EY ROMANIA

  |  2013-09-17

Managing risk of the life sciences companies in the digital world

The demand for reliable, health-related information grows unabated. Without debate, digital technologies have profoundly transformed how we exchange information

The internet provides a variety of electronic channels (e-channels) – websites, blogs, apps and social media. People not only retrieve information but, more often, instantly share personal commentary and experiences with people around the globe.

 

E-channels have become established means for disease awareness, treatment alternatives, clinical enrollment, and much more. One could also argue that managing overall health has become one of the biggest beneficiaries of this digital revolution. Some life sciences companies have embraced this robust world of online exchange; others have not.

 

Unfortunately, for life sciences organizations, the complexities of risk to provide information in this digital world are intensifying – particularly from regulatory and legal perspectives. Risk arise when a life sciences company`s e-channel content is in violation of regulations that govern marketing and post-marketing surveillance.

 

Understanding the drivers of risk complexity

1.    The internet has become the global town square for exchanging information.

In health care, the internet is now the first port of call for key industry stakeholders – patients, physicians and companies – in seeking, or disseminating, tracking and storing health and drug related information. This influx of users and activity brings an increase in risk to an industry that is strictly regulated.

 


*source: EY Performance 5.3 Magazine, August 2013

 


2.    Regulations vary from country to country, and region to region.

Because online content has no borders, all posting must be carefully evaluated for their country implications. The complexity of these variations is compounded by the scarcity of high-level guidance from major regulatory bodies. To fill the void, smaller-market trade associations have taken the lead in defining the appropriateness of behavior and use of new social media platforms. 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.

 

3.    Types of e-channel content are rapidly multiplying and evolving.

Over the last decade, the types of the 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. For life sciences companies, efficiently managing this information is a formidable challenge. An organization may create and own its content or may have content that links directly to its website, for example, from disease management website.

 

4.    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 are often not structured to accommodate the e-channel area.  Most do not have a developed risk framework for digital content, are surprised to see how much content they have actually created from customers.

 

To take fuller advantage of e-channel communications and, at the same time, mitigate the associated risks, life sciences companies will need to invest in and develop comprehensive governance programs, and rigorous content management processes, systems and approaches to identify and monitoring risk.

 

·         Properly govern and assign clear ownership: an interdepartmental governing body should be charged with overseeing and evaluating risks and developing e-channel policy.

·         Understand your actual digital footprint and track it:  companies need to monitor their e-channel presence and identify and analyze its vulnerabilities and critical channels.

·         Periodically create a “heat map” of suspicious company – and user – generated content, by channel and risk:helps the company determine where may be weaknesses in its strategy, process, and skills and if the right technology systems are in place.

·         Develop a robust content management system:devise a detailed process for creating content along with a tool for tracking information and ensuring it is delivered efficiently.

·         Actively train, monitor and invest in risk management programs for your employees:clear policies and procedures are needed to help stuff understand the importance of e-channel use while ensure enough human capital is available to respond at any moment to any e-channels.

 

When thoughtfully use, e-channels are powerful media that add value to customer experience and simplify human connections. Opportunity, however, is not without risk. Life sciences companies will need to address the risks these channels pose and must methodically assess their danger zone, assign clear ownership and implement a comprehensive plan that will safeguard their organizations through the e-channel universe.

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