Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

By Brian Kelly & Katharina Ewert on September 12, 2019

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001. PTC Therapeutics International Limited (“PTC”) had argued before the General Court that a clinical study report it submitted to the EMA in support of marketing authorisation for its ultra-orphan drug Translarna was…

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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?

By Delphine Marchal & Grant Castle on August 22, 2019

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 existing regulatory framework, France has taken several additional actions and significantly amended the anti-gift provisions, by an Ordinance dated 19…

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French medicines regulator produces first in Europe medical devices cybersecurity guidelines

By Harriet Fletcher, Delphine Marchal & Sarah Cowlishaw on August 9, 2019

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 regulator in Europe that apply cybersecurity considerations specifically to medical devices. The full ANSM draft guidelines, ‘Cybersécurité des dispositifs médicaux…

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UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

By Katharina Ewert & Harriet Fletcher on March 7, 2019

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being…

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European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

By Grant Castle & Katharina Ewert on February 26, 2019

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here). The letter seeks to address concerns that a number of pharmaceutical companies will not have been able to adjust their pharmaceutical supply chains to provide for quality control testing and batch release of product in the…

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Reconciling Personalized Nutrition with the GDPR

By Brian Kelly & Kristof Van Quathem on February 18, 2019

As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR. Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, available here.…

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European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

By Kristof Van Quathem on February 12, 2019

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”). The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health. The Directorate General decided to create this Q&A because of perceived contradictions between the GDPR and the CTR, in particular in relation to the legal basis (e.g., the…

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Proposed Changes to UK Allergen Labelling Law

By Brian Kelly & Caecilia Dance on February 8, 2019

Introduction The Department for Environment, Food & Rural Affairs (“DEFRA”) has announced a consultation regarding proposed changes to allergen labelling laws for food prepacked for direct sale in the UK. This follows the death of Natasha Ednan-Laperouse in July 2016, which was the result of an allergic reaction after consuming a baguette from Pret a Manger that contained sesame seeds. The coroner’s inquest in September 2018 found that Pret’s allergen labelling system was “inadequate”, as…

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The Implications of the GDPR on Clinical Trials in Europe

By Kristof Van Quathem on October 22, 2018

On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.” In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical trials in the EU. The second session was devoted to further use of health data for scientific research. Among other things, this…

Inside EU Life Sciences

UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector

By Brian Kelly, Maree Gallagher, Bart Van Vooren, Katharina Ewert & Caecilia Dance on October 4, 2018

Over the past months, the Government has regularly posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019. The UK Government has now published four notices addressed specifically to UK food and beverage producers outlining its plans for a no-deal Brexit. The notices emphasise that the…

Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Blog Authors

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

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 medicines regulator produces first in Europe medical devices cybersecurity guidelines

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

Reconciling Personalized Nutrition with the GDPR

European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

Proposed Changes to UK Allergen Labelling Law

The Implications of the GDPR on Clinical Trials in Europe

UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector

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