Overview Of The French Sunshine Act And Decree “Current Issues In Compliance”, Webinar #5 June 5/6 th, 2013

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 DecreeCIIC Webinar #5

© 2013 Polaris Management Partners LLCBusiness Confidential

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Questions

We welcome questions and ask that you submit them through the “chat” feature of the pop-up window in the webinar. We will try to either address them at the end of this webinar or in an e-mail to the group.

Disclaimer

Polaris Management Partners does not offer legal advice, and no part of this presentation, including any question and answer exchange, shall be considered the offering of legal advice or interpretation. Companies should consult legal counsel for the interpretation of laws.

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Contents

1. Overview

2. Reporting Timeline

3. Reporting Requirements

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The Implementation Decree Issued May 21, 2013, Clarifies The French Sunshine Act (Bertrand Law) For Disclosure Requirements

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 No 2013-414 of 21 May 2013).2Article 4133-6 of the Code of Public Health.

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

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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

• 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

Gov’t or Review Board Responsibilities:

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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

• 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

Health Care Company Responsibilities:

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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)

The Decree Provides Provisional Reporting And Publishing Requirements While New Gov’t Website Is Being Created

* The reporting periods are January 1st through June 30th and July 1st through December 31st

Reporting Publishing

• All 2012 agreements or benefits to HCPs/HCOs are reportable to the professional ethics boards on June 1st

• 2013 and future agreements and benefits are reportable to professional boards on August 1st and February 1st for the prior reporting period*

• All 2012 agreements and benefits must be published on the company website by October 1st

• 2013 and future agreements and benefits must be published on the company website by October 1st and April 1st for the prior reporting period*

Interim Requirements

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First Disclosure Must Begin On June 1st, 2013 For All 2012 Reportable Agreements

June 1st August 1st October 1st

Reporting to Professional Board

• All agreements with HCPs/HCOs from 2012

• All benefits paid to HCPs/HCOs in 2012

• All agreements with HCPs/HCOs from January through June of 2013

• All benefits paid to HCPs/HCOs from January through June of 2013

Publishing on Company Website

• All agreements with HCPs/HCOs for 2013 and from January through June of 2013

• All benefits paid to HCPs/HCOs for 2013 and from January through June of 2013

2013 Sunshine Reporting Schedule*

* 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

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

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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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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

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)

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 • GiftHospitality Reimbursement of expenses incurred by its contracting party

• 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

Treatment of Consulting Fees

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What Must Be Published: Information Published For Both Agreements And For Benefits

Healthcare Professionals:

First & Last Name

Professional Address

Qualifications

Title

Specialty

Professional Board Registration Number (RPPS)

Healthcare Student:

First & Last Name

Educational Institution

RPPS Number (if applicable)

Organizational Entities1:

Legal Entity Name

Corporate Purpose

Registered Address

1 Health Institutions, associations, companies

The following information on the identity of the parties must be published BOTH for agreements and benefits:

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What Must Be Published: Information to Publish Per Agreement And Per Benefit

1 Rounded to the nearest euro

Information published ONLY for Agreements:

Date of signature

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)

Information published ONLY for Benefits:

Amount of each benefit (tax inclusive (VAT))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

Additional information which must be published for respective agreements or benefits:

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Where To Publish: Disclosure To Government And Company Owned Websites

Website Disclosure

Data Retention

PrivacyConsideration

• 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

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In The Near Future A Circular Will Be Published By The French Government Providing Answers To Outstanding Questions

1(Direction Générale de la Santé – DGS)

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

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Q & A

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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 [email protected].

If you would like to discuss any of these topics in more detail, please contact Fred Eaton at [email protected].

mailto:[email protected]

mailto:[email protected]

Documents

Overview Of The French Sunshine Act And Decree “Current Issues In Compliance”, Webinar #5 June 5/6 th, 2013