2014 The Red Book Code of Business Conduct - IFPMA
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The Red Book
Code of Business Conduct
2014 Nothing is more important than integrity. We must act in
a manner consistent with the highest ethical standards,
consistent with what is required of a company whose
products people depend on for their lives.
John C. Lechleiter, Ph.D., Chairman, President, and CEO
Table of Contents
Module 1 – Introduction.......................................................................2 Manufacturing, Product Quality, and Physical Assets
Message from the CEO . .............................................................. 4 Key Principles ......................................................................33
Overview.........................................................................................5 References . ......................................................................... 33
Integrity in Action................................................................. 34
Module 2 – Integrity..............................................................................7
Leader Discussion ....................................................................... 8
Module 5 – Information......................................................................35
Leader Discussion ..................................................................... 36
Integrity and Reporting
Key Principles ....................................................................... 9 Research and Development
References . ......................................................................... 11 Key Principles ......................................................................37
Integrity in Action................................................................. 12 References . ......................................................................... 37
Integrity in Action................................................................. 38
Adverse Event and Product Complaint Reporting
Key Principles........................................................................13 Information Management
References . ......................................................................... 14 Key Principles ......................................................................39
Integrity in Action..................................................................15 References . ......................................................................... 40
Integrity in Action................................................................. 41
Module 3 – Interactions......................................................................16 Privacy
Leader Discussion ..................................................................... 17 Key Principles ......................................................................43
Interactions and Communications with External Parties References . ......................................................................... 43
Key Principles ..................................................................... 19 Integrity in Action................................................................. 44
References . ......................................................................... 21 Finance and Transactions
Integrity in Action................................................................. 24 Key Principles ......................................................................45
Module 4 – Workplace........................................................................27 References . ......................................................................... 45
Leader Discussion ..................................................................... 28 Integrity in Action................................................................. 46
Human Resources Module 6 – Conclusion........................................................................47
Key Principles ......................................................................29 Closing Thoughts ....................................................................... 48
References . ......................................................................... 29
Integrity in Action................................................................. 30
Health, Safety, Security, and the Environment
Key Principles ......................................................................31
References . ......................................................................... 31
Integrity in Action................................................................. 32
1
Introduction
The Lilly Code, established
in 1899 and illustrated in this
1932 version of the code,
served as the company’s
first mission statement and
code of conduct. The code
established three areas
of focus that endure
to this day.
2
1
The Lilly family founded Eli Lilly and
Company with strong values.
“Ours is the responsibility “The same fair and liberal “May the Red Lilly trademark,
for preserving the customs attitude toward the three which has become so
and ideals upon which this important elements in our prominently identified with
organization was built, so company life—namely, pharmaceuticals, remain a
that we may pass on to those customers, employees, and symbol of all that is upright
who follow us an even finer owners, all of whom deserve and creditable and be passed
inspirational record than that the utmost consideration— on to successive generations
which we inherited.” remains the order of the day, unsullied. A weak generation
—Eli Lilly just as it has been since could wreck this truly splendid
May 10, 1876...” business.”
—J.K. Lilly, Jr. —J.K. Lilly, Sr.
3
3
Module 1 | Message from the CEO
Shortly after joining Lilly in 1979, I recall learning aspirations to be the company that people can
about the Lilly values: integrity, excellence, and trust, and which reflect the changing societal
respect for people. Those were talked about even expectations of how a pharmaceutical company
then and, of course, they go way back to probably a should behave.
century or so ago, when they were first articulated.
We all want to be a part of a company like that, a
They reflect, I think, what the Lilly family intended
company that learns from its mistakes, that moves
this company to be all about.
on, and indeed, becomes even better and better.
You know, Colonel Lilly also admonished his son
to “take what you find here and make it better and
better” and that’s our obligation. He was speaking
to us, back in the 1880s, when he uttered those
words. We must expect of one another that we
manifest, in our words and our actions, the very
highest standards of conduct, standards that
are relevant to today, to 2014, that reflect our
John C. Lechleiter, Ph.D.
Chairman, President,
and Chief Executive Officer
Eli Lilly and Company
4
Module 1 | Overview
The Lilly Code of Business Conduct, The Red The Red Book covers a lot of information, so you External parties play an important role in Lilly
Book, sets expectations for conducting business are encouraged to refer back to the Key Principles, business. Requirements that apply to other external
consistent with Lilly values of integrity, excellence, References, and Integrity in Action examples in parties are established by contract. Lilly requires
and respect for people. When we live our values, The Red Book as often as needed. As you read the external parties who are engaged to conduct
our customers should be able to feel genuinely “Integrity in Action” examples, consider how you activities on Lilly’s behalf to follow applicable legal
cared-for and that they are able to trust us. might respond if the situations described were requirements. Lilly employees who have questions
The Red Book helps guide our actions with actually happening. If the facts of a particular about code of conduct requirements for external
colleagues, supervisors, payers, health care example seem unrelated to your job or assignment parties should contact human resources,
providers, regulators, suppliers, and most at Lilly, challenge yourself to think about other procurement, Lilly Legal, or an ethics and
importantly, the patients and others we serve. ways the principles illustrated may apply to compliance representative.
It is an important, foundational element of Lilly’s situations you encounter in your role. Because of
Lilly expects you will apply the knowledge gained
brand, culture, and overall ethics and compliance our diverse roles, not all of the examples will apply
from The Red Book to:
program. In addition, it demonstrates how to live to employees in every area or to contract workers
and protect the Lilly brand. on assignment at Lilly. Please note that the names • act with integrity,
of companies and various product names and • think critically and ethically, and
indications used in the Integrity in Action examples
are fictional references used for illustrative • apply good judgment.
purposes only.
