Doing Business in the European Union | Reporting Systems and the Importance of Culture & Language
Doing Business in the European Union | Anonymity & Keeping the Whistleblower's Identity Confidential
Doing Business in the European Union | Key Elements of the EU Directive on Whistleblower Protection
Doing Business in the European Union | Global Laws & Compliance Program
Nota Bene Episode 102: Examining European Union State Aid in the Face of COVID and Brexit with Jacques Derenne and Robert Klotz
JONES DAY PRESENTS®: EU Mandatory Disclosure Rules (DAC 6)
Nota Bene Episode 81: European Check In: How the EU is Dealing with the Pandemic’s Economic Fallout with Oliver Heinisch
Jones Day Talks: EU's New Foreign Direct Investment Regulations Eye Specific Sectors
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more
European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more
The European Commission has published its long awaited and leaked proposals for a once-in-a-generation revision of the EU general pharmaceutical legislation (GPL)....more
Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more
The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more
The last week has seen crucial developments at the European Commission (EC) and U.S. Federal Trade Commission (FTC) regarding the antitrust review of the $7.1 billion proposed acquisition by Illumina (the leading supplier of...more
The European Commission (EC) has published new guidance on the application of the referral mechanism set out in Article 22 of the EU merger regulation (EUMR) allowing for mergers falling below national merger thresholds to be...more
In 2018, the EU Commission adopted a “Paper on the obligation of continuous supply to tackle the problem of shortages of medicines”, providing that Member States may take measures to prevent or address shortages of medicines...more
Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more
Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more
Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or...more
On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more
CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more