global standard operating procedure fresenius … standard operating procedure fresenius kabi...

global Standard Operating Procedure

Fresenius Kabi

Services from and Sponsoring of Health Care Professionals

Document No.: gSOP-LE-002 Date: 14 October 2014 Version: 00 Page: 1 of 19 Date of Publication: 18 November 2014

Field of Application: Fresenius Kabi AG, including all subsidiaries / affiliates in which Fresenius Kabi AG holds

a share exceeding 50 % or has otherwise Management Control.

Scope:

The scope of this global Standard Operating Procedure (gSOP) is to specify the interactions between Health Care Professionals (HCPs) and Fresenius Kabi regarding reasonable payments for services provided to Fresenius Kabi, HCP sponsoring, travel expenses and accommodations.

Process Owner: Fresenius Kabi Corporate Compliance

This global Standard Operating Procedure is issued by Global Quality Management of Fresenius Kabi and becomes valid on the date of publication in the global Quality Management Database. Printouts of this gSOP are only valid on the day of printout. Distribution by a Q-Unit outside the global QM-Database, electronically or as paper copy, needs to follow local document control procedures. The user is responsible to verify the currently valid version in the global QM-Database before using this document.

Authorization:

Generated by: Daniela Hommel Date Dr. Christina Mahl Date

Vice President Compliance VP Global Trial Management & Global KOL

Fresenius SE & Co. KGaA Management - GMCRA

Reviewed by: Matthias Fenner Date Dr. Andrea Bauer Date

Vice President Legal Executive Vice President

Fresenius SE & Co. KGaA Global Quality Management

Prof. Dr. Martin Westphal Date

Chief Medical Officer

Fresenius Kabi AG

Approved by: Mats Henriksson Date Gerrit Steen Date

Chief Executive Officer Chief Compliance Officer

Fresenius Kabi AG Fresenius Kabi AG


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1 Objective Fresenius Kabi is a leading company in infusion therapy, I.V. generic drugs, clinical nutrition and transfusion technology / application devices (Fresenius Kabi Products). It is focused on the therapy and care of critically and chronically ill patients in and outside the hospital. The competitiveness of Fresenius Kabi in the medical community is strongly influenced by the balance between the need to invest in research, development and innovations on the one hand and patent expiries and generics on the other hand. Within this context, HCPs play an important role, because they provide the industry with expert guidance throughout the entire product life cycle. Therefore, it is crucial that interactions with HCPs are conducted based on objective criteria and strictly in compliance with all applicable laws, rules and regulations. The purpose of this gSOP is to ensure transparency, equivalence and appropriateness of business relationships with HCPs in a complex international regulatory environment especially with regard to remunerations paid to HCPs in order to achieve sustainability via compliance, compliance with external laws and internal rules and regulations and traceability of interactions with HCPs by comprehensive documentation in accordance

with Fresenius Kabi’s company policy U12.

2 Definition of Terms & Abbreviations 2.1 Abbreviations Abbreviation Definition

CAPA Corrective and Preventive Actions

CCM Corporate Compliance Manager

FCPA Foreign Corrupt Practices Act

FCT Fee Calculation Tool

FMV Fair Market Value

GMCRA Global Medical, Clinical & Regulatory Affairs

gSOP global Standard Operating Procedure

HCP Health Care Professional

KOL Key Opinion Leader

LCC Local Compliance Coordinator

LCO Local Compliance Officer

PC Primary Contact

R / DCC Regional / Divisional Compliance Coordinator

UK United Kingdom

US United States

2.2 Terms Term Definition

Items of value Any payment or transfer of anything with a real or perceived value, including gifts, educational items, meals or services provided to HCPs. Items of value that can create a conflict of interest, because they may appear to actually or potentially influence, compromise judgment or obligate the HCP, are not allowed (undue advantage). Fresenius Kabi’s company policy U12 “Interaction with Health Care Professionals” describes in detail in the subchapter “Policies” ten of


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Term Definition the most common situations of items of value that can be provided to an HCP.

Fair Market Value (FMV) FMV is the appropriate price at which a willing buyer will buy from a willing seller a certain contractually defined service.

Fee Calculation Tool (FCT) The tools in place within Fresenius Kabi to determine reasonable fees for services provided by HCPs to the company. In order to be reasonable, the fees need to be equal to the ones a comparably skilled HCP would receive and be determined in a transparent manner and without bias. Fresenius Kabi’s FCTs consider these criteria. For engagements on an international level Fresenius Kabi has two FCTs in place. Either FCT I or FCT II is used based on the applicable national legal framework. For engagements on a national level a local FCT can be defined.

Local Fee Calculation Tool Local FCTs are for engagements on a national level. They are based on national benchmarks, e.g. national laws and regulations, Codes of Ethics of the national pharmaceutical industry. They must be in line with this gSOP and not contradict national laws.

