Life sciences companies are continuing to rapidly grow their use of social media and digital channels as a form of communication with the public, healthcare professionals (HCPs), healthcare organizations (HCOs), patient organizations (POs) and others. Because of this, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) – both pharmaceutical trade associations – issued a joint guidance on social media and digital channels that applies to their member companies (i.e., companies and industry bodies who are a member of the IFPMA or EFPIA). This joint guidance will serve as an important new standard in an area of compliance that is rapidly evolving as a result of the growing and increasingly multi-faceted use of social media by the life sciences industry.
The IFPMA and EFPIA emphasize that this joint guidance will be continuously evolving. Nevertheless, it is also firmly rooted in compliance principles that already form some of the key elements of effective risk mitigation, such as the need for having a robust process when creating externally facing content or when engaging with external stakeholders.
The below sections highlight how this guidance uses and adapts some of these key elements of effective compliance in the context of social media interactions while also providing additional practical guidance for more robust risk management.
There are four sections within the joint guidance that incorporate key elements of effective compliance in the context of social media interactions.
The social media and digital channels communication principles section notes several principles for member companies. A few highlights include prohibiting both on-label and off-label advertising; restricting access to promotional content/materials to the appropriate audience (e.g., only HCPs) as direct-to-consumer (DTC) advertising is prohibited in all countries except for the U.S. and New Zealand; ensuring generated or sponsored content is truthful, non-misleading, balanced, current and accurate; and assessing and verifying adequate information technology (IT) security.
The risk considerations section poses a series of questions for member companies that can be insightful in assessing digital communication risks and appropriateness of digital channel content, access, set-up and maintenance.
The member guidance for this section touches upon the select digital channel types, including websites, social media platforms, blogs, podcasts, webinars, direct channels and discussion forums. The guidance emphasizes that the use of keyword optimization for websites to display high on search result lists needs to be appropriate for the intended audience and any unauthorized promotion to the public must be avoided. Additionally, member companies should ensure that any linked websites do not promote prescription pharmaceutical products to the public. Lastly, the guidance cautions member companies who are using social media platforms that limit or restrict their ability to monitor or access comments (e.g., encrypted apps).
The guidelines for engaging with online influencers and digital opinion leaders sections are noteworthy as other guidances have not touched upon life sciences companies' interactions with online influencers and digital opinion leaders. The guidance outright prohibits online influencers from promoting products on-label or off-label to the public (unless permitted under local law). Additionally, to avoid the perception of undue influence, the guidance recommends that the rationale for a company to engage with an influencer or opinion leader is both considered and documented. Also, services provided by online influencers and digital opinion leaders must serve a bona fide/legitimate need, and any compensation must be appropriate and reasonable. Full transparency of relationships with online influencers should also be ensured and disclosed according to local regulations.
The following are some key takeaways from the IFPMA’s and EFPIA’s joint guidance:
Overall, it is worth emphasizing the importance of conducting an overall engagement assessment to assess the risks involved when engaging with HCPs on social media. It is imperative that a life sciences company ensures that any HCP engagement aligns to the overall mission and with the goals of the organization and that consensus amongst cross-functional teams (possibly through a formal governance structure) is obtained prior to engaging with an HCP.
Based off this guidance, we believe there needs to be an increased emphasis on ensuring that the entire external materials process is robust so that content on a digital channel is properly reviewed, accurate and balanced. Similarly, it is important to make sure that established and appropriate access controls are in place so that only HCPs can view promotional content on a digital channel (whether it be through a third party or the life sciences company itself). The necessity for such controls also creates a close linkage between a company’s external outreach and communications strategy and its data protection and consent management processes.
From a data protection perspective, it is critical to ensure that the collection of personal data (e.g., name, email, phone number, etc.) through the sign in process is done with an appropriate lawful basis. This digital touchpoint with the HCPs offers an opportunity for further engagement through appropriate channel consent collection. A key challenge is then to ensure that consent is managed holistically across the company given the many potential touchpoints with an individual across functions and digital platforms. Life sciences companies should therefore consider strengthening their consent management and data protection processes and elevate these areas in terms of importance when determining compliance risk for the company as a whole.
It is important to consider that external stakeholder contracts may need to be structured differently to include a new way of tiering and determining FMV for digital opinion leaders. Traditional compensation methodologies, based as a best practice on the basis of objective salary data analysis and a related differentiation by levels of expertise, may no longer be fully applicable as some online influencers may not have generally accepted compensation data and may be nonmedical professionals.
Life sciences companies must then determine how to establish an objective FMV approach that takes into account the nuances of social medical/digital engagement. From a time perspective, this should include the amount of time or effort needed not only for producing content but also the value of the time spent obtaining a network of followers and developing a presence on social media. This should be combined with a robust tiering approach that is also uniquely tailored to the specific requirements of social media engagement. Evidence of scientific or medical experience should be evaluated along with simple quantitative measures that may include determining how many followers, likes, views or connections an online influencer or digital opinion leader has. Qualitative measures may include determining whether an influencer is an active content creator or measuring the quality of the content produced. Thus, companies will ideally have FMV and tiering models that are still anchored into compliance best practices but also consider the unique skillset of digital opinion leaders.
Within the digital space, it can be difficult to combat misinformation and ensure patient safety. It is essential to develop protocols on how to identify, document and communicate information related to adverse events. This includes monitoring adverse events on social media and escalating adverse event reports that need immediate attention and should be reviewed by a clinician.
Life sciences companies might consider using a machine learning-based model to identify adverse events on social media, which can be quite challenging due to term diversity and informal language typically used on social media. Therefore, the key to developing a machine learning-based model is determining the inputs needed (i.e., what the machine learning-based model is asked to do). By using machine learning, the model will continuously improve and become scalable. A life sciences company may thus become a social media listener to utilize sources of postmarketing safety data that can lead to meaningful findings, improve the patient experience, delivery of care, lead to greater patient safety, and even support auditing and monitoring.
This guidance is notably novel within the digital space, providing both a global perspective and detailed specificities, albeit touching upon some principles that have existed for a while within the life sciences industry. It is also important to remember that communicating digitally can lead to potential compliance risks and therefore it is imperative that life sciences companies keep abreast of new regulations and guidances that are issued and proactively measure, mitigate and monitor the risk areas highlighted above to ensure compliance. Companies always need to keep the rationale for an activity and the desired outcome at the forefront of their engagement process while considering the need for an evolving and more mature governance framework in this continuously changing space.
For more information on this topic or to learn how Baker Tilly’s life sciences specialists can help, contact our team.