IPPOSI welcomes the adoption by the European Parliament of a new regulation on Health Technology Assessment (HTA).
The assessment of innovative medicines, as well as of certain medical devices, medical equipment, and prevention and treatment methods, is changing in Europe with the recent adoption by the European Parliament of a new regulation on health technology assessment (HTA).
The regulation, entered into effect on January 12, 2022, represents an important commitment between Member States to increase cooperation around the review of clinical evidence during the health technology assessment (HTA) process, as well as around horizon scanning and scientific advice. Currently, national HTA bodies complete much of this lengthy and onerous work on an individual basis, resulting in significant duplication of effort and resources by governments, industry, and patients alike. The regulation offers a new, centralised approach and the potential to build greater collaboration between Member States within the HTA space in the future.
Our patient members hope that the regulation will address some of the many existing concerns around access, transparency, and involvement within the assessment process. From our interactions with our members, we understand that patients have repeatedly highlighted major challenges, such as differences in the treatment of evidence by national HTA bodies, the unpredictable timeframes for decision-making, and the poor consideration of patient evidence.
We call on all Member States, in implementing the regulation, to learn from best practices among national HTA bodies and to work to establish procedures and methods at the European level which adhere to the highest standards of assessment. It is important that governments and citizens have confidence in the new system and that quality, timely, person-centred outputs emerge from this joint endeavour.
Transparency around what recommendations are made and what evidence is used to inform these recommendations is essential, and this detail must be clearly and publicly communicated. To this end, joint clinical assessments and subsequent national assessment reports should be accessible, with minimum levels of redaction for commercial confidentiality, and complemented by shorter, explanatory lay summaries.
We urge Member States to view the regulation as an opportunity to innovate by increasing the involvement of patients both in the general governance of the new regulation, as well as across specific elements of the joint clinical assessment, horizon scanning, and scientific advice processes. We invite the Coordination Group to think carefully about how they can meaningfully include patients, especially as their work involves the critical elements of planning the programme of work and evaluating the work completed. Across the HTA process, both at the national and European levels, it is essential that Member States co-create with patients a framework or guidelines for their early, equal, and sustained involvement.
As the consensus voice of Irish patients in this area, we are focused on our own preparedness here in Ireland, and we encourage the Department of Health to:
- Review national HTA policies and processes for their compatibility with the letter and the spirit of the new regulation, in particular, the provisions for a single pan-European clinical assessment model
- Engage the Irish patient community in a dialogue around the procedures and methods proposed for the joint clinical assessment, horizon scanning, and scientific advice; and feed this perspective back to EUnetHTA and those tasked with finalising the governance and process arrangements
- Establish a national, multi-stakeholder advisory committee to inform national HTA reform in advance of January 2025, comprising of patient, science and industry representatives with an interest in horizon scanning, scientific advice, clinical assessment, non-clinical assessment, real-world evidence, and patient experience
- Ensure current national timelines are aligned with the EU process to minimise delays and commit sufficient resources and expertise to national HTA to allow Ireland to review joint clinical assessment reports, consider non-clinical factors, and make timely recommendations about new technologies apace with other Member States
- Consider the impact of greater cooperation in the area of assessment on existing joint cooperation in the area of pricing and reimbursement (such as Ireland’s participation in BENELUXA), and share findings with other Member States
A more efficient, predictable, administratively lean, and evidence-based HTA process is a worthy goal that many stakeholders can collectively get behind. As patients, we stand ready to support our national HTA bodies when and where we can. We ask that you engage with us in preparing for the implementation of this regulation in Ireland, and we ask that we use this opportunity to address shortcomings in our existing process so that Irish patients can be guaranteed equitable and timely access to the life-changing or life-saving technologies that they need to achieve the best possible health outcomes.
To download a copy of our response to the new regulation on health technology assessment and view some frequently asked questions, click here.