Fee Calculation Tool I The FCT I lists appropriate fees specific to certain Fresenius Kabi service types (events). HCP specialty and HCP country of residence are considered implicitly in the range of fees provided by this tool. Each initiator has the obligation to consider those two criteria in determining the appropriate fees for a specific service within the provided range. See Annex 2.

Fee Calculation Tool II The FCT II lists appropriate fees based on explicit selection of a KOL specialty and KOL country of residence while using generic service types. Based on these two selection criteria, FCT II provides a single maximum fee amount for a HCP service. FCT II has to be used in countries where national legal frameworks require such a fee determination. See Annex 3.

Health Care Professional

Any individual or entity (whether private or public) who can, in her / his professional capacity, influence the use, purchase, ordering, prescribing or recommendation of Fresenius Kabi products, or affect tender decisions, formulary placement, award status or other preferential or qualifying status of Fresenius Kabi products. Examples of HCPs include, but may not be limited to, the following: licensed HCPs and their staff (e.g. physician, pharmacist, nurse and

dietitian), researchers employed by, or affiliated with, academic medical centers or

other health care facilities, employees of hospitals, clinics and pharmacies (i.e. director of pharmacy,

purchasing agent), employees of government or private health plans and insurance programs, employees of group purchasing organizations and employees of blood banks in hospitals.

See also Fresenius Kabi’s company policy U12.

Key Opinion Leader (KOL) KOLs belong to the group of HCPs. A KOL is typically a HCP, who is of crucial importance to Fresenius Kabi due to his professional experience on a very high level. KOLs may include, but are not limited to, the following: licensed healthcare professionals and their staff (physician, pharmacist,

nurse, registered dietitian), employees of hospitals, clinics and pharmacies, employees of group purchasing organizations, and employees of managed care organizations and health plans.

See also gSOP-CR-018 “Global KOL-Management Concept”

National KOLs National KOLs are individuals, who have a reputation only in their country of residence and normally do not interact with Fresenius Kabi functions outside their country of residence or work. National KOLs are coordinated by countries and / or supported by regions. Within specific countries, further segmentation (e.g. regional, local) may be required. See also gSOP-CR-018 “Global KOL-Management Concept”.


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Term Definition

Cross-border KOLs Cross-border KOLs are KOLs, who fulfill at least the first of the following criteria (the second criteria is optional): high reputation due to knowledge, skills, experience and expertise beyond

their country of residence or work (international actions), interaction with global, regional or national functions outside their country of

residence or work. Cross-border KOLs are identified, nominated and coordinated according to gSOP-CR-018 “Global KOL-Management Concept”. See also gSOP-CR-018 “Global KOL-Management Concept”.

Top KOLs

Top KOLs are cross-border KOLs with the highest reputation and importance for Fresenius Kabi. See also gSOP-CR-018 “Global KOL-Management Concept”.

Initiator An initiator is any employee / function within Fresenius Kabi, who plans activities that involve one or more HCPs.

(HCP) Specialty Categorizes the medical specialty of HCPs. It is based on the nomenclature of the medical specialties used in determining the FMV. Categorization of specialties is listed in the manual of the FCT II.

(HCP) Service Any service which HCPs may render to Fresenius Kabi. This includes, among others, clinical consulting, speaking engagements, advisory board services, regulatory consulting services, product development and marketing consulting services. The service must be related to the professional expertise of the HCP and Fresenius Kabi has to have legitimate business need for the service. Services soley concerning the application of health care services in direct interaction with patients and the supervision of such services in Fresenius Kabi’s Home Care business are not within the scope of this gSOP. See also gSOP-CR-018 “Global KOL-Management Concept”.

(HCP) Sponsoring Any allocation provided to HCPs without any obligation to provide consideration by the HCP.

Engagements on a national level

All engagements of a national HCP, performed by the local Fresenius Kabi entity, are engagements on a national level.

Engagements on an international level

International engagements are all engagements involving HCPs resident in countries others than the location of the acting Fresenius Kabi entity.

Primary Contact (PC) In accordance with the gSOP-CR-018 “Global KOL-Management Concept” a PC prevents overlapping communications and contacts with HCPs. He is assigned to cross-border and Top KOLs. As well the PC ensures the following aspects: efficient use of KOL capacity and cohesive strategy.

The PC is the main, but not exclusive contact for the KOL within Fresenius Kabi. The PC has: the best knowledge about the respective KOL and the closest relationship to the respective KOL.

It has also to be guaranteed that the PC: is informed about all services and sponsorships concerning the respective

KOLs and has an understanding of Fresenius Kabi processes, especially those related to

the KOL Management Concept. (See also gSOP-CR-018 “Global KOL-Management Concept”).