The Red Book Key Principles apply to:
• all employees globally,
• members of the Lilly board of directors carrying
out duties as directors,
• certain business partners who are subject to
contractual agreements with Lilly, and
• some employees of external-party suppliers to
Lilly, subject to local law.
5
Module 1 | Overview
Details to support The Red Book principles, and The Red Book, or Lilly policies, standards, or
other elements of Lilly’s ethics and compliance procedures, may not directly address all of the
program, can be found in Lilly policies, standards, situations encountered in your work for Lilly. If
and other materials available through the Global employees have a question about applying a legal
Ethics and Compliance LillyNet site or in areas and/or Lilly requirement, it is their responsibility
where function-specific policies, standards, to seek advice or clarification from a supervisor
procedures and other materials are stored. Lilly or other member of management, an ethics and
also provides additional job-specific information compliance or human resources representative,
and training to its employees as appropriate for or Lilly Legal. Contract workers on assignment at
their responsibilities. Similarly, external parties Lilly should consult their employer or Lilly sponsor.
may provide additional training to their contract It is always the right thing to consult the experts on
workers on assignment at Lilly. difficult and/or complex situations.
6
2
Lilly switchboard operators connect
calls from all parts of the world to the
more than 1,300 Lilly telephones in
service in 1957.
Lilly continues to use and improve call
centers to support various aspects of its
current business and improve customer
experiences.
7
7
Module 2 | Leader Discussion
Melissa: As employees of Lilly, each of us holds • Would I be embarrassed if my colleagues or my
the company’s reputation in our hands every day. In family knew that I was the person responsible for
every interaction with a stakeholder, whether it be a the action?
healthcare professional, a regulator, or a member
If employees have concerns about something
of the community in which we operate, we are the
that they’re doing or something that a colleague
face of Lilly. We represent the company, and we
is doing or what’s expected of them, they should
represent its values.
reach out to the resources that are available
Mike: We need to conduct ourselves, each of us, through ethics and compliance and legal, and
in every interaction, with integrity. We have to clarify what is acceptable and what’s not acceptable
Melissa Barnes think about how our conduct will look if it’s viewed before moving forward. We don’t want anybody
Senior Vice President – in a newspaper or by our stakeholders outside of to be operating in an environment where they’re
Enterprise Risk
the company. uncomfortable or uncertain.
Management and
Chief Ethics and In some situations, it is not easy to know the right Melissa: This goes well beyond just how we act
Compliance Officer
Mike Harrington action to take. If you are unsure what to do, consider in our specific responsibilities. If we see something
Senior Vice President the following questions: that looks wrong or just doesn’t feel right, we have
and General Counsel
• Does the action align with Lilly’s values an obligation to ask questions. If the answers to
and brand? those questions don’t satisfy us, we need to
Melissa: The environment in which we operate is report it appropriately. What we can assure our
clearly changing. We see it across the business, • Do I know what company policies apply and their employees in those situations is that if they are
in guidelines from regulators, standards for the requirements? reporting a legitimate concern, and they are doing
protection of privacy, and expectations for ethical • Do I know for certain that my proposed actions that in good faith, there will absolutely be no
business practices. While the environment will are legal and consistent with the letter, and the retaliation. That is something we, as a company,
continue to evolve, the one thing that will not spirit, of the law and company policies? simply will not tolerate.
change is our values and foremost among those
values is integrity. • Have I consulted with the appropriate company
subject matter experts?
Mike: We need to build our business practices and
our policies around a set of principles that will • Would the action promote the best interests of
endure and fortunately, we have those principles at patients, shareholders, fellow employees, and
Lilly: integrity, respect for people, and excellence. other company stakeholders?
8
Module 2 | Integrity and Reporting: Key Principles
Lilly is committed to operating with integrity, − If Lilly policy or standard is more − ethics and compliance personnel,
striving for excellence in its performance and restrictive than local law, you must meet
− the Bioethics Advisory Committee (for human
that of its products. Lilly is also committed to Lilly’s requirements unless an exception
bioethics), and
demonstrating respect for all those who share in has been authorized for your geography or
its mission and are affected by its work: patients, functional area. − 3Rs Committee (for animal bioethics).
health care providers, payers, governments,
− If you are conducting a business activity that Contract workers on assignment at Lilly should
employees, shareholders, and business partners.
touches participants from more than one contact their employer, human resources group,
Conduct Lilly business, make decisions, and take country, you need to comply with all local laws or Lilly sponsor for guidance.
actions that are aligned with the Lilly values of and policies that could apply to the activity.
integrity, excellence, and respect for people. Seek advice if the requirements that apply are Report any known or suspected violations.
not clear. • All Lilly employees and contract workers on
ct in a way that is aligned with internal and
• A
external requirements and expectations that − If there is a conflict between the laws of assignment at Lilly have an ethical obligation to
apply to Lilly business and to each of our specific two or more countries that apply to the report to Lilly any known or suspected violation
jobs, including: same situation, consult a company attorney of the law; company policies, standards, or
to understand how to resolve the conflict procedures; official orders or decrees that apply
− local laws and official orders and decrees that
properly. If there is a conflict between local to company business; and any requests to do
apply to Lilly business, and
policies, contact an ethics and compliance something that might be a violation.
