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Pharma compliance in a digital world

Rina Newton examines the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code’s Principles for the use of digital channels.


We’ve heard it so many times before – the UK pharma industry and associated agencies asking year after year for some/better digital guidance in relation to the Association of the British Pharmaceutical Industry (ABPI) Code; the Prescription Medicines Code of Practice Authority (PMCPA) agreeing and telling us all it will be “out soon”.

The sad reality is that the PMCPA has archived its Guidance About Digital Communications that relates to the ABPI Code and the ABPI Working Group that was tasked with updating this guidance expected its publication soon after the ABPI Code 2021 became operational (in July 2021). To date, nothing has appeared.  

Dr Felix Jackson, Founder of medDigital, was involved with this digital guidance as part of the ABPI Code Working Group in 2020. Although not an official representative of the ABPI or the Working Group, his opinion on the matter is: “I believe that the ABPI is still very keen to do this and it is still much-needed.” He sympathises with their efforts, though, and surmises that: “The delay to its publication is likely to be due to several factors – Covid, Brexit and the implementation of the new ABPI Code in 2021.”  

An ABPI spokesperson said: “The ABPI has previously worked closely with members to develop draft guidance on the ABPI Code as it pertains to use of digital communication channels. With the ABPI 2021 Code of Practice now live, this draft digital guidance is being updated with new content, with the aim of publishing later this year.”

The ABPI has also commissioned PwC to create Guidance on the Use of Social Media (which will likely be published in March 2022).

In the meantime, the PMCPA and Appeal Board have both been ruling about cases that involve the use of hashtags, tagged accounts, sponsored social media advertisements, Google indexing and app stores etc. on a case-by-case basis. Not only does this mean companies have to second-guess what may or may not be acceptable by deciphering very specific (and sometimes confusing) rulings, ‘compliance’ appears to entirely depend on the PMCPA and Appeal Board’s understanding of digital channels, functionality and technology.

Therefore, it’s a useful reminder to revisit the digital guidance contained within Annex 3 of the EFPIA Code. This article describes and interprets advice for ‘member companies’ (MC) on digital principles, content and channels.

There are 4 key overarching principles to consider and for each, my key take home message

Overarching PrincipleSummary Key take home
1.     Compliance

 

The content, audience and use of the platform should be considered to identify relevant laws and regulations.The UK’s ABPI Code incorporates requirements of the EFPIA Code and the law (except GDPR).

 

 

 Digital communications fall under the scope of Directive 2001/83/EC and the EFPIA Code of Practice.All promotional and non-promotional digital communications under the scope of the ABPI Code must therefore be compliant with it – in terms of intent, target audience and method of dissemination.
2.     Responsibility

 

Material shared either by MC or third parties acting on their part, is the responsibility of MC (includes branding, sponsorships, promotion of Medicinal Products).All UK pharma companies will be held liable for the actions of their agencies (and sub-contractors) if their activity breaches the Code.

See 2.

 

 

Material on social media pages or websites owned by MC is their own responsibility; this responsibility may also apply when connecting with other companies/organisations.They may be held liable if social media ‘connecting’ (ie. URL links, hashtags or tagged accounts) to other accounts.

See Cases 3431/11/20, 3441/12/20 and 3162/2/19.

MC are responsible for content shared by their staff (including private accounts) when they are deemed to be acting on behalf of MC or advocated by MC to disseminate material.Personal social media is under the scope of the Code if the employee or agency posts/likes/shares about a subject that is of commercial interest to the company.
Company guidelines should guide staff on how to navigate this.There should be in place clear and specific UK .
MC should develop guidelines to review and delete unfit comments (within the scope of data protection regulations) on their own digital channels.Accounts that are under the company’s liability, should have comments disabled or moderated to ensure compliance.
3.     Pharmacovigilance

 

MC should establish guidelines for digital channels which may include processes to adhere to pharmacovigilance requirements (recording and reporting adverse effects).Accounts that are under the company’s liability, where comments are not disabled, should have in place moderation to ensure potential adverse events are reported.
4.     Transparency

 

MC must indicate sponsored content/communication in accordance with EFPIA Code of Practice.Pharma companies should be clear about their involvement at the outset – whether it is their activity, sponsored or at arm’s length (eg. disease awareness websites).
Content on digital channels should state involvement of MC whether posted by MC or third party – define content and funding.Pharma companies should make sure that material published by their agencies on their behalf is clear about pharma involvement at the outset (eg. emails sent by mailing houses).
EFPIA Code of Practice (Chapter 5) requires reporting of “value transfers to HCPs, HCPs and POs.”Any transfers of value should be disclosed, and certain digital activities may involve these (eg. virtual advisory boards).
Definition of target audience important.Some activities may be intended for a certain target audience (eg. medical education to HCPs) but may be visible to other audiences (eg. public because open access social media is used).

 

Four key content considerations affecting all digital communications

1. The MC should determine the correct digital channel and audience in relation to the content in compliance with relevant regulations and laws.

