EFPIA Disclosure Code - Kort introduksjon og spørsmål til implementering Kari Heimholt EFPIA Implementation Lead, Sverige, Finland & Norge Pfizer AS 3 mai 2016 Building trust and earning greater respect from society.
Oversikt Offentliggjøring av alle verdioverføringer et firma har til helsepersonell eller helseorganisasjon Offentliggjøres på firmaets nettside (link fra LMI) Offentlig tilgjengelig i 3 år (pluss krav om lagring i ytterligere 5 år) Første offentliggjøring for Norge 30 juni 2016 for verdioverføringer gjort i 2015 Noen land har allerede publisert eller vil publisere før oss Offentliggjøring skal skje i det landet hvor helsepersonellet har sin vesentlige praksis
EFPIA Disclosure Code Roadmap EFPIA Disclosure Publication Timelines Netherlands Provide data to central platform UK, Romania (local law) Belgium Czech Republic Finland, Sweden, Estonia Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Publication Germany, Spain, Austria, Croatia, Hungary, Ireland, Italy, Hungary, Ireland, Belarus, Malta, Russia, Switzerland, Turkey, Slovenia, Ukraine Czech Republic and Belgium (public), Serbia Greece, Slovakia, UK (public) Bulgaria, Cyprus, Lithuania, Norway, Poland, Romania, Latvia Out of scope: France, Portugal, Denmark Building trust and earning greater respect from society. 3
EFPIA Disclosure Code Roadmap EFPIA Disclosure Publication Timelines Netherlands UK Belgium Czech Republic Finland, Sweden, Estonia Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Publication Germany, Spain, Austria, Croatia, Hungary, Ireland, Italy, Hungary, Ireland, Belarus, Malta, Russia, Switzerland, Turkey, Slovenia, Ukraine Serbia, Greece, Slovakia Bulgaria, Cyprus, Lithuania, Norway, Poland, Romania, Latvia Out of scope: France, Portugal, Denmark Building trust and earning greater respect from society. 4
Overview of EFPIA categories Donations and Grants Aggregated level E.g expenses related to; - Clinical Trials - Data Monitoring Committees related to studies - Non Interventional Studies - Investigator- Initiated Research Research & Development Main Expense Type Categories Contribution to cost of Events Split: Registration Fees Travel & Accommodation Sponsorship Split: Fee for service & consultancy Fees Related expenses 5
Hva skal publiseres? Rapporten med verdioverføringer Metodenotatet
SCHEDULE 2 - TEMPLATE Date of publication:.. Full Name HCPs: City of Principal Practice HCOs: city where registered Country of Principal Practice Principal Practice Address Unique country identifier OPTIONAL Contribution to costs of Events (Art. 3.01.1.b & 3.01.2.a) Fee for service and consultancy (Art. 3.01.1.c & 3.01.2.c) (Art. 1.01) (Art. 3) (Schedule 1) (Art. 3) (Art. 3) Donations and Grants to HCOs (Art. 3.01.1.a) Sponsorship agreements with HCOs / third parties appointed by HCOs to manage an Event Registration Fees Travel & Accommodation Fees Related expenses agreed in the fee for service or consultancy contract, including travel & accommodation relevant to the contract TOTAL OPTIONAL INDIVIDUAL NAMED DISCLOSURE - one line per HCP (i.e. all transfers of value during a year for an individual HCP will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate) Dr A N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount Dr B N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount etc. N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount HCPs OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasons Aggregate amount attributable to transfers of value to such Recipients - Art. 3.02 N/A N/A Aggregate HCPs Aggregate HCPs Aggregate HCPs Aggregate HCPs Optional Number of Recipients in aggregate disclosure - Art. 3.02 N/A N/A number number number number Optional % of the number of Recipients included in the aggreate disclosure in the total number of Recipients disclosed - Art. 3.02 N/A N/A % % % % N/A INDIVIDUAL NAMED DISCLOSURE - one line per HCO (i.e. all transfers of value during a year for an individual HCO will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate) HCO 1 Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional HCO 2 Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional etc. Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional HCOs OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasons Aggregate amount attributable to transfers of value to such Recipients - Art. 3.02 Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Optional Number of Recipients in aggregate disclosure - Art. 3.02 number number number number number number Optional % of the number of Recipients included in the aggreate disclosure in the total number of Recipients disclosed - Art. 3.02 % % % % % % N/A AGGREGATE DISCLOSURE R &D Transfers of Value re Research & Development as defined - Article 3.04 and Schedule 1 TOTAL AMOUNT OPTIONAL
Metodenotat Må utarbeides av alle firmaer Forklare hvordan firmaet har bygget opp sine opplysninger Skal være tilgjengelig på hjemmesiden Beregningsmetoder for beløpene (moms, skatt etc.) Hvilke type ToV som ligger i de ulike kategoriene Redegjøre for behandling av personopplysninger Hvordan enkeltpersonsforetak behandles Redegjøre for hvordan verdioverføringer over landegrenser offentliggjøres Oversikt over hva som er offentliggjort (grensen mellom reseptfritt/pliktig, type helsepersonell etc.) Etc
Samtykke HCP + enkeltpersons foretak Krav til samtykke Kan når som helst trekkes tilbake Aggregert (Alle verdioverføringer, ikke «delvis samtykke») HCO Ikke samtykke, skal offentliggjøres Siste Epfia survey resultat for Norge: 49% consented 51% not consented or undetermined