There’s very little time for planners of medical events to adapt to the new guidance related to what’s known as the French Anti-Benefit Law. The adoption of a decree by the French legislature dated June 15, 2020, was followed by two ministerial orders in August that provide some clarity to the law, which went into effect on October 1
What does this mean for medical-event planners and their colleagues in compliance? First, it’s imperative to take inventory of your engagements/consulting agreements with French HCPs and ensure you are following the law. In addition, you should update your compliance policies, fair-market-value net remunerations, meal caps, hotel caps, operating procedures, and any guidance documents you provide to staff and third-party suppliers.
For planners, it is especially important to check your invitee/attendee lists for upcoming programs to confirm whether French HCPs will be invited to attend. Then, make sure to address the following regarding their participation:
• If logistical accommodations (hotel/transportation/food & beverage) are being provided, keep in mind these caps: €150 per hotel night, including breakfast; €50 per meal; €15 per coffee break; and a maximum €2,000 for all event costs, including transportation, per HCP. (At current rates, €2,000 is equal to about $2,350.)
• These rates include VAT. For the average advisory board and, assuming hotel accommodations, dinner, lunch, and AM/PM breaks all at the cap, this leaves €1,720 for air and ground transportation.
• Factor in exchange rates and provide yourself some buffer for fluctuations.
• Students can no longer accept hospitality, so they cannot receive benefits even to the caps listed above.
• Work with your suppliers/providers so that they are clearly aware of, and agree to, the limitations.
More Details of the New Law
First, it is important that you always contact your legal department or counsel when considering the application of this and other laws upon your business. In general, the French Anti-Benefit Law that governs benefits provided by health care companies (HCCs) to health care professionals (HCPs) now more clearly defines the “benefits” or “advantages” that can be extended to HCPs. It was modified by the Ordinance 2017-49 of January 19, 2017 and the two ministerial orders of August 7.
The new law will apply to most health-sector players. For example, the definition of HCC under the law includes providers such as hospitals or biomedical laboratories, as well as manufacturers and marketers of health products such as pharmaceuticals or medical devices. The definition of HCP includes doctors, nurses, medical students, pharmacists, medical associations, and others who provide care, as well as civil servants participating to the development of public-health policy:
Further, the law has specified certain benefits that medical students in initial training and student associations cannot be offered.
A Four-Category System for Items of Value
The first category is for gifts, which are mostly not allowed but have a few limited exceptions, while three other categories detail further exceptions where “items,” “benefits,” or “advantages” are allowed under certain circumstances.
Category 1: Gifts
In general, gifts from manufacturers or promoters of pharmaceutical and medical devices to HCPs are not permitted. The main change brought about by the new law is to provide some exemptions related to the prohibition of gifts. Besides the exemption for research and evaluation, hospitality, or to finance continuing education (already covered by the system in place before October 2020), donations and gifts intended for associations of health professionals will now be allowed. The language related to these exemptions has also been modified. A piece written by French law firm Geneste & Devluder explains that under the old system, exemptions were subject to the agreement being sent to France’s Conseil National Medecin (CNOM). But now, this process is replaced by either a declaration procedure if the value of the benefits is less than a certain amount (see below), or by an authorization procedure if the value of the benefits is greater than that threshold.
Category 2. Items of Negligible Value
Category 3: Declarable Items, Benefits, or Advantages
The declaration procedure must be completed online if the benefit is permitted and the value is greater than the negligible value as outlined below.
The declaration must be made at the latest eight working days before the day of the granting of the advantage (transfer of value) to the council of the order concerned or to the competent ARS (agence régionale de santé), which can then issue recommendations.
Items, benefits, or advantages that can be declared are as follows:
- Hospitality: Hotels; meals; transfers
- Funding for participation in training/conferences
- Charitable donations
- Remuneration: net compensation, defrayal of research activities, development of research, scientific evaluation, advice, provision of services, commercial promotion
Declarations must be filed by the concerned HCC with the professional board or the regional health agency (ARS) that is competent to oversee the activities of the HCP.
There are other benefits or advantages granted to associations that can be the subject of a simple declaration. The scope of the "anti-gifts" rule covers associations representing member of the health professions and students, and has been extended to associatioons to bring together health professionals, osteopaths, chiropractors, psychotherapists, or students of each, including those who intervene within the scope of their training.
- Donations intended to finance exclusively research activities, research development, or scientific evaluation: €8,000
- Donations intended for another purpose related to health (be sure to read the statute for clear guidance as this is a very generic category): €1,000
- Donations benefiting associations declared to be of public utility: €10,000
In addition, it is acceptable to offer the aforementioned associations a net remuneration, compensation, or defrayal of research activities, development of research, scientific evaluation, advice, provision of services, or commercial promotion within certain limits.
Category 4: Authorizable Items
Little specific guidance is provided on authorizable items, except that any benefits, items, or advantages conveyed in excess of the values or not specifically enumerated as a “declarable benefit” should be submitted for authorization.
Applications for authorization must be filed by the concerned HCC with the professional board or the ARS that are competent to oversee the activities of the HCP. The procedure can take up to two months, though it may be reduced to three weeks in urgent cases.
In a recent webinar, Mark Handforth, managing director of 3Sixty Event Consulting, and Laurent Clerc, CEO of BMI Systems, discussed the authorization process, noting the details to be included in a submission. They acknowledged that more direction from the French government was forthcoming. Clerc also cautioned planners to thoroughly review all requests for authorization before submitting them. If a request is rejected because it is incomplete, then it could take an additional two months to be reviewed and a determination made.
Consequences of Non-Adherence or Violations of Law
French law firm Geneste & Devulder cautions that “it is essential that industry and health professionals incorporate these new rules in preparation for their effectiveness on 1 October 2020”. Non-compliance with these provisions carries a criminal penalty:
- Manufacturers may incur up to two years' imprisonment, a €750,000 fine (or 50 percent of the expenses incurred for the disputed practice) and additional penalties such as a ban on activity or exclusion from public contracts.
- Health professionals may incur up to one year of imprisonment, a fine of €75,000, and additional penalties such as a ban on practicing.
The bottom line is that this law will have a big impact on how life sciences companies and meeting planners interact with HCPs. It is very important for all parties involved to thoroughly understand the law and its complex requirements in order to avoid missteps.
NOTE: This information is not intended to confer legal advice, a legal opinion, or professional advice. This document is for general information purposes only and is not a substitute for consulting with legal advisors. Its accuracy or completeness cannot be guaranteed.
Laura Konwinksi is senior director of global compliance for BCD Meetings & Events. Peggy Muntner is a compliance manager for BCD Meetings & Events.