7. Patients’ involvement in product information

Patients’ involvement in product information

As described above considerable information on medicines is directed specifically towards patients. For medicines authorised via the centralised procedure the EMA involves patients in the review of PLs and EPAR public-friendly overviews and in the preparation and dissemination of EMA safety communications.

All new PL, EPAR overviews and safety communications are systematically sent to patient organisations (PO) for comments. The purpose is to obtain feedback on whether the information is readable and understandable for the target population and that it fulfils the public’s needs in terms of information content. Such consultations have an impact on the informational material. EMA has reported that close to 50% of the comments are incorporated.

Each of the relevant POs nominates ‘contact persons’, who are recognised as EMA experts to review these documents. The EMA arranges training sessions for the nominated experts to prepare themselves.

Any organisation that proposes patient experts to review the above-mentioned documents must fulfil the Criteria to be fulfilled by patients’ and consumers’ organisations (EMA/MB/24913/2005 rev. 1) and be listed in the EMA’s list of “eligible organisations” on the EMA’s Patients and consumers’ webpage. The Rules of involvement of member(s) of patients’ and/or consumers’ organisations in committees related activities’ (EMEA/483439/2008 rev. 1) will apply. Patient experts should adhere to the same rules as all other experts participating in EMA activities, especially with regard to confidentiality. Since the documents to be reviewed are in English, experts should be fluent in English and they should
have access to appropriate information-technology equipment and to the Internet.

All documents subject for review are confidential (i.e. PLs, EPAR overviews and safety communication material) until they are made public. All experts must have signed a confidentiality undertaking at the time of being involved in the review.

The consultations need to be strictly controlled due to the timelines in procedures. For PL review the PO expert will need to respond within 10 days. The comments are considered by the EMA’s Working Group on Quality Review of Documents (QRD) and by the applicant, and are implemented as appropriate. In complicated situations, the PO may be requested by the EMA for a QRD sub group meeting. For EPAR overviews, the process is similar, including a 10-day deadline.

Safety communications may be especially urgent. In such a case, the relevant PO will be contacted in parallel with the EMA Committee for Medicinal Products for Human Use (CHMP) experts. When the draft communication is ready, it is sent to the PO. The deadline for comment from the PO expert will normally be 12-24 hours. In urgent cases, it may be even shorter, e.g., only 3 to 4 hours.