The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.
In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.
The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.
The Guidance is applicable to communications with healthcare professionals (HCPs), healthcare organisations (HCOs), patient organisations (POs) and other stakeholders including the general public. It sets out the various channels of digital communication with specific guidance for each. Digital channels are defined as “platforms for electronic communication through transmission of digital content over the internet or computer networks. Digital Channels include but are not limited to social media”.
The overarching principle remains that the legislation and Codes of Practice apply to communications on social media and digital channels. Such communications are generally considered as communications to the public, unless verification is required to restrict access. Further, companies are responsible for all content disseminated via a digital channel when the content is initiated, branded, and/or sponsored by the member company or a third party acting on its behalf. It is therefore important to understand what content is appropriate for the different digital channels and the respective audience. The Guidance includes a list of questions that companies can use to assess risk and appropriateness of digital activities.
Below are some key takeaways from the Guidance based on areas where we see questions from clients, and that expand on the legislative and self-regulatory provisions that industry is already familiar with.
Control, procedures and monitoring
- Establish procedures to:
- assess and verify IT security of social media and digital channels
- review and monitor company activities, content and materials
- monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner
- Take care when using social media platforms that limit or restrict the ability to monitor or access comments, such as ephemeral and encrypted apps
- There is no expectation to monitor independent third party activity on non-company digital channels (i.e. channels not initiated or sponsored by the company or on its behalf)
- Keep information on social media and digital channels up-to-date and date stamped with the date posted or last updated
- When providing content (or where a third party does so on your behalf) state clearly the involvement and role of the company
- Ensure compliance with data protection regulations and applicable laws and codes. Monitoring of digital media in accordance with pharmacovigilance obligations should be considered separately
- Information disseminated by an employee on their personal social media may be the responsibility of the company, if:
- the employee can reasonably be perceived as representing the company, and
- if the employee is instructed, approved, or facilitated by the company to do so
- Provide training to employees, relevant to their role, regarding appropriate conduct on social media
Websites, webinars, podcasts, blogs and discussion forums
- These digital channels generally follow the same principles
- It is acceptable to use appropriate search engine optimisation and marketing tools
- Companies should ensure key words are appropriate and that unauthorised promotion to the public is avoided
- Be confident that linked websites do not contain promotional content directed to the public
- It is permissible to include promotional website addresses in advertisements of pharmaceutical products to HCPs where the website is verified to ensure only HCPs have access
- A company can own, support or produce content if:
- the audience is well defined and targeted; and
- content is appropriate
- In terms of responsibility for content:
- Where a company is the direct organiser, sponsor, or has used a third-party facilitator, the company is responsible for the content
- If there is a strictly arm’s length relationship, with the company simply providing financial support, the company may not be responsible
- If discussion forums are hosted or facilitated by the company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws and codes
Social Media Influencers and Digital Opinion Leaders
- Engagement with online influencers requires subtle and careful evaluation
- Assess the risks of undue influence on HCPs, patients and vulnerable groups
- Assess the risk that digital content could be perceived as improper promotion
- The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented
- There should be a bona fide service requirement or legitimate need
- Remuneration should be appropriate and reasonable
- Companies are encouraged to establish a methodology for calculating fair market value rates
- Attach disclaimers to posts identifying the company involvement
- Disclose transfers of value in accordance with the usual requirements
- Consider implementing written guidelines or rules governing these engagements