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July 2025
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HCS DIRECTIVE
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COMPLIANCE FRAMEWORK FOR HN ACTIVITIESSOUTH AFRICA
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AGENDA
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1- WHY A Hcs COMPLIANCE programme AT danone?
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Why A Compliance program AT DANONE?
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INTERNATIONAL PRESSURE
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Increasing number of anti-corruptions laws which are extraterritorial, allowing authorities to sue companies anywhere in the world and simultaneously in several countries
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FTSE4GOOD INDEX
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Danone has entered into the “FTSE4Good Index” in 2016, that implies being compliant with corporate social responsibility criteria
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
B-CORP
Danone is “B-Corp” certified”, a certification given to companies having a benefic impact on the world. This certification imposes social, societal (including compliance) and environmental criteria.
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2-FROM WHO CODE TO 8 procEdures AT Dnaf
FROM WHO CODE… TO OUR OWN DANONE COMMITMENTS
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WHO code regulates marketing practices for breast milk substitutes
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
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FOR MORE information ON WHO CODE
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LET’S CONNECT TO SIKI ! « Coe – decodING W.H.O. code »
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Paeds’ actions
Adults’ actions
restrictions
HCS COMPLIANCE DIRECTIVE – THE CONTENT
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Interactions with Healthcare Professionals (HCPs)
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Collaboration with HCPs
HCPs’ consents for digital information/documents
Inviting and/or supporting HCPs to Events (Danone’s or 3rd parties’)
Donations of Samples & Products for HCP Exclusive Usage (EUP)
Giving Gifts and Hospitality
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Interactions with Healthcare Organizations (HCOs)
No relevant for ZA
Calls to Tenders
Sponsorships
Grants & Donations
DEFINITIONS TO BE KNOWN
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HCM
Healthcare systems Compliance Manager = Fanny Lebouc
A person who practices a profession in the medical, dental, pharmaceutical, dietetic, nutritional or nursing field, a midwife or any other person who, in the course of his or her professional activity, may prescribe, or purchase, provide, recommend or administer on behalf of a patient, a nutritional product or perform a health service. A HCP can also be an opinion leader, which includes KOLs and all other types of experts who have an influence on the Health System.
HCP
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A public or private, for-profit or not-for-profit healthcare organization
HCO
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Government Official HealthCare Professional Any HCP working in a university hospital or public health facility AND Who holds a legislative, administrative or judicial position;OR who is responsible for procurement or Head of department in an administrative position within a HCO or member of the board of a public health care organization (HCO);OR who is actively involved in the pricing, RECORDING, clearance or formulation processes of our product in a country; OR who is President of the Paediatric Society/ association.
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
GO-HCP
TPV
Third Party Vetting / A Danone online third-party assessment tool (distributors, marketing agencies, HCPs, etc.) used to assess the integrity of our partners and the risks (corruption, unethical practices, reputation, etc.) that they could represent for Danone. At HN, it is used by Supervisors and HC Managers.
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RIGHT CLICK
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INTERACTIONS WITH HCP:
5 PROCEDURES
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Adults’ actions
Paeds’ actions
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Under conditions
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EVENTS & VISITS
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Procedure : AFR-HN-PRO-01- Participation of Healthcare professionals to Events
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HCS DIRECTIVE DEFINes different possible types of INVITATIONS
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EVENTS ORGANISED BY THRID PARTIES
EVENTS ORGANISed by DANONE
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Ex. ESPGHAN
Ex. AFPN congress /!\ includes WEBINAR
= HCPs’ meetings insite a HCO, organised by the HCO and in which Nutricia is invited to speak.
- LOCAL EVENTS < 50 ATTENDEES
Ex. round-tables, VIP dinners
- LOCAL EVENTS > 50 ATTENDEES
Ex. Symposium
Ex. RANI
Ex. visit to the Utrecht research center /!\ includes WEBINARS
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
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Possible to support HCPs
Possible to invite HCPs
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Invite hcps TO DANONE EVENTS – HOW TO PROCEED
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The Reps identify HCPs they wish to invite They complete the internal approval form (AFR-HN-FS-12) and send it to their Supervisor for her to read / finalise and sign. The Supervisor is in charge of getting the signatures of Danone authorized persons.
INTERNAL APPROVAL
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When they receive the approved list of guests invited, the Reps transmit the written official invitation to the HCP (either provided by Marketing, or completed as from the form (AFR-HN-FS-14)) and keep a copy that will be archived
INVITATION
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ATTENDANCE LIST
During the event, the Reps have the attendance list signed by all attendees (Template AF-HN-FS-18) For webinars, they take a screenshot with date and time, and keep it for archiving.
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
If it has been concluded with the HCP that Danone will pay for minor costs directly to the HCP (ex. taxi, fuel), the Reps give the HCP a letter of reimbursement (AFR-HN-FS-16), retrieve the proofs and proceeds to the payment to the HCP
REIMBURSMENT
- After the event, the Reps complete the event in PITCHER also mentioning costs.
