[Legislative frame and clinical trials in Lebanon].

UNLABELLED

In Lebanon, as in other developing countries, most of the clinical trials are achieved without considering any rule adopted in the industrialized countries, which causes serious ethical problems. This study aims to review the different Lebanese texts related to clinical trials in order to show the existing legislative frame, and to formulate suggestions that help the legislator defining better this activity. We reviewed and analyzed the Lebanese legislation related to the clinical trials especially the Lebanese law project about "therapeutic trials on human subjects" and conducted semi-directive interviews with actors from the society.

RESULTS

We noticed a legislative gap in this domain, highlighting the fragility of the social link in the health domain, and reverberating negatively on the physician/physician, physician/hospital, physician/industrial and industrial/hospital relationships, in addition to many gaps affecting the skills of physicians-investigators. In spite of the promising institutional effort, the national frame of clinical trials does not seem to be sufficient regarding the ignorance of applied legislative texts, the industrial promoter's weight, and the pressures. This is applied to the absence of a powerful national coordinator, the inexistence of a pharmacovigilance system or a skillful authority for the sanitary security of health products, and the confusion in the concepts of medical ethics and deontology. In conclusion were presented for achieving improvements on many levels: an objective criticism of the law project proposed in 2002 followed by a call to review its content and improve it in order to reach an instructive and applicable global legislation ; an action that can be realized only through educating adequately the investigators, and informing the large public in order to guide the governors towards a legislation allowing people in Lebanon to "live well " with complete dignity.