As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“theProposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations for Marketing Authorization Holders (“MAH”) and competent authorities are given more power to better monitor and control the availability of medicines on the market.
As we have discussed previously, these measures aim to tackle the broader problem of security and robustness of pharmaceutical supply chains, which became especially prominent during the COVID-19 pandemic. In this blog, we briefly explore some of the changes introduced by the Proposal.
Preventing Supply Disruptions and Shortages
Critical Medicinal Products
The Proposal expands the monitoring of “critical medicinal products” beyond emergency situations. Now, medicinal products “for which insufficient supply results in serious harm or risk of serious harm to patients” will be included in the “Union list of critical medicinal products” (“Union list”), and the Commission will have the power to implement measures such as stockpiling of active pharmaceutical ingredients or finished dosage forms.
While it is not yet clear what criteria would be considered for the inclusion of a medicinal product in the Union list, the decision will be adopted by the Commission on the basis of a proposal by the Executive Steering Group on Shortages and Safety of Medicinal Products (“MSSG”), taken in collaboration with the Medicine Shortages Single Point of Contact (“SPOC”) Working Party. It is expected that the European Medicines Agency (“EMA”) will develop a common methodology, as well as criteria and procedures for identifying, establishing and reviewing the Union list.
Once the Union list is adopted, the MSSG may provide recommendations on possible measures, and the Commission may decide to adopt an implementing act to improve security of supply. The EMA will publish the Union list on its web-portal to ensure transparency.
The Proposal also sets out three different categories of shortages for which reporting and monitoring obligations are defined:
- “shortage”: a situation in which the supply of a medicinal product that is authorized and placed on the market in a Member State does not meet the demand for that medicinal product in that Member State;
- “critical shortage in the Member State”: a shortage of a medicinal product, for which there is no appropriate alternative medicinal product available on the market in that Member State, and that shortage cannot be resolved; and
- “critical shortage”: a critical shortage in the Member State for which coordinated action at EU level is considered necessary to resolve that shortage.
Both the EMA and Member State competent authorities have expanded competences to monitor shortages. The EMA will monitor any potential or actual shortage of centrally authorized products, while each Member State competent authority will monitor medicinal products authorized at national level, and report to the EMA any shortage of a medicinal product that it identifies as a “critical shortage in that Member State”. Notably, information about a shortage can be submitted not only by the MAHs, but also by wholesale distributors.
Once a “critical shortage” (for which an action at EU level was considered necessary) has been identified, the MSSG, in consultation with the EMA and SPOC, will adopt the “list of critical shortages of medical products”. Critical shortages are then monitored by the EMA, in coordination with Member State competent authorities. In response, the MSSG may provide recommendations on measures to resolve or mitigate the situation, and the Commission may decide to implement relevant measures.
For “critical shortages in Member States” (for which an action at EU level was not considered necessary), Member States remain competent to take measures to address them. In such case, national competent authorities are required to inform the EMA of any action taken by the Member State to mitigate or resolve the situation.
Obligations of MAHs to prevent Shortages
Early notification requirements
Under the Proposal, a MAH must notify the competent authority of the Member State where the medicinal product has been placed on the market, and in addition the EMA for centrally authorized medicinal products, of the following:
- A decision to permanently cease the marketing of a medicinal product in that Member State, no less than twelve months before the last supply;
- A request to permanently withdraw the marketing authorization for that medicinal product authorized in that Member State, no less than twelve months before the last supply;
- A decision to temporarily suspend the marketing of a medicinal product in that Member State, no less than six months before the start of the temporary suspension;
- A temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as the MAH becomes aware of such temporary disruption.
The Proposal specifies the minimum information that MAHs should provide in these cases:
- In case of suspension, cessation or withdrawal, MAHs are required to notify competent authorities and provide a Risk assessment of the impact of the suspension, cessation or withdrawal (“Risk Assessment”) and any risk-mitigating measures taken by the MAH to address the shortage. The Risk Assessment should include, where available, potential alternative medicinal products, the estimated size of the population affected, the impact on the supply of other medicinal products and/or the impact on the consumption or demand of other medicinal products;
- In case of disruption of supply, MAHs are required to notify competent authorities, among other information, a Shortage Mitigation Plan (“SMP”).
Monitoring requirements of potential or actual shortages
Every MAH must have in place and keep up to date a Shortage Prevention Plan (“SPP”) for the medicinal product placed on the market. The plan must include, among other information, measures on shortage prevention and a supply chain risk assessment (e.g., alternative marketed medicinal products, a supply chain map presenting potential vulnerabilities in the supply chain, shortage management measure, etc.). The EMA will draw up specific guidance on how to put in place the SPP.
MAHs also need to comply with a series of information obligations to enable Member State competent authorities, the MSSG and the SPOC to propose the Union list and to enable competent authorities to monitor shortages of medicinal products. These obligations include, among others, the provision of correct, not misleading and complete information when requested by competent authorities, as well as the duty to cooperate and disclose any relevant information without undue delay.
Obligations of MAHs once a product has been added to the Union list or a Critical Shortage has been declared
Once a medicinal product has been added to the Union list or a critical shortage has been declared, the MAH must:
- provide any additional information that the EMA may request;
- provide additional relevant information to the EMA;
- take into account the recommendations of the MSSG;
- comply with any measures taken by the Commission based on the MSSG recommendations;
- inform the EMA of any measures taken by the MAH to comply with the foregoing and report on results of such measures; and
- if applicable, inform the EMA of the end date of the critical shortage.
This blog is based on the wording of the EU’s proposal published on 26 April 2023. This wording could significantly change during the legislative process. Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation. We will be hosting a webinar to discuss the impact on 9 May. To sign up for the webinar please click here.