Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-12-Speech-2-075"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2000-12-12"^^xsd:date2
dcterms:Is Part Of	lp_eu:VOTE2
dcterms:Language	"fr"^^xsd:language2
lpv:document identification number	"en.20001212.5.2-075"2
lpv:hasSubsequent	lp_eu:2000-12-12-Speech-2-0762
lpv:speaker	lp:Nicole Thomas-mauro2
lpv:spokenAs	unknown; Mouvement pour la France (2000-11-23--2003-06-16)3 member; UEN (1999-07-20--2001-01-30)3 member; Committee on the Environment, Public Health and Consumer Policy (1999-07-21--2002-01-14)3 substitute; EMPL (1999-07-21--2002-01-14)3 member; Delegation to the EU-Lithuania Joint Parliamentary Committee (1999-09-30--2002-01-14)3 member; Committee on Women's Rights and Equal Opportunities (1999-10-04--2002-01-14)3 substitute; Delegation to the EU-Hungary Joint Parliamentary Committee (1999-09-30--2001-01-30)3
lpv:translated text	"The Union for a Europe of Nations Group has supported Mr Liese’s report. It was really necessary to simplify the plethora of legal and administrative arrangements applying to clinical trials in the Member States. Promoting the development of medicines in the Community is desirable because that makes it possible to give patients a better chance of benefiting from high-performance treatment. Research also needs to be promoted into medicines for children, and the Health Ministers of the various Member States must rally behind it. Two-thirds of children’s medicines were in fact designed for adults. For lack of data, their marketing authorisation (MA) does not provide for use with children. So use in paediatric medicine sometimes falls under the heading of empirical individual prescriptions, and we need to promote the development at pharmaceutical laboratories of specific products prepared for children and their pathologies so that the doses and forms of the medicines are suited to their bodies. Dr Liese’s report means we can establish shorter time periods, harmonisation of procedures, and above all, a high level of protection, especially for children. As a result of the determination shown by both the Member States and Parliament, laboratories previously discouraged by the complexity of clinical trials will perhaps find the courage to develop the market for children’s medicines, even if it is not yet big enough to provide a return on the investment! Furthermore, the legitimate determination to protect patients who take part in trials at Union level is inseparable from respect for the principle of subsidiarity. So the conditions for consent must be very strict. In our view, trials on people incapable of giving their consent should be banned. Here Dr Liese’s determination to lay down stricter conditions for consent by persons incapable of giving it is interesting. We think consent should be governed by national legislation. While it is appropriate to establish a set of rules to be taken into account, the Member States must retain the power to adopt stricter legislation, as France has done in this respect. That would merely be an intelligent application of the principle of subsidiarity."@en1

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