In Pharmaceutical business in Middle East, Are we really compliant to local regulations in our daily practice with HCPs and GO Do we encourage and incentivize the compliant practice, regardless the impact on business? Are we all responsible and accountable? How can we build a compliant culture within our organizations, and what are this culture components? How mature is the risk assessment and management in our cultures ? Some questions I tried to answer in this short presentation I did during the 2nd annual pharma commercial and SEF summit in Dubai last month. Please provide all your comments and guidance Enjoy reading

1. Excel
with compliance
DUBAI 28TH JAN 2016
THE 2ND PHARMA COMMERCIAL AND SFE SUMMIT MENA
Wesam Nehad
Country Head GCC / Actavis

2. EXCEL WITH COMPLIANCE
LOOK MY DEAR, I
ONLY TRAVEL WITH
MY WIFE AND ON FIRST
CLASS .. YOU CAN
ARRANGE THIS WITH
YOUR TRAVEL AGENT
HEY, WHERE ARE YOU
TAKING US TONIGHT,
IT’S MY BIRTHDAY!
I’M NOT ATTENDING THE
LECTURE, BUT I WILL
TAKE THE LUNCH
SOME TIMES WE FACE THIS ..

3. EXCEL WITH COMPLIANCE
I APPRECIATE
INVITING ME TO THIS
EDUCATIONAL
PROGRAM, IT IS
REALLY IMPORTANT
TO GET THE LATEST
MEDICAL UPDATES
REGULARLY
I USE YOUR
PRODUCT AS PER
THE APPROVED
INDICATIONS
YES, I WILL MAKE SURE
TO ATTEND YOUR
LECTURE TODAY
AND MOST OF THE TIMES WE FACE THIS ..

4. PHARMA PAID PHYSICIANS $6.5B in 2014, IN
USA
http://www.troyshu.com/blog/2016/01/15/pharma-paid-physicians-6-5b-in-2014-looking-into-the-open-payments-dataset/
https://openpaymentsdata.cms.gov/
Pharmaceutical and medical
device manufacturers routinely
pay doctors and hospitals in
the form of meals, travel
reimbursements, gifts,
entertainment, compensation
for speaking engagements, and
more.
EXCEL WITH COMPLIANCE

5. EXCEL WITH COMPLIANCE
HOW PHARMA PAYS PHYSICIANS

6. EXCEL WITH COMPLIANCE
HOW PHARMA PAYS PHYSICIANS

7. EXCEL WITH COMPLIANCE
HOW PHARMA PAYS PHYSICIANS

8. EXCEL WITH COMPLIANCE
I Have been here so
long …..
I don’t remember what
I did .. but
It had something to do
with
Non-compliance
I DON’T REMEMBER WHAT I DID…

9. WHAT IS COMPLIANCE
To create and promote a compliant culture and maintain a
standard of corporate governance which enables employees to
make smart decisions and protects the company and its people
EXCEL WITH COMPLIANCE
FOLLOWING ALL
LAWS
RULES AND
REGULATIONS
BEHAVING
ETHICALLY
AND WITH
INTEGRITY
WHAT COMPANIES NEED TO DO

10. local regulations/codes regulating pharmaceutical practice
EXCEL WITH COMPLIANCE

11. General principles as per Saudi code of pharmaceutical
promotional practices
EXCEL WITH COMPLIANCE

12. Terms of Saudi Code of Pharmaceutical Promotional
Practices in the Kingdom of Saudi Arabia
EXCEL WITH COMPLIANCE
Don’ts
promote before MA
Give Incorrect or misleading impression to the nature, results,
scope, application, summary, or significance of studies used
in promotional materials
use the words safe or effective unless it is supported by
documented and published medical information
distort or misinterpret the meaning of information from
medical source
offer any cash payment by any means to HCPs
exaggerate about product characteristics
Dos
Promote approved indications in your MA
Promotional materials should be approved by medical
qualified person
Any comparison between many products or similar generics
should be supported by medical prove
Mention the reference of any medical information, and make
it available for public evaluation
Advertisement or promotion of pharmaceutical product In
general should be in conformance with the Islamic Sharia ,
social traditions, ethical, and cultural fundamentals for this
society.
Gifts can be offered to HCPs with max SR 50, linked to
medical field, and should hold the trade name of the product.
Donation can be offered to government or private hospitals
promotion should be based on encouragement on moderate
usage of medicine and to be presented logically
NO WORRIES, I'M
PRESCRIBING YOUR
PRODUCT TO ALL MY
PATIENTS

13. Terms of Saudi Code of Pharmaceutical Promotional
Practices in the Kingdom of Saudi Arabia
EXCEL WITH COMPLIANCE
Don’ts
‣ distribute samples contain narcotics or used in
psychotropic conditions
‣ conduct meetings or professional meetings in luxury or
fancy venues
‣ provide HCPs with entertainment programs or invite to
venues with live shows or similar
Dos
provide samples to qualified HCP who are able to prescribe in
small quantity
must have a adequate system to control samples
Books, scientific sources, Information, anatomical skeletons, or other
similar educational materials can be offered to HCPs, if it is for
absolute scientific
HCPs can provide companies with consultations service against
reasonable compensation
Meetings, seminars, congresses, and professional meetings
organized or sponsored by companies must be held in an
appropriate venue that is conductive to the main purpose of the
event
Hospitality should be limited travel, meals, accommodation and
registration fees

