00:00The implementation of the European regulation of HTA, which, as we know, was released in a European newspaper in 2021,
00:14but which officially came into force in January 2025,
00:21basically provides for a joint clinical assessment of some therapies,
00:30specifically oncological products and advanced therapies, as a pilot this year at the European level,
00:41and an assessment of non-clinical domains at the national level, therefore belonging to the Member States.
00:48There must therefore be a strong collaboration between the world of institutions, the world of developers,
00:55scientific societies and patient associations, so that the value of a sanitary technology can be put to the ground,
01:05according to the logic of HTA.
01:07The logic of HTA provides nine different perspectives, which essentially evaluate a new technology.
01:16One of the perspectives concerns the perspective of the patient, of the patient association.
01:21Therefore, a strong collaboration is required in the coming months,
01:28to be able to redesign the process of access and assessment of sanitary technologies in light of this regulation.
01:37At the same time, we are experiencing, and this is what has been released in the last balance sheet law,
01:47the establishment of a register at the Ministry of Health of the patient associations operating in the health world,
02:00so that their collaboration can be more synergistic in the policy institutions that will be requested
02:10and which will see a strong involvement from the world of institutions and patient associations.
02:18In addition, Agenas has also established a stakeholder network within the groundwork of the European regulation of HTA
02:27in the National Programme for HTA Medical Devices,
02:31a network of stakeholders where many patient associations have already made requests
02:38and which will somehow see an operational groundwork in the coming months.
02:47There are many, this year we are putting in place something that has started over the years,
02:56but also the regions, there are many regions that are activating the participant health.
03:01So basically at all levels we see a greater awareness of working synergistically with associations.
03:08It is clear that on the other hand there is a great need for training,
03:13awareness of technical skills to be able not only to bring the patient's perspective,
03:23and therefore the experience of the pathology of their experience,
03:26but to be able to dialogue on the technical skills as well as the other components that will be called in the decision tables.
Comments