Business Conduct Standards for Interactions with Healthcare Professionals. Pocket Guide for U.S. Sales Professionals. Do The Right Thing

Transcription

1 Business Conduct Standards for Interactions with Healthcare Professionals Pocket Guide for U.S. Sales Professionals Do The Right Thing

2 As Amgen s Vice President of Sales and Marketing Operations and Planning, Compliance Officer for U.S. Sales and Marketing, and an Amgen staff member for 14 years, I am very proud of our organization s business conduct track record over the last 25 years. As the face of Amgen, ethics and integrity must always be in the forefront of how you conduct business with customers. We ve adopted a new policy entitled Interactions with Healthcare Professionals to clarify how the Do The Right Thing program applies to Sales and Marketing specifically. To make it easy to know how to comply with the letter and spirit of this policy, we ve prepared a series of compliance standards which detail how we do the right things the right way. This field reference guide summarizes the compliance standards and is designed to provide a quick reference in situations that arise when you are on the road. For the complete standards, including definitions of terms referenced throughout this guide, please consult the Compliance section on the MYAMGEN portal or your Business Conduct Standards binder. Michael Savin Vice President Sales and Marketing Operations and Planning This summarized guide should not be viewed as a substitute for learning and abiding by the standards in their entirety.

3 Gifts to Healthcare Professionals Gifts Gifts Defined: Anything of value given by an Amgen employee or agent without payment or without an even exchange of services from the recipient. Gifts do not include items provided to persons who are performing services for Amgen if the items are necessary to the provision of services (e.g., CRA supplies, notebooks and pens to study sites for use in connection with performing data collection for an Amgen study). Standard: Gifts may only be provided by Amgen personnel to Customers in compliance with the principles set forth in this Standard. Under no circumstances may a gift be offered or provided with the intent of, directly or indirectly, influencing or encouraging the recipient to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend formulary placement of any Amgen product. Gifts may not be provided in connection with discussions, negotiations, or decisions involving product pricing or purchasing, or formulary status. Marketing-Initiated Reminder Item Programs: Gifts of minimal value (e.g., items such as company or product branded pens, mugs and notepads) may be provided to Customers when they are administered through a headquarters-driven promotional program. Marketing-Initiated Textbook and Premium Item Programs: Textbooks and other patient- or practice-related items (e.g., stethoscopes, anatomical models) may be offered to Customers in accordance with a headquarters-driven program. Items given through such a program should have a retail value of no more than $100. Prohibited Gifts: Cash or cash equivalents (e.g., general gift certificates) Gifts purchased by an Amgen employee, in a manner inconsistent with this Standard, with his/her own funds, even if the employee does not intend to seek reimbursement from Amgen Gifts for the personal benefit of a Customer or a Customer s family member (e.g., clothing, golf balls), even when they bear a company or product logo Gifts of tickets to recreation and entertainment events

4 The provision of samples for a Customer s personal or family use (as opposed to patient use in accordance with the Prescription Drug Marketing Act) Gifts to Government Employees No gifts may be provided to federal, state or other government personnel unless the requirements of the Amgen Dealing with the Government Policy are also met. Annual Gift Limit: With the exception of reminder items, no Customer may receive gifts with a combined total retail value in excess of $150 per year from Amgen. Field Action: Follow headquarters instruction. Manager Responsibility: Managers shall be responsible for monitoring the activities and performance of their respective employees against the requirements set forth in this Standard.

5 Grants and Healthcare Donations by the Medical Education Department Standard: All donations are approved through and funded by the Medical Education department. Donations are grants, contributions or payments, in cash or in kind, made by Amgen, to further an educational, scientific or other charitable purpose, and made to a Qualified Recipient (see below). Grants Amgen may only make Donations to Qualified Recipients for the following purposes: To advance medicine and healthcare To promote healthcare professional education or serve another genuine educational function To educate the public on disease states and medical conditions Other genuine philanthropic and charitable purposes that demonstrate good corporate citizenship and represent a benefit to society. Donations may not be linked, directly or indirectly, to an agreement to use, prescribe, recommend or refer Amgen products or be used to reward past business. Qualified Recipients: Hospitals Universities Patient groups Organizations exempt from federal income tax under Internal Revenue Code Sections 501(c)(3) non-profit organizations, 501(c)(4) social welfare organizations, and 501(c)(6) trade and professional associations. Note: Physicians and individuals are not Qualified Recipients. Decision Making Process: The Donation Review Committee and Medical Education Department must make all funding decisions based on a complete Donation application. Field Action: Sales personnel may not participate in the Donation application or decision making process, but may provide a copy of the approved Donation application form and procedures to individuals and organizations who want to make a Donation request. Sales personnel are not to call the Medical Education Department to inquire about the status of grants.

