For how long after an event can a complaint be raised?


Occasionally a delegate on our training courses or a client will ask for how long after an event can a complaint be raised. The answer has always been that there is no specified limit, however, naturally over time and according to specific company records retention policies, evidence and indeed employee recollection diminishes, and thereby the ability to fairly respond reduces.


The ABPI Code states that companies must retain paper or electronic copies of certificates together with the material in the form certified and information as to whom it was addressed, the method of dissemination, and the date of first dissemination for at least three years after final use (Clause 14.6). The MHRA Blue Guide goes beyond this and considers that the minimum time that materials should be kept is a period of three years after either the last use of the piece, or the conclusion of any regulatory or self-regulatory action, whichever is later. They additionally note that 'companies should consider the need to retain material for a longer time if there are other reasons, particularly if there has been a safety concern or a complaint about advertising for the product'.

In Ireland the HPRA recommends that electronic or hard copies of material used with HCPs and/or patients or the public are kept for a minimum of three years after they have ceased to be used. The IPHA Code does not specify any period, leaving companies to form their own position.

Recently, the PMCPA published a case concerning the arrangements for a series of meetings that took place in New York in 2002. The case was raised following a 2019 BBC Radio 4 Broadcast and subsequent article on the BBC website "Doctors were used as 'guinea pigs' in opioid painkiller promotion" (https://www.bbc.com/news/health-48268030). 17 years after the meetings took place.

Aside from the details of the complaint, the respondent company submitted that its archive (unsurprisingly) did not contain any original documentation in respect of certified materials, and any relevant financial records were destroyed in 2013. In compiling their response, they had to rely on the memory of its ONE remaining employee who had some recollection of the programme. Based on this individual's recollections, the company was able to provide the PMCPA with some details about the meeting. In making their rulings, the Panel had to rely upon the "common ground" that existed between the matters raised in the complaint, the account of the delegate and the respondent company's submission. As could be predicted and is often seen in PMCPA case reports, "no breach of the Code" was ruled on some allegations due to the failure to "establish the case on the balance of probabilities", and there being "insufficient evidence before the Panel".

Whilst companies will not have to change their records retention policies in light of this case, this specific case is likely to have the longest lapse of time from the event to receipt of complaint in PMCPA complaint history.

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