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EU Implements New Rules for Health Technology Assessments in Italy

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The European Commission has introduced new rules for health technology assessments (HTA) across the European Union. These regulations, outlined in the Implementing Regulation (EU) 2024/1381, aim to establish a uniform procedure for the preparation and update of joint clinical assessments of medicinal products for human use. Effective from January 12, 2025, this regulation will enhance cooperation between member states, improve transparency, and ensure timely access to innovative health technologies.

The implementation of these rules marks a significant step forward in the EU’s approach to health technology assessment. By creating a standardized framework, the regulation aims to harmonize the diverse HTA practices currently in place across member states. This will not only streamline the assessment process but also reduce duplication of efforts and ensure that all countries have access to the same high-quality information. The uniform procedure will facilitate a more coordinated response to the evaluation of new health technologies, ensuring that decisions are based on the best available evidence.

Furthermore, the regulation emphasizes the importance of transparency in the HTA process. By making the assessment reports and underlying data publicly available, the European Commission aims to build trust among stakeholders, including healthcare providers, patients, and the general public. This transparency is expected to lead to more informed decision-making and greater accountability in the approval and use of new health technologies.

In addition to improving cooperation and transparency, the new regulation also seeks to enhance the involvement of patients and clinical experts in the HTA process. By incorporating the perspectives of those directly affected by health technologies, the assessments will be more comprehensive and reflective of real-world needs and experiences. This patient-centric approach is a key component of the regulation and is expected to lead to more patient-friendly outcomes.

New Health Technology Regulation Enhances EU HTA Process

The regulation also sets out detailed procedural rules for the interaction between the European Medicines Agency (EMA) and other relevant stakeholders. This includes guidelines for the timing and exchange of information, as well as the roles and responsibilities of the various parties involved in the HTA process. By clearly defining these procedures, the regulation aims to ensure a smooth and efficient assessment process, minimizing delays and administrative burdens.

Moreover, the regulation introduces specific measures to support the development of joint clinical assessments. This includes the creation of templates for assessment reports, which will standardize the format and content of the documents produced. These templates will help ensure consistency and comparability across assessments, making it easier to draw meaningful conclusions and recommendations.

The new rules also address the issue of data protection and confidentiality. Given the sensitive nature of the information involved in health technology assessments, the regulation includes strict provisions to safeguard personal and commercially sensitive data. This will protect the privacy of patients and the proprietary interests of health technology developers, while still allowing for the necessary exchange of information to support the HTA process.

Overall, the Implementing Regulation (EU) 2024/1381 represents a comprehensive and forward-looking approach to health technology assessment in the EU. By establishing a uniform procedure, enhancing cooperation and transparency, and incorporating the perspectives of patients and clinical experts, the regulation aims to ensure that new health technologies are assessed in a timely, efficient, and patient-centered manner. This will ultimately support the goal of providing high-quality, innovative health technologies to patients across the European Union, improving health outcomes and contributing to the sustainability of healthcare systems.

The primary objective of this regulation is to facilitate the exchange of information and collaboration among EU member states during HTA processes. The regulation lays down procedural rules for interactions with the European Medicines Agency (EMA) and other relevant stakeholders, including health technology developers, patients, and clinical experts. It aims to standardize the format and templates for joint clinical assessment reports, ensuring consistency and clarity in the evaluation of new medicinal products.

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One of the significant provisions includes the requirement for health technology developers to provide relevant information to the HTA secretariat at the same time they submit applications for marketing authorization to the EMA. This information includes the summary of product characteristics and clinical overview, facilitating early preparation for joint clinical assessments. Additionally, the regulation mandates the involvement of patients and clinical experts in the assessment process to ensure comprehensive evaluations.

The regulation specifies detailed procedural steps for the joint clinical assessment process. This includes the selection of assessors and co-assessors, the involvement of patient and clinical expert consultations, and the development of assessment scope proposals. The HTA secretariat will play a crucial role in coordinating these activities, ensuring all relevant information is communicated efficiently among stakeholders.

Transparency and confidentiality are key elements of the new regulation. The HTA secretariat is responsible for facilitating information exchange while safeguarding sensitive data. The regulation outlines strict confidentiality agreements for all participants in the assessment process, ensuring that personal and commercially sensitive information is protected. Additionally, the results of joint clinical assessments will be published, promoting transparency and public trust in the HTA process.

Health technology developers will benefit from a more streamlined and predictable HTA process. The regulation provides clear guidelines on the documentation and timelines required for joint clinical assessments, reducing administrative burdens and accelerating the evaluation process. This is expected to facilitate faster access to the market for innovative medicinal products, benefiting patients across the EU.


Resource: Agenzia Nnazionale Per i Servizi Sanitari Regionali, May 24, 2024

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