As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more
Italy was the first and among the hardest-hit countries in Europe by the COVID-19 pandemic. Emergency regulation for COVID-19 clinical trials and compassionate uses...more
In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
3/16/2020
/ China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
EU ,
Good Clinical Practices ,
Infectious Diseases ,
Italy ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health
The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in...more
1/23/2020
/ Agribusiness ,
Cannabis Products ,
Dietary Supplements ,
Hemp ,
Hemp Cultivation ,
Italy ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Regulatory Standards ,
Retail Market ,
Supply Chain
In Italy, the cultivation and the industrial use of hemp has a long tradition and recent changes in the law have led to a revival. While a law enacted in 2016 promotes the cultivation of hemp as a means to preserve...more
7/31/2019
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cosmetics ,
Decriminalization of Marijuana ,
EU ,
Hemp ,
Italy ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Regulatory Requirements
This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more
7/19/2019
/ Advertising ,
Appeals ,
Clinical Trials ,
Court of Justice of the European Union (CJEU) ,
General Court of the European Union (GCEU) ,
Intellectual Property Protection ,
Marketing Perspectives ,
Non-Use of Trademarks ,
Pharmaceutical Industry ,
Regulatory Standards ,
Revocation ,
Trademarks
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
In the aftermath of this year investigation against business operators not complying with the requirement of Italian law on label notification (see here), the Italian Competition Authority ("Authority") - in charge of...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter.
...more
9/19/2018
/ Algorithms ,
Anti-Competitive ,
Anti-Steering Rules ,
Antitrust Provisions ,
Antitrust Violations ,
AT&T ,
China ,
Competition ,
Competition Act ,
EU ,
Excessive Pricing ,
False Advertising ,
Foreign Investment ,
Internet Retailers ,
Legislative Agendas ,
Merger Controls ,
Monopolization ,
National Health Service Corp (NHSC) ,
Ohio v American Express ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
SCOTUS ,
Single Entity Rule ,
Telecommunications ,
Time Warner ,
UK ,
UK Competition and Markets Authority (CMA) ,
UK Competition Appeal Tribunal (CAT) ,
Unfair or Deceptive Trade Practices
The Administrative Court of Lazio (“TAR Lazio”) decided with judgment No. 09050 of 3 July 2018 (but published only few days ago) that, as a rule, the parallel importer does not have a right to change the trademark affixed on...more
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more
Fast track for orphan diseases and rare forms of cancers -
By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more
The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more
By Law passed today, August 2nd, 2017 (Law for the improvement of the competition on the market), further to a recommendation of the Italian Competition Authority (“ICA“), the Italian legislature enacted provisions for the...more
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more
7/10/2017
/ Appeals ,
Direct Marketing Association ,
EU ,
European Court of Justice (ECJ) ,
European Medicines Agency (EMA) ,
Generic Drugs ,
Intellectual Property Protection ,
Italy ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supplementary Protection Certificate
By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more
6/23/2017
/ Drug Pricing ,
Generic Drugs ,
Italy ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reimbursements ,
Teva Pharmaceuticals
By Ministerial Circular of 23 March 2017, AIFA clarified the conditions under which unauthorized medicinal products may be purchased abroad further to the procedure laid down by the Ministerial Decree of 11 February 1997....more
Focus I: International black market trade -
Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more
The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more
By judgement of January 3rd, 2017, the Turin Court of Appeal delivered a monumental decision in a longstanding patent dispute concerning the validity and infringement of patents relating to an Electronic Program Guide (EPG)...more
2/6/2017
/ Appeals ,
Digital Goods ,
Digital Services ,
EU ,
Infringement ,
Intellectual Property Protection ,
Italy ,
Patent Infringement ,
Patent-Eligible Subject Matter ,
Patents ,
Satellites ,
Software Patents ,
Technology ,
Technology Sector ,
Television Programming