France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading
On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here). The letter seeks to address concerns that a number of pharmaceutical companies will not have been able … Continue Reading
This article was originally posted on our sister blog Inside Medical Devices The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”). In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that … Continue Reading
Since its in-depth inquiry into the pharmaceutical industry in 2008-2009, the European Commission (the “Commission”) has monitored patent settlement agreements. In its 2014 report published on 2 December 2015, the Commission revealed the results of its analysis of 76 patent settlement agreements between originators and generics (a number “far below” the figures of previous years), … Continue Reading
On 14 July 2015, the European Commission (the “Commission”) published the preliminary non-confidential version of its decision in the Servier case, one year after the decision was issued. This is the second key Commission decision, after Lundbeck, on reverse payment patent settlement agreements. In Servier, the Commission went further than in Lundbeck and in its … Continue Reading
This article was originally published on our sister blog InsidePrivacy May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention. The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just … Continue Reading
The European Commission (the Commission) confirmed on 27 March 2015 that a German scheme exempting pharmaceutical companies from mandatory rebates is in line with EU State aid rules. The Commission concluded that the scheme facilitated price freezes on certain medicines, which in turn allows the costs of the public health system to be kept under … Continue Reading
Article originally posted on our sister blog InsidePrivacy The Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s mHealth initiative to clarify the definition of data concerning health in relation to lifestyle and wellbeing … Continue Reading
This post originally appeared on our sister blog, Covington eHealth. The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health… Continue Reading
The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software. The manual also provides new … Continue Reading
On 9 July 2014, the European Commission’s Directorate General for Competition imposed fines totalling € 427.7 million on innovative pharmaceutical company Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin. The Commission’s decision was the result of proceedings opened in 2009 and follows a Statement of Objections sent to the parties involved … Continue Reading
The European Commission has launched a public consultation on possible EU measures to increase the transparency of nanomaterials on the European market. The consultation is the first step of a Commission drafting procedure that is likely to end in a proposal for a Regulation on an EU Nano-Registry that the Commission could formally present by … Continue Reading
On 11 December 2013, the European Commission (“Commission”) sanctioned pharmaceutical firms Johnson & Johnson and Novartis with fines totaling EUR 16.3 million over a co-promotion agreement which allegedly delayed the sale of generic versions of pain killer Fentanyl in the Netherlands. Johnson & Johnson initially developed and commercialised Fentanyl in the 1960s. In the Netherlands, … Continue Reading
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for cosmetic product safety reports. The … Continue Reading
Hannah Edmonds, a trainee associate in Covington’s London office, contributed to this post. Currently, legal regimes governing protection of trade secrets and confidential information across the EU are fairly disparate. A study published by the European Commission in July (http://ec.europa.eu/internal_market/iprenforcement/docs/20130711/final-study_en.pdf) has identified a ‘widespread appetite for a harmonized approach’ across the region. Harmonisation of the … Continue Reading
On 26 September 2013, the highest EU Court issued two important judgments, Dow and EI DuPont. These judgments confirm that a parent company can be held liable and fined by the European Commission (“Commission”) for the antitrust infringement of its 50:50 JV in the EU. In so stating, the EU Court endorsed the current hardened … Continue Reading
On 19 June 2013, the European Commission imposed fines totaling EUR 146 million to Lundbeck and several producers of generic medicines, including Alpharma, Merck KGaA/Generics UK, Arrow, and Ranbaxy, for infringement of Article 101 TFEU. This is the first Commission decision dealing with so-called “reverse payment” patent settlements or “pay for delay” agreements.… Continue Reading
By Chris Bracebridge In March 2013, the European Commission published preliminary results of its study of the top ten most burdensome EU laws for SMEs. Employee-related legislation forms a significant part of that list, and is among the most costly and onerous. The “top ten” study is part of an initiative — the Regulatory Fitness … Continue Reading
On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls and other field safety corrective actions. It will also help avoid device-related medical errors and injuries … Continue Reading
The times when private antitrust damages claims were not a serious risk in the European Union are gone. The European Commission and national competition authorities are actively promoting follow-on damages claims by private plaintiffs, and national health authorities are themselves bringing huge claims for damages arising from anticompetitive practices. The following are examples of recent … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure. For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. Following recent developments regarding breast implants and metal-on-metal hip joint replacements, the European Parliament (EP) adopted a resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices. While the Commission has not endorsed the EP’s resolution for a premarket authorization system in its Proposal for a new EU medical devices’ … Continue Reading
Article originally published in the FDLI Update (January/February 2013) “Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU … Continue Reading
