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Published 9 enero 2018
Manufacturers of medical devices should note the changes being phased in by the Association of British Healthcare Industries ("ABHI") this year, which will align the UK approach with that of MedTech Europe by January 2019, and they should ensure their business practices are compliant.
The ABHI Code of Ethical Business Practice (the "Code") is the self-regulated industry standard for the sector and is binding on members of the ABHI. MedTech companies who are not members of the ABHI often follow the Code in order to guide their interactions with healthcare professionals ("HCPs") and to assist with compliance with the relevant UK anti-corruption legislation.
While there is no anti-corruption law relating specifically to manufacturers' interactions with HCPs, such dealings are governed primarily by the Bribery Act 2010 (the "Act") and industry codes of conduct. While compliance with the Code does not guarantee compliance with UK anti-corruption legislation, it is certainly a helpful place to start and will assist in showing that a company had adequate procedures in place, in accordance with the guidance issued by the Ministry of Justice: Bribery Act 2010 Guidance: Adequate Procedures. Where such compliance is integrated into corporate policy, it will provide a defence under section 7 of the Act which addresses the failure of commercial organisations to prevent bribery. Having adequate policies and procedures in place will also reduce the risks of active (section 1) and passive (section 2) bribery offences.
Penalties under the Act include:
International companies should review their policies and procedures to ensure they fully meet the UK regime as compliance with other EU or US anti-corruption regimes does not guarantee compliance with the Act.
Contracts should also be reviewed to ensure they contain an anti-corruption clause, which is bespoke to the risks faced by individual organisations when dealing with domestic or international businesses.
Against this backdrop, members of the Code will be aware that the revised Code has come into effect in two stages:
The Complaints Procedure & Panel Constitution set out in Part 4 became binding on members from 1 January 2017.
The remainder of the Code came into effect on 1 January 2018 and includes a transition period until 31 December 2018, by which time members must have ceased all financial or in-kind direct support to individual HCPs to attend third party organised educational conferences (subject to exceptions).
Members of the MedTech Europe Code of Ethical Business Practice should be aware that under the MedTech Europe Code, this prohibition became effective from 1 January 2018 with the transition period ending on 31 December 2017.
From 1 January 2018 ABHI members should be phasing out all financial or in-kind support which is provided directly to individual HCPs for third party organised educational conferences in preparation for the prohibition on this type of support from 1 January 2019.
There is an exception whereby assistance is still permitted in relation to third party organised procedure training or pursuant to a consulting agreement with a HCP engaged by a member to speak at a satellite symposium.
From 1 January 2019 members will only be permitted to support third party organised educational events through the routes prescribed in Chapter 2 and Chapter 4 of the Code.
For advice and guidance on this topic, please contact:
Alison McAdams, Head of Life Sciences, email@example.com or
Dr Anne-Marie Gregory, Solicitor, firstname.lastname@example.org
London - Walbrook
+44 (0)20 7894 6588
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