Excel with compliance

Excel with compliance

DUBAI 28TH JAN 2016

THE 2ND PHARMA COMMERCIAL AND SFE SUMMIT MENA

Wesam Nehad

Country Head GCC / Actavis

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 ..


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 ..

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.



HOW PHARMA PAYS PHYSICIANS






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…

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


FOLLOWING ALL

LAWS

RULES AND

REGULATIONS

BEHAVING

ETHICALLY

AND WITH

INTEGRITY

WHAT COMPANIES NEED TO DO

local regulations/codes regulating pharmaceutical practice


General principles as per Saudi code of pharmaceutical

promotional practices


Terms of Saudi Code of Pharmaceutical Promotional

Practices in the Kingdom of Saudi Arabia


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

Terms of Saudi Code of Pharmaceutical Promotional

Practices in the Kingdom of Saudi Arabia


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

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


CREATING A COMPLIANCE CULTURAL


COMPLIANCE CULTURE

Risk assessment

To create a compliance culture, we need to work on the below 5 components

and develop them simultaneously



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



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



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



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



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


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

Thank You

Healthcare

Excel with compliance