Question 3378 — overseas

Summary

Mr. Philippe Dunoyer alerts the Minister of Health and Prevention to the impossibility of developing medical research involving humans in New Caledonia, due to the delay in extending the national texts governing this research. The MP reminds the Minister that, by virtue of its jurisdiction in New Caledonia in terms of guarantees of public freedoms, criminal law and research, the State has, by Article 4 of Ordinance No. 2008-1339 of December 18, 2008 relating to the extension and adaptation in New Caledonia, French Polynesia and Wallis and Futuna of provisions relating to the protection of people's rights in matters of health, carried out an update of Article L. 1541-4 of the Public Health Code, in particular in order to extend to the New Caledonia and French Polynesia certain provisions of this code and in particular those resulting from the laws of August 6, 2004 relating to bioethics, of August 9, 2004 relating to public health policy, of August 13, 2004 relating to health insurance and of April 22, 2005 relating to the rights of patients and the end of life. However, this article L. 1541-4 has been modified very little since then, so that the legislation applicable locally in matters of research involving humans is closer to the national legislation of 2008 than the national legislation currently in force. On the other hand, these legislative provisions need to be specified by decree, which has never been done in terms of research involving humans, so that it is, for example, impossible to develop a research protocol involving humans, or even to submit a research project for analysis by a committee of protection of people. He asks him if he will adopt the necessary corrective measures so that article L. 1541-4 of the public health code is updated and the national regulatory provisions applicable to research involving humans are extended to New Caledonia.

Machine translation from French. The official text remains authoritative.

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