On 24 November 2022, the French Agency for the Safety of Medicines and Health Products issued three sentences against pharma companies that have failed to meet their reporting obligation regarding the risk of a medicinal products supply shortage or a supply shortage.
At COP 27 in November 2022, South Africa launched its new Just Energy Transition Investment Plan and announced a five-year investment plan for the USD 8.5 billion financing package, which was announced as part of the country’s Just Energy Transition Partnership with France, Germany, the United Kingdom, the United States and the European Union at COP 26. The JET IP is aligned with the Cabinet-approved National Just Transition Framework and outlines the investments required to achieve the country’s decarbonization commitments, while promoting sustainable development, and ensuring a just transition for affected workers and communities.
On Monday 3 October 2022 from 08:30 am – 10:00 am CEST, Baker McKenzie will be hosting an intimate in-person roundtable discussion on Sanctions and Export Controls in our Paris office. This event will give you the chance to ask questions to our team of experienced lawyers from Europe and the US and discuss best practices with us and your peers.
In August 2022, the French Agency for the Safety of Health Products published an updated version of its guidelines for determining financial penalties, which will come into effect on 1 October 2022.
The French Authorization for Temporary Use and Recommendation for Temporary mechanisms enabling a derogation for coverage of medicines were substantially amended by the Social Security Financing Bill for 2021.
With the aim of speeding up market access for innovative medicines and allowing exceptional access for medicines that meet a therapeutic need on an ad hoc basis, the new mechanisms of early access authorization and compassionate use were implemented as from 1 July 2021.
Almost a year after the implementation of such new early access mechanisms, the French High Health Authority and the French National Agency for the Safety of Medicines and Health Products gave a very positive first report on EEA.
Through the EU Directive on Restructuring and Insolvency of 20 June 2019 (EUR 2019/1023, “Directive”), the European Union has imposed an obligation on its member states to offer a more attractive and flexible restructuring scheme in their respective local law. The initial deadline to do so had been 17 July 2021. Only a handful of countries (most notably Germany and The Netherlands) had implemented the Directive within the initial deadline, whilst the other countries made use of the possibility to ask for a one year extension.
On 20 April 2022, the French government adopted an ordinance adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although the MDR is directly applicable since its entry into force on 26 May 2021, adaptations of the provisions of the French Public Health Code were necessary and much awaited by the medical device industry.
Baker McKenzie’s Sanctions Blog published the alert titled G7 Countries Move to Revoke Russia’s “Most Favored Nation” Status and Impose Other Sanctions on 16 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled “EU, UK, US and Canada announce upcoming restrictions related to SWIFT and the Russian Central Bank” on 27 February 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.