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  • New Challenges for European Defense

    Two days before NATO celebrated its seventieth anniversary in Watford, close to London on December 3–4, Ursula Von Der Leyen started her 5 years as president of the European Commission. She had announced that her Commission would be ‘geopolitical’, and appointed a commissioner, the French Thierry Breton, to deal with ‘Defense Industry and Space’, among...

  • French Supervisory Authority publishes guidance on facial recognition

    On November 15, 2019, the French Supervisory Authority (“CNIL”) published guidance on the use of facial recognition. The guidance is primarily directed at public authorities in France that want to experiment with facial recognition. The guidance warns that this technology risks leading to biased results because the algorithms used are not 100% reliable and the...

  • Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

    French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits. To strengthen the.

  • French medicines regulator produces first in Europe medical devices cybersecurity guidelines

    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...

  • French medicines regulator produces first in Europe medical devices cybersecurity guidelines

    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...

  • Application of the private investor test in State aid cases: lessons from the EDF saga

    On 13 December 2018, the European Court of Justice (“ECJ”) rejected an appeal by Electricité de France (“EDF”) against a General Court (“GC”) judgment confirming a Commission decision ordering France to recover EUR 1.37 billion in State aid from EDF (Case C-221/18 P EDF v Commission). The ECJ judgment confirms that the aid, which had...

  • Google fined €50 million in France for GDPR violation

    On January 21, 2019, the French Supervisory Authority for data protection (“CNIL”) issued a fine of €50 million against Google for violations of the General Data Protection Regulation (“GDPR”) (the decision was published in French here).  The CNIL’s decision was triggered by complaints from two non-profit organizations together representing 9974 individuals. The case raises a...

  • What Companies Need to Know About France’s Loi Sapin II Anti-Corruption Law

    On June 3, 2018, French tycoon Vincent Bolloré warned investors that Groupe Bolloré—a logistics provider with extensive operations in former French colonies in Africa—may suffer negative commercial and financial consequences as a result of a corruption investigation initiated by French authorities. Mr. Bolloré was questioned for two days by French police in April 2018 over...

  • AG Opinion on Software Medical Devices

    On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices....

  • France Boosts Its eHealth Initiatives

    The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health.  The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity...

  • Transparency and Conflicts of Interest: France Heading Towards Additional Healthcare Reforms

    Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners.  As it sets a new course, France is now at the European forefront of increasing the...

  • Employees in France and Germany May No Longer Have to Respond to Work-Related Emails Out of Working Hours

    As people head off on their summer breaks, regulators in Europe, particularly Germany, are increasingly focused on the breakdown of the division between home and work life and how this division is changing as mobile devices become used for work-related emails. Regulators are considering new rules that would limit an employer’s ability to require employees...

  • European Consumer Legislation and Online Privacy Policies: Opening Pandora’s Box?

    Regulators and courts in the EU are increasingly vigilant in relation to privacy practices and policies of large online companies.  In recent years and months, the pressure increases not only through privacy-specific regulations and enforcement, but also through the application of consumer legislation.  As the below examples from France and Germany show, some courts or...

  • Reduced Risk for International Companies Operating In France: Potential Removal Of Severe Sanctions For Failure to Consult with Works Councils

    We are writing with another update on French labor law that could impact international corporate transactions.  French President Francois Hollande has proposed a change to French legislation that could remove the threat of imprisonment for directors and senior employees who are found to have breached obligations to consult with works councils and other employee representatives. ...

  • A Trap for the Unwary in International Acquisitions: New Information Rights for Employees Prior to Sale of Company in France

    By: Chris Bracebridge, Luciana Griebel, Helena Milner-Smith, and Jenna Wallace A French law that comes into force on November 1, 2014 will give employees new rights to be informed prior to the sale of a small or medium-sized company, thereby allowing them the opportunity to make an offer to purchase the company.  Companies that meet certain...

  • Abercrombie and Fitch under investigation in France over potentially discriminatory recruitment policies

    Abercrombie and Fitch – renowned for its attractive shirtless model hosts greeting customers at store entrances – is currently under investigation by the French human rights watchdog (Defenseur des Droits) over claims that it hires employees based solely on their good looks. The watchdog is concerned that Abercrombie’s recruitment methods are based on discriminatory criteria...

  • French Sunshine Rules and the Medical Devices Industry

    At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act.  The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the health sector in France....

  • French Sunshine Rules and the Medical Devices Industry

    This post originally appeared on our sister blog, InsideMedicalDevices.   At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act.  The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the...

  • European Mobile Operators Agree to App Privacy Guidelines

    This week, the U.K.-based GSM Association unveiled voluntary app privacy guidelines, which are being implemented by several major European mobile telephone service operators for their own branded applications.  According to the GSM Association, the companies adopting these guidelines includes Deutsche Telekom, France Telecom – Orange, Telecom Italia, Telefónica, and Vodafone.  This development ...

  • France – A Revolution for the Medical Devices Industry

    Originally published as Covington E-Alert on February 13, 2012 New Advertising Rules Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a tremendous impact on the medical devices industry. The industry will now be subject to new advertising rules, sunshine-like...

  • France – A ‘Sunshine Act’ for the Healthcare Industry

    Originally published as Covington E-Alert on January 20, 2012 Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of...

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