Crucial Compliance Resources for Country Compliance Officers

Transcription

1 Crucial Compliance Resources for Country Compliance Officers Tomasz Kruk - Director Global Ethics & Compliance International Pharma Congress, Madrid, Wednesday, May 22, :45 p.m.

2 Chosen TASKS of country compliance officers 1. Providing continuous compliance advice to all staff 2. Adapting global versions of policies & procedures to the local organization 3. Trainings / certification on policies & procedures for all staff 4. Periodic risk assessments 5. Regular testing & review of the compliance program 6. Internal investigations 7. Providing mechanisms of confidential reporting of suspected misconduct 8. Enforcing disciplinary measures (reliably and promptly) 9. Due diligence of third parties 10.Trainings / certification for chosen third parties 11.Monitoring of third party relationships 12.Protecting the autonomy of the local compliance function from the management as well as his/her appropriate authority On a basis of: Hallmarks of an Effective Compliance Program A Resource Guide to the U.S. FCPA 2

3 RESOURCES for country compliance officers 1. Direct support of the Country Manager (e.g. direct communication, periodical meetings with compliance functions, involvement in events organized by compliance) 2. Involvement of other functions (e.g. human resources, finance, legal) 3. Budget for outside services (e.g. for legal analysis, translations, audit services) 4. Automated tools (e.g. anonymous hotlines, software systems, databases) 5. Expertise of the local compliance officer (e.g. trainings, workshops, certifications) 6. Direct support from the global compliance team (e.g. fast & reliable corporate responses to country questions, ongoing corporate guidance, periodic meetings and coaching) 3

4 Effective Compliance Program & Resources Hallmarks of an Effective Compliance Program (A Resource Guide to the U.S. FCPA) 1.Commitment from Senior Management and a Clearly Articulated Policy Against Corruption 2.Code of Conduct and Compliance Policies and Procedures 3.Oversight, Autonomy, and Resources. 4.Risk Assessment 5.Training and Continuing Advice 6.Incentives and Disciplinary Measures 7.Third-Party Due Diligence and Payments 8.Confidential Reporting and Internal Investigation 9.Continuous Improvement: Periodic Testing and Review 10.Mergers and Acquisitions: Pre-Acquisition Due Diligence and Post- Acquisition Integration. 4

5 Effective Compliance Program & Resources Office of Inspector General's (OIG) U.S. Department of Health & Human Services Compliance Program Guidance for Pharmaceutical Manufacturers A pharmaceutical manufacturer s implementation of an effective compliance program may require a significant commitment of time and resources by various segments of the organization. ( ) Although an effective compliance program may require a reallocation of existing resources, the long-term benefits of establishing a compliance program significantly outweigh the initial costs. 5

6 6 S U R V E Y

7 Survey Key objectives: Which TASKS require more RESOURCES than country compliance officers currently have? Methodology: Respondents were asked to: 1. allocate six types of RESOURCES within twelve TASKS, 2. attribute values equal to 0, 1, 2, or 3 to particular types of RESOURCES where 0 means no need for more resources and 3 means this type of resources is very highly desirable. Respondents: 15 country compliance officers from multinational pharmaceutical companies listed on NYSE, EURONEXT, Frankfurt Stock Exchange, Tokyo Stock Exchange. 7

8 Local compliance officers TASKS Providing continuous compliance advice to all staff Adapting global versions of policies & procedures to the local organization Trainings / certification on policies & procedures for all staff Periodic risk assessments Regular testing & review of the compliance program Internal investigations Providing mechanisms of confidential reporting of suspected misconduct Enforcing disciplinary measures (reliably and promptly) Due diligence of third parties Trainings / certification for chosen third parties Monitoring of third party relationships Protecting the autonomy of the local compliance function from 8 the management as well as his/her appropriate authority RESOURCES NEEDED: (where 0 = no more of this resource needed, and 3 = more of this resources urgently needed) MORE direct support from the Country Manager HIGHER involvement of other functions HIGHER budget for outside services MORE automation INCREASE of the expertise of the local compliance officer MORE direct support from the global compliance

9 9 Quiz: Which TASKS need more RESOURCES than you currently have?

10 Which TASKS need more RESOURCES than you currently have? 1. Due diligence of third parties 2. Periodic risk assessments 3. Monitoring of third party relationships 4. Regular testing & review of the compliance program 5. Adapting global versions of policies & procedures to the local organization 6. Trainings / certification for chosen third parties 7. Trainings / certification on policies & procedures for all staff 8. Providing continuous compliance advice to all staff 9. Providing mechanisms of confidential reporting of suspected misconduct 10. Enforcing disciplinary measures (reliably and promptly) 11. Internal investigations 12. Protecting the autonomy of the compliance function as well as the appropriate authority

11 Quiz: What types of RESOURCES are most needed? 11

12 What types of RESOURCES are most needed? 1. INCREASE of the expertise of the local compliance officer 2. HIGHER involvement of other functions TASKS 3. MORE automation 4. MORE direct support from the global compliance team 5. MORE direct support from the Country Manager 6. HIGHER budget for outside services 12 RESOURCES

13 13 Bonus

14 Which TASKS need more RESOURCES than you currently have? 1. Due diligence of third parties 2. Periodic risk assessments 3. Monitoring of third party relationships 4. Regular testing & review of the compliance program 5. Adapting global versions of policies & procedures to the local organization 6. Trainings / certification for chosen third parties 7. Trainings / certification on policies & procedures for all staff 8. Providing continuous compliance advice to all staff 9. Providing mechanisms of confidential reporting of suspected misconduct 10. Enforcing disciplinary measures (reliably and promptly) 11. Internal investigations 12. Protecting the autonomy of the compliance function as well as the appropriate authority HIGHER budget for outside services MORE direct support from the Country Manager MORE direct support from the global compliance team MORE automation HIGHER involvement of other functions INCREASE of the expertise of the local compliance officer

15 15 Conclusions

16 We need to ask local compliance officers/liaisons about their needs more often. 16

17 A Resource Guide to the U.S. Foreign Corrupt Practices Act the amount of resources devoted to compliance will depend on the company s size, complex-ity, industry, geographical reach, and risks associated with the business. In assessing whether a company has reasonable internal controls, DOJ and SEC typically consider whether the company devoted adequate staffing and resources to the compliance program given the size, structure, and risk pro-file of the business. 17

18 Tomasz Kruk - Director Global Ethics & Compliance Actavis, Turmstrasse 24, Zug 6300, Switzerland t , m (+41) TKruk@actavis.com, w