Perspectives from the Global Life Sciences Center

Without a doubt: • Digital technologies have profoundly transformed how we exchange information.

• The internet and smartphones provide unparalleled access to information through a variety of electronic channels (e-channels), from websites, blogs and podcasts to apps and social media.

• Social media platforms such as Twitter, YouTube and Facebook, coupled with the widespread distribution of wireless and mobile technologies, are rewriting the rules for how, and how often, people interact.

• People not only retrieve information but, ever more often, instantly share personal commentary with legions of people around the globe, from a feeling in the moment, to a routine everyday task, to a reference (good or bad) for a product, service or experience.

• There is no evidence that the complexities and risks of a digital world will be decreasing anytime soon.

We would also argue that the management of personal health has become one of the biggest benefits of this digital revolution. E-channels are now established means for disease awareness, treatment alternatives, clinical enrollment, research, sharing experiences and so much more. These channels provide ways to reach and engage health consumers, health providers and other stakeholders, to communicate marketing messages and to enhance disease awareness. They also drive competition through data mining and better understanding of stakeholder needs (see Exhibit 1). It’s no wonder the demand for reliable health-related information continues to grow. Unfortunately, for life sciences organizations seeking to participate in this robust world of online exchange, the risks of providing information in the digital world are intensifying and becoming more complex, particularly from regulatory and legal perspectives. Risks arise when a life sciences company’s e-channel content is in violation of regulations that govern marketing and post-marketing surveillance. But the question is, Which regulations govern? The borderless nature of the internet and access to information no longer fits easily into regional or country regulatory structures.

Prescriptions

This is one of a series of articles written by thought leaders from EY’s Global Life Sciences Center. The Center is dedicated to offering relevant insights and industry leadership on the accounting, tax, risk, transaction and industry issues facing executives and boards in the biotech, pharmaceutical and medical device sectors.

From new market entrants and regulatory reform to expiring patents and the growing challenge of chronic diseases, the business of health for life sciences companies is changing. Through the Center, we bring together more than 7,000 sector-focused professionals worldwide to anticipate trends, address implications and help you achieve success.

For additional research, insights and perspectives, visit ey.com/lifesciences or connect with us on our blog at lifesciencesblog.ey.com. You can also follow us on Twitter @EY_LifeSciences.

Managing regulatory and legal risk in the digital worldMeeting the challenge in the life sciences industry

• Websites: A website is a collection of web pages that can be accessed through the internet at a static web address. It can consist of one page, or of tens of thousands of pages, depending on the goals of the site owner. Companies have complete control over how information is presented. Life sciences companies use their websites to provide information about their companies and products as well as develop a positive brand image.

• Apps: Apps, short for “applications,” are software programs that are design to run on personal computers, smartphones and other electronic devices. Life sciences companies are using apps in a variety of ways, from helping patients learn more about their prescription drugs and adhere to treatment plans, to managing clinical trials and engaging health care providers in product education.

• Community forums: Forums, online discussion sites where people can hold conversations in the form of posted messages, may be 1) sponsored and monitored by companies; 2) not affiliated with a company or brand, including those sponsored by patient support groups such as www.patientslikeme.com and information platforms such as WebMD; or 3) created as an online community for health care professionals, such as www.sermo.com. Discussions can be joined or started. Insights from this knowledge transfer can help the industry to understand customer perspectives and current treatment trends, which can lead to better positioning of products and stronger customer relationships.

• Blogs: A blog is a web log that is updated regularly by its author. It can contain information related to a specific topic and often serves as a venue for delivering personal and professional viewpoints. Blogs provide life sciences companies with opportunities to interact with online visitors on industry “hot topics” while promoting company products and solutions.

• Podcasts: Podcasts are similar to blogs in that they offer user commentary on a subject, but they are distributed in audio rather than written format. Users may load these podcasts onto their phones or other MP3-playing devices, or listen to them on a computer at the time of download.

• Video and photo sharing sites: On sites such as YouTube and Flickr, users can post videos and pictures, tagging posts with information about their themes and content. For life sciences companies, there are many opportunities from leveraging these visual sites, from offering health education videos to creating a photo gallery that features customer-submitted photos, illustrating how the company’s products have impacted patient lives.

