2. August 2007
Dear Colleagues:
Together, we have accomplished enormous positive change in our Company since we
first issued our Standards of Global Business Practices in September of 2004. This
transformation has been driven by our people, aligned around a new, high-performance
way of working. At the center of our culture is operating with business integrity.
Business integrity means doing the right thing. It starts with following the letter and
spirit of the law, as well as the letter and spirit of our own policies and procedures. But it
also means following our own moral compass to do what is right, even when the rules are
not clear. It means seeking advice when there is any doubt about what is right to do.
This booklet and the other elements of Schering-Plough’s Global Compliance and Business
Practices program are designed to give colleagues the knowledge they need to do their jobs
in full compliance with the law and Company policies. All colleagues can be confident
that whenever they do the right thing, they will receive the Company’s full support.
However, this booklet and our Global Compliance and Business Practices program
are only guides. Ultimately, it is the responsibility of Schering-Plough colleagues,
individually and collectively, to do the right thing.
Please read the booklet carefully. In addition to describing a number of important
compliance laws and policies, it offers examples of some business integrity questions that
you may face. However, it is not designed to answer every possible question that might
arise. If you have questions about how the Standards apply to your responsibilities or a
specific situation, seek advice from your manager or a member of the Global Compliance
and Business Practices, Global Law or Global Human Resources departments. You can
also contact any Executive Management Team member. Our signatures represent our
Standards of Global Business Practices intranet site:
commitment to the Standards of Global Business Practices and all the elements of
http://standards.us.schp.com/
“Leading with Integrity.”
Sincerely,
Global Compliance and
Executive Management Team
Business Practices department
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, N.J. 07033-0530
Integrity Action Line U.S.: 1-866-SPCORP-1
Integrity Action Line International:
AT&T U.S.A. Direct Service > 678-250-7535 >
8441569585 > 2309
3. TABLE OF CONTENTS
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
2
THE STANDARDS – IN OUR WORKPLACE
8
Equal Treatment
9
Discrimination/Harassment-Free Work Environment
9
Safety, Health and Security
10
Drug and Alcohol Abuse
12
THE STANDARDS – IN THE MARKETPLACE
14
Marketing Integrity
15
U.S. Healthcare Laws
16
Gifts and Entertainment
17
Bribery and Corruption
18
International Trade
20
Competition and Antitrust Laws
21
Competitive Intelligence
23
Unfair Business Practices
24
Information Privacy and Security
25
Scientific Integrity
26
Product Quality and Patient Safety
27
Animal Welfare
28
THE STANDARDS – IN OUR BUSINESS
32
Books and Record Keeping
33
Records Management
35
Company Assets
36
Company Computers and Software
36
Confidential Information, Intellectual Property and Proprietary Information of Others
38
Conflicts of Interest and Corporate Opportunities
41
Trading on Inside Information
43
THE STANDARDS – IN OUR COMMUNITIES AND THE PUBLIC
46
Protecting the Environment
47
Media and Public Inquiries
48
Political Activity and Lobbying
49
Investigations
50
54 UPHOLDING THE STANDARDS
56 RAISING CONCERNS AND SEEKING ADVICE
61 ACKNOWLEDGEMENT
63 INDEX
The Standards do not alter the terms and conditions of your employment. Rather,
they help each of us to know what is expected of us to make sure we always act
with integrity.
5. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
insurers. Special laws to regulate business practices, pricing and
Introduction to the Standards of price reporting may be in place to protect the people who use our
products and to assure the money that pays for them is properly
Global Business Practices spent. Promotional and pricing practices that are accepted or common
in other industries may not be acceptable or lawful in our industry.
The Standards demonstrate our commitment to Lead with Integrity
What are the Standards of Global Business Practices?
in our highly regulated business.
The Standards of Global Business Practices are Schering-Plough’s
guide to Company policies and the legal requirements that govern Why does Schering-Plough need the Standards?
how we conduct business around the world. They are the foundation
People often feel that publication of a “business practices” code
of our commitment to business integrity. The Standards explain
implies that employers do not trust their employees. Nothing is
many of the basic rules that apply to our businesses and the
further from the truth here at Schering-Plough. Our colleagues
personal responsibilities each of us has to speak up if we ever
worldwide come to work every day to do a good job in the right
see something that doesn’t seem right.
way. The Standards are both a statement of, and guide to, our shared
way of working with integrity and in full compliance with the law. The
The Standards are not a stand-alone document. They work together
Standards also are designed to comply with the requirements of the
with, and support, our Vision, Mission, Values, and Leader Behaviors.
New York Stock Exchange, where Schering-Plough stock is listed.
Business Integrity, a Leader Behavior, is the cornerstone on which the
Standards are built. Focusing on applying all the Leader Behaviors is
Who should follow the Standards?
important to achieving compliance.
