vf en vendors integrity and compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh...

52
Work with Integrity and Compliance Training for Distributors, Customers, Suppliers and Third Parties Compliance CAC Innovative Medicines - Sandoz 2018 Integrity and Compliance

Upload: others

Post on 28-Jul-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Work with Integrity and ComplianceTraining for Distributors, Customers, Suppliers and Third PartiesCompliance CACInnovative Medicines - Sandoz2018

Integrity and Compliance

Page 2: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Agenda

What is Integrity?

Our Code of Conduct

Anti-bribery and Third Party Guideline

One P3

Conflict of Interest

Usage of Novartis logo

2

Page 3: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

What is integrity?

It is what we do when nobody is seeing us; is always doing the right thing, even if it can go against personal interests.

3

For you,

What doesintegrity means?

Think about how your decisions can

influence your work and your personal

life.

At Novartis we defend and apply high ethical standards every day, integrity is one of the values most

appreciated by the company

Page 4: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Our Vision

“The Novartis vision is to be trusted leaders to change the practice of medicine”

With our medicines, we influence the lives of almost one billion people eachyear. It is a great responsibility and we must act in accordance with thehighest standards of values, integrity and quality.

4

Page 5: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Code of conduct

5

Page 6: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Our Code of conduct

Our code of conduct is essential to our way of

working and establishes rigorous ethical

standards

The Code of Conduct, as well as the policies

and guidelines, establish the principles that help us make decisions with

integrity.

The principles-based approach allows better decisions and reduces risks for the company

However, in such a regulated sectorlike ours, does not mean thatthere are no rules.

Page 7: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

What we value Observed Behaviors

Innovation Experiment and encourage others to do it

Quality Always look for better ways of doing things

Collaboration Encourage high performance team work

Performance Passionate for achieving goals and making additional efforts

Courage Give your opinion and challenge the status quo

Integrity

We defend and apply high ethical standards everyday

Works with high ethical standards. Is humble, kind and attentive, shows trust, respect and empathy. Follows the code of conduct, even when encountering resistance or difficulties

7

Novartis values and behaviors

Page 8: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

PatientsPatient benefit and safety is at the heart of everything we do

Patient benefit and safety Research and development

Product quality and safety Access to healthcare

AssociatesWe treat our associates fairly and respectfully

Fair working conditions Diversity and inclusion

Associate appraisal and development Freedom of opinion, speech and association

ShareholdersWe are committed to outstanding and sustainable performance with integrity

Financial integrity Business continuity Safeguarding corporate assets

Information security Conflict of Interest

Healthcare partnersWe strive to be a trusted healthcare partner

Customer satisfaction Anti-bribery and corruption Fair competition Marketing practices

Commitment to all laws and regulations

Third party integrity

SocietyWe aspire to be a good corporate citizen

Corporate citizenship Transparency Human Rights

Health, safety and environment Data Privacy

Five core principles related to our stakeholders guide the key areas of our code:

Our Code of Conduct

Our five core principles Key areas of our code

8

Page 9: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Patients

Patient benefit and safety

• We expect our associates in all areas of ourbusiness to focus on enabling better patientoutcomes and providing innovative solutions topatient needs around the world, while adheringto the respective laws governing thoseactivities. Compromising patient benefit orsafety is not an option.

Research and development

• In all our research activities we strive to ensurethe rights, safety and well- being of allparticipants. We are committed to a global setof core ethical principles based on theDeclaration of Helsinki and the principles ofGood Clinical Practice. When we have to useanimals for research purposes we arecommitted to minimizing their discomfort andpain. We will use alternatives to animalresearch whenever possible.

Product quality and safety

• We discover, develop and manufacture high-quality products that meet all regulatory requirements, and pursue quality beyond compliance in both our products and processes. We protect patient safety by identifying, assessing, managing and reporting any product-related risks in a timely manner.