• Social networking sites: Sites such as Facebook, LinkedIn and Pinterest enable individuals to connect to and communicate with others based on friendship, professional relationships or shared interests. Typically, users can create personalized profile pages and post content to their own or other users’ profiles. For example, on Facebook, companies might use the “messaging” feature to communicate directly with consumers who have submitted questions or comments about the company or its products. Or they may build a community for patients who have a shared chronic condition, providing them with an opportunity to exchange personal stories online and improve their experience in living with the disease. Facebook members can also become “fans” of the company or of one of its products, furthering awareness and fostering brand loyalty.

• Twitter: Through Twitter, users can distribute “tweets” — limited to 140 characters — to a large audience at one time. Companies are using Twitter for varied purposes, from providing alerts and updates to sponsoring chats.

• Wikis: Websites such as Wikipedia contain dynamic articles, edited by multiple people, on a variety of topics. They provide an opportunity for company representatives to share the latest knowledge, such as research breakthroughs and advances in treating disease.

Exhibit 1. Types of e-channels and their uses

2 | Prescriptions Perspectives from the Global Life Sciences Center

Of course, in recent years, pharmaceutical companies have learned that the cost of marketing noncompliance is steep. According to Société Générale, the cumulative amount of marketing-related litigation costs and penalties paid out by a panel of 21 pharma companies in 2012 was a staggering US$26 billion. This amount was not driven by activities in the digital realm, but beyond the litigation costs and fines imposed for noncompliance, negative feedback (including on e-channels) from these penalties can damage a company’s brand, share price and overall revenue.

Current regulations did not anticipate social media, and comprehensive rules from regulatory bodies have been slow to emerge. Some guidance has come in the form of published warning letters from the U.S. Food and Drug Administration (FDA), as well as guidance from multiple industry trade associations, such as the European Federation of Pharmaceutical Industries and Associations, the Prescription Medicines Code of Practice Authority (PMCPA)/The Association of the British Pharmaceutical Industry and the Swedish Association of the Pharmaceutical Industry.

In the US, the FDA has addressed the issue with a series of warning/untitled letters delineating problems with online content. These notifications cite the specific violation and request prompt and voluntary corrective action. From 2008 to 2012, the agency issued 199 warning letters with 525 cited violations, 34% of which were related to e-channels (see Exhibits 2 and 3). In 2011, the FDA provided some direction on how life sciences companies can address unsolicited requests on the internet for off-label information on drugs and medical devices. However, the agency has yet to issue comprehensive and updated guidelines for the industry on reporting any adverse drug experiences they learn of online or on internet sites they sponsor. This lack of clarity has given life sciences companies ample reason to proceed with caution in their online activities.

Exhibit 2. Volume of promotion rules violations cited by the FDA, 2008–12

Source: FDA warning and untitled letters (DDMAC/CPDP, APLB, OCBQ).

0 20 40 60 80 100

Omission and minimizationof risk information

Unsubstantiated claims

Overstatement of efficacy

Broadening of indication

Misleading efficacy claims andmisleading presentation

Omission of material facts

Promotion of an unapproved use and promotionof an investigational new drug

Failure to submit under form FDA-2253and failure to submit for review

Inadequate presentation of established nameand failure to use required established name

Inadequate communication of indication

Failure to provide adequate directions for use

Use of outdated product labeling

Inappropriate reminder labeling

Offline

Online

3 Managing regulatory and legal risk in the digital world |

Following methodologies long established by trade associations, the FDA in 2010 launched its Bad Ad Program, designed to help raise awareness of misleading drug promotion and provide an easy way to report it. Because of its accessibility and broader visibility, content on the internet will likely be a leading source of reports in the years to come.

In the UK, the PMCPA issued a warning for promoting prescription products on a company-managed Twitter handle. The 140-character messages were extracted from titles of press releases, the full version of which had been approved by the company’s legal and compliance teams but not the content of its related tweets. The 2011 guidance from the PMCPA provides another parameter for the industry. It notes that although prescription information can be supplied directly or indirectly to the public, this information must be factual and presented in a balanced way with mentions of product risk and safety.

