What is needed to successfully implement the EU HTA Regulation enabling broad patient access in Europe

Improving Stakeholder Engagement & Connectivity

It is expected, that the new JCA framework should help to reduce the timeline between regulatory approval and the initiation of a country’s national drug appraisal – an important step in the broader effort to expedite patient access to new therapies. A more consistent clinical evaluation process could also lead to an overall reduction in decision-making time.

The phased implementation and transition to the JCA offers tremendous opportunities for collaboration – including the sharing of best practices – among stakeholders to ensure readiness for the new framework and to explore opportunities to improve the system.

In order for the European Commission to achieve its objective of creating more equitable access to medicines across Europe, we want to make the following success-critical recommendations:

• Execute a thorough communication strategy: Consistent communication is critical to eliminate questions and uncertainty around implementation, particularly as member states will need to manage two systems until full implementation in 2030. The benefits and efforts should be made clear to all stakeholders, generating enough incentives (financial and non-financial) to attract member states to the common purpose and/or deterring them from using JCA as a convenience tool. Equally important is communicating how the JCA framework aligns with the Commission’s overarching strategy and complements other pieces of legislation. Best practice sharing and identification of improvement areas are key to fully leveraging the first phase, as well as a transparent tracking system ensuring a constructive debate with similar conclusions across Europe.
• Engage healthcare system stakeholders: All stakeholders, including patients and clinical experts, should be engaged and involved throughout the process. A constant feedback loop from a broad range of healthcare system stakeholders – especially the HTA network – will help to establish new methods and guide important process improvements proposed and accepted by the Coordination Group. In 2028, the EC will collect feedback from different healthcare systems and ask them to make suggestions for improvement. This is a great opportunity to optimize the process in a transparent way and reach the overall objectives for this centralized procedure.
• Secure commitment from 27 EU member states: All countries need to be committed to collaborate in the JCA process, build the necessary capabilities and equip the HTA with needed resources. While at this moment, we see some leading countries driving the efforts and leading the development of this new process and its requirements, we also anticipate that smaller and midsize countries struggle to prepare well for this EU HTAR. Not only are resources already constrained, but also many local systems don’t seem to be ready for optimal support of the centralized EU procedure. We hope very much that member states will support each other, especially in the beginning, ensuring that manufacturers have clarity about local requirements and the potential impact of a JCA report.

Together with the recommendations for a successful JCA implementation, we would also suggest policymakers build a more reliable and attractive HTA ecosystem by

• Considering the new regulation as a starting point: As several pieces of legislation come together, the EU should also provide a wider perspective on collaboration via Centres of Excellence or capacity sharing. A fundamental part of this is the consolidation of the European Health Data Space (EHDS); therefore, advancing how this interplays with the EU HTAR seems paramount.
• Building common trust: Part of the policy process relies on the capacity of Member States and their technical bodies to establish trust in other Member States (especially with those with less capabilities or more reluctant to fully engage with a transparent HTA system), sharing knowledge and experience. Defining and communicating in an appropriate manner progress (or the lack of it) will also depend on the capacity of all stakeholders to define some concise albeit efficient metrics to monitor progress.

The goals of the HTA regulation offer tremendous promise for patients across Europe, which not only remains after the USA, the second largest market in the world for pharmaceuticals but also a prime breed for innovation. But it’s important that the final framework doesn’t stifle innovation or result in a more complex, duplicative process that could potentially delay access to the therapies being developed today. One concern countries, as well as manufacturers, have raised is the challenge of connecting the JCA outcome with the local pricing and reimbursement process (3).

As we move closer to 2025, it’s imperative that all healthcare system stakeholders and all 27 EU member states be strong partners in supporting a transparent and efficient process.

As an EU HTA Think Tank, we are ready to follow the communication process and expand the discussion to a broader audience to support establishing a transparent and successful implementation of this new EU HTAR.

Disclosures

Conflict of interest: None of the participants declares any conflict of interest.

FM, IL, and PL-C received participation fees for attending the meeting.

Financial support: The meeting was organized and sponsored by Cencora and Fundació HiTT.

Author contributions: All authors contributed equally and made contributions to the initial version of the manuscript and the final version.

Data Availability Statement: No data were used in this manuscript.