The new French “anti-gift” legislation applicable to the relationship between healthcare professionals/establishments and health product companies is taking effect even if some aspects of the reform are still under discussions.
Article 180 of the Act of January 26, 2016 on the modernization of health system empowered the French Government to adopt, by means of an ordinance as provided for in Article 38 of the Constitution, various amendments to the legal framework of the so-called "anti-gift" legislation. The order was adopted on January 19, 2017. Section 5 of the Article provides that the measures set forth in the Act "go into effect on dates to be fixed by decree and on or before July 1, 2018”.
What is the applicable system considering that the measures to implement this order have not been adopted by July 1, 2018?
To answer this question, it is necessary to make a distinction, in accordance with Article 1 of the French Civil Code, between those measures of the ordinance which are sufficient in themselves and therefore do not require measures of implementation and those which, upon examination, show that they cannot go into effect if they are not followed by decrees or orders of implementation.
- The measures that are sufficient in themselves go into effect on July 1. However, as the bill ratifying the ordinance was only submitted to the Senate without having been adopted by Parliament, contrary to what is required by Article 38 of the Constitution, the measures in question do not yet merit legislative rank and therefore retain their regulatory status (it would be impossible, for example, to establish a “QPC”, i.e. ex post constitutional review). This point is crucial for our subject, since the definition of offences, which are essentially self-sufficient, is largely a matter for the domain of law.
In the Public Health Code, this first category includes the new Articles L 1453-3, L 1453-4, L 1453-6 (with the exception of item 4 of Article L 1453-6), the new L 1453-14, the amended Articles L 1454-1 and L 1454-4, as well as the new Articles L 1454-6 to L 1454-10, Articles L 1312-3, L 1312-4, L 1414-4, L 1419-1, L 1451-2, L 5122-10 and L 4343-1.
For example, the expansion of the scope of application for the “anti-gift” provision took effect on July 1, 2018. The law has indeed considerably expanded the list of health professionals and associations (L. 1453–4) as well as the list of companies subject to the “anti-gift” legislation (L. 1453–5).
- The measures for which decrees or orders of implementation are necessary will not go into effect until the date of entry into effect of those decrees or orders. The relevant articles include Article L 1453-5 (which will go into effect on the date of entry of the decree provided for in 1° of Article L 1453-13), Article L 1453-7 and the subsequent articles for which the entry into effect are subject to the adoption of the decree provided for in Article L 1453-13 and the ministerial order provided for in Article L 1453-11.
Thus, the new system of prior authorization of agreements with health professionals (which replaces the current system based on declarations) has not entered into force; indeed, the new Article L. 1453-11 provides that prior authorization is required for benefits whose value exceeds a threshold to be determined by a ministerial order. As this decree has not yet been adopted, these provisions cannot go into effect.
Between July 1 and the effective date of the new regulatory measures, the old regulatory measures continue to apply unless they have become inconsistent with the new legislation, which is partially the case.
In practice, since the new sanctions system provided for by the Ordinance (Articles L1454-1, L 1454-4 to L 1454-9) is directly applicable, one could argue that the new sanctions system applies if it corresponds to an offence provided for by the old legislation and revised in equivalent terms in the new legislation (if entered into effect), which should often logically be the case, since the new law has broadened the scope of application of the law.
However, the application of this rule is strongly tempered here by the fact that, for the most part, the offences in question cannot be defined in a regulatory text and necessarily fall within the scope of the law, which prohibits the imposition of sanctions in the event of disregard for the provisions in question.