6 Independent Medical Education Standard: Independent Medical Education (IME) consists of live presentations and/or written, enduring materials that are intended to educate healthcare professionals, and are developed by entities external to Amgen. Independent Medical Education provides valuable education to healthcare professionals. Funding Authority: Amgen s Medical Education Department shall make all decisions concerning funding of IME based on applications that have been submitted to it by third party providers of education. Decision to Support: The decision to support IME should be made on the basis of the program topic only. It should not be made with knowledge of program content, speakers, moderators, etc. Qualified Topics: Amgen generally supports IME that relates to a disease state of interest to the company. Qualifying topics can discuss the disease state generally, or the use of a product class for the treatment of that disease. A topic is not qualified if: No products in the class are indicated for the treatment being discussed, or; The title of the program specifically mentions an off-label use of an Amgen product. Independent Medical Education Program Development: To ensure the content of IME remains independent, Amgen employees must adhere to the following standards concerning program development: Provider Control of Content: Amgen must be hands off, which means Amgen employees may not participate in any aspect of program planning or development. Speakers: The program provider must select the speakers. Materials: Amgen may not offer materials to the provider. Invitations: The program provider is responsible for promotion of its own program. However, the field may be requested by the program provider via marketing to distribute invitations or save the date cards.

7 Attendance by Amgen Employees at Live Events: Amgen employees may attend IME events; however, they may not participate in audience discussions, or ask questions of the presenter. In addition, Amgen employees may not perform any promotional activities including the provision of non-programrelated meals or entertainment in connection with an IME program. Field Action: Follow instructions provided by your marketing team for all IME programs.

8 Meals and Entertainment with Customers Standard: Meals and entertainment may only be provided by Amgen personnel in compliance with this Standard. Under no circumstances may meals or entertainment be offered or provided with the intent of, directly or indirectly, influencing or encouraging the recipient to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend formulary placement of any Amgen product. Modest meals may be provided in connection with a legitimate business purpose. Legitimate business purposes include: Informing Customers about the benefits and risks associated with Amgen products. Providing scientific and educational information to Customers as it relates to the clinical areas in which Amgen has ongoing business interests. Obtaining legitimate and valuable feedback and information from a Customer. Negotiating contracts and sale terms. Performing work under a bona fide consulting agreement. Meals Informational presentations and discussions with Customers: Meals may be provided in connection with informational presentations and discussions in a venue and manner conducive to conducting business matters and/or engaging in a scientific or educational exchange of information. No more than four (4) Customers may be present for every Amgen employee in attendance. Entertainment and recreational events may not be offered in connection with these activities. The total cost of such meals, including tax and tip, may not exceed $125 per person. Provision of In-Office Meals: In-office meals may be provided in connection with informational presentations and discussions only where they are modest in amount and occur in a manner conducive to the legitimate purposes set forth above. The total cost of such meals, including tax and tip, may not exceed $30 per targeted healthcare professional and Amgen employee in attendance.

9 Meals Provided in Connection with Amgen Meetings: Attendance at Speaker Programs must be documented, and the meals provided to attendees shall be included in the spending limit, as determined by Amgen (see Field Action). Prohibited Meals & Entertainment: Recreation and entertainment events are prohibited, even where Amgen personnel are present. No meals may be provided in cash or in cash equivalents (e.g., gift certificates for restaurant meals). No meals may be provided where an Amgen employee is not present. An Amgen employee may not provide meals and entertainment, in a manner inconsistent with this Standard, with his/her own funds, even if the employee does not intend to seek reimbursement from Amgen. Inclusion of a Customer s spouse or other guests in meals provided at any informational presentation or reception is not appropriate; therefore spouses and guests should not be invited. This restriction does not apply where Amgen provides a grant to a convention sponsor. Up-Front Verification of Eligibility: Prior to providing a meal to a Customer, Amgen employees must determine the Customer has not yet reached the spending limit. Expense Reporting: All expenses for meals must be recorded in the Amgen employee s expense report consistent with the Amgen General Travel and Expense Policy. In addition, the Amgen employee must record the names of all Customers who were in attendance at the meal and the business purpose of the meal. Orion: For all calls and programs, ensure that all attendees are captured and the meal is categorized. Field Action: Speak with your manager to confirm your Annual Per-Customer Spending Limit, and ensure you plan your activities to stay within the limit.

