Lymphoma Coalition
LC
Lymphoma Coalition, a worldwide network of patient groups with a full or partial focus on providing support to patients with lymphoma, was formed in 2002 and incorporated as a not for profit organisation in 2010.
ID: 809500545743-75
Lobbying Activity
25 Jun 2025
Lymphoma Coalition (Europe) welcomes the opportunity to provide feedback on the draft implementing regulation on Joint Clinical Assessments (JCAs) on medical devices and in vitro diagnostic medical devices (IVDs). Medical devices and IVDs are vital to diagnosis and effective treatment of lymphoma and play an essential role in precision diagnostics, treatment planning, and monitoring disease progression. The availability of medical devices and IVDs profoundly shape the patient diagnostic and therapeutic experience. In relation to lymphoma and chronic lymphocytic leukaemia (CLL), accurate diagnosis, subtyping, prognosis, and monitoring are dependent on timely access to high-quality IVDs and imaging technologies. These tools are foundational to lymphoma care and treatment. Any delays or variabilities in access to diagnostics are substantial, directly impacting treatment decisions and affecting patient outcomes. It is important that the evaluation of the IVD consider more than the analytical and clinical validity. The role of the IVD in the diagnostic-treatment pathway can determine treatment intensity as well as potentially inform variable value based on treatment availability, such as predictive biomarkers for targeted therapies. Additionally, it is imperative that JCA administrative processes and mechanisms do not unduly burden stakeholders from the patient community. Consistent, structural and systematic involvement of patient organisations and patient experts requires meaningful and concise involvement in early scoping, definition of PICOs, and prioritisation phases to effectively ensure clinical and real-world value. Further, it is essential that efficient and effective mechanisms fully support robust and timely engagement for patient input to address and integrate the practical challenges and real-world complexities associated with diagnostics, therapies and innovation. Implementation guidance and processes are critical factors as access to diagnostics is often a precondition for efficient care and treatment access. Patient input is vital to addressing unmet needs, including accessibility to advanced diagnostics across Member States. Without efficient coordination and guidance, the risk for JCAs to further reinforce existing disparities, especially where diagnostic capacity is inconsistent or lacking, cannot be overlooked. In closing, Lymphoma Coalition remains committed to ensuring the voice of patients with lymphoma are effectively represented in consultative processes and express our appreciation for the opportunity to respond and for the consideration given to our feedback. Thank you.
Read full response25 Nov 2024
Lymphoma Coalition welcomes the publication of the draft Implementing Act on the joint scientific consultations on medical devices and in vitro diagnostic (IVD) medical devices. We value the opportunity to engage in the process as medical devices and IVDs are fundamental to supporting precise diagnosis and effective treatment of lymphoma and play an essential role in precision diagnostics, treatment planning, and monitoring disease progression, in addition to having a direct and significant impact on clinical decisions. Increasingly, patients serve as stakeholders in their respective care. While transparent communication about the evidence base for medical devices and IVDs is necessary, patients often lack clear information on the accuracy, limitations, or risks of diagnostic tools. To address this concern, it is imperative that patient representatives are actively engaged in discussions to enhance the clarity and transparency of evaluations, in addition to processes that ensure patient-facing summaries of device evaluations accompany all regulatory approvals. Further, the availability of medical devices and IVD profoundly shape the patient diagnostic and therapeutic experience. However, despite this, persistent disparities in access and reliability of diagnostic tools across regions contribute to inequitable care and disproportionately affect patients in less-resourced healthcare systems. We support the inclusion of patient-centered metrics (such as accessibility, ease of use, and interpretability in consultations) in addition to the integration of patient-reported outcomes and quality of life metrics into device evaluation criteria to ensure real-world applicability. We believe the implementing regulation represents a pivotal opportunity to align medical devices and IVDs with patient needs in lymphoma care. We also fully support and call for greater emphasis on patient-centered outcomes as well as increased focus on addressing disparities in both access and quality. We also raise the significance of maintaining a culture that fosters transparency and promotes the values and directives associated with meaningful patient engagement. By adopting these measures, we believe the regulation can drive the development of tools that genuinely improve the lives of lymphoma patients across Europe. In terms of our feedback to the public consultation, we