3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION

Transcription

1 1. PURPOSE UCB periodically engages physicians and other healthcare professionals ( HCPs ), patients or caregivers, and others in the healthcare field to advise the Company on legitimate business objectives. This procedure governs UCB s relationships with such Advisors in the Advisory Board context. 2. SCOPE The scope of this procedure applies to all types of Advisory Boards that are conducted by UCB, Inc. ( UCB ), including Advisory Boards initiated by or at the direction of UCB, Inc., even if performed by another UCB entity, e.g., UCB Biosciences, Inc. This procedure applies regardless of 1) the topic or focuses of the Advisory Board, 2) the individual or function initiating the Advisory Board, and 3) the type (e.g., specialty) of Advisors engaged. This procedure does not cover 1) the engagement of consultants on an individual basis outside of an Advisory Board context, 2) investigator meetings, or 3) Market Research (as specifically defined below). Such activities are covered under separate policies and procedures. 3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION There are no significant hazards or special instructions relating to the arrangements described in the process that need to be detailed in this SOP. 4. RESPONSIBILITIES UCB Compliance Committee Oversees this procedure and conflict resolution. Compliance Department Monitors Advisory Board activities to ensure compliance with this procedure. UCB Advisory Board Review Committee (ABRC) Reviews and approves 1) the Advisory Board portion of the Semi-annual Activity Budget Plan for HCPs/HCIs (and any exceptions or changes thereto) and 2) all Advisory Board proposals and supporting materials. Page 1 of 14

2 Functional Owner Head Provides consolidated Functional Area input to the development of the Semi-Annual Activity Budget Plan for HCPs/HCIs and provides updates to the Plan as needed. Functional Owner Executes Advisory Boards in compliance with this procedure, the Semi-Annual Activity Budget Plan for HCPs/HCIs Plan requirements, and the decisions of the ABRC. Responsibilities include, but are not limited to: Developing the Advisory Board Review and Approval Form (RAF) and associated documents for submission in the electronic review system for review by the ABRC Assurance of contract execution Execution of the Advisory Board per approved Plan Assurance of use of outputs and related documentation Capture of related expenses and transfers of value, reporting of expenses and transfer of value information. Managing and ensuring all documentation is provided in the electronic review system Review Services Manages the Advisory Board Review process. Schedules and chairs ABRC meetings. 5. PROCEDURE 5.1 Compliance with HCP Consulting Policies and Procedures In addition to following the procedures set forth in this SOP, Advisory Boards must also comply with all UCB policies and procedures governing the engagement of HCPs (e.g., U.S. Compliance - Engaging Healthcare Professionals (HCPs), Healthcare Institutions (HCIs) and Patients/Caregivers in Fee For Service Arrangements; Contracts with Healthcare Professionals and Consultants for Cross-border Activities; U.S. Meals and Educational Materials for Healthcare Professionals and Customers; and U.S. Fair Market Value Policy). Page 2 of 14

3 5.2 Semi-Annual Activity Budget Plan for HCPs/HCIs The Functional Owner Head or designee must submit a Semi-Annual Activity Budget Plan for HCPs/HCIs detailing the Advisory Board plan for the following semi-annual period. The plan should include at a minimum: Business need for the Advisory Board - A review of the Advisory Boards conducted during the preceding semi-annual period. Business needs for each of the respective Advisory Board meetings planned for the next semi-annual period, with assessment of potential duplicative events. Estimated numbers of Advisory Board meetings to occur in next semi-annual period. Estimated budgeted amounts to be spent on Advisory Board meetings. Exceptions or changes to the plan must be submitted to the ABRC with an explanation for why the change or exception is needed and was not anticipated when creating the Semi- Annual Activity Budget Plan for HCPs/HCIs. 5.3 Advisory Board Meeting Proposal and Review Submission of the Advisory Board Review and Approval Form (RAF) To help ensure that Advisory Boards comply with applicable laws and policies, the Functional Owner of an Advisory Board is responsible for completing the Advisory Board Review and Approval Form (RAF) and uploading in the designated electronic platform for review and approval (see Associated Documents and References section). The Advisory Board must be identified as a Commercial or Scientific Advisory Board, based on the objectives and intended outcomes of the Advisory Board. When outcomes are used to guide medical and scientific business needs, it will be identified as a Scientific Advisory Board. When outcomes are used to guide business needs of the Commercial organization, it will be identified as a Commercial Advisory Board. The review-and-approval process of the RAF is the same for commercial and scientific advisory boards. The RAF submission should include specific details about the proposed Advisory Board meeting, such as: Needs assessment Numbers and qualifications of the HCPs, HCIs, patients/caregivers or other experts to be engaged, and proposed fees Agenda A description of the proposed work to be done and type of work to be generated Proposed UCB attendees, including role and justification for attendance Venue for event and rationale for selection Other information that the ABRC may request from time to time Page 3 of 14