10 Product and Reimbursement Discussions Standard: This Standard also addresses, without limitation, product and reimbursement discussions by Field-Based Employees that arise in the following contexts: Discussions about disease states Responding to Customer questions Contracting discussions Sampling Discussions about participation in clinical studies Discussions about patient assistance programs Field-Based Employees Discussions: All Field-Based Employees discussions about Amgen products must be consistent with the approved prescribing information. Only material that is approved for promotional use may be used in connection with these discussions. Regional Medical Liaison Discussions: Field-Based Employees may engage RMLs to address specific unsolicited questions that require a greater depth of clinical expertise, or information Field-Based Employees have not been authorized to use in discussions with Customers. RML discussions are governed by the US Standard for Regional Medical Liaison Discussions. Field-Based Employees may never call upon RMLs to promote Amgen products in a manner that is inconsistent with approved product labeling. GEM and CAM Discussions: GEM and CAM employees are permitted to have materials at their disposal for discussing reimbursement matters with payors, with the designation that the materials are for GEM and/or CAM use only, as appropriate. GEM and CAM employees must take care to ensure their discussions with payors are accurate, and within the boundaries authorized by the home office. Product Promotion Field Materials Classification: Class I Promotional Materials, Disease State Education and Basic Reimbursement Pieces: Class I materials may be shown to Customers and, quantities permitting, left behind. Class II For Responsive Use Only: This material may be shown to Customers only in response to a specific, unsolicited request for the information contained in this piece. This material may not be used for product detailing, and may not be left behind.

11 Class III For Dissemination Only: These materials may be given to Customers, but they may not be discussed in any way (e.g., approved articles). On a later sales call, if the Customer asks a question, these materials may be used to answer the question. Class IV For Use, But Not Dissemination: Includes any contract performance sheets and proprietary pricing and sales information related to a specific Customer. May be used proactively with Customers, but because they include proprietary information they may not be distributed or left behind. Class V For Internal Use Only: These materials may not be used with Customers. They include sales training materials, and interest only articles to provide Field-Based Employees with background information about the products they sell. Specific Requirements for Reimbursement Discussions with purchasers: Field-Based Employees must emphasize that prescribing decisions should always be based on safety, efficacy and appropriateness for each patient and may not discuss reimbursement topics beyond the scope of the approved materials. Consequently, unless addressed in the approved materials, Field-Based Employees must not discuss reimbursement for competing products. Further, Field-Based Employees may never discuss how much money a Customer can make on the difference between the Customer s acquisition cost and reimbursement from Medicare or other third party payors (e.g., spread, profit, return to practice or other similar concept). Discussions About Disease States: When discussing disease state materials, Field-Based Employees must use only approved materials, and not affirmatively mention products unless: The materials allow for the discussion of product. The product discussion, when combined with the disease state educational material, would not suggest use of an Amgen product that is inconsistent with approved product labeling. Answering Customer Questions: Field-Based Employees should ensure their answers to Customer questions about safety and efficacy are consistent with the approved prescribing information. If an answer requires information that is inconsistent with the approved prescribing information, the Field-Based Employee may give the answer to the Customer under the following circumstances: Specific and Unsolicited: The question must be a genuine question that has not been prompted by the Field-Based Employee in any way. The question must also be sufficiently specific to warrant a response that provides data. The answer must be narrowly tailored to address only the question asked. It is inappropriate to volunteer additional information.