In the US, the FDA counseled against the inappropriate use of the Facebook Share widget, which enabled consumers to share on their personal Facebook pages a link to one of the company’s drug brand pages. The thumbnail generated by the tool was cited for omitting risk information, broadening indications of the drug and neglecting to substantiate superiority claims.

In the absence of in-depth guidance, companies can use such warnings from regulators as cues in devising their e-channel risk management strategies. Broadly, precautions that must be provided on a label or in a print or television advertisement, as well as in off-line interactions with health care professionals at conferences or at their place of work, must also be provided in the e-channel space, and risks must be fairly presented alongside benefits.

Beyond regulations: addressing other risks Beyond financial penalties for noncompliance, e-channels expose companies to other business risks, such as potential damage to brand and reputation and leakage of sensitive and confidential information. Yet being without a community of active “followers” can leave a company equally vulnerable. It can be argued that the stronger a company’s e-channel presence, the greater its defense in managing conversations and diffusing crises. When credibility is under attack, companies that have built a community of active online “followers” may fare much better than those who have not. Conversely, a weak online presence may lead to the theft of online identity, providing room for health and safety hazards such as counterfeit selling.

Yet just as companies are testing online venues to expand their markets, the risk of providing information in the digital world is intensifying and becoming more complex.

Ignoring potential vulnerabilities is, irrefutably, risky business. To safeguard against these types of e-channel risks, life sciences companies need to install comprehensive governance programs, rigorous content management processes and systems, and vigilant approaches to identifying, monitoring and mitigating risk. In this white paper, we provide an overview of e-channel opportunities and challenges, with a focus on regulatory and legal risk.

Exhibit 3. Volume of FDA warning/untitled letters, 2008-12

Source: FDA warning and untitled letters (DDMAC/CPDP, APLB, OCBQ).

1820

36

22

16

8

6

6

1

3

1816

912

6

2008 2009 2010 2011 2012

Online (APLB/OCBQ)Online (OPDP)

Offline (APLB/OCBQ)Offline (OPDP)

1

1

4 | Prescriptions Perspectives from the Global Life Sciences Center

Understanding the drivers of risk complexityFor life sciences companies in the e-channel world, risk complexity is driven by four factors:

1. The internet has become the global “town square” for exchanging information. People around the world are getting connected to digital content in many more ways than we could envision just a few years ago. In health care, the internet is now the first port of call for key industry stakeholders — patients, physicians and companies — in seeking, disseminating, tracking and storing health- and drug-related information (see Exhibit 4). Payers, employers and regulators are also using e-channels to learn about industry developments. This influx of users brings an increase in risk, as life sciences is the most highly regulated of all industries — raising the chances of breaking the rules that structure how companies dispense information and interact with patients and other stakeholders. For many drugmakers, the explosion in e-channel use, internally and externally, has outpaced the ability to develop policies, adjust strategies and train staff.

2. Regulations vary from country to country and region to region. Different rules apply to different countries and regions. Yet because online content has no borders, all postings must be carefully evaluated for their country implications. Some of the major differences will lie in a product’s approved label uses, which may vary considerably from one country to the next — opening venues for inappropriate label communication on the internet (off-label promotion). A similar case can be made for prescription product direct-to-consumer advertising, which is suitable only in some parts of the physical world. The complexity of these variations is compounded by the scarcity of specific guidance from major regulatory bodies noted previously. A second layer of complexity is the pervasiveness of the internet, which raises the question of how a company applies the boundaries and the sovereign country regulations to internet communications.

The lack of clarity from the FDA has given life sciences companies ample reason to proceed with caution in their online activities.

Recent surveys of patients, physicians and pharmaceutical companies reflect an increased reliance on e-channels for information and communication:

Patients

• Seventy-three percent of US adults (age 18 and older) use online health information and tools, and new research finds that these resources are shaping consumers’ choices of health products and services.

• Seventy-two percent of European online consumers (age 18 and older) are social health users (they have conducted some of the following activities online for health: used a community, group or social networking website or conducted social-related activity online such as reading or posting on health blogs, message boards or health ratings websites).