The Standards apply to all officers, full and part-time colleagues of
Schering-Plough, and all subsidiaries worldwide. Temporary workers,
The Standards are in some cases “values based” and in others “rules
vendors, agents and consultants worldwide, while working for or
based, but all are designed to help assure that compliance with laws,
”
representing Schering-Plough, must also adhere to the Standards
regulations and Company policy become part of our operational DNA.
and should consult them for guidance when acting on behalf of the
The Standards are not intended to describe every detail of every law,
Company. The Board of Directors is subject to the Schering-Plough
regulation or Company policy that may apply to you. To learn more
Corporation Board of Directors Code of Business Conduct and Ethics,
about applicable laws, regulations or Company policies, see the
(available at www.schering-plough.com) which is consistent with
additional resources identified throughout the Standards with the ,
the Standards and is in accordance with the requirements of the
ask your manager, the Global Law department, Global Human
New York Stock Exchange.
Resources department or your local Compliance Officer. You may
also contact the Integrity Action Line which is described more fully
Where do the Standards apply?
on page 56. A complete listing of Company policies is available to
you on the Company intranet at http://corporatepolicy.us.schp.com/. The Standards apply globally, in every location Schering-Plough
conducts business. However, application of the Standards may
How do the Standards relate to our role in healthcare? vary in different countries, due to local business practices or a
need to comply with local laws and regulations.
We work in a unique industry – healthcare – that is regulated
differently from other industries in most countries in which we
What laws apply to me?
do business. First, our products affect the health and safety of
people and animals. Second, medicines are bought or their cost is The Standards establish principles for business conduct applicable
reimbursed by the government in many countries, or by third party throughout Schering-Plough, regardless of location. The Standards are
2 3
6. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
available in many languages and Schering-Plough attempts to provide • Enforcing Company policy by monitoring colleague compliance and
examples applicable to colleagues at all locations. Where differences implementing appropriate discipline for misconduct.
exist as the result of local customs, norms, laws or regulations, you • Supporting colleagues who in good faith raise concerns regarding
must apply either the Standards or local requirements – whichever potential misconduct.
sets the highest standard of behavior. Because Schering-Plough is
Can the policies summarized in the Standards be waived?
incorporated in the United States, colleagues outside the United States
may also be subject to certain U.S. laws and regulations. If questions Waivers of the policies summarized in the Standards are an exception
arise about what law or rule applies, you should consult your manager, and will only be granted in special circumstances.
the Global Law department, Global Human Resources department or
your local Compliance Officer. You should also consult a colleague from Schering-Plough will waive a policy only where:
one of these departments if you do not understand portions of the
• Circumstances warrant granting a waiver,
Standards in the context of a local regulation or custom.
• Such waiver would not permit illegal or unethical conduct, and
• There are appropriate controls over the particular situation.
What are my individual responsibilities?
You are responsible for knowing and following all the laws, regulations Waivers for colleagues will be made only with the approval of the
and Company policies that apply to your job and level of responsibility. Senior Vice President, Global Compliance and Business Practices.
You also have the obligation to seek advice when needed, to raise Waivers of any of the provisions of the Standards for corporate officers
concerns and to report suspected or known violations of law, may be made only by the Business Practices Oversight Committee
regulation or Company policy. There are many more regulations and of the Board of Directors after receiving the recommendation of the
policies that may apply to your specific position than can be covered Senior Vice President, Global Compliance and Business Practices.
in this booklet, and it is your responsibility to take all appropriate Waivers relating to the CEO, CFO and Controller will require approval
opportunities for training offered to you by your manager. (Depending of the Audit Committee of the Board of Directors. Such waivers, if
on your role, examples of policies for various operations include Good granted, will be promptly disclosed as required by law, regulation
Clinical Practices, Good Laboratory Practices, Good Manufacturing and New York Stock Exchange rules.
Practices and Internal Controls over Financial Reporting.) If you know
or have a suspicion that something is not right, seek help or advice How do I use The Standards?
immediately. Use the resources described in these Standards – your
The Standards consist of:
manager, the Global Law department, Global Human Resources
• This Introduction;
department or your local Compliance Officer. You may also call the
• Four substantive sections that cover policies and legal requirements
Integrity Action Line to find an answer or raise a concern.
relating to conduct in the Workplace, in the external Marketplace
where we sell our products, in our internal Business operations, and
What are management’s responsibilities?
in the Communities where we operate;
Managers have a responsibility to set the right example – to Lead
• A brief but important section, Upholding the Standards, that offers
with Integrity. The obligations of each Schering-Plough manager under
some common sense tips for applying the Standards;
these Standards include:
• A section offering guidance in effectively Raising Concerns and
• Informing the people who work for him or her about Seeking Advice regarding any compliance or integrity issues that
Company policies. arise; and,
• Ensuring that the people who report to him or her have adequate • An Acknowledgement that we each must read and understand the
knowledge and resources to take appropriate action. matters contained in this Booklet.
4 5
7. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
In the four substantive sections, key policies and legal requirements
are simply stated, and followed by a review of what “this means” to
each colleague. References are made to Company policies and other
internal resources where appropriate and are identified with the . The Standards – In Our Workplace
Q&As are also included to give real-world examples of many of the
topics discussed.
