Welcome to our February Newsletter which focusses on digital communication. First we look the implications under a range of regulations as well as the ABPI Code of Practice (CoP) for the use of Chatbots and Voice Assistants in healthcare. The article included here is an expansion of our contribution to a White Paper co-produced with earthware, which is available as a pdf download here.

In addition we review a recent PMCPA case relating to the use of promotional email and several of the pitfalls of this if correct processes are not followed. Finally an important reminder….certification & re-certification

Rise of the machines?- Bots in healthcare marketing

Artificial Intelligence (AI) is increasingly being used for many applications and healthcare is no exception with the development of many new Apps and interfaces to replace traditional patient/clinician interactions. Voice Assistants and Chatbots are proliferating in many areas of life driven by technology giants and integrating into increasing numbers of domestic appliances. So what are the implications for pharmaceutical and Med-Tech companies who might like to use this technology to enhance their business?

A key consideration for any pharmaceutical/med tech company considering exploring the use of Chatbots/Voice Assistants (VAs) is compliance with the relevant regulations and Codes of Conduct.

The following list of considerations is based upon the UK Market. It is important to consider how access to a Chatbot/VAs designed for a specific jurisdiction can be controlled to ensure that only users for whom it is intended can make use of the system.

ABPI/PMCPA Compliance

Currently the ABPI Code of Practice (CoP) contains very little information specific to digital communications and while the he PMCPA has issued guidance on digital communication this is “broad brush” and relates more to what could now be seen as more traditional forms of digital communication than the technology that is the subject of this paper.

Despite this it is important to be mindful that the PMCPA Digital Guidance states that, "much of the Code (ABPI CoP) applies irrespective of the method of communication”. With this in mind, there are a number of key clauses of the ABPI CoP that should be considered when developing a solution which incorporates chatbots/voice assistants:

Clause 1.2 - Defines whether an activity is promotional or not
Clause 3 - Marketing Authorisation
Clause 7 - Information, Claims & Comparisons
Clause 9 - High Standards
Clause 9.10 - Clear identification of pharmaceutical company sponsorship of any information provided regardless of subject
Clause 14 - Certification
Clause 26 - Relations with Public and Media
Clause 26.2 - Information shared with the public regarding prescription medicines

Pharmoco vigilence should also be considered and incorporated where necessary in line with the ABPI CoP and MHRA regulations.

Which clauses apply and how, will depend on the information being exchanged and the audience that it is intended for/exchanged with. It is also important to consider how different types of information are only shared with an intended audience to ensure that the ABPI CoP is not breached e.g. members of the public gaining access to promotional information.

Alongside the ABPI CoP there are also legislative considerations, most prominent of these are General Data Protection Regulation (GDPR) and Healthcare Regulations (Health & Social Care Act)


Coming into force on 25th May 2018, replacing the current Data Protection Act (1998, GDPR this defines how personal information is collected, retained, stored and deleted as well as expanding on the accountabilities and responsibilities of organisations who control or process data.

Healthcare Regulations

The wide-ranging potential application within healthcare for Chatbots/VA’s means that they could to be used in the delivery of a regulated activity as defined by the Care Quality Commission (CQC) in England. Should this be the case the organisation deploying them would be subject to Registration and Regulation under the Health & Social Care Act 2012.

In a very recent development the Department of Health have granted the CQC the power to regulate more healthcare services including medical advice websites, apps and online GP services a clear sign that a more rigorous approach to stand alone virtual healthcare will be taken over the coming years.

Promotional email from third-party provider ruled as breach

A recent complaint Case Auth/2976/9/17 a third party provider to a pharmaceutical company sent out a promotional email which the recipient considered to be without prior permission claiming and that the content was not relevant to their practice. The complainant additionally claimed that the subject line of the email suggested that the email contained important information about the product rather than the content being purely promotional.

In reviewing this case The Panel considered several Clauses of the ABPI CoP relevant to the case the first of which was Clause 9.9 which states that;

"The telephone, text messages, email, …......must not be used for promotional purposes, except with the prior permission of the recipient”

In this case while the third party had obtained consent from the complainant for the receipt of external emails in both 2002 and later in 2015 The Panel "considered that either the consent process in 2002 nor the 2015 update amounted to the complainant consenting to the receipt of promotional emails.” This highlights the need to ensure that not just consent is obtained but also that the consent to receive promotional emails is obtained. It is also a requirement of the CoP that each email informs the recipient how to unsubscribe to further emails. While it is not specified in the CoP it is implicit that the unsubscribe system is actually functional as in other cases breaches have been ruled where links were not functional

In addition to the requirements of Clause 9.9 as highlighted by this case there are several other clauses where a breach was found:

11.1 - Material tailored to audience - The main point in relation to this clause from the ruling is that in addition to tailoring the communication to an audience it of also necessary to make it very clear to whom the promotional item is relevant as part of the material. It is also important to establish very clearly prior to sending promotional communications that the audience it is sent to is as well defined as possible and match the intended audience that it is relevant to.

7.2 - Information & 12.1 - Disguised promotion - The Panel ruled that the subject of the email suggested that the content was "a clinical alert or contained safety information” however when the email was opened that the content was promotional. This demonstrates that it is important to ensure that the content of an email is reflected in the subject/title and that this is not misleading in order to encourage the recipients to open it.

In addition due to the breaches above the Panel also ruled a breach of Clause 9.1 - High Standards

While there is no reason to avoid electronic and digital communcations this case demonstrates the risk of breaches of several Clauses of the CoP if care is not taken. The CoP makes it very clear that Pharmaceutical Companies are responsible for the actions of 3rd Parties who act on their behalf and therefore careful due diligence is required when utilising information complied and controlled by an external source.

Website past its sell by date - When did you last check your Websites were Certified?

Under the CoP websites as well as other materials must be certified and re-certified on a regular basis in line with a clear process to ensure continued compliance and relevance of all material.

To maintain compliance with the CoP organisations should have an approved Standard Operation Procedure (SOP) that includes clear responsibility and accountability for ensuring re-certification of all materials, how content is version controlled and how review dates are monitored.

Please note: all images are used in this Newsletter are for illustration purposes only and do not purport to belong to a specific product, person or particular case.

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