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EFPIA Implementation&

Analysis of Data

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Presenters

Dario GhoddousiVP Product Management, Compliance Solutions, QuintilesIMSdghoddousi@it.imshealth.com

Ned MumtazPractice Leader Life Sciences, qordataned.mumtaz@qordata.com

Copyright © 2016 QuintilesIMS. All rights reserved.

Transparency Landscape in EuropeEFPIA code Implementation

Dario GhoddousiVP Product Management, Compliance Solutions

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201520142013

First Publication as per EFPIA Code

EFPIA Code of Disclosure

EFPIA Code Transposition at National Level

Data collection by member companiesDisclosure consent

Collection

Aggregate R&D

Individual HCO

Individual HCP

First Disclosure by June 30th 2016 based on 2015 data

European Transparency Code

2016

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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EFPIA Template for Reporting

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Local Transpositions: Examples

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Global Compliance: Country, Federal &State Laws Regional & Country Codes

US Federal + State Laws Washington

D.C., Massachusetts,

Minnesota, Vermont, etc.

Portugal - Law Slovakia - Law

Estonia - LawEFPIA Code covering 33 country

members + Iceland & LuxembourgLocal transposition of the EFPIA Code completed for all countries

Japan Code

Australia Code

Netherlands Code

UK Code

Greece - Law

France - Law Denmark - Law

Romania - Law

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• At the end of the local transposition process only CYPRUS and MALTA are using the original EFPIA template with no changes

• Several last minute changes or clarifications impacting the June 2016 report format> January 5th 2016: ROMANIA new reporting format> March 8th 2016: IRELAND new publication platform and new format> March 18th 2016: SLOVAKIA new reporting format> May 17th 2016: ITALY added a second language> June 29th 2016: GREECE Data Protection Authority clarified which event type to

disclose individually

Local Transposition Process

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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Example of Governmental web site: US

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Example of Governmental web site: France

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Example of Association web site: UK

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Example of National Link page

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Forms of publication at June 2016

Central Platform provided by Local Association

Central Platform provided by Governmental Body

Company PDF with National Link page

Company PDF

Belgium Denmark Australia Austria

Czech Republic France Cyprus Bulgaria

Ireland Portugal Finland Croatia

Netherlands Romania Germany Estonia

UK Slovakia Iceland Greece

US Federal Latvia Hungary

Lithuania Italy

Luxembourg Japan

Norway Malta

Poland Slovenia

Sweden Spain

Ukraine Russia

Serbia

Switzerland

Turkey

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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Languages and Alphabets

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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54 deadlines (ex US) in 2017 1/2

IMS Health Confidential

Country Jan 17 Feb 17 Mar 17 April 17 May 17 June 17 July 17 Aug 17 Sept 17 Oct 17 Nov 17 Dec 17Australia √ √ √Austria √Belgium √Bulgaria √Croatia √Cyprus √

Czech Republic √Denmark √Estonia √Finland √France √ √

Germany √Greece √

Hungary √Iceland √Ireland √

Italy √Japan √

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54 deadlines (ex US) in 2017 2/2

IMS Health Confidential

Country Jan 17 Feb 17 Mar 17 April 17 May 17 June 17 July 17 Aug 17 Sept 17 Oct 17 Nov 17 Dec 17Latvia √

Lithuania √Luxembourg √

Malta √Netherlands √

Norway √Poland √Portugal √ √ √ √ √ √ √ √ √ √ √ √Romania √ √

Russia √Serbia √

Slovakia √ √ √Slovenia √

Spain √Sweden √

Switzerland √Turkey √

Ukraine √United Kingdom √Total 3 2 5 3 2 29 2 2 2 1 1 2

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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Why is Consent Important ?

European Union Directive 95/46/EC and national data protection laws: Data privacy protection rights afforded to EU citizens

EFPIA Disclosure Code: voluntary form of self-regulation

In general, companies must obtain the consent of a recipient of their TOV in order to publicly disclose the individual reporting required by the EFPIA

Disclosure Code in a legal manner

According to Directive 95/46/EC – Article 2 :

(h) 'the data subject's consent' shall mean any freelygiven specific and informed indication of his wishesby which the data subject signifies his agreement to

personal data relating to him being processed.

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• From May 24th 2016, the new General Data Protection Regulation n. 2016/679 (“GDPR”) is officially in force even though it will be applicable for Member States starting from May 25th 2018.

• The GDPR will replace the Directive 95/46/EC, and shall provide a common set of rules for all the 28 EU Countries.

