GlaxoSmithKline TITLE: Healthcare Support Services in GSK Estonia GSK ESTONIA STANDARD OPERATING PROCEDURE NUMBER: SOP/GSKEst/AD/048 EFFECTIVE VERSION: 01 DATE: 08.12.2014 SOP AUTHOR: Sander Sepp, Healthcare Support Services Manager Appendice(s): Appendix 1 Healthcare Support Services process flow Revised: Monika Isak, Quality Lead Supercedes: n/a Approval: Toomas Pruunsild, Medical Director Authorisation: Dan Millard, General Manager Page 1 of 6
History Date Version Short description 08.12.2014 01 Initial version Table of Contents 1. Purpose 2. Scope 3. Roles and Responsibilities 4. Definitions 5. Alignment 6. Procedure 7. References Appendix 1 Healthcare Support Services process flow Page 2 of 6
1. Purpose The purpose of this procedure is to define the approval process and governance structure for GlaxoSmithKline Eesti OÜ (hereinafter GSK Estonia) Healthcare Support Services. A Healthcare Support Service (HCSS) is any service which GSK provides, directly or indirectly, to Healthcare Organisations and/or patients and that has a defined purpose to achieve better health outcomes for patients, encance patient care or benefit healthcare. 2. Scope This Standard Operating Procedure (SOP) applies to all staff of GlaxoSmithKline Estonia who are involved in the set-up and management of HCSS. This SOP also applies to third parties where they perform all or part of a HCSS. 3. Roles and Responsibilities 3.1 The Business Owner of the HCSS is responsible for consulting local legal partner and/or GSK Legal prior to initiating new type of HCSS must inform NSC about all HCSS s in e-mail obtains approval for HCSS s from Management Team ensures final approval is obtained from the Medical Director via Zinc takes on the responsibility for all Initiator actions as per the ChimAERa process (SOP-GSKF- 400) provides HCSS status updates at least quarterly at Medical Governance Committee meetings and presents final report within a month after end of HCSS maintains proper documentation throughout the lifecycle of any HCSS and enures record retention in accordance with SOP/GSKEst/MD/022. 3.2 The Medical Director is responsible for reviewing and approving all HCSS s via Zinc, including all related materials. 3.3 The NSC is responsible for ensuring that adequate measures are taken for Adverse Event reporting training for recipients and 3rd party service providers of the HCSS routing and reconciliation of Adverse Event reports collected as part of the HCSS ensuring that any adverse event reports generated by the HCSS are tracked and maintained for efficient reporting in accordance with regulatory requests and in compliance with POL-GSK-400 and SOP/GSKEst/AD/029. 3.5 The Management team is responsible for endorsing all HCSS proposals before final approval is given by the Medical Director. 3.6 The Medical Governance Committee is responsible for the ongoing governance of all active HCSS s including making decisions on who is eligible to receive the service. This ongoing review and any decisions is recorded in the Medical Governance Committee minutes stored electronically in P:\Medical\MEDICAL AFFAIRS\Medical Affairs iganädalane koosolek. 3.7 Sales representatives may introduce, but must not provide, deliver or demonstrate healthcare support services. 4. Definitions Business HCSS Manager or any other member of GSK Estonia Medical Affairs team Owner ChimAERa GSK corporate program for ensuring compliance with SOP-SGKF-400 Page 3 of 6
HCSS NSC SOP Healthcare Support Service Any service which GSK provides, directly or indirectly, to Healthcare Organisations and/or patients and that has a defined purpose to achieve better health outcomes for patients, encance patient care or benefit healthcare. It can bear company branding but must not bear the name of any medicine or product. The involvement of GSK in the provision of HCSS must be made clear to all recipients of the service. HCSS must not be designed to promote any medicines and must be kept clearly seperate from the activities for the promotion of medicines. Patient confidentiality must be maintained at all times. The provision of HCSS must not constitute an inducement to recommend, prescribe, purchase, supply, selle or administer specific medicines or for the purpose of sales representative or other GSK representative gaining access to a medical facility. HCSS must not be provided to individual Healthcare practitioners for their personal benefit or their own financial advantage. HCSSs must not be provided to underwrite a commercial business or generate income to for a Healthcare practitioner, practice, administrative staff or other Helthcare Organisation. GSK must not engage, nor provide funding for the engagement of Healthcare practitioners to perform an activity that includes recommending or prescribing a particular medicine Named Safety Contact Standard Operating Procedure 5. Alignment This procedure is written in accordance with the requirements of the following external legislation and internal GSK Global Policies: Estonian Medicinal Products Act Chapter 4. Advertising Medicinal Products and Inducement Designed to Promote Sales and Prescription EFPIA Code on Disclosure of Transfers of Value From Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations STD-GSK-401 GSK Code of Practice for Promotion and Customer Interactions POL-GSK-400 Management of Human Safety Information for GSK Products 6. Procedure See Appendix 1 for the summary process flow. 6.1 A team (if applicable) is created and a Business Owner assigned for the HCSS. For the purposes of this SOP, the Business Owner takes on the role of 'Initiator' as per SOP-GSKF-400. Business Owners for HCSSs are limited to HCSS Manager and other members of Medical Affairs team. 6.2 If new type of HCSS is being developed local legal partner and/or GSK Legal need to be consulted to ensure compliance with local laws and GSK requirements. 6.3 The HCSS Business Owner develops the HCSS and brings a proposal to the GSK Estonia Management team. Management team can either approve the HCSS, approve it conditionally after requested amendments are made, ask to amend and resubmit or reject the HCSS proposal. 6.4 Business owner submits the HCSS to Medical Director for final approval via Zinc. 6.5 Prior to HCSS initiation NSC has to be informed by e-mail. New HCSSs are introduced to Medical Governance Committee at their regular meetings. Making HCSS governance decisions (i.e. who is eligible to receive the service) is responsibility of the Medical Governance Committee. Business Owner provides at least quarterly updates to the Medical Governance Committee and a final report Page 4 of 6
within a month after the closure of HCSS to Medical Governance Committee and if requested to the Management team. 6.6 Throughout the lifetime of the HCSS Business Owner is responsible for maintaining proper documentation and ensuring record retention in line with project ChimAERa (SOP-SGKF-400 'Project Execution' and 'Reconcile, Record & Store') and SOP/GSKEst/MD/022 7. References SOP/GSKEst/MD/022 Archiving of Clinical Trial Documentation and Other Medical Department Records within GSK Estonia Medical Department SOP-SGKF-400 Procedure for identification and tracking of Patient Support Programmes (PSP), Market Research (MR) and Interactive Digital Media (IDM) activities that may generate human safety information for GSK Products SOP/GSKEst/AD/029 Standard Operating Company Procedure for Pharmacovigilance, Materiovigilance, cosmetovigilance, nutrivigilance and Human Safety Related Activities Page 5 of 6
Appendix 1 - Healthcare Support Services process flow Page 6 of 6