Embed Size (px)
DESCRIPTION
Simone Mitchell delivered the presentation at 2014 Pharmaceutical Law Conference. The Pharmaceutical Law Conference is the foremost meeting place and networking hub of the pharmaceutical law industry, and the only pharmaceutical law event in the Asia-Pacific region. The 2014 event highlights included pharma law reform, IP, competitive strategies, industry transparency, sustainable drug pricing and patenting life sciences and more. For more information about the event, please visit: http://www.informa.com.au/pharmalawevent14
Citation preview
7th Annual
Pharmaceutical Law Conference
Achieving Business
Conduct Compliance
through Auditing
Dr Simone Mitchell – DLA Piper Australia
Sydney Harbour Mariott
Friday 30 May 2014
Agenda
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
30 May 2014 Achieving Business Conduct Compliance through Auditing 2
1. Why is it important to
audit?
1. Why is it important to audit?
30 May 2014 4 Achieving Business Conduct Compliance through Auditing
1. Why is it important to audit?
Pharmaceutical Industry
Medicines Australia Code of Conduct
Australian Consumer
Law
Privacy Act 1988 (Cth)
Anti-Money Laundering/F
CPA
Internal policies and procedures
Therapeutic Goods
Administration policies and
procedures
30 May 2014 5 Achieving Business Conduct Compliance through Auditing
1. Why is it important to audit?
Areas of concern:
• Interactions with HCPs
• Interactions with consumers
• Interactions with wholesalers
• Interactions with advocacy groups
• Relationships with distributors
• Charitable contributions
• Involvement in industry bodies
Date of presentation Insert filename here 6
1. Why is it important to audit?
What are the benefits?
Identify potential risk exposures
Anticipate and prevent issues before they arise
Should result in increased awareness by employees and
contractors of the obligations and requirements imposed by
law, policies and procedures.
Provide insight to allocating limited resources
Date of presentation Insert filename here 7
2. Preparing the business
for an audit
2. Preparing the business for an audit
Identify areas of risk to be evaluated as part of the audit by
considering:
internal and external risk factors
previous audits and monitoring programmes
known issues
training
volume of transactions/annual expenditure
level of processes and controls
responsibility
30 May 2014 9 Achieving Business Conduct Compliance through Auditing
2. Preparing the business for an audit
Planning
1. Obtain buy-in for the methodology
2. Conduct kick off meetings will all interviewees and related
parties
3. Schedule status updates to all stakeholders
Date of presentation Insert filename here 10
3. Conducting the audit
3. Conducting an audit
Paper Audit Interviews Reporting Implementation
Date of presentation Insert filename here 12
3. Conducting an audit
Paper Audit
Locate policies and other
control documents
Identify other documents/
sources of information
Sampling can be random
targeted, such as based on
geography, products, sales,
performance issues,
previous compliance
violations
30 May 2014 13 Achieving Business Conduct Compliance through Auditing
3. Conducting an audit
Interviews
Determine who you will
interview
Order of interviews can be
important
Develop interview guidelines
Plan questions but be
prepared to be flexible
Allocate enough time
Date of presentation Insert filename here 14
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 across the organisation
Process • Procedural documents are in DRAFT form and
have not been finalised
Documentation/Tools • Control documentation is not being used as
directed
Audit • No prior audits
Monitoring • Field monitoring via a well developed plan – reach
limited by manpower constraints
Issues • Issues with awareness and understanding of policy
and procedures
Training • Speaker training occurs regularly but internal
training is mainly for new employees only
Dept. involved • Many
Date of presentation Insert filename here 16
4. What to do with the results?
Identify issue
Assess & triage issue
Implement follow
up/corrective action
Evaluate corrective action &
related results
30 May 2014 17 Achieving Business Conduct Compliance through Auditing
4. What to do with the results?
Corrective action plan
Define who owns the plan
and ensure that it is properly
documented
Communicate to business
Date of presentation Insert filename here 18
What to do with the results?
Link behaviours to incentive
compensation models
Retrain staff
Monitor
Hold supervisors
accountable
Establish disciplinary model
Educate the business
Date of presentation Insert filename here 19
Contact details
Simone Mitchell
Partner
DLA Piper
T. 02 9286 8484
30 May 2014 20
This presentation is intended as a first point of reference and should not be relied on as a substitute for professional 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.
Achieving Business Conduct Compliance through Auditing
