– Training session –
By Edith Klapwijk
Chairperson of BOPPI (Belgium PID patient group)
On 29 November I participated in a training session for Patients and Consumers interested in the activities of the European Medicine Agency (EMA).
The EMA and patient involvement
The EMA is the EU regulatory body responsible for the scientific evaluation and supervision of medicines developed by pharmaceutical companies for use in the European Union.
Its activities range from providing scientific advice for the development of medicines, through the evaluation of marketing authorisation applications for medicines and the coordination of European pharmacovigilance to the provision of information on medicines to patients and healthcare professionals.
Ever since its creation in 1995 the EMA has highlighted the importance of involving patients in their activities and procedures. Patients know about living with a disease. They are familiar with the needs of other patients and their family and they know what it is like to live with a disease on a daily basis.
They know how diseases are managed, what treatment options are on offer and what needs remain unmet. They also understand what would be realistically feasible in a clinical trial design.
The centralised authorisation procedure is rolled out in a number of scientific committees – in some of which patients act as full members – and supported by the EMA secretariat that is responsible for the interaction with patients and consumers.
The training session
In its effective hands-on approach, the training focused on the way patients are called upon to contribute to the different steps of the centralised procedure. We as participants (patient and consumer representatives), interacted in different workshops with the people responsible for these steps at the EMA. The steps range from pre-submission stage (information and advice to the requesting companies on their development plans), the evaluation stage (examination of the request) and the post-authorisation stage (follow-up and monitoring of the marketing process).
In preparation for the training, participants were given documents representing each of the different steps in the procedure and during the training we were invited to comment as we wanted, focusing on the practicalities of all aspects of the proposed medicines (clinical trial, feasibility of dosages and treatment, clarity and appropriateness of package leaflets, etc.).
Patients’ input was very assertive and relevant contributing to great discussions.