The Association of British Healthcare Industries ("ABHI") is expected to publish a new Annex to its Code of Business Practice ("Code") pending final approval of this by its next EGM on 28 March 2012.  The new Annex will regulate advertising of medical devices and related services directed primarily at healthcare professionals.  The new advertising guidelines will form Appendix 3 to the Code and will apply from April 2012 for new materials and from January 2013 for existing materials.  Complaints will be administered by the independent panel set up for this purpose.

What do the new advertising rules cover?

  • The advertising restrictions and standards set out in the Annex only apply to ABHI members and companies that have formally agreed to abide by the Code.
  • The new guidelines apply to "advertising" (which is drafted broadly to cover any marketing communication in any form and through any media including the internet, or advertorial) that is intended "wholly or mainly" to influence healthcare professionals or health institutions in their choice of medical devices or related services.  They supplement the existing general UK advertising law.
  • They do not therefore apply to advertisements directed wholly or mainly to consumers, patients or other non-healthcare professionals (which continue to be regulated by UK advertising law and through self-regulatory advertising codes enforced by the Advertising Standards Authority).
  • The new rules only apply to UK promotional activities and so they do not cover, for example, materials intended for use at a symposium in Germany.  However, the ABHI encourages companies to operate in accordance with the same principles outside the UK to the extent they are not overridden by local laws.
  • As well as regulating other aspects of advertising, the Annex lays down standards regarding the substantiation of claims and comparative advertising.

The need for self-regulation

  • The new advertising guidelines are intended to fill an enforcement "gap".  Currently, anyone wishing to make a complaint about the promotional materials of a company directed at healthcare professionals may not have satisfactory means of redress under either advertising law or existing self-regulatory codes in the UK.  In the context of comparative advertising, a company may have grounds to bring an action for trade mark infringement but this is likely to be a lengthy and expensive procedure.  
  • Overall, the new Annex has been welcomed by industry and is intended to create a level playing field by setting a benchmark standard for all medical device advertisers, irrespective of whether they are ABHI members or not.  Self-regulatory guidelines have the benefit of providing a means of regulation which enables advertising disputes to be resolved quickly and effectively.  The guidelines will also be more adaptable to changing circumstances than is the general law. 

Complaints procedure

  • Companies and individuals can initiate a complaint under the new advertising guidelines.  If they are not an "Applicable Company" (i.e. an ABHI member or a company that has agreed to abide by the Code), they must agree to abide by the provisions of the Code (for 18 months for companies and, for individuals, for the duration of the complaints procedure).
  • Complaints may only be brought against "Applicable Companies" which in this context is widely defined and covers e.g. an ABHI member whose non-ABHI affiliate has approved or placed an advertisement.
  • The complaints procedure is set out in Appendix 4 to the current ABHI Code.  Before any complaints can be adjudicated under the Code, companies must prove that they have made a genuine attempt at mediation to resolve the matter.  Individuals must initially attempt to resolve the complaint utilising that company's internal or external whistleblowing and/or dispute resolution procedures.
  • If a complaint is upheld under the advertising guidelines, the main sanction is 'naming and shaming' resulting from publication of the case report.  An administrative charge is also payable although the level of this charge has not yet been set.  Persistent offenders or companies that seriously flout the rules could be suspended or expelled from ABHI membership.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 23/03/2012.