Part eight: Mistakes
Steve Gray answers your questions about compliance with the ABHI Code of Business Practice and other industry codes that govern commercial activity.
Thank you for the suggestions we have received regarding future articles. Do please keep sending in your questions and comments.
Dear Steve:
What can you do if you have crossed the Code line through oversight, haste or just not knowing and want to make amends? What steps do you take to get back on track?
Steve says:
This is a great question. Quite often when we present at meetings, our consultants are 'taken to one side' by a representative and asked about such situations.
It is absolutely natural to worry if you think you have done something wrong. However, this is an area where honesty is absolutely the best policy.
Imagine a scenario where our representative for Lakeshore Diagnostics has told a hospital doctor it will be "no problem" to secure funding for a departmental meeting. As the day draws closer the representative learns that the event is not an in-house educational session requiring food, but an external event at a local restaurant. The organiser has not booked a private room, but is offering the representative the chance to say "a few words" about the product before the celebrations for the unit's tenth anniversary get under way.
In effect, sponsorship of education has turned into sponsorship of entertainment in a public environment. The representative has two options: either cancel the support or go ahead and hope everything is OK.
Suppose the representative proceeds with the event. He creates the appropriate documentation to meet Lakeshore's compliance policies, including an agenda and a brief letter from the meeting organiser requesting sponsorship. The representative arranges for a cheque to be paid to the organiser, rather than settling the restaurant bill on his company credit card.
During a routine check, the finance team identify that the payment request is for an individual. They ask the representative to explain this before they release the payment. Unhappy with the explanation, the finance team escalate the issue to the compliance officer. Eventually, the truth of the matter is revealed. Everyone understands the situation the representative was in, but it looks like the representative has tried to cover up something that was inappropriate. This blemishes his professional reputation. The company has been placed at risk because there could have been a complaint raised about the meeting in the restaurant. The ABHI's principles of transparency and documentation have been breached, which means that any complaint could result in sanctions being imposed by the industry association.
However, if the representative had spoken to his manager when the issue first became apparent, the manager and the compliance officer could have supported the representative in managing the situation very differently.
Clearly it is inappropriate for the company to support the event, as it is about entertainment rather than education. A suitably worded letter or conversation with the organiser could have resulted in a withdrawal of the sponsorship in a manner that maintained the relationship or even led to a change in the meeting's structure so that it became a genuine educational event that Lakeshore could support - which would actually have enhanced the reputation of the company because of the manner in which the issue was handled.
It is important to remember that mistakes do happen - we are all human. There may be ways to resolve the issue - or there may be consequences that arise from the mistake having been made. It all depends on the circumstances. What is absolutely clear, however, is that transparent and open management of the issue is far better than being the proverbial ostrich with its head in the sand.
Raise the issue as soon as possible with your manager or the company's compliance officer. They really are there to help!
Steve Gray is Managing Director of Compliance Hub, specialists in Healthcare Codes of Practice and accredited trainers for the ABHI. The company regularly runs engaging and enjoyable(!) workshops and training courses for field-based and office-based teams.
Do you have a compliance query for Steve Gray? If so, e-mail your question to us at joel.lane@medtechbunesiness.co.uk. Your anonymity is guaranteed.