Policy & Medicine Compliance Update
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October, 2021
Issue Summary:
This month we focus on Governance and Operations with three articles from external contributors. First, the Epsilon Life Sciences team examines the basic building blocks of a privacy program in the context of recent changes to global privacy requirements. The need for a modern privacy program is a growing imperative for all life science companies.
Next, the Porzio Life Sciences team outlines the current regulatory expectations around a modern compliance monitoring function. The article also provides concrete considerations as companies establish or modernize compliance monitoring.
Kristin Rand then discusses the need for radical change in compliance roles to achieve a NextGen compliance function. Here, she explores creating a positive attitude towards compliance by becoming more coaches or trainers to use the sports analogy.
Moving to litigation and enforcement developments, the Deloitte Life Sciences, Regulatory, and Compliance team provides an overview of the recent Pharma Code changes made in response to the recent OIG Special Fraud alert. Next, we focus on the recent developments in the ongoing prescription opioid litigation. These include the approval of the Purdue bankruptcy settlement, the multistate proposed settlement with AmerisourceBergen, Cardinal Health, McKesson, and J&J. We also review Ohio’s novel approach for gaining municipal settlement support with its OneOhio program.
Finally, we are introducing two columns in this issue that we hope will become a regular part of each issue. The first is a column featuring a noted life science compliance professional discussing how they became involved in compliance. The second, which we call “Shifting Sands,” highlights recent job and roles changes within the profession supplied by you, our loyal subscribers.
Articles
FEATURE
People, Process, Technology
Right Sizing the Building Blocks of a Privacy Program
By Brian Segobiano and Sei UnnoSummary: With the increasing attention and regulation of privacy around the world, it is imperative that organizations develop and implement a robust program to identify and manage risk. This responsibility is increasingly assumed to be an effective compliance program component within many life sciences companies. This article highlights considerations and practices for industry professionals to build and operationalize a data privacy program.
Governance & Operations
It’s All About the Data
What Regulators are Looking for in a Modern Compliance Monitoring Program
By Michael T. O’Connor and Isha Arora
Summary: Compliance monitoring is an essential function of any effective compliance program. However, it is constantly evolving, and recent developments highlight the importance of the proper use of data to support compliance.
The Radical Game-Changer
NextGen Compliance
By Kristin Rand
Summary: The functional descriptor “Compliance” no longer reflects the diverse roles played by compliance professionals. The function has grown from having a rudimentary focus on assuring strict compliance with the law to include activities more in line with those conducted by sports team coaches or trainers, including helping companies achieve their goals. Applying a sports team framework within a company allows for “compliance” professionals to be valued team members while also strengthening overall organizational engagement and morale.
Litigation & Enforcement
Adapting to Change
PhRMA Updates Its Code in Response to Latest DOJ Special Fraud Alert
By Paul Silver, Jack Tanselle, Dominique Donovan, Russell Rose
Summary: In August 2021, PhRMA announced its latest update that was last revised in 2019. The new update will take effect on January 1, 2022.
The Beat Goes On
Challenging RECENT Opioid Settlements
By Kirt Kraeuter, Staff Writer
Summary: The two most significant agreements to resolve the U.S. opioid crisis continue to offer uncertainty amid attention-grabbing headlines. The Department of Justice appealed the conditional approval of the proposed Purdue bankruptcy agreement. Meanwhile, seven states failed to sign on to a “global” MDL settlement with the three major distributors and J&J, while two additional states signed on partially. In addition, other matters involving manufacturers (Teva, Mallinckrodt, Indivior), retailers and wholesalers (CVS, Walgreens, Walmart), and complex situations with sovereign Native American tribal nations continue. In short, the opioid litigation shows little sign of ending soon.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. And as always, thank you for subscribing and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor