European Access Academy Faculty hosted by Vlerick Business School
EAA Faculty
The European Access Academy (EAA) was founded in 2021 with the aim to support a successful implementation of the EU HTA Regulation.
ID: 261420248809-37
Lobbying Activity
21 Nov 2024
Evidence requirements within the European Union for innovative Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDs) are subject to fundamental change. With the Medical Device Regulation (MDR) 2017/745 greater emphasis was put on clinical evidence to substantiate safety and efficacy of innovative procedures. The EU HTA Regulation (EU HTAR) 2021/2282 builds upon the MDR and specifies comparative evidence requirements for certain class IIb and class III MDs. The European Access Academy (EAA) would like to provide several comments regarding the draft Implementing Act on JSC for Medical Devices (IA MD JSC): 1) Allow for involvement of Notified Bodies (NBs) in the (parallel) JSC process. The IA MD JSC does not include any reference to the role of NBs in the evolving JSC process. However, considering the important role of NBs e.g., in the conformity assessment procedures it seems important that NBs may join those parallel JSC processes. Also, in order to reduce administrative burden and avoid duplication of effort, respective clinical and technical information supporting the JSC may be shared with the NBs. NBs should also have access to the IT platform and should be invited to the meeting with the Health Technology Developer (HTD). 2) Ensure planning for sufficient MD JSC capacity to allow for informed HTA clinical development programs. Sufficient capacities on the side of the Coordination Group (CG) are required to address the advice needs from HTDs. Without the opportunity of a prior MD JSC a HTD is lacking the opportunity to explore if the envisioned clinical trial design aspects meet the requirements of a respective JCA for the planned indication. 3) Ensure sufficient JSC request periods and revisit JSC selection criteria. Leveraging the full potential of the MD JSC instrument to ensure optimization of HTDs clinical development programs would require a considerable increase of request periods or the establishment of continuous / rolling request opportunities. Also, the EAA Faculty kindly suggests that all requests from HTDs will be selected for MD JSC. Any decline of a HTDs advice request might have negative implications on the acceptance and relevance of the JSC instrument overall and might have implications for companies competitive clinical development programs. 4) Strengthening the inclusion of relevant stakeholder organisations (IA MD JSC, Articles 6, 11, 12). Considering the relevance of an inclusive civil society dialogue for the successful implementation of the EU HTAR, the EAA Faculty suggests a modification of article 6, 11, and 12 of the IA MD JSC to strengthen the inclusion of relevant stakeholder. Therefore, the HTA secretariat, with support of the stakeholder network, shall identify suitable stakeholder organisations, shall compile a respective list, and shall provide the MD JSC subgroup with that list while the MD JSC subgroup shall make the final selection of stakeholder organisations to be consulted during a MD JSC. Involved stakeholder organisations should also be invited to attend the meeting with the HTD according to article 13.1 of the IA MD JSC. 5) Clarification that MD JSC outcomes will be given due consideration in a subsequent JCA. Article 14 of the IA MD JSC provides some detail on the MD JSC outcome document. It should be specified in the outcome document that the consultation is aimed to inform a subsequent JCA process, and that the MD JSC outcomes will be given due consideration in the JCA. 6) Reducing administrative burden for participating individual experts. As previously mentioned in EAAs comments to the Conflict of Interest Implementing Act, reduction of duplication of effort is aimed for in the EU HTAR. Acceptance of mutual EMA/ EU HTA Declarations of Interest seems an appropriate means to reduce administrative burden and should be covered in the IA MD JSC.
Read full responseResponse to Health technology assessment – Joint scientific consultations on medicinal products for human use
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 the likely evidence requirements of a subsequent joint clinical assessment(JCA). JSCs shall in particular concern all relevant clinical study design aspects, or clinical investigation design aspects, including comparators, interventions, health outcomes and patient populations . The European Access Academy (EAA) is committed to support the successful implementation of the EU HTAR . Considering the critical importance of the JSC process for overall success of EU HTA the EAA Faculty would like to provide several scomments regarding the draft implementing act on JSC (IA JSC) . Further details and suggested changes of wordings are provided in the attached document: 1) Ensure planning for sufficient JSC capacity to allow for informed HTA clinical development programs. In order to fulfill the JSC principles that are laid down in article 16 of the EU HTAR sufficient capacities on the side of the Coordination Group (CG) are required to address the advice needs from Health Technology Developers (HTDs). 2) Ensure sufficient JSC request periods and revisit JSC selection criteria At least 6 periods per year or continuous / rolling request opportunities seem mandatory to realistically match dynamics of clinical development programs. Also, any decline of a HTDs advice request might have negative implications on the acceptance and relevance of the JSC instrument overall and might have implications for companies competitive clinical development programs. 