If you have a compliance or integrity question, use the Standards as
a guide. Begin by asking yourself the Questions to Ask listed in the
box below. Use the Table of Contents and the Index to locate the
issue about which you seek clarification or guidance. Reread the
applicable section carefully. Think about the tips offered in Upholding
the Standards. Finally, if you are still having difficulty resolving the
issue, refer to the Raising Concerns and Seeking Advice section for
further guidance. Whenever possible, the best place to start is with
your manager.
QUESTIONS TO ASK
Asking yourself these questions can help determine if a course of
action demonstrates Leading with Integrity:
• Am I following my own moral compass?
• Are my actions legal?
• Am I acting in accordance with the Standards?
• Would failing to act make the situation worse, or allow a
“wrong” to continue?
• How would this look on the front page of a newspaper?
• What would those outside the Company – our customers, the
people in the communities where we work, and the general
public – think about these actions?
• Is it right?
If the answers to any of these questions raise doubts in your
mind, you should seek assistance and resolve the concern before
taking action.
6
8. THE STANDARDS – In Our Workplace
Q&A
Equal Treatment
The Standards – In Our Workplace
Schering-Plough is committed to a
diverse workplace that is free from Discrimination/Harassment-
discrimination. Free Work Environment
Leading with Integrity in our workplace means applying our
Q. My department is very diverse.
Leader Behaviors to build a workplace that is safe, professional This means: My manager refers to our group
and that promotes teamwork, high performance, diversity and • Recruiting, hiring, training, as the United Nations and has a
trust. Hostility, harassment, unwelcome sexual advances and other promoting and other employment nickname for each of us based on
unprofessional conduct are wrong and undermine what we strive for. actions will take place without regard our national origin. Although
We especially need to listen carefully to colleagues and respect she thinks this is cute, it makes
to a person’s race, color, religion,
what we hear. Leading with Integrity, and earning the trust of our all of us feel uncomfortable.
gender, sexual orientation, gender
colleagues, creates a productive working environment. What should we do?
identity, national origin, age, disability,
marital or military status, or any other A. Your manager should be
This means we are committed to: made aware that her use of
legally protected characteristic.
• Treating all colleagues with honesty, fairness and respect. nicknames based on national
• Offering reasonable accommodations
• Providing equal employment opportunities for all colleagues. origin is creating a negative work
to colleagues with disabilities, as
environment. You or your group
• Promoting a positive work environment, free of harassment necessary.
may address this issue with her if
or other discriminatory conduct.
you are comfortable doing so but
• Promoting diversity, cooperation, teamwork, and trust. Equal Treatment Policy C-124.
you are not obligated to confront
• Protecting the safety and health of all colleagues. Your local Human Resources her yourself. You or your group
• Maintaining a workplace free from the effects of drug or representative can answer your can bring it to the attention of
alcohol abuse. questions about how the policy another manager or Human
applies in the country where Resources. You may also contact
you work. the Integrity Action Line.
Discrimination/Harassment-Free
Work Environment
Schering-Plough is committed to
providing a workplace free of unlawful
discrimination or harassment and will not
tolerate discrimination or harassment by
or toward employees or non-employees
with whom the Company has a business,
service or professional relationship.
Unlawful harassment does not just refer
to sexual harassment, but to all forms of
verbal, physical or visual behavior where
the purpose or effect is to create
8 9
9. THE STANDARDS – In Our Workplace
Q&A Q&A
an offensive, hostile or intimidating excellence in safety and health
environment. performance as an essential element
of every activity or process and as a
Q. I am a sales representative. Safety, Health and Security
shared business value that must not
This means:
Every time I call on one Q. I have been asked by a
• Jokes, slurs and other remarks be compromised. A safe and healthy
particular physician in my colleague to perform a task
that are about race, color, religion, work environment also means a secure
territory, he comments on how that I believe may be unsafe.
gender, sexual orientation, gender workplace free from violence. Acts
nice I look and asks me when I What should I do?
identity, national origin, age, of violence, threats, threatening and
will agree to have dinner with
A. The first thing you should
disability, marital or military status, malicious behavior, intimidation or any
him. I have been able to handle
do is discuss your specific safety
or any other legally protected other form of workplace violence will
this by jokingly telling him that
concerns about the task with
it is not appropriate but he characteristic are never appropriate not be tolerated.
your manager. You should ask
doesn’t seem to be getting the at Schering-Plough.
whether the specific hazards of
message. What should I do? • Unwelcome sexual advances or This means: the task have been identified
A. The Company’s Workplace requests for sexual favors do not • Creating an atmosphere where and evaluated, and what controls
Discrimination/Harassment belong in the workplace. safety, health, environmental are in place for your protection.
policy, protects colleagues • Verbal remarks or unwanted physical excellence and coaching among If, after discussing your concerns
from discrimination and/or conduct that interfere with another colleagues on safe work practices with your manager, you are
harassment from any source, person’s work performance or that are encouraged and valued. still not comfortable with
including our customers. An performing the proposed task
create an intimidating, hostile, or • Complying with all applicable laws,
occasional, general comment you should contact a higher level
offensive working environment have regulations and other requirements
such as “your new outfit is nice” of management, the Global
no place at Schering-Plough and will designed to protect safety and health.
