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On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision of the CJEU, dated 10 July 2014, joined cases C-358/13 and C-181/14 (criminal proceedings against Markus D. and G.)). The CJEU thus clarifies the scope of the definition of medicinal products under EU laws and overrules diverging case law at Member State level. This decision is potentially relevant for the regulatory classification of other borderline products.

This CJEU decision answered a request for a preliminary ruling issued by the German Federal Supreme Court on whether a product containing herbs and synthetic cannabinoids must be classified as a medicinal product. The product in question was sold in small bags and did not contain fixed quantities of active substances or any indications on the active substance or dosage guidance. However, it was proved in pre-experimental studies that these substances had a physiological effect, but did not have any desired health effects. The sellers declared those products to be “air fresheners” whose content was not suitable for human consumption.
Continue Reading EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions

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

On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015.

The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices.  The MHRA hopes that the DEAC will help the MHRA “have stronger links with the wider scientific community to facilitate access to specialist expertise.”  The DEAC is expected to be relatively small in size with around 12 members and a chair to enable the group to be more agile and responsive to important regulatory issues concerning medical devices.
Continue Reading MHRA Creates New Expert Advisory Group on Medical Devices

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

On 6 February 2014, the EMA released an amended Q&A document on the implementation of the new Variations Guidelines of 2013, which provides details on the different variation categories and the operation of procedures laid down in Commission Regulation 1234/2008 concerning the examination of variations to the terms of marketing authorizations for human and veterinary medicinal products.

In its press release, the EMA notes that the Q&A document has been amended in agreement with the European Commission and these amendments aim to clarify specific points related to the new (as of August 2013) variation categories to the terms of marketing authorizations.  This concerns, in particular, category C.1. 11  on the introduction of, or changes to, the obligations and conditions of a marketing authorization (including the risk management place) and category C.1.13. on other variations not specifically covered by the Variations Guideline which involve the submission of studies to the competent authorities.
Continue Reading EMA clarifies interpretation of new variation categories in an amended Q&A document

On 19 March 2014, the EMA announced the launch of its adaptive licensing pilot project along with an invitation to interested companies to submit their ongoing medicine development programmes to be considered as pilot cases.

The term “adaptive licensing” (also known as “staggered approval” or “progressive licensing”) describes a process which allows patients to have early access to new medicinal products by starting with an early authorisation of a product for a specific, restricted patient subset and gradually adapting the marketing authorisation to include broader patient populations as additional clinical evidence is gathered.

The adaptive licensing approach is expected to ensure timely access for patients to new medicines, especially those addressing serious conditions with unmet medical needs, while at the same time safeguarding the principle of risk-benefit assessment.
Continue Reading EMA launches adaptive licensing pilot project

In August last year, we wrote about the extent to which the French “sunshine rules” apply to the medical devices industry (see our post), alongside the pharmaceutical and cosmetic industry, and other health-related industries.

A number of developments have occurred since then.

First, we highlighted in our previous post the uncertainty regarding the territorial scope of the French sunshine rules, which apply to companies engaged in manufacturing, distribution, or other services related to products covered by those rules.  An official from the Ministry of Health has confirmed that the reporting requirements apply to all such companies that interact with healthcare professionals or other persons in the healthcare sectors covered by the French sunshine rules (e.g., healthcare students, HCP associations, healthcare institutions, patient associations etc.), i.e., those conducting their activities in France.  It is irrelevant, in that respect, whether the company is established or has its registered office in France or whether its products are actually marketed in France.  This interpretation is in line with the applicable legislation and the interpretative Guideline published by the Ministry of Health in May last year.
Continue Reading Update on the French Sunshine Rules

In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive.

Purpose and mode of action

The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of the product and its mode of action.”  The intended purpose will be determined by the labelling, instructions for use, and promotional material for the medical device.  However, the governing factor in assessing whether a product is a medical device or medicinal product is the mode of action of the product concerned.

Application to products

The guidance provides examples of borderline devices across a number of categories, including medicines, sport and leisure products, personal protection equipment, software, machinery, spare parts, second-hand devices, and custom-made devices.
Continue Reading New MHRA Guidance on Borderline Medical Devices

Last month, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device.

This category of software, dubbed “Software as a Medical Device” (SaMD), includes PC, cloud or mobile applications (apps) that are intended to be used for a specific medical purpose, for example, to assist healthcare professionals in making a diagnosis.  SaMD is distinct from embedded medical software, such as the software that runs MRI control panels, which the IMDRF refers to as “software in a medical device.”

The IMDRF is a taskforce composed of US, EU, Brazilian, Canadian and Japanese regulators.  It was launched in 2013 as the successor to the Global Harmonization Task Force (GHTF).  The abandonment of the GHTF was motivated in part by a desire to relegate industry participants to mere observer status; only regulators have voting rights within the IMDRF.
Continue Reading International Consensus on “Software as Medical Device” Definition

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices.

The European Commission defines HTA as a means to assess the ways science and technology are used in healthcare and disease prevention.  It covers medical, social, economic, and ethical issues and provides policy-makers with objective information, so they can formulate health policies that are safe, effective, patient-focused and cost-effective.  According to the Commission, HTA should be transparent, unbiased, robust and systematic, firmly rooted in research and the scientific method.
Continue Reading Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers