A contribution to our Thought Process by Dr. Malcom Barrett-Johnson, MD, Associate Partner, LSCP

Prescribing / Patient Information is a fascinating area and lends itself to significant change.
Three areas which may merit discussion are:

• In addition to the Patient Information Leaflet included as part of the packaging, Prescribing Information is used as you know on all marketing materials and an urgent need exists for version control in this area. Normally it’s left to the Medical Information Team to keep tabs on the version currently in use and this is of ongoing concern to both the Medical Affairs and Marketing Teams. This is increasingly the case with the granting of provisional licenses by the EMA- especially in oncology / orphan uses. Licenses are granted on the proviso of follow up safety data / Registry study outputs being supplied to the EMA in a narrow timeframe.
• This often necessitates rapid changes to the PI and Patient Information Leaflet based on the updated safety data, requiring on occasion the halting of distribution and destruction of current stock. The potential to rapidly turn around this additional data at both the Company and EMA level through the appliance of eCTD, could bring tangible benefits to both client Companies and patients, speeding the information available to medics / patients and limiting downtime between a safety signal being detected and the stock / labeling / marketing materials being updated, besides managing public opinion. At present huge discrepancies exist in the patient information provided in the US and EMA regions- that in the US being considerably more descriptive. It would in my view be of considerable worth to find out whether Companies feel that an upgrading of this information is inevitable in the EU to bring it in line with the US. As an output from a visioning process for a global labeling repository a competent audience may recommend to the FDA / EMA the level of information which should be included in the patient information, but This is very much to set the scene for discussion of the Global reach of eCTD in this area.
• Thirdly, the input of patients and what patients feel they need from medicines labelling. Patients form by far the greatest group affected by labelling and the information it provides. I know from personal experience that patient groups feel extremely strongly that their voice should be heard in discussions involving product labelling. I’m not advocating that patient groups should necessarily be invited, but the EMA has a remit to take account of patient’s viewpoints

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