Privacy and the Pharma Chain of Trust
By Jay Cline, CIPP
When Eli Lilly won the HP-IAPP Privacy Innovation Award at last month's IAPP Privacy Academy, it was no surprise to Judy Beach. As Chief Privacy Officer (CPO) of Quintiles Transnational Corp. -- a provider of clinical-trial services to pharmaceutical, biotechnology and medical-device companies -- Beach has been a longtime admirer of Lilly's privacy accomplishments.
Eli Lilly won the award in the Large Organization category for its global privacy program, which includes procedures for customer, consumer and employee information as well as an array of cutting-edge compliance tools for internal audit, vendor compliance and privacy training.
"We use Lilly's global privacy program as our gold standard," Beach told INSIDE 1to1: Privacy.
Beach's own privacy program is a case study in how a strong vendor-assurance program in a company such as Lilly can have lasting ripple effects throughout an entire industry. When it comes to privacy and pharmaceuticals, there is perhaps no more critical business process than clinical trials. In a typical trial, a pharma company will test a new drug on scores of willing patients in many different countries to determine the safety and efficacy of the drug. A trial is an enormous undertaking that involves sensitive health information, cross-border data flows, regulators and many third parties. That's where Quintiles enters the picture.
Founded in 1982 by Dennis Gillings, its current CEO, the Durham, North Carolina-based company employs more than 19,000 in 50 countries. The multinational's annual net revenues of more than $2 billion make it the largest contract-research organization in the world. Indeed, Quintiles and its subsidiaries have helped develop or commercialize the 30 best-selling drugs in the world. According to its annual report, a typical year will see the company recruiting 94,000 patients for studies at 21,500 investigator sites.
"The foundation of our service is health information necessary for improving healthcare worldwide," Beach said. "Given the nature of our work, the protection of patients, including their sensitive medical information, is critical for our company and our customers."
In 1999, Beach, the vice president and senior associate general counsel for regulatory and government affairs, became the first CPO at Quintiles. Following Eli Lilly's inadvertent exposure of patient email addresses in 2001, it significantly strengthened its privacy program. In order to meet this important customer's escalating vendor requirements, she determined to deploy something similar at Quintiles, and the importance of her own position as CPO grew in the process.
One of Beach's first tasks was to strengthen the company's existing Council on Data Protection, which oversees compliance with the company's privacy and security policies. With the CEO's direct backing, the council meets monthly and has grown to include 50 people, including a privacy official or officer from each business unit. Quintiles showcases the council on the corporate governance section of its public Web site.
"The council provides an ideal framework for the protection of medical data," Beach said, "and these data are necessary for the development of new medicines worldwide."
Beach also has rolled out detailed privacy training for all employees and participates in the council's Privacy Incident Response Team. With encouragement from clients and external privacy experts, Quintiles certified to the U.S.-EU Safe Harbor in 2005 under Beach's direction. As part of this process, Quintiles has subjected its own vendors to a robust data-protection assurance process, further extending the pharmaceutical chain of trust.
Most remarkably, Beach has championed the formation of the Carolina Privacy Officials Network (CPON), which meets at Quintiles every other month. The group grew out of a dinner in early 2006 including Beach and two other Durham-based privacy officers. While discussing North Carolina's recently passed security-breach notification act, they discovered that despite their different industries, they had many objectives in common.
"CPON is an informal group of North Carolina privacy officials with companies from a broad spectrum of industries," Beach said. "We discuss North Carolina, national and international privacy issues of concern to our industries. We're benchmarking and working on developing industry standards and best practices."
Vendor-assurance programs can sometimes seem like bureaucratic red tape that provide little value to the business. But in the pharmaceutical industry, where patient participation depends on trust in the process, a rising tide is lifting all boats.
Cline is President of Minnesota Privacy Consultants and can be reached at email@example.com.