The Association of British HealthTech Industries (ABHI) has this week published an update to their Code of Ethical Business Practice for the recently rebranded “health technology” sector. The changes to the previous version, from May 2017, are mainly to the Q&A section, which provides further clarification to the substantive provisions of the Code. The Code itself has not (for the most part) changed.

By way of example, the amendments have clarified the restrictions surrounding:

  • The use of resorts as event locations, by stating that certain hotels and resorts might be considered acceptable where the venues are well adapted to business meetings and where there is a compelling need to use the chosen venue, such as a lack of alternative venue or genuine security issues; in such cases, event organisers must take account of the appropriateness of an event location given the time of year in which the event is planned.
  • The provision of in-kind support in connection with third party organised educational conferences.
  • The provision of direct support for the attendance by healthcare professionals (HCPs) engaged to speak at satellite symposia at third party organised educational conferences.
  • The use of the Conference Vetting System (CVS) and the interactions with third party travel agencies.

The amendments also include:

  • References to the new Medical Devices Regulations to define the intended purpose of the device in the context of the Code.
  • A new annex on the verification of the use of funds provided by companies as Educational Grants (annex IV).
  • A new annex (annex VI) summarising in a chart the requirements applicable to the provision of direct support to HCP’s participation in events as of 1st January 2019.

Key amendments

Of the more substantive amendments, we believe the following are worth noting:

A new question 23 has been added to highlight that, from 1st January 2019, it will not be possible for companies to directly support travel and/or accommodation or other expenses of individual HCPs participating as delegates in company organised events, which take place during and in the same approximate location as third party organised events. It also describes the costs that a company may cover for HCPs attending such meetings as consultants to the company (i.e., with an active participating role). The pre-existing exceptions for product launches fall within the scope of Product and Procedure Training and/or Educational Events.

A new question “36-bis” clarifies that it is still possible for companies to provide educational grants or funds earmarked for education to specific hospitals or departments. However, companies should bear in mind that the smaller the recipient, the greater the risk that the funding could be considered as not compliant, because the ABHI Code does not permit companies to name individual HCPs as beneficiaries in this context.

New wording reminds companies to be mindful of any proximate or on-going tender procedure when considering an educational grant to a specific hospital or department.

The only change to the Code itself is to add a new clause 3.10, which provides for mediation between the parties as an alternative dispute resolution method to the existing proceedings before the Panel. The hope is that this will provide a more streamlined mediation process.

There are no changes affecting the disclosure guidelines.

Next steps

Alongside these changes, there are some new documents on the ABHI Code of Ethical Business Practice website, namely:

  • Template Educational Grant Agreement,
  • Template Educational Grant Request, and
  • Educational Grant Process Flowchart.

Given that the substance of the Code has not changed, the new guidance applies immediately.