Ilyssa Levins | Center for Communication Compliance (CCC)
The subject of digital transformation in Europe has been raised quite frequently over the last six months during nearly all of my conversations and meetings with pharmaceutical companies and promotional agencies. And while there is much to be said about this topic, the short answer on what is the best way to compliantly execute digital media across the pond is that you should retain a good lawyer.
Companies can be successful, however, with an efficient promotional review system and some common sense advice that is fairly straightforward.
Nevertheless, it can be tricky to use social media tools that allow for user-generated content, or UGC in Europe. This wide range of social media tools includes: blogs, wikis, discussion forums, posts, chats, tweets, podcasting, pins, digital images, video, audio files, and other forms of media that are created by users of an online system or service, often made available via social media websites.
Legal and enforcement risks make it understandable for companies to “lack social media confidence” which is a term defined in a study by global public relations agency, Weber Shandwick entitled Digital Health: Building Social Confidence in Pharma, fielded in partnership with Forbes Insights.
The study, published in 2013, explores how global pharmaceutical companies are using social media in their external communications. A particular focus was on understanding specific challenges that pharma communicators face in developing and executing social strategies, and identifying how professionals are overcoming these barriers.
The industry must overcome these barriers given the growth in use of these social media channels.
According to a 2012 study conducted by Manhattan Research, 72 percent of European online consumers (ages 18 and older) are social health users. The company’s Cybercitizen Health® Europe 2012 study showed that 44 percent of European online consumers used social networking websites for health, 33 percent read or posted patient testimonials and 34 percent used health ratings or reviews. The study surveyed 3,020 consumers (ages 18 and older) in France, Germany, Italy, Spain, and the United Kingdom online in October 2012, on their use of digital media and technology for health and its influence on treatment and product decisions.
The study also found that adoption of social media for health varies by country. For example, compared with the other surveyed countries online consumers in Spain and Italy are most likely to use Facebook for health, while health ratings and reviews see strongest adoption in Germany. Social health users by country (percent is among those who are online in each country) are as follows:
- All EU: 72 percent
- Spain: 83 percent
- Italy: 82 percent
- Germany: 76 percent
- France: 71 percent
- United Kingdom: 56 percent
No Overall Guidance
While a large share of EU consumers is accessing health information from social feeds, there is no overall European guidance on social media that applies to the life sciences industry. Social media guidances do exist, but these are limited to a small number of European countries such as the UK, Sweden and Ireland.
At this stage, there are relatively few examples of European companies executing social media or using Facebook to host branded over the counter (OTC) drug pages. Furthermore, the rapidly evolving technology of social media has outpaced the current European regulatory framework which raises many unanswered questions.
Tricky does not mean impossible when using social media tools. Rather, it’s an opportunity for cross-functional collaboration, coordination and communication. One of the findings of the Forbes/Weber research: it is imperative for teams to gain experience in using social platforms with distinct audiences. Pharma communicators should start with small pilot projects where diverse members work together.
Starting small, but starting somewhere, is the name of the game in building organizational confidence in this digital medium, according to the study.
“The good news is that a number of pharmaceutical companies are participating in social media listening as a start”, says Violet Aldaia, SVP Omnicom/DAS. “Social listening not only provides insight that can be applied to marketing strategy, but it’s also a low-risk stepping stone into the channel that can help internal stakeholders align on goals, process, benefits and level of risk should the company want to engage in more interactive behavior with social media outlets.”
The Commercial Lead for Digital Innovation at Takeda, Stephanie Bova, agrees and suggests other small but important steps that companies need to take. “To transform, organizations must start with the basics to overcome their digital naiveté and level set their understanding of digital realities. Bova stresses the value of ongoing education and testing, best practice sharing and access to current case law in local regions to stay competitive and compliant.
“Everyone must feel confident that digital program recommendations are conceived by individuals who understand the current regulatory environment,” according to Laura Schoen, president, Weber Shandwick’s Global Healthcare practice, which is the first European public relations health network to certify in promotional regulatory compliance. “You can’t roll out communications programs that comply across markets if you don’t know the nuances.”
Centralization Can Mitigate Risk
There are barriers to social media: strict EU laws regarding privacy and opt-in consent, European Data Protection Regulations regarding data security and confidentiality, and liability. And then, of course, there is pharmacovigilance legislation. The rules governing reporting of adverse events is currently contained in the European Medicines Agency’s (EMA) Guidelines on Good Pharmacovigilance Practices. Pharma companies have strict obligations to report adverse events related to a medicinal substance or product. In particular, all serious suspected adverse reactions in the EU need to be reported to the company and to the European Medicines Agency within 15 days. And all non-serious suspected adverse reactions must be reported within 90 days.
Centralizing digital assets and internal policies is an important step to mitigate compliance risk, according to Jonathan Anscombe, Partner, A.T. Kearny, a global management consulting firm: “Many companies are still wary of fully embracing digital through fear of increasing compliance risk. In reality, the opposite is true and moving to wholly digital assets is the best way to ensure compliance.” He continues: “ However, companies need to develop robust internal policies around things like use of social media, and inevitably need to centralize the creation and management of digital content, which can be a big change for marketing.”
Renee P. Tannenbaum, Head of Global Customer Excellence for Abbvie, puts a fine point on the opportunity for all stakeholders. “To successfully advance digital initiatives, the industry must maintain control over process and content quality. This can be facilitated through cloud based review systems and web-based screeners that help promotional agencies and marketing teams filter out non-negotiable, non-compliant elements. These tools can help to get everyone on the same page, which in turn accelerates success.”
A confounding factor to the widespread adoption of social media is how pharmaceutical advertising is defined in Europe and the ban on direct to consumer advertising of prescription products. By its very definition, social media is public and cannot be restricted to one only group of users, in this case, physicians.
In one case, content from a press release on a new product launch was tweeted on Twitter. The company was fined because the use of Twitter itself was indicative of promotional intent. Twitter communications are public and because anyone could see the post, the use of Twitter was held to be a form of promotion directed to consumers, which is illegal.
William Long, a partner at the law firm Sidley Austin LLP and a member of its Privacy, Data Security and Information Law practice group, comments: “It is crucial for pharmaceutical businesses and their service providers to keep on top of the evolving European and national regulations affecting their use of social media. There are a number of grey areas which – while allowing for a degree of flexibility – also raise enforcement risks”.
Additionally, Thomas M. Lee, Co-Founder of Symplur adds, “Even without direct participation, there is tremendous value in all this for pharmaceutical companies because of the mounds of data being openly produced by the cross section of stakeholders that do participate in health-related social media conversations. Leveraging that data through advanced analytics that can offer deep and detailed insights is a rapidly emerging science, and its relevance in strategic planning will soon be indispensable.”
- Create fairly balanced and objective messaging
- Adhere to use of legally required minimum information
- Practice careful monitoring before publication
- Prevent consumers or patients from accessing healthcare provider websites
- Take care with testimonials
- Utilize take-down notices so the company can remove any content that is not in compliance.
There are more to do’s, but I don’t want to give away the content of our coursework on this subject developed in collaboration with Sidley Austin.
In the meantime, don’t forget to follow the position of social media platform providers, such as changes in policies by Facebook and others, and become aware of any new regulatory guidances impacting on social media and your companies, whether in the US or in Europe.