Code of Conduct Alerts

May 2010 - UK

From 1^st May onwards BHBIA member companies must ensure that all newly initiated UK MR projects have AE processes in place that will be compliant with the ABPI's revised guidelines. The revised Guidelines were issued in November 2009 and take effect from 1^st May 2010.

The revised Guidelines contain several changes – one of them major. In brief, any event linked to a company’s drug needs to be forwarded whether or not a patient identifier is present.

When the UK AE Reporting Guidelines were first launched in 2007, market researchers were required to forward AEs that were cited in the context of an individual, identifiable patient, and events cited in groups of patients did not need to be forwarded (as an individual patient could not be identified). However, MHRA inspections have made clear that this level of AE collection does not go far enough. Consequently the ABPI issued revised guidance which states that in the UK, pharma companies and their legal agents e.g. agencies, must now forward all AEs that are cited in the context of any actual patient or patients whether or not a specific identifier is present. As a result AEs cited in groups of patients and aggregated patient data now also need to be forwarded whether or not specific identifiers are present.

For further information, see the BHBIA’s web-based AE Reporting Training Programme which has been updated and is available online through the BHBIA’s website to non-BHBIA members, as are the Guidelines - http://www.bhbia.org.uk/