France – New notification and authorization scheme for benefit / payment exemptions in the health sector will come into force in October 2020 | King & Spalding

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In France, Ordinance No. 2017-49 of January 19, 2017 significantly modified the rules governing payments by life sciences companies to the health sector. After more than three years, on June 15, 2020, Decree No. 2020-730 (hereinafter the “Decree”) was issued to implement the order. The decree will come into force in October 2020.

While French law generally prohibits pharmaceutical and medical device companies from making payments or benefits to covered beneficiaries (mainly healthcare providers and interns), certain categories of payments or other values ​​are either outside the scope of the ban, be exempt from the ban. .

Companies that transfer value to the healthcare sector that is exempt from the general ban (including donations, service charges and hospitality) must document these value transfers with a written agreement between the parties. Depending on the amount, type and recipient of the value transferred, the company will also be required to provide notification of payment or service, or to request authorization from the health association concerned.

In addition, an order (stopped) will probably be issued to set the thresholds for notifications and authorizations.

  1. GENERAL CONTEXT

Payments and other valuable benefits from pharmaceutical and medical companies to the healthcare industry are governed by:

  • Articles L. 1453-1 and L. 1453-2 as well as article D 1453-1 and articles R 1453-2 to R 1453-12 of the public health code (Public health code or CSP) which relate to transparency, i.e. public disclosure of (authorized) benefits / payments to the health sector; and
  • Articles L. 1453-3 to L. 1453-14 CSP which set out the general prohibition on benefits / payments and the exceptions thereto.
  • Ordinance No. 2017-49, which created new sections in the Public health code (Public Health Code), modified the existing provisions by extending the list of beneficiaries covered, clarified which forms of payments and other benefits are not covered by the ban on gifts, harmonized the criminal provisions and adapted the powers of law enforcement officers.
  • Decree No. 2020-730, which implements the provisions of Ordinance No. 2017-49 and which specifies the agreements required between the parties transferring value which falls under an exception to the ban.

The current rules are as follows:

  • General principle: In general, companies that manufacture, market pharmaceuticals, medical devices, or provide health services may not make payments or other benefits to covered beneficiaries (for example, health professionals, students in the health professions, associations of health professionals, student associations, etc.). The ban is also extended to certain public officials and to those who collaborate occasionally in committee activities.
  • Outside the scope of the ban: Some benefits and payments are outside the scope of the ban. They include standard benefits in commercial contracts, low value benefits, payments made in connection with employment contracts and intellectual property income.
  • Exceptions: Certain benefits and payments are exempt from the prohibition, subject to certain conditions. They include service agreements, donations and gifts, and hospitality. Any transfer of value which falls under this exception must be documented by a written agreement between the parties. The exceptions, however, do not apply to public servants.
  • Formality: Previously, the transfer of certain items of value required seeking a non-binding prior “opinion” from the health care association concerned (medical association, pharmacists association, etc.). The new decree obliges companies to request authorization from this health care association or from the competent public authority for payments and services above a certain threshold, and to notify transfers below this threshold. . This requirement does not apply tosingle convention»For clinical trials.
  1. DECREE No 2020-730

The decree implements the procedural rules for exceptions to the general prohibition. The decree adds the following implementing provisions to the regulations of the public health code:

  1. Definition of health service providers

This section gives a legal definition of health service providers and other recipients covered by the gift ban. These people are natural and legal persons:

  • who carry out an activity subject to an authorization, approval, accreditation or declaration system provided for in Part Six of the Public Health Code, such as those providing medical transport or carrying out biological tests;
  • who have an activity subject to authorization or accreditation by the regional health agency provided for in Book III of the Action Code for the Family and Society, such as those providing home care to the elderly;
  • who provide services which are covered either by the national health insurance system (sickness, invalidity or maternity insurance), state or state medical assistance (titles I and II of book II of disability benefits or retirement pension for war victims).
  1. Exceptions to the general prohibition on benefits / payments

Any payment or transferred service that falls under an exception to the general prohibition must be documented by a written agreement between the parties. The decree defines the basic content of the agreement (explained in more detail below).

