Information Session Sunshine Act - beTransparent

1 Information SessionSunshine ActWELCOME !Marc-Henri Corn lyChairman of Mdeon2 AGENDACONTENT Platform From selfregulationto Sunshine Act Sunshine Act Goal Sunshine Act Scope Nominative publication PrivacyQ&A s 3 NOTIFICATION Registration on Preparation of the file to notify Notification procedure Rectification procedure DemonstrationTRANSPARENCY REGISTER CONTROL & SANCTIONSCOMMUNICATIONQ&A s! Slides are availablein pdf on thehomepage of !4 CONTENT Platform From selfregulationto Sunshine Act Sunshine Act Goal Sunshine Act Scope Nominative publication PlatformSt phanie Brillon Mieke Goossens Director Mdeon Management Committee BTB 5 Agreement byRoyal associationsIndustryMedicalPharmacistsVe terinaryParamedicalHospitaltechniciansNu rses WholesalersPhysiotherapistsDental6 FromSelfregulationtoSunshine Act 7 LawFranceFromselfregulationto Sunshine ActSunshine ActLawDenmarkLawRomaniaLawSlovakia201020 1120132014201520162017 LawPortugalBELGIAN Sunshine DECREE Sunshine device companies members ofBuilding Transparencyin Healthcare RelationshipsFrom selfregulationto Sunshine ActPublication2016 Data 2015 Publication2017 Data 2016 Publication2018 Data 20179 Sunshine Act Goal 10 Sunshine ActGoalPREMIUMS & BENEFITSI ndustryHealthcare professionalsHealthcare

2 OrganisationsPatientorganisations Respondtosocietaldemand Transparency of interactions Trust11 Sunshine Act Scope12 Companies subject tonotification Beneficiariesof premiums andbenefits Premiums andbenefitsSunshine ActScope Companies subject to notification , 1,1 ,SunshineAct: Anyentitythatcarriesoutaneconomicactivit y,irrespectiveofitslegalformandthemanner inwhichitisfinanced,asreferredtoinTitleV IIoftheTreatyconcerningthefunctioningoft heEuropeanUnion,morespecificallyHOLDERS ofplacingonthemarketofmedicinalproductsf orhumanorveterinaryuse,IMPORTERS,MANUFAC TURERSandDISTRIBUTORS ofmedicinalproductsforhumanorveterinaryu se,personsengagedinthebrokeringofmedicin alproductsforhumanorveterinaryuse,anddis tributors,retailersandmanufacturersmedic aldevices =allthepharmaceuticalandmedicaldevicesco mpanies EstablishedinBelgiumorabroad EvenifnoproductontheBelgianmarket!!! EvenifnopremiumorbenefitgrantedtoHCP/HCO /PO13 Sunshine ActScope Beneficiaries of premiums and benefitsHealthCareProfessionals(HCP)Heal thCareOrganisations(HCO)PatientOrganisat ions(PO)Doctor / Dentist / Nurse /Paramedic / Veterinarian /Hospital director / (main)practice in BelgiumSeelist of professionsin ourPractical ModalitiesHospital / Medical practice /Scientific association / PCO Faculty of medicine / fixedplacein BelgiumAlso umbrella associations grouping several patient organisationsWithseator fixedplacein Belgium14 See definitionsin art.

