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 Fentanyl decision concerning a co-operation agreement between Sandoz and Janssen Cilag.  It not only looked at whether the settlement agreements between Servier and certain generic companies restricted competition by object, it also analysed their effects.  As a result of its analysis, the Commission found that Servier’s conduct amounted to an abuse of dominance under Article 102 of the Treaty on the Functioning of the European Union (the “TFEU”).

In July 2014, the Commission fined Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin a total of €428 million for having concluded agreements that delayed market entry of generic versions of Servier’s blockbuster blood pressure medicine, perindopril, and protected it from price competition from generics in the EU.  All these agreements entailed Servier making significant payments (or providing other types of inducements) to the generic companies.  In addition to entering into these settlement agreements, Servier adopted various other practices that the Commission found were part of Servier’s overall strategy to delay or prevent entry of generic versions of perindopril. 
Continue Reading European Commission Published Non-Confidential Version of Servier Decision

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 weeks earlier.  In parallel, the French data protection authority announced a possible crackdown on mHealth app non-compliance with European data protection legislation.  This post briefly summarizes these developments.
Continue Reading May 2015 EU mHealth Round-Up

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 control.

Council Directive 89/105/EEC allows Member States to introduce price freezes on pharmaceutical products. Article 4(2) of the Directive states that derogations from price freezes can be justified for “particular reasons”. Based on these provisions, Germany introduced a mandatory manufacturer’s rebate of 16% on certain prescription medicines sold to public sickness funds and private health insurers between 1 August 2010 and 31 December 2013. Also, under the Article 4(2) exemption, Germany set up a system of derogations for companies whose financial viability would be threatened by the rebate.
Continue Reading German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

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 apps.  (See more here, and here for our blog post on the European Commission’s Summary Report of the mHealth consultation.)

In its latest paper on health data in apps and devices, the Working Party supports a broad definition of health data, distinguishing the following three categories of health data:

  1. The data are inherently/clearly medical data, especially those generated in a professional, medical context.
  2. The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person.
  3. Conclusions are drawn about a person’s health status or health risk (irrespective of whether these conclusions are accurate, legitimate or otherwise adequate or not).
    Continue Reading Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices

 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 Summary Report of European Commission’s mHealth Consultation Published

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 guidance on the classification of two distinct borderline medical device-medicinal products, namely, a riboflavin solution for the treatment of keratoconus and dentistry products with aluminium chloride used in haemostasis.
Continue Reading Commission Updates EU Medical Devices Borderline Manual

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 in 2012, accusing Servier of abusing its dominant position in the market of antihypertensive medicines and entering into anticompetitive agreements with generic competitors.  According to the Commission’s decision, Servier aimed to prevent entry into the market of cheaper versions of Servier’s blockbuster drug perindopril.

The Servier investigation was a new case in the long series of Commission investigations into the pharmaceutical sector, which started in essence with the Commission’s Competition Inquiry into the Pharmaceutical Sector (Sector Inquiry).  The 2009 Final Report of the Sector Inquiry revealed practices that could have an impact on generic competition in the pharmaceutical market and initiated a monitoring exercise by the Commission of anticompetitive patent settlements.  The Commission concluded four monitoring exercises, covering the periods from mid 2008 – end 2009, 2010, 2011 and 2012.  The latest monitoring has shown that the number of patent settlements is increasing but the number of potentially problematic agreements from an antitrust perspective is low.  In the period after the Sector Inquiry, the Commission sanctioned pharmaceutical companies for anticompetitive patent settlements in two major instances, i.e., the citalopram and the fentanyl decisions of 2013.
Continue Reading European Commission Fines Servier and Five Generic Companies For Preventing Entry Of Generic Versions Of Blood Pressure Control Drug

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 Spring 2015.

The Commission’s consultation aims at gathering the views of the public on the currently available information on nanomaterials on the market, whether the information available is sufficient to guarantee the safe use of nanomaterials and products containing them and informed consumer choice, and the different options to address any lack of information.  The consultation will contribute to the preparation of an impact assessment of a possible future Commission proposal.
Continue Reading The European Commission Launches a Public Consultation on a EU Nano-Registry

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, patent protection for the Fentanyl depot patch expired in 2005 and Sandoz (a subsidiary of Novartis) was on the verge of launching its generic fentanyl patch.  According to the Commission, it had already purchased packaging material and obtained market authorizations.
Continue Reading Johnson & Johnson / Novartis: Another Pay-For-Delay Down for the European Commission

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