Regulatory changeIn effectSocial security and healthcareNational

Medicines safeguard clause: single contribution based on a revenue amount M

The 2019 Social Security Financing Act reformed the safeguard clause paid by pharmaceutical companies. The two separate trigger rates for community and hospital care (Lv and Lh rates) are replaced by a single contribution, due when revenue from reimbursable medicines, net of agreed rebates, exceeds an amount M set in value terms. For 2019, M equals 1.005 times the revenue achieved in 2018.

Measure originators

InitiatorGVT
Agnès Buzyn
Gouvernement
InitiatorGVT
Gérald Darmanin
Gouvernement
Impact on public finances

No official estimate found for this measure.

Effective date
1 January 2019

Measure impact

Laboratories whose sales of reimbursed medicines grow beyond the threshold pay a contribution to the health insurance fund, unless they have signed a rebate agreement with the Economic Committee for Health Products. The mechanism aims to keep medicine spending within the national health expenditure target.

Official references

Law number: Loi n° 2018-1203 du 22 décembre 2018 (LFSS 2019), art. 21

Procedure timeline

Follow the progress of this fiscal measure through the different stages of the parliamentary procedure.

100%
3 / 3 steps
Completed
1 January 2019

Administrative implementation

Application

Entrée en vigueur de la mesure et mise en œuvre par l'administration

Entrée en vigueur de la contribution unique (III de l'article 21) ; montant M 2019 fixé à 1,005 fois le chiffre d'affaires 2018.
Completed
22 December 2018

President of the Republic signature

Promulgation

Publication au Journal officiel

Promulgation de la loi n° 2018-1203 du 22 décembre 2018 de financement de la sécurité sociale pour 2019.
Completed
21 December 2018

Possible referral to Constitutional Council

Constitutional review

Décision de conformité / censure partielle

Décision du Conseil constitutionnel n° 2018-776 DC du 21 décembre 2018 sur la loi de financement de la sécurité sociale pour 2019.