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World Bladder Cancer Patient Coalition

WBCPC

Our mission is to improve the lives of those affected by bladder cancer globally and to foster cooperation among bladder cancer organizations globally and with all related and appropriate organizations.

Lobbying Activity

Response to Health technology assessment - Joint clinical assessments of medicinal products

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 organisations, shall be involved in the JCA process. The importance of patient involvement to inform decision-making is well recognised. Involving patients in the HTA process can enhance transparency, legitimacy, and fairness. Importantly, patients have first-hand experience of living with a condition so can provide unique information and insights on the impact it has on their daily lives and on the risks and benefits of treatment. We applaud the introduction of Art. 8, as it addresses specifically the consultation of stakeholder organisations versus individuals during the JCA. However, the IA should clarify the difference between individual and organisation inputs and when one or the other should be involved in the JCA. We strongly believe that organisations should be involved in the process, as they are representative of a community more than just an individual and can express collectively information gathered via surveys or focus groups about the side effects or benefits of a specific medicinal treatment. The organization can also support the process with more than one individual expert. Patient experts and organisations need a baseline of timely, clear, and accessible information on the treatment and decision-making problem they are being asked to address. Therefore, the draft regulation should specifically incorporate the provision of a plain language summary of the technology being assessed, that covers relevant information to support input from patient experts and organisations. This should be made available early in the process and included under article 8 or 9.
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