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CEO letterDear Colleagues:
Ours is a business with many complex dimensions, so being alert to those situations that pose an ethical question requires an understanding of our underlying values, culture and policies. While we are always striving to deliver strong business results, how we achieve those results is as, if not more, important. Our work affects people’s lives, and this immense responsibility should always be top of mind. It is for all these reasons that we must always ask ourselves, “what’s the right thing to do and what’s the right way to do it?”
While fundamentally we trust that Shire employees understand the imperative to always exercise good judgment, sometimes what is right isn’t always clear. This Code of Ethics is designed to help you understand the aspects of our business where there may be an ethical dimension, and provide help in making the right decision. Of course no code or policy can answer every question or eventuality in a business like ours, so please speak to your manager if you are in doubt as to what to do.
By following the spirit of this Code and behaving in a manner consistent with our values, we will continue to earn the trust and respect of those with whom we work, and those we serve.
Sincerely,
DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics2
Flemming Ornskov, MD Chief Executive Officer
July 2015
Section 1: IntroductionDoing Business with Integrity 5
The Importance of the Code of Ethics 5
Section 2: Our Code of EthicsOUR WORK ENVIRONMENT 7
Providing Equal and Fair Opportunities 8
Demonstrating Respect for Others 8
Maintaining a Safe and Secure Workplace 9
THE MARKETPLACE 10
Doing Business Free from Corrupt Activities 11
Protecting Fair Competition 12
Gathering Competitive Intelligence 13
Fair Treatment of Suppliers and Procurement 14
Protecting Privacy and Personal Information 14
PERSONAL INTEGRITY 16
Appropriate Use of Gifts and Entertainment 17
Avoiding Conflicts of Interest 19
Proper Handling of Inside Information 20
Responding to Investor and Media Inquiries 21
Responding to Government Officials 22
Conduct of Political Activities by Employees 22
OUR PRODUCTS 23
Providing Full and Fair Information about our Products 24
Global Trade Compliance 25
Product Quality and Adverse Events 26
PROTECTING COMPANY ASSETS 27
Keeping Accurate Books and Records 28
Protecting the Integrity of Company Technology 28
Safeguarding Intellectual Property 29
Protecting Confidential Company Information 29
Good Records Management Principles 30
OUR COMMUNITY 31
Respecting the Environment 32
Supporting Patient Groups/Organizations 32
Section 3: Being Brave Means Speaking Up
How to Raise Concerns 35
Company Resources 35
Contents
3DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics
DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics
Doing Business with Integrity An important part of our Brave culture is recognizing that doing business with integrity is a shared responsibility for all of us at Shire.
Every person working at Shire, whether as an employee, consultant, contractor or in any other capacity, has a responsibility to act with integrity. How do you do this?
� Be honest in all of your dealings on behalf of Shire.
� Know and follow the laws, regulations and policies that affect your job.
� Seek advice whenever you’re unsure about what to do in a situation that seems to pose an ethical issue.
� Make ethical decisions.
� Speak up if you see ethical or legal problems, policy violations or other behaviors that concern you.
The Importance of the Code of EthicsWhy do we have a Code?As we strive to deliver strong business results, we want to make sure we achieve those results in the right way. Our business has many complex dimensions. It is absolutely fundamental that everyone working for or on behalf of Shire understands our values, culture and policies.
How should I use the Code?While we trust you to exercise good judgment, sometimes what is “right” isn’t always clear. This Code of Ethics is designed to help you make the right decisions, providing guidance in situations that may pose difficult ethical
questions or require difficult judgments.
What if the Code doesn’t answer my question?No single code or policy can answer every question or address every situation. Please speak to your manager or one of our compliance resources if you ever are in doubt as to what to do. You can access additional compliance resources by contacting one or more of Compliance, Legal, Human Resources, Internal Audit, Quality (supporting both R&D and manufacturing operations) and the Global Compliance Helpline.
What happens if someone violates the Code? Anyone who breaches the Code may be subject to corrective and/or disciplinary action. In serious cases, this may include dismissal or reporting to the appropriate authorities for action.
Do managers have additional responsibilities under the Code?Managers are usually the first people employees turn to with questions and concerns. Every Shire manager is expected to know this code, model ethical behavior on a day-to-day basis and make sure employees know what’s expected of them. When employees raise questions or concerns, managers should listen to the concerns objectively and address them effectively, including escalating certain issues to one of the appropriate compliance resources noted above.
What is Shire’s commitment to compliance?Shire is committed to marketing, selling, promoting, researching, developing, providing information about, and advertising the products it commercializes throughout the world in full compliance with applicable laws, regulations and codes. Specifically in the United States these include:
� Federal healthcare requirements
� Food & Drug Administration requirements
� Requirements of Shire’s Corporate Integrity Agreement
Back to Contents
5
Our Work EnvironmentWe strive to create a work environment
where all people are valued so that they
can maximize their contribution to Shire’s
Vision and reach their full potential.
7DOING BUSINESS WITH INTEGRIT Y Our Work Environment
Providing Equal and Fair Opportunities
Our success is driven by diverse employee talent around
the world. We embrace and value all the things that make
us unique individuals.