− Lilly policies, standards, and procedures. representative for advice. The interplay of • Local legal requirements and processes for
Lilly is a global, public corporation rules can be complex. reporting vary; see additional information below.
headquartered in the United States and is part of • C
omplete training on time. This includes annual • Lilly employees are also encouraged to report
the heavily-regulated pharmaceutical industry. Red Book training and all Lilly-required training. other ethical concerns or issues even if they do
Some U.S. laws extend to the operations of Lilly
• S
eek information, clarification, or other not relate directly to a law or company policy,
and its affiliates throughout the world. Lilly must
assistance. Ask for help when the ethical or legal standard, or procedure.
also adhere to laws of other countries, provinces,
states, and organizations, some of which also thing to do is not clear. In some situations, it’s • Reports should be made not out of fear but out
apply across borders. In short, many rules apply not easy to know the correct action to take. If of respect for Lilly customers and business
to Lilly activities. you are unsure, seek guidance from those with partners, for one another, and most importantly,
appropriate local knowledge and expertise. for the patients who use Lilly medicines.
Wherever you conduct Lilly business, you must
Resources available to Lilly employees include: • Lilly expects its employees to report concerns
understand the requirements for that location.
− a supervisor or other member of Lilly line so that Lilly can evaluate the reports and identify
− If the local laws and policies are more
management, and correct any problems promptly.
restrictive than The Red Book provisions or
global Lilly policies, you must adhere to the − human resources personnel,
more restrictive local requirements.
− a Lilly attorney,
9Module 2 | Integrity and Reporting: Key Principles
Because reporting processes vary depending on To contact the Hotline: Report ethics and compliance concerns
geographic location, Lilly employees must follow expressed by external parties.
− In the United States, call 1.800.815.2481
the reporting process established locally.
or submit a report online at www.lillyethics. • If any external party raises any ethics or
• Information explaining the various ways to ethicspoint.com. compliance concern about Lilly with an
make a report is provided at the Report employee, the employee should report
− In locations other than the U.S., employees
a Concern page on the Global Ethics and the concern following the local affiliate
may go to www.lillyethics.ethicspoint.com
Compliance LillyNet site. reporting process.
and select the country where the report is to
• Contract workers on assignment at Lilly should be made. The correct telephone number will • In the United States, Lilly employees may also
contact their employer, human resources group, be provided for that country. Employees may offer health care providers the option of making a
or Lilly sponsor for reporting process options. also submit reports online at www.lillyethics. direct report via:
ethicspoint.com. − the Health Care Provider Hotline:
• Lilly is required by U.S. law to offer a hotline as
one reporting option. Note: In some geographies, local data privacy 1.877.237.8197 or
laws restrict the use of the Hotline for certain − the Health Care Provider website available
• Lilly’s Ethics and Compliance Hotline is available
types of reports. Employees in these countries publicly on Lilly.com.
internationally and is operated by an independent
may only use the Hotline to report known or
company 24-hours-a-day, 7-days-a-week.
suspected violations specifically concerning Employees must notify Lilly within five (5)
The Hotline offers translation services and an
the areas of accounting, auditing, banking, calendar days if they are excluded or restricted
anonymous reporting option. All reports made
internal controls or anti-corruption (bribery). in any other way from doing business with
to the Hotline are referred to Lilly for evaluation
Additionally, anonymous reporting may be any government.
by the appropriate Lilly employees who have
discouraged or not permitted by law in some
expertise in the subject matter of the report.
countries. If Lilly employees are uncertain
about the appropriate processes or limitations
for making reports in their location, they may
refer to the Report a Concern page on the
Global Ethics and Compliance LillyNet site for
further guidance. Lilly employees may also
seek guidance from a Global Privacy Office
representative, a Lilly supervisor, a human
resources representative, an ethics and
compliance representative, or Lilly Legal.
10Module 2 | Integrity and Reporting: Key Principles
Lilly promptly investigates all reports of ethical Lilly employees may be subject to disciplinary Circumstances vary in each case involving the
violations or non-compliance and determines action, subject to local law, for matters including potential for disciplinary action by Lilly. Therefore,
whether there has been a violation. but not limited to: each situation is handled individually. The nature
and level of any action taken will depend on the
Concerns are reviewed and relevant facts are • authorizing or participating in an activity that
nature and severity of the problem, expectations
considered. Corrective action is taken where results in a violation of the law; Lilly policies,
of the position, and circumstances involved. If
appropriate. These actions may include any or all of standards, or procedures; or an official order or
disciplinary action is warranted, subject to local
the following, subject to local law: decree that applies to Lilly operations,
law, it may range anywhere from a warning
• revisions to Lilly policy or standards, • failing to report a violation or suspected violation, to termination of employment. In certain
• enhanced employee training on a circumstances, individual employees could even
• refusing to cooperate with the investigation of a
particular topic, be subject to government-imposed criminal
suspected violation,
fines, imprisonment, and an official prohibition on
• some action to mitigate a risk (e.g., eliminating • retaliating against an individual who reports a working in the pharmaceutical industry.
an ergonomics hazard), or suspected violation,
• feedback to or discipline of an employee. • failing to complete required training,
Lilly does not tolerate retaliation by any • making statements or reports or creating
References
employee against another employee or any records the employee knows are false, or
other person for: • in the case of a supervisor, failing to detect If you have questions about the Key Principles,
please see the following references. Contract
• reporting actual or suspected violations, making a violation if this resulted from inadequate
workers on assignment at Lilly, please contact
a complaint, or otherwise bringing inappropriate supervision.
your employer or Lilly sponsor.
conduct to Lilly’s attention,
• Global Policy on Compliance
• preventing unlawful practices, or
• Global Policy on Governance of Global Policies,
• participating in an investigation, proceeding, Global Standards, and U.S.-All Policies
or hearing.
• Global Ethics and Compliance LillyNet site
It is critical that Lilly supervisors take appropriate
• U.S. Policy on Compliance with Fraud and Abuse
measures to prevent retaliation in their areas of Laws and Whistleblower Protections
responsibility. Lilly sponsors of external parties
who employ contract workers on assignment at
Lilly must also take these measures.