4 The RAF submission should include supporting documents if they apply: Advisory Board invitation - if changes were made to the ABRC approved template Contract - if changes were made to the UCB Legal-approved contract template for US HCP Consultants If there are multiple Advisory Boards on the same or similar topics, an explicit, written explanation of the need for multiple programs must be submitted to the ABRC. An Advisory Board Series may be submitted on the same RAF. Upon request from the ABRC, additional information may be required. Additional, required information must be approved before executing event Review by ABRC of the Advisory Board RAF The ABRC reviews all Advisory Board RAFs. The documentation requirements and criteria for review and approval of Advisory Boards include, but are not limited to, the following: Advisory Boards will be approved only if they are consistent with this policy. Advisory Board proposals and all required ABRC review materials must be reviewed and approved by a representative of each of the three functional areas sitting on the committee. Approval/review is signified by signature or electronic approval from a representative of each member of the ABRC, or a delegate. Review Services will notify the requestor of the decision or request additional information. All documentation of the review for an Advisory Board will be archived in the electronic review platform. The ABRC will review the documents in the electronic system and apply the following stamps: AB: Approved As Is AB: Approved with Changes AB: Re-review AB: Rejected In the scheduled meeting for review of all RAFs, the Review Services chair will apply one of the following stamps to reflect the consensus of the ABRC for the proposed event: AB: MO Approved As Is AB: MO Approved with Changes AB: MO Re-review AB: MO Rejected Page 4 of 14

5 Functional Owner will have access to a feedback document in the electronic system stating status of the review. The Functional Owner of the Advisory Board should submit the Advisory Board RAF 16 weeks (and no less than 12 weeks) before the proposed activity, and 7-10 days before the scheduled ABRC meeting Activity Notification Form (ANF) Submission After approval of the Advisory Board by the ABRC, the Functional Owner must submit an Activity Notification Form (ANF) for review and approval following procedures set forth in sop , Contracts with Healthcare Professionals and Consultants for Crossborder Activities and sop ; U.S. Compliance - Engaging Healthcare Professionals (HCPs), Healthcare Institutions (HCIs) and Patients/Caregivers in Fee For Service Arrangements. Evidence of the ABRC approval for the Advisory Board should accompany the ANF submission. On submission of the ANF in the electronic system, UCB will verify that proposed HCPs do not appear on the FDA, OIG, or SAM federal healthcare programs exclusion or debarment lists. Receipt of contractual documentation from the HCP or HCI does not constitute verification. 5.4 Advisor Selection Advisors must be selected based on their scientific or medical qualifications and/or other relevant expertise or experience that is appropriate to the legitimate need for the Advisory Board. The number of Advisors must be reasonably necessary to achieve the legitimate purpose of the meeting, conducive to meaningful exchange, and approved through the ABRC. Advisors must be selected and approved based on their expertise and experience, without taking into account prescribing or purchasing history or potential. Prescribing history may be considered only where there is a particular and bona fide need for consultation with an HCP who has extensive experience with a particular UCB therapeutic category. The Functional Owner will propose Advisors in consultation with other functional areas as appropriate. For approval, proposed Advisors must be included on the RAF at time of submission. Should there be a need to propose additional Advisors after RAF approval, Advisors must meet criteria for selection, be approved by the ABRC, and have an approved ANF, before receiving an invitation to participate as an Advisor. Sales personnel shall generally not be involved in the selection or retention of Advisors for any UCB Scientific or Commercial Advisory Boards, although they may be requested to provide suggestions for potential Advisors with specific expertise based on established criteria approved by the ABRC. Page 5 of 14

