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What is a Compliance Programme?
Audience PollHow long have you worked in compliance?I don’t work in compliance
Less than one year
1‐ 5 years
5‐10 years
More than 10 years
OIG’s “Seven Elements”*1.
Implement written policies and procedures;
2.
Designate a compliance officer and compliance
committee;3.
Conduct effective training and education;
4.
Develop effective lines of communication;
5.
Conduct internal monitoring and auditing;
6.
Enforce standards through well‐publicised disciplinary
guidelines; and7.
Respond promptly to detected problems and undertake
corrective action
* Office of Inspector General (USA) ‐
http://www.oig.hhs.gov/compliance/compliance‐guidance/index.asp
Hot Compliance TopicsCompliance programme effectiveness
Compliance officer liability
Bribery and corruptionIncluding hospitality, gifts, samples, sponsorship, donations
Competition law breaches / antitrust
Third party oversight
Off‐label promotion
Transparency requirements
Use of Social Media
Audience PollWhich hot topics are in your Top 3?Compliance Officer liabilityCompliance programme effectivenessBribery and corruptionCompetition law breaches / antitrustThird party oversightOff‐label promotionConduct of Clinical Trials and publication of resultsTransparency requirementsUse of Social MediaPost‐marketing studies, e.g. Investigator Initiated StudiesOther
Effective Compliance ProgrammeDevelop evaluation process / checklist, based on “seven elements” and other relevant points
Develop measurable goals and benchmarks with senior managers
Set up system to measure goals achievement
Involve the Board in creating the programme
Regularly update the Board – risks, audits and investigations
Investigate why goals are not met (if they are not)
Assess funding levels and support for programme
Policies and ProceduresAre policies and procedures up‐to‐date and user‐friendly?
Are they so long that nobody will read them, remember them, or apply them?
Are they full of unnecessary jargon and acronyms?
Are they fit for the intended audience?
Regular reviews and updates with appropriate managers will help
Is the language clear and unambiguous?
Do they include guidance as well?Guidance should be separated from
mandatory statements
Compliance Officer / CommitteeEnsure that compliance team members have the aptitude and skills required to do the job
Communication and influencing skills
Innate sense of what is “the right thing to do”
Ability to build trust
Good overview of your company’s operations, goals, and potential problem areas
Ensure the right people are on the Compliance Committee
Senior representation
People who know how business is done
Training and EducationRegularly review and update training programmesTry different approaches, based on feedbackUse “real life” examples as case studiesTest knowledge, understanding and outcomesMake training completion part of job requirementsGive a high priority to compliance staff education and networking
Attend conferences, webinars, etc.Read widely on key topics
Maintain accurate training recordsTrain the Board
Lines of CommunicationClarify that talking with line managers, HR, and / or legal is the preferred route to report problems
Be accessible (e.g. via newsletters, intranet) and communicate openly with employees
Maintain an anonymous “hotline” to report issues (where this is allowed by local laws)
Enforce a non‐retaliation policy for employees who report potential problems
Communicate directly with the Board ‐ regular briefings
Use surveys or other tools to get feedback on training and the compliance programme
Monitoring and AuditingUnderstand the differences between auditing and monitoring, and do both!Identify key risks and how you would know if they occurred (i.e. what you can check)Create monitoring schedules and an audit plan based on those key risksRegularly re‐evaluate monitoring schedules and audit planFind out what others are doing ‐ use networking and other resourcesLook at root causes, as well as at what happenedCreate corrective action plans to fix problems
Enforce StandardsStaff should know the potential sanctions if they do not comply with policies and procedures – publish them
If policies and procedures are unclear, they may need to be updated
If training was inadequate, the training programme should be assessed and any necessary changes made
If disciplinary action is required, it should be:Appropriate to the transgression
As published, and
Applied consistently
React Promptly to ProblemsEmpower teams closest to the issues to perform reviews where possible
Be careful of possible conflicts or personal relationships that may interfere with getting an objective review
Create a system or process to track resolution of compliance problems / complaints
Conduct quarterly and / or annual reviews of cases to understand where improvements could be made:
Timeliness
Consistency
Preventative actions for future
Practical TipsJust because your competitor is doing something, that does not mean that you can or should do the same
…and…
Just because you can do something, that does not mean that you should do it (The Jurassic Park Question)
Behavioural / Cultural AspectsIs there a typical background / career path for compliance officers in your organisation?
