The Servier case: The game isn’t over yet -
The European Court of Justice recently issued seven judgments in the landmark "Servier" case, confirming the anticompetitive nature of "pay-for-delay" agreements between...more
In a decision dated September 12, 2024, the French Administrative Supreme Court (Conseil d’Etat) applied the principles established a year ago by the same court in the veterinary sector. The ruling was made in a summary...more
As is often the case, France has been a pioneer in implementing a mandatory safety stock, especially for essential drugs. Since 2021, pharma companies must hold at least a 2-month safety stock to meet the needs of patients on...more
Key Takeaways -
- As FDI regimes proliferate and mature around the globe, governments are taking an ever-more expansive view of the concept of “national security” to include more than military and defense interests, which...more
5/14/2024
/ Australia ,
Belgium ,
China ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
EU ,
Foreign Direct Investment ,
Foreign Investment ,
France ,
Germany ,
Investment ,
Investors ,
Ireland ,
Legislative Agendas ,
National Security ,
Regulatory Agenda ,
Russia ,
Singapore ,
UK ,
United States
Le 28 décembre 2023, un décret et un arrêté ministériel ont une nouvelle fois élargi à plusieurs égards le régime français de contrôle des investissements étrangers (IEF).
Comme cela était attendu, le seuil d’acquisition...more
On 28 December 2023, a decree and a ministerial order was issued that extends the French foreign direct investment (“FDI”) regime once again on various fronts.
As expected, the threshold of voting rights acquired by...more
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
The Administrative Supreme Court upholds decisions restricting the prescription of a treatment against osteoporosis.
Upon the assessment of a follow-up study, the French National Authority for Health (“HAS”) recommended...more
On 8 September 2022, the French Ministry of Economy and Finance, in charge of approving foreign direct investments (FDI) into strategic sectors, issued its first guidelines, intended to make the process of FDI into France...more
The national security and foreign direct investment (“FDI”) review landscape around the world is evolving rapidly. A pre-pandemic trend of active FDI reviews in countries around the world has gained momentum and resulted in...more
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
To lower the risk of opportunistic trading resulting from the pandemic, the French government temporarily tightened its control over investments in strategic public companies. On 29 April 2020, the Ministry of Finance...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
The EU Foreign Direct Investment Regulation will be in full force from October 11, 2020. We expect it will radically alter the dynamics of foreign investment review in Europe. Any non-EU investor and any EU target company...more
5/18/2020
/ Acquisitions ,
EU ,
European Commission ,
Foreign Direct Investment ,
Foreign Subsidiaries ,
Member State ,
Mergers ,
National Security Review Proceedings ,
New Regulations ,
Non-EU Investors ,
UK Brexit
Strong signal that the EU wants to protect its critical businesses and that the European Commission’s “advisory” role under the EU FDI Regulation will be significant .
Key Takeaways -
In response to concerns raised by...more
With hand sanitiser gel stocks under pressure worldwide, increasing numbers of businesses are considering how they could begin direct production of their own to ensure that they have sufficient stock for their own use.
The...more
UK and French Government Controls on Protective Face Masks During the COVID-19 Coronavirus Pandemic -
Key Takeaways -
With protective face masks becoming a scarce resource during the COVID-19 pandemic and authorities...more
3/25/2020
/ EU ,
Exports ,
France ,
Imports ,
Manufacturers ,
Medical Supplies ,
Personal Protective Equipment ,
Public Health Emergency ,
Relief Measures ,
State of Emergency ,
UK
Brexit has been postponed again, until at least 31 October 2019, but with the possibility that it may occur sooner, maybe even within a few weeks....more
4/15/2019
/ Article 50 Treaty of the EU ,
Customs Unions ,
Election Results ,
EU ,
EU Single Market ,
European Parliament ,
Free Trade Agreements ,
No-Deal Brexit ,
Special Election ,
Tariffs ,
Time Extensions ,
UK ,
UK Brexit ,
UK Parliament ,
Withdrawal Agreement
The UK Parliament, having for the second time rejected the Withdrawal Agreement negotiated between the UK government and the EU, will vote on it for a third time next week. If it is approved, the UK will ask the EU for a...more
The UK House of Commons has rejected the government’s proposed Withdrawal Agreement. Unless the Agreement (or an amended version of it) is approved by the House of Commons, or the Brexit date of 29 March 2019 is postponed or...more
1/16/2019
/ AIFM ,
Alternative Investment Fund Managers Directive (AIFMD) ,
Asset Management ,
Contract Terms ,
Corporate Counsel ,
Corporate Taxes ,
Cross-Border Transactions ,
EU ,
Exports ,
Free Movement ,
Imports ,
Intellectual Property Protection ,
MiFID II ,
No-Deal Brexit ,
Supply Chain ,
Tax Treaty ,
Trade Policy ,
Trade Relations ,
Transitional Arrangements ,
UCITS ,
UK ,
UK Brexit ,
Withdrawal Agreement
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)