Local Compliance Officer (LCO)

The LCO is a Fresenius Kabi employee responsible for compliance issues of the relevant entity. The LCO is the compliance interface for national and central requests from Fresenius Kabi. Usually he / she is the General Manager of a legal entity. In case of mixed entities a LCO is defined in the hotelkeeper list which can be found on the Fresenius Kabi intranet (SharePoint). The LCO can delegate her / his duties to the Local Compliance Coordinator (LCC). In case the LCO is the same person as the initiator, assessment tasks should be delegated to a compliance function on the same level or superior to guarantee appropriate segregation of duties.


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Term Definition

Local Compliance Coordinator The LCC is a Fresenius Kabi employee supporting the LCO in his responsibilities as the LCO on a local level. In a mixed legal entity with Market Unit and Production Unit it is the Local Compliance Coordinator Market Unit. The LCC can be found in the hotelkeeper list in the Fresenius Kabi intranet. The LCC is the delegate of the LCO.

Head of department The head of department is the line manager of the initiator. In case that the initiator is the same person as the head of department the subsequent line manager or respective function has to take over the responsibilities.

Corrective and Preventive Actions (CAPAs)

CAPAs are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. Corrective actions might be e.g. informal notification of employer prior to contract signature. Preventive actions might be e.g. implementation of contracts in local language, trainings and process adaptations.

3 Process 3.1 General Principles

Any actual or potential corruptive payments to HCPs as well as the appearance of such corruptive payments must be avoided. Payments appear to be corruptive, if they might be qualified as granting an undue advantage to a counterparty in order to influence such counterparty. The circumstances, e.g. timing of the interaction or qualification of the individual HCP are relevant for determining whether any advantage can be qualified as undue in the specific situation. Further, to avoid legal consequences for Fresenius Kabi, it is important to consider the national legal framework of the country, where a payment is received by the HCP, where the service is rendered, and where the acting Fresenius Kabi entity is located.

This concerns national laws including but not limited to the Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act. For further guidance please refer to the country specific completed Annex 4 on SharePoint. This gSOP summarizes the general principles for determining the cost limits applicable to HCP interactions according to equivalence principle and the appropriateness of such cost (section 3.1.1 – 3.2.6). The LCO of each country is responsible for checking, whether the described principles are not contradicting the current and future local legislation. She / he decides which FCT can be used. In case an exception from this gSOP is necessary in the respective country, taking into consideration local laws and regulations governing such expenses / fees, the LCO will align an exception with the regional / divisional compliance organization and notify Fresenius Kabi Corporate Compliance. Local processes regulating the remuneration of HCPs according to FMV principles are allowed as long as they do not contradict the processes described in this gSOP. These local processes as well as national compliance requirements are summarized in the country specific completed Annex 4 on SharePoint (template is given in Annex 4). Completed country specific Annex 4 on SharePoint have to be updated at least annually by the LCO and sent to Fresenius Kabi Corporate Compliance who will initiate the upload of the national requirements on the SharePoint site “Medical Community”. Access to the SharePoint site is provided by Global KOL Management. It can be requested via email by the department heads.


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3.1.1 HCP Services In order to avoid that fees paid to HCPs may be considered to be corruptive, any fee needs to be equal to the ones that a comparably skilled HCP would receive. Transparent and adequate remuneration of HCPs is assured, if such fees are determined without bias and based on the following criteria: country of residence of the HCP, qualification of the HCP given by her / his specialty and hourly rates paid to HCPs.

Further criteria to determine appropriate fees are: KOL status, i.e.:

Top KOL, cross-border KOL, national KOL (see gSOP-CR-018 “Global KOL-Management Concept”),

within countries further categories of HCP status can be defined (e.g. provincial, local),

preparation time for service, the type and duration of service and excellent long lasting cooperation experience.

Fresenius Kabi has two global tools and local tools defined by local processes in place which acknowledge the above mentioned criteria for the calculation of reasonable payments. They determine reasonable fees for services provided by HCPs to the company. In order to be reasonable, the fees need to be equal to the ones a comparably skilled HCP would receive and be determined in a transparent manner and without bias. All FCTs consider these criteria. For engagements on local / national level local FCTs should be used. For engagements on international (global) level either FCT I or FCT II is used based on the applicable national legal framework. Both tools are updated annually by Fresenius Kabi Corporate Compliance. FCT I is preferred, if not otherwise defined by applicable national legal frameworks. In case of divergent national legal frameworks, the stricter one has to be applied. Country specific national legal frameworks are summarized by the LCO in Annex 4. Details entailed in the national FCT are reflected in this Annex as well. The FCT I (Annex 2) lists appropriate fees specific to certain Fresenius Kabi service types (events). KOL specialty and KOL country of residence are considered implicitly in the range of fees provided by this tool. Each initiator has the obligation to consider those two criteria in determining the appropriate fees for a specific service within the provided range. Negotiations should be documented by the initiator. If legally permissible FCT I is used for the calculation of services related to: international internal scientific events or external congresses (e.g. satellite

symposium), international educational internal events, i.e. events are sponsored and organized by

Fresenius Kabi (e.g. Fresenius Kabi Advanced Nutrition Conferences (FRANC) Fresenius Oncology Regional Conference (FORCE)),

lecture tours sponsored and organized by Fresenius Kabi, advisory boards (e.g. expert meetings) sponsored by Fresenius Kabi and consultancy.