3 1 Sunshine Act (+RD) Sunshine ActScope Premiums and benefits HealthCareProfessionals(HCP)HealthCareOr ganisations(HCO)PatientOrganisations(PO) Fees, payment and reimbursement of costs for SERVICES AND CONSULTANCYC ontributions to PARTICIPATEin SCIENTIFIC EVENTS Contributions to ORGANISESCIENTIFIC EVENTSDONATIONS AND GRANTS that support healthcareFinancial or other SUPPORTSCIENTIFIC RESEARCH15 Pecuniaryor in kindDirectlyor indirectlyofferedNominativepublication16 Nominative publication RULE:thepremiumsandbenefits granteddirectlyorindirectly-aredisclosed onbehalfofthebeneficiary onanindividualbasis EXCEPTION:premiumsandbenefitsgrantedinth econtextofscientificresearcharedisclosed onanaggregatebasis Experimentsonthehumanperson(includesclin icaltrials,prospectivenon-interventional studies) Clinicaltrialswithveterinarymedicinalpro ducts Non-clinicalstudiesasdefinedintheOECDP rinciplesonGoodLaboratoryPractice( Non-clinicalhealthandenvironmentalsafety study,henceforthreferredtosimplyas"study ",meansanexperimentorsetofexperimentsinw hichatestitemisexaminedunderlaboratoryco nditionsorintheenvironmenttoobtaindataon itspropertiesand/oritssafety,intendedfor submissiontoappropriateregulatoryauthori ties ) ,afterwhichtheywillbeerased17 Nominative publication : Support toorganiseinfo dayforpatients documentationforpatients18 Nominative publication HCP : Lectures Advisory boards Scientificarticles.

4 19 Nominative publication HCP publication HCO -fees! Ifno retrocessiontoHCP21 Nominative publication HCO -congress!!! IfHCO usesfunds topayhospitalitytoHCPs disclosureat HCP sname 22 Nominative publication HCO -grants23 Nominative publicationObligationtocollaborateforthe beneficiariesCommunicatedata requiredforpublication24-Unique ID s-Nominativelist of Act: info Session , Data protection aspectsAnnabelle Bruyndonckx,Counsel, Simmons & Simmons12 September , Woluwe-Saint-Lambert11 September 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. Simmons & Simmons LLP26 Sunshine Act: info Session | Data protection aspectsProcessing HCP s personal data Required to ensure compliance with a legal obligation to which data controllers are subject (and no longer with industry codes, which are of an ethical or deontological nature) Obtaining the HCPs consent prior to the processing of their personal data is no longer requiredBefore1 January 2017 After 1 January 2017 Obligation to obtain consent from HCOsNoNoObligation to obtain consent from HCPsYesNoHCPs refusalto provide consentDisclosure in aggregateIrrelevant(refusalmay be overridden)Obligation to inform HCPsYesYes 11 September 2017.

5 Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. Simmons & Simmons LLP27 Sunshine Act: info Session | Data protection aspectsInformation requirement when personal data are obtained GDPR Content of Information notice (check-list) Identity + contact details of the controller, data protection officer (and where applicable controller s representative) Purposes of the processing (publication on ) + Legal basis (Act of 18 December 2016 and RD of 14 June 2017) Recipients or categories of recipients of the personal data (Mdeon, FAMHP, the general public) 10-year retention period(whereas data are publicly disclosed during 3 years) HCPs rights(data access, data rectification / erasure, data portability, restriction of processing, right to lodge a complaint with the Belgian Privacy Commission or any other competent authority) Acknowledgementthat (i) the provision of personal data is a statutory requirement, (ii)

6 The HCP is obliged to provide the personal data, and (iii) failure to provide such data may result in a fine11 September 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. Simmons & Simmons LLP28 Sunshine Act: info Session | Data protection aspectsSecurity Advisor HCP without NIHDI having several NIHDI nos. Identification via HCP s national registration no. Triggers currentlya strict legal regime, with an obligation to obtain an authorisation from the BPC s SectoralCommittee for the national register Compliance with the currentgeneral BPC authorisationimplies that companies subject to disclosure nominate a Security Advisor Consulentvoordeveiligheidendebescherming vandepersoonlijkelevenssfeer/Conseillere ns curit del informationetenprotectiondelaviepriv e Route to comply with the current general BPC authorisation(Guidelines: link ) New Deliberation coming end September FOLLOW UP!

7 Securityruleswillprobablybemucheasiertha nundertheautoregulationsystem ForeigncompaniescanuseNRNC urrent regimeGeneral authorisation provided by BPC Decision (RN no. 51/2015 of 2 September 2015) to be reviewed Key takeawaysSunshine Act: info Session | Data protection aspects4 Consent No longer necessary Interaction with HCPs for the first time Collect all necessary data on time (and by 31/12/2017 at the latest for the first reporting period) Inform HCPs in line with data protection laws when collecting their data Interaction with known HCPs (personal data previously collected) Information requirements remain applicable however, the Information to be provided is extended under the GDPR Add / update data protection clauses in agreements with HCPs Follow up new Deliberation Privacy Commission Simmons & Simmons LLP 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other you for your attentionQuestions ?

