Question 39004 — pharmacy and medications

Summary

Mr. Jean-Pierre Door draws the attention of the Minister of Solidarity and Health to the effectiveness of maintaining a national security stock of medicines entrusted to pharmaceutical laboratories in response to the increase in situations of shortage or tension in the supply of medicines and vaccines. Difficulties or shortages relating to drugs of major therapeutic interest may lead to interruption or postponement of life-saving treatment. More generally, each patient must be able to access the medications they need and within the time frame they expect. During the sars-cov 2 epidemic, the Government was alerted on several occasions to the major risks of a shortage of essential drugs for the care of patients with covid-19. In the fall of 2019, Parliament voted for the obligation of holders marketing authorization and drug operators to constitute a safety stock intended for the national market, located on French or Community territory. In fact, the purpose of article 48 of the social security financing law for 2020 was to combat the risks of disruptions in the supply of medicines, which have been increasing sharply over the past ten years. But this new obligation was not not come into force until the publication of Decree No. 2021-349 of March 30, 2021, which has just specified the applicable terms, from September 1, 2021. Thus, marketing authorization holders and companies operating a medicine must constitute a safety stock of medicines intended for the national market with a maximum duration of four months to cover drug needs. The decree defines a minimum storage period of at least two months for medicines of major therapeutic interest and at least one week for other medicines. The precedent of the disengagement of the State, due to the delegation to the responsibility of each employer of the mission of safety storage of masks for protection of personnel and the disappearance of the industrial sector of production of masks, must however invite the caution. It therefore asks it to specify how it intends to ensure clear and transparent information on the causes and history of these shortages and the plans for managing drug shortages. He therefore asks him if there are plans to place under the Prime Minister a national body for managing supply disruptions responsible for defining a national strategy for the prevention and resolution of the causes of supply disruptions. supply disruptions which are in fact multiple. He asks how stocks of drugs of major therapeutic interest will be constituted given the number of specialties concerned and the quality standards associated with the management of these stocks. Given the high concentration of drug production sites located over long distances and the length of distribution chains, while prices of drugs among the lowest, he questions him about the reality of a system for controlling safety stocks of drugs located outside the national territory. In the event of a global shortage of medicines and a concomitant reduction in air transport, how is it planned to transport these stocks to the national territory? Finally, he asks how the Government intends to find an industrial and health strategy and relocalize the production of drugs considered strategic.

Machine translation from French. The official text remains authoritative.

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