European Medicine Agency - EMA
If you have ever wondered what it takes for a medicine to get to be available for patients, EMA provides an answer in its new booklet “From laboratory to patient: the journey of a centrally authorised medicine“.
The European Medicine Agency – EMA, is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The booklet describes the steps of the centralised procedure used for the approval of medicines in Europe.This initiative aims to improve public understanding of how EMA procedures are run.
Patient involvement in the elaboration and authorisation of a medicine
EMA provides scientific advice even in the research phase, when developers can discuss all the aspects of creating a medicine, from scientific to legal.
EMA involves often the patients in the elaboration process of a medicine by inviting them to share real-life experiences related to the project and the addressed condition. This input is valuable for the developer as they can understand better how the medicine can respond to the possible issues and adjust where necessary.
The Agency assesses the information received from developers and determines whether or not the medicine is beneficial to and safe for the patients.
For example, EMA makes sure patients are included in studies which are representative enough of the population for whom the medicine is intended.
EMA informs that only in 2017, one in five scientific advice
procedures involved patients and the SAWP members considered that in almost every case (93%) patients provided added value to the scientific advice.
Therefore, if EMA decides to respond to the medicine developer in writing, patients are asked to provide comments; if EMA decides to meet with the medicine developer, patients are invited to attend.
In the evaluation phase, patients are involved as experts to provide their views whether the medicine can address their needs.
Even at a national and regional level patient get involved in the consultations related to the medicine, in the context of the national health system of the respective country. Based on the same, the national authority takes decisions about the pricing and reimbursement.
Once the medicine is marketed, patients provide side effects reports which are continuously assessed and monitored. A dedicated EMA committee is responsible of this monitoring an,dmakes sure that a quick reaction and action is implemented should any issue is detected, in order to protect the patients.
The booklet is available on the EMA website.