Heads of HTA Agencies Group

🚀 The HAG Insight program (Head of Agencies Group Initiative for Knowledge and Skill Enhancement in Health Technology Assessment Regulation) is officially launching! 🎯 Building on extensive preparations during the last 3 years, the program will establish a comprehensive HTAR training platform on procedures and methods with latest insights for the HTA bodies and a selected representation of other stakeholders in order to strengthen the long-term capacity and expertise of EU HTA bodies in executing the HTAR effectively in a sustainable manner for the upcoming health technology scope expansions. 👉 Get to know the programme and the consortium involved: https://lnkd.in/dPHpGy5C

📢 The Heads of HTA Agencies Group (HAG) met in Rome on October 24th. The meeting, with more than 70 participants from 29 member agencies, was hosted and organised by Agenas, AIFA Agenzia Italiana del farmaco and Ministero della Salute. 💬 80 days before the application of the Health Technology Regulation (HTAR), the members of the HAG discussed among others the following: 1️⃣ The latest developments and actions in the implementation of the HTAR. 2️⃣ The status of the key-activities in preparation for the HTAR, presented by Director Marco Marsella (DG SANTE, European Commission), and the HTA Coordination Group, through the Chair Roisin Adams. 3️⃣ The adoption of a joint statement on the implementing regulations on Interactions with European Medicines Agency and Conflicts of Interest. 4️⃣ National developments for the implementation of HTAR. 5️⃣ The development of the Strategic Plan of the HAG 2025-2028 👉Do you want to know more and some conclusions from this meeting❓ Read our last posts on the Heads of HTA Agencies Group website: https://lnkd.in/dFGCyGNH

📢 The HAG welcomes the adoption by the European Commission of two critical implementing regulations concerning the rules for cooperation with the European Medicines Agency (EMA) for joint productions under the Health Technology Assessment Regulation (HTAR), as well as the management of conflicts of interest. 💡 These developments represent tangible steps toward the operationalization of a unified European HTA system. The HAG reaffirms its steadfast commitment to the implementation of the HTA Regulation and will continue to actively engage in this critical process. 💬 "Our shared vision is to establish a European HTA system that embodies the values of solidarity, inclusiveness, transparency, and impartiality, ultimately benefiting patients and healthcare systems across the EU." 👉 Read the full statement here: https://lnkd.in/d8YFsw5b #HTAR Rui Santos Ivo Agneta Karlsson Lionel Collet Niklas Hedberg Johan Pontén Judith Fernandez Maggie Galbraith Tiago Rodrigues Mariane Cossito Luis Vitor Gonzaga Silva Kieran Walsh Katrine Heier

📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”. 📣 There was huge interest from the community with over 350 participants registered, and balanced representation from HTA and regulatory perspectives. The webinar was hosted by the NCPE - National Centre for Pharmacoeconomics in collaboration with the HTA Coordination Group Methodology and Procedures Subgroup, the Heads of HTA Agencies Group and the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and Methodology Working Party (MWP). 👩🏫 Presentations described the distinct remit of HTA and EMA but also where the synergies lie and how through discourse on the challenges, uncertainty can be better understood in the context of these remits. A common understanding will allow for more successful employment of methodologies and solutions to manage uncertainty. 👉 This is the first of an ongoing scientific collaboration between HTA and regulators and we look forward to more fruitful discussions in Autumn.

  The Heads of HTA Agencies Group (HAG) welcomes the adoption of the first implementing regulation ((EU) 2024/1381) by the European Commission pursuant to the HTA Regulation ((EU) 2021/2282).    📌 This implementing regulation is a major milestone in the implementation of the HTA Regulation outlining the procedural rules and templates for the conduct of Joint Clinical Assessments (JCA) for medicinal products.     📌 The HAG is unified in its support for the HTA Regulation and will remain active in promoting important discussions for the remaining implementing regulations to be passed before joint production begins in 2025.    👉 Implementing regulation ((EU) 2024/1381): https://lnkd.in/gnH8Jkxr 👉 Read our full statement: https://lnkd.in/g4dy-HVm

📢 The Heads of HTA Agencies Group met in Brussels for its eighth meeting since its creation   👉 HAG members came together for the meeting to discuss the challenges and implications of the #HTAR, 9 months ahead of its implementation. Particular attention was paid to 𝐣𝐨𝐢𝐧𝐭 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭𝐬 and the 𝐢𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐚𝐜𝐭𝐬 𝐮𝐧𝐝𝐞𝐫 𝐩𝐫𝐞𝐩𝐚𝐫𝐚𝐭𝐢𝐨𝐧.   👉 The HAG reiterated the importance of the European HTA system, which must be built on the principles of solidarity,inclusiveness, and impartiality.   More information on: https://lnkd.in/daj5UuE9

The European Commission has just launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products. The consultation is to run for four weeks, until April 2. Emphasis on the rules on HTA (Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The draft Implementing Act provides detailed procedural rules for the Joint Clinical Assessments. It also provides the format and templates of the submission dossier and the Joint Clinical Assessment report. Every contribution can provide important information and insights on the implementation of the EU Health Technology Assessment Regulation. The Heads of HTA Agencies Group encourages all stakeholders to participate actively on this public consultation. 👉 Find more about the public consultation here https://lnkd.in/eEg3QQsz https://lnkd.in/dQUe6Yew

📢 The Heads of HTA Agencies Group (HAG) adopted a statement on the Revision of the #pharmalegislation, currently under negotiation by the European Council and Parliament.   📌 The HAG welcomes the Commission’s commitment to promoting timely and equitable access to safe, effective and affordable medicinal products across all European countries.   📌 The HAG stresses the importance of consultations with #HTA bodies, in particular for the definitions of unmet medical need, comparative clinical trials, and other topics related to evidence generation along the medicine life cycle.   👉 Read our full statement: https://lnkd.in/diXjGq7j Rui Santos Ivo Agneta Karlsson Lionel Collet Roisin Adams Niklas Hedberg Marco Marchetti Maggie Galbraith Judith Fernandez Johan Pontén Mariane Cossito Tiago Rodrigues https://lnkd.in/diuNfahT