- The Reps archive all documents in relation with the event according to the local archiving process (ex. internal form, written invitation, attendance list, quotation, invoices…)
RECORDING & ARCHIVING
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Invite hcps TO DANONE EVENTS –– points OF Attention
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RULES TO RESPECT FOR THE ORGANISATION
INVITATIONS
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- The event must have a scientific and/or educative content, in classroom or in visioconference (ex. webinar). For events organised for HCPs from paediatric universe, only 100% scientific event are allowed.
- No entertainment during more than 20% of the total duration of the Event (not allowed for Paediatric HCPs)
- Venue appropriate for the event (not too luxuous)
- It is forbidden to give cash nor gifts to HCPS. Only minor costs can be reimbursed to HCPS by the Reps or by NSA (fuel, taxi). All other costs like accomodation or transportation must be organized with an agency in charge of the event.
- When a new agency is used, the Supervisor must complete a « TPV » for the agency and archive it
- For a Webinar, if HCPs are gathered to attend, only refreshments can be proposed (not for HCPs from Paediatric universe)
- Only HCPs can be invited. Their families (children, spouses) are never invited.
- For GO-HCP, the authorization of the employer is necessary. If it is not possible, a validation from DNAF HCM is requested.
- HCP working in paediatric universe can only be invited to Danone events if these events are exclusively dedicated to science. No food nor beverage, nor goodies can be provided to them during the event.
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
INTERNAL APPROVAL FORM
- Selection criteria must be completed for each HCP
- Always mention the date of the request
- For a GO-HCP with no employer ➜ HCM validation needed
- The form must be read carefully, and possible completed by the Supervisor. The Rep is not allowed to sign it. Once done, the Supervisor is in charge of having the document signed, according to the authorized process.
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SUPPORTING hcps TO THIRD PARTIES EVENTS: CONGRESS – HOW TO PROCEED
Not allowed for HCPs from paediatric universe
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The Reps gets from HCPs a letter of sollicitation duly completted with all necessary information (template AF-HN-FS-11)
SOLLICITATION
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The Reps complete the Internal approval form (AFR-HN-FS-12) and send it to the Supervisor for him/her to read, finalise and sign.. The Supervisor is in charge of getting the signatures from Danone authorized persons.
INTERNAL APPROVAL
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If the request is approved, the Reps give to the HCP a letter of positive response (AFR-HN-FS-15) If not, the Reps give to the HCP a letter of refusal (AFR-HN-FS-13)
ANSWER
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The Rep give to the HCP all documents concerning our support to the congress (RECORDING, flight tickets, hotel booking…) and get the HCP signature on the attestation of receipt (AFR-HN-FS-17)
ATTESTATION OF RECEIPT
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During the event, the Reps have the attendance list signed by all attendees (Template AF-HN-FS-18)
ATTENDANCE LIST
If it has been concluded with the HCP that Danone will pay for minor costs directly to the HCP (ex. taxi, fuel), the Reps give the HCP a letter of reimbursement (AFR-HN-FS-16), retrieve the proofs and proceed to the payment to the HCP
REIMBURSEMENT
- After the event, the Reps complete the event in PITCHER also mentioning costs.
- The Reps archive all documents in relation with the event according to the local archiving process (ex. internal form, letter of sollicitation, attendance list, quotation, invoices…)
RECORDING & ARCHIVING
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SUPPORTING hcps TO THIRD PARTIES EVENTS: CONGRESS – points OF ATTENTION
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Not allowed for HCPs from paediatric universe
INVITATIONS
RULES TO RESPECT FOR THE ORGANISATION
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- Only HCPs can be invited. Their families (children, spouses) are never invited.
- If the HCP wishes to come with his/her spouse, the whole trip for the spouse is paid and organised by the HCP. The spouse will not be able to participate to the possible Danone activities organised during the event
- For GO-HCP, the authorization of the employer is necessary. If it is not possible, a validation from DNAF HCM is requested.
- HCPs from the paediatric universe can not be supported by Nutricia to attend third parties’ events.
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- Events organised by a third party (= local or international congresses) must only have a scientific content.
- No entertainment during more than 20% of the total duration of the Event
- The dates of the trip must be closely in relation with the agenda of the event (ex : no support for extra days before or after the event). If the HCPs wishes to extend their stays, they have to do it by themselves, contacteing directly the travel agency.
- No 100% support of HCPs. (HCPs must pay some costs like meals for ex.)
- It is forbidden to give cash nor gifts to HCPS. Only minor costs can be reimbursed to HCPS by the Reps or by NSA (fuel, taxi). All other costs like accomodation or transportation must be organized with an agency in charge of the event.
