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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 have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the definition of medical devices.  The European Commission adopted its draft decision based on Article 13(1)(d) of Directive 93/42/EEC (the “Medical Devices Directive”).

The vote comes more than one year after the Commission prepared a draft decision, in February 2016 (see our analysis of that draft decision here).  The formal adoption and publication of the Cranberry Decision are expected later this summer.  This article first briefly summarizes the regulatory context of EU borderline issues.  It then explains what triggered the decision, analyzes its content, and provides a brief outlook on what is coming next.
Continue Reading EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

This article was originally posted on our sister blog Inside Medical Devices

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions of the revision of the medical device rules, namely, whether the scope of the Regulation changes in comparison to that of the main Medical Devices Directive 93/42/EEC (the “Directive”).  We examine below the changes to the definition of a medical device and whether the Regulation affects borderline determinations.

As discussed in our earlier post, the borderline between medical devices, medicinal products, cosmetics and foods or food supplements is often blurred.  The Regulation sheds some additional light on the definition of a medical device and strengthens the Commission’s power in relation to the borderline issues.  Nevertheless, important questions continue to exist, for instance in relation to the pharmacological versus physical (or purely chemical) mode of action of a product.
Continue Reading EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on:

  • Procedural aspects of submitting clinical reports.
  • The anonymisation of clinical reports.
  • The identification and redaction of commercially confidential information (CCI) in clinical reports, i.e. the disclosure of information that is not in the public domain and may undermine the legitimate economic interest of the applicant.

The Guidance is accompanied by a number of annexes, including template cover letters, template anonymisation reports and process flowcharts.
Continue Reading EMA Publishes Proactive Disclosure Guidance

This article was originally posted on our sister blog Inside Medical Devices

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.”

This agreement is based on the technical work of the Permanent Representatives Committee of EU countries which finalized the Council’s position on the draft Medical Devices and IVD Regulations on September 23, 2015. The core substance of the Council’s position was already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015 (for details please see our previous post of early September). The final agreement of October 2015 does not deviate from the substance of that partial agreement of June 2015. The main difference is that it includes a general approach on the recitals of the draft Regulations on medical devices and IVD. Preambles of EU legislative instruments do not have a binding effect; however, they are useful in the interpretation of rules and usually consulted by EU and Member State institutions and courts in their application of the law.
Continue Reading EU Agreement on a General Approach on the Medical Devices Package

This post was originally published on our sister blog Inside Medical Devices.

On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does not yet include the recitals to the new medical devices and IVD regulations.

The Council’s text on the new IVD Regulation significantly amends the Commission’s proposed definition of ‘companion diagnostics’, an evolution relevant to sponsors of both medicinal products and diagnostic devices.  The Council’s definition of companion diagnostics is almost identical to the definition used by the FDA, but significantly different from the European Commission’s proposal and the European Parliament’s suggested amendments.  An overview is set out below.
Continue Reading IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need.

The MHRA issued the scientific option to Bristol-Myers Squibb Pharmaceutical Limited for its advanced melanoma product, nivolumab.  Nivolumab represents the second medicine, and also the second anti-PD-L-1 monoclonal antibody, to be approved as part of the EAMS.  In March this year, Merck Sharp & Dohme Limited’s product, pembrolizumab, used to treat advanced melanoma received the first EAMS scientific opinion.  The scientific opinions comprise a public assessment report and three treatment protocols, for patients, healthcare professionals, and on the pharmacovigilance system.  Both opinions describe the risks and benefits of the medicines and the context for their use, supporting the prescriber and patient to make a decision on whether to use either medicine before their licence is granted.


Continue Reading MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

On 11 June 2015, the General Court handed down its judgment in Case T-452/14 Laboratoires CTRS v European Commission (the “CTRS Case”) annulling the Commission’s decision to grant Kolbam a marketing authorisation.  The General Court held that references in Kolbam’s SmPC to the efficacy of Kolbam for indications that Orphacol was authorised circumvented Orphacol’s market exclusivity and could encourage off label prescribing.
Continue Reading General Court Confirms Market Exclusivity Rights in CTRS Case

The European Food Safety Authority (EFSA) is launching an ambitious project of public access to data that it collects and holds through the launch of a scientific “data warehouse.” EFSA announced this initiative on March 2, 2015, with the aim to create an “open science organisation” and increase public access to data that it holds. The ultimate goal is to enhance scientific progress by allowing the use of data by third parties for other purposes.
Continue Reading EFSA Grants Public Access to Data through Scientific “Data Warehouse”

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

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the application of the exceptions to the disclosure of information, and invites stakeholders to comment.
Continue Reading EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation