Standard operating procedure

Transcription

1 Standard operating procedure Title: onducting checks for conflicts of interest of Agency employees assigned duties relating to medicinal products for human or veterinary use Status: PULI Document no.: SOP/EMA/0101 Lead author Approver Effective date: 08-JUL-13 Name: John S. Forte Name: Guido Rasi Review date: 08-JUL-16 Signature: On file Signature: On file Supersedes: SOP/EMA/0101 (15-MAY-12) Date: 28-JUN-13 Date: 04-JUL-13 TrackWise record no.: Purpose To describe the procedure for checking for conflicts of interest of Agency employees engaged in roles relating to medicinal products. (The roles are listed in the annex to this SOP.) The checks described in this SOP are not required for: Scientific administrators and assistants performing secretariat duties in relation to scientific groups (including committees, working parties/groups, expert groups, drafting groups, scientific advisory groups and other associated groups); Administrators and assistants engaged in support to product-related procedures listed in the annex and in product-related administrative procedures. 2. Scope This SOP applies to the Human Medicines Development and Evaluation Unit, Patient Health Protection Unit, Veterinary Medicines and Product Data Management Unit, and to the ommunications and Legal Service Sectors in Directorate. 3. Responsibilities It is the responsibility of the Executive Director and each Head of Unit, Sector and Section to ensure that this procedure is adhered to within Directorate or their own unit, sector or section. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column of Section 9. 7 Westferry ircus anary Wharf London E14 4H United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 4. hanges since last revision Revision of step 11 to add references to mandatory use of electronic forms in DoI Database, where applicable. Revision of step 12 to add reference to request for exception form. Revision of section 10 to add reference to electronic records in database. 5. Documents needed for this SOP Annex: Roles and duties for which checks for conflicts of interest are to be conducted in relation to medicinal products for human or veterinary use Template 1: Decision of check for conflicts of interest for category A role (available in DoI Database or at X:\Templates\Others\oI check for staff) Template 2: Decision of check for conflicts of interest for category role (available in DoI Database or at X:\Templates\Others\oI check for staff) Template 3: Decision of check for conflicts of interest for category role (available in DoI Database or at X:\Templates\Others\oI check for staff) Staff declarations of interest (available in DoI Database - link at 6. Related documents Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency (available at Decision on rules concerning the handling of declared interests of national experts on secondment, visiting experts, trainees and interims of the European Medicines Agency (available at: Declaration of interests database user guide (for managers) (available at SOP/EMA/0044 on requesting and recording exceptions 7. Definitions ATMP: oi: D-M: D-LS-PHL: DoI: DREAM: Employee: Advanced therapy medicinal product onflict(s) of interest ommunications Sector Pharmaceutical Law Section Declaration of interests Document records electronic archive management Temporary agent, contract agent, national expert on secondment, visiting expert, interim or trainee (contractors are excluded from this definition) SOP/H/0101, 08-JUL-13 Page 2/11

3 H-HM-OM: H-HM-PDM: H-HM-SA: H-HM-SME: H-HM-SSP: H-QM: H-SE: H-Unit: Manager: MRL: MUMS: P-I-N: P-I-MQ: P-MI-PIN: P-MI-PIQ: P-PV-N: P-PV-DM: P-PV-RM: P-PV-SDA: P-R-P: P-R-RA: P-R-SS: P-Unit: Orphan Medicines Section Paediatric Medicines Section Scientific Advice Section Small and Medium-sized Enterprises (SME) Office Scientific Support and Projects Section Quality of Medicines Sector Safety and Efficacy of Medicines Sector Human Medicines Development and Evaluation Unit Executive Director, Senior Medical Officer, Head of Unit, Head of Sector or Section Head, including deputy managers and acting managers Maximum residue limit Minor uses and minor species linical and Non-clinical ompliance Section Manufacturing and Quality ompliance Section Public Information and Stakeholder Networking Section Product Information Quality Section oordination and Networking Section Data ollection and Management Section Risk Management Section Signal Detection and Data Analysis Section ommunity Procedures Section Regulatory Affairs Section Scientific ommittee Support Section Patient Health Protection Unit : Executive Director, Head of Unit, Head of Sector or Section Head including deputy managers and acting managers charged with preparation of the performance evaluation report of the manager or employee Scientific service: Scientific opinion pursuant to Article 58 of Regulation (E) No 726/2004, compassionate use opinion, plasma master file, vaccine antigen master file, consultation on ancillary substances incorporated in medical devices and ATMP certification procedures in relation to medicines for human use V-Unit: V-VM-APH: V-VM-DEM: V-VM-ROS: Veterinary Medicines and Product Data Management Unit Animal and Public Health Section Development and Evaluation of Veterinary Medicines Section Veterinary Regulatory and Organisational Support Section SOP/H/0101, 08-JUL-13 Page 3/11

