Altana updates
'Implant files': Paris administrative court places cursor between freedom of speech and business secrecy
Altana- Healthcare & Life Sciences
- France
- 20 January 2021
In 2018 the so-called 'implant files' journalistic investigation concerning the certification and control of medical devices put on the market made media headlines. Now, the implant files have again become the centre of media attention due to a recent Paris Lower Administrative Court ruling, which highlights the inherent difficulty which lies in balancing various contradictory – but nonetheless important – rights.
Baclofene saga continues
Altana- Healthcare & Life Sciences
- France
- 23 December 2020
In June 2020 the Cergy-Pontoise Lower Administrative Court ordered the suspension of the marketing authorisation for Baclocur (a Baclofene-based drug) on request of the Collectif Baclohelp patient association. In a recent ruling, the French Administrative Supreme Court found that the conditions necessary for the suspension of an administrative decision (urgency and serious doubt as to the decision's legality) had not been met. As Baclocur's suspension has been lifted, it can once again be commercialised.
Suspension of decision granting Baclocur market authorisation when decision is based on compromise rather than scientific knowledge
Altana- Healthcare & Life Sciences
- France
- 23 September 2020
Over the past two years, the French administrative courts have witnessed several proceedings concerning the use of Baclofen for alcohol-related disorders. The Baclofen saga highlights the difficulty for a health authority to make decisions lacking a purely scientific basis which aim, at least partially, to satisfy third parties.
COVID-19: French Administrative Supreme Court rulings on interim measures challenging government policies
Altana- Healthcare & Life Sciences
- France
- 22 April 2020
Physicians, nursing trade unions and constituents recently petitioned the French Administrative Supreme Court with interim measure requests for the protection of fundamental rights during the COVID-19 crisis, resulting in eight rulings. Such interim measures (ie, injunctions or suspension of regulations) can be ordered for urgent matters when it is necessary to safeguard a fundamental freedom.
French Administrative Supreme Court cancels Ministry of Health decision on assessment of public health interests
Altana- Healthcare & Life Sciences
- France
- 27 November 2019
The French Administrative Supreme Court recently cancelled the Ministry of Health's decision to refuse to include Adcetris's extension of indication on the list enabling healthcare establishments to invoice drugs directly to the French health insurance system, which was based on a National Authority for Health opinion. The court notably ruled that assessments of public health interests concerning drug indications cannot be limited solely to the appreciation of prevalence.