or “I like your new haircut” may Human Resources department,
not be tolerated. • Encouraging the active participation of
be acceptable under certain or your local safety professional
all colleagues in safety and health
circumstances. However, for further advice. You may
If you observe or experience any efforts and initiatives.
repetitive comments like these also contact the Integrity
form of harassment, report it to your • Ensuring that each colleague is aware
and repeated requests for a date Action Line.
manager, your local Human Resources of the potential hazards in their work
may lead to a hostile work
environment. You can tell the representative, or an Equal Employment environment and is qualified to
physician that his comments Opportunity representative within Global perform his/her duties.
are making you uncomfortable Staffing & Diversity. You may also • Bringing any unsafe acts or conditions
but you are not required to contact the Integrity Action Line. – including threats or intimidation –
confront him. You should report
to the attention of a manager, a local
this to your manager, your local
Workplace Discrimination/ Safety and Health Representative,
Human Resources representative
Harassment Policy C-106. your local Human Resource
or the Integrity Action Line.
representative or Global Safety and
Environmental Affairs. You may also
Safety, Health and Security
contact the Integrity Action Line.
Schering-Plough is committed to
providing a safe, healthy and secure
Safety, Health and Environmental
workplace for colleagues, contractors
Management Policy C-170;
and visitors. The Company regards
Prevention of Violence in the
Workplace Policy C-160.
10 11
10. THE STANDARDS – In Our Workplace
Q&A Drug and Alcohol Abuse
Our work requires clear thinking and
the ability to react quickly. Being under
Drug and Alcohol Abuse
The Standards – In the Marketplace
the influence of alcohol or drugs, or
Q. A fellow colleague has
improperly using medication, diminishes
recently been coming back from
a colleague’s ability to perform and can
lunch with slurred speech. She
compromise the safety and well-being
seems somewhat impaired and I
of fellow colleagues and the public.
worry that she may be drinking
at lunch or using drugs. I am
fearful that if I confront her or This means:
tell anyone, this may cause a • Selling, purchasing, possessing or
scene. What should I do? using any illegal drug is prohibited.
• Using legally purchased or doctor-
A. If the colleague has an
alcohol or drug problem, she prescribed drugs is permitted, but
could be compromising her own only if they do not negatively affect
and other colleagues’ safety, as job performance.
well as her ability to perform on • Reporting to work unimpaired by
the job. If you feel that sufficient
alcohol and remaining sober while on
evidence exists to indicate that
duty or on Company property. Alcohol
she is under the influence of
may be permitted on Company
drugs or alcohol while at work,
property in certain Schering-Plough
you are obligated to report it.
facilities under certain limited
You can speak to your manager,
circumstances. However, this is not
or your local Human Resources
true of all locations or operations.
representative. You may also
Check with your manager to see if
contact the Integrity Action
Line. alcohol is permitted at your location.
If you observe that another colleague’s
performance on the job is impaired due
to the use of alcohol, drugs or other
substances, or that another colleague
is using alcohol or illegal substances on
Company property, notify a member of
management, your Human Resources
representative, or your local Health
Services office if one exists. You may
also contact the Integrity Action Line.
Substance Abuse Policy C-157.
12
11. THE STANDARDS – In the Marketplace
Q&A
Marketing Integrity
The Standards – In the Marketplace
We are committed to the truthful and
accurate communication of scientific Marketing Integrity
information about our products and
Remaining competitive in the face of all the laws and regulations Q. Can I hire hard-to-see doctors
services to healthcare professionals
that apply globally to our business may seem like a daunting for a consultant meeting so that I
(defined as individual physicians can ensure I have time with them
challenge. By Leading with Integrity in the Marketplace we make
or nurses authorized to prescribe, to promote my products?
the task manageable. Knowing the laws and regulations that apply
physician practices, and pharmacists),
to our operations is important. But even more important is knowing A. No. Doctors may only be
veterinarians, patients, the general
that each of us is expected to do what is right at all times. Leading hired to provide necessary
public and other customers. In services to Schering-Plough.
with Integrity means doing what is right for Schering-Plough and our
marketing our products, our interactions These arrangements can never
customers.
with these various customers will be used in an effort to induce,
comply with the laws of the countries influence or reward a healthcare
This means we are committed to:
professional for using any
where these contacts take place.
• Providing innovative products, product delivery systems and
Schering-Plough product or as
technology solutions to our customers.
a way to build a relationship with
This means:
• Marketing products honestly, in accordance with laws, or to gain access to the healthcare
• Schering-Plough does not buy
regulations and regional or local marketing codes. professional.
business; that is, we do not offer
• Not making illegal payments to government officials, or offering
anything of value to our customers
or accepting questionable gifts or entertainment. Q. A doctor told me she was
in order to induce or retain business.
• Following foreign trade control, customs, and anti-boycott laws. interested in prescribing our
• A healthcare professional’s service
• Competing vigorously, while complying with all laws protecting products. Then she asked me if
may only be obtained for sound Schering-Plough could sponsor
competition and the integrity of the marketplace.
business reasons, unrelated to her to an upcoming international
• Gathering competitive intelligence legally and ethically.
any purchases by that healthcare Congress. Can we pay for her
• Ensuring individual privacy by keeping personal information
professional, and only for fair registration fees and travel-related
confidential.
expenses?
market price.
