[Why are new drugs so expensive?].

Putting an end to an innovation crisis, the reality of which is the subject of debate, recent pharmaceutical innovations, the result of a combination of scientific, industrial, financial, political and economic reasons, lead to a diversification of products and to a strong interest of pharmaceutical companies for the so-called "niche" products (targeted therapies, rare diseases, etc.). These new molecules are put on the market at much higher prices than in the past. In the absence of reliable information on the costs borne by manufacturers, and knowing that high levels of margins have been observed, these prices raise legitimate questions. These are also motivated by the lack of relationship between the price and the therapeutic benefit of these new molecules. In France, faced with levels of expenditure likely to weaken the financial sustainability of the social protection system, the public authorities have so far always favored interventions on prices or the conditions and volume of reimbursement, in accordance with the existing regulation. Other regulations (use of the statutory license, group purchase, etc.) could in the future be used in a growing concern for the efficiency of public expenditure. The difficulties encountered in regulating a deeply transformed industrial sector call for a reform of national evaluation and regulation systems.