Pharmaceuticals
15 February 2019 - Posted by: Emma Keeling
On 23 January 2019, the European Data Protection Board (the EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (536/2014) (the CTR) and the General Data Protection Regulation (2016/679) (the GDPR) (the Opinion). The Opinion aims to provide greater certainty for those conducting clinical trials, clarifying: the distinction between consent requirements › Read More
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
European Commission issues report on antitrust enforcement in the pharmaceutical sector
30 January 2019 - Posted by: Dominc Long
A decade on from its inquiry into the pharmaceutical sector in 2009, on 28 January 2019 the European Commission (EC) issued a report providing an overview of antitrust law enforcement (antitrust and mergers) in the EU from 2009-2017 in the pharmaceutical sector. The report confirms that effective enforcement of EU antitrust rules in the sector › 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