- When a new agency is used, the Supervisor must complete a « TPV » for the agency and archive it
- For a Webinar, if HCPs are gathered to attend, only refreshments can be proposed (not for HCPs from Paediatric universe)
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
INTERNAL APPROVAL FORM
- Selection criteria must be completed for each HCP
- Always mention the date of the request
- For a GO-HCP with no employer HCM validation needed
- The form must be read carefully, and completed by the Supervisor. The Rep is not allowed to sign it. Once done, the Supervisor is in charge of having the document signed , according to the authorized process.
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Adults’ actions
Paeds’ actions
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SUPPORTING hcps TO THIRD PARTIES EVENTS SPECIFIC CASE OF GROUP MEETINGS (=staff)
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Definition reminder : Speaking engagement by a Nutricia Rep or Supervisor, with scientific and/or educational content, at an HCO, upon the request of the Head of Department (attendees are invited by the Head of Department and not by Nutricia).
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RULES TO RESPECT FOR THE ORGANISATION
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- No internal form to complete nor sign
- Only a attendance list is requested
- No reimbursement of any costs to HCP
- The only expenses authorized are providing snacks and/or drinks for the staff attending the Rep’s talk. The maximum amount authorized per event is decided and communicated by the HC Manager, while respecting the maximum amount mentioned in the Local List of Reference for the country. For HCPs’ from Paediatric universe, providing snacks is only possible if the topic of the meeting is science only.
- Archiving : After the event, the Rep complete the event in PITCHER mentioning the costs. Then the Rep archive the attendance list and the invoice for snacks/drinks.
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
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EVENTS & SITE VISITS:
OR
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Reference: AFR-HN-PRO-01-ELN Participation of HCP to Events
EVENTS & SITE VISITS:
OR
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Reference: AFR-HN-PRO-01-ELN Participation of HCP to Events
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Paeds’ actions
Adults’ actions
COLLABORATIONS WITH HCPS
Procedure : AFR-HN-PRO-02- Collaboration with Healthcare professionals
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DEFINITION & POSSIBLE TYPES OF COLLABORATIONS WITH A HCP
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DEfinition OF A Collaboration : SPEAKER, scientific advice, editorial work, scientific research, observationnal studies, other consulting services
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PROHIBITION OF ANY PROMOTION OF « CONCERNED PRODUCTS » (IFFO + YCF) and all Paediatric and adult products *
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
2 TYPES DE Collaboration are authorized :
- Collaboration UNPAID (rare cases)
- Collaboration PAID
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
* IFFO : Infant formula & Follow on formula (0 to 12 months) – YCF : Young child formula (1 to 3 y.o.)
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PROCESS FOR A PAID collaboration
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The Reps complete the internal approval form(AFR-HN-FS-22) and mention the names of the HCP(s) able to provide the service. They send it the to the Supervisor for him/her to read, finalise and sign it.The Supervisor does the TPV to get the approval to work with this HCP. Then the Supervisor gets all the authorized signatures from authorized persons.
INTERNAL APPROVAL
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Once the collaboration has been approved, the Reps propose the collaboration to the HCPs.
PROPOSAL
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If the HCPs agree, the HC Manager completes the template of collaboration contract (AFR-HN-CT-21). He/She sends it to the Reps for them to get the HCP’s signature.Then, the Reps send the contract signed by the HCP to the Supervisor who is in charge of getting the authorized internal signatures.
COLLABORATION CONTRACT
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps gather proofs that the collaboration is effective (photo, video, document…).
PROOFS
- The Reps complete the collaboration in the INVESTMENT TAB with all necessary informations.
- The Reps archive all documents relative to the collaboration according to the local archiving process (ex. internal approval form, contract of collaboration, TPV, proofs…).
RECORDING & ARCHIVING
/!\ Do not have the letter signed before the internal validation is done.
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PROCESS FOR A UNPAID collaboration
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The Reps complete the internal approval form (AFR-HN-FS-22) and mentions the name of the HCP(s) able to provide the service. They send it the to the Supervisor for him/her to read, finalise and sign it.If the collaboration concerns a talk (HCP speaker), the Supervisor does the TPV to get the approval to work with this HCP. Then the Supervisor gets all the signatures from Danone authorized persons.
INTERNAL APPROVAL
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PROPOSAL
Once the collaboration has been approved, the Reps propose the collaboration to the HCPs.
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LETTER OF COLLABORATION
If the HCPs agree, the Reps complete the template of Letter of collaboration (AFR-HN-CT-22) and transmit it to the HCP for signature.
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps gather proofs that the collaboration is effective (photo, video, document…).
PROOFS
RECORDING & ARCHIVING
- The Reps complete the collaboration in the INVESTMENT TAB with all necessary informations.
- The Reps archive all documents relative to the collaboration according to the local archiving process (ex. internal approval form, letter of collaboration, TPV, proofs…).
/!\ Do not have the letter signed before the internal validation is done.
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Collaborate with a hcp – points de attention
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INTERNAL APPROVAL FORM
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COLLABORATIONS
- Selection criteria must be completed for each HCP
- Always mention the date of the request
- For a GO-HCP with no employer HCM validation needed
- The form must be read carefully, and possible completed by the Supervisor. The Rep is not allowed to sign it. Once done, the Supervisor is in charge of having the document signed , according to the authorized process.