4 8. Process map(s)/ flow chart(s) Start 1 Identify suitable employee for role or employee engaged in role 2 heck risk level in DoI database 3 Assigned to level 1? No 4 Assess declared interest(s) for potential conflict with respect to product or role 10 Exclude employee from selection; file deviation decision, if applicable ategory 5 Are restrictions applicable to declared interest(s)? Yes 6 Is permission for deviation from rules to be requested? No 9 ategory of role? Yes No Yes No 11 Document decision of check for oi. Ensure employee signs undertaking, if applicable 7 Request permission for deviation from rules (SOP/ EMA/0044) Yes 8 Has permission for exception been granted? ategory A or 12 If applicable, file decision and/or exception form in master file 13 If applicable, inform selected employee of assignment of product or proceed with nomination End SOP/H/0101, 08-JUL-13 Page 4/11

5 9. Procedure Notes hecks for oi in relation to category A and roles are conducted at least once a year when the annual DoIs of employees are assessed and a risk level is assigned by the reporting officer. hecks for oi for category roles are conducted whenever a medicinal product(s) is/are to be assigned to an employee (refer to annex for applicable roles and duties). The timing of the check may be linked, for example, to the appointment of a team leader/member or coordinator and in any case must always be conducted before the employee assumes responsibility for the product(s) and associated procedures/applications. When more than one product is being assigned to an employee, the check may be conducted for each product if individual products are being assigned or for each pharmaceutical company when several products are assigned in one go. A check in relation to any category of roles must always be conducted on another employee when a medicinal product(s), in the case of a category, or role(s), in the case of category A or, is/are assigned to that other employee. Documented checks are not required when assigning a back-up for short-term absence (e.g. missions, vacation leave, sick leave). When an employee s declared interests and/or risk level change, the check for oi must be repeated to take into account any new potential conflicts with respect to the assigned roles or medicinal products or any restrictions that no longer apply. When a Section Head is to undertake a role listed as category or in the annex the check for oi must be conducted independently by the Head of Sector or delegate. Step Action Responsibility 1. Identify a suitable employee to perform a specified role or an employee engaged in a specified role (refer to Annex). 2. heck employee s risk level as recorded in the DoI database (refer to managers user guide). If the risk level has not yet been determined on the basis of the most recent annual/updated valid DoI in the database, assess declaration and assign risk level in database (refer to managers user guide). 3. If the risk level is 2 (i.e. declared indirect interests) or 3 (i.e. declared direct interests), go to step 4. If the risk level is 1 (i.e. no declared direct or indirect interests), a check for potential oi is not required; go to step Assess whether interests declared by the identified employee in the most recent annual/updated valid DoI (available in the database) present a potential conflict: With respect to the medicinal product being assigned, for category roles. With respect to any medicinal product, for category A or roles. Take into account the criteria for the identification of risks and the applicable allowed and disallowed interests detailed in the SOP/H/0101, 08-JUL-13 Page 5/11

6 Step Action Responsibility Decisions on rules. 5. If restrictions apply to the declared interest(s), go to step 6. If no restrictions apply to the declared interest(s), go to step If permission to deviate from the Decisions on rules is to be requested, go to step 7. If no deviation from the Decisions on rules is to be requested, go to step 9. Note: Permission to deviate from the Decisions on rules may be requested if there are exceptional circumstances that preclude you from assigning a medicinal product or a role to another employee. 7. Request the Executive Director s permission to deviate from the Decisions on rules in order to assign a medicinal product or role to the employee (refer to SOP/EMA/0044). Provide a justification in the request for exception based on the criteria for the identification of risks detailed in the Decisions on rules. When applicable, consult the Head of Sector before referring the request form to the Head of Unit. 8. If permission for an exception is not granted by the Executive Director, go to step 9. If permission for an exception has been granted by the Executive Director, go to step If a category role is being assigned, go to step 10. If a category A or role is being assigned, go to step Exclude the employee from the selection for the specified medicinal product. If a deviation from the Decision on rules has been requested and denied, file request for exception form as specified in Section 10. Return to step Document decision of check for oi. Use Template 1 for a category A role, Template 2 for a category role or Template 3 for a category role, as applicable (see notes below; refer to managers user guide for instructions on completing an electronic form in the database). For a category A or role, select on the template: option 1, if no restrictions apply (i.e. if proceeding from step 5); option 2, if restrictions are applied (i.e. if proceeding from step 9); or SOP/H/0101, 08-JUL-13 Page 6/11

7 Step Action Responsibility option 3, if an exception has been granted (i.e. if proceeding from step 8). For a category role, select on the template: option 1, if no restrictions apply (i.e. if proceeding from step 5); or option 2, if an exception has been granted (i.e. if proceeding from step 8). If an exception has been granted, attach a scanned PDF file to the electronic form in the database (refer to managers user guide). Alternatively, attach a photocopy of the request for exception form to the decision, if an MS Word or customised template is being used (see notes below). In the case of category A and roles, ensure that the employee signs the manager s/employee s undertaking in Templates 1 and 3, respectively (electronically in the database when using an electronic form or alternatively on paper when using an MS Word or customised template). Notes: Templates 1, 2 or 3 must be completed electronically in the database by the reporting officer in order to ensure that a permanent auditable record is available. The versions in MS Word must only be used when the database cannot be accessed. However, a customised procedure-specific template may be used by reporting officers in H-HM-OM, H-HM-PDM and H-HM-SA as an alternative to template 2 provided that the same level of assurance of the check performed is given (i.e. all applicable details are recorded). ustomised templates are not available electronically in the database. The database generates automated messages to notify the reporting officer and/or the manager/employee when an electronic form is passed on from one user to another within the workflow. 12. If applicable, file decision on paper and/or original request for exception form in sector/section master file or forward to designated person in the sector/section responsible for filing of decisions, in line with sector/section internal practice. 13. For a category role, inform selected employee of assignment of product or proceed with nomination, as required. Note: When the electronic Template 2 is used an automated notification is sent by the database to the selected employee. SOP/H/0101, 08-JUL-13 Page 7/11