Access to healthcare

• As a healthcare company, our primary responsibility is to discover and develop new products to prevent and cure diseases. With collaborators around the world, we also work to enhance access to healthcare for patients through medical research, new business models and actions to strengthen healthcare systems in both developing and advanced economies

9

Patient benefit and safety is at the heart of everything we do

Page 10: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Associates

Fair working conditions

• We commit to provide our associates fair andcompetitive wages based on performance andethical conduct. We protect associates from unfairor unethical working conditions, including bonded,forced or child labor, or any unsafe workingconditions.

Diversity and inclusion

• We treat our associates fairly, equally andrespectfully. We expect associates to demonstraterespect toward each other and we do not tolerateany form of harassment or discrimination. We seekto create an inclusive work environment whereassociates regardless of their backgrounds cancontribute fully. We appreciate the diversity andindividuality of our associates and do notdiscriminate based on personal characteristicssuch as nationality, gender, age, ethnicity, religion,sexual orientation or disability. We believe adiverse workforce that reflects the globalcommunity of our patients and customers is criticalto our success.

We therefore attract, develop and retain highly talented peoplewith diverse backgrounds and inclusive mindsets.

Associate appraisal and development

• The evaluation of an associate’s performance considers bothachievement on objectives as well as adherence to theNovartis Values and Behaviors. Constructive dialoguebetween the associate and supervisor on goals, prioritiesand development needs is an essential part of the NovartisPerformance Management Process. We offer opportunitiesfor our associates to develop, grow and continuouslyimprove individual skills to strengthen the competencies ofNovartis as a whole.

Freedom of opinion, speech and association

• We respect the right of associates to choose to join anassociation, provided that local law is respected. Novartisengages in constructive dialogue with associates and theirrepresentatives. We recognize that every associate isentitled to freedom of opinion, expression and speech,provided these do not interfere with the associate’s ability tofulfill their job responsibilities or conflict with the NovartisCode of Conduct.

10

We treat our associates fairly and respectfully

Page 11: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Stakeholders

Financial integrity

• We do not compromise our financial integrity.Financial risks and operational measures must beappropriately reviewed and approved. We providetimely, accurate and complete financial information toour shareholders and financial markets. We maintaineffective controls over financial reporting to ensure acomplete and accurate record of our financialtransactions. Associates must not trade shares orother securities on the basis of material non-publicinformation.

Business continuity

• We believe that business continuity management iscritical for our patients, customers, associates andother stakeholders, and is part of responsiblemanagement practice. In the event of an emergencyor significant business disruption, we are committedto doing our utmost to ensure uninterrupted supply ofkey products and services.

Safeguarding corporate assets

• We work to protect assets of Novartis against threats.This applies to our associates, reputation, intellectualproperty, information, products, property and otherassets.

We properly use and maintain assets of Novartis and ensurethat they are protected from misuse, loss, theft and waste. AllNovartis assets must be used for legitimate business purposes.We protect our investments in intangible assets by obtaining,enforcing and defending intellectual property (IP) rights and bymaintaining confidentiality of sensitive information. We alsorespect legitimate IP rights of others. IP created, developed orobtained by associates and related to their employment belongsto Novartis.

Information security

• We protect the confidentiality, integrity and availability ofcritical information, regardless of its form and location.

Conflict of interest

• Personal interests must not influence our business judgmentor decision making. Associates must disclose actual orpotential conflicts of interest to their supervisor. Newly hiredassociates are requested to disclose any actual or potentialconflicts of interest before they begin employment.

11

We are committed to outstanding and sustainable performance with integrity

Page 12: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Healthcare partners

Customer satisfaction

• We strive for the highest customer satisfaction.We listen to our customers and createsolutions that add value and create mutualbenefit for them and for Novartis.

Anti-bribery and corruption

• We do not tolerate any form of bribery orcorruption. We do not bribe any public officialor private person and we do not accept anybribes.

Fair competition

• We are committed to fair competition and willnot breach competition laws and regulations.

Marketing practices

• We market and sell our products in compliancewith all applicable rules and regulations, and inline with high ethical standards.

This commitment also applies to all our other activitiesrelating to the commercialization of our products, such asthe collection and communication of medical and otherinformation.

