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Financial and legislative aspects of drug development of orphan diseases on the European market - a systematic review

机译：欧洲市场上孤儿疾病药物开发的财务和法律方面-系统综述

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摘要

According to the European Commission, medical products for orphan diseases are those which affect fewer than five persons out of every 10 000. Producers are reluctant to develop these drugs under the common market conditions because the demand for these drugs does not guarantee return on investments into research and development of such products. Patients with orphan diseases, however, have the same rights for treatment as any other patient. To stimulate the research and development of drugs for orphan diseases, the governmental offices introduce various incentives for health and biotechnological industry. This started in the USA already in 1983 by passing a special law. Japan introduced this law in 1993 and Australia in 1997. Europe followed in 1999 by introducing common policy for all member states.The aim of this article is to specify current economic and legislative conditions in European countries and compare them with the legislation and approaches of the countries which started this initiative, i.e. USA, Japan, Australia or Singapore. In addition, the treatment costs of orphan diseases are specified and prospects of this field are evaluated.
机译：根据欧洲委员会，用于孤儿疾病的医疗产品是每千人中影响不到五人的产品。生产者不愿在共同的市场条件下开发这些药物，因为对这些药物的需求不能保证对这些药物的投资回报。研发此类产品。但是，患有孤儿疾病的患者享有与任何其他患者相同的治疗权利。为了刺激孤儿病药物的研究和开发，政府办公室对健康和生物技术产业实行了各种激励措施。这项法律早在1983年就通过了一项特殊法律在美国开始。日本于1993年引入了该法律，澳大利亚于1997年引入了该法律。欧洲随后于1999年引入了对所有成员国的共同政策。本文旨在明确欧洲国家目前的经济和立法状况，并将其与欧盟的立法和方法进行比较。启动该计划的国家/地区，例如美国，日本，澳大利亚或新加坡。此外，还规定了孤儿疾病的治疗费用，并评估了该领域的前景。

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  • 来源
    《Applied Economics》 |2016年第27期|2562-2570|共9页
  • 作者

    Maresova Petra; Klimova Blanka; Kuca Kamil;

  • 作者单位

    Univ Hradec Kralove, Fac Informat & Management, Dept Econ, Rokitanskeho 62, Hradec Kralove 50003, Czech Republic;

    Univ Hradec Kralove, Fac Informat & Management, Dept Appl Linguist, Hradec Kralove, Czech Republic;

    Univ Hosp Hradec Kralove, Biomed Res Ctr, Hradec Kralove, Czech Republic|Univ Hradec Kralove, Fac Informat & Management, Ctr Basic & Appl Res, Rokitanskeho 62, Hradec Kralove 50003, Czech Republic;

  • 收录信息 美国《科学引文索引》(SCI);
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

    Orphan diseases; financial aspects; legislative aspects; drug development; Europe;

    机译：孤儿疾病;财务方面;立法方面;药物开发;欧洲;

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