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Health technology assessment - Joint clinical assessments of medicinal products

Public health

Regulation (EU) 2021/2282 on health technology assessment (HTA) establishes a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies. It requires the Commission to adopt implementing rules to ensure that joint clinical assessments of medicinal products at EU level are conducted in a timely manner and that relevant experts are involved or consulted appropriately on these assessments.

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Public consultation

ID: 13708

Lobbying Activity

54 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 2 Apr 2024

The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to innovative therapies for patients with the declared goals to reduce inefficiencies and duplications, goals that the…

Novartis urges greater industry involvement in EU clinical assessments

Novartis International AG, 2 Apr 2024

Novartis requests meaningful and systematic involvement of developers throughout the joint assessment process. They propose mandatory meetings to clarify assessment scopes and executable timelines for dossier preparation. The company also advocates for stronger protection of commercially confidential information.
Rebalanced timelines would reduce the volume of analytical work performed at risk.
Enhanced confidentiality protections may limit the transparency of information available to patients.

EuropaBio Urges Early Developer Involvement in Clinical Assessments

EuropaBio, 29 Mar 2024

Developers seek involvement in the scoping phase to provide quality evidence. They also request harmonized timelines to prepare submissions and correct factual inaccuracies.
This would improve predictability and minimize the burden of duplicating clinical data.
Regulators may struggle with assessment scopes that exceed their time and resources.

Sanofi warns EU clinical assessment rules risk patient access

SANOFI, 2 Apr 2024

Sanofi requests greater developer involvement in scoping and mandatory meetings to clarify expectations. They advocate extending the dossier submission timeline to 135 days. For vaccines, rules must explicitly involve National Immunisation Technical Advisory Groups.
This would allow the company to shape the assessment scope and reduce submission errors.
Patients risk losing fast access to treatments if the current unworkable rules are adopted.

Johnson & Johnson warns EU clinical assessment rules are unworkable

Johnson Johnson, 2 Apr 2024

J&J requests involvement in defining the assessment scope and more preparation time. They propose a 4.5-month window to develop robust and informed evidence dossiers.
This avoids penalizing companies that have fast regulatory approval timelines for medicines.

AstraZeneca urges greater developer involvement in EU health assessments

AstraZeneca PLC, 2 Apr 2024

AstraZeneca requests to heighten the role of developers as key partners in evidence generation. They argue for sufficient time to produce a high-quality submission and comprehensive dossier.
This would allow the company to avoid duplicative processes and reduce work performed at risk.

MSD Urges Faster Timelines for EU Joint Clinical Assessments

Merck Sharp Dohme Europe Belgium SRL, 2 Apr 2024

MSD proposes finalizing the assessment scope within 90 days rather than waiting for regulatory questions. They advocate for earlier certainty to ensure timely preparation of the assessment dossier.
This change would streamline the submission process and reduce administrative delays for developers.
Patients could face delayed access to new therapies if the assessment timeline is unoptimized.

European Patients' Forum urges deeper patient involvement in health assessments

European Patients' Forum (EPF), 2 Apr 2024

The group demands that patient input be included from the very beginning to avoid tokenistic involvement. They also call for financial support, translation services, and more time for representatives to review materials.
This ensures patient expertise is formally embedded and adequately funded throughout the assessment process.
Resource-constrained Member States may struggle to meet the proposed high standards for involvement.

Vaccines Europe urges EU to recognize vaccine-specific assessment needs

Vaccines Europe, 1 Apr 2024

Vaccines Europe calls for including national immunization groups and the ECDC in assessments. Methodologies should account for vaccine-specific data like herd immunity and modeling. Developers must also be involved when reports are re-evaluated.
This would ensure that joint assessments are accepted nationally and avoid market delays.

AbbVie urges greater developer involvement in EU clinical assessments

AbbVie, 29 Mar 2024

AbbVie requests strengthening the involvement of health technology developers throughout the scoping process. They advocate for extending dossier preparation timelines to at least four and a half months. They also suggest longer deadlines for identifying technical inaccuracies in assessment reports.
Extended timelines and earlier visibility would help the company submit high-quality dossiers.

