Ask a Compliance Officer Series: Michael Clarke of ConvaTec discusses COVID-19 impacts on Compliance
By Timothy P. Glynn
Senior Associate Dean and Andrea J. Catania Endowed Professor of Law
We’re rolling out a new series where every week, Seton Hall Law School’s Center for Health & Pharmaceutical Law will “sit down” (virtually, of course) with a life sciences compliance officer to find out what is top-of-mind for him or her right now. Here is the first installment in this series, a conversation with Michael R. Clarke.
How do you think the current climate will impact the compliance function for pharmaceutical and device companies?
Currently, I am the compliance officer for a medical technology company, but I have also served in a similar role for pharmaceutical manufacturers. Although there are similarities as well as distinctions in drug promotion versus device promotion and each company is different, we spend a great deal of time thinking about and discussing the current health crisis-driven changes to our health care institution customers, since our products are mostly used in both the acute surgical space as well as for chronic conditions managed at home or in clinical settings. While important, in some contexts, the individual health care professional customers’ concerns are outweighed by the hospital and clinic concerns.
I have heard discussion from commercial leaders that some aspects of the current virtual promotion model that many of us are using now will remain at some level even after this health crisis has abated. From a cost perspective, there are advantages to keeping some virtual components in a marketing strategy, whether to increase the efficiency of product education sessions or to save travel costs for larger or more rural sales territories.
With what new risks will compliance officers need to grapple? Are there any areas that may see less risk with a changing model?
While I can’t argue with the cost savings and efficiencies, a number of my ethics and compliance colleagues as well as members of my own team are concerned about whether and how to provide meal transfers of value as a component of a virtual education meeting. If no meal is provided, then there is less risk, but the lack of a physical presence when a meal is delivered causes concern about whether the meal recipients are actually attending the virtual meeting. This requires more significant logistical elements, such as having an office staffer facilitate the meal delivery; only providing individual meals, like small salads or sandwiches; and limiting the number of attendees to a manageable size.
There is also the possibility of promotional activities that are more directly reaching actual or potential patients via social media messaging channels, particularly outside the United States. Depending on the country, the promotional regulations may be very different, but there are concerns about broad audiences consisting of HCPs and non-HCPs participating in web broadcasts and possibly engaging in Q&A chats that may lead to discussions outside of the product indications.
The greater limits on interpersonal contact imposed by virtual interactions does however, limit the possibility of clinicians and field sales representatives exchanging inducements in the privacy of a clinician’s office. In the current age, I believe the nature of a computer-based interaction gives many the impression that someone is always watching. This may lead to greater care in how the communications occur.
What are your thoughts regarding virtual sales meetings taking place on Zoom or similar platforms? Is it helpful to record them?
The cost savings and the ease certainly weigh in favor of Zoom, Microsoft Teams, GoToMeeting, and other web-based video conference providers, as long as the field sales teams can control the environment and manage the attendees in a virtual setting. My sense is that if a field sales team has to deliver a web presentation, they might increase their level of preparation, which benefits everyone. There have been accounts of cyber security breaches and transfers of individual data that was expected to be kept private via some of these web conference providers, so those issues—if they exist—need to be resolved on an enterprise level.
For clinicians that cannot attend the meetings, there is a benefit in recording them and making them available or allowing them to be recorded if an attendee cannot stay for the entire presentation. There is a risk in recording of these events, such as if a presenter is less than prepared and does not adequately or appropriately adhere to the approved presentation materials, but the benefits outweigh those risks if the commercial presenters have been appropriately trained. These presentations can reach a wider audience and allow product education that can benefit even more patients than in the non-virtual setting.
Speaking of virtual meetings, how have education meetings changed since COVID-19? Are meals being incorporated into these virtual meetings? And were some of the changes already happening before COVID-19?
I did not see any changes to educational meetings happening before COVID-19, but now there is a significant move towards virtual in-service sessions; meaning, one-on-one meetings with sales and HCPs, or virtual education sessions with a number of HCPs in a physician practice or in hospitals and clinics. Generally, though, this conforms with medical society congresses moving towards virtual sessions as well. I expect that going forward, paid HCP consultants will be used for distance learning, but I have not seen that yet.
I have seen requests for meals to be incorporated into some of the virtual education sessions. Our guidance has been that most of these meetings should not have meals, and we have imposed additional controls and limits on those meetings where meals are sought.
Timothy Glynn is the Senior Associate Dean and Andrea J. Catania Endowed Professor of Law. His scholarship focuses on the areas of employment and corporate law, including compliance. He also supervises the Law School's Healthcare Compliance Certificate Programs held in the U.S., Europe, Asia, the Middle East, and Latin America. Professor Glynn's biography and publications are available online.