COVID-19 Pandemic Compliance Action Plan

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On April 6, 2020, Global Health Care LLC held a webinar on a COVID-19 Pandemic Action Plan for Pharmaceutical and Medical Device Ethics and Compliance. The webinar panelists discussed a variety of compliance topics pertinent to the COVID-19 pandemic response, and encouraged compliance professionals to stay focused during this time of business disruption.

Panelists discussed several different topics, including:

Responsibility to Patients: Supply chain disruptions are likely, and companies should develop criteria for determining priority before shortages occur. Companies should also foster transparent communication of supply shortages to regulatory authorities, and evaluate clinical trials for risks resulting from supply interruptions. In addition, compliance professionals should remind staff that HIPAA and other privacy provisions remain in effect and that patient privacy must still be protected. Compliance teams must also be made aware of planned or scheduled price changes, as any upward change in price during this public health crisis will be viewed skeptically.

Physician and Hospital Support: Health care providers and health care organizations need to focus solely on their primary mission, which is patient care. Accordingly, life sciences companies need to reconsider how to ensure safe access to customers, sales targets and other incentives, payment term modifications, how to provide medical information and adverse event reporting. Since there will likely be a significant disruption in business as normal, companies should evaluate distance learning and other technologies to continue providing scientific information. Companies should also re-evaluate communication and training for effective detailing and webinars.

Maintaining Reasonable Internal Controls: In dealing with the crisis, compliance professionals should consider controls that may be flexible. Some areas to consider include modifying due diligence for new customers and new suppliers, balancing employee privacy with the need to communicate transmission risk when an employee has a COVID-19-related absence, delaying or waiving routine review requirements, the possibility of expediting donation requests, and how to handle conversations around leveraging unapproved technologies.

The panelists suggested different time horizons for evaluating and implementing appropriate compliance measures, including what do right now, then continuing throughout the crisis, and finally when normal business begins to resume.

The panelists also commented on workplace changes that are giving rise to new challenges, notably that many employees with compliance functions, as well as those in the organization more broadly, are now largely or exclusively teleworking, and adjustments have to be made to account for that. In addition, decisions need to be made quickly in this time of crisis, and accordingly compliance professionals need to be agile, connected, focused and available.

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