YOUR ROLE
� Contribute to a supportive work environment that values different perspectives and ensures that everyone’s voice is heard.
� Speak up if you see someone being treated unfairly.
� If you hire anyone or make any employment-related decisions, make sure your evaluation is based on ability, skills, knowledge, work experience and job performance (when such information is available).
� Make sure you work with HR and Legal to understand what local labor and employment laws require in the areas where you do business.
ADDITIONAL RESOURCES
� Equal Employment Opportunity/Affirmative Action Policy 05-105US (US scope)
� Equality Policy 05-164UK (Outside US scope)
Demonstrating Respect for Others
Our employees, patients, business and society benefit when
we show respect, consideration and inclusion of different
perspectives in our work every day. The same applies to
our interactions with external business partners. Each of us
should contribute to a work environment that is free from
harassment and intimidation. Disrespectful behavior will not
be tolerated.
YOUR ROLE
� Never take actions that are intended to intimidate or harm someone.
� Avoid actions that could be considered harassment—even if meant as a joke.
� If you witness behavior that you believe is harassment, report it.
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Here are some examples of behavior that our Code prohibits:
� Jokes or slurs related to race, religion, ethnic origin or other personal characteristics
� Sexually explicit conversations, questions, stories or communications
� Teasing that causes someone to feel humiliated
� Unwelcome flirting or sexual advances
� Displays of inappropriate material
� Bullying or “ganging up” on someone
� Violence or threats of violence
What is harassment ?Typically, harassment is behavior the recipient
finds insulting, demeaning, hurtful, threatening,
or exclusionary. Harassment takes many forms
and can include words, gestures, or acts.
Be aware that behavior that is “acceptable” in your
home country may not be acceptable elsewhere.
? Q&A
DOING BUSINESS WITH INTEGRIT Y Our Work Environment8
Maintaining a Safe and Secure Workplace
We strive to help employees stay healthy and safe. We work together to
maintain a safe, secure and pleasant work environment, prevent injury and
accidents, and promote healthy lifestyles. The unsafe use of alcohol, drugs or
medication is prohibited, since this can lessen an employee’s ability to perform
their role and compromise the safety and well-being of fellow employees and
the public.
YOUR ROLE
� Always operate in a safe manner and avoid actions that you know could be dangerous or harmful.
� Never sell, purchase, possess or use illegal drugs.
� Never abuse alcohol or drugs while at work.
� Follow all building security procedures for your site.
� Report any threatening or potentially violent situations to HR or Corporate Security immediately.
� Report any unsafe acts or conditions right away.
ADDITIONAL RESOURCES
� Please refer to the Health, Safety & Environment web page for additional guidance.
Shire reserves the right,
subject to local laws and
practices, to test applicants
and current employees and
contractors for illegal drugs,
alcohol or abuse of doctor
prescribed drugs.
If you or another employee
is struggling with substance
abuse, we have resources that
can help. Contact HR for more
information.
Back to Contents
9DOING BUSINESS WITH INTEGRIT Y Our Work Environment
The MarketplaceWe operate openly and fairly, understanding that our behavior and
business practices underpin our reputation. We observe both the
letter and spirit of the laws and regulations that govern our industry
in the global economy.
DOING BUSINESS WITH INTEGRIT Y The Marketplace
Doing Business Free from Corrupt Activities
We conduct business responsibly, ethically and free of any form of bribery or
corruption—regardless of local practice or custom.
Shire does not buy business. We prohibit bribery by employees, contractors or
any third parties acting on our behalf—regardless of local custom or practice.
YOUR ROLE
You are responsible for knowing and following Shire’s policies and procedures.
You must comply with anti-bribery and corruption laws.
� Be honest and transparent about the money you spend and the purpose for which it is spent. Never attempt to conceal or misrepresent a payment.
� Do not offer, give or promise anything of value for the purposes of influencing someone in a position of authority to make favorable decisions about our business.
� Oversee the work of third parties carefully. Make sure they do not engage in activity that is or could be perceived as, bribery or corruption as part of their work for Shire.
� Record all payments and expenditures accurately and honestly in the company’s books and records. The establishment of “off books” arrangements or “slush funds” is prohibited.
ADDITIONAL RESOURCES
� Anti-Bribery and Corruption Policy 06-106GL
What is a bribe? Bribery is the act of offering,
promising or giving a financial
or other advantage to another
person with the intent to induce
improper performance of a
business or public function. We
tolerate neither giving nor re-
ceiving bribes. Anti-bribery laws
have severe penalties and often
apply outside of the countries
that have passed them.
? Q&A
11DOING BUSINESS WITH INTEGRIT Y The Marketplace
Protecting Fair Competition
Shire strives to win business based on superior products, service and
performance. We comply with competition laws, which prohibit agreements
between competitors that undermine the principles of fair competition.
We will not tolerate any behavior that prevents, restricts or distorts free and
fair competition, including:
� Agreeing with competitors to fix prices.
� Abusing a dominant market position (e.g., forcing a small player out of a market).
