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Center for Regulatory Strategies

Insights from

In Focus: Compliance Trends Survey 2013
LIFE SCIENCES VERSUS OVERALL COMPLIANCE WEEK RESPONDENTS - ROLE OF THE CCO
73% of CCOs meet with
the executive committee
at least once per quarter

60%
60% of CCOs meet with
the executive committee
at least once per quarter

Life
Sciences

73%

Overall

45%

40%
40% of CCOs report
directly to the CEO

45% of CCOs report
directly to the CEO

Re-assessing third-party relationships

80%

of life sciences companies are increasing
oversight (i.e., auditing, monitoring) with
some changes to business partners

59%

of the overall respondents are
increasing oversight (i.e., auditing,
monitoring) with some changes to
business partners

COMPLIANCE RISKS & OPERATIONS
LIFE SCIENCES COMPANIES RANKED THE FOLLOWING REGULATIONS AS THE MOST TIME/RESOURCE CONSUMING

1. Sunshine rules on physician payments
2. Foreign Corrupt Practices Act (FCPA)
3. Good Clinical Practices (GCPs)
IMPORTANCE OF A COMPLIANCE PROGRAM
LIFE SCIENCES
30%

30% of the companies reported
that compliance is perceived
as a good “value-add” function
rather than a check-the-box activity

50% of the companies reported that
the importance of compliance and
ethical conduct is not well
50%
communicated and understood
by the staff at all levels

TOP 3

METRICS LIFE SCIENCES COMPANIES
USE TO EVALUATE THE EFFECTIVENESS
OF A COMPLIANCE PROGRAM

OVERALL
41% of the companies reported
that compliance is perceived
as a good “value-add” function
rather than a check-the-box activity
41% of the companies reported that the
importance of compliance and ethical
conduct is not well communicated
and understood by the
staff at all levels

89%

67%
COMPLETION OF ANNUAL AND
NEW HIRE COMPLIANCE TRAINING

ANALYSIS OF INTERNAL
AUDIT FINDINGS

41%

41%

56%
COMPARISONS TO COMPETITORS
OR SIMILAR ORGANIZATIONS

OF THE COMPANIES THAT MEASURE THE EFFECTIVENESS OF THEIR COMPLIANCE PROGRAM,
NONE ARE ‘HIGHLY’ CONFIDENT THAT THE MEASUREMENT OF EFFECTIVENESS IS ACCURATE
EXTENDED ENTERPRISE COMPLIANCE RISKS
LIFE SCIENCES

10% of the companies are not very
confident that all ethics and compliance
risks are addressed during due diligence
in mergers and acquisitions
OVERALL

77% of the companies are
not very confident that all ethics
and compliance risks are addressed
during due diligence in mergers
and acquisitions

70

70% of life sciences companies do not have any monitoring
procedures to measure the impact that ethical conduct and
regulatory compliance might have on the company’s brand
reputation or shareholder value, while none let the marketing
department take point on this issue

45

45% of the overall respondent companies do not have any
monitoring procedures to measure the impact that ethical
conduct and regulatory compliance might have on the
company’s brand reputation or shareholder value, while 27%
let the marketing department take point on this issue

LIFE SCIENCES

20% of the companies monitor employees
use of company email to look for potential
misconduct, although 50% of these
monitor only for specific individuals when
there is an open investigation into possible
employee misconduct
OVERALL

68% of the companies monitor employees’
use of company email to look for potential
misconduct, although 53% of these
monitor only specific individuals when
there is an open investigation into possible
employee misconduct

TOOLS & TECHNOLOGY

40% OF LIFE SCIENCES COMPANIES DO NOT USE ANY PREDICTIVE MODELING TECHNIQUES
TO BETTER UNDERSTAND COMPLIANCES RISKS, MEASURE EFFECTIVENESS, OR DETERMINE
WHERE TO DEVOTE MORE COMPLIANCE RESOURCES

CONTACT
To learn more, please visit:
www.deloitte.com/us/centerregulatorystrategies/lshcleadership

About the survey
Deloitte and Compliance Week magazine collaborated to conduct a compliance
benchmarking survey. Within the survey, compliance executives were asked about their
compliance department’s organizational structure, current compliance industry risks and
operational challenges, metrics, and tools and technology.
www.deloitte.com/us/compliancetrends

This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice
or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business.
Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor.
In addition, this publication contains the results of a survey conducted by Deloitte. The information obtained during the survey was taken “as is” and was not validated or confirmed by Deloitte.
Deloitte shall not be responsible for any loss sustained by any person who relies on this publication.
As used in this document, “Deloitte” means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of
Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.
Copyright © 2013 Deloitte Development LLC. All rights reserved.
Member of Deloitte Touche Tohmatsu Limited

