Résumé
For several years, the number of situations involving the medicine’s risk of shortage and shortage has been rising steadily in France, mainly due to the relocation of manufacturing sites as a result of globalization, and lower prices for so-called "mature" products. These situations affect supplies to the French market and its distribution system, and have numerous impacts. To curb this growing phenomenon, a number of regulations were introduced in the French Public Health Code in 2016 and then strengthened in 2021, introducing the notion of "médicament d'intérêt thérapeutique majeur" (drug of major therapeutic interest). This notion implies a number of obligations for “exploitant” pharmaceutical sites in France, in terms of making products available on French territory, under the supervision of health authorities. These obligations have necessitated the organization of these sites with regard to the management of situations of risk of shortage and measures to enable a return to a normal situation, as well as the management of shortage management plans. Processes have been put in place in recent years to monitor these operations. However, despite the determination of the entire supply chain to alleviate these tensions, situations of shortage are increasing from year to year. A number of recent studies have highlighted the limitations of these palliative methods. Limits that exist both at the level of the operator, and at the level of the French market and its supply system as a whole. New solutions are being sought and legislated.