Commitment to all laws and regulations

• We comply with all laws and regulations applicable toour activities. We also implement and comply with ourinternal policies.

Third party integrity

• We expect third parties with whom we work to complywith the law, to adhere to ethical business practices,and to observe our standard requirements concerninglabor, health, safety, environmental protection andmanagement systems.

12

We strive to be a trusted healthcare partner

Page 13: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Society

Corporate citizenship

• By actively contributing to social, ecological,cultural, and other projects and programs, westrive to contribute to the solution of societalproblems. We are committed to the UnitedNations Global Compact, the world’s largestcorporate citizenship initiative.

Transparency

• We are open and transparent with respect toour business principles and practices andcomply with applicable laws and regulations.

Human rights

• We strive to ensure that activities within oursphere of influence do not negatively impactfundamental human rights, as set out by theUnited Nation’s Bill of Rights and the coreconventions of the International LaborOrganization, either directly or through ourbusiness relations.

Health, safety and environment

• We strive to be a leader in all aspects of occupationalhealth, safety and environmental protection. Wesystematically identify and manage health, safety andenvironmental risks in our activities and over the entirevalue chain of our products and services. Weproactively foster and encourage a strong culture ofsafe behavior. We make efficient use of naturalresources and minimize the environmental impact ofour activities and products over their life cycle.

Data privacy

• We respect the privacy rights of our associates,patients, physicians, and other stakeholders. We informindividuals of collection and processing of their personaldata, allowing them to make informed decisions andexercise their rights. We collect and process personaldata for specific and legitimate business purposes onlyand secure such data against unauthorized access.

13

We aspire to be a good corporate citizen

Page 14: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

When in doubt ask yourself:

14

Will my conductallow us to

maintain the trust of all ourstakeholders?

Would my familyand friends thinkthat my conduct

was ethical?

Have I thought aboutthe impact on those

who will be affected bymy conduct?

Would I be comfortable if

someone treatedme the same way?

Would I be comfortableif my conduct

appeared in the media?

Is my conductlegal and compliant withNovartis policies?

Page 15: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Anti-bribery Policy

15

Page 16: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Anti-Bribery Policy

The policy providesclarity about

the main areasrisky

Active vs. passive bribery

Sponsoring

Political contributions

Lobbying

New business and join ventures

Rules related to public officials

Engagement of Third parties

Includes the following topics:

Page 17: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

It is not only money – bribery can take manyforms

Bribery means offering, giving or promising (or authorizing someone to offer,give, or promise) an improper benefit, directly or indirectly, with the intention ofinfluencing or rewarding the behavior of someone to obtain or retain acommercial advantage.

Bribery can be given in different ways, offering or giving money or any propertyof value.

Even ordinary business practices or social activities (eg , gifts or entertainment)can be considered as bribes in certain circumstances.

What is bribery?

17

Page 18: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

It is necessary that we all understand the implicationsSome sentences should make us stop and reflect:

A bribe, under any other name, it's still a bribe

You must pay a small commission, that's all

We are helping each other, right?

This is just a small sample of my thanksLet me take care of

18

This is just a littleof motivation

Page 19: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Anti-bribery

19

Medical and scientific personnel qualify as public officials when they work at ahospital, clinic, university or other similar facility owned or partially owned by agovernment. Novartis does not distinguish between public officialsand employees of private sector organizations so far as bribery isconcerned; bribery is not tolerated, regardless of the status of therecipient.

Novartis associates or personal working onbehalf of the company name will not bribe oruse intermediaries (such as agents,consultants, service providers or other thirdparties) to bribe.There is no difference betweenbribing directly or through anintermediary

No money or anything elseof value should be offeredto anyone, as it could beinterpreted as being donein order to gain somebenefit for Novartis.

Page 20: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Global anti-bribery policy

20

Gifts, Hospitality, and Entertainment:

Gifts, hospitality, and entertainment must never be promised, offered, or provided with the intent of causing the recipient to do something favoring Novartis, to reward such behavior, or to refrain from doing something disadvantaging Novartis.

Locally gifts, inappropriate hospitality and entertainment activities are prohibited.

