What is the reporting threshold for benefits provided to Health Care Professionals (HCPs) under the French ‘Sunshine Act’ (Loi Bertrand)?

The reporting threshold is 10 Euros i.e. any benefit to the HCP exceeding 10 Euros.

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What benefits should be reported?

All benefits in kind or in cash and whether direct or indirect

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What agreements must be disclosed?

The disclosure obligation affects any agreement concluded between manufacturing or distributing companies and French HCPs, or any benefit provided by such companies to French HCPs.

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What information needs to be disclosed as far as agreements are concerned?

The current requirement is that undertakings must disclose in full the name of the parties involved, the date of execution of the agreement, the purpose of the agreement, and, for example and if applicable, the programme of the professional or scientific meeting or convention involved.

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Does the French ‘Sunshine Act’ apply to foreign (i.e. non-French) companies?

Yes – if they have provided benefits, to or signed an agreement with,a French HCP.

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How and where should the information be reported?

The French Government has put in place a single website upon which all information should be reported
https://www.entreprises-transparence.sante.gouv.fr/flow/login.xhtml;jsessionid=8CF967FE3EED68655DD42B3DC7B434B2.sunshine-entreprise

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Does the information need to be reported in French or can it be reported in English?

The information should be provided in French.

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How often should the information be reported?

Information regarding agreements should be reported, in French, within 15 days of the signing of each agreement. As for benefits, the reporting needs to come about every 6 months (before 1 February for period 1 July to 31 December and before 1 August for period 1 January to 30 June)

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What are the penalties for failure to report?

There are a number of sanctions, but there is notably a fine of up to 45 000 Euros per offence

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Are the disclosure requirements likely to be extended or toughened up?

Yes – the recently passed ‘Loi Touraine’ will extended disclosure requirements but the relevant decree setting out the practical modalities is yet to be published

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