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This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the whole series, please click here.
In recent years, EU countries have been reporting serious shortages of medicinal products. Beyond the problems arising from increased expenses for replacements, shortages also give rise to significant concerns regarding compromised patient care all over Europe. By way of illustration, the most affected medicines are commonly used antibiotics (e.g., amoxicillin), cough syrup and paracetamol.
As to the potential causes, it should be noted that there are several culprits affecting the ability to meet demand, such as the combination of an increased demand and reduced supply, increase of seasonal infections and inflation (including the current energy crises) influencing pharmaceutical companies’ supply adversely.
Beyond the specific initiatives taken in the context of the Covid-19 pandemic (e.g., establishment of the Health Emergency Preparedness and Response Department, the European Stability Mechanism Platform, etc.), the legislation currently in force already provides several tools addressing shortages of medicinal products. For example, the “sunset clause”, which provides that a marketing authorization becomes invalid after lack of commercialisation of the medicinal product after a prescribed period, and the obligation to ensure permanent and appropriate supply of medicinal products.
The concern of shortages of medicines has been further addressed in the recently announced reform of the EU pharmaceutical legislation, consisting of a new Directive and a new Regulation for a new EU regulatory framework for all medicines. Chapter X of the proposed Regulation sets out specific rules on coordinated management of critical shortages and security of supply of critical medicines; it aims at achieving a better security of supply throughout the Union and to contribute thereby to public health protection by strengthening the rules on monitoring and reporting of (actual and potential) shortages of medicines.
This article provides a brief overview of the initiatives as introduced in the proposed legislation to ensure availability and security of supply of medicinal products.
Chapter X of the proposed Regulation introduces new requirements for monitoring and managing shortages of medicines by the national competent authorities (together with the European Medicines Agency (EMA)), and a stronger coordination role for the EMA has been established. To empower the national competent authorities (NCAs) and the EMA to monitor shortages more effectively, the proposed Regulation introduces more stringent marketing information requirements for the marketing authorisation holder. These apply for both centrally authorised medicines and those with a national marketing authorisation.
Pharmaceutical companies will be required to report shortages and withdrawals, and to develop specific shortage prevention plans. For example, new article 116 of the proposed Regulation requires the marketing authorisation holder to notify the decision to permanently cease the marketing of a medicinal product, the decision to withdraw the marketing authorisation, the decision to temporarily suspend the marketing, and the temporary disruption in supply of a medicinal product. This decision must be notified within six to twelve months beforehand (under the current legislative regime, a timeframe of two months is foreseen). Moreover, article 117 of the proposed Regulation requires the marketing authorisation holder to have a shortage prevention plan. The root causes of shortages of medicines are often multifactorial; these prevention plans allow identification of the challenges along the pharmaceutical value chain (supply chain disruptions, quality and manufacturing problems).
Regarding permanent marketing cessation of critical medicines, the proposed Regulation imposes the obligation upon marketing authorisation holders to offer to transfer the marketing authorisation on reasonable terms to an interested third party. This must be done prior to the notification of withdrawal of the marketing authorisation to the competent authority. This is set out in article 24 (4) of the proposed Regulation.
There is a particular emphasis on supporting shortage management and security of supply of critical medicinal products. The Medicine Shortages Steering Group (MSSG), already established within the EMA, must (as described in article 123-125 of the proposed Regulation) adopt a list of critical shortages of medicines where EU-level action is necessary; the EMA, with national competent authorities, must monitor such shortages. The MSSG may provide recommendations on measures to resolve or mitigate critical shortages, and marketing authorisation holders must cooperate to resolve shortages.
The European Commission can take into account the MSSG recommendations and implement relevant measures (as set out in article 126 of the proposed Regulation) and it can impose legally binding measures to address the supply of critical medicines (as set out in article 134 of the proposed Regulation). The nature and effect of these measures have not been defined for the time being.
Section 2 of Chapter X contains various measures concerning the identification and management of critical medicines by national competent authorities, as well as details of the roles of the EMA, the European Commission and the MSSG; based on MSSG’s proposals, the Commission must adopt and update a “Union list of critical medicinal products”, which is published by the EMA. Inclusion of a product on the list can require the marketing authorisation holder to comply with additional obligations.
In conclusion
On a final note, the pharmaceutical reform package’s objective is to establish a resilient and future-proof regulatory system for medicines in the EU, while promoting innovation to maintain the pharmaceutical industry’s global leadership in innovation. Moreover, the reform’s political priority is to ensure timely and equal access to medicines.
