On January 20, the European Parliament adopted a series of proposals aimed at improving the availability and supply of critical medicines within the EU. The regulation passed with 503 votes in favor, 57 against, and 108 abstentions.

According to a Parliament press release, Members of the European Parliament support the creation of industrial ‘strategic projects’ within the EU to build, modernize, and improve production capacity. They want national governments and the EU to prioritize financial support for these strategic projects in the current budget and the next EU multiannual financial framework. Companies receiving public financial support must adhere to clear obligations, including prioritizing supplies to the EU market.

The proposed Critical Medicines Regulation states, “The EU has a strong and competitive pharmaceutical sector, which holds a leading global position in the production of medicines and contributes significantly to the EU economy, directly employing around 800,000 people. However, in recent years, the Union has experienced a growing number of medicine shortages, including shortages of medicines whose insufficient supply causes serious harm or a risk for serious harm to patients.”

Global Dependencies

The regulation noted that shortages may have structural causes and may result from “supply chain disruptions and vulnerabilities affecting the provision of key ingredients and components.” These issues are linked to the EU’s dependence on a limited number of global suppliers and its insufficient capacity to produce certain medicines, their active substances, or essential pharmaceutical raw materials.

Regulatory Framework

To address these challenges, the proposed regulation seeks to establish a framework designed to:

• Facilitate investment in manufacturing capacity for critical medicines, their active ingredients, and other key inputs within the union.

• Reduce the risk for supply disruption and strengthen availability by encouraging the diversification and resilience of supply chains in public procurement procedures for critical and other medicines of common interest.

• Respond to the aggregated demand from participating member states through collaborative procurement procedures.

• Supports supply chain diversification by facilitating the establishment of strategic partnerships.

Key Measures

This proposal outlines several core components.

• Strategic projects: Industrial projects designated as strategic may benefit from easier access to financing and accelerated administrative, regulatory, and scientific support to modernize EU production capacities.
• Financial incentives. Member states can grant priority financial support to strategic projects that address the identified supply chain vulnerabilities.
• Public procurement. Regulation requires the use of criteria beyond price when justified by a vulnerability analysis in public procurement processes. Preference would be given to suppliers who manufacture a significant share of these critical medicines within the EU.
• Collaborative procurement. The European Commission would support joint purchasing among member states to address disparities in the availability of critical medicines and other medicines of common interest.
• Critical Medicine Coordination Group. A coordination group composed of representatives of the Commission and member states would be established to facilitate the implementation of the regulation.
• International cooperation. The proposal calls on the Commission to explore international partnerships with like-minded countries and regions to expand supply chains and reduce dependence on a single or a limited number of suppliers.

Rapporteur Tomislav Sokol from European People’s Party, Croatia, and member of the European Parliament stated, “Today we agreed on clear priorities: coordinating national and emergency stockpiles, strengthening the competitiveness of the EU pharmaceutical industry, and tackling medicine shortages by ensuring their accessibility and availability for EU patients.”

The European Parliament is now ready to begin negotiations with EU governments regarding the final form of legislation.

This story was translated from Univadis France, part of the Medscape Professional Network.