Imagination at work

Latest Transparency Reporting UpdatesAround the WorldKatharina Graisy, Compliance Specialist

Benedicte Chassagnoux, Compliance Manager

April 5, 2017

7th Global Transparency Reporting

Congress

4-5 April, 2017/London, UK

TOPICS

I. GEHC compliance/transparency team structure

II. Process for Transparency updates

III. Global Transparency regulations

IV. EMEA Transparency regulations

V. AMERICAS Transparency regulations

VI. APAC Transparency regulations

VII. Outlook for upcoming regulations

VIII. Details about new transparency regulations

IX. Updates on existing transparency regulations

See tutorial regarding confidentiality

disclosures. Delete if not needed.

I. GEHC compliance/transparency team structure

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Global compliance

Transactional ComplianceStrategic

Compliance

Legal

Business/ Super user

GEHC LEGAL

(PHARMA AND DEVICES)

Global

Transparency*

Local

Compliance

Analysts

*5 team members located around the

globe responsible for legal analysis,

reporting and data analytics

Regional

Compliance

Manager

See tutorial regarding confidentiality

disclosures. Delete if not needed.

II. Process for Transparency updates

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Global

Transparency

Team

INTERNAL EXTERNAL

Legal/complianceRegional/product lawyers

Regional compliance managers

R&D /regulatory

BusinessSales

Marketing

External law firms

Industry

associations

Business

consultants

Quarterly compliance meetings & communication

Ad-hoc requests for legal reviews

See tutorial regarding confidentiality

disclosures. Delete if not needed. 5

III. Global Transparency regulations

Law

Code

16 countries

>35 countries

See tutorial regarding confidentiality disclosures. Delete

if not needed.

Code (EFPIA)

Law (pharma and devices)

Currently no reporting

requirements

IV. EMEA Transparency regulations

Law (pharma)

Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech

Republic, Denmark, Estonia,

Finland, France, Germany,

Greece, Hungary, Ireland, Italy,

Latvia, Lithuania, Malta, the

Netherlands, Norway, Poland,

Portugal, Romania, Russia,

Serbia, Slovakia, Slovenia,

Spain, Sweden, Switzerland,

Turkey, Ukraine and the United

Kingdom + Iceland**,

Liechtenstein** and

Luxembourg**

Belgium, Denmark,

France, Israel,

Netherlands*, Portugal and

Romania

Estonia, Latvia, Lithuania,

Greece, Slovakia

underlined-> new regulation/extended scope

*CGR/GMH Code classified as law here (Government backed)

** No EFPIA member countries but committed to disclose voluntarily

See tutorial regarding confidentiality

disclosures. Delete if not needed. 7

Code

Law (pharma and devices)

United States

Canada (Innovative Medicines

Canada)

State Laws (pharma and/or

devices)

United States: Connecticut

Massachusetts,

Minnesota, Vermont

Brazil: Minas Gerais State

V. AMERICAS Transparency regulations

City Laws (pharma and/or

devices)

United States: Washington

D.C., Chicago IL, Miami FL

Currently no reporting

requirements

underlined-> new regulation/extended scope

See tutorial regarding confidentiality

disclosures. Delete if not needed. 8

VI. APAC Transparency regulations

Code

Australia (Medicines Australia

Code/pharma)

Japan (Pharmaceutical

Manufacturers Association

(JPMA)/ Japan Federation of

Medical Devices Association

(JFMDA) codes pharma/devices)

Currently no reporting

requirements

Law (pharma and devices)

Indonesia, South Korea

underlined-> new regulation/extended scope

See tutorial regarding confidentiality

disclosures. Delete if not needed.

