The European Patients’ Academy on Therapeutic Innovation (EUPATI) is launching a public consultation in order to review guidance for patient involvement in the medicines Research and Development process. The guidance is provided as three distinct frameworks:
- patient involvement with industry
- with health technology assessment (HTA) bodies
- with regulatory bodies
- a fourth on ethics committees to follow by the end of July
The frameworks have been developed in response to the increasing need to draw on the experience and specific knowledge of patients, and their day-to-day use of medicines, in order to improve medicines development and evaluation. The frameworks suggest approaches to allow structured interaction with patients, and thereby facilitate the exchange of information and constructive dialogue at national and European level where the views from users of medicines can and should be considered.
These three frameworks have already received feedback from a number of partners of the EUPATI consortium (including patient organisations) but further evaluation and feedback from patient organisations and other key stakeholders are essential in order to validate the guidance. The internal review resulted in some suggestions that require more discussion (applies namely to patient involvement with industry, but also with regulators). We specifically welcome further input on these by reviewers
If you have significant expertise and knowledge in patient interaction with industry, HTA, or regulatory bodies, please consider contributing to this review; please add your suggestions (in track change) and comments directly on the three documents at:
Once you have reviewed the documents, please forward them to the following address:
This public consultation will end on September 15. Following the consultation all comments will be carefully evaluated, and the guidance will be revised and released.
If you have any questions on the consultation process or on the documents, do not hesitate to contact Giorgio Barbareschi (Giorgio.firstname.lastname@example.org ).