� Working with competitors to divide markets, customers or territories.
Competition laws are complex, global in reach, and operate differently in
different parts of the world. For specific guidance in your area, contact your
Legal or Compliance representative.
Free and fair competition
benefits patients and society
everywhere by providing
choice and competition.
Competition laws protect
patients and society by
encouraging free, fair and
open markets.
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or A bribe can be anything of value. For example:
� Gifts, entertainment or hospitality that is excessive, lavish or disproportionate
� Offers of employment being extended to a friend or family member
� Requests for donations to otherwise legitimate charities as a means to secure support for a business transaction
� Paying travel expenses or accommodation for an individual when there is otherwise no legitimate business purpose
� Use of Shire’s assets or equipment for activities unrelated to its business
� Accepting a gift, payment or other form of ‘kickback’ in exchange for directing business in a certain way
� Providing goods or services free of charge as a means to secure support for a business transaction
� Payment of so-called “facilitation” or “grease” payments to government officials to influence routine governmental actions – such as paying money to speed up processing of a visa
Offering or requesting a bribe is illegal in most countries—even if the transaction never takes place.
DOING BUSINESS WITH INTEGRIT Y The Marketplace
YOUR ROLE
� Never coordinate with a competitor or anyone else to fix prices or to take action that could lead to such a perception.
� Do not discuss or exchange information about Shire’s business with competitors (e.g., our sensitive commercial strategies, launch plans, pricing formulas, credit terms, promotions, discounts or allowances).
� Do not talk to competitors about dividing markets, customers or territories.
� Do not talk to competitors about placing restrictions on output or limits on production.
� Never take actions to manipulate a competitive bidding process or boycott a supplier, customer or distributor.
Gathering Competitive Intelligence
Shire gathers competitive intelligence ethically. Do not accept information if
you suspect it was obtained inappropriately.
YOUR ROLE
� It is acceptable to use public sources like websites, published articles and advertisements to gather information about competitors.
� Never engage in misrepresentation, deception, theft, spying, industrial espionage, piracy or bribery to obtain information. (See also Protecting Fair Competition)
� Seek guidance from Legal if you have any questions or concerns.
ADDITIONAL RESOURCES
� The Shire Information Protection e-Guide
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Trade association meetings:
Make sure you clearly under-
stand the rules about discus-
sions with competitors. If
anyone starts to talk about
confidential business informa-
tion (e.g., price, markets, future
business plans), identify who
you work for and, if necessary,
leave the conversation.
Friends in the industry: While
it’s fine to maintain personal
friendships in our industry, be
very careful not to exchange
confidential business infor-
mation with a competitor or
someone who might repeat the
information to a competitor.
13DOING BUSINESS WITH INTEGRIT Y The Marketplace
Fair Treatment of Suppliers and Procurement
Shire deals fairly, responsibly and ethically with our contractors,
vendors and suppliers. We expect that they will do the same
in return. Procurement decisions must be based on customary
commercial considerations. We encourage and welcome
diversity in our supplier base, just as we do in our own business.
YOUR ROLE
� Deal fairly, responsibly and ethically with all of our contractors and suppliers.
� Award work to business partners on the basis of customary commercial considerations only.
� Do not take unfair advantage of others by deliberately manipulating, concealing or abusing information or misrepresenting material facts.
� Do not seek or accept special favors, gifts or arrangements with suppliers or customers.
� Make sure your supplier safeguards our information and physical assets. We expect our suppliers to keep our confidential information secure and we do the same for them.
ADDITIONAL RESOURCES
� Supplier Selection Policy GPS-01
� Responsible Supply Chain Management Policy GPS-10
Protecting Privacy and Personal Information
Shire respects the privacy and safeguards the security
of the personal information we collect. Protecting it is
fundamental to our commitment to patients, healthcare
professionals, external business partners, employees and
the communities we serve.
YOUR ROLE
� Respect and maintain the privacy and security of the personal information collected by or for Shire.
� Never collect more personal information than is needed or keep it for longer than needed.
� Make sure that individuals have consented to Shire holding and processing the information.
� Know and comply with all applicable privacy laws and Shire privacy policies.
� Report any privacy breaches to [email protected].
ADDITIONAL RESOURCES
� US-EU-Swiss Safe Harbor Policy
DOING BUSINESS WITH INTEGRIT Y The Marketplace
Most of the countries where Shire does business have laws that require us to protect and secure
the personal information of others that we collect or control. These laws are meant to protect the
personal data entrusted to us and generally require the following:
1) We give notice that we are collecting personal
information and explain how and why we use it.
2) We provide choices about its collection, use
and disclosure.
3) We provide access to individuals so their personal
information can be corrected, amended or deleted
upon request.
4) We maintain the integrity of the information so it is
reliable for its intended use and we retain it only for
as long as needed.
5) We limit access to and disclosure of the information
to third parties.
6) We use appropriate security safeguards to protect it.
7) We provide the means for individuals to ask
questions or register complaints about how we
handle their personal information.
Back to Contents
15DOING BUSINESS WITH INTEGRIT Y The Marketplace 15
Personal integrity underlies all of our efforts to
enable people with life altering conditions to
lead better lives.
