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Development finance facilities: Prospects for APAC
Sponsors and project developers across the renewables and energy transition space are currently facing a challenging macroeconomic environment.
Global | 出版物 | 十二月 2020
The implementation of the new Anti-gift regime in France involves major changes in the compliance procedure of health care companies relating to the grant of benefits to stakeholders in the health sector.
The French Anti-gift regime, which governs benefits provided by health care companies to health care professionals or health care organizations, was modified by the Ordinance 2017-49 of January 19, 2017. However, the adoption of implementing decrees was delayed and only recently completed by a Decree dated June, 2020, as well as four ministerial Orders dated August and September, 2020. The new regime fully entered into force on October 1, 2020.
In order to help HCCs and HCPs/HCOs to comply with this new regulation, the following Q&A answers the most common questions about the new French Anti-gift regime.
Anti-gift regime |
Transparency requirement |
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Timing: Control prior granting of the benefit. |
Timing: Post-granting of the benefit. |
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Only benefits compliant with the Anti-gift regime can be granted and therefore disclosed under Transparency requirements. Both systems have a slightly different scope of application and different reporting modalities. |
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Healthcare Professionals and Organisations | |||
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The French Anti-gift regime only applies to HCPs and HCOs established or exercising their activity in France. |
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Healthcare Companies |
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The French Anti-gift regime applies to all HCC, whether or not they are established in France and whether or not their products or services are produced, operated or marketed in France. It does not apply to companies producing and marketing cosmetic products. However, if a company produces or markets both cosmetics and products for human health purposes, it falls within the scope of the French Anti-gift regime. |
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Article L.1453-5 of the French PHC prohibits HCCs, as defined here above, from offering or promising benefits in cash or in-kind, in any form whatsoever, directly or indirectly, to HCPs and HCO. |
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By way of derogation, certain benefits can be offered subject to strict conditions and formalities and if they are in relation with the professional activity of the HCP/ HCO*:
* wine bottles, chocolates, art objects, museum tickets, etc. are not considered to be in relation with the professional activity of a HCP and are therefore prohibited. |
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Spontaneous meals/snacks |
€30 up to a maximum of two/calendar year |
Books or periodicals, inc. subscription |
€30 per book or periodical within a total limit, including subscriptions, of €150/calendar year |
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Health products samples or demonstration products |
€20 up to a maximum of three/calendar year with some exceptions i.e., the following are authorized with no limit of amount:
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Office supplies |
€20 in total/calendar year |
Other product or service |
€20 in total/calendar year with some exceptions i.e., products whose supply to HCPs is requested by a public authority are authorized with no limit of amount |
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Granting any of the listed benefits is subject to the conclusion of an agreement between the HCC and the beneficiary. The agreement must include:
In specific situations, the agreement shall also include:
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The requirement for prior notification to the relevant professional board is replaced by either (i) a prior declaration or (ii) a prior authorization depending on the amount provided to the beneficiary. The French PHC sets, for each category of beneficiaries (HCPs, students and associations) and each category of agreements (remunerations, donations, hospitality, etc.), the applicable threshold (i) above which a prior authorization is required and (ii) below which a mere declaration is sufficient. This prior declaration/authorization's request is made before the relevant ethic board (if any) or the relevant regional health agency (agences régionales de santé, ARS), depending on the beneficiary involved. It shall include the entire agreement entered into with the HCP / HCO. The table hereafter summarizes the applicable thresholds. |
Beneficiaries |
Category of benefits / agreements |
Applicable threshold |
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Healthcare professionals |
Net remuneration, compensation and disbursement for research, research valorization, scientific evaluation activities, advice, provision of services or commercial promotion |
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Donations and grants intended exclusively to finance research, research valorization or scientific evaluation activities |
€5 000 |
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Hospitality offered during scientific/professional events or promotional events The amounts are all taxes included. |
€150/night Registration fees can be paid in addition. They are subject to authorization if they exceed €1 000. |
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Financing or participation to financing of professional trainings or continued medical education |
€1 000 |
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HCP students |
Net remuneration, compensation and disbursement for research, research valorization, scientific evaluation activities, advice, provision of services or commercial promotion |
€80/hour (up to €320/half-day and up to €800 for the entire agreement) |
Donations and grants intended exclusively to finance research, research valorization or scientific evaluation activities |
€1 000 |
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Associations of HCP and/or students |
Net remuneration, compensation and disbursement for research, research valorization, scientific evaluation activities, advice, provision of services or commercial promotion |
€200/hour (up to €800/half-day and up to €2 000 for the entire agreement) |
Donations and grants intended exclusively to finance research, research valorization or scientific evaluation activities |
€8 000 |
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Donations and grants intended for other health-related purposes |
€1 000 |
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Donations and grants to associations of public utility, including those intended exclusively to finance research, research valorization or scientific evaluation activities |
€10 000 |
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For benefits subjects to authorization |
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Submission at least two months before the day the benefit shall effectively be granted. Three weeks in case of an emergency. Within one month, if the submission is not complete, the competent authority may put on hold the process of authorization in waiting the communication of the missing documents. After two months of silence from the competent authority, the agreement is deemed to be authorized. In the event that the competent authority refuses to approve the agreement, the grantor of the benefit may amend the agreement and submit for a new authorization within three weeks or one week in case of an emergency. Please note that the decision can be challenged before French courts. |
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For benefits subjects to declaration |
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Submission at least eight business days before the day the benefit shall effectively be granted. The competent authority might issue recommendations to the parties on the definition of benefits, their amount or the content of the agreement itself. The recommendations are not binding but they should be taken into account by the grantor. Two dedicated on-line systems are currently available:
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In case of non-compliance with the Anti-gift regime, the following criminal sanctions apply for entities or persons that offer illicit benefits:
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Sponsors and project developers across the renewables and energy transition space are currently facing a challenging macroeconomic environment.
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