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- We are allowed to collaborate with HCPS only, never with an HCO nor an association.
- As much as possible, we make the contract with the employer (HCO). If not possible, the HCO must have given their agreement
- For GO-HCP, the authorization of the employer is necessary. If it is not possible, a validation from DNAF HCM is requested.
- The payment of the collaboration is never made in cash nor equivalent
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
RULES TO RESPECT
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
- During collaborations, it is forbidden to promote « Concerned products » (IFFO and YCF)*, and of any ELN products
- The amount of the fees paid for the collaboration must be compliant with the Local list of reference of the country.
- The template of collaboration contract must not be modified. If the HCP wants to modify it, the contract must then be validated by DNAf Legal department before signature.
- When a new agency is used, the Supervisor must complete a « TPV » for the agency and archive it.
- TPV is mandatory for all HCPs, even if the HCP is not paid (as he/she acts for Danone). The Supervisor must create the TPV BEFORE asking the internal approval form to be signed.
SPECIFIC CASE OF OBSERVATIONAL STUDIES
- To make an observational study, the HC Manager will refer to the HCM to know the process.
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* IFFO : Infant formula & Follow on formula (0 to 12 months) – YCF : Young child formula (1 to 3 y.o.)
Collaboration:
OR
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Reference: AFR-HN-PRO-02-ELN Collaboration with Healthcare professionals
Collaboration:
OR
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Reference: AFR-HN-PRO-02-ELN Collaboration with Healthcare professionals
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Paeds’ actions
Adults’ actions
GIFTS & HOSPITALITY
Not allowed
Procedure : AFR-HN-PRO-05- Gifts & hospitality
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GIFtS TO HCPS
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Not allowed for HCPs from paediatric universe
Remittiing gifts to HCPs is a very sensitive subject because Danone could easily be accused of corruption. As a result, the procedure is very strict.
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A GIFT can be give to a HCP only for:
- Religious celebration (ex. Ramadan)
- National days (ex. Women’s rights days)
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- A gift cannot be offered at the request of the HCP.
- The gift must be intended only for the HCP and not for their family or friends.
- The gift must not bear any product or company branding (i.e., unbranded).
- The gift cannot be given in exchange for prescriptions.
- The HCP does not have to sign any document when receiving a gift.
- The gift can be purchased by the Rep/Supervisor who will be reimbursed through an expense report (A&P expense sheet), or it can be bought in bulk directly from a referenced supplier and thus paid by invoice.
- The gift must be recorded in the INVESTMENT TABLE with all necessary information (name of the HCP, HCO, gift details, price).
- Archiving: the purchase invoice for the gift is archived
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
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GIFTS TO HCPS- LOCAL LIST OF REFERENCE
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Not allowed for HCPs from paediatric universe
A gift must imperatively be chosenin this list:
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The cost of authorized gifts and their frequency are strictly regulated:
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- Candles
- Flower Bouquets
- Non-alcoholic gourmet gift box
- Cakes
- Scarfs
- Water bottle
- Ramadan kit
- Office equipment (stapler, pens, etc.)
- Traditional clothes
- Presentation pointers
- Food products (fruits, chocolats, coffee, etc…)
- Cloth bag
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
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1€=19,15R
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GOODIES FOR HCPS
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Not allowed for HCPs from paediatric universe
DEFINITION of GOODIES : Low value object given to HCP to maintain relationship
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- Goodies are for HCPs and not for Consumers
- Goodies can be Nutricia branded or can have no brand.
- Goodies can not be MEDICAL MATERIAL
- Goodies can be purchased by the Rep/Supervisor who will be reimbursed through an expense report (A&P expense sheet), or it can be bought in bulk directly from a referenced supplier and thus paid by invoice.
- The number of goodies per HCP per year is fixed by the HC Manager.
