LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission addresses State aid support in Communication on tackling nonperforming loans in the aftermath of COVID-19 pandemic
• European Commission...more
1/7/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Relief Measures ,
State Aid ,
State of Emergency
This regular update (no. 29 | 15 December 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
12/15/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
• Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more
12/2/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
• European Commission Executive Vice-President Margrethe Vestager speech on COVID-19 State...more
11/30/2020
/ Competition ,
Coronavirus/COVID-19 ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Relief Measures ,
State Aid ,
State of Emergency
The Development: Belgium's financial regulator, the Financial Services and Markets Authority ("FSMA"), published a recent opinion on "Considerations and good practices with respect to inside information disclosures by listed...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
LATEST KEY DEVELOPMENTS...more
11/17/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency ,
Value-Added Tax (VAT)
This regular update (no. 24 | 13 October 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
10/22/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
LATEST KEY DEVELOPMENTS...more
10/20/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
This regular update (no. 23 | 29 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
10/2/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
10/1/2020
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Medical Supplies ,
Member State ,
Personal Protective Equipment ,
Public Health ,
State Aid ,
Supply Chain
At long last, the new French health care anti-gift regime, modified in 2017, should be applicable as of October 1, 2020, thanks to implementing regulations adopted over the summer.
The French anti-gift regime, which...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
...more
9/1/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Member State ,
Relief Measures ,
State Aid ,
State of Emergency
Note From the Editors -
With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
7/21/2020
/ Acquisitions ,
Buyouts ,
CARES Act ,
Coronavirus/COVID-19 ,
Digital Health ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Foreign Direct Investment ,
Global Dealmaking ,
Investors ,
Life Sciences ,
Market Participants ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Popular ,
Private Equity ,
Public Health Emergency ,
Regulatory Requirements ,
Startups ,
Telehealth ,
Telemedicine ,
Venture Capital
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
6/2/2020
/ Biometric Information ,
Clinical Trials ,
Consent ,
Data Collection ,
Data Integrity ,
Data Privacy ,
Data Security ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Research and Development
In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more
The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• EU approves Member State measures to support the economy
• Austria requests EU to suspend State aid rules
• Eurogroup Report on the comprehensive economic...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Proposed expansion of State aid Temporary Framework to recapitalization
• EU approves Member State measures to support the economy
Trade / Export Controls...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Guidance on allowing limited cooperation among businesses
• EU approves Member State measures to support the economy
Trade / Export Controls
• Commission...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• DG COMP COVID-19 website and mailbox for informal guidance
• Extension of State aid Temporary Framework
• Public short-term export credit insurance available...more
Competition & State Aid
• Delay of merger notifications
• State aid procedures fast-tracked
• Communication on Temporary State Aid Framework adopted
Foreign direct investment control
• Commission urges vigilance in...more
The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more
6/18/2018
/ EU ,
Incentives ,
Intellectual Property Protection ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
Top News -
FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions -
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
1/16/2018
/ Amended Regulation ,
Animal Food ,
CGMP ,
ECHA ,
EU ,
European Food Safety Authority (EFSA) ,
Farms ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Proposed Rules ,
Public Meetings ,
REACH ,
USDA ,
Wetlands
USDA Inspector General Recommends Reform of AMS Organic Program for Imports -
The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more
11/21/2017
/ Additive Manufacturing ,
APHIS ,
Draft Guidance ,
EU ,
European Food Safety Authority (EFSA) ,
Exports ,
Federal Register ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
France ,
Grain & Feed Commoditites ,
Imports ,
Interim Final Rules (IFR) ,
Lumber Industry ,
Menu-Labeling ,
Natural Products ,
Nutrition Facts Labels ,
Organic ,
Safety Training ,
Supply Chain ,
USDA