In addition, the company paying the payment or the service must either notify the payment or the service or request prior authorization from the competent health association. Note that the new requirement for prior authorization is a significant change from the previous system, under which companies had to request a non-binding prior opinion from the relevant health association before making payments or benefits.

Whether a payment or benefit is subject to notification or prior authorization depends on the value, the value category and the recipient. Further details on this distinction, including the threshold value which determines whether prior notification or authorization is required, will most likely be indicated in a future order (arrsummer).

The decree defines the notification and authorization systems:

Mandatory content of the agreement. – Parties to a payment or benefit that fall under an exception to the general prohibition must document the transfer of value through a framework agreement. The agreement must be communicated electronically. The agreement must contain at least the following information:

  • The detailed identities of the parties.
  • The precise subject of the agreement (linked to a category to be specified by a future order (stopped)), subject to respect for secrets, including industrial and commercial secrets, protected by law.
  • Where applicable, information to identify indirect and final beneficiaries who have not signed the agreement.
  • For payments or benefits in cash or in kind:
    • the type of payments / services and the information to be provided for this type of services / payments (to be specified);
    • the individual amount of each benefit / payment and, as the case may be, the total amount of these payments / benefits, including taxes, rounded to the nearest euro;
  • The date of signature of the agreement as well as its expiry date and, if applicable, the period during which the benefits / payments will be granted. However, this information is not required for agreements subject to declaration.
  • If applicable: the program of the event; authorization for additional activities of the authority of which the public official concerned is a member; a French summary of the research or evaluation; and a draft observation notebook or, for scientific activities not covered by article L. 1121-6, the data collection document provided for in the protocol.

Notification regime. – When the agreement provides for a payment or a service whose value is below certain thresholds, the company must transmit the agreement by electronic means to the health association concerned at least eight working days before the transfer of the payment / the service. If the beneficiary is not a health professional, the agreement must be sent to the regional health agency of the territory in which the agreement was signed.

Authorization scheme. – For payments or benefits which exceed a certain value threshold, the company must submit the draft agreement and the authorization file to the competent health association (or to the competent regional health agency) for preliminary authorisation.

The health association must accept or refuse the authorization within two months of the acknowledgment of receipt of a complete file; otherwise, the agreement is deemed accepted. In the event of a refusal, the company may propose modifications to the agreement within 15 days of notification of the refusal. The healthcare association must decide on the amended agreement within 15 days.

In a justified emergency, the health association decides within three weeks (instead of two months) and, in the event of refusal followed by a request for modification, within one week (instead 15 days).

The company must inform the beneficiary if the authorization has been granted.

  1. THRESHOLDS TO COME FOR NOTIFICATION VS AUTHORIZATION?

A future stopped will set the amounts above which exceptions are subject to authorization rather than notification. These amounts vary depending on the category of beneficiaries (health professionals, students of health professions and associations) and payments / benefits.

See below the thresholds in the current version of the Rough draft stopped. Note that these values ​​are subject to change if and when the final arrsummer is issued.

Health professionals (art. L. 1453-4 (1 °))

Students

(Art. L. 1453-4 (2 °))

Associations

(Art. L. 1453-4 (3 °))

Net compensation, compensation and reimbursement of research activities, promotion of research, scientific evaluation, advice, services or commercial promotion

200 € / hour with a maximum of 800 € / half-day and overall less than 2000 €

80 € / hour with a maximum of 320 € / half-day and overall less than 800 €

Reception offered for exclusively professional or scientific events or for promotional events

150 € per hotel night

€ 50 per meal

€ 15 per snack

These overall amounts and transport costs cannot exceed a total of € 2,000.

Registration fees may be added but must be authorized if € 1,000 or more.

Financing or participation in the financing of vocational training or continuing professional development actions

€ 1,000

€ 1,000

Donations / donations intended exclusively to finance research, research development or scientific evaluation activities

5,000 €

5,000 €

€ 8,000

Donations / gifts for another health-related purpose

€ 1,000

Donations / gifts to associations of public utility, including those intended exclusively to finance research, the valorization of research or scientific evaluation

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