Biomedical Research: Diagnosis of Deputies

The law N° 28-13, introduced in June 2014, was finally adopted by the chamber of deputies. The impact of this new legislation on the development of biomedical research was highlighted by the committee of social sectors. Members have declared the gap in the law that has long prevailed in this area and has negatively impacted the quality of research shall be filled.

The final version of the law says : “No clinical biomedical research can now be carried out if it is not based on the latest state of scientific knowledge and sufficient preclinical experimentation,” and “the foreseeable risk, incurred by participating persons, should be proportional to the expected benefit or the interest of research.”

On the other hand, the Members of the social Commitee within the House of Representatives expressed their concern on the limited missions of the independent regional ethical authority envisaged by the law. “The conditions of its exercise is to confine it a role of research analyst, without being entitled to control norwith to follow-up”, as the parliamentary report indicates it, were among the measurements qualified by the deputies as being insufficient.

“The uncertainty which surrounds the voluntarist vocation of the participants ”,was also underlined.The most important priority appears also to be the strict respect of the human rights, established in the Constitution and which will be done via the creation of a national file of the healthy people taking part in biomedical research and of a national database of biomedical research which will be founded.

Concerning the warranties intended to make safe the practice of a biomedical research in Morocco, the Parliament approved a new diagram which subjects the realization of any biomedical research to three obligatory prerequisites: The approval of the sites of research, the favorable opinion of the committee of protection and the respect of the technical requirements required by the ministry for Health. The field of intervention and respective responsibilities for each speaker in research since the promoter to the investigator, were ratified by the deputies. The creation of contract research organisms which can represent sponsors that are not installed in Morocco will also be allowed.

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