On April 13, 2020, Global Health Care LLC presented a webinar entitled, Managing Pharma and Medical Device Ethics and Compliance Function Remotely, the second in a series of webinars addressing compliance issues created by the COVID-19 pandemic. In this webinar, panelists discussed some of the challenges they are facing, as well as suggestions for how to address those challenges, and how to adapt to the rapidly changing conditions brought about by the public health crisis.
The discussion centered around the following topics:
Responses: What are some key actions your compliance department is taking in response to COVID-19?
Here, the panelists discussed reconfirming business priorities and adjusting compliance policies, but also to remember to always keep the needs of people first. Compliance professionals, as experts in risk anticipation, need to be aware that human beings are reluctant to assume that the worst is possible, and account for that in compliance planning. In addition, the panelists noted that, while business needs are changing considerably from one day to another, compliance professionals need to find the right balance between emergency on one side, and compliance on the other.
Challenges: What are some of the most common challenges your business partners are dealing with?
This section focused on adjusting to the “new normal” in a multitude of areas, including interactions with health care providers, keeping teams engaged, risk tolerance, and confidentiality issues arising from the use of technology. There was also a discussion around the realization that virtual interactions are replacing live interactions, and how that is going to impact communicating with various stakeholders. For instance, will the size of sales forces shrink if sales representatives can only engage providers remotely and by appointment, how will presentations that have been approved for a live meeting be modified to be appropriate for virtual audiences, and what are the technology and privacy risks associated with these approaches? Addressing these challenges is complicated, as no one knows when this is going to end and if it will have a lasting impact on how companies interact with their customers.
Leading practices: What does a visionary compliance leader look like in COVID-19-related business continuity planning activities?
The panelists noted that compliance professionals are in a unique position to leverage learning to improve organizational risk management by influencing business continuity planning (“BCP”). In addition, now is the time to develop a BCP program, or to improve an existing program. This public health crisis should serve as a catalyst to realize that companies need to plan and practice for the unexpected, and to recognize that compliance plays an integral role in continuing to do business.
Communication: How should organizations be communicating potential challenges with regulatory requirements and industry codes?
The discussion here related to taking a big picture look at what has and has not changed, and communicating to employees and other stakeholders where there is flexibility around enforcement. In addition, compliance professionals should recognize that the rules are not changing permanently, but rather are being enforced differently, and should remember that this is not a time to walk away from ethics and integrity. In addition, due to the rapidly changing business environment, employees may have to work with tools that may not be the most compliant, but nevertheless are useful because they are stable and work.
Panelists also provided some overarching advice. For instance, the importance of documentation was stressed – specifically, the need to be clear regarding the intent of a particular policy, that the company is intending to do things properly, that a risk assessment was performed, that the policy decision is in the spirit of the law, and that it achieves a business need. There was also a big focus on communication, with recommendations to increase the frequency of communications, and to interact with employees however you can.
The panelists also noted some silver linings amid the torrent of bad news, notably that with so many people teleworking from home, they now have the ability to get see their team members in a different environment and get to know them better.