As the world continues to tackle a global pandemic, the pharmaceutical and life sciences industry has swiftly adapted and transitioned to a new normal. Our article published in April 2020 (The Life Sciences Industry reacts to a Global Pandemic), addressed some of the immediate impacts on compliance, resulting from COVID-19. With time, additional challenges have come to light. This article explores these risks, lessons learned and further considerations to strengthen compliance in this newly formed landscape.

What are the lessons learned so far and potential implications?

While COVID-19 has accelerated digital transformation, the future will likely entail a hybrid engagement model that integrates both face-to-face (F2F) and virtual interactions. This new model will allow companies to quickly and efficiently adapt business strategies; however, such a hybrid approach poses unique risks that organizations will need to mitigate.

One such risk is the increased professional use of communication channels such as emails, texts, WhatsApp^TM, Zoom^TM and Microsoft Teams^TM etc. These channels not only come with technical and security implications that should be considered, but the nature of these tools may also influence the quality of interactions and professional tone of conversations between users, by allowing for more casual conversations. Given the lack of visibility, data security and relaxed controls in such channels, additional due diligence is warranted.

To mitigate this risk, manufacturers should evaluate for appropriate technology or tools to ensure that communication with relevant stakeholders such as HCPs is only conducted through approved channels. Guidelines must be clear in establishing limits around utilizing unapproved technologies such as text messaging and open source video messaging applications.

In this new virtual environment, it’s important to choose a digital communication platform that allows visibility and oversight over messaging in order to mitigate risk. Tools should give companies the ability to actively monitor communications especially for field-based personnel (such as Sales and Medical) that interact directly with HCPs and external stakeholders. The right technology will help to ensure controlled and secure communication while flagging instances of tailored or unapproved personal messaging.

The most evident impact of COVID-19 has been the shift from an in-office environment to working from home. This change has obvious implications on how we work but may also influence the kinds of decisions we make.

By reinforcing social norms, the office environment is known to play a role in moral decision making. Without the office as a physical reminder, employees may feel disconnected from their teams, management and compliance support. Considering these factors along with the influence of a more relaxed, home environment, there may be a tendency for compliance cultural drift.

Given this, it is more important than ever to focus on the core principles of compliance. Compliance must set clear guidelines and establish processes to ensure that any material or information shared with employees or with external stakeholders and HCPs is thoroughly reviewed with regards to content and effective delivery. Appropriate compliance support will ensure that information is clear, concise, and non-misleading, thus mitigating unnecessary risk and capturing the receiver’s attention.

Manufacturers should also effectively update and communicate compliance trainings. Moving from a rules to principles-based compliance culture will help employees understand and internalize compliance expectations. In addition, a “one type fits all” didactic approach, is less likely to be effective than tailoring your compliance trainings to the role and functions of the employee or stakeholder. Utilizing interactive, practical and customizable approaches to online workshops or training sessions will help deliver effective trainings for your various stakeholders (including high risk sales, marketing personnel, and gatekeeper roles such as audit, approval, compliance etc.).

The updated compliance guidance¹ published by the US Department of Justice in April 2019 talks about the effectiveness of a compliance program being more than just a “check the box” exercise, rather compliance programs are expected to be integrated and intrinsic to an organization. Manufacturers can take this opportunity to reassess their current compliance programs to ensure continuous improvement and establish clearly defined policies for investigations and disciplinary action. Companies can also establish accountability plans to address compliance deviations by integrating compliance into HR programs. That, along with a robust Code of Conduct, and effective communication and training plan, will underscore the company’s commitment to compliance and encourage employees to accept, adopt and practice compliance as an embedded value rather than just a “paper program”.

Last but not the least, changes in this transient landscape must be monitored and addressed accordingly. Regular monitoring of high-risk business activity, through transactional and/or virtual monitoring initiatives will allow companies to identify and address issues early, thereby allowing them to more effectively mitigate those risks. Monitoring, accompanied by documenting and reporting any changes in activities, policies, processes, and decision making is a fundamental component of any effective compliance program.

With the evolving landscape, manufacturers must understand and appreciate the implications of COVID-19 on compliance and make adjustments as needed. Further details and current research on the Life Sciences Industry can be found on IQVIA’s dedicated COVID-19 website. To contact IQVIA Commercial Compliance for information on how we can help you navigate the unique compliance considerations of COVID-19, email us at commercialcompliance@iqvia.com.

¹ https://www.justice.gov/criminal-fraud/page/file/937501/download