12 Use of Approved Materials: Only materials that have been approved for this purpose may be used to answer unsolicited Customer questions. If the question cannot be answered using approved materials, it may not be answered, and the Customer should be referred to the Medical Information Department. Fair Balance and Safety Information: Similar to promotional discussions, Field-Based Employees must ensure their answers to specific unsolicited Customer questions present a full and accurate description of all necessary safety information. Contracting Discussions: Field-Based Employees are not authorized to change the terms of contracts or to sign agreements and may not offer anything of value to Customers in connection with entering into a purchase contract. Field-Based Employees must not discuss reimbursement for competing products or how much money a Customer can make on the difference between the Customer s acquisition cost and reimbursement from Medicare or third-party payors (e.g., spread, profit, return to practice or other similar concept). Samples: Field-Based Employees who have been authorized to do so may provide samples to Customers in accordance with sampling initiatives led by the brand team. Participation in Clinical Studies: If a Customer would like to participate in a clinical trial, he or she must be referred to the appropriate RML. Field-Based Employees may not discuss clinical trials with Customers. The opportunity to participate in clinical trials may never be used as a tool for promoting Amgen products. Patient Assistance Programs: Patient assistance programs are strictly for the benefit of patients who qualify. Field-Based Employees may deliver home office-approved educational brochures to educate Customers about these programs. Field- Based Employees may not position these programs as a benefit to Customers, or as a reason to prescribe Amgen products. Field Action: Follow the guidelines as stated.

13 Promotional Speaker Programs Standard: All programs where Amgen employees and agents (e.g., a vendor that manages speaker programs) arrange for a speaker to present information on behalf of the company are considered speaker programs. Speaker programs are promotional events. Speaker Program Content: Speaker program topics must be relevant to Amgen s business and/or products. Speaker programs must be delivered from slide kits that have been approved in advance by the appropriate pink folder team. Product Program Topics: Speaker programs discussing Amgen marketed products must present only information that is consistent with an FDA-approved indication for a marketed product. Disease State Program Topics: Speaker program topics may also address disease states that are of interest to Amgen. Disease state programs should focus on the particular disease or condition. Business Program Topics: Speaker programs may also discuss limited business topics that are directly related to Amgen s products (e.g., coverage and coding issues related to Amgen products). Speaker programs may not be used to provide consulting services to Customers. Attendance: Speaker programs are only appropriate where at least four (4) targeted healthcare professionals are expected to attend, and shall be open to invited healthcare professionals only. Spouses or other guests of attendees may not be invited or accommodated. The company does not reimburse attendees travel and other expenses. Arrangements with Speakers: Speakers must be trained members of the appropriate Amgen Speaker Bureau with a valid contract that includes an agreement to adhere to Amgen s Speaker Rules. Selection of a speaker from the Speaker Bureau must be based upon the speaker s qualifications, skill and geographic location. Speakers may not be selected on the basis of their prescribing patterns, or their potential to generate future business. Speaker Programs

14 Field Action: Persons wishing to conduct a speaker program shall submit a request to Medical Education no later than four (4) weeks in advance of the planned event. The person requesting the program shall be considered the Responsible Amgen Employee (RAE). The RAE is responsible for ensuring that any meals connected to a speaker s program comply with the Meals Standard. Invitations: Invitations to speaker programs must be generated from a template that has been approved in advance by the appropriate pink folder team. Field Personnel Involvement at Meeting: The RAE should attend the speaker program. Amgen employees should refrain from engaging in the program discussion. If they do engage, all statements are considered promotional, and must be consistent with the package insert for the product being discussed. Field Monitoring of Individual Speaker Programs: The RAE is responsible for ensuring the speaker program is conducted in compliance with this Standard. If a speaker fails to follow these rules, the RAE shall report the failure to his or her manager. The manager and the RAE should work with speakers to correct occasional lapses. If a speaker repeatedly fails to follow Amgen s Rules Governing Speakers, the RAE and the manager must: Stop using the speaker immediately. Inform the brand team that the speaker should be removed from the Speaker Bureau. Orion: For all promotional speaker programs, ensure that all attendees are captured.

