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Will Roche's precedent push the regulatory community to create standards that will level the playing field for all contenders?
Swiss drug maker Roche has moved to master the hazard-prone digital communications space with a new set of internal guidelines on when, where, and how to apply social media tools to communicate with key stakeholders and the public. The initiative is a novelty for Big Pharma—Roche says it is the first in the industry to go public with a transparent standard for online behavior—and follows on the heels of written guidance issued by other corporate behemoths such as IBM, Wells Fargo, and Coca-Cola.
The 14 Social Media Principles (see chart) piggyback on Roche's existing group code of conduct and communications policy. The guidance relies on simple "common sense" language, but carves new ground in making explicit the need to: 1) Differentiate between using social media in a personal versus professional context; 2) Build clarity in speaking about the company and on behalf of it, through third parties; and 3) Advocate for employees to serve as "scouts" in tapping networks to identify "sentiment and critical issues."
Roche Social Media Principles
The 14 principles consist of brief bullet points and are divided into two sections of seven principles each, covering personal and professional online activities.
The document has been welcomed—if not widely celebrated—by the digital pharma community as a good example of corporate transparency and openness. Speaking on his STweM blog (Stwem.com) on Aug. 17, the day the guidelines were released, Andrew Spong, Editorial Director, Nexus, at the PSL Group, called it "trust enabling," a "spur to ethical conduct," and heralding "a new era for healthcare communications."
But for all their simplicity, clarity, and common sense, are the guidelines too general to be meaningful? The question is important as it also goes to the heart of how legal approaches to the regulation of online communications differ between the US and Europe. In the latter case, such information is subject to self-regulation, with the industry policing itself, while in the US companies must take a far more cautious stance because the FDA is the ultimate arbiter of what companies and their employees can or cannot say.
Where Roche can be said to be breaking new ground—and where it is also laying itself open to criticism—is in its attempt to bring structure to the kind of ambivalent behavior that obscures the dividing line between personal and professional use of social media. Coming from a US legal perspective, Arnie Friede of FDALaw.com, in an Aug. 17 post on the EyeOnFDA blog, noted the principles "suggest that employees can speak 'about Roche' in some kind of 'personal capacity' ... without providing clear ground rules about the permissible content of these communications." He adds that while the guidance document amounts to a "nice touch" from a PR/perception-of-transparency perspective, "absent clear rules about what things may be discussed ... the new standards may create more problems than they solve."
Not surprisingly, Sabine Kostevc, Roche's head of Corporate Internet and Social Media, disagrees. She told Pharm Exec: "Before this set of guidelines, we had a very elaborate document with do's and don't's as well as many references to some very detailed SOPs [standard operating procedures]. It is a key learning from that document that we needed a shorter and more basic first reference that was not too long to scare people away from reading it at all."
Certainly, parts of the guidance are refreshingly straightforward, encouraging staff to disclose their affiliation with Roche when blogging or commenting on any related products or initiatives in a public forum. This seems responsible enough. Removing the shield of anonymity that can both define and cloud debates in online forums should, in theory, lead to more accountable and 'trustworthy' debating. Not least, as Spong comments, it should act as "a disincentive for the sort of 'Jekyll and Hyde' characters I am sure we have all met in our professional lives."
But for some, the 'refreshingly straightforward' also yields a faint whiff of 'Big Brother'. "You are 'speaking' publicly and your contribution may stay searchable and retrievable for a long time to a broad audience," the guidelines say. "Anything that brings damage to our business or reputation will ultimately be your responsibility."
Friede suggests that this leaves "too much liability associated with company employees. The principles need to be very clear on who has the authority and responsibility to speak about the company online." Even Spong admits that this responsibility is "empowering to the point that some of those on the payroll may consider it downright terrifying."
Kostevc counters, "It is a fact of life that people will always discuss topics or issues around us—online and offline—and nobody is in a position to prevent this. We can only try to make sure that it happens in a responsible way where our employees are involved.
The flexibility that the principles aim for is motivated by the fact that Roche is a global company and thus has to confront the challenges of implementing the guidelines in a specific country. The Roche document concedes as much in the 'professional' section of the principles when it says, "it is not realistic to have each response undergo full approval by communications, legal, and regulatory. Therefore, you should establish with your usual approval partners a common agreement on a bandwidth of topics and instances that may not require the normal process."
Different countries will likely interpret this "bandwidth" differently. Could what is acceptable in one country raise serious concerns in another, rendering the operating procedures meaningless on a truly global scale? "On the contrary," says Kostevc. "As a highly decentralized organization, this is a standard approach for Roche spokespersons worldwide. They are trained professionals and handle issues independently in their fields, and would know when a certain topic exceeds their competence."
Perhaps the most talked about point in the principles is the call for employees to act as scouts. "You are one of the most vital assets for monitoring the social media landscape," the document tells Roche staff. "If you come across positive or negative remarks about Roche or its products online that you believe are important, consider sharing them by forwarding them to your local communications department." The language is less strident here, and no one is under any illusion that this is an obligation. And if it gently secures the services of most of Roche's 80,000-strong workforce as global media scouts, tracking and monitoring what is being said about the company worldwide, so much the better for Roche.
Nevertheless, the principles have to be sound in addressing the burden of compliance, especially on safety issues where the industry is uniquely vulnerable. Hence the stern directive: "When you come across information where somebody mentions side-effects after having taken one of our drugs in a credible and identifiable way, you have to immediately forward such information to the global Drug Safety Team for further action."
This language prompted the Social Media Healthcare blog to declare: "So, in an off-the-clock capacity, the employee is not only burdened with understanding global regulatory structures/impacts, but is now charged with flagging adverse reactions to the Roche Drug Safety Team? And what if they don't?" Friede commented, "I submit that Roche employees, who are encouraged by the company to speak 'about Roche' may be effectively acting as 'agents' of the company and that their communications may be ascribed to the company for regulatory, legal, and other purposes."
In a recent interview on InPharma.com, Kostevc casually played down any negative connotations to the call for employees to act as scouts. "There has not been general training on monitoring on being a 'scout', as this is not seen as a specific task for the social media user. We merely wanted to offer guidance on where to go if colleagues come across any issues. Apart from that, all employees are educated and required to report adverse event information that they encounter, [regardless of the] communication channel."
Squabbles about wording and the concerns of those with a less charitable view of the guidelines notwithstanding, the consensus seems to be that Roche's document is a step forward for an industry still feeling its way around the social media minefield. Whatever the principles' long-term impact, it is inevitable that other Big Pharma companies will try to build on the document and follow the Roche lead. Companies that don't, Spong warns, "do not have a hope of reaching these heights unless they begin to participate more fully in the social media dialogue." Over time, these multiple responses may produce a consensus approach and prod the regulatory community to fall in line with clear standards that emulate the best practices that emerge.