Compliance As A Profession Aditi Taylor, Senior Manager, Deloitte & Touche LLP

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1 Compliance As A Profession Aditi Taylor, Senior Manager, Deloitte & Touche LLP 7 th International Pharmaceutical Compliance Congress and Best Practices Forum May 23, 2013

2 The job that everyone loves to hate! Compliance, long viewed as a chore, is being transformed into a valued and valuable business asset Regulations and reputational concerns have pushed compliance to the top levels of visibility Bigger challenges, higher stakes A quick rundown of the factors in today s compliance environment that literally keeps many compliance professionals up at night. Businesses are subject to more laws and regulations than ever, and the laws and regulations address a wider variety of issues. Companies are being held to higher standards of evidence of compliance. Compliance itself is now subject to compliance. New whistleblower regulations may increase the chances of compliance failures being caught. Penalties for compliance failures have become more severe, putting executives and boards at greater personal risk. Compliance has become a board-level concern. Everyone cares about compliance, and it s easy for them to stay informed on the subject

3 Where are we today? The US Labor Department expects the number of compliance jobs to jump at least 15% by 2020 The Society of Corporate Compliance & Ethics (SCCE) found that a high percentage of compliance officers have considered quitting due to job-related stress and frustration. Put those two trends together, and there s a recipe for a dire shortage of skilled compliance professionals in a few years!!! 3

4 What are the drivers? Lack of a cross-industry standards for compliance professionals Certification indicates a certain level of competency in a specific profession In the absence of a certification, there isn t a tangible way to provide assurance of competency Conflicting expectations about the look and feel of the compliance function Distributed vs. dedicated compliance Need for a steady hand at the rudder, someone with enough authority and independence 4

5 What is the compliance profession anyways? It s not just keeping up with the regulations Skillful compliance must know how to navigate through the process. It is a real intellectual challenge In 1914, Louis Brandeis, progressive writer and Supreme Court Justice defined a profession as first an occupation involving knowledge and learning as distinguished from skill. Second, it is an occupation pursued largely for others. Third, an occupation in which the amount of financial return is not the accepted measure of success. Compliance meets all three requirements! The special status of compliance must be recognized by its practitioners, employers, and by the members of the public who deal with them. 5

6 A look at the Compliance Profession. Yesterday Thought of after the fact Part of legal function Administrative burden Unclear expectations Today Moved to the top, C-Suite It s own budget line Value added Covers risk management, ethics and then some! 6

7 Compliance Program Maturity In response to the growing level of regulation Life Science companies are evolving to more mature Risk Management / Compliance Framework strong leadership is essential to achieve the strategic growth Emerging Evolving Mature 7

8 Credentializing Compliance There has been a surge in the number of training and certification programs dedicated to the exchange of compliance best practices Certification and continuing education courses are focused on increasing the proficiency of compliance professionals at spotting risk and ethics lapses, in general while networking with like-minded peers Some programs such as the Society of Corporate Compliance and Ethics (SCCE) s Certified Compliance and Ethics Professional (CCEP) and the Ethics and Compliance Officer Association (ECOA) s Advanced Practitioner in Ethics & Compliance (APEX) program have gotten increased visibility A professional certification would definitely put compliance on an equal footing with related professions - law, accounting, etc. But there is an ongoing debate on whether the value of the effort and achievement of a certification can be monetized What s most valuable is the networking advantages offered through the certification and training sessions!! 8

9 Importance of Sharing Ideas and Networking Where medicine, innovation and technology increasingly extends beyond national cultural boundaries, there is a growing need to promote a culture of networking and sharing of ideas within compliance Compliance is an open field, where the really model relies on the sharing of best practices and consulting with one another about our experiences. Standards harmonization and mutual recognition of challenges will help only help the compliance community grow The U.S. Sentencing Guidelines require for programs to meet industry practice; in order to determine what industry practice is, we need to know what others are doing Not only should compliance professionals leverage the various external forums, networking opportunities, they should also encourage setting up internal idea-sharing network In conclusion, compliance is a great profession, with varied experiences and supportive community certainly a job you can look forward to every Monday morning! 9

10 Disclaimer This presentation contains general information only and Deloitte is not, by means of this presentation, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This presentation 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. Deloitte, its affiliates, and related entities shall not be responsible for any loss sustained by any person who relies on this presentation. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee, and its network of member firms, each of which is a legally separate and independent entity. Please see for a detailed description of the legal structure of Deloitte Touche Tohmatsu Limited and its member firms. Please see 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. Member of Deloitte Touche Tohmatsu Limited