THE PULSE: LIFE SCIENCES WEBINAR - DLA Piper · PDF filethe pulse: life sciences webinar how compliant is your business? – a proactive approach to regulatory compliance dr. simone

THE PULSE: LIFE SCIENCES WEBINARHOW COMPLIANT IS YOUR BUSINESS? –A PROACTIVE APPROACH TO REGULATORY COMPLIANCE

Dr. Simone Mitchell & Sammy FangTuesday 4 August 2015

Introductions and outline

1. The need for compliance audits.2. Preparing the business for an audit.3. Conducting the audit.4. What do you do with the results?5. Questions.

The Pulse: Life Sciences Webinar - How Compliant is your business? 24 August 2015 |

1. THE NEED FOR COMPLIANCE AUDITS

What are the benefits?• Identify potential risk exposures.• Anticipate and prevent issues before they arise.• Should result in increased awareness by employees,

business partners and contractors of the obligations andrequirements imposed by law, policies and procedures.

• Provide insight to allocating limited resources.• Demonstrate a culture of compliance, including to

regulators.

1. The need for compliance audits

4The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August 2015 |

Areas of focus:• Anti-bribery and anti-corruption• Transparency• Anti-trust



Areas of concern:• Interactions with HCPs.• Interactions with government agencies and officials.• Interactions with consumers.• Interactions with advocacy groups.• Charitable contributions.• Interactions with wholesalers.• Relationships with distributors.• Involvement in industry bodies/medical associations.• Joint ventures and other third party transactions.



2. PREPARING THE BUSINESS FOR AN AUDIT

Identify areas of risk to be evaluated as part of theaudit by considering:• Internal and external risk factors.• Previous audits and monitoring programmes.• Known issues.• Existing policies and procedures.• Training.• Volume of transactions/annual turnover.• Level of processes and controls.• Responsibility.• Current risk areas from local market enforcement action.

2. Preparing the business for an audit


Planning and developing audit protocol1. Obtain buy-in for the audit scope and methodology.2. Developing audit protocol:

• background materials and audit overview• audit teams and resources• lead contacts for the audit• data privacy and local law restrictions• use of eRooms for handling of data.

3. Conduct kick off meetings will all in-market business, legaland compliance leads and related parties.



Planning and kick-off1. Schedule status updates to all stakeholders.2. Prepare questionnaire and data request .3. Prepare communication explaining the audit to the

business:• mindful of local market considerations; and• use of appropriate language for the local business.

4. Conduct pre-market calls with the business to betterprepare for the audit .



3. CONDUCTING THE AUDIT

3. Conducting an audit

Paper/Accounting

AuditInterviews Reporting Implementation


Paper audit• Locate policies and other

control documents.

• Identify other documents/sources of information.

• Sampling can be random ortargeted.

• Finalise audit work plan duringthis phase.



Forensic accounting audit• Forensic accounting review by

accounting firm.

• Walkthrough meetings with the localfinance team.

• Select test samples.

• Conduct forensics review of selectedtransactions.

• Handover of audit results to legalteam prior to interviews.




Interviews/ Transaction testing

• Determine who you will interview:

– business team

– third party vendors/distributors.

• Order of interviews can be important.

• Develop interview guidelines.

• Plan questions but be prepared to beflexible.

• Allocate enough time.

• Mindful of local cultural and regulatoryconsiderations.


4. WHAT TO DO WITH THE RESULTS?

4. What to do with the results?

Speaker Programs

Policy • Speaker program policy exists but has not been socialised acrossthe organisation

Process • Procedural documents are in DRAFT form and have not beenfinalised

Documentation/Tools • Control documentation is not being used as directed

Audit • No prior audits

Monitoring • Field monitoring via a well developed plan – reach limited bymanpower constraints

Issues • Issues with awareness and understanding of policy and procedures• Tone from the top to the bottom• How are policies implemented

• Speaker training occurs regularly but internal training is mainly fornew employees only

Dept. involved • Various (e.g. HR, Compliance, Marketing, etc)



Identify issue Assess &triage issue

Implementfollow

up/correctiveaction

Evaluatecorrective action& related results



Corrective action plan

• Define who owns the planand ensure that it isproperly documented.

• Communicate to business.

• Set out targeted timelinefor completion.

• Schedule review ofcorrective action.



• Link behaviours to incentivecompensation models.

• Retrain staff.

• Monitor.

• Hold supervisors accountable:

– financial/ budgetaryincentives

– heightened reportingobligations.

• Establish disciplinary model.

• Educate the business.20The Pulse: Life Sciences Webinar - How Compliant is your business? 4 August 2015 |

Contact details


This presentation is intended as a first point of reference and should not be relied on as a substitute forprofessional advice. Specialist legal advice should always be sought in relation to any particular circumstances

and no liability will be accepted for any losses incurred by those relying solely on this presentation.

Dr. Simone MitchellPartner

DLA PiperT. +61 2 9286 8484

[email protected]

Sammy FangPartner

DLA PiperT. +852 2103 0649

[email protected]

Documents

THE PULSE: LIFE SCIENCES WEBINAR - DLA Piper · PDF filethe pulse: life sciences webinar how compliant is your business? – a proactive approach to regulatory compliance dr. simone