Let the Sunshine in - Global MedTech Compliance...
Transcript of Let the Sunshine in - Global MedTech Compliance...
U.S.state&Federallegislation
BelgiumCodeofConduct
Denmarklegislation
GlobalTransparencyLandscape- Medtech
JFMDACodeofConduct
Francelegislation Netherlands
legislation
Romanialegislation
MedTechEuropecodeofethics
U.S.state&Federallegislation
BelgiumCodeofConduct
Denmarklegislation
GlobalTransparencyLandscape- +Pharma
JFMDACodeofConduct
Francelegislation Netherlands
legislation
Romanialegislation
JPMACodeofConduct
AustraliaCodeofConduct
CanadaVoluntaryCode
LuxembourgCodeofConduct
Turkeylegislation
IcelandCodeofConduct
EFPIA Code33EUcountries
Add’lU.S.states(pharmaonly)
MedTechEuropecodeofethics
U.S.state&Federallegislation
BelgiumCodeofConduct
Denmarklegislation
GlobalTransparencyLandscape- +Emerging/Watchlist
JFMDACodeofConduct
Francelegislation Netherlands
legislation
Romanialegislation
JPMACodeofConduct
AustraliaCodeofConduct
CanadaVoluntaryCode
LuxembourgCodeofConduct
IcelandCodeofConduct
EFPIA Code33EUcountries
Add’lU.S.states(pharmaonly)
ColumbiaDraftResolution
IndiaWatchlist
ChinaWatchlist
Turkeylegislation
MedTechEuropecodeofethics
S.KoreaWatchlist
EuropeanGeneric&BiosimilarCode
Slovakialegislation
Bosnia&HerzegovinaWatchlist
NewZealandWatchlist
www.efpia.eu 7
• The R&D-based pharmaceutical industry is committed to working in partnership with allstakeholders to improve healthcare across Europe. The creation of new or improvedmedicines relies upon the collaboration between healthcare professionals and thepharmaceutical industry
• Industry is conscious of the importance of providing accurate, fair and objectiveinformation about itsmedicines to allow rational decisions to be made about their use
• In the same spirit, industry is committed to working towards greater transparency,accountability and ethical behaviour within an industry framework of self-regulation, whichhas been successful in protecting clinical independence but the expectations are increasingand we need to keep up with these
• Therefore, EFPIA will continue to develop additional guidance around areas where industry’scredibility is engaged
Legitimatecollaboration
www.efpia.eu 8
EFPIADisclosureCode
What?Paymentsmadedirectlyorindirectly toHCPsandHCOsforactivitiessuchasadvisory boards, speakingandchairingmeetingandconsultancy
Whatisnotcovered?PaymentsrelatedtoOTC,commercialactivities,mealsanddrinks, etc.
Where?TheEFPIACodecoversthe28memberstatesoftheEUplus:Norway,Russia,Serbia,Switzerland,Turkey,Ukraine
When?Companieswilldisclose paymentsbefore30June2016forpayments
madein2015
Why?Disclosure ofpaymentsisabout
securingthebasis forcollaborationinthefuture
Where?Companywebsitesor
whereavailable,centralplatformsfordisclosure
www.efpia.eu 9
DisclosureCategories
LevelofDisclosure Disclosure Categories
Aggregate Research & DevelopmentToV to HCPs/HCOs related to the planning and conduct of:
a. Non-clinical studies (as defined in the OECDPrinciples of GLP)b. Clinical trials (as defined in Directive 2001/20/EC)c. Non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or
groups of, HCPs specifically for the study (cfr Section 15.02 of the EFPIA HCP Code)
Individual HCORecipient
Donations&GrantstoHCOsContributiontocostsofeventsØ Sponsorship agreements with HCOs/third parties appointed by HCOs to manage an eventØ Registration feesØ Travel & accommodation
Fee-for-service&consultancyØ FeesØ Related expenses agreed in the fees for service or consultancy contract
Individual HCPRecipient
ContributiontocostsofeventsØ Registration feesØ Travel & accommodation
Feesforservice&consultancyØ FeesØ Related expenses agreed in the fees for service or consultancy contract
Eachcompanyshallpublishanotesummarisingthemethodologies usedinpreparing theirdisclosuresandidentifying transfers of valueforeachcategory describedabove(Methodological Note).
SCHEDULE2- TEMPLATEDateofpublication: ………………..
Full Name
HCPs: City of Principal Practice HCOs: city where
registered
Country of Principal Practice
Principal Practice Address
Unique country identifier
OPTIONAL
Donations and Grants to HCOs
(Art. 3.01.1.a)
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)
TOTAL OPTIONAL
(Art. 1.01) (Art. 3) (Schedule 1) (Art. 3) (Art. 3)
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
HCPs
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 amountOTHER, 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
HCO
s
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 OptionalOTHER, 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
R &D
AGGREGATE DISCLOSURE
Transfers of Value re Research & Development as defined - Article 3.04 and Schedule 1 TOTAL AMOUNT OPTIONAL
latest update: 11 December 2013 v1
Disclosuretemplate