French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine

Jeanne Fabre

The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for Read More

French 2019 Social Security Financing Act introduces new healthcare measures

Eveline Van Keymeulen

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 Read More

French State held liable in PIP case

Eveline Van Keymeulen

On 29 January 2019, in an instance brought by a victim in the infamous case of defective (Poly Implant Prothèse) PIP breast implants, the Administrative Court of Montreuil held the French State liable, considering that AFSSAPS, the predecessor of the current National Agency for Medicines and Health Products Safety (ANSM), did not “take the necessary Read More

French regulator (ANSM) introduces third fast-track authorisation procedure for clinical trials

Eveline Van Keymeulen

Following the introduction of two fast-track procedures to allow faster patient access to innovations in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) implemented another fast-track authorisation procedure (see our previous update, ANSM introduces fast-track authorisation procedures for clinical trials). On 5 December Read More

French pharmacist representatives call for implementation and expansion of biosimilar substitution

Eveline Van Keymeulen

On 12 December 2018, seven representative pharmacy organisations (ANEPF, USPO, FSPF, APR, Federgy, le Collectif and UDGPO) addressed a joint letter to the French Health Ministry to call for the implementation of biosimilar substitution in France. While the principle of biosimilar substitution at the initiation of treatment has been established in French law since 2014, Read More