Page 21: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Any elected or appointed officer or employee of a government or government department, government agency, or of a company owned or partially owned by a government

Any elected or appointed officers or employees of public international organizations, such as the United Nations

Any person acting in an official capacity for or on behalf of a government or a government department, government agency, or of a public international organization

Politicians and candidates for a political office

Any other person who is considered to be a public official according to applicable laws, regulations and industry codes

Definition of public officials

21

Page 22: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

• For any activity that our Third Parties sub-contract to any othercompany or individuals (assuming that this is possible under thecontract and NVS has provided consent), we require that the samestandards apply. Sub-contractors need to have: Same anti-briberycontractual clause in the agreement, due diligence process and anti-bribery certification.

Sub-Contracting

• Novartis may make political contributions only where these are part of the political culture in a country and are seen as part of the corporate social responsibility of corporations.

Political Contributions

• Payments in cash are not allowed under any circunstances.• We don´t have “facilitation” payments. Novartis and Sandoz

prohibits facilitation payments, irrespective of whether locallaw permits.

• All financial transactions must be documented, reviewed regularlyand properly accounted.

• Payments shall be made within the country where the service is tobe provided or the goods to be delivered.

Payments

22

Global Anti-Bribery Policy

Page 23: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

• Grants and donations may only be given if Novartis does not receive(and is not perceived to receive) any tangible consideration in return.At the same time, grants and donations must never reward (or beperceived to reward) any tangible consideration.

• Sponsoring must not be used (or perceived to be used) to receive animproper commercial advantage in return. At the same time,sponsoring must never reward (or be perceived to reward) animproper commercial advantage.

• Grants, donations, and sponsoring may not be provided toindividuals.

Grants, Donations and Sponsoring:

• Lobbying should not be misused for any corrupt or illegal purposes,or to improperly influence any decision. Relevant functions (e.g.,Public Affairs) provide guidance on how lobbying should beconducted based on the values of transparency, honesty andintegrity.

Lobbying

• Before entering into an agreement for new business or entering intoa joint venture, adequate anti-bribery due diligence must becompleted. In addition, a remediation plan should be developed andimplemented to address identified issues.

New Business and Joint Ventures

23

Anti-Bribery Policy

Page 24: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Global Anti-Bribery PolicyRed Flags

• Unusual payment terms, such as:

– payment in cash;

– request for commission payments to a thirdparty or other countries;

– unusually large commissions;

– request for reimbursement for poorlydocumented or questionable expenses.

• Contracts with Third Parties that have family orbusiness ties to public officials.

• Rumors of unethical behavior of Third Parties;

• Incomplete or inadequate disclosure by ThirdParties (i.e., undisclosed principals, associates,or subcontractors);

• Large or frequent political contributions made byThird Parties;

• Refusal to certify compliance with anti-briberyprovisions..

Novartis do not allow:

• Payments/loans for any committee membersor other individuals in a position of improperlyinfluencing sales of our products.

• False contracts:

– Consulting/Servicing with no need;

– Consulting/Servicing where there is noplan to use services provided;

– Consulting/Servicing where theintermediary does not have the adequateexperience to perform the service;

– Consulting/Servicing where services arepriced above fair market value;

– Consulting/Servicing with vague orambiguous deliverables or scope of workto be performed by the intermediaries.

24

Page 25: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Third Party Guideline - TPG

Page 26: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

• At Novartis and Sandoz, we are responsible for the actions of those who work on our behalf.

• Third Parties (suppliers, customers, distributors, etc.) may pose a significant risk of bribery.

• Therefore, the risk management with third parties is essential to become a trusted leader in the change of the practice of medicine.

• This document is a guide for hiring Third Parties.

• If you perform a service on behalf of Novartis, this guideline applies to you

26

Guidelines for Third Parties Effective as of May 1, 2017

Page 27: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Our Guideline has evolved to meet the latest standards

27

In/out scope 1. Pre-classification 5. Monitoring4. Contracting2. Due Diligence 3. Decision-making

2017 Risk-based Due Diligence process Post-approval process

2012

1. Due Diligence, decision-making and monitoring 2. ContractingIn/out scope

Third Party management process

If you want to know more about this guideline, you can go to the following link: https://share.novartis.net/sites/icacademy/SitePages/UI/pages/index.aspx

Page 28: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Third Party management –What’s new?