6 5.5 Invitations A UCB legal-approved invitation template should be used to invite potential Advisors. When an alternate invitation is created, then the invitation must be submitted and approved by the ABRC. Invitations to Advisory Board activities will be sent directly to Advisors by the Functional Owner or appropriate delegate. Appointed vendors may serve as the inviting party. Invitations to any Advisory Board may not be distributed by Field personnel. Invitations may be distributed only after approval of the RAF and ANF. 5.6 Advisory Board Consulting Agreement The Functional Owner must ensure that a Legal-approved Advisory Board consulting agreement is executed with each Advisor before scheduling travel, and before the provision of monetary compensation or benefits to the Advisor. The contracting process may begin immediately following the fully documented approval of the RAF and ANF and before the Advisor incurs any costs or engages in any Advisory Board service. It is strongly encouraged that Functional Owners begin the planning and contracting process early to allow sufficient time for contract negotiation to occur. If the Advisor makes any changes to the Legal-approved template, such changes must be reviewed and approved by the Legal reviewer before execution of the agreement. Functional Owners may not engage in contracting negotiations with potential Advisors, but may serve to liaise between the Legal reviewer and the Advisor. Fully executed contracts must be uploaded in the electronic platform for ANF review and approval. A fully executed contract shall contain the Advisors signature in addition to two (2) signatures from UCB Personnel. Refer to procedure U.S. Compliance - Engaging Healthcare Professionals (HCPs), Healthcare Institutions (HCIs) and Patients/Caregivers in Fee for Service Arrangements regarding the HCP consulting agreement. 5.7 Review of Meeting Materials Meeting materials should generally be provided for review at least two weeks in advance of the date needed. The Functional Owner must ensure advance Legal and Medical review and approval of the materials (e.g., slide decks, associated meeting materials used with Advisors).Once materials are approved by the Legal and Medical reviewers, the content may undergo minor editing, provided the substantive content remains the same. Any substantive changes to the materials after review must be approved by the Legal and Medical reviewers. After event a copy of all final meeting materials presented and/or used at the Advisory Board must be uploaded to the electronic platform of the appropriate Advisory Board. Page 6 of 14

7 5.8 Advisory Board Meeting Requirements Advisory Board Meeting Interaction The interaction between UCB and Advisors will primarily consist of Advisors providing advice or information to UCB. UCB will only provide information to Advisors that is necessary for the Advisors to perform their consulting services properly. The significant majority of the working time of an Advisory Board is to be spent receiving feedback from HCPs (versus, for example, presenting to Advisors). This should be reflected appropriately in the proposed Advisory Board meeting agenda. If the Advisory Board meeting involves disclosure by UCB of scientific data that relates to unapproved products or indications (e.g., off-label information), such disclosure must be determined necessary and be limited to the scope required to enable the Advisory Board participant to perform the services. Any disclosure of such scientific data must be delivered in a scientific, non-promotional, factual, and fair-balanced manner. The Advisors should be informed that the product or indication being discussed is unapproved and is not endorsed or recommended by UCB. If the information provided to Advisors is not publicly available, Advisors should be required to sign a confidentiality agreement before attending the Advisory Board meeting. Typically, the confidentiality provisions of the Advisory Board consulting agreement will suffice, although Advisors should be reminded of the confidentiality obligations set forth in the agreement. If the topic is particularly sensitive, this point should be discussed with the Legal reviewer to assess whether additional confidentiality protections are needed. In addition, any confidential materials provided to Advisors during the Advisory Board meeting (e.g., hard copies of non-public slides) must be returned at the end of the meeting. Payment should not be made to Advisors who have not returned these materials Advisory Board Meeting Attendance by UCB Employees Functional areas may develop their own recommendations for Advisory Board meeting attendance rules subject to the approval of the ABRC. Field sales representatives should not attend or observe working or non-working portions of Advisory Board meetings. Regarding other UCB Personnel, attendees and their proposed role (e.g., passive or active participant) must be vetted and approved by the ABRC as part of the review-and-approval process. Legal or Compliance personnel may attend in an observational capacity without prior approval. UCB Personnel attendance/participation must be based upon a legitimate business need to participate and be appropriate to the purpose and focus of the Advisory Board meeting. The ratio of UCB attendees to Advisors and the role of each UCB attendee must be clearly documented in the RAF. UCB attendees in observer roles may not actively participate in any portion of the meeting. Page 7 of 14