• Acting responsibly in our relationships with healthcare
• Promotional messages must always A. No. While it is appropriate
professionals, patients, academics, collaborators, governments,
be within label, truthful and fairly in certain countries for Schering-
regulatory entities, customers, suppliers and vendors.
balanced – that is why promotional Plough to support a healthcare
• Ensuring that all our activities including research, development,
professional in his or her medical
materials are subject to a promotional
manufacturing, marketing, sales and distribution of human drugs
or scientific education by sponsoring
review process.
(including drug samples), animal care products, and consumer
the healthcare professional to
healthcare products meet or exceed the requirements of attend medical or scientific
Global Marketing Policy C-100. You
applicable laws and regulations worldwide. programs organized by third
should always check to see if there
• Respecting the welfare of animals. parties, such support may not
is a local marketing policy for your
be made on the basis of, or to
business unit or country. Many encourage, prescribing Schering-
times, the laws governing our Plough products.
marketing interactions will vary
from country to country.
14 15
12. THE STANDARDS – In the Marketplace
Q&A
• Business gifts or meals should be
U.S. Healthcare Laws
infrequent.
Both the United States federal government and many state
• Gifts, meals and entertainment
governments in the United States have enacted laws to prevent, Gifts and Entertainment
may be provided or accepted in the
detect and punish healthcare fraud and abuse. These laws include Q. I recently met with a
normal course of business as long
the Federal Civil False Claims Act, the Federal Program Fraud Civil potential vendor to evaluate
as they:
Remedies Act and similar state laws. Under these laws, false or their services to perform work
• Involve persons with whom
fraudulent claims submitted to the government for payment or on a large project. I mentioned
Schering-Plough has or may have
reimbursement of healthcare expenses are subject to the payment to them that my son was a fan of
business;
of damages and punishable by substantial fines and penalties. The their local football team. Several
• Are reasonable and consistent with days later, I received tickets for an
federal False Claims Act and some state False Claims Acts also
applicable laws and with accepted upcoming game from this vendor,
include provisions under which individual citizens with evidence of
ethical standards and local in appreciation for considering
fraud against the government may file “whistleblower” suits on the
business practices; their company as a candidate.
government’s behalf to recover the lost funds. If a whistleblower suit
Can I accept these tickets from
• Are of modest value and properly
is successful, the person who filed it may receive a portion of
the vendor?
recorded in Company records so
whatever money the government recovers. These laws also prohibit
they could not be construed as a A. No. Schering-Plough is
retaliation against persons who file whistleblower suits.
bribe, payoff or kickback; and committed to an unbiased,
objective evaluation of all of our
• Are not in violation of the rules of
U.S. Laws and Schering-Plough Policies Regarding Healthcare
current or potential suppliers and
the recipient’s organization.
Fraud and Abuse Policy, C-171.
vendors. There should not be
• Honorariums or fees for speaking
even the slightest hint that any
or presenting on behalf of the
Gifts and Entertainment contractual relationship is colored
Company should not be accepted.
by personal gain. Personal trips
Exchanging social amenities or business gifts of a modest value
or entertainment like this are
such as small gifts, meals and entertainment is permitted as a What is considered “modest” may vary, inappropriate. However, user
common practice meant to create goodwill and establish trust in depending on the country in which we conferences or other educational
business relationships. Schering-Plough expects the use of good are doing business. Certain exceptions events that relate to your work
judgment and moderation when giving or receiving entertainment to the Standards may be made in for Schering-Plough may be
or gifts. Avoid situations that could compromise or appear to countries where differing practices appropriate. You should always
compromise your impartiality. are customary with approval of your consult your manager before
accepting such trips. In deciding
management in consultation with your
This means: among competing vendors, you
local Compliance Officer. Any questions
• Business gifts or meals should never be conditioned upon, or be a must be objective and unbiased
regarding the appropriateness of a
reward for, purchasing, prescribing or promoting Schering-Plough’s to avoid even the slightest hint of
gift should be addressed with local
products and services. favoritism. If you were to accept
management and your local Compliance
these tickets, it could appear as
Officer.
if your independent judgment
is affected.
Special gift and entertainment rules
apply to government employees.
Schering-Plough colleagues may not
16 17
13. THE STANDARDS – In the Marketplace
Q&A Q&A
provide money or its equivalent, gifts, government employees. These laws
meals or entertainment of any value apply even when the payment is made
to any government employee, unless outside of the home country. that this money is not used as a
Q. Can I provide gifts to my
specifically allowed by law. Laws bribe. You must seek the advice
customers during the holiday
concerning this matter are often In the United States there is a related of your manager, the Global
season?
complex and vary from country to anti-bribery law, known as the anti- Law department or your local
A. Not only do countries have
country. Before offering or accepting kickback law, that prohibits inducing Compliance Officer before
different laws regarding what entering into this arrangement.
any gifts, meals or entertainment to someone to recommend or purchase
types of gifts can be provided,
or from a government official, consult a healthcare product or service covered Q. A regulatory official from
but our customers may also be
with the Global Law department or by a federal healthcare program. The Thailand is visiting our New
subject to specific guidelines
your local Compliance Officer. purpose of this healthcare law is to Jersey facilities in connection
of their employers. You should
with a new drug application.
eliminate the influences of money or
ensure that holiday gifts are
He wants to bring his wife and
Conflict of Interest, Gifts and things of value in the selection of such
allowed in your country and
make a stop in Los Angeles.