- Goodies must be reported in the INVESTIMENT TAB with all the necessary details (specific page GOODIES/SNACK)
- Archiving: the purchase invoice for the gift is archived
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GOODIES for HCPs - local LIST of REFERENCE
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Not allowed for HCPs from paediatric universe
Goodies must imperatively be chosen in this list :
The cost of goodies are strictly regulated:
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- Agenda
- External battery
- Tissue box
- Nominative stamp
- Notebook,
- Calendar
- USB key
- Fan
- Water bottles, mugs, cups
- Clocks
- Office equipment (staplers, paper clips, desk pads, pens, mouse pads, post-its, calculator)
- Umbrella
- Presentation pointer
- Paper press
- Collect change
- Fabric bag
- Pens
- Kits
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
+ branded goodies developped by Marketing teams
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1€=19,15R
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Warning: DO NOT CONFUSE GIFTS WITH GOODIES
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GOODIES
GIFTS
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Issued to an HCP only for:
- Religious celebration (ex. Ramadan)
- National days (ex. Women’s rights days)
- Short list defined and non negotiable
- Max cost : 35 euros (30 euros for GO-HCP)
- Frequency : 2 per year per HCP
- Low value object given to HCPs to maintain relationship
- For any occasion considered as appropriate byt the Rep/Supervisor
- Defined list, other proposals can be assessed by HCM and Quality Managers
- Max cost: 20 euros
- Frequency fixed by the HC Manager
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HOSPITALITY
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Definition : invitation of a HCP for lunch or dinner
Not allowed for HCPs from paediatric universe
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POSSIBILITY # 1
- Invitations for lunch or dinner in a restaurant
- Invoice paid by the Rep (reimbursement on A&P expense form)
- TO BE REPORTED IN THE INVESTMENT TAB
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
POSSIBILITY # 2
- Snack offered to a HCP during a call (takeaway meal/ drinks, cereals barres, fruits…)
- Invoice paid by the Rep (reimbursment on A&P expense form)
- TO BE REPORTED IN THE INVESTMENT TAB : specific page GOODIES/SNACK
31
Paeds’ actions
HOME TAB
HOME TAB
Adults’ actions
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HCP consent for digital documents / INFORMATION
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FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Procedure : AFR-HN-PRO-06 - HCP consents for digital documents / information
32
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HCP consent for digital documents / INFORMATION
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- HCPs must give their agreement to receive informative messages on their phone or by email.
- Collecting this agreement is done on PITCHER (e-consent module) and is valid for 1 year.
- Any written communication given to a HCP must have been previously validated by the Group Claim.
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
33
Adults’ actions
Paeds’ actions
HOME TAB
HOME TAB
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Not allowed
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Donations of Samples
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Click 'Reset Slide' button to revert the slide to its original layout & font
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Procedure : AFR-HN-PRO-08- Donations of Samples & Products for HCP Exclusive Usage (EUP)
34
Donations OF samples of adults products– HOW TO PROCEED
HOME TAB
Use ‘Indent’ button for subheader
HOME TAB
When the HC Manager has given his agreement to give samples to HCPs, the Reps complete the Sampling approval form (AFR-HN-81) to request approval of the list of HCPs who will receive samples of adult products
HCPS’ APPROVAL
Use ‘Indent’ button for text formats
When the internal approval form is signed,
- The Reps mention the names of the product given, the quantity and the expiry dates on the attestation of receipt of Samples (AFR-HN-FS-83),
- The Reps request the HCP’s signature
- The Reps give the product to the HCP, ensuring that the product properly bears the 'Free product for HCP' label
ATTESTATION OF RECEIPT
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps completes the Investment tab (page Samples & EUP) and archives all associated documents
RECORDING & ARCHIVING
35
HOME TAB
Donations OF samples of adults products– POINTS OF ATTENTION
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Adults’ actions
HOME TAB
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- Samples can be given only if the HC Manager authorizes it
- Samples must imperatively have a specific label difficult to take off with the mention : « Free product - not for sales». These labels must be given to the Reps together with the products.
- The number of products that can be given has been defined by the Compliance Committee : 100 units per year per hospital (units meaning the smallest unit. Ex. for a pack containing 4 bottles, the unit is the bottle, not the pack)
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
36
HCS DIRECTIVE ZA part1
Isabelle Malafosse
Created on September 2, 2025
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Transcript
HOME TAB
HOME TAB
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July 2025
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HCS DIRECTIVE
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COMPLIANCE FRAMEWORK FOR HN ACTIVITIESSOUTH AFRICA
Start
SLIDE FILL
PICTURE TAB
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HOME TAB
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AGENDA
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Use ‘Indent’ button for subheader
HOME TAB
HOME TAB
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Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
Click 'Reset Slide' button to revert the slide to its original layout & font
Internal training for hn teams 6 do no share nor remit to externals
PICTURE TAB
PICTURE TAB
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HOME TAB
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1- WHY A Hcs COMPLIANCE programme AT danone?
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Why A Compliance program AT DANONE?
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INTERNATIONAL PRESSURE
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Increasing number of anti-corruptions laws which are extraterritorial, allowing authorities to sue companies anywhere in the world and simultaneously in several countries
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FTSE4GOOD INDEX
Internal training for hn teams 6 do no share nor remit to externals
Danone has entered into the “FTSE4Good Index” in 2016, that implies being compliant with corporate social responsibility criteria
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
B-CORP
Danone is “B-Corp” certified”, a certification given to companies having a benefic impact on the world. This certification imposes social, societal (including compliance) and environmental criteria.