28

1. Pre-classification 3. 5. Monitoring2. Due 4. Contracting

WH

AT’

S

THE

GO

AL? Identify if Third Party

is in scopeDefine a risk level to select appropriate actions

Gather information to identify risks

Decide final status and monitoring plan

Have an appropriate contract in place

Make sure the right monitoring is in place

WH

O’S

IN

VO

LVE

D? Business Owner Business Owner

Due Diligence Coordinator / SQ Analyst

Due Diligence Coordinator / SQ Analyst

Business Owner*

Local Compliance Officer

Legal Head

Business Owner Business Owner

Due Diligence Coordinator/ SQ Analyst

KE

Y N

EW

AC

TIO

NS

• Risk pre-classification using Third Party risk classification tool (low, medium or high risk)

• Perform Due Diligence based on pre-classification (risk-based approach)

– Background check

– Manage Questionnaire

• Make final risk classification

• Depending on (final) risk classification, different stakeholders need to be involved

• Risk mitigation and monitoring activities

• Apply escalation route for decisions, if needed

• Update of contractual clauses

• Reference to Anti-Bribery training

• Section specifically on monitoring

• Ongoing monitoring of Third Party

In/out scope 1. Pre-classification 3. Decision-making 5. Monitoring2. Due Diligence 4. Contracting

Risk-based Due Diligence process Post-approval process

Page 29: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

In/out of scope

The Guideline applies to Third Parties who...

• Sell or resell Novartis products (or assist in selling or reselling)

• Act on behalf of Novartis in dealing with:– Government agencies– Healthcare Professionals

• Conduct clinical trials on behalf of Novartis

1. Pre-classification 2. Due Diligence 5. Monitoring4. Contracting3. Decision-makingIn/out scope

In scope examplesAgents, intermediaries, marketers, promoters, contracted sales force, Clinical Research Organizations (CROs)

Out of scope examplesSuppliers, customers such as doctors or pharmacies

Note: Distributors/wholesalers who promote Novartis products or who are involved in ‘demand generation’ for Novartis products are in scope

Who’s responsible? Business Owner

What’s the goal? Determine if the Guideline applies

29

Page 30: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

One P3 – Policies and Professional Practices

Page 31: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Our P3 PrinciplesObjective

The vision of Novartis is to be trusted leaders to change the practice of medicine. Based on this vision, Novartis is committed to the same standard of ethical business conduct wherever it conducts business.

For this reason, Novartis has adopted a unique set of ethical principles that must be applied to the daily decision making of all Novartis employees in any interaction they maintain with clients and in any activity related to professional practice.

We must take into account the5 principles P3:

Page 32: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

BACK

All interactions with our customers must ultimately benefit patients by enhancing the standard of care, raising awareness about diseases and their treatment options, or otherwise contributing to the ethical delivery of healthcare.

We will treat patient information with respect, protect confidentiality, where required obtain informed consent, and be transparent with patients at all times.

We must protect patient safety. If an Associate becomes aware of a product-related risk or complaint (e.g., adverse event, manufacturing defect or product failure) related to Novartis products (approved or investigated) it must be reported in a timely manner.

32

Put patients first

Page 33: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

33

Fund responsiblyExternal funding, including grants, donations and sponsorships, must only be given to legitimate organizations and provided in a way that protects our reputation, aligns with society’s expectations, and is consistent with the Novartis Mission to discover new ways to improve and extend people's lives.

The same rules apply for external in-kind support.

BACK

Page 34: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

BACK

34

Act with clear intentAs trusted partners in healthcare, all of our activities must have clear objectives that are accurate, truthful, not misleading, and appropriate for their intended context.

