Regulatory & compliance
French 2019 Social Security Financing Act introduces new healthcare measures
12 February 2019 - Posted by: 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
New Belgian life sciences regulations on pricing and clinical trials published
06 February 2019 - Posted by: Tine Carmeliet
Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018. A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported › Read More
French State held liable in PIP case
01 February 2019 - Posted by: 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
29 January 2019 - Posted by: Francesca Miotto
Last week, a spokesperson for the Belgian consumer association Test Aankoop/Test Achats announced that the association is likely to lodge a complaint with the Belgian Competition Authority against the Italian pharmaceutical company Leadiant. Allegedly, Leadiant abused its dominant position in the market for chenodeoxycholic acid (CDCA), the active substance in the treatment of the rare › Read More
French regulator (ANSM) introduces third fast-track authorisation procedure for clinical trials
25 January 2019 - Posted by: 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