FCT II (Annex 3) lists appropriate fees based on explicit selection of a HCP specialty and her / his country of residence while using generic service types. Based on these two selection criteria, FCT II provides a single maximum fee amount for a HCP service. The FCT II is to be used for fee calculation applicable to those HCPs and services where it is required by applicable national legal frameworks, e.g. the strict application of the calculated fees is mandatory for all HCPs with residence in the US or Canada or any event conducted in the US or Canada.


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3.1.2 HCP Sponsoring

Fresenius Kabi might consider providing HCP sponsoring concerning the participation of HCPs in an external scientific event or participation in an internal scientific or educational event, hosted by Fresenius Kabi. The HCP sponsoring is intended to achieve a professional exchange between specialists from all fields of the medical community, thereby supporting development of Fresenius Kabi products. The sponsoring is restricted to compensation of the travel, accommodation costs and participation fee as appropriate. The sponsoring must not be suitable to influence or obligate the HCP. Future compliance requirements may exacerbate HCP sponsorships. Local laws and codices must be considered upfront as they might not allow any or full sponsorship, e.g. Scandinavian countries or Singapore. For HCP sponsoring participation agreements should be issued before the start of the sponsoring.

3.2 Specific Principles The specific principles are described in the U 12. For comprehensiveness of this gSOP some of them are outlined here.

3.2.1 Hospitality An individual business unit shall not organize or sponsor an event that takes place outside of its home country, unless the event was approved in writing (e.g. be email) by the General Manager responsible for the country where the event takes place and one of the following can be documented: Most of the invitees are from outside the home country and, considering the location

of most of the invitees, it is more efficient to hold the event in another country. Considering the location of the relevant resources or expertise, it is more efficient to

hold the event in another country. The meeting is held in the context of an international event, e.g. subsequently to a

congress. Any location selected for HCP services must be based primarily on the business need. Therefore, the location shall be moderate in appearance and reasonable for a business character. The duration of the hospitality shall be restricted to the necessary. Fresenius Kabi is not allowed to provide any hospitality to spouses, family members or other guests of the invited HCP unless they also provide a service to Fresenius Kabi. The number of participants shall be restricted reasonably.

3.2.2 Gifts In the context of HCP services and sponsoring, company employees must not provide, offer or promise gifts of any kind to HCPs. For details please refer to Fresenius Kabi’s company policy U12.

3.2.3 Remuneration of Travel and Accommodation Cost Reasonable and appropriate travel and accommodation expenses for HCPs with regard to time (i.e. restricted to the duration of the event) and cost (i.e. no first class; business class travel may only apply for international flights exceeding 3 hours of flight time; in all other cases, only economy class) is applicable.


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Travel expenses must be in connection with the event sponsored by the company. Reimbursement of a HCP, who is anyhow attending the event, is not allowed to avoid double reimbursement. Travel expenses must be approved in advance by using Annex 1. Before expenses of the HCP can be assumed, a signed agreement has to be in place. Suitable contract templates, e.g. for participation agreements, can be found on SharePoint. For reimbursement of travel and accommodation expenses, original receipts have to be provided. Expenses for spouses, family members or other guests of the HCP are not allowed to be reimbursed by Fresenius Kabi, unless they also provide a service to Fresenius Kabi. Local laws and codices must be considered upfront.

3.2.4 Remuneration of Meals Management of each country is responsible for establishing cost limits applicable for such business meals offered to HCPs in their respective country taking into consideration local laws and rules governing such expenses (refer to country specific completed Annex 4 on SharePoint). Please refer also to the Country Regulation Database available on the SharePoint site “Medical Community”. HCPs can be invited for meals at a modest venue that is conducive to business decisions (no lavish / deluxe venues or venues known for their entertainment facilities). Spouses, family members or other guests of the HCP are not allowed to be remunerated for meals by Fresenius Kabi, unless they qualify themselves by their professional activities for the participation. At least one Fresenius Kabi employee has to be present during the meal.

