From the ethics committees to the tables of the regulatory agencies passing through the boards of the pharmaceutical companies that decide how to carry out clinical trials, there is an increasing need for 'expert patients' able to participate on an equal footing in the development process of innovative drugs. The European project Eupati (European Patients' Academy on Therapeutic Innovation) was launched to train them.
More than 100 patient organizations participated in the launch of the Italian 'Eupati National Platform' in Rome. 'I think your project is commendable - wrote the Minister of Health Beatrice Lorenzin in a greeting message - developing and disseminating objective, credible, correct and up-to-date information on drug research and development represents a very important tool for increasing ability and competence of patients”. And according to Filippo Buccella, chairman of the Italian 'EupatI National Liaison Team' (Nlt), "there would already be a need to have at least 100 'expert' patients in Europe but currently there are none".
The first European course with 50 enrollments, in which three Italian patients also participate, fortunately has already begun and will end in December, while enrollments for the second which will begin in June have just closed". The first hundred patients trained will be directly 'used' in the tables where their presence will be necessary, but a specific training kit is also being produced, translated into the seven main European languages, which will be made available to reach the widest possible audience. "It is no longer the era in which only doctors counted - said the Extraordinary Commissioner of the ISS Walter Ricciardi – the empowerment of patients has become fundamental”.
The general manager of Aifa Luca Pani also agrees. "Patient's Empowerment, a key principle of the Eupati project, is a fundamental tool to allow truly informed patients to exercise their rights and to be an integral part of the regulatory system - he says - Aifa has long been promoting the qualified involvement of patients in various phases of the surveillance approval of medicines, for example for a better pharmacovigilance system”. “It is sick people – explains Pani – who experience the undesirable effects of drugs on the front line (including the lack of efficacy) and it is important that they are given the opportunity to report them directly to the health authorities. An educational system in progress, such as the one we are building with Eupati, makes it possible to provide patients and their families with the possibility of acquiring useful notions relating to the drug regulatory process, from the clinical trial stage to the post-marketing surveillance phase. commerce, in order to be able to contribute effectively to decision-making processes in healthcare".
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The project is now entering its operational phase and through the Nlt has established an executive committee and a scientific board. The following are part of the board: Aifa, Ministry of Health, Higher Institute of Health, Farmindustria, Clinical Trials Center Un. Cattolica, Irccs Mario Negri, Fofi, Favo., Federanziani and Apmar. A collaboration has also been launched with Ispor Italy Chapter Rome which includes, among other things, the detection, evaluation and quantification of the possible impact of the project in terms of patient awareness and therefore also of adherence to therapies. While Stefano Vella, director of the Department of Medicines of the ISS underlines that the importance of the project "can be understood starting from an example with which I have been very involved, the antiretroviral therapy of HIV infection, in whose extraordinary history the patients and patient associations immediately had a prominent role - he explained - cultured and prepared they also knew how to guide research, check what was being done, criticize and make us readjust the shot; not to mention their role in the battle for universal access to care”.