are pleased to highlight the following for review and consideration: With respect to Article 3: Submission of Requests: while the provision for submitting requests for joint consultations will help to align device development with patient needs, no explicit mechanism is outlined to ensure the involvement of patient organisations. We propose a requirement for developers to consult patient organisations be integrated during consultations to ensure that devices are developed with real-world challenges in mind. Regarding Article 6: Selection of Individual Experts: we note that criteria for selecting experts addresses technical expertise however, it does not explicitly prioritise patient representation. We propose that the documentation specifically include patient representatives as experts, ensuring that their input addresses the practical challenges, including delays in diagnosis or the burden of invasive procedures. In response to Article 7: Professional Secrecy Obligations: as protection of confidentiality is essential, the regulation should clarify how transparency will be balanced with this obligation. We recommend the development of a framework or processes to capture insights from consultations to further foster trust and inform broader advocacy efforts. As addressed in Article 8: Briefing Package, although the requirement for a standardised briefing package is well received, it lacks specific provisions for patient-centered data. We recommend a mandated inclusion of patient-reported outcomes (PROs) and/or quality-of-life metrics in the briefing package and further data...
Read full responseResponse to Health technology assessment – Cooperation with the European Medicines Agency
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), pursuant to Regulation (EU) 2021/2282. We firmly believe cooperation and the timely and effective exchange of information are essential factors, fostering and enabling continued transparency, constructive collaboration, synergy, and the complementarity of streamlined processes between the EMA and EU HTA. We wish to emphasise the need for additional clarification on how recommendations of experts by EMA will be considered by both the HTA Secretariat and subgroups, as we strongly believe clarity will help to further ensure and support effective and robust patient engagement. Additionally, we draw attention to the essential need to ensure the inclusion of patient organisations as recommended experts by EMA. We know that the involvement of patient organisations is critical to HTA processes. Further, as patient organisations effectively represent the broader collective patient voice, we recognise their ability to support enhanced dialogue within the patient community with respect to health technology assessment. Respectfully, we also wish to raise our concern regarding the potential risk of duplication in relation to efforts between EMA and the HTA Secretariat. More specifically, the risk that duplication of efforts may contribute to and/or lead to delays in patient access to crucial medicines. We recommend that to avoid duplication, existing procedures established and implemented by the EMA be leveraged to support practices and ensure that streamlined processes are adopted. Further, we propose close alignment of HTA secretariat procedures for identifying experts - especially patient experts - with established EMA practices as we believe this supports the adoption of processes and enhances expertise in JSC and JCA consultations. Finally, it is our position that the safeguarding of patient information and confidentiality is of critical importance and must be protected. We strongly advocate for strict measures, best practices and protocols that ensure data sharing occurs only with patient consent; that information is shared based firmly on criteria and guidelines that establish the protocols and clearly address the necessity of sharing or disclosing information amongst the EMA, HTA Secretariat, and the Member State Coordination Group on HTA.
Read full response26 Jun 2024
The Lymphoma Coalition (Europe) remains committed to advocating for a robust and transparent conflict of interest policy that ensures the integrity of the HTA process while promoting meaningful patient involvement. Lymphoma Coalition (Europe) appreciates the opportunity to respond to the Public Consultation on the EU HTA Implementing Act on Conflict of Interest (CoI). We welcome and support the procedural rules that establish clear avenues for the involvement of patient experts while upholding the clinical effectiveness and safety of new health technologies. To ensure a robust and inclusive process, significant areas in the draft procedural rules must be considered and addressed. We have thoroughly reviewed the draft procedural rules and identified several key areas that require attention to achieve a robust and comprehensive framework. In the document attached, we present strategic recommendations to further enhance the transparency, inclusivity, and efficacy of the patient experts' conflict of interest management process within the HTA framework. Our strategic recommendations are intended to complement our previous submission, addressing additional key areas and proposing actionable steps to strengthen the current procedural rules.