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2-FROM WHO CODE TO 8 procEdures AT Dnaf
FROM WHO CODE… TO OUR OWN DANONE COMMITMENTS
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WHO code regulates marketing practices for breast milk substitutes
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Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
HOME TAB
FOR MORE information ON WHO CODE
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LET’S CONNECT TO SIKI ! « Coe – decodING W.H.O. code »
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Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Paeds’ actions
Adults’ actions
restrictions
HCS COMPLIANCE DIRECTIVE – THE CONTENT
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Interactions with Healthcare Professionals (HCPs)
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Collaboration with HCPs
HCPs’ consents for digital information/documents
Inviting and/or supporting HCPs to Events (Danone’s or 3rd parties’)
Donations of Samples & Products for HCP Exclusive Usage (EUP)
Giving Gifts and Hospitality
HOME TAB
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Click 'Reset Slide' button to revert the slide to its original layout & font
Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Interactions with Healthcare Organizations (HCOs)
No relevant for ZA
Calls to Tenders
Sponsorships
Grants & Donations
DEFINITIONS TO BE KNOWN
HOME TAB
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HCM
Healthcare systems Compliance Manager = Fanny Lebouc
A person who practices a profession in the medical, dental, pharmaceutical, dietetic, nutritional or nursing field, a midwife or any other person who, in the course of his or her professional activity, may prescribe, or purchase, provide, recommend or administer on behalf of a patient, a nutritional product or perform a health service. A HCP can also be an opinion leader, which includes KOLs and all other types of experts who have an influence on the Health System.
HCP
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A public or private, for-profit or not-for-profit healthcare organization
HCO
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Government Official HealthCare Professional Any HCP working in a university hospital or public health facility AND Who holds a legislative, administrative or judicial position;OR who is responsible for procurement or Head of department in an administrative position within a HCO or member of the board of a public health care organization (HCO);OR who is actively involved in the pricing, RECORDING, clearance or formulation processes of our product in a country; OR who is President of the Paediatric Society/ association.
Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
GO-HCP
TPV
Third Party Vetting / A Danone online third-party assessment tool (distributors, marketing agencies, HCPs, etc.) used to assess the integrity of our partners and the risks (corruption, unethical practices, reputation, etc.) that they could represent for Danone. At HN, it is used by Supervisors and HC Managers.
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HOME TAB
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HOME TAB
RIGHT CLICK
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Click ‘Right Mouse button’ on photo and select ‘Send to back’ or reset slide
INTERACTIONS WITH HCP: 5 PROCEDURES
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PICTURE TAB
PICTURE TAB
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10
HOME TAB
HOME TAB
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Adults’ actions
Paeds’ actions
HOME TAB
Under conditions
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EVENTS & VISITS
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Procedure : AFR-HN-PRO-01- Participation of Healthcare professionals to Events
11
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HCS DIRECTIVE DEFINes different possible types of INVITATIONS
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EVENTS ORGANISED BY THRID PARTIES
EVENTS ORGANISed by DANONE
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- International congresses
Ex. ESPGHAN- LOCAL CongrESS
Ex. AFPN congress /!\ includes WEBINAR- STAFFS – GROUP MEETINGS
= HCPs’ meetings insite a HCO, organised by the HCO and in which Nutricia is invited to speak.- LOCAL EVENTS < 50 ATTENDEES
Ex. round-tables, VIP dinners- LOCAL EVENTS > 50 ATTENDEES
Ex. Symposium- PANAFRICAN EVENTS
Ex. RANI- VISITS OF DANONE SITES
Ex. visit to the Utrecht research center /!\ includes WEBINARSClick 'Reset Slide' button to revert the slide to its original layout & font
Internal training for hn teams 6 do no share nor remit to externals
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Possible to support HCPs
Possible to invite HCPs
12
HOME TAB
Invite hcps TO DANONE EVENTS – HOW TO PROCEED
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The Reps identify HCPs they wish to invite They complete the internal approval form (AFR-HN-FS-12) and send it to their Supervisor for her to read / finalise and sign. The Supervisor is in charge of getting the signatures of Danone authorized persons.
INTERNAL APPROVAL
HOME TAB
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When they receive the approved list of guests invited, the Reps transmit the written official invitation to the HCP (either provided by Marketing, or completed as from the form (AFR-HN-FS-14)) and keep a copy that will be archived
INVITATION
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Internal training for hn teams 6 do no share nor remit to externals
ATTENDANCE LIST
During the event, the Reps have the attendance list signed by all attendees (Template AF-HN-FS-18) For webinars, they take a screenshot with date and time, and keep it for archiving.
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
If it has been concluded with the HCP that Danone will pay for minor costs directly to the HCP (ex. taxi, fuel), the Reps give the HCP a letter of reimbursement (AFR-HN-FS-16), retrieve the proofs and proceeds to the payment to the HCP
REIMBURSMENT
RECORDING & ARCHIVING
13
HOME TAB
Invite hcps TO DANONE EVENTS –– points OF Attention
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RULES TO RESPECT FOR THE ORGANISATION
INVITATIONS
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Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
INTERNAL APPROVAL FORM
14
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SUPPORTING hcps TO THIRD PARTIES EVENTS: CONGRESS – HOW TO PROCEED
Not allowed for HCPs from paediatric universe
Use ‘Indent’ button for subheader
The Reps gets from HCPs a letter of sollicitation duly completted with all necessary information (template AF-HN-FS-11)
SOLLICITATION
HOME TAB
The Reps complete the Internal approval form (AFR-HN-FS-12) and send it to the Supervisor for him/her to read, finalise and sign.. The Supervisor is in charge of getting the signatures from Danone authorized persons.
