Physician Payment Sunshine: Navigating the French Sunshine Act

Sophie Pele, an Associate in the law firm Norton Rose Fulbright’s Paris office published “Basics to navigate the Sunshine Act ‘à la française’“. The article is a summary designed to provide practical guidance on the French law. The focus is on the “sunshine like” aspects of the law, and not the anti-kickback rules found in the same law. Policy and Medicine has previously discussed the French law here.

Introduction

In response to the recent Mediator health scandal that reduced the trust of French citizens in their public health system, France has implemented a vast transparency program which is aimed at restoring confidence in the independence of healthcare professionals.

Further to the law of 29 December 2011, a decree and a governmental circular were published respectively on 21 and 29 May 2013 (the package being referred to below as the “French transparency Act”). The reform became effective as of 1st June 2013, and is applicable to the relationships between healthcare professionals (HCPs) and the health industry as of 1st June 2012.

What is the law?

The French transparency Act aims at making public the following information:

(i) Advantages granted to HCPs in kind or in cash amounting to EUR 10 or more per advantage.

This encompasses any and all kind of advantages, in kind or in cash, granted directly or indirectly.

The following information must be made publicly available concerning these advantages:

• Name and details of the concerned HCP;
  
• Aggregate amount, date and nature of advantages granted per semester.
  

In practice, it is therefore necessary to split the amount declared by type of advantage.

(ii) Various agreements entered into by the health industry with HCPs.

This concerns only the situations in which HCPs receive payment or advantages from companies. On the contrary, and logically, purchase agreements under which a company sells products or services to HCPs, rebates or other advantages linked to such commercial arrangements, are not required to be publicized.

The following information must be made publicly available concerning payment or advantages granted by companies to HCPs:

• Name and details of the relevant HCP
  
• Signature date
  
• Subject matter of the agreement: this must be referred to in general terms (clinical trial, congress speech, advice in scientific board, promotional event, etc).
  
• For scientific events, the detailed agenda.
  

After legislative debate, and contrary to other countries, France does not require the amount of fees paid by companies to HCPs to be made publicly available.

However, any advantage granted in the framework of an agreement falling under this category must be declared pursuant to the above provision. It is therefore key to define the nature of the advantages concerned. Pursuant to the anti-kickback rules, an advantage is defined by reference to the absence of any counterpart. For instance, a free ticket and transportation to a congress would be deemed an advantage, contrary to fees paid for scientific advice. However, the governmental circular published on 29 May 2013 emphasises that fees that are disproportionate compared to the value of the advice could be deemed an advantage, as is already the case under applicable anti-kickback rules.

Who is affected?

The French transparency Act has a much broader scope than the pre-existing anti-kickback rules. It applies to any company which manufactures or markets pharmaceutical products or medical devices in France, regardless of their status vis-à-vis reimbursement by social security.

To a lesser extent, they include companies manufacturing or marketing cosmetic products (including personal care products) or contact lenses, when they enter into agreements with HCPs (or related associations) concerning research, vigilance and safety assessment of their products.

More importantly, the French transparency Act is also applicable to any company delivering services in connection with such products, including marketing, public relations and events agencies.

With whom?

The scope of beneficiaries is also particularly broad as it encompasses HCPs, their professional associations, as well as students, patient associations, foundations, healthcare centers, prescription software editors, media and professional training institutions.

Where is the information published?

After intense debate, France has opted for a publication on a dedicated website administered by French authorities, rather than on each company’s website.

However, the design of this website will require several precautions to address data privacy issues. The French data privacy agency will be consulted to ensure, in particular, that identifying data made publicly available cannot be processed and referenced by search engines.

In the meantime, until the ministerial order featuring this public website is issued, each company will have the responsibility of providing access to the information on the website of the professional body representing the relevant HCPs and on its own corporate website or a website common to several companies such as a professional trade association. In the latter case, a link must be provided between the company’s corporate website and the dedicated website hosting its data.

Access to this information must be free and easily identifiable, and any and all information must be in French.

On a temporary basis, it will therefore be the companies’ responsibility to ensure compliance with the data privacy requirements summarised above as long as the public website is not up and running. HCPs should also receive an information form concerning the automatic processing of their personal data. However, it is worth noting that, by exception to French data privacy rules, HCPs cannot refuse their personal data from being processed.

In addition, although it is not expressly stated in the French transparency Act, each company should file a declaration with the French data privacy agency concerning the data processing necessary for gathering the information being transmitted to the person responsible for the website.

When does this go into effect?

As stated above, the new French transparency Act applies to any agreement entered into and advantage granted as of 1st January 2012.

The information concerning 2012 should be transmitted to the HCPs professional body on 1st June 2013 and should be made available on websites on 1st October 2013.

As for 2013 onwards:

• information on agreements and advantages granted during until 30 June of each year will be made available as of 1st October of each year.
  

Companies should transmit the corresponding information before 1st August concerning the advantages, but within15 days from signature concerning agreements.

• information on agreements and advantages granted between 1st July and 31 December of each year will be made available as of 1st April of the following year.
  

Companies should transmit the corresponding information before 1st February concerning the advantages, but within 15 days from signature concerning agreements.

All data will remain available for 5 years, or longer if an agreement is entered into for more than 5 years.

Applicable provisions do not provide for a specific sanction if data is transmitted or published late. Therefore, the general provisions could apply, i.e. EUR 45,000 fines against companies deliberately omitting to declare an agreement or advantage, and possibly the publication of the sanction and the temporary or permanent closing of the company.

American law

International pharmaceutical and medical devices company based in the United-States could benefit from their experience in the implementation of the US Sunshine Act adopted in 2010, but local peculiarities will preclude them from implementing all transparency requirements through a uniformed international database.