3.2.5 Contracting Contract templates for HCP business relationships (services or sponsorships) are provided by the Fresenius SE & Co KGaA Corporate Compliance Department. The use of such templates is mandatory in case of international engagements. Valid templates are accessible on the SharePoint site “Medical Community” via the Fresenius Kabi intranet. Templates are protected, only highlighted parts are to be adapted to the special purpose. Changes in other parts of the templates can only be made by Fresenius SE & Co KGaA Corporate Compliance. Templates are updated on an annual basis at least. For national engagements local contract templates can be used as long as they do not contradict global templates and are locally approved by local legal function (Fresenius Kabi internal or external). If the language of the contract template is not English, bilingual templates are preferred using local language and English. Local templates have to be protected; only highlighted parts are to be adapted to the special purpose. Changes in other parts of the local templates have to be approved by the LCO.

3.3 Process 3.3.1 Initiation

The initiator decides about the type of cooperation with HCPs, i.e. HCP service or sponsorship and selects the HCP according to her / his qualification. The PC, the head of department of the initiator, and the regional or departmental medical / scientific head are informed in writing about the planned HCP service or sponsorship and selected KOLs e.g. by informative email. The initiator of the HCP service or sponsorship documents the following by using the HCP selection form (Annex 1): the appropriateness of the business need,


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the justification that HCP selection is according to the qualification of the HCP regarding the requested service or sponsorship (e.g. CV, agenda of the event) and

the draft itinerary and details for travel and accommodation.

3.3.2 Fee Determination and Approval Engagements on a national level All engagements of a national HCP, performed by the local Fresenius Kabi entity, are engagements on a national level. The principles of equivalence and appropriateness must be followed for determining the cost limits applicable to HCP interactions. The LCO is responsible to define local contract templates according to section 3.2.5 and a local FCT (see completed country specific Annex 4). If no local FCT is available the LCO defines whether FCT I or FCT II should be used. The LCO is also responsible to consider local laws and regulations, including but not limited to definition of annual caps for e.g. number of engagements or maximum amount of payments per year. The LCO has to ensure that the number of engagements of individual HCPs is appropriate. Details have to be incorporated into Annex 4. The initiator fills in the HCP selection form (Annex 1) to document the business need and the appropriateness of HCP sponsoring or services. For the fee calculation the FCT as defined by the LCO has to be used and this has to be documented (Annex 1). The initiator ensures that other regulations as defined in this gSOP and local SOPs are followed. For HCP sponsorship no fees are allowed to be paid. The initiator sends the completed Annex 1 to her / his head of department for approval. The head of department reviews the Annex 1. She / he can either refuse the Annex 1 in its current form or she / he approves the Annex 1 in writing (signature or email). In case of refusal the following options apply: selection of other HCPs for service or sponsorship and / or adaptation of fees and / or other cost or rejection of HCP service or sponsorship.

The LCO reviews and approves the Annex 1 only in case of exceptions. In case of uncertainties regarding applicable legal frameworks the Regional / Divisional Compliance Coordinator (R / DCC) or the Fresenius Kabi Corporate Compliance Manager (CCM) can be contacted. The initiator should use the contract templates according to section 3.2.5. for the contract negotiations. Any deviations from the local contract template or the local FCT must be approved by the LCO. Engagements on an international level International engagements are all engagements involving HCPs resident in countries others than the location of the acting Fresenius Kabi entity. For the US and Canada additional rules apply which are described in section 3.3.2. “Special requirements for US and Canada”. The initiator sends the HCP selection form and an email request to her / his responsible LCO to check which tool can be used for fee calculation if not obvious from respective Annex 4. For HCP sponsorship no fees are allowed to be paid. In case the requirements of the country of residence of the HCP are not obvious from the completed Annex 4 the initiator is responsible to obtain a confirmation from the LCO of the


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HCP’s country of residence which FCT has to be used for fee calculation. The LCO checks the legal framework of the country of residence of the HCP, as well as the legal framework of the country of the acting Fresenius Kabi entity. If applicable, any potential international legal framework (e.g. FCPA and / or UK Bribery Act) has to be taken into consideration. For further guidance please refer to the country specific completed Annex 4 on SharePoint. The LCO advices the initiator in writing by email including which tool should be used for fee calculation if not evident from respective Annex 4. The principles of equivalence and appropriateness must be followed for determining the cost limits applicable to HCP interactions. For requests in case of uncertainties regarding applicable legal frameworks the R / DCC or the CCM can be contacted. Annex 1 is to be used in any case for documentation. The initiator calculates the fee and documents it in Annex 1. The completed Annex 1 has to be sent to the head of department and the LCO. The head of department and the LCO check the HCP selection form including attachments and approve by email or signature. They inform the initiator and / or hand back the signed HCP selection form. In case of refusal the following options apply: selection of other HCPs for service or sponsorship and / or adaptation of fees and / or other cost or rejection of HCP service or sponsorship.

