的空間及效力。至於立法的方式，單獨立法或初期附屬在一個法之下，或初期以軟性方式描述，隨著國內的HTA報告之參考性逐漸被認可及能產生效應，再階段性演進為硬性規範，都是可行的方式。 而在執行模式的探討上，由研究結果可知，科學、透明、公正，具有公信力，是各界對HTA報告之最重要的要求，至於執行單位，則不限政府單位設立的財團法人、學術界、社團學會、研究中心或產業界等都可以執行。至於HTA機制與目前決策委員會間角色功能的探討，因為科學能提供的是有限證據，仍需要各領域專家就其經驗提供實務意見，政策單位再考量其特定的政策或政治目的，將科學證據、實務經驗與政治考量結合，進行最後的決策。觀諸國際經驗，大多數以國家力量執行HTA的國家，雖然都已設立具法律依據、獨立的科學專責機構執行HTA的評估或研究，但是中央政策單位仍會組織相關的委員會進行督導或審議。因此，以專家委員會協助決策制定的機制在短時間內是不會改變的方式，HTA評估機制也無法完全取代專家經驗。 參、對於我國HTA運作規劃之探討： 1. 研究能力 相對於我國有已建置之健保資料庫，各國也都面臨研究所需之資訊不足的問題，因此國際各國的HTA機制除了專職的評估或研究人員外，也聘請了許多的專家顧問或外審人力，整個機制中也含括許多的專家委員會，及與學研界間之合作管道；而除了各國本身的機制外，國際間也成立了許多的HTA合作網絡及跨國的HTA學會，以期增進針對HTA相關知識與經驗之合作研究及資訊分享。國內除善用國際資源及建立與學研單位間的合作管道外，我國機制中若能由政府投資經費並出面協調與整合相關的HTA組織，含括學界、醫界及HTA機構共同進行整合性應用研究，甚至將相關需求以國際競標的方式，請國際專家來幫忙，則可望各界均有機會自實案中逐步學習與累積相關研究實力。由政府投資經費進行整合性應用研究的好處是可避免學界依靠廠商的捐款或補助進行研究，而使HTA的研究成果失去公正客觀。除相關機制的建立外，研究人員可嘗試於已建置的健保資料庫取得抽樣資料，依不同狀況建立假說，進行不同可能性的模型推估。 至於需否制定政策誘因，以激發產業界願意投入，共同產生國內目前不足的本土流行病學資料或新科技適當使用的指引規範。自研究中之訪談結果顯示，雖然目前政策單位已就如何訂立鼓勵政策進行相關可行性設計，但若能先將制度的透明度及一致性做好，產業界能預期效果，自動就會投入，且若政策重視好的本土數據，並能在決策上看到效果及影響，則學術界、學會等自然也會願意付出行動，各方面能量就會很快的啟動。 2. 研究執行 國內執行HTA研究，不需要開發自我的方法學，因為國際公認的方法學已經過演進，能接受挑戰，且研究結果較能被國際標準認同。 由於進行一個HTA評估需耗費相當的人力、時間、金錢，在資源有限的情形下，HTA資源的運用需有其優先順序之安排；觀諸國際經驗，各國的HTA機制對於研究議題的產出也有不同的方式，若自新藥是否納入給付之層面而言，我國與國際各國類似，工作計畫單純來自政府委託評估的個案。但對於醫療照護領域相關之公共政策議題的研究，我國尚未發展出民眾及基層醫療人員參與提出健康照護相關議題之機制，是否朝更開放透明的全民社會參與的機制進行設計，因涉及整個運作流程的效率問題，可由政策主管單位視需要性進行研議。但研究結果完成後應有周延的檢討，且對於現行使用中的科技也應有定期檢視的機制。 3. 政策運行方式 建議建構溝通平台，邀集各界討論及溝通，進行各方面意見的整合，使產業界去敏感性並願意尋求合作利基。溝通平台的發起及召集者，應由政策主導單位擔任。各項法令的定義及標準的設立，主政機構能連動可用資源及最終期望能達到的目標進行整體的策略思考，避免因片段的決策，衍生其他額外問題，同時盡量避免過多模糊的空間，以使產業界為其產品進行策略規劃時能有清楚明確的依據，並能預期可能結果。 / Perspectives from industry, technology, medicine, management, economics and people are essential to the establishing of an innovative health technology assessment (HTA) mechanism for the purpose to placing the assessment results as a basis of public policy decision-making. The impacts of an innovative HTA mechanism were not only occurred to the government and people's needs but also to huge commercial interests and competitions, and even to the future progression of science & technology of a country. Different stakeholders might have different thoughts and standpoints and these conflicts might lead to the failure of a HTA mechanism at the end. In addition to that roles of HTA, consensus on important components for planning & executing models, capabilities of research & groundwork of science, infrastructure etc. all are influencing factors to the establishment and the successful operation of a HTA mechanism of a country. The purposes of the study were to explore the policy possibility and the factors connected to the system planning and operation design of HTA mechanism in Taiwan. Comprehensive literature review and in-deep interviews to the experts from government, academia and industry affiliates were executed to discover the most critical points. A potential HTA mechanism in Taiwan has been projected after the considerations of global experiences and the study findings. Study revealed that the most important issue of the HTA mechanism in Taiwan was the nervousness and the opposition from the industry. In addition to that consensus has not been reached on the roles, position, methods of assessment, criteria of judgment, and even the usage of reports of the HTA. How to establish a comprehensive planning and operation system, potential impacts of HTA to small and medium enterprises in Taiwan, lack of domestic data, insufficient person of talent, and no confidence to the HTA reports from the users etc. were all important factors exposed by this study and have to be resolved in the future. Conclusion of the study was provided as below: 1. Aspect of the policy possibility: Although there existed different opinions on the HTA mechanism in Taiwan among industry, government and academia the necessity and essentiality of HTA mechanism were recognized and currently was a suitable time to endorse such a mechanism in Taiwan. However under current situations where consensus not reached for the roles of HTA, lack of persons with talents and experiences the most practical ways in this early beginning stage were to cultivate people and to go through learning process. By following the acceptance of HTA report and the appearance of important issues concerned by the society roles and directions of the HTA in Taiwan would be consolidated. Why