• Thirty-five percent of US adults are “online diagnosers”; they have gone online to try to figure out what medical condition they or someone else might have.

• Twenty percent of internet users have consulted online reviews of particular drugs or medical treatments, doctors or other providers, and hospitals or medical facilities.

Physicians

• More than two-thirds of US physicians use online videos to learn clinical information.

• Twenty-two percent of European physicians use physician-only social networks, up from 13% adoption in 2011.

• More than 4 in 5 European physicians who use or are interested in using physician-only social networks are open to interacting with pharmaceutical companies on these networks.

Pharmaceutical companies

• Top 10 drugmakers have invested in digital marketing groups and have on average more than 23 FTEs dedicated to these new media activities.

• Ninety-one percent of the companies maintain internal resources to perform or manage eMarketing activities.

Exhibit 4. Statistics tell the story of the e-channel surge

Sources: Health Online 2013, Pew Internet and American Life Project; Cybercitizen Health® U.S. 2012, Manhattan Research; Taking the Pulse® Europe 2012, Manhattan Research; Cybercitizen Health® Europe 2012, Manhattan Research; Taking the Pulse® US 2012, Manhattan Research; Pharmaceutical Digital Marketing and Social Media, Cutting Edge Information, 2012.

5 Managing regulatory and legal risk in the digital world |

Source: EY, 2013.

Most control Least control

Owned by the company

Owned or contracted content

Private contentInvitation only; static or dynamic

Identifiable userInvitation only

Identifiable userRegistered

Unidentifiable user

Static

Company-generated User-generated

Regulatory and compliance Brand and reputationRisk continuum

Static with contact information

Dynamically updated

Contracted by the company

Sponsored or contributed by the company

Linked to the company

Relevant to the company

Exhibit 5. Forms and sources of e-channel content

Source: EY, 2013.

The myth of pharmacovigilance risk In protecting brand and reputation in the online world, companies face multiple hazards. A consumer may use a social media tool to share an adverse event or a product complaint resulting from his or her use of a drug, further eroding consumer trust. Although organizations cannot control or change such events, they can face even more peril if they fail to properly monitor their online activities or to respond appropriately when a response is warranted, such as in an unsolicited off-label query or inquiry about the availability of a certain product.

In this context, and considering the industry’s tight regulations of, and uncertainties over, pharmacovigilance reporting requirements, Facebook initially offered pharmaceutical companies the option of reviewing public comments before their posting. It revoked its exception in 2011, leading several high-profile drugmakers to take down their Facebook pages, while those still on Facebook navigate today through uncharted waters.

However, despite the rapidly growing volume of user-generated content available online, a recent study has found that as few as 0.1%–0.2% of posts in product-related social media conversations mention adverse events, and only one in seven of these mentions provides enough information for a full pharmacovigilance report (source: “Adverse event reporting in social media,” Visible Technologies, October 2011).

3. Types of e-channel content are rapidly multiplying and evolving. Over the last decade, the variety of information and means of exchange on e-channels has expanded beyond company-generated content and company-governed distribution to include online dialogues and user-generated postings. As life sciences companies move out into the world with information about their products and services, managing this information — and getting it to the right people at the right time, in the right format and through the appropriate channels — is a formidable challenge.

The forms, sources, accessibility and interconnections of e-channel content are many (see Exhibit 5). A company needs to understand what types of media are being produced, what information is being discussed in each of these types and who is producing the information. An organization may create and own its content, may have content created on its behalf, or may have content that links directly to its website, for example, from disease management websites. If a company sponsors an organization, links to the organization on the web could be interpreted as an endorsement. Also, conversations that happen on the web may be relevant to the company and must be closely monitored.

6 | Prescriptions Perspectives from the Global Life Sciences Center

Incr

easi

ng le

vels

of r

isk

Receiving or answering Poor response time Information escalation issue Non-compliant answer

Updating or maintaining Content not up to date

Posting Approval not received

Transposing Content distorted, mistranslated, incomplete

Editing Non-compliant content

Dialoguing Adverse event non-reporting Non-compliant response

Analyzing Lack of transparency in listening mode Usage of patient statement Data confidentiality issues

Source: EY, 2013.