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Compliance Trends Survey 2013

  • 1. Center for Regulatory Strategies Insights from In Focus: Compliance Trends Survey 2013 LIFE SCIENCES VERSUS OVERALL COMPLIANCE WEEK RESPONDENTS - ROLE OF THE CCO 73% of CCOs meet with the executive committee at least once per quarter 60% 60% of CCOs meet with the executive committee at least once per quarter Life Sciences 73% Overall 45% 40% 40% of CCOs report directly to the CEO 45% of CCOs report directly to the CEO Re-assessing third-party relationships 80% of life sciences companies are increasing oversight (i.e., auditing, monitoring) with some changes to business partners 59% of the overall respondents are increasing oversight (i.e., auditing, monitoring) with some changes to business partners COMPLIANCE RISKS & OPERATIONS LIFE SCIENCES COMPANIES RANKED THE FOLLOWING REGULATIONS AS THE MOST TIME/RESOURCE CONSUMING 1. Sunshine rules on physician payments 2. Foreign Corrupt Practices Act (FCPA) 3. Good Clinical Practices (GCPs) IMPORTANCE OF A COMPLIANCE PROGRAM LIFE SCIENCES 30% 30% of the companies reported that compliance is perceived as a good “value-add” function rather than a check-the-box activity 50% of the companies reported that the importance of compliance and ethical conduct is not well 50% communicated and understood by the staff at all levels TOP 3 METRICS LIFE SCIENCES COMPANIES USE TO EVALUATE THE EFFECTIVENESS OF A COMPLIANCE PROGRAM OVERALL 41% of the companies reported that compliance is perceived as a good “value-add” function rather than a check-the-box activity 41% of the companies reported that the importance of compliance and ethical conduct is not well communicated and understood by the staff at all levels 89% 67% COMPLETION OF ANNUAL AND NEW HIRE COMPLIANCE TRAINING ANALYSIS OF INTERNAL AUDIT FINDINGS 41% 41% 56% COMPARISONS TO COMPETITORS OR SIMILAR ORGANIZATIONS OF THE COMPANIES THAT MEASURE THE EFFECTIVENESS OF THEIR COMPLIANCE PROGRAM, NONE ARE ‘HIGHLY’ CONFIDENT THAT THE MEASUREMENT OF EFFECTIVENESS IS ACCURATE EXTENDED ENTERPRISE COMPLIANCE RISKS LIFE SCIENCES 10% of the companies are not very confident that all ethics and compliance risks are addressed during due diligence in mergers and acquisitions OVERALL 77% of the companies are not very confident that all ethics and compliance risks are addressed during due diligence in mergers and acquisitions 70 70% of life sciences companies do not have any monitoring procedures to measure the impact that ethical conduct and regulatory compliance might have on the company’s brand reputation or shareholder value, while none let the marketing department take point on this issue 45 45% of the overall respondent companies do not have any monitoring procedures to measure the impact that ethical conduct and regulatory compliance might have on the company’s brand reputation or shareholder value, while 27% let the marketing department take point on this issue LIFE SCIENCES 20% of the companies monitor employees use of company email to look for potential misconduct, although 50% of these monitor only for specific individuals when there is an open investigation into possible employee misconduct OVERALL 68% of the companies monitor employees’ use of company email to look for potential misconduct, although 53% of these monitor only specific individuals when there is an open investigation into possible employee misconduct TOOLS & TECHNOLOGY 40% OF LIFE SCIENCES COMPANIES DO NOT USE ANY PREDICTIVE MODELING TECHNIQUES TO BETTER UNDERSTAND COMPLIANCES RISKS, MEASURE EFFECTIVENESS, OR DETERMINE WHERE TO DEVOTE MORE COMPLIANCE RESOURCES CONTACT To learn more, please visit: www.deloitte.com/us/centerregulatorystrategies/lshcleadership About the survey Deloitte and Compliance Week magazine collaborated to conduct a compliance benchmarking survey. Within the survey, compliance executives were asked about their compliance department’s organizational structure, current compliance industry risks and operational challenges, metrics, and tools and technology. www.deloitte.com/us/compliancetrends This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. In addition, this publication contains the results of a survey conducted by Deloitte. The information obtained during the survey was taken “as is” and was not validated or confirmed by Deloitte. Deloitte shall not be responsible for any loss sustained by any person who relies on this publication. As used in this document, “Deloitte” means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting. Copyright © 2013 Deloitte Development LLC. All rights reserved. Member of Deloitte Touche Tohmatsu Limited