The National Assembly unanimously adopted a socialist text against drug shortages on Thursday.
It aims to “reinforce the obligations” made to 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 deputy Valérie Rabault, author of the text, which must now go to the Senate.
“The number of drugs in shortage has increased tenfold in ten years,” insisted the MP, saying she was “aware that the heart of the subject remains production.”
It calls for building “a medium and long-term industrial strategy”.
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Its text, 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.
Significantly increased penalties
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.
In certain cases set by decree, the director of the medicines agency (ANSM) could impose smaller stocks.
But it would also have the possibility, after the adoption of an amendment by Valérie 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 Delegate in charge of Health, Frédéric Valletoux.
He underlines that beyond the need to relocate part of the production in Europe, we must act on the unequal distribution of stocks across the territory and on “the visibility of these stocks”.
The bill also plans to give the ANSM powers of on-site inspection, but also to increase the penalties provided for by law.
They 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;
against 30% and 1 million euros currently.