INTERNAL APPROVAL
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If the request is approved, the Reps give to the HCP a letter of positive response (AFR-HN-FS-15) If not, the Reps give to the HCP a letter of refusal (AFR-HN-FS-13)
ANSWER
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Internal training for hn teams 6 do no share nor remit to externals
The Rep give to the HCP all documents concerning our support to the congress (RECORDING, flight tickets, hotel booking…) and get the HCP signature on the attestation of receipt (AFR-HN-FS-17)
ATTESTATION OF RECEIPT
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
During the event, the Reps have the attendance list signed by all attendees (Template AF-HN-FS-18)
ATTENDANCE LIST
If it has been concluded with the HCP that Danone will pay for minor costs directly to the HCP (ex. taxi, fuel), the Reps give the HCP a letter of reimbursement (AFR-HN-FS-16), retrieve the proofs and proceed to the payment to the HCP
REIMBURSEMENT
RECORDING & ARCHIVING
15
SUPPORTING hcps TO THIRD PARTIES EVENTS: CONGRESS – points OF ATTENTION
HOME TAB
Use ‘Indent’ button for subheader
Not allowed for HCPs from paediatric universe
INVITATIONS
RULES TO RESPECT FOR THE ORGANISATION
HOME TAB
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
INTERNAL APPROVAL FORM
16
Adults’ actions
Paeds’ actions
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SUPPORTING hcps TO THIRD PARTIES EVENTS SPECIFIC CASE OF GROUP MEETINGS (=staff)
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Definition reminder : Speaking engagement by a Nutricia Rep or Supervisor, with scientific and/or educational content, at an HCO, upon the request of the Head of Department (attendees are invited by the Head of Department and not by Nutricia).
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RULES TO RESPECT FOR THE ORGANISATION
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Internal training for hn teams 6 do no share nor remit to externals
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
17
EVENTS & SITE VISITS:
OR
18
Reference: AFR-HN-PRO-01-ELN Participation of HCP to Events
EVENTS & SITE VISITS:
OR
18
Reference: AFR-HN-PRO-01-ELN Participation of HCP to Events
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Paeds’ actions
Adults’ actions
COLLABORATIONS WITH HCPS
Procedure : AFR-HN-PRO-02- Collaboration with Healthcare professionals
19
DEFINITION & POSSIBLE TYPES OF COLLABORATIONS WITH A HCP
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DEfinition OF A Collaboration : SPEAKER, scientific advice, editorial work, scientific research, observationnal studies, other consulting services
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PROHIBITION OF ANY PROMOTION OF « CONCERNED PRODUCTS » (IFFO + YCF) and all Paediatric and adult products *
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INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
2 TYPES DE Collaboration are authorized :
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
* IFFO : Infant formula & Follow on formula (0 to 12 months) – YCF : Young child formula (1 to 3 y.o.)
20
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PROCESS FOR A PAID collaboration
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The Reps complete the internal approval form(AFR-HN-FS-22) and mention the names of the HCP(s) able to provide the service. They send it the to the Supervisor for him/her to read, finalise and sign it.The Supervisor does the TPV to get the approval to work with this HCP. Then the Supervisor gets all the authorized signatures from authorized persons.
INTERNAL APPROVAL
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Once the collaboration has been approved, the Reps propose the collaboration to the HCPs.
PROPOSAL
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If the HCPs agree, the HC Manager completes the template of collaboration contract (AFR-HN-CT-21). He/She sends it to the Reps for them to get the HCP’s signature.Then, the Reps send the contract signed by the HCP to the Supervisor who is in charge of getting the authorized internal signatures.
COLLABORATION CONTRACT
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps gather proofs that the collaboration is effective (photo, video, document…).
PROOFS
RECORDING & ARCHIVING
/!\ Do not have the letter signed before the internal validation is done.
21
HOME TAB
PROCESS FOR A UNPAID collaboration
Use ‘Indent’ button for subheader
The Reps complete the internal approval form (AFR-HN-FS-22) and mentions the name of the HCP(s) able to provide the service. They send it the to the Supervisor for him/her to read, finalise and sign it.If the collaboration concerns a talk (HCP speaker), the Supervisor does the TPV to get the approval to work with this HCP. Then the Supervisor gets all the signatures from Danone authorized persons.
INTERNAL APPROVAL
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PROPOSAL
Once the collaboration has been approved, the Reps propose the collaboration to the HCPs.
Click 'Reset Slide' button to revert the slide to its original layout & font
LETTER OF COLLABORATION
If the HCPs agree, the Reps complete the template of Letter of collaboration (AFR-HN-CT-22) and transmit it to the HCP for signature.
