green light from the Assembly to set floor stocks
The National Assembly unanimously adopted on Thursday a socialist text against drug shortages, aiming to “reinforce the obligations” imposed on manufacturers to build up stocks, by including floors in the law, and by increasing sanctions.
“Not being able to access the medications we need constitutes indescribable anguish (…) for parents, for patients,” defended PS MP Valérie Rabault, author of the text, which will now have to go to the Senate. “The number of medicines in shortage has increased tenfold in ten years,” insisted the MP, saying she was “aware that the heart of the subject remains production”, and calling for “a medium and long-term industrial strategy”.
From decree to law
The version of its text adopted Thursday, amended in particular by the general rapporteur of the Social Security budget Stéphanie Rist (Renaissance), plans to include in the law minimum stocks which are currently only provided for in a decree. They would be between a minimum week and a maximum of four months for medicines in general.
Another range is retained for “medicines of major therapeutic interest” (MITM), namely those for which an interruption of treatment is likely to jeopardize the vital prognosis of patients in the short or medium term, or represents a loss of significant opportunity for patients. In this case, the inventory floors and ceilings would increase to a minimum of two months and a maximum of four months.
ANSM involved
In certain cases set by decree, the director of the medicines agency (ANSM) could require smaller stocks. But it would also have the possibility, after the adoption of an amendment by Ms. Rabault, to impose stocks of up to six months for MITMs for which a stock shortage or a risk of shortage is highlighted or declared. .
“Increasing stocks of medicines or even making them compulsory are not the alpha and omega of managing shortages,” warned the Minister of Health Frédéric Valletouxemphasizing that beyond the need to relocate part of the production in Europe, it was necessary to act on the unequal distribution of stocks on French territory and on “the visibility of these stocks”.
The bill also plans to confer on the ANSM powers of on-site inspection, but also to increase the penalties provided for by law, which could go up to 50% of the turnover of the last financial year. relating to the medicine in question, with a ceiling raised to 5 million euros (compared to 30% and 1 million euros currently).