Personal Integrity
16 DOING BUSINESS WITH INTEGRIT Y Personal Integrity
Appropriate Use of Gifts and Entertainment
We do not give or accept gifts, entertainment or hospitality that could
raise questions about our integrity or appear to generate an improper
business advantage.
Small gifts and meals are often used to create goodwill and build appropriate
business relationships. While these exchanges may be appropriate in many
business settings, they can also create real or perceived concerns about
personal integrity and undue influence—even when offered or accepted with
the purest of motives.
Whether or not a gift or offer of entertainment is appropriate will depend on
the circumstances. Be alert to what others, including competitors, might think
if the gift, entertainment or hospitality were made public. (See also Doing
Business Free from Corrupt Activities)
PLEASE NOTE: Specific gift, entertainment and hospitality rules apply to
our interactions with healthcare professionals which may differ by country
and location. Shire has specific policies covering such interactions in most
jurisdictions. You must familiarize yourself with local rules on interactions with
healthcare professionals. Severe penalties apply for violations in many places.
Even where permissible, all
gifts, entertainment and
hospitality must:
� Be modest and infrequent
� Be appropriate to the occasion
and not go beyond common
courtesy and accepted local
business practices
� Not consist of cash or cash
equivalents like gift cards or
gift certificates
� Keep within the bounds of good
taste—avoid inappropriate or
culturally insensitive forms of
gifts, entertainment or hospitality
� Not be in violation of the rules
of Shire or the recipient’s
organization
� Never be conditioned upon,
or be a reward for purchasing,
prescribing or promoting Shire
products and services
17DOING BUSINESS WITH INTEGRIT Y Personal Integrity
YOUR ROLE
Please follow these general guidelines to avoid both real and perceived
concerns about inappropriate exchange of gifts, entertainment or hospitality:
� Do not solicit gifts, entertainment or hospitality.
� Know and follow the local laws, codes and Shire policies, as there are some circumstances under which even modest meals, entertainment or gifts are prohibited.
� Exercise good judgment and moderation when providing or accepting business gifts, meals or items of value and seek advice if you are unsure.
� Maintain accurate and complete records of events where you provide anything of value.
ADDITIONAL RESOURCES
� Please refer to the Global Compliance and Risk Management web page for additional guidance.
What do you mean by inappropriate or culturally insensitive forms of entertainment or hospitality? Certain venues or activities are not in good taste—for instance
gentleman’s clubs, venues that exclude women, hospitality
involving excessive luxury, and illegal activities. This is true
whether a Shire employee initiates the event or someone else
does. Always consider how your activities could reflect on Shire
if they were made public.
? Q&A
18 DOING BUSINESS WITH INTEGRIT Y Personal Integrity
Avoiding Conflicts of Interest
Your personal interests must not influence your decisions or cloud your
professional judgment.
A “conflict of interest” exists when your personal, social, financial, civic or
charitable activities could conflict with Shire’s interests or compromise your
objectivity. Be aware that the activities of your relatives and close associates
can also create conflicts of interest.
Even the appearance of a conflict of interest can be damaging to you and to
Shire. The first step to address any real or perceived conflict of interest is to
disclose the issue to your manager. Many conflicts can be resolved quickly
and easily, in a way that is acceptable to both you and Shire.
YOUR ROLE
� Do not use your position with Shire to benefit yourself, your relatives or close associates.
� Be alert to situations in which your objectivity may be compromised. This includes situations in which your interests or the interests of your family or associates conflict with the interests of Shire.
� Know how to recognize a conflict of interest and watch for potential conflicts of interest in your work at Shire.
� If you think you may have a conflict, raise it with your manager right
away and work to resolve the conflict.
ADDITIONAL RESOURCES
� Employment of Relatives Policy 05-117GL
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The following are just a few
examples of the many different sit-
uations where a conflict of interest
may arise; there are many others:
� Making procurement decisions when a family member or close friend stands to benefit personally, financially or otherwise, from the decision
� Hiring or managing relatives or close friends
� Working as a consultant, advisor, director or officer for a company that does business with Shire or is in the same business as Shire
� Taking personal advantage of opportunities you learned about as part of your role at Shire
� Using Shire property or information for a business opportunity that is not related to your role at Shire
� Competing with Shire’s business for personal gain
Thinking of joining an external
board where a conflict of interest
with Shire may exist? Please
consult with your manager before
making a commitment.
19DOING BUSINESS WITH INTEGRIT Y Personal Integrity
Proper Handling of Inside Information
We protect inside information and prohibit violations of
insider trading laws. Such violations are a serious offense
and can result in criminal prosecution.
Inside information, broadly, is information relating to
securities which is not in the public domain but which
an investor would consider important in making an
investment decision.
If you are in possession of inside information whether about
Shire or any other company as a result of your work at
Shire, you must keep that information confidential and you
must not trade in the relevant securities until the information
has been made public.
Also, you must not share this information with anyone else
who then buys or sells securities, including friends and
family members.
YOUR ROLE
� You must understand and comply with all applicable insider trading laws and Shire’s securities dealing policy.
