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France has enacted new rules on the off-label use of medicines.  A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”).  This Decree follows the adoption of the amended social security budget bill in August last year, which introduced revisions to the preexisting Article L5121-12-1 PHC.  According to the legislative history of the law, this change may have been intended to allow off-label prescription of Roche’s cancer drug Avastin® after reformulation to treat the eye condition age-related macular degeneration, instead of the Novartis product Lucentis®, which is specifically developed and approved for that indication.
Continue Reading New French Rules On Off-Label Use

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection in relation to food information whilst ensuring smooth functioning of the EU market.

The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
Continue Reading Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

On 20 November 2014 the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) confirmed that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices.
Continue Reading The German Supreme Administrative Court Confirms That E-Cigarettes Are Not Medicines Or Medical Devices

The health sector handles substantial quantities of personal information, including information that is deemed to be “sensitive” under European data protection regimes.  For that reason, health care providers sometimes question their ability to take advantage of increasingly popular e-health cloud services.  While EU lawmakers are contemplating a “European Privacy Seal” – which could, if done properly, be useful for would-be cloud customers to assess the robustness of a cloud provider’s data protection measures – a leaked EU Council document revealed that discussions over the scheme are floundering.  We therefore learnt with interest from our colleagues at the InsidePrivacy blog that the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) jointly adopted a new standard this summer governing the processing of personal data in the cloud — ISO/IEC 27018 (“ISO 27018”).
Continue Reading E-Health Take Note: Standards Published For Personal Data In The Cloud

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