Myeloma Patients Europe
MPE
Myeloma Patients Europe (MPE) is an umbrella organisation of myeloma and AL amyloidosis patient groups and associations from across Europe.
ID: 514101642770-73
Lobbying Activity
25 Nov 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 medical devices and in vitro diagnostic medical devices. Overall, we commend the European Commission for its commitment to involve patient experts and patient organisations in carrying out JSCs on medical devices and in vitro diagnostic medical devices. We would like to draw attention to some concerns regarding the lack of clarity for the involvement of patient experts and patient organisations, namely: 1. In the case of JSCs which will take place in parallel with the scientific advice on medical devices by the European Medicines Agency (EMA), there is a real possibility that the same experts might be called to provide information in both procedures. This possibility would be stronger in the case of rare/ultra-rare diseases which have a small pool of available experts. In this case it would be critical for the expert that both EMA and HTA Secretariat would be aware of this fact and ensure that the expert would have enough time to reply to both. 2. Aside from clearer timelines, more support from the HTA Secretariat could be provided to patient experts in terms of ensuring they understand the selection and engagement process, including the stipulations of the confidentiality agreement detailed in Article 7, and being offered training on the use of the HTA IT Platform. 3. While we welcome the potential involvement of stakeholder organisations to be consulted by the JSC Subgroup on the medical condition and therapeutic area (Recital 12 and Article 12(1)), we are concerned that very strict timelines might limit this involvement in practice. Many patient organisations have small teams and thus might have low capacity to reply to short notice requests. It would be very useful for these organisations to be informed of their potential involvement as early as possible. 4. In the case of the selection of patient experts (Article 6 of this implementing act) and considering the Implementing Regulation on the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups, adopted by the European Commission on 25 October 2024, we remain concerned that the recruitment of patient experts for rare and ultra-rare diseases will remain difficult. We appreciate the emphasis placed on rare diseases as part of exceptional circumstances that would allow the inclusion of patient experts with conflict of interests if no other experts will be identified. But this inclusion remains very much exceptional as well as vaguely described. For example, would all conflicts of interests be treated as having the same importance? How much time will be given to the identification of experts given the tight deadlines for both JSCs and JCAs? 5. Moreover, in the light of European Medicines Agency (EMA)s planned new policy on handling of competing interests of scientific committee members and experts (Policy 0044), a coordination of Declarations of Interest between EMA and HTA Secretariat could avoid duplication and streamline the involvement of individual experts. 6. Lastly, patient experts could greatly benefit from feedback on how their input was used. This could improve their future contributions as well as building a better relationship between HTA bodies and patients. MPE remains committed to supporting the implementation of the HTA Regulation and remains available for any clarifications on the comments detailed above.
Read full responseResponse to Health technology assessment – Joint scientific consultations on medicinal products for human use
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 JSCs to be well-described. We commend the European Commission for its commitment to involve patient experts and patient organisations in carrying out JSCs. We would like to draw attention to some concerns regarding the lack of clarity for the involvement of patient experts and patient organisations, namely: In the case of JSCs on medicinal products which will take place in parallel with the scientific advice on medicinal products by the European Medicines Agency (EMA) as stipulated in Article 11 of this implementing act, there is a real possibility that the same experts might be called to provide information in both procedures. This possibility would be stronger in the case of rare/ultra-rare diseases which have a small pool of available experts. In this case it would be critical for the expert that both EMA and HTA Secretariat would be aware of this fact and ensure that the expert would have enough time to reply to both. While we welcome the potential involvement of stakeholder organisations (Recital 9 and Article 11(1)), we are concerned that very strict timelines might limit this involvement in practice. Many patient organisations have small teams and thus might have low capacity to reply to short notice requests. It would be very useful for these organisations to be informed of their potential involvement as early as possible. In the case of the selection of patient experts (Article 5 of this implementing act) and considering the Implementing Regulation on the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups, adopted by the European Commission on 25 October 2024, we remain concerned that the recruitment of patient experts for rare and ultra-rare diseases will remain difficult We appreciate the emphasis placed on rare diseases as part of exceptional circumstances that would allow the inclusion of patient experts with conflict of interests if no other experts will be identified. But this inclusion remains very much exceptional as well as vaguely described. For example, would all conflicts of interests be treated as having the same importance? How much time will be given to the identification of experts given the tight deadlines for both JSCs and JCAs? In the case of the HTA IT Platform, while a secure dedicated platform for exchanging information is greatly welcomed, many patient experts might require training to learn how to use it properly, as well as additional training to grasp the stipulations of the confidentiality agreement as described in Article 6 of the present implementing act. MPE remains committed to supporting the implementation of the HTA Regulation and remains available for any clarifications on the comments detailed above.
Read full response26 Jun 2024
Myeloma Patients Europe would like to thank the European Commission for the opportunity to comment on the draft of the second implementing act of the health technology assessment (Regulation 2021/2282) focusing on procedural rules for assessing and managing conflicts of interest. We commend the European Commission for its commitment to the involvement of patient experts throughout the Regulation. In this spirit, we express concern over what we consider overly restrictive procedural rules for managing conflicts of interests. While we support the need for transparency, impartiality and independence, we worry that an overly strict approach to conflicts of interests might lead to serious difficulties recruiting patient experts to participate in assessments and thus jeopardise patient involvement overall. We have attached a document with detailed additional feedback.
Read full responseResponse to Health technology assessment - Joint clinical assessments of medicinal products
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 specifically provide feedback on the proposed patient expert and patient organisation involvement in joint clinical assessment (JCA) process. In particular, we would like to see (1) stronger wording on patient involvement (e.g. reduce instances of may invite and improve to will invite etc) (2) clearer timelines on patient involvement, how they will be supported and the method of involvement at each stage (3) clarity on the involvement of patient organisations, how we can provide support to patient experts and what we will be asked to comment on (ensuring this is meaningful) (4) better alignment between patient expert involvement in EMA and JCA processes and (5) provision of lay summaries to patient experts to ensure they have the information needed to comment effectively. MPE welcomes the incorporation of patient involvement into the implementing act, and we look forward to continuing our involvement in these discussions through the EU HTA stakeholder network.
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