  • Eg. Sponsored advertisements on LinkedIn or Twitter using targeting parameters such as geography, age and ‘follower look-alikes,’ can help ensure content targets users with a relevant interest (see Case AUTH/3393/10/20). Instagram may be better for a younger audience; websites with different content should consider how access is restricted between different groups.

2. Information should be regularly updated and state most recent date of update on each item or page.

  • Eg. Although promotional content on websites should be certified and could be compliantly recertified every two years, it can attract complaints, so it may be better instead to reapprove (and update dates on) websites.

3. Consider a risk assessment as to how suitable the ‘content, access, set-up and maintenance’ is.

  • What is the communication aim?
    Eg. The intent of the communication should be agreed first at a concept meeting and the approval system should reflect this  to aid efficient approval.
  • What kind of content is planned? Material on Medicinal Products? Disease awareness? Promotional/non-promotional?
    Eg. It is essential to first categorise the material according to context (who will read or use and how) and only then can the correct compliance criteria be used to achieve efficient approval.
  • Is MC involvement clearly indicated?
    Eg. This should be accurate and prominently displayed at the outset without the user searching to find it.
  • Audience – does the audience need to be verified and how?
    Eg. Consider promotional emails where prior permission of the recipient is always required vs log-in for websites (not always required).

4. Consider how the channel works in relation to content.

  • Is it open access with interaction enabled? How is information shared? Is it closed group or targeted?
    Eg. Open access social media campaigns to encourage more visitors to company websites should not promote prescription- only medicines to the public or disguise promotion, they should be clear who the target audience is and ensure the website itself clarifies this before content is displayed.
  • Are there limits to the material content?
    Eg. Character size of content on Twitter may prevent the communication aim.
  • Are relevant guidelines for users considered? 
    Eg. Twitter does not allow content that relates to medicines – does this prevent closed groups for promotion to healthcare professionals?
  • How is audience data handled?
    Eg. If collecting sensitive and personal data (eg. for log-in to certain types of patient support programmes), are the proper permissions in place?
  • There must be a method of assessing and approving material.
    Once content is appropriately categorised, only then can a decision about route of approval (certification by a medical signatory vs examination by an appropriately qualified person) be made.

There are many channels that can be utilised by MC in digital communications (not all can be included thanks to evolving innovation):

Websites

  • Log-in is only required if content is promotional and there is no other information for the public available. Otherwise, it is acceptable for different content to be clearly signposted for different users.
  • Keyword and search engine optimisation can be used to increase ‘traffic’ to website, but this should be used with the audience in mind (ie. public must not be encouraged to access HCP-only content).
  • Websites can be created or sponsored by MC and created by a third party. MC involvement should be clearly indicated without a user needing to search for this information.
  • MC should be wary of links on websites. If it is not made clear to users that such links may direct them to websites for which the company has no responsibility, then the company may be liable for unacceptable content such as promotion to the public.

Social media:

  • Open access should be approved with the public in mind. Therefore, content such as promotional materials for HCPs or press releases for the media, cannot be shared in this way.
  • Closed groups can prove to be useful as tailored content can be delivered in a compliant way eg. video content for patients prescribed a medicine published on a private YouTube group.

Blogs:

  • MC may directly own and author their own blog or sponsor/contract other blog authors. If open access, neither type may promote to the public.
  • MC involvement must be accurate and clearly indicated at the outset for both.

Podcasts:

  • Considering intent and audience, a webcast may be better or a downloadable podcast housed on company website instead.
  • Podcast intent and content may render it promotional or non-promotional – this affects approval.
  • If the podcast is housed on Spotify (or similar), a process for reapprovals or recalls must be considered.

Applications:

  • The MC should first check if the app is regarded as a medical device whereby relevant regulations apply.
  • The guidance for websites could be followed but consider how the app is advertised on the Apple/Google AppStore. See Case AUTH/3403/10/20.
  • If the app is aimed at a select audience, then only these individuals should have access.

Webinars:

  • These can be live streamed or recorded for later access.
  • MC is accountable for content and audience even when using a third party.

Direct channels: 

  • These are usually private channels directed at one or many other channels.
  • According to this guidance, MC must obtain permission from target individual to receive messages and they must be able to request to opt out, keeping in mind the need to avoid excessive contact.
  • According to the ABPI Code, permission is only needed if promoting via these channels.

Discussion forums:

  • MC are responsible for moderating forums on their own or third party platforms.
  • These should clearly identify the target audience eg. closed group of advisors at a virtual advisory board.

Whilst this overview serves to prompt our thinking on all things relating to digital content and channels, it does not replace or override individual company SOPs and policies. In that regard, those creating/approving such documents should consider including how to mitigate the biggest compliance risk to digital activities – prohibiting promotion to the public by defining a promotional claim (which is not included in the EFPIA or ABPI Codes).

1 EFPIA Code of Practice 2019: Accessed www.efpia.eu/media/636597/211222-efpia-code.pdf
2 All PMCPA rulings mentioned can be found at www.pmcpa.org.uk

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Rina Newton
Rina Newton
Dr Rina Newton is an ABPI Code and healthcare compliance expert.

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