Read full responseResponse to Health technology assessment - Joint clinical assessments of medicinal products
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 achieve robust patient participation early in the process. While we understand there are challenges that may impede and/or affect the degree of patient involvement and that those may vary amongst patient, patient representatives, and civil society (patient organisations), this should not adversely affect patient involvement at key intervals or stages, including the scoping, assessment, and review phases. We acknowledge that data collected from a broader representation of the patient population oftentimes presents the most convincing and representative input from the patient community. We hold the expertise, experiences, and contributions of the patient community patients, patient representatives, and patient organisations - in the highest regard. However, we also appreciate that patient representatives and/or patient organisations may have greater access to population evidence-based data, and that access to data may be a key factor in equipping them to represent broader and more extensive patient data that matches the indication for which the JCA is being held. In this regard, we believe it is of critical importance to ensure all patients, patient representatives and patient organisations have clear and precise direction and clarity when providing input, whether it be from patients living with a condition who represent themselves or those patient representatives and/or patient organisations that represent the broader patient community. This is of relevance given that lived experience is individual and by nature, not likely to be representative of the broader patient population. We believe it is both timely and relevant to ensure that patients are fully reflected in relevant processes, practices, and/or protocols to ensure consistent involvement. Additionally, we recognise that patient involvement may be adversely impacted as a result of existing processes and other underlying factors, such as complexities of language or language issues, and increased demand on capacity or resources. We also understand that a lack of reciprocal communication with the patient community is detrimental. We support actions that ensure the patient community receives ongoing, timely and relevant communication to achieve standardised patient involvement. We strongly suggest consideration be given to accessing some of the current best practices and governing processes currently in use that may be of value for instance, the international Summary of Information for Patients (SIP) template that helps to develop a consistent information resource to support patient and patient group input to HTA. We understand that patient involvement varies (and will continue to vary) significantly across Europe, and that countries experience differences in relation to HTA processes. While some countries offer patient groups a more central role in the HTA assessment process, allowing that the experiential knowledge of physicians, healthcare providers, regulators and patients are wisely reflected during the decision-making, we are acutely aware that other countries do not. We have extensively mapped HTA systems and processes worldwide with key findings demonstrating that variances can be significant. For instance, some countries include the systematic collection of patient insights (primarily through well-structured surveys and the inclusion of patient representatives in formal meetings) while others might leverage real-world evidence yet have minimal involvement in the JCA. We understand that the Implementing Act on JCA provides some details as to how the PICO assessment scoping will take place, however, information in this regard remains unclear.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
Lymphoma Coalition response on the Pharmaceutical Legislation Consultation Lymphoma Coalition (LC) is a global network of patient organisations focused on providing support to those affected by lymphoma, including chronic lymphocytic leukaemia (CLL) for over two decades. It was clear there was a need for lymphoma patient organisations to share resources, best practices, policies and procedures to the point where there are now over 90 member organisations from 55 countries. LCs current strategy remains focused on ensuring impact within two key pillars: information and advocacy. Our membership embraces patient organisations and advocates who have expertise in patient empowerment and community engagement, producing patient-meaningful information and advance health literacy, policy, regulatory issues, advocacy and research. To learn more about the overarching vision and mission, please visit: Vision & Mission Lymphoma Coalition. LC welcomes the revision of the EU pharmaceutical legislation, and would like to see implemented processes to guarantee patient involvement in the regulatory and decision-making processes. The pharmaceutical legislation should serve the patients, by improving timely and equitable patient access to affordable, effective, high-quality and safe treatments, that better address the medical and non-medical unmet needs, and ensuring the objectives of availability, access and affordability of medicinal products in Europe. LC, in response to the open consultation, emphasizes the key points explained in the document attached for consideration.
Read full response