VII. Outlook for upcoming regulation

EMEA AMERICAS APAC INDIAPROPOSED Transparency regulation

Scotland (P law)Saudi Arabia ((TBC)

Colombia (TBC)Argentina (TBC)

New Zealand (TBC)Philippines (TBC)

India (TBC)

PASSED Transparency regulation (2016/2017)

Belgium (P+D law) Portugal (D law)

Netherlands (D code)MedTech Code (D code)

Turkey (P law/TBC)

US/CT State (P+D law)US Chicago (P law)

Canada (P code)Brazil/Minas Gerais (P+D law)

South Korea (P+D law)Indonesia (P+D law)

NEWREPORTING IN 2017

Portugal (D law)Turkey (P law/TBC)

US/CT State (P+D law) US Chicago (P law)

Brazil (awaiting agency process)

Indonesia (P+D law)

NEWREPORTING IN 2018

MedTech Europe (D code)Netherlands (D code)

Belgium (P+D law)

South Korea (P+D law)

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P=Pharmaceuticals

D=Medical devices

See tutorial regarding confidentiality

disclosures. Delete if not needed.

Country/State/

Association

Scope Regulation Reportable transactions First report

due

PortugalMedical

devicesLaw(Decree 5/2017)

All direct and indirect transfers of value to

Portuguese HCPs/HCI

2017/30

days after

event

Canada/

Innovative

Medicines

Canada

PharmaCode(2016 Code of

Ethical Practices)

Fees for consulting, speaking and other services

provided by HCPs, T&L (+reg. fee) support for

events and grants

2017

US/CT State

Medical

devices

&

Pharma

Law(Substitute Senate

Bill No. 257/Public

Act No. 15-4)

Gifts, meals and other payments to APRNs 2017

US/Chicago Pharma

Law(Pharmaceutical

Representative

License 2017)

Tracking and reporting of list of HCPs who were

contacted, the location and duration of each

contact, the pharmaceuticals that were

promoted, and whether product samples or any

other compensation was offered in exchange for

the contact

2017

Indonesia

Medical

devices

&

Pharma

Law(Regulation No. 58 of

2016)

T&L (+reg. fee) support for events, HCP

services, sponsoring of events, educational

grants

2017/30

days after

event10

VIII. Details about new transparency regulationsReports due in 2017

See tutorial regarding confidentiality

disclosures. Delete if not needed.

Country/State/

Association

Scope Regulation Reportable transactions First report

due

South Korea

Medical

devices

&

Pharma

Law (Article 47-2 of the

Pharma. Affairs Act and

Article 13-2 of the

Medical Devices Act)

Samples, Clinical trials, Post-market

surveillances, Product presentations to

medical Institutions, Academic conferences,

Price discounts

2018

Netherlands

Medical

devices

Code(Gedragscode

medische hulpmiddelen

(GMH) - Art 22 to 26)

Consultancy services, Advisory board

services, Services for non-interventional

research outside the scope of the Dutch law

on medical research in humans, other

services, Grants/donations (scope will be

expanded)

2018

MedTech

Europe

Medical

devices

Code(Code of Ethical

Business Practice)

Educational Grants 2018

Belgium

Medical

devices

&

Pharma

Law (Chapter I of Title 3,

entitled “Sunshine Act”)

All direct and indirect transfers of value to

Belgian HCPs/HCI incl. meals2018 (TBC)

Brazil/Minas

Gerais State

Medical

devices

&

Pharma

Law (Lei No 22440)

Gifts, T&L (+reg. fee) support for events,

research, services provided by HCPs

2018 (TBC)

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Reports due in 2018

See tutorial regarding confidentiality

disclosures. Delete if not needed.

Country Scope Regulation Changes First report

due

France

Medical

devices

& Pharma

Arrêté » of the New

French Transparency

Law published on

March, 22nd

• Date of all publications (« avantages » and

« conventions ») : March, 1st and on

September, 1st

• Scope of disclosure extended to: veterinaries,

association of students, health protection

groups

• New template to be used starting data

publication from April, 1st 2017

• Exact list of transaction types

• New section for remuneration for consulting

fees, sponsorship, R&D, grant amounts

April 1 2017

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IX. Updates on existing transparency regulations

See tutorial regarding confidentiality

disclosures. Delete if not needed.

Thank you for your

attention!

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