and how to bridge HTA results to policy decision-making was under discussion and construction presently. Nevertheless purely scientific assessment was emphasized to maintain its entirely objective standpoint of the HTA. Otherwise bias or policy leading will happened and the accountability of the HTA in Taiwan will be lost. 2. Aspect of the regulation envirement:Whether explicit law and regulation wanted for the endorsement of HTA mechanism had debates with different thoughts and rationales. Study revealed that affecting with political order has been the most efficiency way presently. However in the long run law or regulation will be desired as the HTA environment been established and society consensus been attained. Considering the modes of legislation on matter single legislation, attended to current law, or graduated from soft guidance to consolidated law all were sufficient. 3. Aspect of the executing model: The most significant requirements to HTA executing models and HTA reports were scientific, transparency, justice and accountability. SOPs of HTA research were recommended to set up as the environment of HTA conduction in Taiwan been matured. Accreditation mechanism applied to HTA researcher and HTA institution was also suggested. Field experts to provide professional opinions were crucial owing to the limitation of scientific evidences. For the positioning of HTA experiences from experts will not be wholly replaced by the HTA mechanism, therefore by using experts committee to help for decision making will not be changed in short time. 4. Aspect of the operation planning: In front of shortage of data and expertise in Taiwan one recommendation was to retrieve data from the national health insurance database while models can be explored under different assumptions. Different levels of assessment reports may have their levels of value for references. As experience and capability increased, related database built up and as time moving forward the deficiency of data can be enhanced. In addition to that networking with research institutes domestically and internationally was essential seeing that the extension of resources. Government should lead to coordinate and to integrate related HTA organizations and to invest money for the research of the integration. Incentive scheme to related parities was not suggested right away. More important facets were the transparency and the consistence of the system. If the final consequences of the HTA in Taiwan are predictable and then the industry will have their input. And if good research can be acknowledged by the policy and the impacts on the decision-making can be recognized then the academia and related associations will have their actions. After all powers from different sources will be initialed. It was not necessary to determine self-owned HTA methodology in Taiwan but just followed the global standards because HTA methodologies have developed for a period of time and by this way the results found in Taiwan can be accepted globally. HTA assessment is resources consuming while lots of human resources, time and money required. Since resources are scare the utilization of HTA resources should has its priority setting. A mechanism to have people or basic health care workers to provide health care issues was not been developed in Taiwan. Considering the efficiency of operation whether to design a more transparency mechanism with whole society participation can be considered by the authorities according to the demands in the future. Comprehensive evaluation to the HTA results and routinely assessment to the technologies in uses were also recommended. Plate-form of communication was suggested to construct to invite related parties for discussion and for connection. If opinions can be integrated and the susceptibility from industry can be released then a cooperation foundation can be built. To initial and to chair of the plate-form should be the responsibilities of the authorities. Comprehensive strategic planning including definition of the regulations, establishment of the guidance was critical to the authorities to avoid pieces of decision-making, surprised problems and too much uncertain room occurred. By this way the industry will have unambiguous basis with predictable outcomes to make strategic planning for their innovative medicinal products.