Standards of Global Business Practices




Version August 2007
August 2007
                                                        Dear Colleagues:

                                    ...
TABLE OF CONTENTS



     INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
2

     THE STANDARDS – IN OUR WORKPL...
Introduction to the Standards of
Global Business Practices
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



                                                            ...
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



available in many languages and Schering-Plough attempts to ...
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



In the four substantive sections, key policies and legal req...
THE STANDARDS – In Our Workplace



                                                                                      ...
THE STANDARDS – In Our Workplace



Q&A                                                                                   ...
THE STANDARDS – In Our Workplace



Q&A                                    Drug and Alcohol Abuse
                        ...
THE STANDARDS – In the Marketplace



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THE STANDARDS – In the Marketplace



                                                                                    ...
THE STANDARDS – In the Marketplace



Q&A                                                                                 ...
THE STANDARDS – In the Marketplace



Q&A                                                                                 ...
THE STANDARDS – In the Marketplace



Q&A                                                                                 ...
THE STANDARDS – In the Marketplace



                                                                                    ...
THE STANDARDS – In the Marketplace



Q&A                                                                                 ...
schering-plough standards
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schering-plough standards
schering-plough standards
schering-plough standards
schering-plough standards
schering-plough standards
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schering-plough standards

  1. 1. Standards of Global Business Practices Version August 2007
  2. 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. 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.
  4. 4. Introduction to the Standards of Global Business Practices
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
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