3) Strengthening of inclusion of relevant stakeholder organisations (IA JSC, Article 11) Considering the relevance of an inclusive civil society dialogue for the successful implementation of the EU HTAR, the EAA Faculty kindly suggests a modification of article 11 of the IA JSC in line with article 5, to strengthen the inclusion of relevant stakeholder organisations in addition to the involvement of individual subject matter experts. Therefore, the HTA secretariat, with support of the stakeholder network, shall identify suitable stakeholder organisations, shall compile a respective list, and shall provide the JSC subgroup with that list while the JSC subgroup shall make the final selection of stakeholder organisations to be consulted during a JSC. Involved stakeholder organisations should also be invited to attend the meeting with the HTD according to article 12.1 of the IA JSC. 4) Clarification that JSC outcomes will be given due consideration in a subsequent JCA Article 13 of the IA JSC provides some detail on the JSC outcome document. It should be specified in the outcome document that the consultation is aimed to inform a subsequent JCA process, and that the JSC outcomes will be given due consideration in the JCA. 5) Leveraging synergies across EMA and EU HTA Scientific Consultations As previously mentioned in EAAs comments to the Conflict of Interest Implementing Act , reduction of duplication of effort is aimed for in the EU HTAR. For example, leveraging available lists of relevant individual experts and stakeholder organisations, acceptance of mutual EMA/ EU HTA Declarations of Interest, and provision of further procedural details on Joint EMA/ EU HTA scientific consultation should be covered in the Implementing Act. Finally, the EAA faculty would like to thank the Commission for the opportunity to comment on this draft Implementing Act. Further details and suggested changes of wordings are provided in the attached document:
Read full response25 Jun 2024
EAA Commentary to Draft Implementing Act on Conflict of Interest (CoI) The European Access Academy, EAA, is committed to support the successful implementation of the EU HTA Regulation (EU HTAR). The EAA Faculty would like to thank the Commission for the opportunity to comment on this draft Implementing Act (IA). The implementation of the EU HTAR will be an important step towards a European Health Union and will have a strong impact on the approach to evidence-based medicine across the union. Leveraging this perspective, and commenting on the draft IA the EAA Faculty would like to propose: 1) Avoidance of Duplication of Effort and Reduction of Administrative Burden 2) Balancing the Principles of Transparency and Expertise 3) Inclusion of all Sources of Conflict of Interest in the Implementing Act 4) Considering External Advice from Patient Associations and Clinical and Scientific Societies in addition to individual expert input e.g., on comparator selection Detailed comments and suggested changes of the wording of the Implementing Act are provided in the attached document.
Read full responseResponse to Health technology assessment - Joint clinical assessments of medicinal products
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 European Health Union and will have strong impact on the approach to evidence-based medicine across the union. Leveraging this perspective, the EAA faculty would like to suggest several comments (suggested changes of wordings are provided in the attached table): Articles 6, 10, and 14.3: There are two critical time points to ensure an early evidence - centric dialogue during the JCA procedure; the availability of i) the assessment scope proposal and ii) draft assessment report. The main concern of the EAA faculty regarding the published draft IA on JCA is, that draft PICO schemes and draft assessments are neither transparent to the public nor will there be opportunities for the public to comment. With the selection of patients and experts as suggested in Article 6 (and Article 14.3), an early evidence - centric societal dialogue is not possible. Experts are selected by the HTA secretariat in collaboration with the JCA subgroup. Additional Article: In line with the establishment of an early evidence - centric societal dialogue alongside each HTA assessment it is suggested to include a new article that encourages European patients, clinical and other relevant experts to share their perspectives with their respective national partner organisations in the EU Member states. Article 5: Appointment of an assessor and co-assessor by the JCA Subgroup should occur as early as possible. Furthermore, selection and evaluation criteria for the assessor and co-assessor should be made transparent. Article 9 should provide specification that the assessment scope proposal should be based on the principles of evidence-based medicine. Involvement of experts as defined in Article 9.1 should focus on organisations rather than individuals, and timelines and procedural details of member state feed-back require clarification. Article 11: The EAA faculty suggests that the scope explanation meeting should be standard procedure but may be omitted in case neither the JCA Subgroup nor the HTD request the meeting. Article 14: It is suggested to broaden the scope of the HTD review to allow for content-related comments and an oral explanation meeting. Sidelining the content competency in such a critical phase of the assessment will weaken the scientific credibility of the assessment. Article 16: If the joint clinical assessment requires re-initiation in line with article 17 of the IA it remains unclear if the draft assessment report will be available within the timeframe stipulated in the regulation, i.e., no later than 30 days following the Market Authorization. Article 18: The possibility to provide new relevant information that might result in an update of the clinical assessment should be opened up to scientific societies and patient associations. Various articles within the IA detail timelines of the scoping process, timelines for submission of relevant materials, timelines for JCA procedures etc. Partially, those timelines appear extremely ambitious. E.g. article 12,2 suggests a 90-day deadline for the submission of the dossier, which may even be reduced to 60 days.Considering the expectation regarding dossier completeness, the extent of information to be provided, and the challenge with multiple PICO schemes, the EAA faculty would like to point to the necessity to gather experience regarding the feasibility of those timelines. Finally, we would like to thank the Commission for the opportunity to comment on this draft Implementing Act. The EAA Faculty (Undersigning members of the EAA Faculty are provided in the attachment)
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