Entertainment Policy C-112. products or services.
by your customers’ employers,
Can we pay for this?
and determine if there is a cost
limit. You should also discuss A. It would be appropriate to
Schering-Plough colleagues must
Bribery and Corruption
with your manager the reimburse reasonable expenses
comply with these anti-bribery laws.
Often in our industry, a country’s
appropriateness of providing for the trip from Thailand to
Violations of these laws will not only
government is both the regulator of
gifts to customers. At all New Jersey for an official with
result in the loss of business but may
our products and a major customer.
times, gifts must be modest, legitimate reason for inspecting
also lead to severe criminal and civil
We also retain the services of scientists
appropriate and customary our facilities as long as it is
penalties for Schering-Plough and the
and doctors for consulting and research
with local standards. permitted under local law.
individuals involved. To put it simply,
activities and many of them are However, we cannot pay the
bribery of any kind is illegal worldwide
Bribery and Corruption employees of public institutions and expenses for his wife and the
and we will not engage in it. stopover in Los Angeles.
may be considered government
Q. I was told that I could hire
employees.
a consultant to take care of
This means: Q. We missed a deadline for
getting all the permits we need
• Never, either directly or through an filing an official document and
from a foreign government. Most countries in which we do
it has been suggested that we
agent or other third party, making
He requested a $40,000 retainer business have laws that forbid making,
backdate the document to bring
payments or offering gifts, services
and said that he would use the offering or promising any payment or it within the deadline. Can we
money to “help move the or anything of value to government
giving anything of value (directly or do this?
process along.” Since we don’t employees, employees of public
indirectly) to a government employee
really know where the money is A. The U.S. Foreign Corrupt
institutions, or persons that prescribe,
when the payment or gift is intended
going, do we have to worry Practices Act has a requirement
purchase or promote the Company’s
to influence an official act or decision to
about it? for accurate recording of all
products that are intended to
obtain or retain business or secure an transactions in the Company’s
A. Absolutely. You must know influence or even appear to be
unfair business advantage. Under the books and records, which is
where that money is going and intended to influence that person’s
U.S. Foreign Corrupt Practices Act, separate from the prohibition
for what purpose it is being actions with respect to the Company.
foreign political parties and candidates of improper payments to
used. Moreover, the Company is
• Always exercising great care and
as well as officers and employees of government officials.
required to take steps to ensure
vigilance when entering into
state-owned companies are considered
transactions with employees of public
18 19
14. THE STANDARDS – In the Marketplace
Q&A Q&A
institutions or other government or affiliated with a country subject
employees in order to avoid potential to significant U.S. trade sanctions
bribery and corruption issues. (commonly called “embargoes” in
Falsification of any Company to shipments to any party in any
• Accurately recording in Schering- their most extreme form) without
record, including a false country. If you do not know
Plough’s books and records all obtaining prior Global Law
statement of the date of the export classification of and
transactions, including any gift or department review. Contact the
signature, could be a violation export limitations that apply to
payment to any third party. Global Law department for the list of
of this requirement. You must what you have been asked to
affected countries and the relevant
seek the advice of your manager, send, you must check with the
Anti-Bribery and Corruption Policy restrictions.
the Global Law department or Global Law department before
C-147; Global Marketing Policy • Screening our business partners
your local Compliance Officer any such shipments take place.
to determine how best to deal C-100. A person is considered a against various government-restricted
Competition and Antitrust Laws
with your filing requirement government employee if he or parties lists to avoid dealings with
without creating any backdated she either receives any part of his what we refer to as “denied parties. ” Q. I was at a trade show when
or otherwise false documents. a representative who sells an
or her salary from the government • Being aware of products, materials,
allergy product that directly
(including a state-owned and technical information that are
International Trade competes with my product
company), or performs a subject to heightened export
stopped me. He suggested I
Q. While processing an governmental function with or control and of the export license
limit my sales calls to retail
order for products for Syria, without pay. If you have questions requirements that apply to such items.
pharmacies since he had decided
you identify a document that whether a healthcare professional • Not participating in or responding to focus exclusively on hospital
requests a statement regarding
or individual is considered a to requests relating to international pharmacies. He figures this way
dealings with Israel. What
government employee, or boycotts in which the United States we won’t interfere with each
should you do?
whether a payment or gift is does not participate, notably the Arab other and we’ll both benefit. It
A. Immediately report the appropriate or legal, seek advice League boycott of Israel. Receipt made sense to me. Can I agree
receipt of the document to the
from the Global Law department of any requests relating to such to this?