GSK urges greater industry participation in EU health assessments

GSK, 2 Apr 2024

GSK wants developers to help define the assessment scope and receive longer data submission deadlines. They also demand more time to review reports and protect confidential trade secrets.
This prevents the accidental release of secrets and allows more time for data preparation.
National health systems may experience slower assessments, delaying reimbursement decisions for new medicines.

EURORDIS urges realistic deadlines and deeper patient involvement

EUROPEAN ORGANISATION FOR RARE DISEASES, 28 Mar 2024

EURORDIS requests realistic assessment scopes based on medical knowledge and longer deadlines for data submission. They also call for meaningful, predictable involvement of patient experts throughout the evaluation.
Realistic timelines would ensure high-quality assessments and faster access to rare disease treatments.
National health systems lose if tight deadlines result in poor quality or inconclusive clinical reports.

EUCOPE Warns Short Timelines Risk Quality of Drug Assessments

European Confederation of Pharmaceutical Entrepreneurs, 2 Apr 2024

EUCOPE demands earlier involvement in scoping meetings to clarify assessment requirements. They also request extending deadlines to allow companies to prepare high-quality clinical data submissions.
This would help smaller firms manage regulatory costs by providing predictability and clarity.
Patients could face delayed medical access if poor quality data compromises clinical assessments.

Bristol-Myers Squibb Urges More Involvement in EU Clinical Scoping

Bristol-Myers Squibb Company, 29 Mar 2024

BMS requests that drug developers propose assessment scopes and be involved throughout scoping. They also call for longer deadlines to submit high-quality evidence dossiers.
The company would gain better predictability and resource efficiency during assessments.
Public transparency is reduced by stricter protections for commercially sensitive data.

German social insurance warns of EU assessment delays

Deutsche Sozialversicherung Europavertretung, 2 Apr 2024

The association requests complete methodological guidelines to ensure joint reports are clear. They also argue for stricter transparency regarding clinical data and redactions.
Standardized EU assessments would prevent redundant clinical evaluations at the national level.
Technology developers would lose the ability to selectively report only positive data.

Pharma Deutschland urges mandatory industry involvement in drug assessments

Pharma Deutschland e.V, 28 Mar 2024

Pharma Deutschland demands mandatory bilateral meetings and the right to provide input during the scoping phase. They also seek longer submission deadlines and better protection for commercially sensitive data.
Mandatory involvement and longer deadlines would help companies protect trade secrets and improve submission quality.
Health authorities may face slower assessment timelines due to mandatory manufacturer consultations and longer deadlines.

SIOPE Urges Faster EU Clinical Assessments for Pediatric Cancer Medicines

European Society for Paediatric Oncology, 28 Mar 2024

SIOPE requests involving clinical and patient experts early to accelerate children's access to treatments. They seek guidance on using real-world evidence and single-arm trials for rare pediatric cancers.
Standardized assessments would help pediatric oncologists secure faster reimbursement for new life-saving therapies.
Fragmented national assessment systems currently delay vital treatment access for children and their families.

BPI urges early involvement in EU health technology assessments

Bundesverband der Pharmazeutischen Industrie e.V., 2 Apr 2024

The group requests systematic and early involvement for developers during the clinical assessment scoping phase. They demand longer timelines for data submission and stricter protections for confidential business information.
Extended timelines and earlier involvement would lower administrative pressure and business risks for manufacturers.
Stricter confidentiality rules could limit public transparency regarding clinical data and assessment evidence.

ESMO urges use of oncology tools in EU clinical assessments

European Society for Medical Oncology (ESMO), 2 Apr 2024

ESMO wants its clinical benefit scale and guidelines used to evaluate treatments. They also demand that medical oncologists are formally consulted during assessments.
This would solidify ESMO's influence over European drug reimbursement and clinical standards.

