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All things Pharma

The science of compliance

Part five: The travel grant

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:

How can I make sure that my target doctors are the ones who attend overseas conferences? It used to be easy, but now I understand that we are not able to select delegates directly any more. Can you please explain how it works?

Steve says:

Imagine that Lakeshore Diagnostics is intending to attend the European Urology Society meeting in Barcelona next year.

Lakeshore’s management has decided to allocate sufficient funds to enable the marketing team to take 10 Key Opinion Leaders as sponsored delegates of the company. Lakeshore will pay for their flights, accommodation, registration and meals. The ABHI and Eucomed Codes of Business Practice are very clear as to what the company needs to do.

The first consideration is that the visit to the EUS event must meet all the standards of hospitality that we have discussed in previous articles. The attendance at the event must meet the principle of separation. This means that it cannot be linked to any attempt to sway the KOL to use or recommend any particular product as a result of receiving hospitality. However, in these circumstances the requirement goes further. The hospitality includes the entire package for the event, including the flights, accommodation, meals and registration fee.

The new process indicated by the ABHI and Eucomed codes contains strict regulations regarding the offer of places to attend medical congresses. To begin with, the offer of a place cannot be conditional on any support for the company’s product. Lakeshore Diagnostics must write to the person to whom they wish to offer a place, making it clear that the offer is independent of product usage. The letter can be based on a template supplied by the ABHI if required. However, it is in effect a contract between the recipient and the company, and meets the requirements of the principle of documentation.

The letter must also inform the intended recipient that a copy of the letter has been sent to their employer. This is where the Eucomed and ABHI codes differ in their requirements. To comply with the Eucomed code, the letter must inform the hospital management that a place has been offered. To comply with the ABHI code, the letter must do that and must give the invitee’s organisation the absolute right to refuse to send the nominated KOL but retain the place and offer it to another individual.

Both the ABHI and Eucomed code requirements are more stringent than those in other industries, such as the pharma industry. The ABHI code in particular virtually guarantees that the offer of a place cannot be seen as inducing an individual. This protects the medtech company, the clinician and the hospital from accusations of inappropriate influence, and therefore also provides a measure of protection for all concerned in respect of the UK’s new Bribery Act.

So the best way to get the KOL you want is to give a clear set of educationally-based reasons why that KOL should be chosen. Warn them personally that the offer is en route and that there is a new process to follow. This will enable the KOL to work with their own internal system and explain why they are the best person to attend the medical congress.

Remember: forewarned is forearmed.

Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd. The company supplies training and materials to support all codes of conduct, including Eucomed, and is an accredited training provider to the ABHI. For details, see www.compliance-hub.com.

Do you have a compliance query for Steve Gray? If so, e-mail your question to us at joel.lane@medtechbusiness.co.uk. Your anonymity is guaranteed.
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