八零年代起，我國政府即對生技新藥產業寄予厚望，為促使生技醫藥產業成為明星產業，行政院也自1982年起，將生物技術列為國內八大重點科技產業之一，並投入相當大的金額補助產業之發展；至今已歷經35年，卻仍僅極少由台灣本土研發之新藥成功上市。 本研究主要採用文獻探討以及個案訪談作為主要的研究方法，先藉由文獻探討建立起論文整體之架構，之後再透過兩間國內本土新藥研發公司的訪談加以實證。本研究探討衛生福利部中央健康保險署現行之藥價政策對於國內本土研發新藥上市策略之影響，以及《全民健康保險藥物給付項目及支付標準》第17-1條實施後，是否有助於國內本土研發新藥上市的問題，進行深入分析與探討。而可得到以下初步之研究結論： 一、我國政府的鼓勵措施對於台灣的新藥發展之影響 我國政府多以科技專案補助臨床試驗的形式協助國產新藥公司研發新藥。 二、比較在台灣及其他國家研發新藥的鼓勵措施 我國與日本政府皆有提供新藥不同形式之新藥相關加成給付；本研究未發現韓國政府有針對新藥提供相關加成給付措施。 三、台灣健保藥價制度與台灣研發的新藥藥價 1.對新藥開發類型之國產新藥公司而言，期望政府在設定參考藥品之藥價時，可以選擇使用參考藥品之初始藥價作為reference price。 2.對新藥開發類型之國產新藥公司而言，期望在選擇參考藥品時，可以鼓勵創新藥理作用之新藥、跳脫侷限治療相同疾病用藥之思維。 3. 對新藥開發類型之國產新藥公司而言，全民健康保險藥物給付項目及支付標準第17-1條規範參考類似藥品之十國藥價不合理，因為若以台灣為第一上市國，則尚未在其他國家取得藥價，此法規自相矛盾。 四、我國藥品政策與台灣研發新藥上市策略 對新藥開發類型之國產新藥公司而言，健保給付國產新藥之藥價無法符合國產新藥公司期望之藥價，國產新藥公司改採取由病患自費購買藥品的方式銷售。 / Since the 1980s, our government has placed great hopes toward the industry of biotech and new drugs in order to take such industry to a booming stage. The Executive Yuan has also listed biotechnology as one of the eight key technological industries in the country since 1982. Furthermore, large amounts of subsidies have aided the development of this industry. This industry has been in development for 35 years, however, very few new drugs developed by domestic pharmaceutical companies have been launched successfully in Taiwan. This study mainly used literature review and case interview as the main research methods. Firstly, the structural development of the thesis was built on reviewing past literature. Then, the empirical study was conducted through interviews with two domestic new drug research and development pharmaceutical companies. This study examined the impact of the current drug pricing policy of the National Health Insurance Administration on the domestic market for research and development of new drugs. Moreover, the effectiveness of implementation of Article 17-1 of the "National Health Insurance Drug Payment Program and Payment Standards" was investigated in relations to the development of domestic new drugs in the country. In-depth analysis was employed to explore and discuss our research. The following preliminary conclusions were obtained: First, the influence of the government's encouragement measures on the development of Taiwan's new drugs was examined. Results revealed that the government have mainly been funding domestic new drug companies to research and develop new drugs through subsidized clinical trials of technological projects. Second, the encouragement measures for developing new drugs in Taiwan and other countries were compared. Results showed that both Taiwan and the Japanese government have been providing new forms of new-drug-related premiums for new drugs. However, in this study, we did not find the Korean government providing relevant premiums measures for new drugs. Third, we explored the drug price system of Taiwan's national health insurance and the prices of new drugs that were developed domestically. We found that 1) for domestic pharmaceutical companies that specializes in developing new drugs, they anticipate the government to use the initial drug prices of the reference drugs as reference prices when setting the prices of reference drugs; 2) for domestic pharmaceutical companies that specializes in developing new drugs, they anticipate the government to encourage innovations of new drugs leading to new pharmacological effects and overcoming the idea of limiting treatment to the same illness or conditions when they are selecting reference drugs; 3) for domestic pharmaceutical companies that specializes in developing new drugs, under Article 17-1 of the "National Health Insurance Drug Payment Program and Payment Standards", the statement that drug prices should be referenced from ten countries is unresonalbe because prices cannot be obtained from other countries if Taiwan is the first country to launch the new drug. Thus, the regulation is contradictory in itself. Fourth, we examined Taiwan’s pharmaceutical policy and the marketing strategy of new drugs developed domestically. Findings showed that for domestic drug companies that specializes in developing new drugs, when the drug payment provided by the national health insurance does not meet the drug prices set by the new drug companies, these companies employ a strategy that the patient pay for the drugs instead of the national insurance system.

由於醫療科技的進步以及人口老化造成各國政府對於健康支出越來越高，導致財務上的壓力；很多創新的藥品因為研發成本高或是病人族群太少所以價格高昂。醫療保險也因為財務衝擊過大而無法給付，最後演變成醫療的需要無法被完全滿足。 因此藥品公司採用創新核價模式，透過分擔財務上風險來降低交易成本，近年來更有藥品公司與保險公司或政府簽訂契約，以分擔治療結果上的風險來降低市場進入障礙。 本篇論文嘗試以新制度經濟學交易成本理論，初探製藥產業為了降低市場進入障礙採用創新核價模式的可行性。透過文獻整理、外在環境與兩個個案分析發現，創新核價/給付模式提供政府與藥品公司足夠的誘因，讓雙方願意坐下來協商雙方都可接受的可能性。 因此，創新核價/給付模式確實能有效降低市場進入障礙，提高新藥的可近性。適合採用創新核價模式的產品通常有以下三個共同特點：交易頻率相對較低，單價高或財務衝擊大，有明確的審查依據並能取得客觀可靠的資訊。台灣目前已有產品部份採用創新核價/給付模式。 不確定性是影響交易成本的主要因素，事實上台灣也有越來越多的創新核價/給付模式用來增加市場可近性，除了個案所提的價量協議合約以外，事實上健保局早就將以成效為基礎給付的創新核價/給付模式隱身在給付規定中。未來，創新核價/給付模式除了財務上的風險分攤以外，依實證發展給付（coverage with evidence development, CED）模式或許會成為下一個發展的重點。