8 Key Contact Annabelle Bruyndonckx Counsel T +32 254 209 64 E ContactsFollowus on Twitter @Simmons_LLPQ&A 3132 NOTIFICATION Registration on Preparation of the file to notify Notification procedure Rectification procedure Demonstration33 Registrationon on Homepage: Iamacompany Createoneaccountpercompany: Chooselogin(e-mail)+password 1accountperlegalentityandpercountry=1acc ountperVAT-number CompaniesoutsideEU affiliateorlegalrepresentative Acknowledgementofreceiptofregistration sapplicationbyemail+activationlink Activatetheaccount(viatheprovidedlink) (confirmationbyemail)35 Preparationof thefile tonotify36 Preparationof the file to notify Use (new) Flat Templatedownloadable from the Extranet Format: Excel or csv file Content file: 1 line per beneficiary per year Nominatively (! no more anonymously) Exception: scientific research One total amountper category In EURO, excluding VAT Disclosure year = year of the financial transactionAlways respect the Technical Modalities as well as the following legal notification modalities (see Chapter 3 of the Royal Decree implementing the Sunshine Act)37 Preparationof the file to notifyFlat Template38 Keep the4 linesof titleFillthefile in fromline 5 Preparationof the file to notifyType of beneficiary / Premium -Benefit HCP = healthcare professional HCO = healthcare organisation PO = patient organisation RD = scientific research NPB = no premiums nor benefits granted (empty file)39 Preparationof the file to notifyFlat Template40 Write the official name, as mentioned on -identitycard/NIHDIDB(forHCP)-CBEdatabas e(forHCO/PO)Profession only if Nat.

9 Reg. nr(No column Facultative name HCO anymore)Preparationof the file to notifyUnique Identifiers CBE nr. (DB available on Extranet!) NIHDI nr. (DB available on Extranet!) If no NIHDI or several national registration number (to be provided by the HCP) If none of these ID communicated by BTB41 Preparationof the file to notifyCategories of premiums and benefits42 TechnicalSpecificationsPreparationof the file to notify43 TechnicalSpecificationsPreparationof the file to notify44 Notification procedure (file upload)45 Notification the draft file to of the draft file (automatically) Template complete?/Unique ID correct? (check via external databases) If data incomplete/incorrect report/error message (web or email) potential errors Whenalldataarecomplete/correct confirmthefilebyclicking Iwishtoreceivethedraftfileforvalidationb yemail of PRE-REPORTFOR VALIDATION purposes total amount of uploaded premiums and benefits pdf file showing the data as they will be made public status on the extranet: awaiting notification 46 Notification NOTIFICATION of the file Extranet: NOTIFY Email: general conditions + link to confirm final submission Confirmation of final submission by clicking the link Confirmation by email Extranet status: Sent for publication OF RECEIPT47 ExtranetAnalysisEmail 1 Draft fileExtranet NOTIFY Email 2 Link toconfirmEmail 3 Acknowl.

10 Of receiptStatus file: AwaitingnotificationSent forpublicationNotification calm+ PUBLICATIONRECTIFICATIONas Periodof reference: procedure-Timeline49 First Periodof reference: !Exception:premiumsandbenefitsformedicin alproductsforveterinaryuse first reference year = 2018 first notification =2019 First procedure Update of the Transparency Register: 1stand 15thof each month (due to Privacy legislation) Modify the file where necessary Upload the entire file again (not only the modified lines) Corrective file: as from the 1stof July Privacy corrections:51 Demonstrationof notificationprocedure525321541. Upload draft file6 STEPS552. Analyse of thedraft file563. Correctionof potentialerrors574. Reception of pre-report for validation purposes584. Reception of pre-report for validation purposesOnceJanuary1, status willbeAwaiting for notificationNotify595.