On the 25th of November, ECPC Board Member Rafal Swierzewski and Projects Officer Kalliopi Christoforidi attended a Patient training session at the EMA in London. The objective of this training day was to give patient and consumer organisations’ representatives an overview of the evaluation and post marketing surveillance of the medicines in Europe. Information on Scientific Advice procedures, SAGs meetings and the role of patient involvement within the EMA was also part of the agenda.

ECPC is pleased to share with you a report with the most important points raised during the training:

The European Medicines Agency (EMA) involves patients and patients’ representatives as critical stakeholders in the regulatory process to incorporate their views and their knowledge throughout the long process of developing, assessing, licensing and monitoring medicines.

One of the most important ways patients can contribute to both pre- and post-licensing development of medicines is by sharing information derived from their use of medicines. This is particularly important post-authorisation, where sharing data over long periods of time and across a more varied population can help to understand benefit – risk in a real world context.

As part of the evaluation process, the Committee for Human Medicinal Products (CHMP) commonly convenes Scientific Advisory Groups (SAGs), to allow it to benefit from specialist advice where the Rapporteur and Co-Rapporteur, the two members charged with leading the evaluation, have come to different conclusions, or where there are other difficult or controversial issues to be addressed. Patient representatives are commonly involved as members of SAGs (over 80% in 2013).

In 2012 the EMA’s newest scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC) came into being, embodying new European legislation designed to improve the reporting and assessment of medicines safety before and after licensing. Although the EMA had previously begun to involve patients in the process of safety assessment, the formation of the PRAC allowed the patient role to be formalised, with a patient representative and alternate sitting as full members of the Committee. As a result, patients are now fully involved with the difficult assessments of benefit-risk that sit at the heart of the regulatory process. Patient organisations are often consulted by the CHMP for advice on matters of benefit-risk, and their input has sometimes resulted in significant changes to the CHMP’s views. Click here to read and download the full document. 

Adverse Drug Reaction (ADR) reporting – info for patients.

Patients have the right to report unwanted side effects of medicines directly to the authorities. Caregivers are also allowed to report a side effect on belalf of a patient, for instance a child or a relative. Click here for the EMA’s general information of ADRs reporting.

If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.

You can usually report side effects by filling in an online form or with the help of your doctor or local pharmacy. For more details, and to report online, please check the website of your national authority. Click here to ensure that you are reporting to the appropriate website.