GlobalTransparency

LettheSunshinein

GlobalTransparencyLandscape

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

EuropeanFederationofPharmaceuticalIndustries&Associations(EFPIA)DisclosureCode

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

www.efpia.eu 11

Implementationchallenges

1. Complying with privacy laws & other regulationsÞ Supportcollective solutions developed at national level

2. CollaborativeworkÞ EFPIA MembersÞ Healthcare communityÞ Healthcareassociations/organisations