Novartis may conduct promotional and non-promotional activities throughout the product lifecycle. These activities ensure that products are developed to meet the needs of patients, to advance scientific understanding of disease, including disease management and treatment outcomes, and to discuss the appropriate use of products.

Non-promotional activities should never be conducted in a way that are intended or perceived to be promotional.

Page 35: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

BACK

35

Engage appropriatelyAssociates must not offer, approve, or provide anything of value with the intent or consequence of inappropriately influencing or rewarding our customers for the use of Novartis products.

Novartis may choose to engage healthcare professionals or other customers to provide necessary and legitimate services to help us research, develop, and/or promote our products.Any compensation must be for a bona fide service, consistent with fair market value, properly documented and accounted for, and disclosed where required.

Allowable items of value, when provided to customers, must be modest, reasonable, infrequent, free from actual and perceived conflicts of interest, and disclosed where required.

Page 36: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

BACK

36

Research for the right reasonResearch and development must only be conducted to address valid medical or scientific questions aimed at enhancing patient care. We must always respect and protect the rights, safety and well-being of patients and animals and safeguard the integrity and validity of the data obtained.

Research and development activities must follow established ethical and scientific standards and be conducted by qualified investigators.

Research and development activities must never be promotional in nature.

Page 37: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Clinical research

• Novartis CAC must carry out clinical research for the right reasons.

• The investigation must carried out only if it is scientifically valid and has been designed to respond to relevant medical, scientific, health or economic issues.

• Prices and market access Novartis CAC can interact with People at the individual level, such as HCP, involved in the recommendation or in the decision to refund the purchase of products or in the acquisition of Novartis CAC products.

• These interactions should not interfere with the independent judgment of HCP, nor be perceived as a form of inappropriate influence.

General guidelines

37

Page 38: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Communication of prior approvals and scientific exchange

• The products should only be promoted in accordance with the approved labels that appear in the inserts in each of the countries of the region.

• Novartis CAC supports the right of the scientific community and society to be informed about the scientific and medical progress that concerns them.

• When permitted by local laws and regulations, and by sector codes, Novartis CAC may exchange scientific information.

• Such exchange may include communications at scientific events, public disclosure of information to investors / shareholders, governments, reimbursement agencies or their agents and public.

Promotional interactions

• After obtaining the marketing authorization, Novartis CAC can interact with customers, directly or through a third party, to promote the products of Novartis CAC, its characteristics and benefits.

• All interactions should have a clear intention, transparent objectives, and should not interfere with the independence of the clients.

General guidelines

38

Page 39: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Promotional content

• Novartis CAC can produce and distribute content to inform, educate about, or promote your products.

• All content must be accurate, fair, balanced, truthful, and not be misleading, must be based on adequate evidence and be consistent with the scope of the relevant marketing authorization of the product.

Articles of medical utility and cultural acknowledgement of special occasions

• When local legislation and regulations, and industry codes permit, items of medical utility may be offered to HCPs if such items are modest, have reasonable value and offered on an occasional basis.

• Cultural acknowledgement are prohibited for all divisions of Novartis CAC.

General guidelines

39

Page 40: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Medical samples and demonstration and evaluation devices

• When permitted by local legislation and regulations, as well as industry codes, free samples of Novartis CAC products (medical sample) may be given to HCPs authorized to prescribe such products to improve patient care or provide experience with the patient.

• Pharmaceutical samples should always be labeled as such, and should be administered with control and accounting systems. They should never be resold or applied for misuse.

Events • Novartis CAC can organize

events or contribute to fundraising events organized by third parties throughout the life cycle of a product in order to provide scientific information or educate customers about the products or disease areas to which they can be applied.

• All events must have clear objectives, have a responsible financing and be coherent with the mission of Novartis CAC, so that they meet the expectations of society.

General guidelines

40

Page 41: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Venue, travel and hospitality

• All events, meetings or activities must be held in an appropriate place for scientific or educational exchange, and in accordance with local legislation and regulations, and industry codes.

• Novartis CAC must avoid venues that may be perceived as extravagant or as a way to exert undue influence.

Rates for services

• Novartis CAC may contract HCP and Healthcare Organizations to provide professional services, directly or through a third party.