� Never trade in securities when you have inside information. This includes inside information about companies other than Shire that you have learned about in the course of your employment at Shire.
� If you have any doubt as to whether you have inside information, consult with Legal.
ADDITIONAL RESOURCES
� Securities Dealing Policy 06-105GL
What is Inside Information?Inside information is material, non-public information
which investors would consider relevant to making an
investment decision. Some examples include:
� Approval of new products
� Earnings statements or forecasts
� Negotiation of a merger, acquisition, licensing or
similar transaction
� Entry into significant new contracts
� Sales of assets or subsidiaries
� Changes in management
� Major developments in litigation or expected
governmental actions
� Clinical trial results
� Any information you obtained about Shire or another
company or entity on a confidential basis during the
course of your work
What are Securities?Securities include ordinary shares, American
Depository Shares (“ADS”), Stock Appreciation Rights
(“SAR”), or any other transferable financial instrument.
? Q&A
20 DOING BUSINESS WITH INTEGRIT Y Personal Integrity
Responding to Investor and Media Inquiries
Take care not to speak for Shire—either inadvertently or on purpose.
As a company whose shares and other securities are traded on a stock
exchange, we are subject to rules and guidelines about when and how we
communicate certain types of information. To ensure clarity and a consistent
message, Shire has designated certain individuals to speak on the
company’s behalf to the media, financial analysts and investors.
YOUR ROLE
� Refer any external inquiries to Corporate Communications or Investor Relations. This includes questions from the investment community (e.g., shareholders, brokers, investment analysts, etc.) or the media.
� Do not make any statement to the press, radio or television about Shire’s business unless you have been specifically authorized to do so.
� Do not disclose unreleased financial information or any other non-public information to anyone outside the company.
� If you believe non-public information has been—or is about to be—wrongly disclosed, report it to your manager immediately.
ADDITIONAL RESOURCES
� Media, Legal and Government Inquiries Policy 01-165GL
I've been asked to participate in a public forum on topics related to Shire's business. Can I participate?Check with your manager first.
In fact, you should check with
your manager before agreeing to
participate in any public event
related to Shire’s business.
? Q&A
21DOING BUSINESS WITH INTEGRIT Y Personal Integrity
Responding to Government Officials
It is Shire’s policy to cooperate fully with government
authorities in connection with requests for information,
site visits and investigations. Because these types of
inquires carry the risk of potential legal exposure or
financial liability to the company, they require the immediate
involvement of Legal or another appropriate department
depending on the nature of the inquiry.
YOUR ROLE
If you are contacted by a government agency or authority
regarding a non-routine request for information or a site
visit, you should obtain the name of the government official
seeking information and the agency they represent as well
as their contact information and then immediately contact
Legal, Regulatory, Compliance or another appropriate
department for guidance. The appropriate department
will coordinate any response to the government to ensure
that accurate information is provided, consistent with
legal requirements.
PLEASE NOTE: Shire attorneys are obligated to act in
the best interest of Shire and cannot serve as personal
attorneys for individual employees.
ADDITIONAL RESOURCES
� Media, Legal and Government Inquiries Policy 01-165GL
Conduct of Political Activities by Employees
Shire supports the right of its employees to engage in
personal political activities outside of work. However,
personal political activity must remain separate from your
job responsibilities at Shire.
If you engage in the political process, make sure to do
it on your own time, with your own resources and avoid
suggesting that Shire has provided support.
YOUR ROLE
� Keep your work and political activities separate.
� Do not make political contributions, directly or indirectly, on Shire’s behalf.
� Do not lobby on behalf of Shire unless authorized by senior management.
� Do not use Shire’s company name, your job title, property or equipment, including e-mail, for personal political activities.
� While at work, do not solicit donations or try to persuade others to support political parties or candidates.
ADDITIONAL RESOURCES
� If you have any questions about participation in political activities please speak to your manager or a member of our Government Relations team.
Back to Contents
22 DOING BUSINESS WITH INTEGRIT Y Personal Integrity
We research, develop, manufacture and sell our
products understanding the responsibilities we have to
patients, health care professionals, payors and those
who regulate us. We know that our scientific methods
and business practices underpin our reputation.
Our Products
23DOING BUSINESS WITH INTEGRIT Y Our Products
Providing Full and Fair Information about our Products
Shire strives to provide balanced, fair and understandable
information about the safety and efficacy of our products
and their appropriate uses. We respect the need for
healthcare professionals to make unbiased clinical
judgments free from any inappropriate influence from
pharmaceutical manufacturers. (See also Appropriate Use
of Gifts, Entertainment & Hospitality)
Our marketing and educational activity is intended to
provide healthcare professionals, payors, and where
appropriate, patients with relevant medical and scientific
information so that they can make informed and
independent decisions about prescribing and using
our products.
Our promotional interactions and messages must always:
� Seek to educate but not interfere with unbiased clinical judgment.
� Be consistent with the approved label.
� Appropriately balance the risks and benefits of the treatment.
� Be truthful and not misleading.
� Be compliant with all Shire policies, applicable laws
and industry codes of conduct.
