Drug shortages: Assembly votes on minimum supplies

On Thursday, the National Assembly unanimously adopted a socialist text against drug shortages. It aims to “strengthen the commitment” of manufacturers to build up stocks by including minimum levels in the law and tougher penalties.

“The inability to access the medicines we need represents indescribable pain (…) for parents and patients,” defended PS MP Valerie Rabaut, author of the text that is now due to be submitted to the Senate. “The number of drugs in short supply has increased tenfold in ten years,” the deputy insists, saying that she “realizes that the core of the issue remains production.” He calls for building a “medium- to long-term industrial strategy.”

Its text, modified in part by Social Security Budget General Rapporteur Stephanie Rist (Renaissance), plans to include in the law minimum amounts that are currently provided only in the decree. For medications in general, they will range from a minimum of a week to a maximum of four months.

Fines have been significantly increased

A different range is maintained for “medicines of major therapeutic interest” (MITM), namely those for which interruption of treatment would jeopardize patients’ life prognosis in the short to medium term or would represent a loss of significant opportunity for patients. In this case, the lower and upper inventory limits will increase to a minimum of two months and a maximum of four months.

In certain cases established by decree, the Director of the Medicines Agency (ANSM) may introduce smaller stocks. But it will also have the option, following the adoption of the Valerie Rabo amendment, to introduce up to six months of stock for MITMs for which a stock shortage or risk of shortage has been identified or declared.

“Increasing drug stocks or even mandating them is not the alpha and omega of shortage management,” warned Minister Delegate in charge of Health Frédéric Valletou. He emphasizes that, in addition to the need to move some production to Europe, we must act on the uneven distribution of stocks across the territory and the “visibility of these stocks.”

The bill also plans to give ANSM on-site inspection powers, as well as increase statutory penalties. They can reach 50% of the turnover of the last financial year related to the medicine in question, with a ceiling that can be increased to 5 million euros; versus 30% and 1 million euros currently.