Skip to Main content Skip to Navigation
Theses

Recherche sur le dynamique de construction et d'interprétation des règles applicables à l'expérimentation clinique des médicaments : entre progrès de la connaissance, mise sur le marché et protection des personnes

Abstract : The present work is to analyse the dynamics of construction of the rules applicableto clinical trials, particularly in relation with the pharmaceutical products, minly in France and the European Union. These ones appearing not as a succession of original devices of different nature and force, but as the result of their mutual interpenetration. In this case , following the second world war, the clinical trial data transmission was often being done despising the rights and the dignity of the patients involvesd in such experimentation. This experimentation was considered to be a new way of practising medecine. Recommendations have been given to the researchers, in addition to their Hippocratic obligations, conducting them to respect the autonomy of the will and safety of the people involved in the research.As well as most industrial countries,France wished to go from ethic to law to put in place a regulation in favor of the protection of people involved in clinical experiment.However, some obligations part of the 20th of December 1988 law appeared to bare too many constraints on the institutinal investigators, which they considered to be an obstacle to the development of their research. They were able to put forwardthe importance of their work, in terms of collective ethiccs, for the progress of medecine and the idea that they did not persent a higher risk than the current treatment situation, to obtain twice a derogatory regime to the common principles of the regulation governing the clinical trials. The derogations have dicreased the protection protection of the persons involved in the clinicals trials.The analysis of the construction dynamic of rules governing the clinical trials as summarized is only possible considering the origin of state regulation but also the extra legal production coming from the actors involved.
Document type :
Theses
Complete list of metadatas

Cited literature [1060 references]  Display  Hide  Download

https://tel.archives-ouvertes.fr/tel-02879064
Contributor : Abes Star :  Contact
Submitted on : Tuesday, June 23, 2020 - 2:53:12 PM
Last modification on : Friday, October 23, 2020 - 4:37:54 PM
Long-term archiving on: : Thursday, September 24, 2020 - 5:38:53 PM

File

These-Demarez-Jean-Paul-2019.p...
Version validated by the jury (STAR)

Identifiers

  • HAL Id : tel-02879064, version 1

Citation

Jean-Paul Demarez. Recherche sur le dynamique de construction et d'interprétation des règles applicables à l'expérimentation clinique des médicaments : entre progrès de la connaissance, mise sur le marché et protection des personnes. Droit. Université de Lyon, 2019. Français. ⟨NNT : 2019LYSES032⟩. ⟨tel-02879064⟩

Share

Metrics

Record views

81

Files downloads

84