If the responsible initiator is the General Manager and / or the LCO, then the R / DCC or a delegate with compliance function has to approve. In any case of overlapping functions or due to organizational structure, delegates can take over the tasks described above (see definitions). Most importantly, appropriate segregation of duties must be ensured. For the following contract negotiations the initiator has to use global contract templates which were approved by Fresenius SE Corporate Compliance. Special requirements for US and Canada For US and Canada different rules apply. In case of HCP services involving HCPs resident in the US or Canada or HCP services performed in the US or Canada the strict application of the FCT II is mandatory. The Fresenius Kabi US Compliance Officer may ask for additional information and may provide specific contract templates for the US and Canada.

3.3.3 Pre-service Phase After approvals, the initiator of the HCP service or sponsorship starts the contract negotiations with the HCP by using the appropriate contract template. The initiator must check if all local / country requirements as documented for the respective legal framework in Annex 4 are considered in the contract, e.g. including but not limited to annual caps if required locally. If not, the contract template must be adapted accordingly by the LCO and must be sent for final approval to the R / DCC. In addition, Fresenius Kabi Corporate Compliance should be informed. During the contract negotiations the initiator ensures that the fee does not exceed the maximum remuneration approved in Annex 1 beforehand. It is strictly recommended to start contract negotiations at the lower level of the pre-defined range of the fees. Before the contract is finally signed the following transparency requirements need to be adhered to:


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in case the contract is to be stipulated between two parties of the same country and local law strictly requires prior approval of the HCPs employer (refer to country specific completed Annex 4 on SharePoint), such approval has to be obtained in any case,

if the contract is to be stipulated between two countries and one strictly requires prior approval of the respective hospital administration, such approval should be obtained, if possible. If such an approval cannot be retrieved due to local circumstances of the counter-party mere notification of the HCPs employer is adequate. Additionally any other local law transparency requirements need to be adhered to or

in any case, if the prior approval of the employer of the HCP is not mandatory by any of the laws, the initiator still should always request [remark: but is not responsible to ensure] that the employer of the HCP is notified, e.g. by including a clause in the contract.

After the contract has been signed, the initiator informs the LCO, the regional and departmental medical / scientific head, the PC and

the KOL Management in case of international HCP engagement, has to ensure that the services, fees and sponsorships are entered into the KOL

Database for Cross-border and Top KOLs within 4 weeks after the HCP interaction started (gSOP-CR-018 “Global KOL-Management Concept”), and

archives the HCP selection form including approval documents and attachments, the contract (according to legally approved templates, see SharePoint site “Medical Community”) and notification of the employer for potential inspection / audit for ten years. Archiving has to be done centrally for each Fresenius Kabi entity, and locally, if required, e.g. in a database or in one department (e.g. Finance, Marketing, the LCC etc.). The LCO is responsible to define the appropriate filing system in his Fresenius Kabi entity.

3.3.4 Documentation after Services and Sponsoring

Generally, documentation evidencing performance of services or sponsorships / participations must be provided by the HCPs in the form of a consulting report or other written materials. For advisory board services, a sign-in sheet along with a tape, transcript or written summary of the discussions are acceptable forms of documentation to evidence performance of the services by the KOL. The initiator is responsible to send the HCP selection form including approval documents and attachments, the contract (according to legally approved templates, see SharePoint site “Medical Community”) and notification of the employer to the responsible archiving department of her / his Fresenius Kabi entity. The initiator is responsible to retain a file of all information related to the services including documentation of the approved HCP selection form (Annex 1, inclusive attachments), fee negotiations with the respective HCP, the signed agreement / contract between Fresenius Kabi and the HCP, notification of employer, copies of all invoices from the HCP showing hours worked, copies of payments made by Fresenius Kabi and documentation evidencing performance of the services. Documents have to be archived sustainably for potential inspection / audit for ten years by the initiator or delegate.


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Fig. 1: Procedure for HCP engagements


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Fig. 2: Process of HCP contracting

3.4 Exceptions

An exception is any intended aberration from the process described in this gSOP prior to the HCP engagement. During the approval and contracting process exceptions from the process described above might be necessary. Reasons for an exception may include but are not limited to the following examples: unexpected circumstances close to the performance of service but prior to the final

contract that require alterations from the process described in this gSOP (e.g. sudden changes in an event agenda cause additional, unavoidable and extra-ordinary efforts for the HCP),

rejection of the maximum honorarium by the HCP and evidence that she / he is eligible to higher honorariums and

special considerations regarding the itinerary due to e.g. the health or the age of the HCP.

Exceptions must be justified by the initiator in writing as an informal appendix to the Annex 1. He / she contacts the head of department and the LCO for approval prior to engagement of the HCP. The LCO informs Fresenius Kabi Corporate Compliance about the approved exception. The CCM forward the exceptions to Fresenius SE Corporate Compliance for further reporting as appropriate.


