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Health technology assessment – Cooperation with the European Medicines Agency

Public health

EU rules on health technology assessment (set out in Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The aim is to contribute to a good use of health system resources, while respecting national competences. The initiative concerns cooperation with the European Medicines Agency (EMA). It sets out implementing rules on information exchanges for EU-level assessments of new health technologies, while preserving the remits of Health Technology Assessment Coordination Group and EMA.

Links

Public consultation

ID: 14164

Lobbying Activity

19 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 24 Jul 2024

<p> EFPIA thanks the European Commission for the opportunity to comment on the proposed draft implementing act on the cooperation of the Coordination Group and the European Commission with the European Medicines Agency in the form of exchange of information for JCAs and JSCs. EFPIA recognizes the…

Consultation response

Novartis International AG, 24 Jul 2024

Novartis welcomes the opportunity to comment on the draft Implementing Act for the information exchange with the EMA. The information Health Technology Developers (HTDs) share with the EMA prior to marketing authorization applications (MAAs) is private, competitive and of strictly confidential…

Consultation response

Johnson Johnson, 24 Jul 2024

Johnson & Johnson welcomes the opportunity to provide feedback on the draft Implementing Act (IA). Our feedback relates to the relevance of this Implementing Act across medicinal products, medical devices, and in vitro diagnostics. We are aligned with our trade associations, EFPIA and MedTech…

Consultation response

European Patients' Forum (EPF), 23 Jul 2024

The European Patients' Forum (EPF) welcomes the publication of the draft Implementing Act on Health Technology Assessment (HTA) cooperation with the European Medicines Agency (EMA). We strongly support close interaction between regulators and HTA bodies to enable faster patient access to medicines.…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 24 Jul 2024

EUCOPE welcomes the EU HTA procedure and its aims to provide a transparent and inclusive framework for quality HTA, to reduce duplication for national HTA authorities and industry and to facilitate business predictability and ultimately, to accelerate access of medicines to EU patients. We believe…

Consultation response

European Society for Paediatric Oncology, 24 Jul 2024

The European Society for Paediatric Oncology (SIOP Europe or SIOPE) is the only pan-European organisation representing all professionals working in the field of childhood cancers. With more than 2,500 members across 35 European countries, SIOPE is leading the way to ensure the best possible care…

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 23 Jul 2024

In principle, BPI supports the EU HTA procedure and its goals of creating a transparent and inclusive system for high-quality HTA, minimizing redundancy for national HTA authorities and industry, enhancing business predictability, and ultimately speeding up the availability of medicines for EU…

Consultation response

European Society for Medical Oncology (ESMO), 22 Jul 2024

The European Society for Medical Oncology (ESMO) welcomes the draft Implementing Act setting out the procedural rules for cooperation, in the form of exchange of information, with the European Medicines Agency (EMA) in the context of the joint work under the EU Health Technology Assessment (HTA)…

Consultation response

Cancer Patients Europe, 22 Jul 2024

Cancer Patients Europe, CPE (www.cancerpatientseurope.org) welcomes the third Implementing Act (IA) relating to the cooperation by exchange of information with the European Medicines Agency (EMA) and pursuant to Regulation (EU) 2021/2282 as it clarifies the rules for cooperation with the EMA such…

Consultation response

F. Hoffmann-La Roche Ltd, 22 Jul 2024

<p>As a global leader in biomedical research and in-vitro diagnostics, Roche is committed to advancing healthcare in the EU by promoting scientific excellence and innovation. We back the EU HTA Regulation for high-quality clinical HTA and faster patient access, and we recognise the value of…

Consultation response

European Organisation for Research and Treatment of Cancer, 15 Jul 2024

1. Introduction: The EORTCs position The European Organisation for the Research and Treatment of Cancer (EORTC) is pleased to be able to contribute to the implementation of the European HTA Regulation (HTAR), working towards the successful implementation of a regulation that improves the…

Consultation response

Astellas Pharma Europe Limited, 24 Jul 2024

Astellas welcomes the opportunity to comment on the Implementing Regulation on Information Exchange of the Coordination Group with the EMA and wishes to submit the following comments: General considerations: The period before submitting a Marketing Authorization Application is vital for developers…

Consultation response

Biomedical Alliance in Europe, 24 Jul 2024

The BioMed Alliance welcomes the proposed implementing regulation detailing procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment (HTA) and the Commission with the European Medicines Agency. We support the provisions in the implementing…

Consultation response

Associazione delle Imprese del farmaco, 24 Jul 2024

Farmindustria, associazione italiana delle imprese farmaceutiche, in linea con la posizione espressa da EFPIA, accoglie con favore i principi contenuti nella bozza dell'atto di implementazione relativo allo scambio di informazioni con l'EMA. Farmindustria riconosce i numerosi elementi positivi…

Consultation response

European Association of Urology, 22 Jul 2024

The EAU welcomes the draft procedural rules for exchange of information between the Commission, the European Medicines Agency and the Member State Coordination Group on HTA. The timely and effective exchange of information between these organisations will be vital to ensure implementation of the…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 24 Jul 2024

As stipulated by the Regulation (EU) 2021/2282 on health technology assessment (HTA), the European Commission (EC) is seeking feedback on the draft Implementing Regulation (IR) that lays down detailed procedural rules concerning cooperation, in the form of exchange of information, of the Member…

Consultation response

Lymphoma Coalition, 24 Jul 2024

Lymphoma Coalition Europe (LCE) welcomes the publication of the draft Implementing Act on the Cooperation with the European Medicines Agency (EMA). We value and appreciate the opportunity to provide feedback in support of Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC),…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 24 Jul 2024

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) welcomes the adoption of the Health Technology Assessment Regulation (EU) 2021/2282 (HTAR), which contributes to reducing inequalities and improving patients access to the health technologies needed to stay healthy…

Consultation response

European Hematology Association, 19 Jul 2024

The European Hematology Association (EHA) welcomes the draft Implementing Act laying down procedural rules for the exchange of information between the HTA Coordination Group, the European Commission and the European Medicines Agency. The timely and effective exchange of information with relevance…