HTA systematically evaluates the relative effectiveness, cost-effectiveness and economic, social and organisational impact of health technologies on the lives of patients, healthcare systems and society. The relative effects of a technology or solution are compared to current practices.
HTA reports aim to inform decision-making on, for example, appropriate use, clinical guidelines or national/regional funding.
MedTech Europe welcomes advances in the assessment of medical technology innovations, and the appropriate rewarding of the value these innovations bring. The assessment of the value of medical technologies should take place using tools that are appropriate to the nature of the sector and its innovation model.
In specific cases, HTA can be used to assess a medical technology, for specific purposes and at specific times and implemented to address the specific country needs. This reflects the decentralised and localised market access model, well-suited for Member States’ decision-making.
MedTech Europe’s view on HTA
Fundamental guiding principles of HTA for medical technology and solutions in Europe today shall be: clear purpose of HTA, transparency of the process, appropriate timing and adaptive evidence profile.
At a European level, since years, cooperation in the field of HTA has been ongoing through European joint actions, and the HTA Network within the cross-border Directive to which MedTech Europe has actively participated. As of end of 2021, the Directive had been replaced by a Regulation introducing newly defined cooperation in the field of HTA (HTAR).
Our team supports the creation of an appropriate policy environment and initiatives that:
- Promote timely access to, and funding of, innovation.
- Enable accelerated and equal accessibility of innovative technologies.
- Enhance the use of innovative technologies in healthcare delivery healthcare, to contribute to more sustainable and resilient national health systems.
The road ahead
MedTech Europe will maintain an active role throughout the Regulation’s implementation phase (foreseen until 2025) and beyond. As a member of the Stakeholder Network, maintaining a strong voice will involve: interactions with the Coordination Group’s medical technology configuration and respective subgroups, as well as engaging in a dialogue with the EU Institutions and strengthening our relationship with relevant stakeholders.
MedTech Europe will uphold a strong participation in terms of EUnetHTA21 public consultations. Thus, we will continue to respond to EUnetHTA21 consultations in an attempt to foster an environment where, new methodologies and jointly build out proposals will arise.
At this time, particular focus will be given to the new EU Regulation on HTA. Key focus areas will include the newly defined cooperations such as: Joint Clinical Assessments, Joint Scientific Consultations and Identification of Emerging Innovations, where many open questions remain, and further work is needed if HTA cooperation in Europe is to truly deliver better-informed investment decisions and accelerated patient access to innovation. Hereby recognizing the specificities of medical technologies (medical devices, In-vitro diagnostics, digital and other technologies).
In our view, key factors of success are: securing high-quality expertise in the field of medical technology, building out dedicated methodologies and the involvement of Health Technology Developers (HTD) in the processes.
At all times, any assessment on health technologies, that is to have true value, will need to have a clear purpose and inform decisions of adoption and investment/funding. Equally important is to have no interference with other legislations, avoiding the risk of ambiguity and duplication.
MedTech Europe’s overarching aim is to make the latest medical technology innovations available to European citizens while mitigating the risk of: delays in access to technologies for patients and healthcare systems; an increased burden for the medical technology industry and deprioritising Europe, as a preferred market to innovate.