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3.5 Deviations A deviation is any aberration from the process described in this gSOP which is detected after the HCP engagement. The documentation of any deviation is an integral part of quality assurance. It gives the opportunity to spot frequent aberrations from a given process. Therefore it can be the basis to identify complications or issues within the process and to develop suitable process improvements. Any deviation from this gSOP has to be documented in writing by any employee detecting such deviations. Documented deviations must be sent to Fresenius Kabi Corporate Compliance. The Fresenius Kabi CCM requests further details of the deviation and the justification from: the initiator, the responsible head of department, the LCO responsible for the initiator and the LCO responsible for the country of residence of the concerned HCP.

In addition, CAPAs have to be documented in writing by the R / DCC. In case the initiator assumes a new position within Fresenius Kabi, she / he remains responsible to document the above. In case the initiator is not a Fresenius Kabi employee any more the successor has to provide respective documentation. Completed deviation documentation including CAPA is sent to the R / DCC by the initiator or successor for filing. The R / DCC sends the deviations to Fresenius Kabi’s CCM for assessment (major / minor) and compilation. Compiled deviations should be evaluated twice a year for potential adaptation of the process or identification of training need by the Fresenius Kabi CCM together Fresenius SE Corporate Compliance.

4 Responsibilities 4.1 Initiator

The initiator is responsible for: deciding about the kind of cooperation with HCPs, i.e. HCP service or sponsorship, selecting the HCP according to her / his qualification, informing the PC, the head of department of the initiator and the regional or

departmental medical / scientific head in writing about the planned HCP service or sponsorship and selected KOLs e.g. by informative email, documenting her / his rationale for the HCP selection by using the HCP selection form ( Annex 1 and additional documents e.g. curriculum vitae, agenda of the event),

documenting the appropriateness of business need by using the HCP selection form (Annex 1),

drafting the itinerary for the HCP service or sponsorship, providing details for travel and accommodation by using Annex 1, filling in and – in case of engagements on an international level - sending the HCP

selection form and an email request to her / his responsible LCO to check, which FCT can be used for fee calculation – if not obvious from respective country specific completed Annex 4 on SharePoint,

calculating the fee by using the FCT I, FCT II or an approved local FCT, sending the completed HCP selection form to the head of department and the

responsible LCO for approval for engagements on an international level, looking for solutions in case of refusal such as other available HCPs for service or

sponsorship, adaptation of fees and / or other cost, rejection of the HCP service or sponsorship,

starting the contract negotiations with the HCP after approval,


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checking if all local / country requirements as documented for the respective legal framework in country specific completed Annex 4 on SharePoint are considered in the contract,

ensuring that during the contract negotiations the fee does not exceed the maximum remuneration approved in Annex 1 beforehand,

documenting the fee negotiations with the respective HCP, adhering to the transparency requirements as described in section 3.3.3, informing the LCO, regional and / or departmental medical / scientific head, PC and

KOL Management about the signed contract for engagements on an international level,

ensuring that the services, fees and sponsorships are entered into the KOL Database for cross-border and Top KOLs (gSOP-CR-018 “Global KOL-Management Concept”) within 4 weeks after the HCP interaction started,

local archiving (as long as central archiving is not available)of the HCP selection form including approval documents and attachments, the contract (according to legally approved templates, see SharePoint site “Medical Community”), notifying of the employer and documents evidencing the service or sponsorship for potential inspection / audit for 10 years,

documenting potential exceptions as appendix to the Annex 1 including its justification,

sending the potential exception to the head of department and the responsible LCO for approval prior to engagement of the HCP,

documenting and justifying deviations in writing and informing Fresenius Kabi Corporate Compliance about the deviation.

4.2 Local Compliance Officer

The LCO or delegate is responsible for: checking the legal framework of her / his countries and compiling of the essential

information into the Annex 4, reviewing and updating as appropriate of the content of the country specific

completed Annex 4 on SharePoint at least on an annual basis, checking the legal framework of the country where a payment is to be received by the

HCP as well as the legal framework of the country of the acting Fresenius Kabi entity. If applicable, any international legal framework (like FCPA and UK Bribery Act) has to be taken into consideration,

advising the initiator of the HCP service or sponsorship which FCT can be used in writing, e.g. by email if not evident from completed country specific Annex 4 on SharePoint,

checking the HCP selection form including attachments and approve by email or signature for engagements on an international level,

informing the initiator about the approval or refusal for engagements on an international level,

adapting of local contract template to national compliance requirements if required, sending adapted contract templates to R / DCC, checking of exceptions and approving by email or signature, informing Fresenius Kabi Corporate Compliance about the approved exception, and defining the appropriate filing system in his Fresenius Kabi entity

4.3 The Head of Department

The head of department is responsible for:


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receiving and reviewing of information form the initiator about contract negotiations in case of regional events,

checking the HCP selection form including attachments and approving by email or signature,

informing the initiator respectively, approving of necessary exceptions to this gSOP to take into consideration local laws

and codices, informing Fresenius Kabi Corporate Compliance and Fresenius SE Corporate

Compliance about the exception and answering requests in case of uncertainties regarding applicable legal frameworks.

