In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
6/2/2023
/ Enforcement Actions ,
Failure to Comply ,
French National Drug and Health Product Agency (ANSM) ,
Healthcare ,
Injunctions ,
Life Sciences ,
Medical Devices ,
Patient Safety ,
Pharmaceutical Industry ,
Product Defects ,
Product Recalls ,
Regulatory Standards ,
Remedial Actions
Since October 1, 2020, healthcare companies have been required to implement the new French anti-gift legal framework, as substantially strengthened by the Ordinance No. 2017-49 dated January 19, 2017....more
In the context of the pandemic, Decree No. 2020-1090 of 25 August 2020 on various measures relating to the reimbursement of health products (the “Decree”) could have been overseen as merely being a technical document. ...more
The French anti-gift legal framework was substantially amended by the Ordinance No. 2017-49 dated January 19, 2017. However, these new rules were subject to the adoption of an implementing decree. Their implementation, which...more
Key Takeaways -
- Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus.
- Several countries have adapted their existing FDI rules, or...more
7/29/2020
/ Australia ,
Austria ,
Biotechnology ,
Canada ,
CFIUS ,
Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
Czech Republic ,
EU ,
European Commission ,
Foreign Acquisitions ,
Foreign Direct Investment ,
France ,
Healthcare Facilities ,
Hungary ,
Italy ,
Japan ,
Medical Devices ,
Member State ,
Mergers ,
New Zealand ,
Pharmaceutical Industry ,
Poland ,
Slovenia ,
Spain ,
Threshold Requirements ,
UK ,
Voting Rights
On 12 December 2018, the General Court (“Court”) partially annulled the European Commission’s decision of 9 July 2014 in the Servier case and consequently reduced Servier’s fine by more than 30%, from €330.99 million to...more
12/21/2018
/ Abuse of Dominance ,
Annulment ,
Anti-Competitive ,
Antitrust Violations ,
EU ,
European Commission ,
European Patent Office ,
Fee Reductions ,
General Court of the European Union (GCEU) ,
Generic Drugs ,
IP License ,
Patent Validity ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reverse Payment Settlement Agreements ,
Settlement Agreements ,
Treaty on the Functioning of the European Union (TFEU)