Sarah Dunnett, independent medical operations consultant and UK registered pharmacist, explains how the medical device industry is developing its own codes of ethical business practice and how an increased focus on compliance is inevitable.
Recorded 6 September 2017 at a MedComms Networking event in Oxford. Produced by NetworkPharma.tv
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The UK Association of the British Pharmaceutical Industry (ABPI) Code concerning the promotion of medicines has its 60th anniversary in 2018. By contrast, the compliance framework relating to medical devices is in its relative infancy. European-level guidance, in the form of the MedTech Europe Code, published in 2015, came into force on 1 January 2017, but gives little detail on advertising and promotion. The UK ABHI Code was only launched in 2008, and medical devices are out of scope of the Medicines and Healthcare Products Regulatory Agency (MHRA) Blue Guide.
New European Medical Device Regulations relating to medical devices and in vitro diagnostic medical devices were adopted in Spring 2017, and are now in 3 and 6-year implementation phases, respectively. Article 7 of these new regulations emphasises the professional expectations and requirements for communication not to mislead in any way about the intended purpose, safety or performance of medical devices. The ABHI code, updated every two years, includes a lot of detail around the advertisement and promotion of medical devices. There are learnings to be had from ABHI Code cases where there are breaches in this area – though these are very much lower in number than those for the ABPI Code. It will be important for medical technology companies, and their partner medical communications agencies, to be up to speed with the latest guidance, and to fully understand how the European legislation will be implemented and governed across the UK and Europe.
Written by Penny Gray, Freelance Medical Writer
We are building a library of free webcasts, like this one, for the global MedComms Community and others at http://www.networkpharma.tv and we’d welcome your suggestions for new topics and speakers.
Full details of this MedComms Networking event are at http://medcommsnetworking.com/event_060917.html
Sarah’s presentation (PDF format) is at http://medcommsnetworking.com/presentations/dunnett_060917_02.pdf
Sarah’s Linkedin page is at https://www.linkedin.com/in/sarahdunnett/
More about Sarah Dunnett Consulting Ltd can be found at http://www.sarahdunnett.co.uk
Filming and technical direction by Mario Crispino, Freelance Cameraman & Editor
[For the avoidance of doubt: this video is intended to be freely accessible to all. Please feel free to share and use however you like. Cheers Peter Llewellyn, Director NetworkPharma Ltd and Founder of the MedComms Networking Community activity at http://www.medcommsnetworking.com]