latest transparency reporting updates around the world · latest transparency reporting updates...
Post on 11-Nov-2018
236 Views
Preview:
TRANSCRIPT
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
3
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
4
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)
9
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)
11
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
12
IX. Updates on existing transparency regulations
See tutorial regarding confidentiality
disclosures. Delete if not needed.
Thank you for your
attention!
13
top related