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All things Pharma

The science of compliance

Part six: The Bribery Act

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:

I read something in the newspaper recently about a new Bribery Act. Is this some new European legislation that I should be worried about?

Steve says:

The Bribery Act is new legislation that is specific to the UK. It affects all business transactions that take place in the UK, and all those that a UK company or UK employee carried out while abroad. In essence, you cannot offer an inducement for someone to do something that breaks the trust associated with that person’s role. The inducement does not have to be money – and it does not even have to be given directly to the person you are trying to influence. Giving a large amount of money to their favourite charity would also fall within the scope of bribery, for example.

Imagine that Lakeshore Monitoring Ltd is establishing a contract with Milton Keynes Trust for the purchase of 10 therapeutic monitoring devices for use in operating theatres. Dr Smith is on the decision-making committee.

You know that Dr Smith always enjoys the European Surgical Association events and that this coming year the congress will be held in Amsterdam. You decide to offer Dr Smith sponsorship to attend the congress in the hope that she will think favourably about your product in the forthcoming purchasing decision.

Your actions would be a breach of the Bribery Act. If it was later found out that Lakeshore Monitoring Ltd had not implemented any training on the Bribery Act for its employees, the company might also be liable to prosecution. If Dr Smith accepted the place in return for recommending the purchase of your product, then she would also have acted illegally.

Another example would be if Dr Smith travelled to the ESA independently, but while there received lavish hospitality from Lakeshore Ltd. This could also be regarded as an inducement if the intention behind the hospitality was to influence the purchasing decision when Dr Smith returned to the UK.

However, it is also illegal for someone to accept (or expect) a reward for ‘improper conduct’. So if Dr Smith supported the purchasing decision for Lakeshore’s equipment and then told the local representative about her support in order to obtain a benefit (such as funding to go on a course), that would also constitute improper behaviour and be subject to the Bribery Act.

Of course, the Eucomed and ABHI codes protect us all against accusations of this type. The principles of separation and documentation enshrined in the Code ensure that any decisions in respect of funding or support for clinicians are made in the interests of patients, not for a return in terms of business. Your company will undoubtedly be rolling out a specific training programme on the Bribery Act before long, as Lakeshore Monitoring will be doing for its employees. In the meantime, however, you can be assured that if you follow the Code you will be acting in the right way.

Remember that you must always write to the hospital management to tell them that a place has been offered to one of their employees. This supports the principle of transparency, which also protects you against accusations of inappropriate behaviour.

Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd. The company provides workshops and e-coaching courses on a wide range of regulatory topics, including the Eucomed and ABHI Codes and the Bribery Act. For more information, please contact steve@compliancehub.com or visit www.compliance-hub.com.

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