發(fā)布時間：2018-05-24 00:47

  本文選題：罕用藥 + 研發(fā)激勵��； 參考：《中國藥房》2017年16期

【摘要】：目的:為構(gòu)建和完善我國的罕用藥研發(fā)激勵政策提供參考和建議。方法:從罕用藥的立法沿革、研發(fā)罕用藥的激勵措施與效果方面對美國和歐盟的罕用藥研發(fā)激勵政策進行對比,并為我國完善相關政策提供建議。結(jié)果與結(jié)論:美國與歐盟的罕用藥激勵政策分別始于1983年美國《罕用藥法案》與1999年歐盟《罕用藥管理規(guī)范》,之后通過不斷完善,形成了較為完備的體系。美國與歐盟在罕用藥的認定標準、認定程序、具體激勵措施(研發(fā)資助、稅收減免、費用減免、微型與中小企業(yè)額外激勵、市場獨占、特殊審批程序)等方面有所差異,如在費用減免方面,美國對處方申請費用、生產(chǎn)費用和藥物確認費用進行減免,而歐盟對協(xié)議幫助費用、初始和后續(xù)要求費用,審批前的檢查費用和首次上市申請費用依類型按一定比例進行減免。罕用藥激勵政策推行后,其資格認定數(shù)量及上市數(shù)量大幅增加、微型與中小型企業(yè)成為罕用藥研發(fā)的生力軍、研發(fā)投資涵蓋各類疾病治療領域、罕用藥研發(fā)成為藥物創(chuàng)新和生物技術發(fā)展的主要方向。我國應該盡快確定罕用藥研發(fā)激勵的相關立法、設立罕用藥的資格認定、從多方面入手完善罕用藥研發(fā)激勵具體措施,同時加強與其他國家在罕用藥資格認定和研發(fā)激勵方面的合作。
[Abstract]:Objective: to provide references and suggestions for the construction and improvement of the incentive policy for the research and development of rare drugs in China. Methods: from the legislative evolution of rare drugs, the incentive measures and effects of the research and development of rare drugs, the incentive policies of the United States and the European Union were compared, and suggestions were provided for the improvement of the relevant policies in China. Results & conclusion: the incentive policies of the United States and the European Union began in 1983 and 1999 respectively, and formed a relatively complete system through continuous improvement. There are differences between the United States and the European Union in terms of the standards, procedures, specific incentives (R & D aid, tax credit, fee relief, additional incentives for micro and small enterprises, market monopoly, special approval procedures, etc.) for rare drugs. For example, in the case of fee reduction, the United States waives prescription application fees, production costs and drug recognition fees, while the European Union pays for agreement assistance costs, initial and follow-up requirements, The examination fee and the initial listing application fee shall be reduced by certain proportion according to the type. After the implementation of the incentive policy on rare drugs, the number of qualifications and the number of listed ones have increased substantially. Micro, small and medium-sized enterprises have become the new force in the research and development of rare drugs, and the investment in R & D covers all kinds of disease treatment fields. Research and development of rare drug use has become the main direction of drug innovation and biotechnology development. As soon as possible, our country should determine the relevant legislation on the incentive for the research and development of rare drugs, establish the qualifications for the research and development of the rare drugs, and improve the specific measures for encouraging the research and development of the rare drugs from many aspects. At the same time, strengthen the cooperation with other countries on qualification recognition and R & D incentives.
【作者單位】： 沈陽藥科大學工商管理學院;
【基金】：國家社會科學基金項目(No.13CFX086) 遼寧省教育廳科學研究一般項目(No.W2014119) 沈陽藥科大學中青年教師事業(yè)發(fā)展支持計劃
【分類號】：R95

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