• National Data Protection Laws will, therefore, still apply for the following EFPIA countries: Iceland, Norway, Russia, Serbia, Switzerland, Turkey, and Ukraine.

• Under the GDPR, personal data will be considered as lawfully processed, provided that the consent granted by the data subject (e.g. HCP) is free, specific, informed and unambiguous.

From May 25th 2018

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Where is consent needed now (29 countries)

Code

US

National Association Transposition is explicitly requiring consent

AustriaBelgiumGermanyItalyNorwayPolandSlovakiaSwedenUnited Kingdom

Australia from 2016 d.Spain from 2017 data

Law

*Government backed code**Consent required only for the EFPIA format submission – not required for the gov. submission

National Association Transposition is not explicitly requiring consent

BulgariaCroatiaCyprusCzech RepublicEstoniaFinlandHungaryIcelandIrelandLatviaLithuaniaLuxembourgMaltaRussiaSerbiaSloveniaSwitzerlandUkraine

DenmarkFranceGreeceNetherlands*PortugalRomania

Slovakia**Turkey

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• EFPIA doesn’t clearly specify when consent has to be collected (only that in the methodological note the company should explain the process)

• Consent is typically collected:> At the beginning of the year for a period (that can be one year, two years,

indefinite…) > At the contracting time via the contract> Before publication during the pre-disclosure period

• Consent Revocation option has to be allowed

When is consent collected

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1. No consent – No contract (potential issue with EU Directive 95/46/EC Article 2 (h) )

2. No consent – No consequence

3. No consent – No Immediate consequence but intention not to engage with same HCP next time / next event

Industry Approach to No Consent

We observed three main positions

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Agenda

• Transposition• Platforms• Languages• Deadlines• Consent• Consent Results

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Country Average % YESISLAND 83,2%SWEDEN 80,1%LATVIA 79,9%UK * 70,0%FINLAND 66,1%ESTONIA 64,8%NORWAY 63,3%LITHUANIA 61,8%ITALY 60,2%IRELAND 59,1%CYPRUS 57,8%LUXEMBOURG 45,0%UKRAINE 37,4%GERMANY 32,6%POLAND 22,5%RUSSIA 22,4%SPAIN 20,0%

Analysis on Consent % by Country

Based on June 2016 Reports – 16 Countries analyzed + ABPI estimation for the UK – 576 Companies analyzed – 492 Reports (84 Reports not present / Empty)

Average 54,5 % YES

* ABPI estimation

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Company Average % YESMEDIVIR 100,0%NORPHARMA 100,0%SANOFI PASTEUR 100,0%AEGERION 100,0%WEIFA 100,0%ALEXION 100,0%POLPHARMA 100,0%ALIMERA 100,0%VALNEVA 100,0%CSL 100,0%SICOR 100,0%GALENICA 100,0%HOSPIRA 100,0%JAZZ PHARMACEUTICALS 100,0%AVANTGARDE 98,6%THERABEL 98,5%GSK 96,4%MORFEJUS 96,0%GSK CH 95,4%BIOFUTURA 93,7%BAMA GEVE 91,0%

Analysis on Consent by Company

Based on June 2016 Reports – 16 Countries analyzed – 576 Companies analyzed – 492 Reports (84 Reports not present / Empty)

= > 70 % YES

Company Average % YESEYELAB 90,0%SIGMA TAU 88,0%ORION 87,5%CELGENE 87,2%ACTELION 86,0%ALGOLPHARMA 84,3%BBRAUN 83,5%OCTAPHARMA 83,5%BGP 79,1%IBSA 78,3%ISDIN 77,5%GRIFOLS 77,0%ZAMBON 75,5%SCHARPER 73,9%MYLAN 73,4%VALEAS 73,3%FERRING 73,3%J&J 72,2%GUERBET 72,0%GENESIS 70,1%MEDIGENE 70,0%NORDICDRUGS 70,0%

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Analysis on Consent by Company

Based on June 2016 Reports – 16 Countries analyzed – 576 Companies analyzed – 492 Reports (84 Reports not present / Empty)

Company Average % YESTEVA 68,8%JANSSEN 68,3%SPMSD 67,2%STALLERGENES 65,8%GRINDEX 63,0%LUNDBECK 62,5%AMGEN 61,1%MEDVIR 61,0%SOBI 60,5%SIFI 60,0%MENARINI 59,7%PIERRE FABRE 59,3%BRACCO 58,9%CHIESI 57,8%MERCK 57,5%BIOGEN 56,7%

