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Shortage of healthy products: how to get out of the impasse?

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It was the supply difficulties during the health crisis linked to covid-19 that made it possible to highlight to the general public the topic of problems with the supply of sanitary products in France, a topic that keeps resurfacing due to the shortages affecting the code. products.

In an organized context such as that of sanitary products, it is necessary to find solutions that enable the French market to be supplied in sufficient quantities without sacrificing the quality of sanitary products. If the legal arsenal allows a certain flexibility, palliative solutions are not sufficient to curb a deeper and multifactorial phenomenon.

The shortage in supply is defined as the inability of the pharmacy to dispense the medicine to the patient within 72 hours, after submitting a supply request to two companies that carry out drug distribution activity, a period that can be reduced according to its compatibility with continuing to treat the patient optimally. Shortages in supply may be attributed in particular to a lack of stock, which is defined as the impossibility of manufacturing or using a drug.[1].

Other critical situations require solutions of opportunity. This is the case, for example, of amoxicillin, which is the subject of the December 29, 2022 recommendation.[4] Under which the Director General of ANSM has authorized pharmacists, on an exceptional and temporary basis, to provide a judicial preparation suitable for children under 12 years of age if the prescribed medicine is not available. This option is available to some pharmacies licensed by regional health agencies to produce Magstral preparations for pediatric purposes, which may offer these preparations to other pharmacies, according to studies published on the ANSM website. Another way to reduce the impact of shortages is to regulate access conditions to majors, as has been approved for paracetamol. In addition to the quantity quota since July 2022 for the supply of city pharmacies, the sale of paracetamol has now been restricted in the absence of a prescription, by limiting delivery to two boxes per patient at the doses available since October 19, 2022.[5]. A decree issued on January 4, 2023 suspended the online sale of these specialties until January 31, 2023.[6].

Medical devices are also concerned, which notably led, on January 6, 2023, to postpone the application of two European regulations in order to give operators more time to certify medical devices and thus mitigate the risk of shortages.[7].

However, French and European initiatives are not lacking. The government’s future investment program aims to finance the localization of production activities in France, supported by the action plan of the strategic committee for the sector that was announced last November. European authorities have also addressed this issue through dedicated financing instruments and medium-term initiatives. A dedicated EMA working group will act as a “hub of supply and availability” and monitor the progress of drug supply and availability as part of the EMA Network Strategy to 2025, the European Commission’s Pharmaceutical Strategy for Europe and the “Joint Action on Shortages” and a three-year plan drawn up at the end of 2022. , aims to strengthen systems to combat drug shortages in a coordinated manner[8].

At the same time, however, the financial pressure on France’s pharmaceutical laboratories seems to counteract the oomph needed to re-industrialise. The Social Security Funding Act of 2023[9] It provides for price reductions of up to 800 million euros, aimed in particular at old products affected by shortages. The investments made are thus at least partially neutralized by these measures, slowing down the return of sovereignty in the production of sanitary products.

As has been put in place by the European Commission during the covid-related health crisis, it is therefore necessary to favor a certain regulatory flexibility to deal with supply-side emergencies. Over a longer period, detailed mapping of molecules likely to be affected is necessary in order to stage refactoring if necessary.[10]. Finally, the rapid modernization of some old basic particles, the price of which is sometimes very low, would make it possible to avoid discouragement of economic operators in this sector.

By Diane Bandon Tourette, Partner Attorney at Lexcase

[1] Section R5124-49-1 of the Public Health Code.

[2] Social Security Financing Law for the year 2020 No. 1446 of 2019 dated December 24, 2019.

[3] Medicinal products of main therapeutic interest mentioned in Article L.5111-4

[4] Established under Section L 5125-23 of the Public Health Code.

[5] https://solidarites-sante.gouv.fr/IMG/pdf/dgs_urgent_no2022_81_relatif_aux_tensions_paracetamol.pdf

JORF No. 0003 of January 4, 2023, Text No. 25

[7] Proposal from the European Commission dated 6 January 2023: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf Contact from the European Commission https://ec.europa.eu/ commission / press corner / details / en / ip_23_23

[8] Work Program to 2025 for the HMA/EMA Working Group on the Availability of Medicines Authorized for Human and Veterinary Use, EMA/724592/2022 Rev.1.

[9] Law No. 2022-1616 of December 23, 2022 on Social Security Financing for 2023, JORF No. 0298 of December 24, 2022.

[10] See J. Biot, Journal of Health and Insurance Law No. 35.” Health independence strategy: what are the recommendations? »

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