French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine
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The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for a medicine of major therapeutic interest (MTIM), under Law No. 2016-41 of 26 January 2016.
The ANSM sanctioned the pharmaceutical company on the basis that the company had not planned any shortage management plans despite its product having been classified per Article L. 5111-4 of the French Public Health Code as an MTIM, the shortage of which is likely to present a serious and immediate risk to patients. For an MTIM which does not present such risk, a pharmaceutical company must provide alternative solutions to deal with the shortage.
With this decision, the ANSM aims to underline the fact that the responsibility for supply disruptions does not only lie with wholesalers (who bear public service obligations), but also with pharmaceutical companies. Both must comply with the legal requirements and manage the risks related to these medicines and safeguard accordingly, or consider which internal measures to adopt in order to ensure compliance.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2018 Issue (Thomson Reuters).