2024-03-01 00:19:13
Faced with drug shortages, MEPs are putting pressure on the pharmaceutical industry. On Thursday February 29, the National Assembly unanimously adopted a socialist bill aimed at “strengthen obligations” make manufacturers build up stocks. The text paves the way for the inclusion of minimum stocks in the law and provides for increased sanctions in the event of non-compliance with these obligations.
“Not being able to access the medications we need is an indescribable anguish (…) for parents, for patients »defended the socialist deputy Valérie Rabault, author of the text, which will now have to go to the Senate.
“The number of drugs in shortage has increased tenfold in ten years”insisted the MP, saying she had “awareness 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.
Another range is retained for “drugs 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 significant loss of 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.
Heightened sanctions
In certain cases set by decree, the director of the medicines agency (ANSM) might impose smaller stocks. But it would also have the possibility, following the adoption of an amendment from 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 Valletoux, stressing 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”.
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The bill also plans to confer on the ANSM powers of inspection on the spot and on the spot, but also to increase the penalties provided for by law, which might 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).
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