8 5.8.3 Compensation, Travel Reimbursement, Venue, and Entertainment a) Compensation All compensation to Advisors will be reasonable and represent FMV compensation for the services provided, as reflected in the payment ranges established periodically by Compliance. Please refer to the U.S. Fair Market Value Policy for more information regarding how to comply with this section. All compensation must reflect appropriate FMV for each healthcare provider s expertise and specialty. Advisors must attend all mandatory portions of the Advisory Board meeting in order to receive full compensation. On a case by case basis, an advisor may receive approval for earlier departure or a modified schedule with prior approval from Compliance. Compensation should be adjusted to reflect hours contributed to the meeting. Modifications must be approved by Compliance in advance of the meeting and be detailed within the executed contract. Payments to Advisors and associated expenses will be disclosed as required by federal and state law. No compensation will be given without documentation that Advisors participated in the Advisory Board. b) Travel Reimbursement, Venue and Entertainment UCB may pay for the reasonable travel, lodging, meals and other reasonable expenses of speakers attending a UCB advisory board session. Advisory Board meetings must be held in locations that are conducive to the business purpose of the meeting. All Advisory Board Meetings must be structured to comply with the following documents: U.S. Meals and Educational Materials for Healthcare Professionals and Customers and North America Business Travel and Entertainment Procedure. For international advisory boards, local standards will apply for travel and related expenses. Advisory Board meetings should not be held at resort locations Advisory Board Meeting Outputs The Functional Owner is responsible for ensuring that outputs from the Advisory Board are captured and used appropriately by internal stakeholders. The outputs should be treated as confidential and should be distributed only to the appropriate internal stakeholders (e.g., Senior Management, key individuals in the Medical Affairs, Marketing, Managed Markets, Legal, and Compliance Departments). The outputs must not be shared with sales representatives. The internally shared output must include, at a minimum, the following information: Meeting objectives Meeting venue and date Advisor names, affiliations, specialties and roles (e.g., Chair, Moderator, Advisor) Names and titles of all UCB, Inc. employees who attended and their roles (e.g., Moderator, Presenter) Page 8 of 14

9 Topics discussed Questions asked and answered Relevant information obtained or learned from the meeting Evaluations of the meeting and participants Description of how the information will be used by UCB 5.9 Documentation, Record Maintenance and Retention All records, information and deliverables related to this procedure will be retained for a period of six (6) years or longer if required by applicable law, contract or regulatory requirement. Records related to this procedure will be maintained by the activity owner unless otherwise specifically directed by the Legal Department. For GxP records retention refer to Corporate SOP Retention Periods for GxP Records. Functional Owners will ensure that all Advisory Board documentation is received/created, completed and stored in a central repository or repositories. Such documentation includes, but is not limited to, the ABRC proposals, presentation materials, contracts, Advisory Board Outputs and documentation that the outputs were captured and used internally Compliance Monitoring The Compliance Department shall implement monitoring activities in accordance with the Compliance Monitoring Program to assess compliance with this SOP. Such monitoring activities shall be revised from time to time as determined by the Compliance Department and will include live monitoring of Advisory Boards as well as reviews of associated documents. UCB employees and Advisors are required to cooperate fully with the Compliance department in all monitoring and auditing activities Reporting Violations Employees and related individuals, including contractors, subcontractors, agents, and other persons who are involved in UCB s Advisory Boards are required to report suspected violations of this policy, or any laws or regulations, to the next level of management and/or UCB s Compliance or Legal Departments. Concerns and suspected or actual violations can also be reported anonymously and confidentially via the Compliance Hotline/Helpline phone number ( ). Page 9 of 14

10 6. ABBREVIATIONS AND DEFINITIONS Abbreviations and definitions used in this document are in accordance with the UCB Glossary. 6.1 Abbreviations ABRC Advisory Board Review Committee ANF HCI HCP SOW RAF 6.2 Definitions Advisors Advisory Board Review Committee (ABRC) Caregiver Commercial Advisory Board Electronic Review Platform Activity Notification Form Healthcare Institution Healthcare Professional Statement of Work Review and Approval Form Qualified individuals (e.g., HCPs, patients, caregivers, payers, and others in the health care field) specifically selected for their particular expertise and/or experience, as appropriate, to provide input or advice to UCB on a particular topic(s) in an Advisory Board context. The UCB Advisory Board Review Committee (ABRC) is, composed of members from the Compliance Department, Legal Department and Medical Affairs. Other functional area representatives may serve as ad hoc members or information resources as needed. A non-hcp who provides direct patient care (e.g. family member, friend, fee-for service caretaker). A facilitated meeting with a limited number of Advisors for the purpose of providing advice, guidance, information, and/or feedback to UCB, to meet legitimate business needs of the Commercial business function when such information or advice is not reasonably available internally or through other readily available means. Digital platform used for the review, approval and archiving of RAFs, ANFs, and other selected materials. Page 10 of 14