Takeda Warns Proposed EU Health Assessment Rules Are Unworkable

Takeda Pharmaceuticals International AG, 2 Apr 2024

Takeda demands mandatory involvement in the scoping process and significantly longer submission deadlines. They believe current timelines underestimate the resources required for high-quality dossiers.
Longer timeframes would help companies successfully manage complex data requirements for launches.
Patients and health systems may receive low-quality assessments that hinder access.

Consultation response

Lääketeollisuus ry, 29 Mar 2024

Pharma Industry Finland response to JCA Implementing Act public consultation THE SUCCESS OF THE EU HTAR RELIES ON THE ABILITY OF THE SYSTEM TO DELIVER HIGH-QUALITY JCA REPORTS Pharma Industry Finland (PIF) represents the innovative pharmaceutical industry in Finland. Our 40 member companies have…

Cancer Patients Europe seeks mandatory roles for patient groups

Cancer Patients Europe, 2 Apr 2024

CPE urges the Commission to mandate consultation with patient organizations. They request plain language summaries to clarify technical medical information.
Stronger representation ensures patient experiences directly impact the assessment of new treatments.
Health technology developers face increased administrative burdens to provide non-technical assessment summaries.

Roche Urges Deeper Inclusion in EU Drug Assessment Process

F. Hoffmann-La Roche Ltd, 2 Apr 2024

Roche argues that developers must be meaningfully included throughout the procedure to ensure quality. They request access to draft documents and earlier assessor appointments to manage timelines. They also demand a framework to protect commercially sensitive information and trade secrets.
Extended preparation windows would help Roche avoid the risks of incomplete submissions.
Public transparency is reduced if technical documentation is withheld from the public domain.

PHARMIG urges mandatory manufacturer involvement in EU health assessments

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 29 Mar 2024

PHARMIG requests mandatory involvement of manufacturers throughout the assessment process to ensure realistic scoping. They propose extending the dossier submission deadline to 135 days to handle extensive data requirements. The association also demands mandatory consultation of patients and medical experts.
This would prevent unworkable deadlines and reduce the risk of redundant national data requests.
Patients could face delayed access to innovative therapies due to bureaucratic publication timelines.

ARM urges flexible EU assessment rules for advanced therapies

Alliance for Regenerative Medicine, 2 Apr 2024

ARM urges the inclusion of real-world evidence and observational studies in clinical assessments. They request early scoping meetings and more time for companies to submit dossiers.
This would lower compliance barriers for biotechnology companies developing advanced therapies.
Patients with rare diseases face significant delays in accessing transformative treatments.

Consultation response

Astellas Pharma Europe Limited, 2 Apr 2024

After careful review of the draft Implementing Regulation on the Joint Clinical Assessment (JCA), Astellas have significant concerns regarding its provisions in two major categories, specifically: the timelines for (finalizing) the scoping process and dossier preparation, and the lack of meaningful…

BioMed Alliance urges mandatory expert involvement in clinical assessments

Biomedical Alliance in Europe, 2 Apr 2024

The group calls for making expert consultation mandatory by changing the wording from 'may' to 'shall' in the regulation. They also request more flexible conflict of interest policies to allow niche experts with industry ties to participate.
This would ensure medical societies have a guaranteed role in selecting clinical experts.
Transparency advocates lose if conflict of interest rules are weakened for industry-linked experts.

