| Co-Investigator(Kenkyū-buntansha) |
KAWAKAMI Koji 京都大学, 医学(系)・研究科(研究院), 教授 (70422318)
IKEDA Masayuki 長崎大学, 医歯薬学総合研究科, 教授 (10242215)
NAGANO Hiroshi 政策研究大学院大学, 教授 (80463967)
TANAKA Koichiro 東京大学, 新領域創成科学研究, 准教授 (10512353)
MOROOKA Kenichi 政策研究大学院大学, 政策研究科, 教授 (00586406)
ISHIMARU Shohei 政策研究大学院大学, 政策研究科, 准教授 (10612715)
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| Research Abstract |
The purpose of the project was to identify existing mechanisms or factors which could be used to incentivize the development of innovative medicines, particularly those medicines which are not easily developed solely by private companies.
The project team looked into the following two different contexts which provide incentives for developing new medicines:
(i) Clinical trials and the submission of clinical data to drug regulatory authorities for marketing approval ; and
(ii) Intellectual property protection.
Some of the findings are summarized below:
(1) Roles of non-profit research institutions.
Two cases of medicines(paclitaxel(taxol) and exenatide) which were developed and approved under the US Investigational New Drug(IND) system have been investigated to examine how the results obtained from clinical research conducted by publicly-funded research institutes could be utilized. These studies revealed that:
1.Drug regulatory systems should facilitate technology transfer and licensing of de
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liverables of publicly-funded research to private sectors, and
2.Health technology assessment of some Japanese drugs(e. g. statin) suggests that public research institutes in Japan should strengthen management skills for licensing and marketing newly-developed quality products.
(2) Respective cost-effectiveness of certain drugs.
Cost-effectiveness will gain when certain use of drugs is encouraged, and when preventive action is taken.
(3) Sub-field analyses of the reasons for the new drug approval delays.
We analyzed data from Japan and the US for the approval of 36 standard neurological drugs and examined the potential factors that may cause the delay of their launch. Of the 36 standard neurological drugs, all of which were approved in the US, only 26 were introduced in Japan from June 1999 to April 2012.The US led Japan in the number of introductions(25 versus 1), with introductions in Japan occurring at a median of 93 months after introductions in the US. Japan's review time of new drug applications(21 months) could not explain this lag. For 19 of the 26 approved drugs, the application data package included overseas data. The mean review time of these 19 drugs was significantly shorter than that of the other seven drugs without overseas data. These results show that several important reforms in the Japanese drug approval system are closing the large gap between Japan and the US regarding access to standard neurological drugs.
(4) Obstacles to the development of drugs against chemical, biological, radiological, or nuclear agents.
The Japanese regulatory scheme for drug development and approval is devoid of an emergency response in a crisis. First, it does not permit compassionate use. Second, the Japanese regulatory scheme does not have the Animal Rule whereby new drugs or biological products can be approved after successful testing on animals when human efficacy studies with toxic chemical, biological, radiological, or nuclear(CBRN) agents are neither ethical nor feasible. Third, we have no guidelines for collecting human data for establishing the safety and efficacy of a drug in an emergency caused by a CBRN agent. Since CBRN emergencies can cross any border, the international harmonization of comprehensive regulations is indispensable for the efficient development of drugs against CBRN agents.
Ways to find optimal intellectual property(IP) protection for encouraging development of innovative drugs in contemporary, biotechnological contexts.
Legislative amendments and case law relating to various forms of exclusivity to protect biotechnological inventions(extension of patent protection, data exclusivity, purpose-bound patent protection, orphan drug development incentives, patent life-cycle management) were examined, to assess to what extent these forms of protection responded to the nature of biotechnological investigation and medicines based on biotechnology. Our tentative conclusion is that, more than IP protection per se, better resource utilization for knowledge creation, better methods of scientific, pharmacological and clinical collaboration in the process of drug development, better financing and investment mechanisms and management of research institutions and across traditionally segregated organizational walls may be more fruitful. The infrastructure which would provide scientific and technological information for wider groups of researchers and people in need will also be necessary. Less
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