Understanding the Code of Practice
from Steven Gray Consulting
There have been a few complaints recently that representatives have breached the Code of Practice by sending e-mails to customers. This raises two questions: who does the Code consider to be a ‘representative’ and why did the e-mails breach the Code?
Be in no doubt whatsoever that, as far as the Code is concerned, any company employee who visits customers to promote medicines is a ‘representative’. This includes 1st line and (in some cases) 2nd line managers. It includes NHS liaison reps and those with Key Opinion Leader development roles. Depending on the circumstances, it could include company medics and scientists too.
The keys to whether the e-mail itself breaches the Code are the content and whether you have permission from the recipient. There are so many ways to breach the Code according to the content that it is impossible to list them all here. However, in general if you include the name of a medicine (or a disease area) or imply a benefit for the physician it is probably in breach. Several times: once because the content is considered promotional; once because it didn’t contain PI; and, finally, because it wasn’t certified. And if you did not have express permission from the recipient to communicate by e-mail, you are in breach again.
One way to minimise risk, of course, is to have pre-approved e-mail templates to use, for example, when you are inviting someone to speak at a meeting. You could also maintain a list of customers who have given you permission to use their e-mail addresses.
Of course, because you are storing e-mail addresses, all you need to do now is comply with the Data Protection Act!