On 7 December 2017, the Court of Justice of the European Union (‘CJEU’) rendered its judgment in Snitem et al. v. France (Case C-329/16), which essentially addressed the question of when software qualifies as a medical device within the meaning of the Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993). Christian Lindenthal and Dr Daniel Misch of Bird & Bird LLP dissect the rationale to the CJEU’s judgment and the practical implications. / read more

The Florida Supreme Court ruled, on 9 November 2017, in Emma Gayle Weaver, etc. v. Stephen C. Myers, M.D., et al., that the right to privacy under Florida’s Constitution does not end upon an individual’s death. The ruling concerned a medical malpractice claim brought by Weaver as an individual and as representative of the estate of her late husband. In particular, Weaver challenged the constitutionality of the 2013 amendments to Sections 766.106 and 766.1065 of the Florida Statutes (‘the Amendments’), which relate to disclosures that should be made as part of medical negligence actions, on the basis that these violated the right to privacy under Florida’s Constitution. The Florida Statutes and the Amendments required Weaver to authorise the release of her husband’s protected health information (‘PHI’), which she alleged was irrelevant to the case, as well as to consent to secret, ex parte interviews between the health providers and the defendant or his legal representatives, in order to proceed with the medical negligence action. / read more

The Milan Civil Court issued on 24 July 2017 a judgment on whether the publication by pharmaceutical company DOC Generici S.r.l. (‘DOC Generici’) of a list of its medicinal products and the pricing information on its website and in print journals should be qualified as advertising, and therefore fall under the Italian legislation on the advertising of medicinal products. In reaching its conclusion the Court drew on criteria established in a 2011 ruling by the Court of Justice of the European Union, in MSD Sharp & Dohme GmbH v. Merckle GmbH. Elisa Stefanini of Portolano Cavallo analyses the Milan Civil Court’s ruling, which represents one of the few judgments by Italian civil courts to consider the advertising of medicinal products. / read more

On 19 October 2016, the Court of Justice of the European Union (‘CJEU’) held that Germany’s fixed pharmacy prices constitute an unjustified restriction of the free movement of goods principle, which cannot be justified on grounds of the protection of health and human life. The ruling overturned Germany’s retail price maintenance regulation for prescription drugs. Here, Jan Schlimgen and Max Müller of Dutch online pharmacy DocMorris N.V. provide their perspective on this important ruling, which was instigated by a bonus system that a German Parkinson’s disease self-help organisation agreed with DocMorris. It was the legal action taken by the German Association for Protection Against Unfair Practices against this bonus system that led to the ruling from the CJEU. / read more

In October 2016 the Texas Medical Board dropped its appeal of the refusal by the US Court of Appeals for the 5th Circuit (the ‘Court’) to dismiss telehealth company Teladoc’s case against the Board, in a dispute about the passing of what Teladoc considered anti-telemedicine regulations by the Board. Julian Rivera and John Ferguson of Husch Blackwell LLP discuss the reasoning behind the appeal being dropped, the continuing battle between Teladoc and the Board, and the actions of groups in Texas who are looking at developing new regulations relating to the practice of telemedicine in the state. / read more

The Court of Justice of the European Union (‘CJEU’) held on 19 October 2016 (C-148/15) that Germany’s fixed pharmacy prices constitute an unjustified restriction of the free movement of goods principle, which cannot be justified on grounds of the protection of health and human life. Consequently, pharmacies based in EU Member States other than Germany currently have a competitive advantage over German pharmacies when supplying prescription medicines to German patients by mail order, as they may set their prices freely. As a result, the German legislator is currently considering a complete ban on the use of mail order for prescription medicines. Evelyn Schulz, Associated Partner at Noerr LLP, assesses the rationale of the CJEU’s ruling and the impact on the German market. / read more

The Court of Justice of the European Union (‘CJEU’) issued a landmark ruling in case C-148/15 Deutsche Parkinson Vereinigung eV v. Zentrale zur Bekämpfung unlauteren Wettbewerbs eV on 19 October 2016 concerning the cross-border sale of prescription medicines online. / read more

The German Federal Supreme Court (‘FSC’) released on 1 March its judgment in case no. VI ZR 34/15, in which it specified the monitoring duties of medical professional review portal operators, finding it necessary in some cases for such operators to verify the validity of user reviews. / read more

In October last year the UK Court of Appeal delivered its verdict in W, X, Y and Z v. The Secretary of State for Health, a case in which the court looked at whether the sharing of NHS data to recover fees from overseas visitors was lawful. The outcome of the case contains a number of points of interest, such as what can be construed about the use of data in innovative ways to improve the efficiency and quality of NHS services. Richard Parker of Hill Dickinson LLP discusses the case. / read more

The United States District Court of the Western District of Texas blocked the Texas Medical Board from enforcing a new rule relating to the practice of telemedicine, in a ruling made in May following a lawsuit brought by telemedicine provider Teladoc, Inc. The rule in question would have prevented physicians from using the telephone as a means to diagnose and treat Texas patients without the patient first being seen either in person or via certain methods of video engagement. Teladoc claims that such a rule is anti-competitive, and that it would destroy their business. The Texas Medical Board has now filed for the Court to dismiss Teladoc’s lawsuit. Julian Rivera, Partner at Husch Blackwell LLP discusses the many twists and turns in the dispute between Teladoc and the Texas Medical Board so far, as well as the arguments put forward by both parties and the implications of the Court’s upcoming decision. / read more