The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare Professionals), have finally been published. They will implement the new Gift Ban legislation that was passed in January 2017, as well as the Decree of June 2020. See our previous alert. Both arrêtés will become effective on October 1, 2020.
One arrêté sets the value threshold above which an agreement with a Healthcare Professional is subject to prior authorization rather than notification. See chart 1 below.
The other arrêté sets the amounts below which benefits are considered of low value and, as such, are permitted without any formality - see chart 2 below.
As stated above, both arrêtés will enter into force on 1 October. By then, companies must register with the French Medical Association (and other relevant Association) so that they can carry out the required formality online. They also have to adapt their internal procedures and train their employees and contractors on the new procedures and thresholds.
CHART 1 – THRESHOLDS FOR PRIOR AUTHORIZATION VS. NOTIFICATION
The threshold amounts for prior authorization and notification requirements vary depending on the category of Healthcare Professionals (see Art. L. 1453-3 of the Public Health Code) and the nature of the transfer of value.
They apply for total value transferred, but it is unclear whether the amounts include taxes except for those related to hospitality (taxes included).
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Thresholds for Prior Authorization
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Healthcare professionals
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Students
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Associations
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Net remuneration, compensation and reimbursement for research, research promotion, scientific assessment, advice, services, or trade promotion activities
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200 €/hour
with maximum 800 €/half-day and 2,000 € for the entire agreement
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80 €/hour
with maximum 320 €/half-day and 800 € for the entire agreement
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200 €/hour
with maximum 800 €/half-day and 2,000 € for the entire agreement
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Donations intended exclusively to finance research, research promotion or scientific assessment activities
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5,000 €
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1,000 €
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8,000 €
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Hospitality during professional, scientific or promotional events
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150 €/hotel night, 50€/meal and 15€/snack
with maximum 2,000 €/event, including travel cost
+
1,000 € for registration fee
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Grants to finance professional trainings or continued professional education
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1,000 €
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Donations and grants for health-related purposes other than research, research promotion and scientific assessment
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1,000 €
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Donations and grants to associations of public interest
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10,000 €
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CHART 2 – THRESHOLDS FOR BENEFITS OF LOW VALUE
The amounts and periods must be determined per beneficiary and per company. They include taxes.
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Thresholds for Benefits of Low Value
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Unexpected meals and snacks related to the beneficiary’s activity
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30 € and maximum 2/year
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Books, magazines, journals, including subscriptions, related to the beneficiary’s activity
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30 € per educational material
with maximum 150 €/year
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Samples of health products for health or demonstration purposes
Exceptions: No restrictions for
- samples of medicinal products
- samples and demonstration samples provided for the beneficiary’s education or training and that cannot be used for patient care
- samples and demonstration samples used by the beneficiary for patient’s education or given to the patient for testing or adapting purposes and for temporary use
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20 € and maximum 3/year
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Office supplies
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20 €/year
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Other product or service that relate to the exercise of the beneficiary’s profession
Exception: No restriction for products supplied on a public authority’s order
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20 €/year
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