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The long-awaited decree implementing Article L. 1453-1 of the Code of Public Health (“Transparency Decree”) was published in the Official Journal of the French Republic on May 22nd, 2013.

 

A wide scope of companies involved
The decree applies to all companies manufacturing or marketing health products (L.5311-1, II CSP, French Public Health Code). Companies producing or selling cosmetics, non-corrective eye lenses and tattoo products are also affected by more restricted procedures.

All hospitality amounts to be disclosed from 10€!

The decree requires the publication of the payments equal to or over 10 €.

Disclosure requirements

Data to be disclosed covers:

  • Existing contracts
  • Hospitality in kind or cash procured directly or indirectly to HCPs, HCOs, companies, organizations or bodies mentioned in Section I of Article L. 1453-1, including under agreed contracts. This last point is important because it implies the identification, collection and disclosure of hospitality amounts procured through the implementation of these contracts.

Regarding the contracts, the decree requires the disclosure of the following:

  • Identity of signatories of the contract
  • Date of signature of the contract
  • Purpose of the contract, ​​in compliance with proprietary information protected by law, including industrial and commercial secrecy
  • Program of the event when the contract is for an event “with purely professional and scientific purposes.”

Please note that it is not required to publish the amount of the contract but only its existence.

Regarding the hospitality amounts, the decree requires disclosure of the following:

  • Identity of the recipient and the company
  • Amount, including all taxes, rounded to the nearest Euro, date and nature of each hospitality amount received by the beneficiary during a semester.
  • Specification of the semester in which the hospitality was granted.

Disclosure modalities

In the Articles R 1453-4 and following the CSP, the decree stipulates that a device for transmitting the data subject to disclosure will be established. The disclosed data will be available to the public on a single, online platform.  Thus, the transmission device will be specified and adopted by decision of the Minister of Public Health after consulting with the authority responsible for protection of private data.

While awaiting the publication of the decision, the decree provides for the following interim temporary solution.

The modalities for disclosure are different for contracts and hospitality granted in 2012 and contracts and hospitality granted in 2013.

  1. Contracts and hospitality granted between the 1st of January  1st, 2012 and December, 31st2012 are to be disclosed to the National Council of the Order of the profession concerned no later than the June 1st, 2013. Disclosure to the public will take place no later than the October 1st,  2013:
    • On the website of the concerned council
    • On the website of the company or a common platform for two or more companies or on the website of a professional association.
  2. Contracts and hospitality granted during the first half of 2013 are to be disclosed to the National Council of the Order of the profession concerned no later than August 1st, 2013 and will be disclosed on the websites above no later than October 1st, 2013.
  3. Contracts and hospitality granted during the second half of 2013 are to be disclosed to the National Council of the Order of the profession concerned no later than February 1st, 2014 and will be disclosed on the websites above no later than April 1st, 2014.

Conclusion

The timing of implementation is particularly restrictive.

These administrative delays and the retroactive reporting back to January 1st, 2012 will present a real challenge given the amount of information that must be collected and disclosed. The provisions concerning the disclosure as above mentioned describe transitional measures. A future article on the final provisions relating to disclosure on a single, public platform will follow.

 

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