11Module 2 | Integrity and Reporting: Integrity in Action
Q: Sabah, a Lilly marketing director in an affiliate, Sabah did not share his concerns, Faisal The success of ABC Distributor and the fact
asks Faisal, a marketing associate, to complete should have waited to forward the contract they could get upset if payment is delayed do
a contract with ABC Distributor to distribute a to ABC Distributor until he was satisfied that not justify payment for services not mentioned
new product and represent Lilly in government appropriate company requirements had been in the contract. These facts, including Faisal’s
bids. Sabah tells Faisal that she did not have met, including anti-corruption due diligence. earlier observation that the discount seems
time to review it, but since she is going on a Given his concerns, Faisal should escalate unusually high for this distributor, raise further
business trip, she signed the contract for Lilly. this situation to Sabah’s supervisor, or a local concerns of suspected violations of legal and
She asks Faisal to have ABC Distributor sign the Lilly Legal, human resources, or ethics and company requirements that should lead Faisal
contract as soon as possible. Faisal suggests compliance contact. to take additional followup action. Faisal should
report his concerns immediately to another
that the contract be reviewed and asks if anti- Q: ABC Distributor signs the contract. Several member of management or use an alternative
corruption due diligence has been completed weeks later, Faisal asks Sabah about a bill
for the distributor. Sabah tells Faisal that the reporting option outlined in The Red Book so
from ABC Distributor for marketing services.
timing is considered critical by the sales director that the situation may be investigated. The
He points out that marketing services are not
and she assumes the contract has standard appropriate Lilly contact will also need to
covered in the contract terms. Sabah tells Faisal
provisions. Sabah also indicates that the sales advise ABC Distributor to quit charging Lilly for
to approve the charges because ABC Distributor
director did not ask for any additional review. marketing services. If Faisal believes retaliation
is really helping the business gain access to
She instructs Faisal to proceed with getting ABC is occurring after submitting a report, he
new areas and Lilly does not want to upset the
Distributor to sign the contract. Faisal glances needs to speak with a local human resources
distributor. Faisal considers telling someone
over the contract and notices that the distributor representative immediately. Retaliation against
about the inappropriate charges for marketing
is receiving a higher discount than usual. He an individual for reporting concerns is strictly
services and the higher-than-usual discount
decides to trust Sabah and forward the contract forbidden.
ABC receives. He decides against it out of fear
to ABC Distributor. Did Faisal act appropriately? that Sabah might count it against him during his
A: Faisal suspected that something was not right, Performance Management review. Did Sabah
so he should have asked more questions. tell Faisal to do the right thing?
Sabah is responsible for the terms in the A: No. Before payments are authorized, they must
contract. Before asking Faisal to send it to be verified as legitimate services covered under
ABC Distributor, she should have reviewed the contract. This can be done by comparing
the detailed contract provisions. She also the charges against the contract. The charges
should have verified that all Lilly onboarding Faisal reviewed must be rejected if ABC
processes had been met for a new distributor. Distributor was contracted only to distribute
Faisal was right to ask questions. Even though products and not to provide marketing services.
12Module 2 | Adverse Event and Product Complaint Reporting: Key Principles
Report adverse events, product complaints, Product Complaints WHEN TO REPORT
and counterfeiting or tampering. A written, oral, or electronic communication that Any event involving a known or suspected human
Lilly is committed to meeting patient expectations to alleges deficiencies related to the identity, quality, death, counterfeiting, or tampering related to a
receive safe, high-quality medicines. All employees purity, durability, reliability, safety, effectiveness, human or animal health product or device must be
and contract workers on assignment at Lilly are or performance of a distributed Lilly drug product, reported immediately (within 24-hours of receipt).
required to report the following information to the drug/device combination product, medical device, All other reports, whether they relate to humans or
designated Lilly contact. Other external parties are radiopharmaceutical, API (active pharmaceutical animals, must be made within one business day.
also encouraged to use these reporting channels. ingredient), process intermediate, fermentation
If you are in doubt about whether to report a safety product, or any product manufactured and/or HOW TO REPORT
concern, please make a report. distributed by Elanco.
Employees, and contract workers on assignment at
Suspected Counterfeiting or Tampering Lilly, in certain functional groups or organizations
WHAT TO REPORT
ounterfeiting: A counterfeit medicine is one that
• C (e.g., sales, field-based medical) who have a higher
Adverse Events is deliberately or fraudulently mislabeled with likelihood of receiving adverse event or product
• Any undesirable medical occurrence in a patient respect to identity and/or source. A counterfeit complaint reports directly from customers,
administered a Lilly product (drug or device), drug, container, or label bears the trademark, are provided additional training and may have
including side effects already listed in the trade name, or other identifying mark (e.g., additional reporting requirements. Requirements
package insert. shape or color), imprint, or device of a drug for reporting adverse events from clinical trials are
manufacturer, processor, packer, or distributor specified in the trial protocols.
• Any observation in animals or humans that is without requisite authorization and with the
unfavorable and unintended and that occurs after intent to mislead purchasers into believing the
any use of an Elanco product. product is authentic.
• Tampering: The manipulation of any authentic
product or packaging thereby rendering it false
or misleading, with malicious or illegal intent.
13Module 2 | Adverse Event and Product Complaint Reporting: Key Principles
How to Report Issues Relating to Human How to Report Issues Relating to
Health Products and Devices Elanco Animal Health Products References
In the United States: In the United States: If you have questions about the Key Principles
• Any known or suspected death, counterfeiting, or • To make reports related to Elanco products, on Adverse Event and Product Complaint
tampering must be reported immediately (within including any reports of known or suspected Reporting, please see the following related
24 hours of receipt) by calling The Lilly Answers human death, call the Elanco phone line at references. Contract workers on assignment
Center (TLAC), 1.800.LillyRx (1.800.545.5979). 1.800.428.4441 or 1.888.545.5973. at Lilly, please contact your employer or
Lilly sponsor.
