EU HTA Regulation’s First Implementing Act on Joint Clinical Assessment Limits Health Technology Developers’ Involvement and Sets Short Timelines
**EU HTA Regulation’s First Implementing Act on Joint Clinical Assessment: Limiting Health Technology Developers’ Involvement and Setting Short Timelines**
The European Union (EU) has taken a significant step forward in harmonizing health technology assessment (HTA) across its member states with the introduction of the first Implementing Act on Joint Clinical Assessment (JCA) under the EU HTA Regulation. This regulation, which is set to come into full effect in January 2025, aims to streamline the evaluation of health technologies, including pharmaceuticals and medical devices, across the EU. However, the recent Implementing Act has sparked considerable debate within the industry due to its restrictive approach towards the involvement of health technology developers and the stringent timelines it imposes.
### Background on the EU HTA Regulation
The EU HTA Regulation (Regulation (EU) 2021/2282) was adopted in December 2021 with the objective of creating a more coordinated approach to the assessment of health technologies across EU member states. The regulation seeks to reduce duplication of efforts, ensure consistent access to innovative technologies, and improve the efficiency of health technology assessments. One of the key components of this regulation is the introduction of Joint Clinical Assessments (JCAs), which will be conducted at the EU level and will serve as a common basis for national HTA bodies when making decisions on pricing and reimbursement.
### The First Implementing Act on JCA: Key Provisions
The first Implementing Act on JCA, published in 2023, outlines the procedural rules and requirements for conducting JCAs. The Act establishes the roles and responsibilities of various stakeholders, including the Coordination Group (composed of representatives from national HTA bodies), the European Commission, and health technology developers. It also sets out the timelines for the JCA process and the submission of evidence by developers.
#### 1. **Limited Involvement of Health Technology Developers**
One of the most contentious aspects of the Implementing Act is the limited role it assigns to health technology developers in the JCA process. While developers are required to submit clinical evidence and other relevant data, their involvement in the assessment process is largely restricted to responding to specific requests for information from the Coordination Group. The Act does not provide developers with the opportunity to actively participate in the deliberations or to engage in dialogue with the assessors during the evaluation process.
This limited involvement has raised concerns among industry stakeholders, who argue that it could lead to a lack of transparency and a potential disconnect between the developers and the assessors. Developers fear that without the ability to engage in meaningful dialogue, there is a risk that the JCAs may not fully capture the nuances of the clinical evidence or the real-world impact of the technology.
#### 2. **Short Timelines for Submission and Assessment**
Another critical issue highlighted by the Implementing Act is the short timelines it sets for the submission of evidence and the completion of the JCA process. According to the Act, developers are required to submit their clinical evidence within a tight timeframe, often within a few weeks of receiving a request from the Coordination Group. The Coordination Group, in turn, is expected to complete the JCA within a few months.
While the intention behind these short timelines is to expedite the assessment process and ensure timely access to innovative technologies, there are concerns that the compressed timelines may compromise the quality of the assessments. Developers may struggle to gather and submit comprehensive evidence within the limited timeframe, and the Coordination Group may face challenges in thoroughly evaluating the evidence and reaching a well-informed conclusion.
### Industry Response and Implications
The publication of the first Implementing Act on JCA has elicited a mixed response from industry stakeholders. On one hand, there is recognition of the potential benefits of a harmonized HTA process, including reduced duplication of efforts and faster access to new technologies across the EU. On the other hand, the restrictive approach to developer involvement and the short timelines have raised concerns about the potential impact on the quality and transparency of the assessments.
Industry associations have called for greater flexibility in the JCA process, including more opportunities for developers to engage with the assessors and provide input throughout the evaluation. They have also advocated for more realistic timelines that allow for the thorough collection and assessment of clinical evidence.
### Conclusion
The first Implementing Act on Joint Clinical Assessment under the EU HTA Regulation marks a significant milestone in the EU’s efforts to harmonize health technology assessment across its member states. However, the restrictive approach to developer involvement and the short timelines outlined in the Act have raised important questions about the potential impact on the quality and transparency of the assessments. As the implementation of the EU HTA Regulation progresses, it will be crucial for policymakers to strike a balance between the need for timely access to innovative technologies and the importance of conducting thorough and transparent assessments that fully consider the perspectives of all stakeholders.