France: Again The Life Science Industry Will Have To Take A Close Look At A New Set Of Regulations Reshaping Transparency-Related Obligations

The relationship between the life sciences industry and health-care practitioners is being reshaped in France through regulatory developments under both the French Anti-Gift Law and the French Sunshine Act.

The regulatory landscape in France regarding the relationship between the life sciences industry and health-care practitioners (HCPs) continues to undergo significant changes.

Transparency requirements are regulated in France by two main sets of regulation: Law No. 93-121 of 27 January 1993 (the "French Anti-Gift Law or French DMOS Law) regulates the provision of gifts, discounts and other incentives to HCPs by life sciences companies, while Law No. 2011-2012 of 29 December 2011 (the French Sunshine Act) imposes on companies disclosure obligations relating to benefits granted to and agreements concluded with HCPs.

While the French Sunshine Act has been frequently amended to reflect subsequent changes brought by implementing decrees, orders, and circulars, the Anti-Gift Law has been less subject to change, at least until now.

Reshaping of Anti-Gift provisions

Changes to the Anti-Gift Law are contemplated in the near future pursuant to the recent adoption of Ordinance No. 2017-49 on 19 January 2017, which aims at extending the scope of the Anti-Gift Law and at changing the procedure related to the prior submission to the national or departmental board of the relevant HCP professional body.

Under its original provisions, the Anti-Gift Law established the principle that HCPs cannot receive any benefits from companies manufacturing or marketing health products that are reimbursed under the French social security system. However, it provided specific exemptions to this general rule by allowing (i) remuneration under agreements related to research activities or scientific evaluation, provided that such remuneration (a) was not calculated proportionally to the number of products prescribed by the HCP concerned and (b) was of a reasonable amount, and (ii) hospitality offered at promotional, professional and scientific events, provided that such hospitality was (a) reasonable and (b) limited to the scientific and professional purpose of the event.

The new provisions expand the scope of the Anti-Gift Law to broadly cover any company manufacturing or marketing health products, regardless of whether or not payment for the products is reimbursed under the French social security system. However, the Anti-Gift Law does not extend to companies manufacturing non-corrective lenses, cosmetic products and tattoo products.

The new provisions will also clarify what benefits will be specifically excluded from the scope of the Anti-Gift Law. For example, exceptions would include remuneration, compensation, and reimbursement of expenses provided by an employment contract and relating exclusively to the exercise of the HCP's professional activities; or benefits related to the exercise of the HCP's professional activities, provided that the amounts concerned are of a negligible value. In that respect, the maximum amounts paid as a benefit under each category are to be determined by means of a future implementing order.
Another upcoming change relates to the processing of the transparency requirements: as things currently stand, before being concluded or granted, agreements and hospitality proposals must be submitted for prior opinion to the national or departmental board of the relevant HCP body in order for it to assess whether the remuneration for services and the hospitality provided are reasonable in amount and limited to the sole scientific or professional purpose of the relevant event. This procedure is about to be changed into a declaration/authorisation procedure, depending on the amount of the benefits and hospitalities provided. The thresholds for determining whether a declaration or an authorisation is required are also to be set by means of a future implementing order.

Last but not least, the penalties incurred for non-compliance with the requirements of the Anti-Gift Law will be doubled from the current fine of up to €375,000 to a fine of up to €750,000. Alternatively, the fine could be up to 50 per cent of the expenses incurred in carrying out any practice constituting an offence. Although the notion of expenses incurred in carrying out any practice constituting an offence remains to be clarified, such change points towards a clear strengthening of the applicable rules.

The new provisions will enter into force after the adoption of an implementing decree, and at the latest on 1 July 2018. It is already to be expected that the announced changes will particularly impact life sciences companies manufacturing or marketing non-reimbursable health products – which were until now exempt from the rules of the Anti-Gift Law. These companies will have to promptly integrate the procedural rules into their daily business.

Upcoming clarification on the disclosure of remuneration paid to HCPs

In addition to the Anti-Gift Law, life sciences companies are required to disclose certain information on a public Stateportal. In recent years there have been changes concerning the content of the disclosure and this has presented a challenge for life sciences companies trying to meet their disclosure obligations. (See our previous alert).

Initially, life sciences companies were required to disclose any benefits granted to HCPs and the nature of agreements concluded with HCPs, but they were not required to disclose the amounts of any remuneration. However, on 24 February 2015, the French Supreme Administrative Court (Conseil d'Etat) ruled null and void the provision under which only the existence of agreements with HCPs had to be disclosed, but not the remuneration amounts paid to HCPs. As a consequence, Law No. 2016-41 of 26 January 2016 codified the principle that any remuneration contained in agreements concluded with HCPs must be disclosed, with implementation of the new provisions to be carried out by way of decree. In this respect, Decree No. 2016-1939, recently published on 28 December 2016, provides partial clarification as to the basis for the implementation of the new provisions.

The new decree provides that any remuneration above €10 under agreements concluded with HCPs has to be disclosed. This provision harmonises the rules relating to disclosures and aligns the regime applicable to any benefits, hospitality or remuneration for services provided for in agreements.

The new decree also corrects the discrepancy in the reporting timelines. In the past, while agreements had to be disclosed within 15 days after their signature, benefits had to be disclosed only twice a year: by 1 February and 1 August.

Now, details of benefits and remuneration for services above €10 granted during the first half of the calendar year will have to be disclosed by 1 September, and those granted during the second half by 1 March of the following year. This means that, going forward, disclosures of both benefits and remuneration will be in step.

Finally, the decree provides that the new provision on the disclosure of remuneration will enter into force as soon as the relevant implementing order is published, and at the latest on 1 July 2017.

In that respect, the guidelines of the French Pharmaceutical Association (the LEEM), issued in February 2017, anticipate that the first disclosure of any remuneration provided for under an agreement will need to be made by 1 September 2017.
Indeed, since the implementing order was issued after 1 February – the deadline date for the disclosure of data related to the second half of 2016 – it is unlikely that this will have retroactive effect on remuneration under agreements concluded in 2016. However, the LEEM mentions that this possibility cannot be totally excluded and companies should await publication of the implementing order for further guidance.

It should be borne in mind that at the time of its publication in May 2013, the original decree to implement the French Sunshine Act had full retroactive effect to as far back as January 2012 – the date the French Sunshine Act came into force. Both companies and industry associations resisted this interpretation on the grounds that such retroactive disclosure would be too cumbersome for companies to implement.

Under a restrictive interpretation, the new disclosure requirement relating to remuneration should apply as of January 2012, which means adjustments will need to be made to cover the last five years. However, a degree of flexibility will probably be allowed with respect to such retroactive disclosure given the burden of work this would impose on companies.

In any case, companies should be prepared for significant upcoming changes and therefore monitor closely the evolution of the regulation in that respect.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.