The Court of Auditorspublished yesterday its annual report for 2022, in which a chapter is devoted to the security of supply of health products. This analysis follows the investigations undertaken by the Court of Auditors with the health and economic administrations, as well as the review of more than one hundred shortage management plans submitted by the companies concerned.
What should we learn from this?
The covid-19 crisis has brought the phenomenon of health product supply tensions to the forefront of public attention. However, this phenomenon is long-standing, multifactorial and structural. The Court considers that the main difficulty is of an industrial nature due to two major developments: on the one hand, the evolution of the economic model of laboratories (transition from blockbusters to personalised treatment; lengthening of the development phase of health products) and on the other hand, the weakening of supply circuits (recourse to subcontracting the production of health products; just-in-time production; increased dependence on foreign suppliers).
Court of Auditors’ criticism of existing mechanisms
Tensions in the supply of health products have led the public authorities to adopt various measures.
The Law of 26 January 2016 on the modernisation of our healthcare system introduced an obligation for manufacturers of the highest risk medicines of major therapeutic interest (MITM) to draw up shortage management plans. This obligation was extended to all manufacturers of MITM by the LFSS for 2020. However, the Court considers that the contribution of this obligation to draw up management plans is limited in view of the highly variable content of these plans from one operator to another and the solutions provided.
In addition, the LFSS for 2020 requires operators to build up safety stocks for the national market, up to a limit of four months’ coverage of drug needs. However, this measure did not prevent supply shortages during the health crisis because these stocks differ from the strategic stocks managed by the State.
The same observation is made by the Court with regard to the mutualised response mechanism set up at European level to monitor the market and produce opinions on the measures to be taken at Union level. The Court considers that this new regulation has limited effects on the operating conditions of the medicinal products concerned by the shortages.
As regards the pricing of health products, the Court notes that recent measures have been taken to encourage production within the European Union. Indeed, the CEPS-LEEM framework agreement concluded in 2021 provides for :
- a support mechanism for investments and exports;
- taking into account the cost of raw materials to justify an increase in tariffs;
- clauses to support exports of products where at least one significant manufacturing stage is carried out in the EU.
Furthermore, it should be noted that Article 65 of the LFSS for 2022 offers the possibility to the Economic Committee for Health Products to take into account the industrial criterion in the setting of the selling price of medicines and in the setting of the responsibility tariff for medical devices.
However, to date, the Court cannot assess the impact of these measures on the market due to their recent nature.
Proposals of the Court of Auditors
In its report, the Court of Auditors puts forward four proposals to remedy supply disruptions at national level:
- The development of an interface system between the various existing sources of information (declarations to the ANSM, DP rupture, etc.) to better objectify the evolution of drug shortages;
- The implementation of a system for reporting supply shortages affecting medical devices for which such an event would have serious consequences for patients. The MD framework agreement, currently being negotiated, should include certain measures in this area;
- Revision of the definition of MITM, giving the ANSM the power to include medicinal products that justify it, even though they are not proposed by manufacturers, or conversely to exclude them. It should be noted that such a modification would require a legislative provision to complete the third paragraph of Article L. 5121-31 of the Public Health Code;
- For the most essential MITM, an in-depth analysis of the risks of disruption and the implementation of measures to prevent supply tensions as far as possible (reinforcement of safety stocks, price increases, industrial policy action).
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 The Court of Audit assists the Parliament and the Government in the evaluation of public policies. It seeks to verify whether the results of a public policy are in line with the objectives set, and whether the budgetary means are used effectively and efficiently. The Court’s role is to assess the consequences and make recommendations to achieve the objectives voted by Parliament.