11 Fair Market Value Functional Head Functional Owner Healthcare Institution (HCI) Healthcare Professional (HCP) Market Research Needs Assessment The price, expressed in terms of cash equivalents, at which property would change hands between a hypothetical willing and able buyer and a hypothetical willing and able seller, acting at arm s length in an open and unrestricted market, whether neither is under compulsion to buy or sell and when both have reasonable knowledge of the relevant facts. The Vice-President of the function organizing the Advisory Board. For the purpose of this procedure, Functional Owners are the internal UCB initiators of a given Advisory Board (e.g., Medical, Marketing). Any legal entity that is a healthcare, medical or scientific association or organization (irrespective of the legal or organizational form) through which one or more HCPs provide or receive services. Any person that is a member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may directly or indirectly prescribe, purchase, supply, recommend, administer or arrange for the use of a medicinal product. The systematic and objective identification, collection, analysis, and dissemination of information for the purposes of assisting management in decision making related to the identification and solution of problems and opportunities in the marketplace. Market research encompasses primary data, secondary data, qualitative information, and quantitative data. Market research is distinct from Advisory Boards, which are generally conducted by UCB in person, using paid consultants and not on an anonymous basis. A process by which UCB determines the appropriate business rationale for an individual advisory board proposal. The needs assessment shall identify the commercial or scientific need for the information to be provided by the advisory board and provide specific details about the arrangement. (e.g. numbers and qualifications of the proposed advisors to be engaged, description of feedback and deliverables to be obtained, and how feedback will be used for scientific or commercial purposes.) Page 11 of 14

12 Output Patient Documentation of deliverables, results (e.g., executive summary) and/or other feedback obtained from Advisory Board. A person receiving or registered to receive medical treatment. Review Services Scientific Advisory Board Semi-Annual Activity Budget Plan for HCPs/HCIs UCB Personnel 7. RELATED DOCUMENTS UCB Department responsible for management of Advisory Board Review Process. A facilitated meeting with a limited number of Advisors for the purpose of providing advice, guidance, information, and/or feedback to UCB, to meet legitimate business needs of the medical and/or scientific functions, when such information or advice is not reasonably available internally or through other readily available means. A plan that identifies the business need for and the estimated numbers of various fee-for-service engagements and activities with HCPs/HCIs to occur during the following semi-annual period. These plans also identify the budgeted amounts to be spent on fee-for-service-related activities. For the purpose of this policy, UCB Personnel refers to UCB employees and other UCB agents, subcontractors or representatives who may be involved in the planning and conduct of Advisory Boards hereunder (including, for instance, vendors organizing Advisory Boards on UCB s behalf). 7.1 Associated Documents sop-af Advisory Board Review and Approval Form 7.2 References gov , U.S. Meals and Educational Materials for Healthcare Professionals and Customers gov , U.S. Fair Market Value sop , Contracts with Healthcare Professionals and Patients sop , Global Archive Procedure for Critical Records sop , Reporting of Non-Compliant Activity and Seeking Policy Guidance Page 12 of 14

13 sop , Investigating Reports of Non-compliant Activities and Employee Concerns sop , North America Business Travel and Entertainment Procedure sop , U.S. Compliance - Engaging Healthcare Professionals (HCPs), Healthcare Institutions (HCIs) and Patients/Caregivers in Fee For Service Arrangements April 2003 OIG Compliance Guidance to the Pharmaceutical Industry PhRMA Code on Interactions with Health Care Professionals 1 American Society of Appraisers Business Valuation Standards Glossary ; Approved June 2005 Copyright 2005, American Society of Appraisers. 8. LIST OF APPENDICES N/A 9. SOP HISTORY Supersedes SOP(s) (SOP number and version) UCBCOM-SOP sop v1.0 sop v2.0 sop v3.0 sop v4.0 sop v5.0 sop v6.0 sop v7.0 Migration into MIKADO CD Periodic revision Reason for change Corrected form number and updated formatting of SOP Updated due to changing business requirements Minor changes made after document completed Approval workflow in MIKADO CD Adjusted required timelines. Added requirements for documentation to be submitted for review. Added specificity to location for document storage. Minor changes made to reflect designation of the Advisory Board as a Commercial or Medical based on intended use of outcomes. v7.0 never made effective. Additional updates made to reflect submission of material in the new electronic review platform. Page 13 of 14

14 DOCUMENT APPROVAL ELECTRONIC SIGNATURES Signed by Meaning of Signature Server Date (dd-mmm-yyyy HH:mm:ss TZ) JEFFORDS SCHENCK Jan Author Approval 19-Nov :17:06 CET GRAVES Mark Compliance Approval 20-Nov :26:05 CET SANFORD Kristi Subject Matter Expert Approval 20-Nov :49:48 CET DAVIS Clive Management Approval 21-Nov :18:44 CET TREVETT Jennifer Legal Approval 21-Nov :26:27 CET DHALLA Anisa Compliance Approval 01-Dec :03:52 CET Page 14 of 14