[The precautionary principle, research and drugs].
The research, in general, the medical research and the research of new drugs are following the same rules. To be fruitful, they have not to be "a priori" censured, but they have to be prudent on the means they are using and the aims they are pursuing. It's up to the researcher to explain to the public the necessity of the used means and the utility of his discovery. The public, indeed, may be not significantly informed and can be afraid by what is difficult to understand or by what is changing its customs. At the end of the pre-clinic period of research, the discovered substance has to confirm on human being its innocuity and its efficiency. At this time, the experimentation is controlled by several procedures under the control of French and European administrations. All these procedures have to be conducted according to several "Good Practices". The aims are to protect the human being, to define if the new drug is well-tolerated and efficient and what is the ratio Benefit/Risk. Even after the marketing of the new drug, the usage of the new drug is controlled (Drug Safety). So we can consider that precautionary principle is soon applied to the drug according to a very sophisticated and evolutionary mechanism. But as satisfactory it can appear, we must keep vigilant because the zero risk does not exist.
Joly
P
P
Fondation pour la Recherche Médicale, Paris.
D017277:Drug Approval / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods; D015507:Drugs, Investigational / Q000592:standards* / Q000627:therapeutic use; D005060:Europe; D005602:France; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D012106:Research
D015507:Drugs, Investigational