Overview Of The French
Sunshine Act And Decree
“Current Issues In Compliance”, Webinar #5
June 5/6th, 2013
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Overview Of The French Sunshine Act And Decree
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Contents
1. Overview
2. Reporting Timeline
3. Reporting Requirements
Overview Of The French Sunshine Act And Decree
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The Implementation Decree Issued May 21, 2013, Clarifies The
French Sunshine Act (Bertrand Law) For Disclosure Requirements
While French Sunshine Act has been on record since 2011, the industry has been
awaiting the Decree to provide specific instruction around compliance with the law
The Decree is composed of 2 main components1:
• Detailed transparency and disclosure requirements for health care
companies related to:
• Agreements with HCPs/HCOs
• Benefits provided to HCPs/HCOs
French Sunshine Act Summary
• Passed on December 29th, 20112
• Compulsory reporting for health care companies
• Goal is to ensure transparency of decision-making within health care
sector
• Intent is to prevent conflicts of interest between stakeholders
1(Decree
2Article
No 2013-414 of 21 May 2013).
4133-6 of the Code of Public Health.
Overview Of The French Sunshine Act And Decree
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The Decree Clarifies The Reporting And Publishing Requirements
Of Agreements With HCPs/HCOs
General Requirements
•
Contracts must be submitted to the Gov’t or relevant professional boards for
opinion prior to their taking effect
•
High level contract summaries will be published on public websites
Health Care Company Responsibilities:
•
Companies must report to the government each agreement with an HCP/HCO
within 15 days of signing
•
The relevant board must be told of the implementation of the agreement within a
month of opinion
Gov’t or Review Board Responsibilities:
•
•
•
The Gov’t or professional board shall review the agreement, they shall have:
•
•
Two months to provide opinion for scientific research
One month to provide opinions for other types of contracts
No response from the board within this period is deemed a favorable opinion
All unfavorable opinions will be addressed by the relevant board with the company
Overview Of The French Sunshine Act And Decree
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The Decree Clarifies The Reporting And Publishing Requirements
Related To Benefits Provided To HCPs/HCOs
General Requirements
• Requires disclosure of payments or benefits provided to HCPs/HCOs
• key characteristics of those benefits will be published on a new Gov’t Website
Health Care Company Responsibilities:
• Semi-annually, on August 1st and February 1st, companies must report to the
government all benefits provided to HCPs/HCO during the previous period
• Reporting periods are January 1 to June 30 and July 1 to December 31
Overview Of The French Sunshine Act And Decree
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The Decree Provides Provisional Reporting And Publishing
Requirements While New Gov’t Website Is Being Created
 The government still needs to develop a website for collecting and publishing
data on agreements and benefits to HCPs/HCOs
 During this interim period many of the general provisions are superseded by the
following interim reporting and publishing requirements for agreements and
benefits with HCPs/HCOs will be the same (see table below)
Interim Requirements
Reporting
Publishing
• All 2012 agreements or benefits
to HCPs/HCOs are reportable to
the professional ethics boards on
June 1st
• All 2012 agreements and benefits
must be published on the
company website by October 1st
• 2013 and future agreements and
benefits are reportable to
professional boards on August 1st
and February 1st for the prior
reporting period*
• 2013 and future agreements and
benefits must be published on the
company website by October 1st
and April 1st for the prior reporting
period*
* The reporting periods are January 1st through June 30th and July 1st through December 31st
Overview Of The French Sunshine Act And Decree
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First Disclosure Must Begin On June 1st, 2013 For All 2012
Reportable Agreements
 With an effective date of June 1, the decree clarifies the disclosure requirement
and requires reporting of agreements and benefits for the 2012 period
 Additional reporting of for the first half of 2013 begins August 1st
2013 Sunshine Reporting Schedule*
June 1st
• All agreements with
HCPs/HCOs from 2012
Reporting to
Professional
Board
• All benefits paid to
HCPs/HCOs in 2012
August 1st
October 1st
• All agreements with
HCPs/HCOs from
January through June of
2013
• All benefits paid to
HCPs/HCOs from
January through June of
2013
• All agreements with
HCPs/HCOs for 2013 and
from January through
June of 2013
Publishing
on Company
Website
• All benefits paid to
HCPs/HCOs for 2013 and
from January through
June of 2013
* For 2014 (while provisional reporting rules apply) first reporting date will be February 1st for agreements and benefits
provided in the second half of 2013 and the publishing date will be April 1st
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Who Must Publish: The Decree Creates Reporting Requirements
For A Broad Range Of Healthcare Companies
Any company manufacturing or distributing products listed in Article L. 5311 – Of
The French Code Of Public Health is obligated to report under the Decree, such as:
Companies Falling Under France Requirements*
•
•
•
•
•
•
•
•
•
Drugs including pharmaceutical compounds, hospital and pharmaceutical
preparations, narcotic substances, psychotropic or poisonous substances,
essential oils, medicinal plants, insecticides for human use, pharmaceutical
raw materials;
Biomaterials and medical devices
In vitro diagnostics medical devices
Labile blood products
Ancillary therapeutic products
Human or animal organ tissue or cell
Therapeutic cells products
Devices that are not medically necessary but are used in medical biology
laboratories to perform medical biology tests
Other companies providing services to related to these covered
products
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What Must Be Published: Any Agreement Or Benefit Between
Health Care Companies And Stakeholders Must Be Reported
Information which must be reported and published:
• Information regarding agreements entered into between healthcare
companies and stakeholders
• Information regarding benefits in cash or in kind (direct or indirect) to the
stakeholder that is equal or greater to €10 inclusive of taxes (VAT)
Relevant Stakeholders1:
• Healthcare professionals
