Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-090"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2000-12-11"^^xsd:date2
dcterms:Is Part Of	lp_eu:Clinical trials of medicines for human use2
dcterms:Language	"el"^^xsd:language2
lpv:document identification number	"en.20001211.5.1-090"2
lpv:hasSubsequent	lp_eu:2000-12-11-Speech-1-0912
lpv:speaker	lp:Minerva Melpomeni Malliori2
lpv:spokenAs	member; Delegation to the EU-Russia Parliamentary Cooperation Committee (1999-10-06--2002-01-14)3 unknown; Panellinio Socialistiko Kinima (1999-07-20--2004-07-19)3 member; PES (1999-07-20--2004-07-19)3 substitute; Committee on Citizens' Freedoms and Rights, Justice and Home Affairs (2000-02-23--2002-01-14)3 member; Committee on the Environment, Public Health and Consumer Policy (1999-07-21--2002-01-14)3
lpv:translated text	"Madam President, health is the most precious of gifts and everything must be done to maintain and restore it. That is why medical science should be given every possible means of properly protecting individual and public health. Unfortunately, although the right measures are taken, they are unable to prevent new risks and diseases from emerging which the drugs available are unable to treat, and the medical community is obliged to find modern, more effective ways of meeting these challenges. Clinical trials are a necessary step in this direction, provided that they are conducted in a way which safeguards the dignity and the mental and physical welfare of the subjects. Current differences between the laws, regulations and administrative provisions in the Member States are creating obstacles to and competition between pharmaceutical companies in their bid to make new drugs quickly available to patients. Hence the need for harmonisation at European level. Because it recognises the importance of this directive, the European Parliament has endeavoured to overcome its differences rather than hold up the legislative process, focusing on the following safety conditions for clinical trials: the written consent of the subjects to the clinical trial, the consent of the guardian or an authority provided for by law and of the treating doctor to the participation of persons with impaired understanding or a mental disorder which prevents them from giving their consent, the criterion being that the expected benefits of the drug being tested must outweigh any side effects. The participation of children in clinical trials must be regulated properly because it is a particularly sensitive issue. Finally, and here I am dissatisfied with the Council's compromise proposals, I think that the main investigator during clinical trails should be a doctor, because only a doctor has the knowledge and experience needed in order to evaluate the benefits and deal with any side effects or risks which arise during the clinical trial. Of course, the team conducting the clinical trial may include other specialists with the relevant qualifications. I should like to congratulate the rapporteur, Mr Liese, on his report and thank him for his efforts to reach a compromise."@en1

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