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Risk management guide for life sciences companies

Life sciences companies are continuing to rapidly grow their use of social media and digital channels as a form of communication with the public, healthcare professionals (HCPs), healthcare organizations (HCOs), patient organizations (POs) and others. Because of this, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) – both pharmaceutical trade associations – issued a joint guidance on social media and digital channels that applies to their member companies (i.e., companies and industry bodies who are a member of the IFPMA or EFPIA). This joint guidance will serve as an important new standard in an area of compliance that is rapidly evolving as a result of the growing and increasingly multi-faceted use of social media by the life sciences industry.   The IFPMA and EFPIA emphasize that this joint guidance will be continuously evolving. Nevertheless, it is also firmly rooted in compliance principles that already form some of the key elements of effective risk mitigation, such as the need for having a robust process when creating externally facing content or when engaging with external stakeholders.   The below sections highlight how this guidance uses and adapts some of these key elements of effective compliance in the context of social media interactions while also providing additional practical guidance for more robust risk management.   Summary of the IFPMA and EFPIA guidance on social media  There are four sections within the joint guidance that incorporate key elements of effective compliance in the context of social media interactions. 
Key compliance takeaways  The following are some key takeaways from the IFPMA’s and EFPIA’s joint guidance:
Closing remarks  This guidance is notably novel within the digital space, providing both a global perspective and detailed specificities, albeit touching upon some principles that have existed for a while within the life sciences industry. It is also important to remember that communicating digitally can lead to potential compliance risks and therefore it is imperative that life sciences companies keep abreast of new regulations and guidances that are issued and proactively measure, mitigate and monitor the risk areas highlighted above to ensure compliance. Companies always need to keep the rationale for an activity and the desired outcome at the forefront of their engagement process while considering the need for an evolving and more mature governance framework in this continuously changing space.  For more information on this topic or to learn how Baker Tilly’s life sciences specialists can help, contact our team.  

This article discusses the recent guidance from the IFPMA and EFPIA about compliance and risk management in the context of social media interactions for life science companies

Social media risk management guidelines for life sciences companies

Baker Tilly understands the risk with which life sciences companies operate; particularly the risk they are susceptible to through the actions of contracted third parties.  

Our team understands that it is not enough to just conduct pre-contracting due diligence of a third party and that companies must manage the entire relationship from upfront due diligence through post-contracting execution and re-screening.

Life science companies engage with various third parties in order fulfill day-to-day operations. As such, they are open to an array of risks which can violate global compliance requirements such as the Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, Brazil’s Clean Companies Act and France’s Sapan II.  

These risks come directly from actions of third parties for which they are liable.  In fact, the majority of bribery and corruption related investigations and subsequent settlements between life science companies and the Department of Justice (DoJ) and other global regulatory bodies are due to the action of third parties. The financial and reputational penalties can be significant.   

Companies need to know the background and performance of each of the third parties with which they conduct business. From wholesalers and distributors to CROs and HCPs, companies must not only do the traditional front-end, pre-contracting due diligence, but must also conduct continuous monitoring to identify any non-compliant or corrupt behavior as it occurs.  

Baker Tilly can help companies reduce their third party risks by designing, implementing, analyzing and executing on robust risk management solutions: 

Create relationship controls to compel compliance

Assess and develop robust third party due diligence methodologies

Continuous monitoring of third party relationships

Data analytics to identify risky payments and interactions around the globe

Manage third party interactions through outsourced due diligence and screening 

Helping life sciences companies evaluate third party relationships to ensure compliance with global anti-bribery and corruption laws 

Helping clients manage third-party risks through risk driven governance measures which can safeguard companies from anti-bribery and corruption and FCPA related matters

Baker Tilly helps organizations win now, and explore the options for tomorrow, through an orchestrated approach and understanding encompassing all facets of the healthcare ecosystem.

Baker Tilly provides assurance, tax and advisory solutions to healthcare providers, health plans and life sciences companies.

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Protect and enhance your company’s value today for sustained growth tomorrow. 

Baker Tilly provides advisory, tax and assurance solutions that address the unique challenges and opportunities faced by life sciences companies.

Third-Party Risk Management & Due Diligence

Risk management guide for life sciences companies

Social media risk management guidelines for life sciences companies

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