Exhibit 6. Stages of risk in the e-channel pathway4. Life sciences companies have not invested adequately in managing this information. Given the complexity of navigating the regulatory environment and of managing this content for different products, countries and stakeholders, life sciences companies potentially face large and looming risks. To date, many companies have not structured their operations to accommodate the e-channel area. Most do not have a developed risk framework for digital content, know little about how much content they have actually created and cannot gauge their current level of exposure.

Lapses in process and control can typically occur at each step of the e-channel information pathway, compounding the likelihood and impact of risks (see Exhibit 6). For example, content may be non-compliant, distorted, mistranslated, incomplete or outdated. Material may be posted before it is reviewed and granted appropriate approval. Online dialogues may not be monitored systematically, so that consumer inquiries go unanswered or information for signal detection is not collected in a timely way. Analysis of online activity by pharmaceutical companies may be compromised by a lack of transparency when in listening mode or by breaking personal data confidentiality.

Source: EY, 2013.

7 Managing regulatory and legal risk in the digital world |

Addressing digital content and e-channel risksAlong with varying regulations issued from different regulatory bodies, companies must also adhere to trade association codes as well as their own internal company policies. The slow pace of regulatory development and guidance related to internet and social media communications compounds this complexity. As e-channels continue to evolve, regulations may continually fail to keep up. Complete regulatory reform may be required for this new digital paradigm.

Be ever more vigilant of your contentRegardless of the pace of regulation for e-channel use, life sciences companies must be continually vigilant in the posting of content, ensuring that it has been reviewed through established processes, is authorized and complies with regulations. They must also monitor closely user-generated content on their e-channels, being watchful for off-label promotion and adverse event reporting.

Constantly monitor A typical global life sciences company has disseminated since its inception between half a million and a million individual web pages — with its product mentioned on 85% of these pages. Each time the product is mentioned, it is accompanied by a host of content required by regulations. Most companies are unaware that they have created this extraordinarily high level of web volume.

A typical global life sciences company has disseminated between half a million and a million individual web pages — with its product mentioned on 85% of these pages.

Beyond product information, also embedded in this content are email and telephone contact points that are subject to adverse event and product quality reporting processes. For example, in the event a company representative is contacted electronically by a patient or health care professional citing a problem with a product, and the email is not processed timely, the company may be in violation of pharmacovigilance timeline requirements.

Along with monitoring the information they create, or that is created on their behalf, companies need to listen online to what customers and potential customers are saying about them throughout the e-channel universe. This requires keeping up with their blogs and community forums, as well as monitoring their Facebook and Twitter feeds constantly.

Ensure accuracyA second key review area from a content perspective is ensuring accuracy of information. Companies need to make sure they are giving the right information about each product, including the right indication, the right risks and the right benefits, in a fair and balanced way. Because every country has different regulatory requirements, information must be painstakingly managed. Technology might also impact the accuracy of information. For example, Twitter’s 140-word limitation may be a breeding ground for message misinterpretation, or in other cases the use of certain web browsers might impair the balance and display of risk and benefit information.

Equip the organization to leverage digital opportunity and mitigate the associated risksTo take fuller advantage of these opportunities and, at the same time, mitigate the e-channel risks associated with it, life sciences companies need to invest in and develop comprehensive governance programs and rigorous content management processes, systems and approaches to identifying and monitoring risk.

Properly govern and assign clear ownership A governing body, typically an interdepartmental team, should be charged with developing e-channel policies, as well as overseeing and periodically evaluating risk. Because social media cuts across many areas of an organization, from marketing and communications to human resources and legal, any policy surrounding its use should result in a multidisciplinary approach.

8 | Prescriptions Perspectives from the Global Life Sciences Center

Exhibit 7. Taking inventory

How many:• Domains does your company own?• Active web pages does your company currently have online and

accessible?• Email addresses and contact forms are available for inquiries?• Social media accounts does your company endorse and actively

manage?• Third-party websites do your employees contribute content to, and

your company contribute money to?