PLEASE NOTE: Specific rules apply to our communications
with healthcare professionals which may differ by country
and location. Shire has specific policies covering such
communications in most jurisdictions. You must familiarize
yourself with local rules on communications with healthcare
professionals. Severe penalties apply for violations in
many places.
YOUR ROLE
� You must conduct all communications with healthcare professionals about our products, including those relating to sales, marketing and scientific and medical information, in accordance with our principles and in compliance with all Shire policies, applicable laws and industry codes of conduct.
ADDITIONAL RESOURCES
� Please refer to the Global Compliance and Risk Management web page for additional guidance.
24 DOING BUSINESS WITH INTEGRIT Y Our Products
Global Trade Compliance
Shire is committed to importing, exporting and engaging
in all forms of trade in a legal and ethical manner. As a
company we must comply with laws, regulations, licensing
requirements and boycotts or other embargos that have
been approved by recognized national and international
authorities, including the United Nations, the European
Union, the United Kingdom and the United States.
Such requirements may relate to, but are not limited
to, chemicals, biological materials, equipment, finished
products, and software and technology.
YOUR ROLE
� Provide accurate, truthful information about our products and other items to Customs and other relevant authorities.
� Refuse to engage in prohibited restrictive trade practices.
� Do not conduct business with parties subject to recognized trade restrictions.
� When in doubt, consult with your Global Trade Distribution, Legal or Compliance contacts.
? Q&A
What are Trade Restrictions?Trade restrictions, including
sanctions or embargos, seek
to prevent or omit trading with
one or more specific countries,
persons or entities.
A boycott is a country’s refusal to
do business or to prohibit others
from doing business with one or
more countries.
25DOING BUSINESS WITH INTEGRIT Y Our Products
Product Quality and Adverse Events
Shire is responsible for protecting patient safety by
ensuring its products are manufactured, stored and
distributed in accordance with all applicable quality
standards and by ensuring that any adverse events
experienced by patients using our products are promptly
reported to the appropriate authorities.
YOUR ROLE
� Know how to identify a product quality complaint or adverse event report.
� Recognize the information that you will need to collect when documenting a product quality complaint or adverse event report.
� Report any product quality complaint to the Quality Assurance department in accordance with the applicable policy.
� Pass on any adverse event report to the Pharmacovigilance department in accordance with the applicable policy.
ADDITIONAL RESOURCES
� Reporting of Adverse Events Policy PV-001
� Reporting of Product Quality Complaints Policy QA-001
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Product quality complaints can include:
� Damaged tablets, capsules, vials
� Faulty packaging – inadequate closure/seal, missing/incorrect/misleading label, poor quality printing on packaging
� Contamination - foreign objects in pack/bottle/vial or packaging
� Overfilled/underfilled/empty capsules
� Product Mix (“rogues” within a pack/bottle)
� Wrong product (label and contents are different products)
� A product quality defect
Adverse event reports can include:
� Any unfavorable and unintended sign, symptom or disease associated with use of the product
� Exposure during pregnancy or lactation
� Misuse, abuse or overdose
� Withdrawal
� Diversion
� Lack of effect
� An unintended benefit
Back to Contents
26 DOING BUSINESS WITH INTEGRIT Y Our Products
We operate in the best interests of the company and its shareholders, protecting company assets and operating in compliance with the laws and regulations of the communities where we operate.
Protecting Company Assets
27DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets
Keeping Accurate Books and Records
Shire’s financial records must fairly represent our financial
condition and operations. As a company whose shares
and other securities are traded on a stock exchange, we
must abide by laws, regulations and accounting standards
for reporting and disclosing financial information, including
those set by the U.S. Securities and Exchange Commission,
the London Stock Exchange and the NASDAQ.
Operating in accordance with these standards ensures that
we can stand behind the integrity of the information that we
supply to shareholders, investors and governments.
YOUR ROLE
Shire’s Board of Directors and Financial Controller are
legally responsible for the information contained in
financial documents filed with Government agencies and
stock exchanges.
� To support them in their obligations, it is essential that everyone at Shire works to ensure the integrity and prompt, accurate reporting of business information. Never falsify records or misrepresent any facts in order to conceal the true nature of a transaction. Doing so may constitute fraud and may subject you and the company to criminal prosecution.
Protecting Company Technology
We use good judgment and follow company policies
when using company technology. All Shire employees are
responsible for helping to protect our hardware, software,
networks, mobile devices and information—assets that
are critical to our business success. Your use of Shire’s
technology should be appropriate, secure and primarily
for business purposes.
Do not assume that communications sent using company
technology are private. Subject to local law, Shire may have
the right to access, monitor and review all communications,
records and information created at work or with company
resources. In certain countries, you may need to produce
this information in the event of a lawsuit or investigation.
YOUR ROLE
� Do not download unauthorized software or other programs.
� Be reasonable and professional when using Shire technology. Don’t create, send or download content or communications that could be considered offensive, derogatory, defamatory, harassing, obscene or vulgar.
� Keep personal use to a minimum. Never use Shire computers for illegal activities or in ways that interfere with your work or the work of others.