14. AD HOC
Comprised of ad-
hoc responses to
major risk &
compliance issues
Fragmented
Start of a risk
management
strategy, although
methodology and
strategy is not
aligned across
different parts of
the organization
Defined
Standardized
compliance
management
procedures
throughout the
organization,
although not fully
socialized. There
is a clear strategy
in place, although
there is still
susceptibility to
risk due to lack of
employee buy-in,
understanding
and/or skills
Mature
Compliance Risk
Management is
well incorporated
into broader
organizational
strategy;
communicated
and reinforced
through Talent and
Performance
Management,
Learning &
Development, and
organizational
structure.
Optimized
Regular review
and feedback are
used to ensure
improvement
toward
optimization,
elements are often
automated, which
is more effective
and preventing
compliance
failures and
ultimately less
costly than manual
control
COMPLIANCE CULTURAL MATURITY LEVELS
EXCEL WITH COMPLIANCE

15. CREATING A COMPLIANCE CULTURAL
EXCEL WITH COMPLIANCE
COMPLIANCE CULTURE
Risk assessment
To create a compliance culture, we need to work on the below 5 components
and develop them simultaneously

16. CREATING A COMPLIANCE CULTURAL
EXCEL WITH COMPLIANCE
Structure
No formal compliance
structure
No Independent
oversight
Accountability is not
defined
Risk Assessment
Compliance risks are
not understood
Polices
Some compliance
polices exist
No formal
communication for
polices
Training
Formal training is not
provided
Monitoring
Monitoring is ad hoc
AD HOC Compliance Culture

17. EXCEL WITH COMPLIANCE
CREATING A COMPLIANCE CULTURAL
Structure
Management
discourage non
compliance but no
follow up
Inconsistent oversight
accountability
understood but not
forma documents
Risk Assessment
Compliance actions
are reactive
compliance risks
are understood but
no formal
documented
Polices
compliance polices
exist
general guidance
on new polices with
sporadic formal
communications
Training
Sporadic
compliance training
exist
Monitoring
Monitoring exist but
not complete
Fragmented compliance Culture

18. EXCEL WITH COMPLIANCE
CREATING A COMPLIANCE CULTURAL
Structure
Compliance structure
is established
Compliance
committee exist
Accountability on key
officers, compliance
officer has full
responsibility for
compliance practice
Risk Assessment
Process in place to
identify compliance
risks and develop
mitigation plans
Polices
Policies for all
compliance areas
are available and
published
Formal process to
communicate
polices exist
Training
Regular and
scheduled on timely
plan training
Monitoring
monitoring is
regular for all
activities and
covering all areas
Defined Compliance Culture

19. EXCEL WITH COMPLIANCE
CREATING A COMPLIANCE CULTURAL
Structure
Reporting of risk areas
is consistent and
timely controlled
Compliance
committee meets
regularly and receive
reports form
compliance officers
Compliance officer is
independent and
report regularly to the
compliance committee
Risk Assessment
Compliance risk
assessment and
mitigation plans are
completed
Polices
Polices are
available and easy
to be reached on
web site
Compliance polices
and risk for non
compliance is
communicated
Training
Cooperate program
for compliance
development, that
detect the
individuals needs
and practicing
Monitoring
Monitoring and risk
management is fully
documented and
controlled by
dedicated
compliance officer
Defined Compliance Culture

20. EXCEL WITH COMPLIANCE
CREATING A COMPLIANCE CULTURAL
Structure
Network of compliance
officers who meet
regularly and
coordinate compliance
activities
compliance is a
strategic priority, all
risks are identified,
assessed and mapped
Board and audit
committee, and
executive
management
demonstrate
commitment to
compliance and
thought the company
Risk Assessment
Compliance, risk
management and
internal audit is
integrated in work plan
and supported by
automated systems
Polices
Polices are
available and easy
to be reached on
web site
regular formal and
immediate
communications for
new or amended
polices
Training
A compulsory
program
implemented and
automation is used
in monitoring,
assessment and
developing
compliance practice
Monitoring
Monitoring and risk
management are
fully integrated in
annual plans and
used for continuous
improvement
Optimized Compliance Culture

21. EXCEL WITH COMPLIANCE
CRITICAL SUCCESS FACTORS TO BUILD COMPAINCE CULTURE
• Top management endorsement and commitment
• Risk assessment and management is a continues process should be
integrated in work planning
• Training is well planned and integrated in employees development
programs
• Having a compliance officer and/or compliance committee to review and
approve all activities
• Having automated system to control, processing and report all activities to
top management regularly
• Every one is responsible for compliant practice

22. Thank You