Europe 1 with AFP / Photo credit: BURGER / Phanie / Phanie via AFP 9:30 a.m., March 1, 2024

The Assembly unanimously adopted a text against drug shortages.

This aims to “reinforce the obligations” made to manufacturers to build up stocks, by including floors in the law, and by increasing sanctions.

Systems are put in place for “drugs of major therapeutic interest”.

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 medicines we need constitutes indescribable anguish (...) for parents, for patients,” defended PS deputy 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”.

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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.

Specificities for “drugs of major therapeutic interest”

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.

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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 of Health Frédéric Valletoux, emphasizing that beyond the need to relocate part of 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).