The 2019 Social Security Financing Act (2019 LFSS), mostly validated by the French constitutional court on 21 December, was published in the French Official Journal on 23 December 2018.
The LFSS introduces, among other things, the following key measures:
- Creation of hybrid medicines as a new category (Article 66): the French Public Health Code is amended to introduce a new register for substitution with hybrid medicines, a definition of which is included in Article L. 5121-1 5°. Contrary to generic medicines, hybrid medicines can have a therapeutic indication, dosing, pharmaceutical form or route of administration which differs from the reference medicinal product. This introduction will be subject to clarifications by decrees which will only enter into force in January 2020.
- Incentive for generic substitution (Article 66): the 2019 LFSS requires physicians to provide justification, based on objective medical criteria, when they mark a prescription as “non-substitutable”. Moreover, the reimbursement of an insured patient who refuses the substitution of a prescribed medicine for a generic product without medical reason will be based on the generic product’s price, and not on the price of the reference medicine actually delivered.
- Reinforcement of early access to innovative health products and modification of their pricing system (Article 65): the 2019 LFSS notably broadens the Temporary Authorisations for Use system to second therapeutic indications and to authorised medicines, whereas it was previously limited to the initial indication(s) of a medicine.
- Reinforcement of digital use (Article 49): the certification by the High Health Authority (Haute Autorité de la Santé) introduced in 2014 for medical prescription assistance software is no longer required (see Legal update French Administrative Supreme Court quashes mandatory certification of medical prescription assistance software). However, the (optional) certification of medical prescription assistance software will be encouraged by financial incentives (for both software programmers and pharmacies).
The 2019 LFSS also introduces new measures for public health establishments (in particular, incentives for the purchase of biosimilars medicines and flat-rate funding of chronic pathologies) and for pharmaceutical companies (such as the simplification and standardisation of safeguard mechanisms for health products).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2018 Issue (Thomson Reuters).