• Any other adverse event or product complaint In Countries Other than the United States:
must be reported within one business day • To make reports related to Elanco products, • Global Quality Standard GQS130
by calling The Lilly Answers Center (TLAC), including any reports of known or suspected Product Complaints
1.800.LillyRx (1.800.545.5979) or by using an human death, contact the local or regional
alternative reporting method approved for a • Reporting Elanco Complaints and Adverse
Elanco product safety (regulatory or Events
particular Lilly component. pharmacovigilance) representative as designated
In Countries Other than the United States: in local Lilly procedures. • Safety and Efficacy Quality System SEQS301
Pharmacovigilance
• To report an adverse event, contact the
responsible patient safety (pharmacovigilance) • Safety and Efficacy Quality System SEQS302
representative according to the local Device Vigilance
Lilly process.
• For product complaints or known or suspected
counterfeiting or tampering, contact the
responsible complaint person for the local Lilly
affiliate according to the local process.
14Module 2 | Adverse Event and Product Complaint Reporting: Integrity in Action
Q: Olivia, a Lilly employee, is talking to her uncle, A: Olivia must follow appropriate local process to
Lachlan, at a family holiday gathering. Olivia report the product complaint and an undesirable
tells Lachlan she is glad to see him making a medical occurrence in a patient using a Lilly
strong recovery after a heart attack he suffered product (drug or device). She should report
the previous year. Lachlan responds that he within one business day, following the local
is feeling much better and has been given a reporting process. (If Olivia is in the United
prescription for a Lilly product. He mentions that States, she should call The Lilly Answers
he has had trouble pushing the tablets out of the Center.) Reports must be made if there is a
blister and a couple of the tablets have broken. possibility a side effect is related to a Lilly
He also mentions a few side effects, but is not product, whether or not the side effect is already
sure which of his medications is causing them. listed in the package insert. If employees are
What should Olivia do? ever in doubt about whether to report a patient
safety concern, the report should be made.
(Employees must also follow any additional
job-specific training received on this topic.) It
is also appropriate for Olivia to recommend to
Uncle Lachlan that he discuss the situation with
his physician so that he can receive personal
medical advice.
153
With his arrival in Shanghai, China,
in 1918, John G.W. King (third
from left in the front row) became
Lilly’s first resident overseas
representative. Josiah K. Lilly, Sr.
(seated behind the sign) is shown
in Shanghai during a world tour
in 1923. The distribution of Lilly
products in the Far East made Lilly
a worldwide company.
Flags on display at Lilly Corporate
Center represent some of the
125 countries where Lilly products
are sold.
16Module 3 | Leader Discussion
Enrique: It’s obviously very exciting to be able to Bart: We, individually, are the Lilly brand. Our
bring new medicines to patients. We have to really behavior reflects on the company and the
undertake significant work to be able to do this. And company’s history, in a positive way, guides us as
as excited as we are to be able to do that, we have to how we should behave. I think if we keep the Lilly
to make sure that we continue with the rigor and brand in mind, that 137 years of history headlined
discipline to be true to our integrity principles. by the values of integrity, excellence and respect for
people, it’s an important guide to our behavior day
Sue: As we are preparing to launch, and actually
in and day out.
launching, new products in our pipeline, it’s
essential that we keep ethics at the forefront of
Sue Mahony what we do. We need to ensure that the customers
Ph.D., Senior Vice receive accurate, balanced, and credible
President and President – information that reflects the approved label for our
Lilly Oncology medicines. We need to ensure that every interaction
that we have with our customers is done with
Enrique Conterno integrity so that we build trust, we build credibility,
Senior Vice President and so that we ensure that the right patients receive
and President – our medicines in the right way.
Lilly Diabetes
Bart Peterson
Senior Vice President –
Corporate Affairs and
Communications
17Module 3 | Leader Discussion
Chito: I grew up in the emerging markets in most Dave: No matter how challenging your business Chito Zulueta
of my career with Lilly. One thing that I found to targets are, what comes first is integrity, not Senior Vice President
and President –
be very encouraging is a real emphasis of many only for our customers, but for our long-term Emerging Markets
governments across emerging markets to really reputation. And so, although it’s a tough year, this
raise the bar and level of integrity, whether it is not going to be a year where we would, for a
be government or industry, in how business is minute, think about sacrificing our reputation.
conducted in many of these countries. Many of
Jeff: The challenges our businesses can be under
them, if not all of them, are developing countries.
to make plans, to deliver results, no question
I think we play a very important role as Lilly in
there’s a rising bar in that area. But doing it right is,
there. We’re part of the solution. Lilly is being able
we know, the sustainable right way to do it. A great
not only to do the right thing for the company, for
business, a great brand that lasts for generations
customers, for the patients, for our employees,
like Lilly has, is thinking that way, thinking the
but we’re doing the right thing for the countries
long term. When we think the long term, we do the
that we operate in. Living up to the Lilly values,
right thing and that creates sustained, long term
particularly the value of integrity, I think allows
shareholder value, customer value, and ultimately it Jeff Simmons
us to really contribute even more to society beyond Senior Vice President,
comes back to, long term, what Eli Lilly and Elanco
just our very innovative molecules and our and President –
stand for. The consistency of what we stand for
innovative solutions. Elanco Animal Health
today is a differentiator to the customer.