• Novartis CAC is responsible for appropriate contracting, and does not intend or give the impression of being a consequence of improperly influencing HCPs or Healthcare Organizations for the use of our products.

General guidelines

41

Page 42: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Key benefits

Please take note! However, even though P3 principles based policy, it is

important that you keep in mind that some rules, processes and local approvals will still apply.

Page 43: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Conflict of interests policy

Page 44: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Conflict of Interest Policy, to whom does it apply?

• To all Novartis employees.

• To all third parties (clients, suppliers, distributors, among others) that have personnel assigned to Novartis Pharma, Oncology and / or Sandoz for the Central America and Caribbean region.

44

Page 45: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Emitir juicios, tomar decisiones oemprender acciones bajo esta influenciapuede dificultar el desempeño objetivoy eficaz de las labores en Novartis.

45

Page 46: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Understand when a conflict of interest may arise

Avoid, whenever possible, a conflict of interest

Immediately disclose your Manager about any conflict that cannot be avoided

Address properly any conflict of interest

46

Novartis Group company Associates are expected to...

The Global Conflict of Interest Policy is built onthe Novartis four-step approach to managing

conflicts of interest

Page 47: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Conflict of Interest -brief

47

Section Expectation Principles Main Changes

Associates are expected to recognize a conflict of interest.

Associates are expected to recognize when they have, potentially have, or could be perceived as having, a conflict of interest.

“Perceived” is included.The associate asks its manager to receive the guide. Inludes “closely related persons”

It is better to avoid a conflict of interest.

As part of their employment with Novartis, Associates have a contractual obligation of loyalty to Novartis. Accordingly, Associates should avoid conflicts of interest with Novartis.

Explains what is “avoid” and focus why is important to do it.

If a conflict cannot be avoided, the Associate must disclose it.

Disclosure must take place as soon as the Associate identifies that there may be a conflict of interest and, whenever possible, before the associate engages in the conduct in question.

The conflict must be disclosed immediately.

A Disclosure form is implemented. In the case of external personnel (customers, distributors, suppliers, others), they must inform their employers.

Addressing a conflict of interest is the responsibility of the Manager

Managers must:Evaluate the conflict and risks. Seek for guidance if necessary. Decide and communicate to the Associate any decision taken. Keep documentation.

Empower managers.

Encourage managers to seek guidance of their HR Business Partners and/orCompliance Officer.

Page 48: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

• A Purchasing employee, who negotiates hotel rates for conferences and workshops, receives a free hosting notification at one of the hotels that is under negotiation. Apparently, he has won a raffle organized by the hotel.

• Should him/ her accept the accommodation for free?

Answer:

1. Yes, but only if your supervisor agrees

2. No, accepting free hosting from a business partner is a conflict of interest

3. Yes, it has been a random winner, so you are allowed to accept the prize

Practical case

48

Page 49: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Practical case

49

Accepting gifts or gift certificates from a possible or current commercial partner of Novartis or Sandoz, supposes a conflict of interest. Accepting this gift could put in question the ability of the collaborator to maintain its objectivity in the future.

Page 50: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Usage of Novartis Logo

Page 51: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Departamento de Compliance

Usage of Novartis Logo

• Novartis has available a new online tool for using the Novartis logo.

• Through this tool, requests for third-party uses of the Novartis Logo can be submitted with minimal effort, automatically creating permission agreements.

Enter the link below to request an authorization to use the Novartis logo: https://share.novartis.net/sites/legal/GlobalIP/SitePages/No...

51

Page 52: VF EN vendors Integrity and Compliance 2018€¦ · 'hsduwdphqwr gh &rpsoldqfh :kdwlvlqwhjulw\",w lv zkdw zh gr zkhq qrerg\ lv vhhlqj xv lv dozd\v grlqj wkh uljkw wklqj hyhq li lw

Thank you

If you have any questions about the different policies presented in this material, you can contact any member of Compliance Department:

Pharma: [email protected]

Oncología: [email protected]

Sandoz: [email protected]