Date: 20 January 2011
Source: Knowledge Ecology International Online
Link: http://keionline.org/node/1061
Ska Keller tables MEP question on ethical aspects of
pharmaceutical test data protection
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?"
Keyword: Pharmaceutical / EU / MEP
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