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 Implementing Decision will enter into force in mid-December 2013.

Under the Cosmetics Regulation, cosmetic products placed on the EU market must be safe for human health when used under normal and reasonably foreseeable conditions of use, taking into account, among other things, the product’s presentation and labelling.  A legal or natural person designated within the EU as the “responsible person” must ensure that each cosmetic product placed on the EU market has a cosmetic product safety report drawn up in accordance with the requirements of Annex I of the Cosmetics Regulation.  This safety report forms part of the product’s information file, which the responsible person must keep for a period of 10 years following the placing on the market of the last batch of product.

Continue Reading EU Guidelines on Cosmetic Product Safety Reports

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 rules could be of significant financial and practical benefit to life sciences companies.

Ensuring that sensitive information (such as customer supply lists, R & D data and process know how and technology) is legally protected from misuse by employees, consultants, competitors and other third parties is a key concern in the life sciences sector. ‘Trade secrets’ often form the bedrock of a company’s assets. 75% of the 537 EU firms who responded to the Commission’s preparatory survey (some of which were SMEs in the life science sector) indicated that trade secrets were of significant strategic importance to their company’s growth, competitiveness and innovative performance.
Continue Reading A Move to Harmonise Trade Secret Laws Across Europe?

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 approach of the Commission and the General Court, which seeks to attribute antitrust liability to parent companies wherever possible.

In years past, JVs were in principle classified as separate undertakings (with the once-off exception of Avebe).  According to the Commission’s decisional practice, they should not be grouped together with their controlling parents, particularly for the purpose of attributing liability and collecting fines (e.g., Ijsselcentrale, Gosme/ Martell, Rubber Chemicals).  The situation changed with the Commission’s decision in Chloroprene Rubber, where it was held that both parent companies of a 50:50 JV should be held jointly and severally liable for the JV’s conduct. 
Continue Reading Parents’ Liability for Antitrust Infringements of 50:50 JVs: European Court confirms the new stringent approach in EU law

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 Lundbeck: First European Commission Decision on “Pay for Delay”

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 and Performance Program (REFIT) — launched by the Commission back in December 2012 to ease the regulatory burden on SMEs in Europe.  REFIT aims to scrutinize the European legislative and regulatory framework for gaps, burdens and inconsistencies in order to correct them.  The final results and any recommendations to improve and simplify existing legislation will be announced in June 2013.

In the employment context, the Commission is currently taking the following steps:
Continue Reading European Commission Set to Ease Regulatory Burden on SMEs: Key Implications for Life Sciences Employers

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 and support anti-counterfeiting efforts.

The Recommendation seeks to harmonize UDI mechanisms established at national and/or regional level that allow tracing of medical devices. This will help ensure compatibility of these systems with the proposed EU UDI system, the implementation date of which is not yet clear.

Traceability of medical devices is currently not regulated in the EU, but the proposed EU Medical Devices Regulation includes specific traceability provisions and envisages a mandatory internationally compatible UDI system for the EU. Pending the establishment of this EU level UDI system, the Recommendation sets out the data elements that Member States must include in national UDI databases and proposes conditions for economic operators, health professionals and professional users.
Continue Reading Commission Recommendation on Unique Device Identification System in the EU

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 claims:

  • Servier.  In parallel with the EU Commission’s investigation into Servier’s reverse payment patent settlements concerning perindopril, a number of UK health authorities have filed damage claims seeking more than ₤230 million in damages from Servier.
  • Reckitt Benckiser. In connection with the OFT’s 2010 decision imposing a ₤10.2 million fine on Reckitt Benckiser for practices related to Gaviscon Original Liquid, the UK health authorities and a generic competitor have brought follow-on damage claims seeking approximately £89 million from Reckitt Benckiser.
    Continue Reading Private Antitrust Damages Claims in the Pharmaceuticals Sector: Gaining Momentum

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 Bodies,” are involved.

What are Notified Bodies?

Notified Bodies are entities that have been accredited by the competent authority of a European Member State to assess the conformity of the products with the relevant EU legislation.  Their legal status varies from public bodies to associations and commercial undertakings.  Today, 29 EU legislative regimes are implemented in practice by the involvement of Notified Bodies.  These regimes include the rules on personal protective equipment, marine equipment, toys, and machinery.  For medical devices, 78 Notified Bodies have been designated for the assessment under one of the three Directives currently regulating medical devices in the EU,i.e.Directive 90/385/EEC on active implantable medical devicesDirective 93/42/EEC on medical devices, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs).
Continue Reading “Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power

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’ regulation, described in our previous post, it still had to take into account the strong call from the public for safer and more strictly controlled medical devices.  As a result of this political imperative, the Commission included in Article 44 of its Proposal a so-called “scrutiny procedure.”  Like the rest of the Proposal, the scrutiny procedure would become law if adopted by the European Parliament and the Council.  Our earlier post on the legislative process describes this procedure in more detail.

Scrutiny Procedure

Under the scrutiny procedure, any new applications for conformity assessment of high-risk devices (with the exception of applications to supplement or renew existing certificates) would now possibly be subject to a “second look” by the Medical Devices Coordination Group (MDCG).  This newly created expert committee would be composed of Member State officials and chaired by the European Commission.  The Commission will probably also develop some centralized scientific and technical expertise that will allow it to be more directly involved in the assessment of specific products.
Continue Reading EU Proposes a Scrutiny Procedure for High-Risk Devices

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