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

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F16%3A50004635" target="_blank" >RIV/62690094:18450/16:50004635 - isvavai.cz</a>
Alternative codes found
RIV/00179906:_____/16:10323152
Result on the web
<a href="http://dx.doi.org/10.1080/00036846.2015.1125433" target="_blank" >http://dx.doi.org/10.1080/00036846.2015.1125433</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1080/00036846.2015.1125433" target="_blank" >10.1080/00036846.2015.1125433</a>

Result language
angličtina
Original language name
Financial and legislative aspects of drug development of orphan diseases on the European market - a systematic review
Original language description
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.
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
AE - Management, administration and clerical work
OECD FORD branch
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Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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