The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate the implementation of the EU Falsified Medicines legislation.
The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire, and it was initially open until the end of August 2017. Upon the request of various stakeholders, the European Commission has recently decided to keep
Will Germany establish a “Digital Agency” to monitor compliance with competition law rules in digital markets? Will a German “Digital Antitrust Enforcer” become a role model for a European protectionist approach against American and Asian platform providers?
The German Federal Ministry for Economic Affairs and Energy seems to see a pressing need for regulation in digital markets. The White Paper “Digital Platforms”, published on the 20 March 2017, provides an outlook on possible forms of digital regulatory policy in Germany and potentially also in Europe. Of particular interest from a competition law perspective is the proposal to establish a new “Digital Agency”.
In September 2016, the European Commission granted a 30% fine discount to Altstoff Recycling Austria for cooperating with an investigation into its alleged abuse of a dominant position in the Austria waste management market (see our previous post here). The discount was granted on the basis of Paragraph 37 of the 2006 Fining guidelines, which allows
The current eighth European Union Research, Technological Development and Demonstration (“RTD”) Framework Programme, entitled Horizon 2020, will expire on 31 December 2020. On 12 October 2016, the Director General for Research and Innovation announced that the European Commission is currently starting to work on and plan for the ninth RTD Framework Programme (“FP9”) which will
The stage is set for the Euro-drama of our time. We know that giving effect to the UK’s vote for Brexit could require as many as four sets of distinct but closely linked negotiations, or “acts”, dealing with the terms of: the UK’s withdrawal from the EU; the UK’s future relationship with the EU after
The Italian administrative tribunal of Lazio region (tribunale amministrativo regionale del Lazio, “TAR”), the sole responsible court for the appeal of the Italian Competition Authority (“ICA”) decisions, has recently provided detailed clarification regarding when information exchange between competitors is not illegal. In a series of judgments regarding the TV post-production services case, the TAR overturned
Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model
Belgian endives are a divisive vegetable: their bitterness delights some but repulses others. And even amongst Belgian endive enthusiast you’ll find some that prefer them raw – to maintain their crispness – while others like them cooked so that their bitterness comes out even more. But Belgian endives are no longer the exclusive battleground of
On 8 April 2015, the European Commission adopted Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (“Directive 2015/565”) and Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (“Directive
The enforcement of antitrust rules in the agricultural sector has been a taboo in Brussels for decades – and for good reason. Spending on the so-called Common Agricultural Policy (CAP) represented the vast majority of the EU budget until the beginning of the 21st century and the agricultural sector could consequently hardly be seen as open to the principles of the market economy. But things have slowly started to change with the creation of the World Trade Organisation and the reduction of farm subsidies in recent years.
On 26 February 2015, the European Commission published a progress report concerning the Commission’s five year Action Plan on Antimicrobial Resistance (“Action Plan”). The purpose of the progress report is to inform the European Parliament, the EU Member States and other stakeholders about progress to date in relation to the implementation of the Action Plan.
On 5 September 2014, the European Commission released the Implementation report on the Commission Communication on Rare Diseases: Europe’s challenges (COM(2008) 679 final) and Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (the “Implementation Report”).
As part of the European Commission’s drive to take action concerning rare diseases, the Implementation Report analyses the extent to which the Commission’s measures on rare diseases have been established.
The Implementation Report provides an overview of the European Union (“EU”) rare diseases strategy to date, including the Commission Communication (COM(2008) 679 final) and Council Recommendation (2009/C 151/02).
On May 28, 2014, the European Commission approved the acquisition of the second largest mobile telecommunications carrier in Ireland by the fourth largest provider. The US$1 billion merger of O2 Ireland and H3G (known as Three), which had been awaiting regulatory approval since October 2013, will result in a new entity with a 37.5% market
On 22 January 2014, the European Commission (Commission) published a “Recommendation on minimum principles for the exploration and production of hydrocarbons (such as shale gas) using high volume hydraulic fracturing” (Recommendation). The Recommendation sets out minimum core principles for the exploration and production of hydrocarbons (e.g., shale gas) using high-volume hydraulic fracturing. The Recommendation is
On 21 November 2013, the European Commission signed a Memorandum of Understanding (“MoU“) with the Competition Commission of India. A copy has just been published on the European Commission’s website. The aim of the MoU is to further strengthen cooperation between the two parties in the area of antitrust enforcement.
The United States exported an all-time record high of $2.2 trillion worth of goods and services in 2012. But while U.S. business has gone global, the attorney-client privilege has not always come along for the ride. In 2010, the European Court of Justice (ECJ) in Akzo Nobel Chemical Ltd. and Akcros Chemical Ltd. v. European
On Tuesday 24 September 2013, the European Commission adopted a Regulation intended to strengthen the criteria for the designation and supervision of notified bodies under the Medical Devices Directives. On the same day, the European Commission also adopted a Recommendation concerning the tasks to be fulfilled by notified bodies when conducting audits and conformity assessment
The European Commission recently published a consultation paper that invites comments on a proposal to allow review of the acquisition of non-controlling minority shareholdings. The proposed reform is the most significant in the last 10 years and could have a huge impact on many corporate transactions. Under the current E.U. Merger Regulation, the commission only
The European Commission is completing a Consultation on the need for additional regulation of unconventional fossil fuel (e.g., shale gas) exploration and development in Europe. The Consultation period ends on 23 March 2013 and results will be made available on the Commission’s website and at a stakeholders’ meeting to be held by the Commission in
On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in
EU Trade Commissioner Karel de Gucht has announced the EU Commission’s withdrawal of a proposal on the marking of origin requirements for certain products imported from third countries. The Commissioner’s February 17 announcement provided two reasons for the withdrawal. First, the Commission believes that the proposal is inconsistent with the EU’s WTO obligations following the Appellate Body’s decision in
The European Ombudsman, responsible for investigating complaints about maladministration in the institutions and bodies of the EU, has continued his strong criticism of the European Commission’s refusal to disclose a handful of documents concerning its view of the UK opt-out from the EU Charter of Fundamental Rights. The refusal by the Commission to provide access