Part two: Consultants
Steve Gray answers your questions about compliance with the ABPI Code of Business Practice and other industry codes that govern commercial activity.
Dear Steve,
Some of my customers have expressed concern about the latest consultancy arrangements. Apparently, if a medtech company wants to engage the services of an HCP, we have to tell that HCP’s employer as well. Is that correct? It feels like a breach of their confidentiality.
Steve says:
The short answer is “Yes” – you have to tell the HCP’s employer. This is all about transparency.
Imagine there was a medical device company (MK Surgical Instruments Ltd) that wanted to hire a surgeon to speak at a meeting about the latest non-invasive operating techniques. We have to consider how an outsider would perceive the fact that the surgeon paid by MK Surgical Instruments Ltd is also one of its customers. The industry is under such close scrutiny that we need to take measures to protect our image – and to enhance it.
The ABHI Code does not state that permission is required, only that the employer should be given prior written notification fully disclosing the purpose and scope of the engagement. (In this instance, ‘employer’ means the hospital administration.) This means that MK Surgical Instruments Ltd would write to the surgeon to ask them to speak at the meeting, and would simultaneously write to the hospital management to inform them that the surgeon had been invited to speak.
Of course, there are many reasons why MK Surgical Instruments Ltd might want to engage the services of an HCP. The company might be investing in research to find or test new scalpels, or teaching other surgeons how to use a new endoscope safely.
However, some people might view the payments made by MK Surgical Instruments Ltd to the surgeon as inappropriate. The best way to guard against this is through complete transparency in the manner in which the services are engaged and provided. This includes capturing the details of the arrangements in written agreements, and keeping the HCP’s primary employer advised.
Another way to consider the relevance of this would be if one of your own company’s component suppliers decided to give you a contract to speak at a meeting. Your own company would have a good reason to want to be kept informed – especially if you were in a position to place orders for that supplier’s products.
There has been a ‘sea-change’ in our industry and the way it wishes to represent itself. We are all part of that change. The industry’s own leaders have decided that such transparency is needed. And this is not a UK-only change. For many companies, including ones with a US presence, there are further0 international regulations to consider such as the impact of the Foreign Corrupt Practices ACT (FCPA). A number of medical device companies have already been challenged under the auspices of the FCPA.
However, be assured that in the example above, there is no suggestion that MK Surgical Instruments Ltd has breached any aspect of professional confidentiality. It is a condition of the new consultancy contracts required by the ABHI that the HCP’s employer should be informed. Remember, as well, that compliance with the ABHI Code of Business Practice is mandatory for all ABHI members, so all companies will be operating in a similar way. If the HCP is uncomfortable with the arrangement, they may choose not to provide the service – however, in that case their opportunities for speaking engagements will dry up very quickly.
These disclosure arrangements protect you, your company, and the HCP – who may, incidentally, be required in their contract to notify their employer of any extra work being undertaken. The arrangements also protect the HCP’s employers and, above all, the patients.
It is also worth considering that outside the UK, the rules may be even more stringent than those implemented by the ABHI.
A breach of confidentiality? No, merely a vehicle to protect everybody involved.
Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd, an accredited provider of training services to the ABHI. For more details, visit www.compliance-hub.com.