Global Law department, and
or your local Compliance Officer. restrictive trade practices must not A. No, any agreement amongst
take no action whatsoever
be acted upon and must be reported competitors to allocate or “carve
responsive to the document until
to the Global Law department.
International Trade up” the market is a violation of
the Global Law department
antitrust and competition laws.
provides guidance. Schering-Plough does business around
International Trade Policy C-132.
the globe and is subject to and complies
Q. You have been requested with applicable international trade
Competition and Antitrust Laws
to ship biologic materials for controls (trade sanctions, restrictions
vaccine testing from your site
on dealings with denied parties, export Competition and antitrust laws protect
to a Schering-Plough affiliate
controls, and antiboycott regulations) free enterprise for the benefit of
located in another country.
and customs requirements. customers and consumers. These laws
What should you do?
prohibit anti-competitive agreements,
A. There are strict export
such as price-fixing conspiracies, and
This means:
controls on certain pathogens
• Not engaging in any dealing other conduct, such as predatory efforts
and toxins. These controls apply
whatsoever, commercial or to eliminate competitors. Schering-
otherwise, with a party located in Plough must comply with these laws.
20 21
15. THE STANDARDS – In the Marketplace
Q&A Q&A
superior products, service or
This means:
performance;
• Never talking with or exchanging
• Seek legal advice before either (i) selling
information with competitors or
Q. Last week, I spoke with Competitive Intelligence
“below cost” or (ii) creating “bundles”
others to:
some competitors. One said, Q. One of my colleagues
of Schering-Plough products selling
• Fix prices – this can include setting
“Did you notice that our profit recently joined Schering-Plough
collectively at a specific price. While
minimum or maximum prices, or
margins aren’t as good as they from a company that sells a
either of these practices may be
“stabilizing” prices;
used to be?” Another said, competing product. May I ask
appropriate, in certain circumstances
• Fix terms related to price, pricing
“I wish we could do something her about her former company’s
they could violate antitrust laws and
formulas, credit terms, promotions,
about the deep discounts.” confidential plans for marketing
should always be pre-approved; and
discounts, allowances, etc.;
I nodded my head, but said that product, if the information
• Particularly in the United States, seek
nothing. Later, the companies • Divide up markets, customers or would be helpful to Schering-
legal advice before charging different
that were present during the territories; Plough?
prices to customers who compete with
conversation raised their prices. • Place output restrictions or limits A. No, you should never ask
each other.
Was the discussion a problem? on production; anyone to provide you with
What should I have done?
• Rig a competitive bidding process, confidential or proprietary
Competition and Antitrust Policy C-110.
A. Yes, the discussion could including arrangements to submit information about a former
be a problem. Someone might sham bids; or employer, even if that person
Competitive Intelligence
conclude that everyone present • Boycott a supplier, customer or currently works for Schering-
during the conversation, distributor or others in the In our complex business environment, we Plough.
whether they said anything or marketplace. acquire a large amount of information
not, had engaged in price-fixing • Avoid creating even the appearance about our competitors and their products
even though there was never of an improper agreement or under- and services. It is permissible for
an explicit agreement. If you
standing by keeping communications colleagues and third parties working on
find yourself present during
with our competitors to a minimum. behalf of Schering-Plough to gather and
a discussion like this,
• Ensuring there is always a use competitive information. However, the
immediately break away
legitimate business reason for all information must be obtained using only
from the discussion in a
communications with competitors. legal and ethical means.
way that makes it clear you
consider this improper, and
If you find yourself in a situation where
promptly call the Global This means:
a competitor begins discussing these
Law department. • Always gathering information about
topics, you should leave the discussion
competitors from public sources such
immediately making it clear to everyone
as Web sites, published articles, price
present that you are leaving because
bulletins, advertisements, brochures and
the conversation is inappropriate. You
public presentations. You may also use
must report the incident to the Global
information obtained from conversations
Law department as soon as possible.
with customers (unless the matters
being discussed are known by us to
Complying with antitrust and competition
be confidential).
laws also means that you should:
• Not attempt to monopolize or
dominate markets except through
22 23
16. THE STANDARDS – In the Marketplace
Q&A
• Accepting competitive information only when there is a clear and Information Privacy and Security
reasonable belief that receipt and use of the information is lawful Many countries where we do business
and ethical. have privacy or data protection laws Information Privacy and
• Not obtaining information through the use of unlawful or unethical requiring the responsible management Security
means such as misrepresentation, deception, theft, spying or of their citizens’ personally identifiable Q. In my job, I sometimes
bribery. information – information that can be transfer personal information
• Not recruiting or hiring employees of competitors, customers or used to identify, locate or contact an about colleagues to a vendor for
vendors for their knowledge of proprietary information of present individual. These laws, and Schering- processing. How do I make sure
or former employers. I’m doing everything I can to
Plough policies, require that the
• Never using proprietary information of a competitor or information protect the information?