Bart: This is a complicated business and good
intentions aren’t good enough. You have to Dave Ricks
understand the policies in order to comply with Senior Vice President
and President –
them. It’s not always intuitive and I think it’s really Lilly Bio-Medicines
critical that we understand that.
18Module 3 | Interactions and Communications with External Parties: Key Principles
Earn the trust and respect of Lilly customers, Note: Employees or consultants of a government- that apply to various audiences, and must not be
regulators, and the general public through the owned hospital or institution, including health care altered in any way.
manner in which we conduct business and the providers and academics, are considered to be
• F
ollow sampling rules: Provide samples only if it
customer experiences we create. government officials under U.S. law that applies
is acceptable to do so under local law. Sampling
globally to all company operations.
Act ethically and comply with all applicable must be done in accordance with local policies
laws, regulations, industry codes of practice, Lilly employees, and external parties acting on and procedures.
and Lilly policies and standards that govern behalf of Lilly, may provide certain things of value to
• D
o not disguise discounts: Do not offer Lilly
Lilly interactions with all external parties. external parties for legitimate business purposes
support to health care providers, government or
(for example, certain promotional items) if provided
External parties include but are not limited to public officials, or other private or public payers
in compliance with all applicable Lilly policies,
health care providers, health care institutions, (for example, in the form of grants, donations,
standards, and procedures.
governments, government and public officials, or product samples) to disguise or conceal
companies, organizations, and private individuals. • Pay external parties only for legitimate services. discounts.
• D
o not buy the business: Never bribe, offer, − Payments must be of reasonable or fair • Follow the requirements of local law, global
provide, or authorize any inappropriate, non- market value for legitimate services. policies, global standards, and local Lilly
transparent, or disguised incentive (or create − Accurate documentation is required to support policies, when engaged in:
the appearance of doing so) to obtain or retain such payments. − market research activities,
business or any improper advantage from
any external party, whether private or public. • D
o not engage in any sales, marketing, or other − medical research activities or evaluating
Specifically with regard to government and public behaviors that would violate any law, including requests for medical research grants,
officials, prohibited activities include offering, those designed to prevent health care fraud − joint activities with business partners,
giving, or promising anything of value for the and abuse.
− partnering with external organizations,
purpose of:
• P
romote Lilly medicines and devices only − evaluating external parties’ requests for
− influencing any official act or decision, in a manner consistent with the approved nonclinical grants or donations from Lilly, or
− inducing them to do or not do any act in local label: Do not solicit any requests for
violation of their lawful duty, or off-label information. Follow local requirements − organizing any meetings that involve
for managing such requests when they are health care providers and/or government or
− inducing a government or public official
unsolicited. public officials.
to use his or her influence with a government
or government institution to affect or • U
se only Lilly-approved promotional and • When interacting with patients or other
influence any act or decision of the educational materials: All materials used by consumers, follow Lilly policies and standards
government or institution. Lilly employees, and external parties who act that apply to the context of the interaction.
on Lilly’s behalf, for educational or promotional
• Appropriately brand communication going
purposes must be approved by Lilly through
outside Lilly related to compounds in
the appropriate process, must comply with all
development, products, or disease states.
requirements of local policies and procedures
19Module 3 | Interactions and Communications with External Parties: Key Principles
Compete ethically. Do not engage in unethical Do not compensate employees or external Be truthful, accurate, and respectful and comply
or other unfair competitive practices, such as parties acting on behalf of Lilly for engaging with all applicable laws when communicating
cooperating with Lilly competitors to fix or set in any behaviors inconsistent with company and interacting with government or public entity
prices, bypassing a competitive bidding process, values, policies, or standards, or the law, representatives.
or dividing up markets and customers. including improper promotion, sales, or
• If employees, or external parties acting on
marketing activities.
• Seek advice from a Lilly attorney about any Lilly’s behalf, are contacted by representatives
communications, situations, or business Do not buy, sell, or trade Lilly stock while in of the government or a public entity, or have a
strategies that would or could have an possession of important nonpublic information need to initiate contact with them on behalf of
anticompetitive appearance, including: about Lilly. Additionally, do not “sell short” or buy Lilly, the communication must be channeled
− Lilly strategies regarding a product or sell publicly traded options (“puts” or “calls”) through appropriate Lilly personnel. Only Lilly
deemed to have a dominant market position on Lilly stock. personnel whose job it is to engage with these
under local law, representatives should handle communications
• These restrictions apply also to the stock of with them.
− any requirement that a customer must resell another company if:
Lilly products at certain prices, or • Those who interact with government and public
− an employee or a contract worker on officials must follow all laws and applicable Lilly
− joint activities with business partners. assignment at Lilly learns important nonpublic policies and procedures relating to:
information about that company in the course
• Be especially careful at trade and professional of his or her employment or assignment at − gifts, entertainment, or other hospitality
association meetings where current or Lilly, or that may be provided to government and
potential competitors are also present and public officials,
when interacting with suppliers or potential − Lilly has a significant relationship, existing or
proposed, with the other company. − registration and/or reporting with respect
suppliers who provide goods or services to to any contact with and expenses involving
Lilly competitors. government representatives, and/or
• The above restrictions also apply to family
− Do not take part in and do not listen to any members residing in employee or contract − Lilly participation in legislative and
discussions of price, profit margins or costs, worker households. administrative processes.
bids, market share, distribution practices,
terms of sales, boycotts, or blacklists. • Additional advance approval requirements for
• Employees and contract workers on assignment
certain stock transactions apply to members of
at Lilly may contact their elected representatives
senior management (M5 or R8 level or above)
as private citizens for the purpose of expressing
and to key financial employees (M4 or P6 level
personal views about legislation or other political
or above).
matters of personal interest.