> 50 % YES

Company Average % YESASTRAZENECA 56,4%GRUNENTHAL 56,3%NOVARTIS 54,9%KRKA 54,8%UCB 54,1%LEO PHARMA 53,8%NOVO NORDISK 53,4%TAKEDA 53,1%ORPHAN 52,6%ALK ABELLO 52,0%SANTEN 52,0%OTSUKA 52,0%ABBVIE 51,5%MUNDIPHARMA 51,0%SANOFI 51,0%PFIZER 50,9%DOMPE 50,9%ALLERGAN 50,2%

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Analysis on Consent by CompanyBased on June 2016 Reports – 16 Countries analyzed – 576 Companies analyzed – 492 Reports (84 Reports not present / Empty)

< 50 % YES

Company Average % YESROCHE 48,2%EGIS 48,2%GEDEON 47,7%GUIDOTTI 47,5%FRESENIUS 46,0%IPSEN 45,6%EISAI 45,5%IBSA BIOCH 45,5%ASTELLAS 45,0%NORGINE 44,4%RECORDATI 44,3%GALDERMA 43,1%ACTAVIS 42,9%GILEAD 42,3%BOEHRINGER INGELHEIM 41,7%SERVIER 41,3%PHOTOCURE 41,3%LILLY 41,1%BAYER 40,5%CHUGAI 40,0%ABIOGEN 36,4%PROPHARMA 35,5%INNOVA 35,1%ITALCHIMICI 34,0%

Company Average % YESMSD 33,0%DAIICHI SANKYO 32,7%KEDRION 31,7%BAXTER 31,3%SHIRE 31,1%ALMIRALL 29,4%JUSTE 28,5%VIFOR PHARMA 27,2%SANDOZ 25,0%BRISTOL-MYERS SQUIBB 24,8%ESTEVE 21,5%ALCON 20,4%ANGELINI 14,3%GENZYME 14,2%ABBOTT 12,3%LABORATORIO REIG JOFRE 11,6%FAES FARMA 10,3%VISUFARMA 4,3%LACER 0,3%BOIRON 0,0%GE 0,0%SEQUIRUS 0,0%QPHARMA 0,0%NAVAMEDIC 0,0%

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Thank You

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Contact us at

quintilesims.com

Rev. 9/30/2016

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1 – Summary of Numbers from 2015 EFPIA disclosure2 – What the numbers may tell us if we look closer3 – EU wide analytics – case study 13 – Country wide analytics – case study 24 – Company wide analytics – case study 35 – Business and compliance considerations6 – Q & A

Agenda:

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EFPIA Consent Analysis Dashboard

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Merck Serono KOL Dashboard Summary

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EFPIA Spend Data Set Availability Timeline

CountryEstimated Date for Data

Availability Total

CompaniesCompanies Available

FranceFull data-set available in EU

Analytics 1276 1276

UKFull data-set available in EU

Analytics 109 109

GermanyJanuary 6th, 2017 Partial data

already available 40 34

ItalyJanuary 6th, 2017 Partial data

already available 42 25

SpainJanuary 6th, 2017 Partial data

already available 42 26Finland January 6th, 2017 34 31Hungary January 6th, 2017 26 19Iceland January 6th, 2017 16

Luxembourg January 31st, 2017 38 25

Slovakia January 31st, 2017 26 20Sweden January 31st, 2017 52 40Ukraine January 31st, 2017 17 10Norway January 31st, 2017 41Poland January 31st, 2017 30

Switzerland January 31st, 2017

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Summary of Numbers from 2015 EFPIA data

The EFPIA transparency directive received its first data set in June of 2015, some 3 months ago. During this time press has questioned the rates of consent received from physicians in reporting spend details, and questioned if the program met its objective.

We will present many numbers – you draw your own conclusions…

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One view of consent ratio’s

35%

65%

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Summary of Numbers from 2015 EFPIA data

• The national press has reported that in in UK a total spend of £300+ M were reported where 70% of physicians consented to have their data included.

• In Germany 20,000 of the 71,000 reportable physicians consented. With data disclosed by 54 companies that represent 75% of the market.

• We found that the ratio’s may be lower.

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What the numbers may be telling us if we look closer

Averages and generalizations are convenient but they may not reveal the true color of disclosure.

Three case studies:

EU wide Country wide (Germany)Company wide (masked)

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Compliance – know where you stand in the context of the industryConsider programs to increase your absolute consent %Consider programs to increase your aggregate consent %Consider programs to increase your nominal consent %

Business – Spend comparison by drug, device, specialty, physician, HCO, etc.Understand your spend end to endMonitor your spend end to endEffectively compare your spend against the industry

Business & Compliance considerations