efpia implementation and analysis of data
TRANSCRIPT
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EFPIA Implementation&
Analysis of Data
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Presenters
Dario GhoddousiVP Product Management, Compliance Solutions, [email protected]
Ned MumtazPractice Leader Life Sciences, [email protected]
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