Questions of Copyright

Health and Quality of Life Outcomes

Catherine Acquadro²  Katrin Conway²  Marie-Pierre Emery²  Caroline Anfray¹ 

[1] MAPI Institute, 27 rue de la Villette, 69003 Lyon, France;MAPI Research Trust, 27 rue de la Villette, 69003 Lyon, France

关键词: Intellectual Property;    Copyright;    Patient-Reported Outcome Measures;    Patient-Reported Outcomes;   

Others  :  825941
DOI  :  10.1186/1477-7525-10-16

 received in 2011-05-30, accepted in 2012-01-31,  发布年份 2012

【 摘 要 】

The Berne Convention and the national laws on intellectual property fully apply to PRO instruments. The identification of and access to an original PRO instrument is often associated with copyright ownership. This is the copyright holder of the instrument who will control its access (distribution and reproduction), its adaptation or modification, and its translation. Copyright is a means to protect the integrity of an instrument. The ownership of an instrument should be defined in the beginning between all parties involved, and each step of the instrument's life, including distribution, should be anticipated for purpose of copyright.

【 授权许可】

   
2012 Anfray et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Anfray C, Emery MP: Use of PRO instruments: licensing and copyright issues [abstract]. Qual Life Res 2006, 15(suppl 1):A-112.
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• [3]Anfray C, Emery MP: Use of Patient-Reported Outcomes (PRO) Instruments: Copyright Issues [abstract]. Value in Health 2007, 10(3):A189.
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• [7]European Medicines Agency: Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. London. 2006. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf webcite