Keeping it Simple

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."

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.

Assessing the Risk Factors

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."

A Hint of Big Brother?

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 http://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.