� Do not use Shire computers or other assets in connection with an outside business.
� Take precautions to protect the security of computer systems, including corporate data, electronic communications and application software.
ADDITIONAL RESOURCES
� Corporate Information Security Policy DOC-GBL-02
Other Government Reporting Requirements
In addition to our legal and accounting responsibilities, all
financial and non-financial arrangements with customers
must be properly recorded so that Shire can abide by all
government contracting and reporting requirements in
the US and other countries, as applicable.
28 DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets
Safeguarding Intellectual Property
Intellectual property rights are a key business asset.
Shire’s business is the discovery, development and
commercialization of innovative treatments and therapies.
Shire’s efforts are protected by intellectual property rights that
prevent others from copying and profiting from our work.
Intellectual property includes patents, trademarks,
copyrights, registered designs, trade secrets and domain
names (e.g. shire.com). We take steps to protect Shire’s
intellectual property rights. We respect the intellectual
property rights of others and we do not knowingly infringe
on any valid third party patents.
YOUR ROLE
� Respect and help preserve Shire’s intellectual property rights.
� Protect Shire’s business secrets by not speaking openly about or disclosing confidential business material to third parties.
� Document and make the company aware of new ideas, including technological or medical advances or unique solutions to business problems. Shire can then take steps to protect these new works under intellectual property laws.
� Please contact Legal without delay if you become aware of:
» New work that could benefit from intellectual
property protection.
» Any copying or misuse of Shire’s intellectual property.
» Suspected infringement of a third party’s intellectual
property by Shire.
Protecting Confidential Company Information
Confidential company information is a key business asset
that must be protected.
The products, services, ideas, concepts and other information
that Shire produces are a product of our hard work. They
require significant investment and are important and valuable
company assets. Shire owns this confidential or proprietary
information just as it does other kinds of property.
Shire employees at all levels have access to information
that is confidential or proprietary to the organization. We
all share an obligation to protect that information. The loss
or theft of Shire’s confidential information is a significant
risk to the company. We must also take care to respect
confidential information that belongs to people and
companies outside of Shire.
Examples of Confidential Information
Sales, marketing and other corporate databases
� Marketing strategies and plans
� Pricing information
� Customer and employee records Manufacturing
techniques
� Research and technical data
� New product development, ideas or projects
� Inventions, trade secrets and know-how
� Salary, wage and benefits data and all other
personnel information
29DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets
YOUR ROLE
� Respect your confidentiality obligations to Shire.
� Share confidential information only with other Shire employees who need to know it to perform their jobs.
� Make a habit of securing your workstation.
� Don’t discuss confidential business in public areas or work on it where others might be able to view the information.
� Before disclosing confidential information to outsiders, obtain prior approval from your manager and check to see if the recipient needs to sign a confidentiality agreement.
� Be aware of competitive intelligence activities by our competitors. Careless conversations can seriously damage Shire’s interests.
� Always respect the confidentiality and proprietary information of other companies and individuals, including physicians, scientists and patients.
� Report the loss or theft of Company laptops, devices or information to the Shire Global IT Service Desk immediately.
Good Records Management Principles
We manage our records and information in compliance with
laws and regulations.
Shire’s business is heavily regulated and its records and
information are essential company assets. We must meet
multiple requirements when we create, use, store and
dispose of company records and information. We may
face legal proceedings that require us to hold and preserve
relevant records and information. Failing to meet any of these
requirements can result in serious consequences including
loss or corruption of the assets, or sanctions and fines
against the company.
YOUR ROLE
� Be familiar with the Records and Information Management Policy plus any relevant recordkeeping policies or procedures applicable to your functional area. These procedures apply to records and information in any format, including electronic or hard copy.
� Be familiar with the Hold Orders issued by Legal if you are asked to preserve relevant records or information relating to a particular dispute or investigation. You must not alter or destroy records or information that are identified by Legal Hold Orders.
� If you have any questions, consult the Records & Information Management group at [email protected].
ADDITIONAL RESOURCES
� Records and Information Management Policy
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30 DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets
Our CommunityWe care about who we are and the legacy we leave behind. As a leader in many of the areas in which we operate, we have social and environmental responsibilities to ensure our position of strength is a positive force in society. This includes how we engage with our communities and how we manage our relationship with the environment.
31DOING BUSINESS WITH INTEGRIT Y Our Community
Respecting the Environment
We operate as an environmentally sustainable
organization, taking steps to protect the environment
wherever we conduct our activities. We strive to meet
or exceed regulatory requirements and maintain a high
level of environmental performance in the specialty
biopharmaceutical industry.
This means we:
� Promote the sustainable and efficient use of natural resources, waste minimization, recycling, energy efficiency and responsible product stewardship in our business activities.
� Integrate environmentally-sound principles and
practices into our day-to-day activities.
Good performance in this area is achieved by the
collaborative efforts of all employees.
YOUR ROLE
� Familiarize yourself with our environmental policy and adhere to its standards.
� Respect the environment and actively seek ways to help reduce our environmental impacts.