Also, an executive should be charged with owning the effort — and driving and managing awareness throughout the organization. In some companies, this person is the global head of communications; in others, it is the chief risk officer or chief information officer. Some organizations have created the equivalent of an “e-channel czar,” a position that typically resides in the compliance department and serves as the central clearinghouse for all e-channel postings and accounts.

Understand your actual digital footprint and track it Companies need to see how far their presence on e-channels extends. Tools such as web crawlers are useful to search the internet and return relevant posts based on specified criteria. Companies should prepare raw inventories of their internet-based channels, mapping all the channels and content they have created or contributed to (see Exhibit 7). They can then assess each form of content from a risk perspective and identify and analyze their most critical channels and vulnerabilities.

Periodically create a “heat map” of suspicious company- and user-generated content, by channel and riskIn the absence of clear regulatory guidelines, each company needs to assess its acceptable level of risk. A heat map tool can help company management more easily determine where there may be weaknesses in its governance strategy, its processes and the skills of its people, and whether the right technology systems are in place to manage information on the web.

Such heat maps are generated by assessing company- or user-generated content available through chosen channels against an agreed-upon risk framework. There are, however, two key challenges in doing this: companies typically do not know what content they are producing, nor have they developed a risk framework for digital content.

To overcome these challenges, a company needs to:

• Employ sophisticated crawling tools to capture a snapshot of its digital footprint

• Convene relevant stakeholders (legal, medical, regulatory, etc.) to agree on the risk profile for digital content — often a robust conversation

The sheer volume of information and the complexity of the risks involved now require the use of modern assessment techniques.

Depending on its design and purpose, the heat map will help in identifying channels that pose risk and assessing the robustness of the systems (governance, people, process and technologies) in place to mitigate those risks.

Develop a robust content management system Companies should devise a detailed process for curating content — writing, editing, approving, publishing, updating and removing it when it is inaccurate or outdated — along with a digital asset library for tracking information and ensuring it is delivered at the right time to the right market.

Actively train, monitor and invest in risk management programs for your employees As regulatory guidelines continue to evolve, clear policies and procedures are needed that will help staff understand the importance of e-channel use — and share accountability for avoiding risk. An often-cited study (Altimeter, 2011) found that 76% of social media crises could have been prevented or diminished had the company had in place the proper training, staff and processes to avert these crises. E-channel monitoring and risk mitigation is a 24x7 job. Companies must ensure that they have enough human capital to respond online at any moment, in any time zone, on any channel.

E-channel monitoring and risk mitigation is a 24x7 job.

9 Managing regulatory and legal risk in the digital world |

Exhibit 8. Sample heat map

PCV Safety Accuracy Promotion

Domain type

Geography Overall risk rating

PV_1 IA_7 IA_10 IA_15 IA_18 IA_19 IA_22 IA_23 IA_24 Promo_29 Promo_35 Promo_37 Promo_38