20Module 3 | Interactions and Communications with External Parties: Key Principles
Lilly employees must have written approval Obtain appropriate documented Lilly approval
before using company resources or personnel and a written agreement before retaining any References
to support a political party, official, committee, external party to conduct an investigation on
or candidate. Specifically, prior approval is behalf of Lilly. If you have questions about the Key Principles,
please see the following references. Contract
needed before employees can offer, use, or
workers on assignment at Lilly, please contact your
authorize company funds, property, or people Observe Lilly requirements and limitations
employer or Lilly sponsor.
for political purposes. related to the conduct of public policy analysis
and research. Do not pay external parties to • Global Policy on Anti-Corruption
• Such political financial support and involvement conduct public policy analysis or research on
may only be approved if permitted by local law. behalf of Lilly without appropriate approval. • Global Policy on Antitrust and Competition
• Prior approval in these cases is required whether • Global Policy on Authorship of
company resources are being offered directly Avoid conflicts of interest. Scientific Disclosures
by Lilly, or indirectly through an external party. • Avoid situations in which personal interests, • Global Policy on Care and Use of
The one exception is the use of trade association outside activities, or relationships conflict Research Animals
membership dues. or appear to conflict with Lilly interests. For • Global Policy on Company and External Party
• Employees and contract workers on assignment employees, potential conflicts of interest include Information Assets
at Lilly may choose to support a political certain outside employment and donation of
• Global Policy on Compliance
candidate or party using their personal time, services; certain board or panel memberships;
money, or other resources. Lilly will not consulting arrangements; accepting payment for • Global Policy on Conduct in the Workplace
reimburse such contributions. making work-related presentations, authoring • Global Policy on Conflicts of Interest
or editing publications or other technical or
professional activities; investments in certain • Global Policy on Dealing with Suppliers
entities; and dealings with relatives. • Global Policy on Ethical Interactions with
External Parties
• Certain types of dealings with suppliers or
potential suppliers also present conflicts or the • Global Policy on External Communications
appearance of conflicts. • Global Policy on Financial Responsibility and
• Employees may seek Lilly approval, with any Authorization (FRAP)
appropriate conditions or limitations set by Lilly, • Global Policy on Governance of Global Policies,
to address situations that present potential Global Standards, and U.S.–All Policies
conflicts of interest.
• Global Policy on Health, Safety, and
the Environment
—Continued
21Module 3 | Interactions and Communications with External Parties: Key Principles
References (continued)
• Global Policy on Import and Export Controls • Global Standards on Consumer Advertising and • Global Standards on Speaker Training for Health
Promotion Care Providers
• Global Policy on Interactions With Government and
Public Officials • Global Standards on Disclosing Off-Label • Global Standards on Sponsorship of Independent
Information Meetings for Health Care Providers
• Global Policy on International Boycotts
• Global Standards on Gifts • Global Standards on Use of Social Media for
• Global Policy on Outsourcing
• Global Standards on Grants and Donations Personal Purposes
Investigative Services
• Global Standards on Health Education Meetings with • Customer Experience Principles
• Global Policy on Political Financial Support and
Involvement Health Care Providers • Elanco Quality System
• Global Policy on Pre-clearance of Lilly Stock Trades • Global Standards on Hospitality and Entertainment • Elanco Global Policy on Ethical Interactions and the
by Senior Management and Key Financial Employees Promotion of Animal Health Products
• Global Standards on Interactions with Patients and
• Global Policy on Privacy and Data Protection Other Consumers • Global Financial and Accounting Policies
• Global Policy on Protecting People and • Global Standards on Partnering with External • Global Quality System
Physical Assets Organizations
• Global Records Retention Schedule
• Global Policy on Public Policy Research • Global Standards on Payments
and Analysis • Medical Quality System
• Global Standards on Pharmacy Interactions
• Global Policy on Records Management • Product Research and Development Quality System
• Global Standards on Promotional and Educational
• Global Policy on Scientific Disclosure Materials • Regulatory Quality System
• Global Policy on Securities Laws and Trading • Global Standards on Promotional Meetings with • Safety Quality System
Health Care Providers • U.S. Policies Relating to Interactions with External
• Global Policy on Trade or Economic Sanctions
• Global Standards on Public Relations Activities Parties
• Global Policy on Use of Electronic Resources
• Global Standards on Samples • U.S. Policy on Compliance with Fraud and Abuse
• Global Standards on Consultant Meetings with Laws and Whistleblower Protections
Health Care Providers • Global Standards on Scientific Exchange Meetings
with Health Care Providers • Virtual Privacy Office (VPO)
22A load of Lilly goods is ready for delivery, circa 1915. At Lilly’s Elanco manufacturing site in Speke, England, modern equipment helps deliver quality products to customers. 23
Module 3 | Interactions and Communications with External Parties: Integrity in Action
Scenario One
Q: Jacqueline is a Lilly employee at a European other transfers of value given to physicians. provided. Such a payment is a legitimate fee for
affiliate in pricing, reimbursement, and access. Jacqueline must also determine what other receiving expedited government service. It is
Jacqueline invites Dr. Delgado to serve as a controls apply. For example, anti-corruption not acceptable for Lilly to pay a fee for expedited
consultant to interact on Lilly’s behalf with due diligence review is required because service directly to an individual ministry
representatives of the local ministry of health Dr. Delgado will be representing Lilly in employee for his or her personal benefit, or to
who make decisions about product availability. interactions with government officials. Finally, make a payment or donation to another external
Dr. Delgado was selected because he is a Jacqueline would also need to follow applicable party that could influence the exercise of a
renowned oncologist and the lead investigator travel requirements. If she needs assistance, ministry official’s duties.
