Remaining French Sunshine regulations have finally been adopted
French Decree n°2013-414 dated 21 May 2013 implementing the French Sunshine regulations was published in the Official Journal of 22 May 2013 (the "Decree").
The Sunshine regulations were introduced to French law pursuant to a law dated 29 December 2011 (aka. Bertrand law) setting out the obligation for enterprises working in the health sector to publish benefits granted and agreements entered into with several players in the health sector, including healthcare professionals.
A further governmental publication will be adopted soon by the French State Health Department (Direction Générale de la Santé – DGS) to specify the interpretation of the French Administration on the various concepts contained in the Decree (the "Circular"). The Circular is expected to be published in the coming days.
WHAT COMPANIES ARE CONCERNED BY THE REGULATIONS?
As a reminder, the Decree covers "enterprises" producing or marketing health products or providing services connected to these products.
There are uncertainties on the scope of the concept of enterprises "providing services connected" to such products. The interpretation of the French Administration on this matter should be provided in the Circular which should also clarify the way to handle the overlapping cases in which the same information might be published by different players.
A previous draft of the Circular specified that only enterprises established in France would be subject to the Sunshine regulations. This still needs to be confirmed.
WHAT INFORMATION NEEDS TO BE PUBLISHED?
Information which must be published is the following:
(a) information on agreements entered into with stakeholders listed in article L.1453-1 of the French Public Health Code. Commercial agreements which purpose is the purchase of goods or services, as well as the convention unique entered into between suppliers and distributors, do not need to be published; and
(b) benefits in cash or in kind granted directly or indirectly to these same stakeholders, when such benefit is of an amount equal or greater than EUR10 inclusive of taxes (VAT). This concept should cover the benefits granted without consideration, such as grants, gifts or hospitality. The concept of "benefit" should be further defined in the Circular.
As a reminder, the stakeholders referred to above and listed in article L.1453-1 of the French Public Health Code include in particular healthcare professionals, healthcare professionals' associations, healthcare students, health institutions, foundations and learned societies, press agencies and publishers of online communication to the public. The various categories listed in the regulations are potentially far reaching and details on this matter are expected to be included in the Circular. A priori, the concerned stakeholders should only be those established in France, and the Circular should confirm the interpretation of the Administration on this aspect.
Information published both for agreements and for benefits
The following information on the identity of the parties must be published both for agreements and benefits:
(a) healthcare professionals: name, first name, professional address, qualifications, title, speciality, registration number with the professional board or RPPS number;
(b) healthcare student: name, first name, educational institution and, if applicable, RPPS number;
(c) legal entities (health institution, associations, companies): name, corporate purpose, and registered address.
Information published only for agreements
The following information must be published for agreements:
(a) date of signature;
(b) purpose of the agreement (which can be described in a manner making sure trade secrets are protected);
(c) if the subject matter of the agreement relates to an event, the programme of such event.
Information published only for benefits
The following information must be published for benefits:
(a) amount of each benefit (tax inclusive (VAT)), rounded to the nearest euro;
(b) date and nature of each benefit granted to the beneficiary;
(c) the calendar semester during which the benefit was granted.
The Decree specifies that the "benefits" mentioned in agreements must also be published (as "benefits"). This addresses, for instance, the reimbursement by a company of expenses incurred by its contracting party (meal, transport, accommodation costs). Requiring the publication of such amounts as "benefits" does not seem consistent with the principle that a benefit is granted without consideration.
HOW WILL THE PUBLICATION TAKE PLACE?
The information will be disclosed in French language on a unique public website. This website will be set up by public authorities and the authority responsible for this website will be the recipient of the information to be disclosed. The conditions for the functioning of the website will be determined by ministerial decree.
However, until the website is set up, information will be published:
(a) on the website of the relevant French national professional body (e.g. CNOM for physicians) if the agreement/benefit relates to a healthcare professional/student/association; and
(b) on the enterprise's website or on a common website shared by several enterprises or on the website of professional trade-union of which the enterprise is a member (in the two latter cases, the concerned website must be identifiable from the enterprise's website or by any other means in case such website does not exist). Enterprises are free to decide how they want to present the information. The website must integrate technical measures ensuring its integrity and the safety of the information disclosed, and prohibiting the reindexing of directly identifying data. Setting up the website will require complying with data protection regulations (declaration obligations, compliance with data subjects' access rights).
WHEN MUST THE INFORMATION BE TRANSMITTED AND PUBLISHED?
Timetable for the transmission of the information
The enterprise must transmit the information to the authority responsible for the unique website according to the following timetable:
(a) for an agreement: within 15 days following the signature of the agreement – a periodic data transmission for agreements will accordingly need to be put in place by enterprises;
(b) for a benefit:
(i) benefit granted between 1 January and 30 June: transmission occurs at the latest on 1 August of same year;
(ii) benefit granted between 1 July and 31 December: transmission occurs at the latest on 1 February of the following year.
Dates of publication of the information
The authority responsible for the unique website will publish the information on the agreements and benefits as follows:
(a) agreement concluded/benefit granted between 1 January and 30 June: publication occurs at the latest on 1 October of same year;
(b) agreement concluded/benefit granted between 1 July and 31 December: publication occurs at the latest on 1 April of the following year.
First information reporting period
(a) The first publication under the Decree will cover agreements concluded and benefits granted during the period between 1 January 2012 and 30 June 2013.
(b) Planning for 2013
The following planning must be complied with in 2013 as regards transmission and publication of the information:
(i) at the latest on 1 June 2013: transmission to the relevant French national professional body (as applicable) of the information relating to agreements concluded and benefits granted in 2012. This date being very close to the publication date of the Decree, many enterprises will likely face difficulties to comply with such obligation.
(ii) at the latest on 1 August 2013: transmission to the relevant French national professional body (as applicable) of the information relating to agreements concluded and benefits granted during the first calendar semester of 2013.
(iii) at the latest on 1 October 2013: first publication (by professional bodies and enterprise websites referred above) of information relating to agreements concluded and benefits granted between 1 January 2012 and 30 June 2013.
(c) After 2013
After 2013, as long as the unique website is not set up, information on agreements and benefits must be transmitted to the relevant French national professional body (as applicable) at the latest on 1 August and 1 February of each year. Publications will need to take place at the latest on 1 October and 1 April of each year.
HOW LONG WILL THE INFORMATION BE ACCESSIBLE AND STORED?
The information relating to agreements and benefits will remain accessible to the public for 5 years once it is on line, and will be kept by the authority responsible for the unique website during 10 years from the last date at which the information was modified.
WHAT SANCTIONS APPLY IN CASE OF NON-COMPLIANCE?
As a reminder, the infringement of the sunshine regulations may expose to criminal sanctions (fines up to EUR45,000 for an individual and up to EUR225,000 for a company, as well as other sanctions such as publicity of sanctions, prohibition to manufacture products), where the offender has deliberately omitted to publish the relevant information. Risk exposure in this respect will require a case by case analysis, due in particular to the specific context in which the applicable legal provisions have been adopted.
OTHER DETAILS IN RELATION TO FRENCH ANTI-BENEFITS REGULATIONS (DMOS LAW)
The Decree provides further details on the changes made by the Bertrand law to French anti-benefits regulations:
(a) time periods allocated to the professional bodies to provide their opinion on the agreements that are submitted to them under article L.4113-6 of the Public Health Code are:
(i) 2 months for scientific research/evaluation agreements;
(ii) 1 month for all other agreements.
(b) the enterprise must inform the relevant professional body of the implementation of agreements submitted to it within 1 month.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...08 September 2016