Company and its representatives
belonging to a competitor marked “confidential” or something respect the privacy of personally A. You need to make sure that the
similar, including information that someone has offered to sell. identifiable information, and use only personal information being
sent to the vendor is that which is
reasonable and appropriate security
Proprietary and Confidential Information Policy C-148. needed for the specific business
safeguards to protect such information
purpose. You should also verify
from unauthorized access, use or
Unfair Business Practices that the vendor uses appropriate
disclosure. This may include, for
levels of security to protect the
Schering-Plough seeks competitive advantage through superior example, personally identifiable
information and that there are
products, services and performance, never through unethical or illegal information collected from our
privacy and security agreements
business practices. We compete vigorously for business, but some colleagues, clinical trial subjects and in place. You may also want
conduct in the name of competition may not be consistent with the site personnel, and personal information to consider encrypting the
law or our commitment to integrity. collected through our sales and information before you transfer it.
marketing initiatives. If you have any questions about
This means: any of these measures, please
• Never competing by using unfair practices such as: This means: contact your local Data Privacy
Steward, the Office of Global
• Making false or disparaging statements about competitors • Respecting the privacy of personally
Privacy or the Office of Global
or their services; identifiable information, and using
Information Technology Security.
• Stealing or misusing competitors’ trade secrets; appropriate security safeguards to
• Cutting off a competitor’s sources of supply in order to hurt protect such information against loss,
Q. I am a sales representative.
its business; misuse and unauthorized access,
During a sales call, a physician
• Inducing customers to break contracts with competitors; or, disclosure, alteration or destruction.
revealed confidential information
• Offering or paying bribes to help our Company’s business or • Collecting and protecting all about a patient. Can I include that
to hurt a competitor. personally identifiable information in information in my call notes?
• Never taking unfair advantage of any other person through compliance with Company policy or
A. No. You should never
manipulation, concealment, abuse of privileged information, local law, whichever sets the highest
include personal health
misrepresentation of material facts or any other unfair dealing standard. information or other sensitive
or illegal business practice. • Reporting any data security breaches personal information about
• Always dealing fairly with clients, suppliers, competitors and our immediately to the Global Services
fellow colleagues. Help Desk, your local Data Privacy
Steward or the Office of Global
Privacy.
24 25
17. THE STANDARDS – In the Marketplace
Q&A Q&A
Information Privacy & Security properly documenting and monitoring
Policy C-143; End-User nformation these relationships.
Security Policy C-134. Questions • Not giving gifts or other items of
Product Quality and Patient
patients, physicians or their
regarding your privacy obligations, value to induce business or influence Safety
family members in call notes.
or reporting of security breaches, outcomes.
If you have questions about Q. A manufacturing supervisor
should be directed to your local
what type of information should has told us not to notify Quality
Data Privacy Steward or the Clinical Research and Medical and
be collected in call notes, you Assurance about a deviation from
Office of Global Privacy at Scientific Research Programs Policy
should contact your manager, the manufacturing instructions
privacyoffice@spcorp.com. C-146; Global Medical Affairs
local Data Privacy Steward or that occurred during the
Policy C-151.
local Compliance Officer. manufacturing of a batch.
Scientific Integrity She said that “we can handle it
Scientific Integrity Product Quality and Patient Safety internally without anyone else
Schering-Plough enters into
being involved.” I think this
Q. I know a great cardiologist relationships with doctors, hospitals, Schering-Plough is committed to the
violates Company policy, but she
who sees 300 new patients
universities and contract research highest manufacturing standards for
is the supervisor. Should I just
per year and I want him to
organizations to perform clinical trials our products to ensure product quality follow orders and ignore this?
participate in an upcoming
and other sponsored research. It is and patient safety, which are critical to
clinical trial. The problem is, A. No. If you think that the
critical that we act with objectivity achieving our mission to earn the trust
the results of the initial study supervisor is giving instructions
and integrity during these trials and of doctors, patients, customers and
were somewhat negative, and that are contrary to the current
in our relationships with healthcare regulatory agencies. They should
he might not participate if he Good Manufacturing Practices
professionals, veterinarians, expect no less from Schering-Plough.
knows this. Do I even have (cGMP) regulations or our
collaborators, patients, universities We will meet these expectations through
to mention the results of the internal policies and procedures,
initial study? and hospitals. consistently effective execution of our and you do not feel comfortable
global quality policies and standards, talking with your supervisor
A. Yes. We have an obligation
which are designed to ensure
This means: directly, contact your supervisor’s
to give our investigators a clear,
manager, your facility’s Quality
• Not allowing business pressures or compliance with all applicable
complete picture of the study in
Assurance department, or the
which they are participating. time constraints to compromise the governmental quality and safety
Integrity Action Line.
You should give him all the objectivity or integrity of our scientific requirements.
information, even negative investigations and the resulting data.
results. • Protecting the safety of research This means:
participants comes first. • Following all government requirements,
• Following and maintaining good including good manufacturing
clinical practices (“GCPs”) and good practices, and all applicable Company
laboratory practices (“GLPs”) as quality policies and worldwide quality
required by law and regulation. standards.
• Communicating objective, complete, • Adhering to local standard operating
honest and accurate information procedures for the quality control and
about research programs. quality assurance of raw materials,
• Defining the roles, responsibilities manufacturing processes, testing,
and deliverables for investigators and storage, handling and shipping of
our products.
26 27