European Forum for Primary Care
EFPC
The European Forum for Primary Care was initiated in early 2005 by a group of interested parties from several countries.
ID: 181778123351-61
Lobbying Activity
Response to Health technology assessment - Joint clinical assessments of medicinal products
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 substantive changes or expansion of the basic act is key to safeguard transparency and the accountability. Informing Member States (MS) and all actors and stakeholders regarding key steps and roles for effective and efficient implementation necessitates avoiding generalisations or phrasing that may be arbitrarily interpreted. We consider there is substantial room for improvement in this drafting effort, incl. in the preamble, specific articles, and overall. Key examples pertain to the timing of the procedure in relation to the marketing authorisation procedure and how this may affect the essence of the basic act. Further elaborations are needed on the role, expertise and capacity of the Secretariat and Coordination Group (CG), on the timing of key procedural steps and to ensure sound governance, deliberative processes with stakeholder engagement. Art 3, Art 4 and Art 6 A very complex process, incl. in terms of exchanges between the Secretariat and the EMA, is set forth. There is lack of clarity in terms of coordination for this exchange. The parallel nature of assessing available data / evidence raises questions in terms of a potential duplicative nature. Furthermore these procedures require a high level of expertise in terms of regulatory science, sound regulatory project management support and clarity in terms of who is driving the procedure. Further elaboration is required in terms of the role, expertise, resources and monitoring mechanism for the functioning of the Secretariat and the CG. Art 6 Clarity is required in terms of how the list of experts is to be compiled, what form and prioritisation their input will have and, critically, how representativeness and legitimacy of representation. The same applies to ensuring the highest level of expertise will be ensured, whilst, of course, avoiding potential conflicts of interest. Art 9 and Art 18 Sharing the assessment scope with MS and then with patients, clinical experts and other relevant experts is not conducive to evidence-informed decision-making or, indeed, compatible with a patient-centred approach. An important technical challenge stems from Art 18 of the HTAR given how the PICO is to be established. This aspect would be better addressed during earlier stages, e.g., during the JSA, to avoid compromising scientific robustness and sound governance -let alone the timeliness- of the overall procedure. Art 10, Art 12 and Art 14 Clarity regarding the consolidation meeting given its timing. The regulatory clock proposed raises questions in terms of both the feasibility of timely interaction and steps (e.g., inclusion and adequate consideration of new clinical data), as well as mechanisms to reconcile diverging opinions. Furthermore, the ambiguous phrasing JCA Subgroup, via the HTA Secretariat -may- invite patients, clinical experts and other relevant experts to provide their input during a dedicated part of the assessment scope consolidation meeting further raises questions about whether this would be a final step for sound deliberation or a purely perfunctory one. Art 14, Art 20 and Art 21 Scientific independence and transparency are key to evidence-informed decision-making. It is critical to identify a sound and unambiguous policy to determine what truly represents Commercially Confidential Information (CCI) and what protected personal data (PPD). Policy 0070 (European Medicines Agency) should, therefore, be duly considered. Given the complexity of HTA, an effort is urgently needed across all levels of care, incl. primary, and in all MS to increase capacity and to improve expertise, not of simply the HTAR per se, but of the overall complex methods required to conduct HTA.
Read full responseResponse to A comprehensive approach to mental health
6 Feb 2023
The European Forum for Primary Care is pleased to read that the EU Commission takes mental health seriously and focuses on a comprehensive approach . We support and emphasise the problems described. EFPC offers some constructive feedback, mainly on the aims of this approach. 1. Rather than focussing on early detection of mental health problems, there is a wider need for normalizing mental challenges and support for self-directing and self-managing recovery. Special attention for refugees and people with severe mental problems and little social support, is more urgent. Focussing on early detection of mental disorders, keeping mental problems in a biomedical context, is in our view not a solution at all. We anticipate this could lead to further medicalisation of mental health and expansion of the larger mental health organizations, with a compromising reduction in the knowledge and understanding of recovery interventions. What we see in daily practice is a diminished attention for those people with mental health problems without solid ground for their livelihood security. We need many more facilitators in the neighbourhood to support the recovery and self-direction of target groups (especially young people, the very old and the refugee and migrant population). This brings us to the next comment. 2. We understand the need for policy change accordingly for mental health. But what we see is that a lot of money goes to the big institutes. Small hometown organisations truly supporting people with serious mental health problems and their recovery pathway are barely able to acquire financial resources. We advocate for a fair distribution of the EU money, with a significant proportion for service user-led research and the funding and of peer-support groups inside the capillaries of society. This will generate the non-stigmatised support that is needed and create communities that are built on a sense of societal support, advocacy and reciprocity. The last remark the EFPC wants to make is about stimulating the shift of the scientific paradigm on mental health issues. See our EFPC Position Paper Mental Health https://euprimarycare.org/wp-content/uploads/2020/12/EFPC-Position-Paper-Mental-Health-2020-DEF-1.pdf. If we focus too much on mental health problems, the social determinants of mental health stay invisible. If we continue to medicalize mental health problems, people remain dependent on professionals and the health care system. This is costly and undermines the self-direction of people with mental health problems. Mental health support then will be seen as "mopping the floor with the tap open".
Read full responseMeeting with Vytenis Andriukaitis (Commissioner) and
3 May 2018 · HTA
Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis) and European Social Network AISBL and
15 Sept 2016 · Primary Care