How experienced / senior are your compliance colleagues compared with commercial colleagues?
How can you “set yourself up for success” as a compliance officer?
What is the role of compliance within your organisation?
Do you and your colleagues have the right skills and resources to enable you to do your jobs effectively?
Have you heard of / read the “The Trusted Advisor”*?*Maister, David H.; Green, Charles H.; Galford, Robert M. (October 2000), “The Trusted Advisor”, The Free Press
Culture of Compliance vs. Ethical Culture
Culture of ComplianceAvoid regulatory issuesChief Compliance OfficerClarify the rulesMonitor and enforceHighlight impact of non‐compliance Encourage “permission seeking”behavior
Ethical Culture“Do the right thing”Chief Executive OfficerClarify expectationsRole models and feedbackCelebrate positive behaviorEncourage initiative to “do what is right”
Audience PollHow would you like us to split the time in this session?Mostly (or all) transactional, e.g. “seven elements”, hot
topics
Mostly (or all) behavioural / cultural, e.g. how to develop compliance officers
Roughly 50:50 transactional and behavioural
Other – please explain! ☺
Bribery and CorruptionUnderstand potential abuse areas, both internal and external
Manage financial relationships well (follow the money!)
Think about how your company rewards its staff, especially bonus payments
Think about what opportunities might arise for people to abuse the system, both internal and external
Manage third party relationships appropriately, and use your audit rights!
Competition Law / Anti‐trustEU Competition Law penalties include fines up to 10% of global turnover
European Commission Pharmaceutical Sector Inquiry (2008/9)
EU Director General Competition issued brochure “Compliance Matters”* for antitrust programmes
Pay‐for‐delay allegations still appearing
*Available at http://ec.europa.eu/competition/antitrust/compliance/
Third Party OversightRisk based approach
What are the third parties doing on your behalf?
What are the risks involved in those activities?
How could you mitigate those risks?
What has already been done to mitigate those risks?
Some suggestionsHave clear, written rules for third parties, depending on what they do for you
Include auditing rights in contracts and use them
Check training records and training effectiveness
Off‐Label PromotionHigher risk areas include:
Scientific discussions where a healthcare professional may express views about using your product for an unapproved use – especially if speaking for your company
Distribution of journal papers about using products for unapproved uses – pay attention to circulation methods
Reps (internal and third party) who may not fully understand the limits of the label – mitigated by training
Promotional materials and advertisements – ensure these go through a rigorous review process
Transparency RequirementsEFPIA and local industry codes now include requirements for transparency relating to:
Payments to physicians / healthcare professionals (HCPs)
Sponsorship to attend conferences
Support for Patient Organisations
Results of Non‐Interventional Studies
Affordable Care Act require disclosure of payments to U.S. physicians
AllTrials campaign
Use of Social MediaGrowing trend in many industries to use Social Media
Guidance from industry bodies still being developed
Understand the “risk appetite” of your company
Write a pragmatic Social Media policy based on current guidance and future risk
Ensure employees understand where to draw the line between personal and professional posts on Social Media
Remember – if it’s not normally allowed, it won’t be allowed via Social Media
Post Marketing StudiesEnsure there is a genuine need:
Primary purpose is to gain scientific / safety information
Factors not tested prior to grant of Marketing Authorisation, e.g. larger volumes of ethnic groups
Scale of study
Total global studies – could a single study serve a whole geographic region, rather than having many repetitions?
Post marketing studies should be under the control of the medical team, not a commercial team (e.g. marketing)
Be aware of the potential for post marketing studies to be used as disguised promotion