ADDITIONAL RESOURCES
� Global Health, Safety & Environment Policy HSE-GP-01
Supporting Patient Groups/Organizations
Shire’s giving through grants and sponsorships to advocacy,
health and therapeutic-related organizations is guided by
our commitment to patients and the therapeutic areas in
which we work. Decisions about which patient organizations
to support and at what level are made in consultation with
our R&D and Medical Education units, ensuring that the
investments we make help patients and their families.
As part of our commitment to transparency and openness,
we disclose publicly on shire.com the patient groups we
support, along with a short explanation of how the funding
is intended to be used. In some countries, Shire is required
by law to disclose the amount and related details of the
financial support.
YOUR ROLE
� Know and follow the applicable policies to your business and region.
� Do not make donations, grants or sponsorships to Patient Groups or other organizations, directly or indirectly, on Shire’s behalf unless properly authorized.
� Make sure that any donations, grants or sponsorships to Patient Groups or other organizations are properly recorded and reported.
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32 DOING BUSINESS WITH INTEGRIT Y Our Community
You are expected to speak up if you have questions
or if you see ethical or legal problems, policy violations
or other behaviors that concern you. When you
communicate honestly about how we are conducting
business, you show respect for your colleagues and
the patients who depend on Shire products and
provide us with an opportunity to address or correct
problems before they become significant.
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How do I raise a concern?
In most cases you should contact your manager first and
ask for guidance. Shire expects managers to listen to your
concerns objectively and address them effectively. If you’re
uncomfortable talking to your manager or if your concern
involves your manager, please consult one of the additional
compliance resources listed below.
Could raising a concern hurt my job?
No. Shire does not tolerate any form of retaliation against
employees who report concerns or issues in good faith. For more
information please see our Whistle Blowing Policy 01-100GL.
Can I remain anonymous when contacting the Global Compliance Helpline?
Certain countries have laws regarding the use of company
helplines but in many cases you can remain anonymous*.
Why do we have a Global Compliance Helpline?
The purpose of the Global Compliance Helpline is to provide
a safe, secure way to ask questions or report concerns about
ethical problems, legal violations or violations of Shire policies or
procedures. If you are uncomfortable speaking to your manager
or one of the additional compliance resources available to you,
please contact the Global Compliance Helpline.
What types of issues can I report to the Global Compliance Helpline?
The Helpline can be used to report issues such as:*
� Fraudulent financial reporting
� Misconduct regarding sales and marketing policies
� Insider trading
� Data privacy breaches
� Disclosure of confidential information
� Environment, health and safety issues
� Harassment or discrimination
� Any other violations of Shire’s Code of Ethics
Compliance ResourcesThere are many resources available to assist you in making the right decisions and to report
concerns or violations, including:
� Your manager
� Compliance
� Legal
� Human Resources
� Internal Audit
� Quality (supporting both R&D
and manufacturing operations)
� Global Compliance Helpline
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How do I contact the Global Compliance Helpline?
ON THE WEB
File a report online 24/7 in your native language at
www.Shire.Ethicspoint.com
BY PHONE
Call our trained specialists 24/7 to ask questions or discuss
concerns (translation services available):
� US & Canada: 1-866-747-4473
� UK: 0-800-032-8483 then dial 1-866-747-4473
� Other Countries: visit www.Shire.Ethicspoint.com for international dialing instructions
What happens after I contact the Global Compliance Helpline?
When filing a report with the Helpline, you’ll receive a
reference number for checking on a report’s status and will be
notified of any follow up actions taken. If there are questions
or more details are needed, a response will be posted on the
Helpline website under your reference number.
Other Questions?
If you have any additional questions about the
Helpline please email the Global Compliance team at
* Certain countries have laws regarding the use of company helplines. Please find additional details below.
FOR US EMPLOYEES:
Federal and state governments have enacted laws to prevent, detect
and punish health care fraud and abuse. At the federal level, these laws
include (but are not limited to) the Federal Anti-Kickback Statute (42
U.S.C. §1320a-7(b)), Federal Civil False Claims Act (31 U.S.C. §3729-
33), Federal False Statements Act (18 U.S.C. §1001) and administrative
penalty provisions under 31 U.S.C. §3801-12. Many states have enacted
similar laws. The federal FCA provides civil penalties of up to $11,000
for each false claim submitted to the government. Pharmaceutical sales
and marketing activities that might violate the FCA include (but are not
limited to) submitting false claims for government payment, fraudulently
reporting false pricing information to government agencies and similar
activities. The federal FCA, and some state FCAs, also include provisions
under which individual citizens with evidence of fraud against the
government may sue on behalf of the government to recover the lost
funds. These laws also prohibit retaliation against persons who file
whistleblower suits.
FOR EUROPEAN EMPLOYEES:
In most countries you may submit reports anonymously. In certain
European Economic Area (EEA) countries, however, laws may restrict
submitting anonymous reports and may limit the topics on which you can
report (for example, to bribery).
In such cases, reports should be made to your manager or you can
contact Human Resources, Legal or Global Compliance directly.
Further details are available on www.Shire.Ethicspoint.com.
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