Regulatory changeEndedSocial security and healthcareNational

Medicines safeguard clause: L rate set at −1% and W amount of €700m for hepatitis C

The 2015 Social Security Financing Act rewrites the contribution owed by pharmaceutical companies when their turnover from reimbursable medicines, net of rebates, grows faster than a rate L set by law. For 2015, L is set at −1%: the contribution is triggered as soon as turnover exceeds 99% of the previous year's. Orphan drugs with turnover below €30m and most generics are excluded. The same article sets at €700m, from 1 January 2015, the amount W above which hepatitis C treatments give rise to a specific contribution.

Measure originators

InitiatorGVT
Michel Sapin
Gouvernement
InitiatorGVT
Marisol Touraine
Gouvernement
Impact on public finances

No official estimate found for this measure.

Effective date
1 January 2015

Measure impact

Applies to companies marketing reimbursed medicines. The contribution is due only if overall turnover exceeds the threshold; as an illustration, the impact assessment estimates that a 1% increase in reimbursed spending would yield a theoretical €132m. L and W were set for 2015; the mechanism was later replaced by an amount M in 2019.

Official references

Law number: Loi n° 2014-1554 du 22 décembre 2014 (LFSS 2015), art. 14
Official Journal: JORF n° 0297 du 24 décembre 2014

Procedure timeline

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

100%
3 / 3 steps
Completed
1 January 2015

Administrative implementation

Application

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

Taux L de −1 % applicable à la contribution due au titre de 2015 ; montant W de 700 M€ à compter du 1er janvier 2015.
Completed
22 December 2014

President of the Republic signature

Promulgation

Publication au Journal officiel

Promulgation de la loi n° 2014-1554 de financement de la sécurité sociale pour 2015, publiée au Journal officiel du 24 décembre 2014.
Completed
18 December 2014

Possible referral to Constitutional Council

Constitutional review

Décision de conformité / censure partielle

Décision du Conseil constitutionnel n° 2014-706 DC du 18 décembre 2014 sur la loi de financement de la sécurité sociale pour 2015.