Patients’ role and contribution to safety communication

Since patients will be using medicines, it is important to incorporate their experience and knowledge at different stages throughout the process of developing, assessing, licensing and monitoring medicines [1] .

Previously, older and more paternalistic models of health practice often treated patients as a passive group who were to be given instructions but who should not be confused or worried by too much information. Although the best healthcare professionals have always recognised the importance of listening carefully to their patients, the idea that patients’ knowledge, views and preferences are as important as those of any other stakeholder was not a standard part of this model.

The involvement of patients and consumers in the review of package leaflets (PL) and in addition in summaries of the European Public Assessment Report (EPAR) is an example. This exercise was extended to also include the review of the EMA’s safety communications policy from 2010.

Patients’ organisations (POs) are now involved in many activities of EMA, including:

With regards to safety communication the procedure for review in short is described as follows.

Safety communications often relate to ‘referral’ procedures (in a referral, the EMA is requested to conduct a scientific assessment of the safety concern for the EU). The EMA communicates on safety referrals at different stages of the procedure and patient experts will be involved in the review of all related communications.

The procedure involves and implies:

  • short timelines with limited predictability for preparing safety communications
  • taking into account views of many stakeholders
  • ·multiple stages of review
  • input from internal and external experts
  • publication of finalised safety communication on the EMA website which may differ substantially from the initial draft reviewed.


4.1. Patient expert review

The purpose of the consultation and interaction between EMA and patients and consumers on safety communications is to ensure that the message to be conveyed is clear and comprehensible to its targeted audience.

Patient experts will be consulted at the same time as or after the CHMP Rapporteur/Co-Rapporteurs (experts nominated from the NCAs) and the documentation will be exchanged by secure e-mail (Eudralink system, a secure e-mailing system for the exchange of confidential documents).

The procedure is as follows:

  • Upon request from the expert, EMA will set up a Eudralink account for them;
  • When the EMA is aware of an upcoming safety concern, it will contact the selected organisation(s) requesting availability to review the related communication, indicating the expected timelines;
  • As soon as a draft document is available it will be forwarded to the selected expert(s), usually giving 12-24 hours to provide comments on the text, however in some urgent cases only 3-4 hours may be available for consultation;
  • The expert(s) are welcome to contact the EMA for further discussion or clarification on the specific issues and in some cases; particularly when timelines are tight, comments may be given via telephone;
  • The reviewer will receive a link to the final document at the time of publication for dissemination within the organisation and to any other interested parties - no confidentiality applies at this stage, as the document is published on the EMA website.

[1] EMA, Training Manual, Review of European Medicines Agency documents addressed to the general public by patients and consumers (24 November 2011, Rev. 4, EMA/115803/2007). Available at: Training Manual - Review of EMA documents addressed to the general public, by patients and consumers (