Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU

On Tuesday, 11th March, the European Commission (EC) published the Critical Medicines Act, focusing on strengthening the security of supply of critical medicinal products (CM) within the EU (scope limited to those in the Union list of Critical Medicines).

The Act also aims to address the availability and accessibility of medicinal products of common interest (MPCI), a new term for those medicinal products, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to cover patient need.

Overview of proposed ActWhile we are currently conducting a detailed assessment of the proposed changes, below is a brief/not so brief overview. 

The Act, which is a Regulation, sets out a framework to:

1. facilitate investments for Strategic Projects supporting the manufacturing capacity of CM, their APIs and other key inputs in the EU
2. lower the risk of supply disruptions and strengthen availability by incentivizing supply chain diversification and resilience in the public procurement procedures of CM and MPCI
3. leverage the aggregated demand of participating Member States through collaborative procurement, 
4. support the diversification of supply chains by facilitating the conclusion of strategic partnerships

• Defined as a project located in the EU and related to creating or increasing manufacturing capacity and fulfilling at least one of the following criteria for CM or their APIs: 1) creates or increases manufacturing capacity; 2) modernises an existing manufacturing site to ensure greater sustainability or efficiency; 3) creates or increases manufacturing capacity for key inputs; 4) contributes to the roll-out of a technology that plays a key role in enabling their manufacrting
• Could receive support for administrative tasks (i.e. reporting obligations), regulatory and scientific support for approval of inspections of new/extended/modernised manufacturing sites, as well as environmental assessments and authorisation
• May be prioritised by Member States for financial support when addressing vulnerability in the supply chains of CM; however, any company that has benefitted from the financial support shall prioritize supply to the EU market, and the Member State that provided the financial support may request the necessary supplies of CM (including APIs or key inputs) to the EU market to avoid shortages 
• May be supported by EU funding when addressing vulnerability in the supply chains of CM, as long as support is in line with the objectives in the regulations of those programmes (i.e. EU4Health, Horizon Europe, Digital Europe Programme)

• Composed by EC and Member States, and EMA with an observer status, and will work closely with MSSG, EMA, and NCAs
• Decisions made through consensus, where possible
• Tasked with coordinating and implementing the Regulation, and advising the EC to maximize the impact of measures and avoid unintended effects 

• EC shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of CM, their APIs and key inputs
• EC shall explore possibilities of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen production of CM in the EU

• MAHs and other economic operators in the supply and distribution chains of CM and MPCI shall upon request by the EC or NCAs provide the requested information necessary for the purpose of this Regulation 
• EC and NCAs shall aim to avoid duplication of the information requested and submitted
• EC and NCAs shall assess merits of duly substantiated confidentiality claims made by MAHs requested to provide the information, and shall protect any information that is commercially confidential against unjustified disclosure

• The vulnerability assessment methodology is not mentioned in the document and will probably be left for the MSSG to address it. 
• The Act is to be evaluated 5 years after the date of application and every 5 years thereafter (including its impact and to what extent its objectives have been met), NCAs and economic operators shall upon request provide the EC with relevant information for this evaluation.
• Impact assessment: the text highlights that, "given the urgent need to address the policy challenges identified, the proposed Regulation will be proposed without an impact assessment. However, its provisions are based on existing analyses, stakeholder consultations, and lessons learned from past initiatives to ensure a proportionate and evidence–based approach. To further assess its expected impacts, a staff working document will be published within three months of the proposal’s adoption, providing a summary of available evidence on the expected impacts of the proposed Regulation and the analysis underpinning the proposal"

Next steps

• EFPIA and Vaccines Europe have published a press release, available in the following Link
• EFPIA will prepare a deeper analysis of the Regulation in the coming days
• EFPIA's Drug Shortages Workstream will meet on March 18th (online) to discuss the Act content and the next steps in detail
• Members are encouraged to review the proposed text and inform us of any major considerations

The Critical Medicines Act will also be sent to both the European Parliament and the Council, following the legislative process.