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps gather proofs that the collaboration is effective (photo, video, document…).
PROOFS
RECORDING & ARCHIVING
/!\ Do not have the letter signed before the internal validation is done.
22
Collaborate with a hcp – points de attention
HOME TAB
23
INTERNAL APPROVAL FORM
Use ‘Indent’ button for subheader
COLLABORATIONS
HOME TAB
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
RULES TO RESPECT
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
SPECIFIC CASE OF OBSERVATIONAL STUDIES
23
* IFFO : Infant formula & Follow on formula (0 to 12 months) – YCF : Young child formula (1 to 3 y.o.)
Collaboration:
OR
24
Reference: AFR-HN-PRO-02-ELN Collaboration with Healthcare professionals
Collaboration:
OR
24
Reference: AFR-HN-PRO-02-ELN Collaboration with Healthcare professionals
HOME TAB
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Paeds’ actions
Adults’ actions
GIFTS & HOSPITALITY
Not allowed
Procedure : AFR-HN-PRO-05- Gifts & hospitality
25
HOME TAB
GIFtS TO HCPS
Use ‘Indent’ button for subheader
Not allowed for HCPs from paediatric universe
Remittiing gifts to HCPs is a very sensitive subject because Danone could easily be accused of corruption. As a result, the procedure is very strict.
HOME TAB
A GIFT can be give to a HCP only for:
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
26
HOME TAB
27
GIFTS TO HCPS- LOCAL LIST OF REFERENCE
Use ‘Indent’ button for subheader
Not allowed for HCPs from paediatric universe
A gift must imperatively be chosenin this list:
HOME TAB
The cost of authorized gifts and their frequency are strictly regulated:
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
27
1€=19,15R
HOME TAB
28
GOODIES FOR HCPS
Use ‘Indent’ button for subheader
Not allowed for HCPs from paediatric universe
DEFINITION of GOODIES : Low value object given to HCP to maintain relationship
HOME TAB
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Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
28
HOME TAB
GOODIES for HCPs - local LIST of REFERENCE
29
Use ‘Indent’ button for subheader
Not allowed for HCPs from paediatric universe
Goodies must imperatively be chosen in this list :
The cost of goodies are strictly regulated:
HOME TAB
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
+ branded goodies developped by Marketing teams
29
1€=19,15R
HOME TAB
30
Warning: DO NOT CONFUSE GIFTS WITH GOODIES
Use ‘Indent’ button for subheader
HOME TAB
GOODIES
GIFTS
Use ‘Indent’ button for text formats
Issued to an HCP only for:
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
30
HOME TAB
HOSPITALITY
31
Use ‘Indent’ button for subheader
Definition : invitation of a HCP for lunch or dinner
Not allowed for HCPs from paediatric universe
HOME TAB
POSSIBILITY # 1
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
POSSIBILITY # 2
31
Paeds’ actions
HOME TAB
HOME TAB
Adults’ actions
Use ‘Indent’ button for subheader
Click 'New Slide' button to insert a slide tailored to your content.
HOME TAB
Use ‘Indent’ button for text formats
HCP consent for digital documents / INFORMATION
Click 'Reset Slide' button to revert the slide to its original layout & font
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Procedure : AFR-HN-PRO-06 - HCP consents for digital documents / information
32
HOME TAB
HCP consent for digital documents / INFORMATION
Use ‘Indent’ button for subheader
HOME TAB
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
33
Adults’ actions
Paeds’ actions
HOME TAB
HOME TAB
Use ‘Indent’ button for subheader
Click 'New Slide' button to insert a slide tailored to your content.
Not allowed
HOME TAB
Donations of Samples
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
Procedure : AFR-HN-PRO-08- Donations of Samples & Products for HCP Exclusive Usage (EUP)
34
Donations OF samples of adults products– HOW TO PROCEED
HOME TAB
Use ‘Indent’ button for subheader
HOME TAB
When the HC Manager has given his agreement to give samples to HCPs, the Reps complete the Sampling approval form (AFR-HN-81) to request approval of the list of HCPs who will receive samples of adult products
HCPS’ APPROVAL
Use ‘Indent’ button for text formats
When the internal approval form is signed,
ATTESTATION OF RECEIPT
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
The Reps completes the Investment tab (page Samples & EUP) and archives all associated documents
RECORDING & ARCHIVING
35
HOME TAB
Donations OF samples of adults products– POINTS OF ATTENTION
Use ‘Indent’ button for subheader
Adults’ actions
HOME TAB
Use ‘Indent’ button for text formats
Click 'Reset Slide' button to revert the slide to its original layout & font
INTERNAL TRANING FOR HN TEAMS – DO NOT SHARE NOR REMIT TO EXTERNALS
FORMATION INTERNE A DESTINATION DES EQUIPES HN – NE PAS DIFFUSER
36