Consultation response

Associazione delle Imprese del farmaco, 2 Apr 2024

Farmindustria, associazione italiana delle imprese farmaceutiche, in linea con la posizione EFPIA, sostiene il Regolamento UE su HTA che ha il potenziale di accelerare e migliorare l'accesso per i pazienti e di ridurre inefficienze e duplicazioni. LItalia si posiziona fra i primi Paesi per numero…

Consultation response

France Assos Santé, 2 Apr 2024

France Assos Santé, which brings together around 100 patient and healthcare user associations, has closely followed the process of setting up joint clinical assessments of medicinal products (JCA) at EU level with the adoption of Regulation (EU) 2021/2282. It has supported from start a strong…

Consultation response

Hellenic Association of Pharmaceutical Companies, 1 Apr 2024

The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to patients as well as reduce inefficiencies and duplications, goals that the pharmaceutical industry shares. The EU HTA…

Consultation response

European Public Health Association, 29 Mar 2024

EUPHA, with EUPHA-HTA Section, welcomes the opportunity to provide input. A comprehensive implementing act free of ambiguity and arbitrary interpretations is a key step to inform MS how to prepare for the HTAR implementation, as well as for transparency and accountability in the interest of public…

Consultation response

Kassenärztliche Bundesvereinigung, 2 Apr 2024

The German Association of Statutory Health Insurance Physicians (KBV) comments on the draft implementing regulation - Ares(2024)1703728 as follows: Article 9 (3) and Article 10 (1): The renewed involvement of patient representatives and clinical experts following the consolidation of the assessment…

Consultation response

Digestive Cancers Europe, 2 Apr 2024

Digestive Cancers Europe (DiCE) is a European umbrella organisation with close to 40 national members, representing patients with digestive cancers. DiCE would like to suggest the following improvements to the DRAFT text: 1. Embedding patient involvement into entire JCAs is essential to its…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 2 Apr 2024

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We bring together 45 national associations from 26 countries and channel their knowledge…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 28 Mar 2024

The introduction of the Joint Clinical Assessment is intended to improve the availability of innovative therapies in the EU, reduce the bureaucratic burden for HTA authorities and health technology developers and should aim to achieve the highest level of quality of the assessment. Germanys…

Consultation response

European Multiple Sclerosis Platform, 2 Apr 2024

The EMSP welcomes the integration of patient involvement (PI) in the process, recognising its pivotal role in providing valuable information into patients experiences with the disease, its impact on various aspects of life and their preferences. However, we believe there is a necessity to…

Consultation response

European Forum for Primary Care, 2 Apr 2024

EFPC welcomes the opportunity to provide input on HTARs implementation on JCAs for medicinal products. An implementing act must always be consistent with the procedural as well as substantive requirements set forth in the basic act. Therefore, clarity in the preamble, particularly in cases of…

Consultation response

ASOCIACIÓN NACIONAL EMPRESARIAL DE LA INDUSTRIA FARMACÉUTICA, 2 Apr 2024

The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to innovative therapies for patients as well as reduce inefficiencies and duplications, goals that the pharmaceutical industry…

Consultation response

Asociace inovativního farmaceutického průmyslu/ Association of Innovative Pharmaceutical Industry, 2 Apr 2024

The EU HTA Regulation represents step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to patients as well as reduce inefficiencies and duplications, goals that the pharmaceutical industry shares. The EU HTA Reg. is…

Consultation response

Thalassaemia International Federation, 29 Mar 2024

The Thalassaemia International Federation welcomes the draft Implementing Act on JCAs and the effort to define the exact role of patients. We firmly believe that patients should actively contribute to scoping, assessment and report review in a prominent manner, as per the Regulation and…

Consultation response

Forum of International Research and Development Pharmaceutical Companies, EIG, 27 Mar 2024

FarmaForum embraces HTA Regulation to fulfill the objectives of ensuring timely and improved access to medicines for patients, while also reducing inefficiencies and duplications across Europe. An inclusive and collaborative approach of all stakeholders in the process will enable the successful…

Consultation response

World Bladder Cancer Patient Coalition, 2 Apr 2024

The World Bladder Cancer Patient Coalition welcomes the first Implementing Act (IA) relating to Joint Clinical Assessments (JCA) and pursuant to Regulation (EU) 2021/2282 especially as it is aimed at clarifying the who, how, and when relevant stakeholders, including patients and patient…