4.4 Regional / Divisional Compliance Coordinator

In case the General Manager is the initiator of a HCP service or sponsorship R / DCC has to approve the completed Annex 1. The R / DCC is responsible for: receiving and reviewing of information form the initiator about contract negotiations in

case of regional events, checking the HCP selection form including attachments and approving by email or

signature for engagements on an international level and on the national level, if required by local processes,

informing the initiator respectively for engagements on an international level and on the national level, if required by local processes,

approving of necessary exceptions to this gSOP to take into consideration local laws and codices,

informing Fresenius Kabi Corporate Compliance and Fresenius SE Corporate Compliance about the exception

answering requests in case of uncertainties regarding applicable legal frameworks, requesting further details of deviations from the initiator, the LCO responsible for the

initiator, from the responsible head of department and from the LCO responsible for the country of residence of the concerned HCP,

documenting and filing of deviations and CAPAs for ten years, notifying Fresenius Kabi Corporate Compliance and Fresenius SE Corporate

Compliance about exceptions for local and regional events and approving of local changes to contract templates by LCOs.

4.5 Fresenius Kabi Corporate Compliance

Fresenius Kabi Corporate Compliance is responsible for: monitoring local exceptions to this gSOP and evaluate whether process adjustments

are necessary, monitoring whether national compliance requirements summarized in country specific

completed Annex 4 on SharePoint require process adjustments, initiating the upload of the national requirements (using Annex 4) on the SharePoint

site “Medical Community”, receiving information from the initiator about contract negotiations with HCPs in case

of international events, providing, adapting and approving changes to contract template, answering requests in case of uncertainties regarding applicable legal frameworks, receiving and reviewing deviation as well CAPAs, requesting further details of the deviation and the justification from:


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the initiator, the responsible head of department, the LCO responsible for the initiator and the LCO responsible for the country of residence of the concerned HCP;

assessing deviations (major / minor), compiling and filing deviations and CAPAs, evaluating compiled deviations twice a year together with Fresenius SE Coproate

Compliance and defining appropriate mitigation actions, receiving and reviewing exceptions for regional / international events and initiating an annual update of the national requirements (Annex 4) on the SharePoint

site “Medical Community”.

4.6 Local Legal Functions Local Legal Functions are responsible for approving local contract templates and individualized contract drafts for a certain HCP service or sponsorship.

4.7 Fresenius SE Corporate Compliance Fresenius SE Corporate Compliance is responsible for: initiating the update of the country specific completed Annex 4 based on local

exceptions to the gSOP and on national compliance requirements, answering requests in case of uncertainties regarding applicable legal frameworks, evaluating deviations twice a year together with Fresenius Kabi Corporate Compliance, summarizing exceptions for further reporting and providing / adapting changes to the global contract template.


Fresenius Kabi



Process StepDocumentation Responsibilitya

InstructingDocument/Template Informed

Contract template? Local contract

templateGlobal contract

template

Development of suitable contract template

Approval of contract template

Finalized local contracttemplate

General need for contracts suitable for HCP services or

sponsorshipsCorporate Complianceb,Local Compliance Officer

Corporate Complianceb,Local Compliance Officer

Legal departmentc

Any Fresenius Kabi employee

Finalized global contracttemplate

Draft local contracttemplate

Draft global contracttemplate

Publication of global contract template

End

Individual local procedure

Sharepoint site „Medical Community“

Draft local contracttemplateDraft global

contracttemplate

a In any case of overlapping functions or due to organizational structure respective delegates can take over the tasks (see definitions). Most importantly the four-eyes principlemust be followed.

b Fresenius Kabi Corporate Compliance and Fresenius SE Corporate Compliancec Legal departments (Fresenius Kabi internal or external)

Corporate Complianceb

Legal departmentc


Legal departmentc


Fig. 3: Responsibilities for HCP contract templates

5 References

Document Title

U12 Company guideline “Compliance Policy on Interactions with HCPs”

Annexes

Annex 1 HCP selection form

Annex 2 Fee calculation tool I

Annex 3 Fee calculation tool II

Annex 4 Country Compliance Requirements

other Fresenius Kabi QM-Documents gSOP-CR-018 Global KOL-Management Concept


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6 Document Change History

This gSOP replaces: none

Version Reason for Change & Change Description 00 Document newly established

7 Publication & Distribution

Publication: Lotus Notes Database – Section Global Distribution: Global Standard Distribution List