Disease .es 4 0% 87% 47% 13% 0% 0% 100% 0% 0% 100% 38% 43% 0%

Disease .nz 4 0% 75% 50% 88% 0% 100% 100% 0% 0% 75% 13% 13% 13%

Disease .cz 3 0% 80% 0% 0% 0% 0% 0% 0% 0% 0% 0% 30% 80%

Disease .com 3 0% 80% 40% 60% 50% 0% 0% 0% 0% 80% 0% 40% 40%

Product .hk 3 5% 50% 5% 45% 0% 0% 0% 0% 0% 60% 5% 10% 55%

Product .es 3 3% 62% 3% 50% 0% 0% 0% 0% 0% 29% 3% 76% 44%

Corporate .uy 3 21% 40% 0% 1% 0% 50% 0% 0% 0% 41% 0% 0% 40%

Corporate .com 3 1% 39% 5% 32% 0% 0% 0% 0% 0% 38% 2% 5% 30%

Disease .ba 3 0% 100% 0% 100% 0% 0% 0% 100% 0% 100% 0% 0% 100%

Disease .com 3 0% 50% 12% 43% 0% 0% 100% 100% 0% 45% 1% 13% 26%

Disease .br 3 0% 50% 12% 43% 0% 0% 100% 0% 0% 45% 1% 13% 27%

Disease .com 3 0% 50% 0% 50% 0% 0% 100% 100% 0% 0% 0% 0% 50%

Disease .cz 3 0% 96% 17% 17% 0% 0% 0% 0% 100% 74% 0% 22% 13%

Product .com 3 0% 63% 0% 94% 0% 0% 0% 0% 0% 94% 0% 0% 94%

Disease .com 3 0% 4% 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 4%

Product .uk 3 0% 4% 0% 4% 0% 0% 0% 50% 0% 100% 0% 0% 4%

Corporate .md 3 0% 38% 13% 38% 0% 50% 0% 0% 0% 100% 0% 13% 13%

Product .com 3 0% 0% 0% 0% 100% 0% 0% 0% 0% 100% 0% 0% 0%

Product .com 3 0% 94% 12% 71% 0% 0% 0% 0% 0% 99% 1% 1% 95%

Disease .uk 3 0% 94% 47% 94% 0% 0% 0% 0% 0% 18% 6% 12% 94%

Corporate .com 3 0% 70% 40% 28% 0% 0% 0% 100% 0% 84% 13% 13% 17%

Disease .cz 3 0% 60% 40% 40% 0% 0% 0% 0% 100% 100% 0% 40% 0%

Disease .com 3 0% 100% 0% 100% 0% 100% 0% 0% 0% 0% 0% 100% 100%

Disease .com 3 0% 100% 0% 0% 100% 0% 0% 0% 0% 100% 0% 0% 100%

Corporate .com 3 1% 90% 8% 80% 0% 0% 0% 0% 0% 86% 4% 9% 79%

Product .com 3 0% 100% 0% 0% 0% 0% 0% 0% 0% 47% 22% 22% 91%

Disease .rs 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 7% 0% 0% 0%

Disease .dk 2 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0%

Corporate .br 2 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0%

Clinical .com 2 0% 0% 0% 0% 0% 0% 20% 100% 0% 0% 0% 0% 0%

Product .cl 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .ar 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .hu 2 0% 0% 0% 0% 0% 0% 50% 50% 0% 0% 0% 0% 0%

Corporate .ee 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Corporate .cz 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Corporate .am 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0%

Product .nz 2 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0% 0%

Clinical .com 2 0% 0% 0% 0% 0% 0% 20% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Disease .com 2 0% 0% 100% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%

Note: Red = high risk Orange = medium risk Yellow = low risk Gray = minimal risk Green = zero risk

10 | Prescriptions Perspectives from the Global Life Sciences Center

PCV Safety Accuracy Promotion

Domain type

Geography Overall risk rating

PV_1 IA_7 IA_10 IA_15 IA_18 IA_19 IA_22 IA_23 IA_24 Promo_29 Promo_35 Promo_37 Promo_38