Consultation response

Romanian Association of International Medicines Manufacturers, 2 Apr 2024

ARPIM, the Romanian association representing 28 of the most important international innovative pharmaceutical manufacturers operating on the Romanian market, strongly supports the ambition of the EU JCA process, especially as it has the potential to provide an uniform assessment level and,…

Consultation response

European Access Academy Faculty hosted by Vlerick Business School, 2 Apr 2024

The European Access Academy, EAA, is committed to support the successful implementation of the EU HTA regulation. The EAA Faculty would like to commend the Commission for drafting this first Implementing Act, IA. The implementation of the EU HTA Regulation will be an important step towards a…

Consultation response

Lymphoma Coalition, 2 Apr 2024

Lymphoma Coalition (Europe) appreciates the opportunity to respond to the open consultation on the draft Implementing Act on Joint Clinical Assessments. We firmly believe that patient input is essential when assessing the value of a new medicine. As such, we fully support processes that aim to…

Consultation response

European Federation of Statisticians in the Pharmaceutical Industry, 2 Apr 2024

EFSPIs HTA European Special Interest Group (HTA ESIG) is a group within the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI), a learned society representing over 2000 pharmaceutical statisticians in Europe. The EFSPI HTA ESIG provides a direct link to scientific and…

Consultation response

Irish Platform for Patient Organisations, Science & Industry, 2 Apr 2024

As IPPOSI, we welcome the opportunity to provide feedback on the EU consultation regarding Joint Clinical Assessments (JCA) for health technology. Our response underscores the crucial role of patient involvement and transparency in decision-making processes. We emphasize several key points:…

Consultation response

European Hematology Association, 2 Apr 2024

The European Hematology Association (EHA) welcomes the emphasis throughout the draft Implementing Act on Joint Clinical Assessments on involvement of clinicians, patients and other relevant experts. Getting such involvement right will be crucial to ensuring that EU HTA contributes to better,…

Consultation response

Myeloma Patients Europe, 2 Apr 2024

Myeloma Patients Europe (MPE), a network of 52 myeloma and AL amyloidosis patient organisations across Europe, welcomes the opportunity to comment on the draft implementing regulation pursuant to Regulation (EU) 2021/2282 on health technology assessment (HTA). In the attached document, we…

Consultation response

ΕΛΕΑΝΑ, 31 Mar 2024

HELLENIC LEAGUE AGAINST RHEUMATISM/ELEANA welcomes the roles patients and other experts might have in defining the assessment scope, in providing input during the assessment, and in reviewing the JCA reports. HELLENIC LEAGUE AGAINST RHEUMATISM/ELEANA would like to highlight conditions of success…

Consultation response

PLATAFORMA DE ORGANIZACIONES DE PACIENTES, 29 Mar 2024

La Plataforma de Organizaciones de Pacientes - POP, acoge con satisfacción la publicación del proyecto de Ley de Ejecución sobre Evaluaciones Clínicas Conjuntas (JCA) de medicamentos, en la misma linea que lo hacemos de forma conjunta a través del European Patient Forum (EPF), entidad de la cual…

Consultation response

Asociácia inovatívneho farmaceutického priemyslu/Association of Innovative Pharmaceutical Industry, 28 Mar 2024

The success of the EU HTA Regulation is contingent on the ability of the system to deliver high-quality JCA reports which provide added value to national decision-makers. As such, the JCA process needs to: - facilitate early engagement with the health technology developer (HTD), to ensure a timely…

Consultation response

Associação Portuguesa da Indústria Farmacêutica, 27 Mar 2024

APIFARMA's contribution to JCA implementing act public consultation The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at the EU level and has the potential to accelerate and improve access to patients as well as reduce inefficiencies and…

Consultation response

Bundesarbeitsgemeinschaft Selbsthilfe von Menschen mit Behinderung, chronischer Erkrankung und ihren Angehörigen e.V., 27 Mar 2024

We comment the Implementing Act pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in the preparation and update of joint clini-cal assessments of medicinal products for human use at Union…