The Evidence Base Post 18 October 2024

European Medicines Agencies Network Strategy 2028: key highlights and public reactions

Katie McCool

The EMA and HMA have launched a public consultation for the European Medicines Agencies Network Strategy 2028, which emphasizes six strategic focus areas including accessibility, data, AI, and antimicrobial resistance.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have launched a public consultation on their updated strategy for the European Medicines Agencies Network Strategy to 2028 (EMANS 2028). This updated plan builds on the original five-year strategy, EMANS 2025, and reflects significant changes in the regulatory and technological landscape. New EU legislation for handling public health emergencies, the creation of the Directorate-General for Health Emergency Preparedness and Response (DG HERA), and advances in AI have accelerated the need for a revised approach. These developments, along with the largest reform of EU pharmaceutical legislation in decades, present new opportunities to transform medicine development and regulation across Europe.

“The overarching theme of our updated strategy to 2028 is that of change – rapid, somewhat unpredictable but nonetheless full of promise,” said Emer Cooke, EMA’s Executive Director. The strategy aims to harness these changes and guide the network through opportunities and challenges, from public health threats to the potential of AI.

Six strategic focus areas

EMANS 2028 centers around six key focus areas that aim to ensure the sustainability of the EU’s healthcare landscape:

Accessibility – The strategy makes a clear distinction between availability and accessibility. While regulatory approval may be granted, patients across the EU often face barriers due to cost, reimbursement policies, or supply chain issues. EMANS 2028 emphasizes collaboration with Health Technology Assessment (HTA) bodies to harmonize clinical assessments across the EU, particularly with the HTA regulation coming into effect in 2025.
Leveraging data, digitalization, and artificial intelligence – The strategy emphasizes the use of digital technology, particularly AI, to enhance efficiency and automate processes across the network. AI has become more widespread since EMANS 2025, and the network plans to harness its full potential to improve regulatory decision-making, personal productivity, and overall process efficiency.
Regulatory science, innovation, and competitiveness – EMANS 2028 focuses on fostering a regulatory and research environment that stimulates innovation while maintaining the EU’s competitiveness in the global healthcare market. By integrating EMA’s Regulatory Science Strategy, the updated approach aims to ensure that the network is prepared for the rapid evolution of scientific advancements and technologies.
Antimicrobial resistance and other health threats – AMR remains a critical focus area. The strategy adopts the EU’s One Health approach, a unified strategy that balances the health of people, animals, and ecosystems, which is essential for addressing global health threats. To manage AMR, the network emphasizes promoting responsible antimicrobial use and supporting the development of new antimicrobial agents. International collaboration is crucial in this effort, as AMR's global impact demands shared expertise. As the reflection paper warns, "If the emergence and spread of AMR continues unabated, the annual number of deaths worldwide is expected to be in the millions, making AMR a more common cause of death than cancer by 2050."
Availability and supply – Addressing supply chain challenges is crucial for ensuring the consistent availability of medicines across Europe. EMANS 2028 aims to enhance these areas to safeguard public health and ensure the reliable supply of essential medications.
Sustainability of the network – To achieve its goals, the strategy underscores the importance of enhancing the network's capacity and ensuring adequate resources, including funding, expertise, and efficient governance structures. Protecting public health is a long-term objective, requiring the network to pursue both immediate and future projects effectively. Key focuses include reinforcing scientific and regulatory capacity, establishing a collaborative operating model, and strengthening public engagement and global partnerships.

Reflection paper and public consultation

The updated strategy replaces the current network strategy for 2025 and incorporates aspects of EMA’s Regulatory Science Strategy. Informed by a mid-term review of EMANS 2025 and developed with input from EU medicines regulatory experts, it outlines essential adjustments to navigate the evolving regulatory landscape, particularly with the largest reform of EU medicines regulation in decades on the horizon. Additionally, a reflection paper published alongside the consultation provides additional details on the drafting process and considerations driving EMANS 2028.

Maria Lamas, Chair of the HMA Management Group, stressed the importance of these focus areas: “The six focus areas have been carefully chosen to support the network’s core work of evaluating medicines as we take strides to promote the development of medicines and ensure that they reach those who need them.”

Stakeholders are encouraged to provide feedback on the draft strategy until November 30, 2024. The final strategy is expected to be adopted by March 2025, following an 8-week public consultation.

Reactions to the EMANS 2028

The announcement of EMANS 2028 has generated insightful commentary from industry professionals. Enosium Life Science commented on the strategy’s focus on AI and digitalization, noting,

"With goals ranging from leveraging AI and digitalization to improving access to medicines and combating antimicrobial resistance, the strategy seems to address the most pressing issues in healthcare."

However, they cautioned that, "The real test lies in its actual implementation. The ambitions are clear, but the devil is in the details."

Malvika Vyas, reflecting on her experience in health policy – especially in oncology – emphasized the crucial distinction between the availability and accessibility of medicines, a point also acknowledged in the reflection paper. She stated, “The new reflection paper of the EMA, which is the basis for EMANS 2028, provides a clear distinction between these two terms.” Vyas also noted that, “All inexpensive medicines should be accessible and available. The latter is still not the case in many countries, even within the EU.”

Regulatory expert Neil Grubert referenced the strategy’s initiatives, including DARWIN EU, while cautioning that, "some Member States will undoubtedly be more active in these cross-border collaborations than others." However, concluded on an optimistic note, stating, “It will be fascinating to see to what extent they shape the future evolution of the access environment across Europe.”