15 Marketing Standards Advisory Boards An Advisory Board is a small group of experts convened to advise Amgen on research, commercial and/or product development strategy issues. Advisory Boards shall be conducted solely for the purpose of obtaining necessary medical, scientific or commercial advice. Advisory Boards may not be conducted for the purpose of promoting Amgen s products or pipeline or for providing education or training to advisors. Advisory boards may not be conducted by members of the sales organization. Advisors must be selected solely for their expertise and ability to provide meaningful advice on the topic(s) identified. Advisors may not be selected on the basis of their prescribing patterns, or their potential to generate future business. Advisors shall be paid Fair Market Value for their participation in an Advisory Board. For commercial advisory boards, Marketing, with the assistance of Amgen Clinical Development and Medical Affairs, will be responsible for the selection of Advisors. Sales staff may not participate in any process for selecting Advisors. The number of Amgen attendees shall be limited to the Amgen personnel necessary to the conduct of the meeting. In general, attendance by Marketing should be limited to the RAE and others who have clearly defined roles. Members of the Sales Department should not attend unless their attendance has been approved in connection with the approval for the concept of the meeting. Advertising, Exhibit Space, Joint Marketing and Other Communication Arrangements with Customers This Standard covers arrangements where Amgen purchases the right to promote its products at a Customer-sponsored event. Amgen may only enter into a communication arrangement with a Customer for a legitimate Amgen need to increase awareness of its current or prospective products. Healthcare professionals and other Customers selected for such arrangements must be well qualified, in terms of education and experience, and, if applicable, available facilities. Under no circumstances may a payment be offered or provided with the intent of, directly or indirectly, influencing or encouraging the recipient to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend formulary placement of any Amgen product. Marketing Standards

16 Arrangements may not be offered in connection with discussions, negotiations, or decisions involving product pricing or purchasing, or formulary decisions. Sales personnel will not generally arrange for these events, but they may be asked to participate in a promotional capacity. When requested to participate in these events, sales personnel should follow all instructions from headquarters. Any promotional items to be given away at Customer-sponsored events must comply with the Amgen Standard for Gifts to Healthcare Professionals. Discounts Amgen will only offer those discounts, rebates and GPO Administrative Fees that comply with the requirements of all applicable federal and state laws, including but not limited to the federal anti-kickback statute. These arrangements must also comply with applicable antitrust laws. All discounting arrangements must be documented in advance in an agreement that is approved by the Law Department. Amgen will not tolerate any business transaction or activity that violates the letter or spirit of the antitrust and competition laws of any country in which Amgen conducts business. Headquarters-based staff will work with the Law Department to develop product purchase agreements that meet the requirements of this standard. Sales personnel may offer product purchase contracts if authorized to do so by headquarters. Sales personnel may not negotiate or otherwise alter the terms of these agreements. Service Agreements Sometimes Amgen has a need to purchase services from healthcare professionals and other Customers. When Amgen has such a need, it must enter into a service agreement that meets the requirements of the Service Agreement Standard. Service agreements with Customers must meet a legitimate Amgen business need. Service providers must be well qualified, in terms of education and experience, and, if applicable, available facilities. Compensation may not exceed the fair market value of services provided. Under no circumstances may a service agreement be offered or provided with the intent of, directly or indirectly, influencing or encouraging the recipient to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend formulary placement of any Amgen product. Service agreements may not be offered in connection with discussions, negotiations, or decisions involving product pricing or purchasing, or formulary decisions.

17 Sales personnel should not enter into service agreements with Customers. Sales personnel who receive a Customer request to provide services to Amgen should refer the Customer to the appropriate Director of Marketing. The Director of Marketing will work with the Law Department and the Compliance Officer as necessary to determine whether Amgen has a need to purchase the services. Speaker Bureaus Promotional speaker programs play an important role in the marketing of Amgen products. Healthcare professionals who speak on behalf of Amgen have the ability to engage an audience of their peers in a more meaningful dialogue than may be possible through most other promotional methods. This, in turn, leads to Customers having a better understanding of the appropriate use of Amgen products. When healthcare professionals speak on behalf of Amgen, they are considered agents of Amgen. They must represent the company well, and their presentations must comply with the Food and Drug Administration (FDA) regulations concerning product promotion. In addition, Amgen s arrangements with its speakers will comply with the PhRMA Code, as well as the principles set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. This Standard is intended to ensure that Amgen s dealings with external speakers, as well as the services they perform on behalf of the company, will meet these requirements. The Marketing Department will follow the Speaker Bureau Standard in conducting and managing Amgen Speaker Bureaus. Sales personnel shall consult the Speaker Program Standard when arranging speaker programs with members of an Amgen Speaker Bureau.

18 Amgen Inc. One Amgen Center Drive Thousand Oaks, CA Amgen Inc. All rights reserved. P50486/Rev