Jacqueline should review required business
for several studies on Lilly’s new oncology
processes and raise any questions with
Q: Jacqueline then asks William about another
product. Dr. Delgado accepts the offer. What project in which their group has been asked
requirements should Jacqueline consider before her supervisor or local ethics and
to participate along with several other peer
requesting a contract for Dr. Delgado? compliance officer.
pharmaceutical companies. The project is
A: Jacqueline must consider and comply with all Q: A few weeks later, Jacqueline is talking to being led by a local trade organization that is
local requirements related to hiring and paying William, her supervisor. She tells him how well analyzing policy barriers to patients related to
Dr. Delgado to serve as a consultant for Lilly. the presentation went with the local ministry pricing, reimbursement, and access and specific
Following local processes will allow for the of health and how well Dr. Delgado answered initiatives these companies are considering
appropriate fair market value for his services their questions about safety and efficacy of the to address these issues. What additional
to be applied to his contract and for physician new product. William asks Jacqueline to outline information will Jacqueline need to know before
annual cap restrictions to be observed. the next steps to get the product on the national participating in the program?
formulary. Jacqueline explains that there are
Jacqueline will also need to determine and
two options: submit the product information
A: Initiatives like the one Jacqueline is considering
arrange for Dr. Delgado to be informed of any can pose potential antitrust risks, particularly
local transparency reporting requirements on a normal review schedule or pay a fee for
activities that include discussions with
before being asked to sign a contract. These expedited review. Jacqueline adds that paying
competitors and/or involve discussions related
reporting requirements, which can vary by the fee could save several months of review
to pricing or market access. Jacqueline must
country, relate to publicizing payments and time. Is paying the fee for expedited processing
consult with legal counsel prior to agreeing to
a legitimate payment?
participate in any activities of this nature.
A: The fee for expedited processing is a legitimate
payment that Lilly may make provided it is (i)
publicized by the government ministry as
being available to all those who make
submissions to the ministry; (ii) the fee is
paid to the ministry itself; and (iii) a receipt or
similar written form of acknowledgment is
24In response to heavy flooding of the Ohio River early in 1937, Eli Lilly and Company sent much-needed medicines, including typhoid vaccine, to flood-ravaged areas. Women learn about tuberculosis (TB) at a rooftop awareness campaign organized by TB Alert at Burari in Delhi, India, sponsored by the Lilly MDR-TB [Multidrug-Resistant Tuberculosis] Partnership. 25
Module 3 | Interactions and Communications with External Parties: Integrity in Action
Scenario Two
Q: Oscar, a Lilly analytical chemist, has been Q: Later, Oscar is invited to speak at an industry The meeting sponsor may also reimburse
asked to serve on the board of directors of the conference. He tells his coworker, Gloria, that Oscar’s expenses for travel, lodging, and meals
local chapter of a patient advocacy association. if he accepts the speaking engagement, the if (i) the payment is paid directly to Lilly; (ii)
He respects the work this nonprofit group organizers will waive his conference registration does not exceed the actual amount of Oscar’s
does to educate patients and is excited about fees; pay for his meals, travel, and lodging; and expenses; (iii) is not paid (directly or indirectly) by
the opportunity. Oscar can attend the board pay him a speaker’s fee. Which of these offers a supplier or potential supplier; and (iv) does not
meetings on his own time, so he does not think must Oscar decline? otherwise create an actual or perceived conflict
serving on the board will conflict with his duties of interest for Oscar.
A: Oscar must decline the speaker fee. Because
at Lilly. What should Oscar do next?
this situation involves an offer of honoraria, Q: At the conference, a supplier representative
A: Oscar should send an email outlining the reimbursement of related expenses, and offers to take Oscar and his Lilly coworkers
invitation to his supervisor. Without prior waiver of the conference registration fee, Oscar to a soccer match. Oscar asks Gloria if she is
company approval, Lilly employees must not be must request an evaluation according to the planning to attend. Gloria is not sure they should
officers, consultants, or members of the board Lilly Global Procedure on Conflicts of Interest attend as guests of the supplier. Oscar tells
of directors, or on a committee or an advisory Evaluations. In addition, he must obtain approval Gloria it will be acceptable to attend because the
board, of any business or organization involved of his presentation consistent with the Global supplier takes all of its clients to local events.
in health care, any other field related to Lilly Policy on External Communications. Whether How should Gloria respond?
business, or doing business with Lilly (such or not Oscar can accept the invitation will be A: Gloria should refuse the ticket and remind
as a partner, supplier, or customer). Before dependent on obtaining these approvals and Oscar that it is against Lilly policy for employees
accepting this offer, Oscar must first follow the on following any conditions imposed by Lilly. to accept entertainment paid for by suppliers.
Lilly Global Procedure on Conflicts of Interest Generally, a Lilly employee must not accept Employees must politely refuse gifts,
Evaluations. He would initiate this by sending an anything of value as compensation for speaking entertainments, or favors offered by suppliers.
email to his supervisor outlining the invitation at a professional forum that is related to work or Gloria should also remind Oscar that accepting
to serve on the board. His supervisor must professional development. Lilly employees who a ticket from the supplier to attend the match
carefully review the request and forward it with are invited to speak at a professional association would be a violation of Lilly policy. If they want to
a recommendation to the appropriate member meeting may accept a waiver of registration fees see the match, Oscar and Gloria could choose to
of Lilly Legal. Management has a responsibility for the industry meeting, provided the waiver attend by purchasing their own tickets.
to help employees in their areas to identify applies to all meeting speakers and does not
potential conflict situations and handle them create an actual or perceived conflict of interest
appropriately. Non-Lilly employees should between the speaker’s personal interests and
follow the conflicts of interest policies of their Lilly interests.
respective employers.
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