• Healthcare professional associations
• Healthcare students
• Institutions that represent healthcare students
• Health institutions
• Foundations and learned societies
• Press agencies
• Publishers of online communication to the public
• Advisory bodies and companies assisting in the
development and marketing of healthcare products
1Article
L. 5311 – Of The French Code Of Public Health
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How It Must Be Published: Reporting Is Divided Into Agreements
And Benefits
Agreement:
•
•
Interpreted as a contractual arrangement
Negotiated and typically legally binding arrangement between parties as to a course
of action: "a trade agreement“
Benefit:
•
•
A transfer of value occurs between the healthcare company and the HCP
Benefits can be in cash, or in kind such as:
• Meal to a doctor
• Grant
• Gift
Hospitality
Treatment
of Consulting
Fees incurred by its contracting party
Reimbursement
of expenses
•
•
•
Under the French Sunshine Act, the total value of the agreement does not have
to be disclosed. However, the value of all benefits as listed above must be
disclosed
It is unclear at this time whether consulting fees are consider a reportable benefit
This uncertainty is expected be clarified in future guidance
Overview Of The French Sunshine Act And Decree
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What Must Be Published: Information Published For Both
Agreements And For Benefits
The following information on the identity of the parties must be published BOTH
for agreements and benefits:
Healthcare
Professionals:
Healthcare Student:
Organizational Entities1:
First & Last Name
Legal Entity Name
Educational Institution
Corporate Purpose
RPPS Number (if
applicable)
Registered Address
First & Last Name
Professional Address
Qualifications
Title
Specialty
Professional Board
Registration Number (RPPS)
1
Health Institutions, associations, companies
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What Must Be Published: Information to Publish Per Agreement
And Per Benefit
Additional information which must be published for respective agreements or
benefits:
Information published ONLY for
Agreements:
Information published ONLY for
Benefits:
Date of signature
Amount of each benefit (tax inclusive
(VAT))1
Purpose of the agreement (described
in a manner to protect trade secrets)
Program of such event (if the subject
matter of the agreement relates to an
event)
1
Date of benefit granted to the
beneficiary
Nature of each benefit granted to the
beneficiary
The calendar semester during which
the benefit was granted
Rounded to the nearest euro
Overview Of The French Sunshine Act And Decree
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Where To Publish: Disclosure To Government And Company
Owned Websites
Website
Disclosure
Privacy
Consideration
Data
Retention
Overview Of The French Sunshine Act And Decree
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• A public authority will be given responsibility for the submission
website
• During transitional phase:
• Disclosures will be posted on the individual health care company's
website, or joint company or trade associations websites
• Professional Ethics Boards will receive and publish the relevant data
on their websites
• Disclosures must be done through appropriate notification to the
French Data Protection Authority (CNIL)
• In order to comply with French data privacy regulation, websites
must not be indexed by search engines
• HCPs/HCOs must be adequately notified about the information
disclosed and given modification and removal rights
• Information relating to agreements and benefits will remain
accessible to the public for 5 years
• Information will be retained by authority responsible for the
unique website during 10 years from the last date at which the
information was modified
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Penalties For Non Compliance May Reach € 225,000
Original penalties declared in Bertrand
apply in the case of non- compliance
•
Infringement of the sunshine regulations may expose to criminal sanctions
•
Fines up to € 45,000 for an individual, and up to € 225,000 for a company
•
Other sanctions apply where the offender has deliberately omitted to publish the
relevant information
-
Publicity of sanctions
Prohibition to manufacture
Overview Of The French Sunshine Act And Decree
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In The Near Future A Circular Will Be Published By The French
Government Providing Answers To Outstanding Questions
Expect Clarification From The French Government:
 An additional governmental publication will be adopted soon by the French State
Health Department1 to specify the interpretation of the French Administration on
the various concepts contained in the decree
 The decree does not provide specific wording for its exact application
• Decree states that companies manufacturing or distributing health products
are subject to disclosure obligations
• Not clear if the disclosure obligation will be limited to companies that
produce/distribute products in France, or if companies outside of France are
affected
• A previous draft specified that only enterprises established in France would
be subject to the French Sunshine regulations
 The concept of "benefit" should be further defined
 A future order (Arrêté) will further specify the conditions of the functioning of the
website
1(Direction
Générale de la Santé – DGS)
Overview Of The French Sunshine Act And Decree
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Overview Of The French Sunshine Act And Decree
CIIC Webinar #5
© 2013 Polaris Management Partners LLC
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Polaris 2013 Webinar Series
Current Issues In Compliance
Date
CIIC #1: US Sunshine Act Simplified
Feb 5, 2013
CIIC #2: Practical Implications to Your Aggregate Spend Solutions
Feb 12, 2013
CIIC #3: Structuring a Global FMV Solution
Mar 26, 2013
CIIC #4: Measuring Compliance – Are We Moving The Bar?
May 1, 2013
CIIC #5: Overview Of The French Sunshine Act and Decree
June 5, 2013
Possible future topics include:
•
•
•
•
International Transparency Trends
Assessing Your International FMV Rates – Are you overpaying?
Monitoring Programs – Where Is Their True Value
Evaluating Investigator Initiated Trials – FMV Considerations
TBD
If you have questions about a webinar, please contact us at
PolarisWebinars@PolarisManagement.com.
If you would like to discuss any of these topics in more detail, please contact Fred Eaton at
Featon@PolarisManagement.com.
Overview Of The French Sunshine Act And Decree
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