The Situation: The European Commission ("Commission") has requested that the European Chemicals Agency ("ECHA") investigate the need for an EU-wide restriction on "intentionally added' micro-plastic particles.
The...more
11/29/2018
/ Chemicals ,
Cosmetics ,
ECHA ,
EU ,
European Commission ,
Landfills ,
Manufacturers ,
Member State ,
Nanomaterials ,
Public Consultations ,
Public Health ,
REACH
The UK's Competition Appeal Tribunal (the "CAT") has overturned a finding of abuse of dominance against Pfizer Inc. and Flynn Pharma Ltd. The ruling followed appeals by those companies against a 2016 Competition & Markets...more
The Situation: The German Parliament has approved the Act on Model Declaratory Proceedings ("Act"), which introduces, for the first time, class action-style litigation for consumer claims.
The Plan: The Act will give...more
7/5/2018
/ Class Action ,
Collective Actions ,
Collective Redress ,
Consumer Protection Laws ,
Declaratory Judgments ,
EU ,
European Commission ,
Germany ,
Injunctive Relief ,
Member State ,
New Legislation ,
Settlement Offer
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
6/18/2018
/ Biosimilars ,
EU ,
European Commission ,
Exports ,
Generic Drugs ,
Intellectual Property Protection ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Supplementary Protection Certificate ,
Transparency
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
The Situation: Currently, European law provides only for representative actions to stop or prohibit infringements of EU consumer law, but not for collective redress. As a result, significant differences exist in the...more
6/13/2018
/ Class Action ,
Collective Redress ,
Consumer Protection Laws ,
Cross-Border ,
Declaratory Judgments ,
Disclosure Requirements ,
EU ,
European Commission ,
Injunctive Relief ,
Member State ,
Proposed Legislation
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
The Situation: As agreed in the Coalition Contract of the current German government, the Federal Ministry of Justice officially presented the Act on Model Declaratory Proceedings ("Draft Act") on May 9, 2018, after protracted...more
The Situation: The recent EU Commission proposal for a tightening of consumer protection regulations envisages, in one of its pillars, to step up government enforcement of EU consumer rules, including by introducing a...more
A proposal released by the European Commission for tightening consumer protection regulations in the European Union includes an expansion of both class actions and enforcement powers. The proposal, titled "The New Deal for...more
The Situation: German law does not provide a means of collective redress for consumer claims. Attempts to introduce a corresponding act in the previous legislative term were made; however, no political agreement was reached...more
The Situation: On January 31, 2018, the Italian Supreme Court ruled on the first Italian product-related class action promoted by a consumers' association.
The Result: The Court upheld the consumer's class action claim...more
The Situation: The French Intellectual Property Office ("IPO") previously refused to adjust the expiration date of a granted supplementary protection certificate ("SPCs") when it had been calculated on the date of grant of...more
June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more
On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
6/30/2017
/ Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Legislative Agendas ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OMB ,
Pharmacies ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more
Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more
French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
6/20/2017
/ Anti-Competitive ,
Antitrust Investigations ,
Antitrust Violations ,
Competition Authorities ,
Enforcement Actions ,
EU ,
European Commission ,
Generic Drugs ,
Italy ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Price Gouging ,
Spain ,
Treaty on the Functioning of the European Union (TFEU) ,
UK Competition and Markets Authority (CMA)
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and was...more
New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more
5/15/2017
/ App Developers ,
Attorney General ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
GPS ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
Mobile Medical Applications ,
OCR ,
Privacy Policy ,
State and Local Government
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
5/12/2017
/ Biosimilars ,
EU ,
European Commission ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Standards ,
UK Brexit