[Ip-health] MEP question on ethical aspects of pharmaceutical test data protection

Judit Rius Sanjuan judit.rius at keionline.org
Thu Jan 20 04:34:58 PST 2011


Ska Keller tables MEP question on ethical aspects of pharmaceutical test data protection

http://keionline.org/node/1061
KEI Blog
Submitted by James Love

On Tuesday the 18th of January 2010,German Green MEP Franziska Keller tabled this Parliamentary question: 

The EU Pharmaceutical Legislation adopted in 2004 (Directive 2004/27/ EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use) created a harmonised EU eight-year data exclusivity provision with an additional two plus one year market exclusivity provision. During these up to eleven years of exclusivity, if a generic or biosimilar product wants to enter the European market without the authorization of the originator, it will have to present its own data on already demonstrated safe and effective products and therefore some times unnecessary forcing duplication of clinical data and testing on human beings and animals.

Does the EU directive comply with the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects? For example, does the directive comply with Articles 17-21 of the declaration, and how? What measures are being taken to avoid unnecessary and duplicative clinical trials on pharmaceutical and biological products on human beings and animals?

In proposed agreements with Canada and India, the EU has proposed cost sharing mechanisms as an alternative to exclusive rights, to avoid duplicative testing in the area of plant protection products.

Should cost sharing be considered for human use drugs when regulatory obligations conflict with ethical rules on duplicative tests involving humans?"



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