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欧洲制药研发的前瞻性视角。减少碎片化并提高竞争力的政策选择。

A prospective view on European pharmaceutical research and development. Policy options to reduce fragmentation and increase competitiveness.

作者信息

Kanavos P

机构信息

Department of Social Policy & Administration and LSE Health, London School of Economics & Political Science, England.

出版信息

Pharmacoeconomics. 1998 Feb;13(2):181-90. doi: 10.2165/00019053-199813020-00003.

DOI:10.2165/00019053-199813020-00003
PMID:10178646
Abstract

This article analyses 3 areas of policy that could reduce the fragmentation and improve the competitiveness of the European pharmaceutical sector. It argues that a potential solution to the issue of fragmentation of pharmaceutical research, development and innovation may be the development of policies at the European level, in those areas that European institutions have a competence. These areas may not necessarily rely exclusively on solving the issue of pricing and reimbursing pharmaceuticals as European Union (EU) Member States invoke the subsidiarity principle to claim policy exclusivity in this area. By contrast, policy areas where European institutions have a competence may include: i) a more intensified collaboration in science and technology policy (supporting the science base, identifying education needs for the future, collaborating in the development of new technologies and fostering university-industry collaboration); ii) support of research and development (R&D) by means of directly channelling funds into basic pharmaceutical research, avoiding duplication of the research effort, developing a set of research priorities, tackling the issue of technology transfer, promoting university-industry and cross-border collaborations or providing incentives that would induce private R&D activities in areas with large socioeconomic impact; and iii) an improvement in the environment for the financing of innovation in the EU, by means of selective use of tax policy at the national level (and where applicable, at the EU level), institutional reform in order to widen the pool of available funds for private investment, and the introduction of schemes that would encourage individuals and institutions to hold equity in innovative companies. The article identifies specific research, regulatory, medical and financing needs that require policy intervention, evaluates the possible dynamic implications of such interventions and highlights the benefits that may accrue from their implementation.

摘要

本文分析了能够减少碎片化并提高欧洲制药行业竞争力的三个政策领域。文章认为,对于制药研究、开发和创新的碎片化问题,一个潜在的解决方案可能是在欧洲机构具备管辖权的领域制定欧洲层面的政策。这些领域不一定仅仅依赖于解决药品定价和报销问题,因为欧盟成员国援引辅助性原则在这一领域主张政策排他性。相比之下,欧洲机构具备管辖权的政策领域可能包括:i)在科技政策方面加强合作(支持科学基础,确定未来的教育需求,在新技术开发方面开展合作,并促进产学研合作);ii)通过直接将资金投入基础制药研究来支持研发,避免研究工作的重复,制定一系列研究重点,解决技术转移问题,促进产学研和跨境合作,或提供激励措施以促使在具有重大社会经济影响的领域开展私人研发活动;iii)通过在国家层面(以及在适用情况下在欧盟层面)有选择地使用税收政策、进行体制改革以扩大私人投资可用资金池,以及引入鼓励个人和机构持有创新型公司股权的计划,来改善欧盟创新融资环境。本文确定了需要政策干预的具体研究、监管、医疗和融资需求,评估了此类干预可能产生的动态影响,并强调了实施这些干预可能带来的好处。

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引用本文的文献

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The pros and cons of a single 'Euro-price' for drugs.药品单一“欧元价格”的利弊。
Pharmacoeconomics. 1998 Mar;13(3):271-6. doi: 10.2165/00019053-199813030-00001.

本文引用的文献

1
The role of the research-based pharmaceutical industry in medical progress in the United States.美国研发型制药行业在医学进步中的作用。
J Clin Pharmacol. 1993 May;33(5):412-7. doi: 10.1002/j.1552-4604.1993.tb04680.x.
2
Innovation in the pharmaceutical industry.制药行业的创新。
BMJ. 1994 Aug 13;309(6952):422-3. doi: 10.1136/bmj.309.6952.422.