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Health technology assessment – Joint scientific consultations on medicinal products for human use

Public health

EU rules on health technology assessment (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. This initiative concerns joint scientific consultations on medicines. It set outs implementing rules detailing how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product.

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Public consultation

ID: 13759

Lobbying Activity

26 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 29 Oct 2024

EFPIA welcomes the possibility to comment on this implementing act (IA) aiming to establish the basis for a unified EU level approach to Joint Scientific Consultations (JSC) - a critical component of the EU HTA Regulation. EFPIA would call on the HTA Secretariat, the Member States Expert Group on…

Consultation response

Novartis International AG, 28 Oct 2024

Novartis welcomes the opportunity to comment on the draft Implementing Act on the joint scientific consultations (JSC) for medicinal products. Early dialogue between health technology developers (HTD), authorities, patient and clinical experts is a much-valued platform to inform the design of…

Consultation response

EuropaBio, 28 Oct 2024

EuropaBio welcomes the publication of the draft implementing act (IA) on procedures for joint scientific consultations (JSC) under the framework of Regulation (EU) 2021/2282 (HTA Regulation), which is timely considering the Regulation will apply from 2025. The HTA Regulation is an important tool to…

Consultation response

European Patients' Forum (EPF), 29 Oct 2024

The European Patients Forum (EPF) welcomes the draft Implementing Act on Joint Scientific Consultations (JSCs) on medicines as a critical step towards securing mandatory, meaningful patient participation in EU health technology assessments. We advocate for robust, transparent and expert patient…

Consultation response

Vaccines Europe, 29 Oct 2024

Vaccines Europe welcomes the openness of the EU JSC for vaccines early January 2025. However, its applicability to vaccines seems unlikely as no specific methodological approaches for vaccines are planned, nor the inclusion of NITAGs (National Immunization Technical Advisory Group),…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 23 Oct 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. The request…

Consultation response

Bristol-Myers Squibb Company, 28 Oct 2024

BMS welcomes the opportunity to comment on the JSC Implementing Act. JSCs play a key role in establishing a dialogue between HTDs and HTA bodies on variations in clinical practice and how these will be handled methodologically. Discussions on the relevance of comparators for the EU process, the…

Consultation response

Deutsche Sozialversicherung Europavertretung, 28 Oct 2024

On 1 October, the European Commission presented the third of a total of six drafts of an implementing regulation for health technology assessment (Commission Implementing Regulation (EU.../...) of XXX laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures…

Consultation response

Pharma Deutschland e.V, 29 Oct 2024

Pharma Deutschland e.V. would like to thank you for the opportunity to comment on the draft implementing act - Ref. Ares(2024)6931211 - 01/10/2024. In view of the crucial importance of the JSC process for the overall success of the EU HTA, Pharma Deutschland considers the regulations proposed in…

Consultation response

European Society for Paediatric Oncology, 21 Oct 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., 24 Oct 2024

BPI welcomes the EU HTA procedure and its goals to provide a transparent and inclusive framework for quality HTA, to reduce duplication for national HTA authorities and industry, to facilitate business predictability and ultimately, to accelerate access to medicines. Request windows for Joint…

Consultation response

European Society for Medical Oncology (ESMO), 28 Oct 2024

The European Society for Medical Oncology (ESMO), representing more than 40,000 oncology professionals from over 177 countries, welcomes the consultation on the draft Implementing Act laying down the procedural rules for Joint Scientific Consultations on medicinal products. Please find the full…

Consultation response

Takeda Pharmaceuticals International AG, 29 Oct 2024

An effective system for engagement and dialogue is essential for attracting R&D in the region and improving the EU's competitiveness. The development of this framework should be seen as an opportunity to enhance, not reduce, the EUs competitiveness. Takeda believes that addressing our concerns in…

Consultation response

Cancer Patients Europe, 29 Oct 2024

Cancer Patients Europe (https://cancerpatientseurope.org/) welcomes the fourth Implementing Act (IA) relating to Joint Scientific Consultations (JSC) on medicines and pursuant to Regulation 2021/2282 as it clarifies the who, how and when relevant stakeholders, including patients and patient…

Consultation response

F. Hoffmann-La Roche Ltd, 28 Oct 2024

<p>Roche, as a world leader in biomedical research and the in-vitro diagnostics sector, is committed to contributing to the future of healthcare in Europe. We support the implementation of the EU HTA Regulation (HTAR) to ensure timely and high-quality assessments for patient access across Europe…

Consultation response

Alliance for Regenerative Medicine, 28 Oct 2024

The Alliance for Regenerative Medicine (ARM) welcomes the opportunity to comment on the draft Implementing Act on JSC. The JSC is of critical importance for the successful implementation of JCA. As stated in Article 16 of the HTA Regulation, [the JSC] shall facilitate the generation of evidence…

Consultation response

Biomedical Alliance in Europe, 29 Oct 2024

The BioMed Alliance, representing 35 European medical and research societies, welcomes the proposed implementing regulation outlining the procedures for joint scientific consultations on medicinal products for human use at the Union level, as part of Regulation (EU) 2021/2282. Healthcare…

Consultation response

CCI Europe, 29 Oct 2024

Childhood Cancer International Europe (CCI-E), the largest pan-European organisation representing childhood cancer patients, parents and survivors, welcomes the opportunity to give feedback on the public consultation Implementing Regulation on joint scientific consultations on medicinal products…

Consultation response

France Assos Santé, 28 Oct 2024

France Assos Santé, which brings together around 100 French patient and healthcare user associations, welcomes the systematic involvement of patients in the joint scientific consultations (JSC) as laid out in the HTA regulation and the draft implementing act. It is essential to ensure that health…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 29 Oct 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 regarding the procedures for joint scientific consultations (JSC) on medicinal products for human use at the European Union…

Consultation response

European Public Health Association, 29 Oct 2024

The European Public Health Association (EUPHA) welcomes the implementing act laying down rules for the application of Regulation (EU) 2021/2282 regarding the procedures for Joint Scientific Consultation (JSCs) on medicinal products, taking the opportunity of this public consultation to pinpoint…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 29 Oct 2024

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) welcomes the opportunity to provide written feedback to the HTARs fourth draft Implementing Regulation that covers the joint scientific consultation (JSC) on medicinal products and structures the selection and…

Consultation response

Associação Portuguesa da Indústria Farmacêutica, 29 Oct 2024

The EU HTA Regulation marks a significant change in assessing clinical evidence for new technologies across the EU, with its impact expected within four months. The Joint Scientific Consultation (JSC) was created to continue the successful HTA advisory framework from EUnetHTA Joint Actions,…

Consultation response

Myeloma Patients Europe, 28 Oct 2024

Myeloma Patients Europe (MPE) welcomes the opportunity to comment on the draft of this implementing act of the health technology assessment, Regulation 2021/2282, focused on Joint Scientific Consultations (JSCs) on medicinal products for human use. Overall, we consider the process of conducting…

Consultation response

European Hematology Association, 26 Oct 2024

The European Hematology Association (EHA) welcomes the European Commissions draft Implementing Act laying down procedural rules for the Joint Scientific Consultations (JSC) on medicinal products for human use under the HTA Regulation. EHA proposes stronger emphasis on the following key elements:…

Consultation response

European Access Academy Faculty hosted by Vlerick Business School, 22 Oct 2024

EAA Faculty Commentary to Draft Implementing Act on Procedural Rules for Joint Scientific Consultations Key Principles of Joint Scientific Consultations (JSC) are outlined in Article 16 of the EU HTA Regulation (EU HTAR): Those consultations shall facilitate the generation of evidence that meets…