8 10. Records ompleted decision of check for oi forms are retained electronically in the database. Forms completed in MS Word and original request for exception forms are filed in the respective sector/section master file. Decision forms on paper may be filed electronically in the respective product folder (e.g. Presubmission folder) or a sector/section-specific folder in DREAM, if applicable. SOP/H/0101, 08-JUL-13 Page 8/11

9 Annex Roles and duties for which checks for conflicts of interest are to be conducted ategory Role Unit/Sector/Section Product-related duties A Manager Directorate H-Unit P-Unit Involvement in or oversight of productrelated procedures Interactions with pharmaceutical companies V-Unit Product team leader / product team member H-QM H-SE Pre/post-authorisation, maintenance and scientific service procedures for medicines for human use Product team leader / product team member P-R-P H-QM H-SE Union/ommunity referrals and review procedures, applications made under Article 29 of Regulation (E) No 1901/2006 for medicines for human use ommunity referral procedures made under Articles 16c(1)(c) and 16c(4) of Directive 2001/83/E for herbal medicinal products Project manager Project team leader / project team member V-VM-APH V-VM-DEM V-VM-ROS Pre/post-authorisation and maintenance procedures, MRL applications, Union/ommunity referrals and review procedures, scientific advice and MUMS/limited markets classification for veterinary medicines Product team member Project team member P-I-N P-I-MQ Pre-authorisation and scientific service procedures, Union/ommunity referrals and review procedures, and applications made under Article 29 of Regulation (E) No 1901/2006 for medicines for human use ommunity referral procedures made under Articles 16c(1)(c) and 16c(4) of Directive 2001/83/E for herbal medicinal products Pre-authorisation procedures and Union/ommunity referrals and review procedures for veterinary medicines Orphan coordinator H-HM-OM Orphan designation and maintenance procedures for medicines for human use SOP/H/0101, 08-JUL-13 Page 9/11

10 ategory Role Unit/Sector/Section Product-related duties Paediatric coordinator H-HM-PDM Paediatric-related procedures for medicines for human use Scientific advice administrator H-HM-SA Scientific advice and protocol assistance procedures for medicines for human use Legal advisers D-LS-PHL For all product-related procedures for medicines for human use and for veterinary medicines Product team member (where applicable) H-HM-OM H-HM-PDM Pre/post-authorisation, maintenance, scientific service and ATMP classification procedures for medicines for human use H-HM-SSP Union/ommunity referral and review P-MI-PIN procedures, applications made under Article P-MI-PIQ 29 of Regulation (E) No 1901/2006 for medicines for human use P-PV-RM ommunity referral procedures made under P-PV-SDA Articles 16c(1)(c) and 16c(4) of Directive P-R-RA 2001/83/E for herbal medicinal products P-R-SS Project team member P-MI-PIN P-MI-PIQ Pre/post-authorisation and maintenance procedures, MRL applications, Union/ommunity procedures and MUMS/limited markets classification for veterinary medicines Inspections coordinator (where applicable) P-I-N P-I-MQ Post-authorisation and maintenance procedures (including quality defects and sampling and testing) for medicines for human use and for veterinary medicines Scientific administrator P-PV-N P-PV-DM P-PV-RM P-PV-SDA Signal detection, EudraVigilance queries, peer-review of risk management plans, validation of data, activities related to postauthorisation safety studies, commissioning of studies/research, and other pharmacovigilance product-related activities for medicines for human use Scientific P-R-SS Establishment of ommunity herbal administrator monographs and list entries Regulatory affairs P-R-RA Scientific advice and protocol assistance adviser procedures for medicines for human use SOP/H/0101, 08-JUL-13 Page 10/11

11 ategory Role Unit/Sector/Section Product-related duties Scientific administrator Regulatory affairs adviser H-HM-SME P-R-RA SME-related activities including procedures related to medicines for human use and veterinary medicines Innovation Task Force member D-LS-PHL H-HM-SSP H-QM H-SE Eligibility advice and briefing meetings on emerging and advanced therapies and technologies and borderline therapeutics, ATMP classification in relation to medicines for human use P-PV-RM P-R-RA P-R-SS Press/media officer Web editor D-M Press, media and web content related to medicines for human use and veterinary medicines SOP/H/0101, 08-JUL-13 Page 11/11