Disease .es 4 0% 87% 47% 13% 0% 0% 100% 0% 0% 100% 38% 43% 0%

Disease .nz 4 0% 75% 50% 88% 0% 100% 100% 0% 0% 75% 13% 13% 13%

Disease .cz 3 0% 80% 0% 0% 0% 0% 0% 0% 0% 0% 0% 30% 80%

Disease .com 3 0% 80% 40% 60% 50% 0% 0% 0% 0% 80% 0% 40% 40%

Product .hk 3 5% 50% 5% 45% 0% 0% 0% 0% 0% 60% 5% 10% 55%

Product .es 3 3% 62% 3% 50% 0% 0% 0% 0% 0% 29% 3% 76% 44%

Corporate .uy 3 21% 40% 0% 1% 0% 50% 0% 0% 0% 41% 0% 0% 40%

Corporate .com 3 1% 39% 5% 32% 0% 0% 0% 0% 0% 38% 2% 5% 30%

Disease .ba 3 0% 100% 0% 100% 0% 0% 0% 100% 0% 100% 0% 0% 100%

Disease .com 3 0% 50% 12% 43% 0% 0% 100% 100% 0% 45% 1% 13% 26%

Disease .br 3 0% 50% 12% 43% 0% 0% 100% 0% 0% 45% 1% 13% 27%

Disease .com 3 0% 50% 0% 50% 0% 0% 100% 100% 0% 0% 0% 0% 50%

Disease .cz 3 0% 96% 17% 17% 0% 0% 0% 0% 100% 74% 0% 22% 13%

Product .com 3 0% 63% 0% 94% 0% 0% 0% 0% 0% 94% 0% 0% 94%

Disease .com 3 0% 4% 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 4%

Product .uk 3 0% 4% 0% 4% 0% 0% 0% 50% 0% 100% 0% 0% 4%

Corporate .md 3 0% 38% 13% 38% 0% 50% 0% 0% 0% 100% 0% 13% 13%

Product .com 3 0% 0% 0% 0% 100% 0% 0% 0% 0% 100% 0% 0% 0%

Product .com 3 0% 94% 12% 71% 0% 0% 0% 0% 0% 99% 1% 1% 95%

Disease .uk 3 0% 94% 47% 94% 0% 0% 0% 0% 0% 18% 6% 12% 94%

Corporate .com 3 0% 70% 40% 28% 0% 0% 0% 100% 0% 84% 13% 13% 17%

Disease .cz 3 0% 60% 40% 40% 0% 0% 0% 0% 100% 100% 0% 40% 0%

Disease .com 3 0% 100% 0% 100% 0% 100% 0% 0% 0% 0% 0% 100% 100%

Disease .com 3 0% 100% 0% 0% 100% 0% 0% 0% 0% 100% 0% 0% 100%

Corporate .com 3 1% 90% 8% 80% 0% 0% 0% 0% 0% 86% 4% 9% 79%

Product .com 3 0% 100% 0% 0% 0% 0% 0% 0% 0% 47% 22% 22% 91%

Disease .rs 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 7% 0% 0% 0%

Disease .dk 2 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0%

Corporate .br 2 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0%

Clinical .com 2 0% 0% 0% 0% 0% 0% 20% 100% 0% 0% 0% 0% 0%

Product .cl 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .ar 2 0% 0% 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0%

Product .hu 2 0% 0% 0% 0% 0% 0% 50% 50% 0% 0% 0% 0% 0%

Corporate .ee 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Corporate .cz 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Corporate .am 2 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0%

Product .au 2 0% 0% 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0%

Product .nz 2 0% 0% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0% 0%

Clinical .com 2 0% 0% 0% 0% 0% 0% 20% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Product .com 2 0% 0% 0% 0% 50% 0% 0% 0% 0% 0% 0% 0% 0%

Disease .com 2 0% 0% 100% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%

Note: Red = high risk Orange = medium risk Yellow = low risk Gray = minimal risk Green = zero risk

Moving forwardWhen thoughtfully used, e-channels are powerful media that simplify human connections and present prime opportunities for adding value to the customer experience. As online conversations continue to proliferate, life sciences companies can help shape the dialogue — focusing on and addressing consumer needs, extending market reach and building long-term relationships.

Opportunity, however, is not without risk. As e-channel-related breaches continue to surface, life sciences companies, rather than taking a piecemeal approach, will need to address holistically the risks these channels pose to all parts of their businesses. They must methodically assess their danger zones, assign clear ownership and implement comprehensive plans that will safeguard their organizations, today and tomorrow, throughout the e-channel universe. Only by taking the risk of engaging online can companies reap the rewards — becoming a trusted partner in the health care journey of patients and other stakeholders.

For more information, please contact: Adlai Goldberg Partner, Advisory ServicesEY, Switzerland+41 58 286 4488adlai.goldberg@ch.ey.com

Dr. Frank KumliSenior Manager, Advisory Services and Resident,Global Life Sciences CenterEY, Switzerland+41 58 286 8637frank.kumli@ch.ey.com

Dr. Hicham NaimSenior Manager, Advisory ServicesEY, Switzerland+41 58 286 3152hicham.naim@ch.ey.com

Dr. Caroline Falciola Manager, Advisory ServicesEY, Switzerland+41 58 286 4073caroline.falciola@ch.ey.com

11 Managing regulatory and legal risk in the digital world |

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© 2013 Ernst & Young LLP. All Rights Reserved.

SCORE no. FN0122

1308-1116901

ED 0114

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting, tax, or other professional advice. Please refer to your advisors for specific advice.

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