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Eveline Van Keymeulen

Counsel

Paris

Eveline Van Keymeulen

Counsel

Paris

Eveline is a Counsel at Allen & Overy and heads the firm’s Life Sciences Regulatory practice.

Eveline’s practice focuses on EU regulatory law in the Life Sciences sector, and she has in-depth expertise in national regulations in France, Belgium and the Netherlands. She advises multinational clients, in the pharmaceutical, medical devices, cosmetics, and food sectors, on a broad range of regulatory issues, including clinical trials, marketing authorisations and CE marking, advertising and promotion, product life cycle management, pricing and reimbursement, and general compliance matters.

In addition, Eveline is a specialist in EU and national regulations related to cannabis/hemp based products (including THC, CBD and other cannabinoids), and has advised numerous clients, from start-ups to large corporations as well as trade associations, in navigating the complex and scattered regulatory landscape. She is also involved in the first referral related to “well-being” cannabis products before the Court of Justice of the European Union.

Eveline is an active speaker and writer on Life Sciences topics, and serves as editor-in-chief of the A&O Life Sciences Hub, the A&O blog dedicated to Life Sciences. She is Associate Editor of the European Pharmaceutical Law Review and country correspondent for the Bio-Science Law Review.

Ranked as a Practitioner- Life Sciences Expert Guide 2019

EU Regulatory Law Firm of the Year - (Corporate LiveWire Global Awards 2019)

Women in Law Award – Life Sciences (Lawyer Monthly Magazine, 2019)

Eveline has been named as a "Next Generation Lawyer" by Legal 500 for Life Sciences (in 2018) and recognised by Who's Who Legal Life Sciences as one of the leading lawyers for Life Sciences: Regulatory (in 2016, 2017, and 2018). Clients say that Eveline is "excellent" and "very good and always a pleasure to work with."

Eveline received her law degree from Ghent University and holds an LL.M. from the University of California, Berkeley, as well as a Master in European Law from Ghent University and a Master in Intellectual Property Law from Brussels University. She is admitted to the Brussels, Paris and New York bar.

News & insights

Publications: 28 AUGUST 2019

NICE consults on Draft Guideline on prescribing medicinal cannabis

On 8 August 2019, the National Institute for Health and Care Excellence (NICE)1 published a draft guideline on prescribing cannabis-based medicinal products (the Draft Guideline) for consultation.2

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Publications: 27 JUNE 2019

French cannabis committee unveils recommendations for medical cannabis pilot programme in France

Yesterday, the French specialised committee on cannabis (CSST), which was established in mid-2018, held its last meeting and presented its final recommendations for the implementation of a medical cannabis pilot programme to the French National Agency for Medicines and Health Products Safety (ANSM).

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Publications: 20 JUNE 2019

Italy launches urgent tender for the supply of 400 kg of medical cannabis: New opportunities for cannabis producers

For the second time, the Italian Ministry of Defence has launched an open tender for an urgent need of cannabis for therapeutic purposes by the Florence Pharmaceutical Chemical Plant. The estimated reference price of the tender is EUR 1,520,000 (net of VAT) for 400 kg, which represents an average of EUR 3.8 per gram. This tender represents a great opportunity for foreign investors to enter the Italian medical cannabis market, which was the second largest European medical cannabis market in 2018. Compliance with EU Good Manufacturing Practice (GMP) and Good Agricultural and Collection Practices (GACP) is required. Offers must be submitted by 3 July 2019 (10 AM) at the very latest.

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Publications: 12 JUNE 2019

Medical cannabis in France: Latest state of play

Following the penultimate meeting of the specialised committee on cannabis (CSST) established by the French National Agency of Medicine and Health Products Safety (ANSM) (see our previous blog posts "French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability" and "French ANSM recommends medical use of cannabis under certain conditions"), the French Senate held a hearing on 28 May 2019 entitled "Cannabis, a major public health issue" during which the senators present at the hearing came (despite existing concerns) to a quasi-consensus regarding the need of legally permitting medical cannabis in France.  In the days and weeks following the debate, both politicians and experts, amongst others Nicolas AUTHIER, the chairman of the CSST, provided some further insights on the future of medical cannabis in France.

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Office

Paris

Allen & Overy LLP
52 avenue Hoche
75008 Paris

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Qualifications

Professional

Admitted to the Paris Bar, 2013

Admitted to the New York Bar, 2010

Admitted to the Belgian Bar, Brussels, 2007

Academic

Master in Intellectual Property Law, Brussels University, 2011 – magna cum laude

LL.M. in Law and Technology, University of California – Berkeley, Boalt Hall School of Law, 2008 – BAEF fellow

Master in European Law, Ghent University, 2007 – magna cum laude

Master in Law, Ghent University, 2006 – magna cum laude

Erasmus exchange, Universidad de Barcelona, 2006

Published work

The EU Clinical Trials Regulation: A Practice Note, Lexis PSL, August 2018

Rewarding Innovation: Pharmaceutical incentives as a crucial instrument to foster public health, European Pharmaceutical Law Review, July 2018

The CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?, European Pharmaceutical Law Review, February 2018

“Sunshine” in Belgium: New statutory transparency requirements for life sciences companies, European Pharmaceutical Law Review, October 2017

The revised French transparency regime: additional disclosure obligations for life sciences companies, Practical Law Company (PLC), October 2017

Court of Justice of the EU anchors market exclusivity for orphan medicinal products (annotation of Cases T-140/12 and C/138/15P), Jurisprudentie Geneesmiddelenrecht (in Dutch), July 2016

Digital Health in the EU: Moving “Beyond the Pill”, mHealthNews, January 2015

La vente des lunettes “sous la loupe” (The sale of glasses “under the magnifying glass”), Le Monde du Droit, 27 May 2014

France’s biosimilar law may set trend inside the EU, LAW 360 (a LexisNexis company), 18 February 2014

Specific provisions for medicines, in J. YSEWYN, M. VAN SCHOORISSE a.o., The Belgian Competition Act 2013 (in Dutch), Antwerp, Intersentia, 2013

The proposed EU device regulation: a look on the - possibly - bright side, SCRIP Regulatory Affairs, June 2013

The new import regime for APIs in the EU: too much too soon?, SCRIP Regulatory Affairs, March 2013

US fashion copy‘cat’ bill onto its seventh life?, Intellectual Property Magazine, February 2013

Copyrighting couture or counterfeit chic? Fashion design: a comparative EU-US perspective, Journal of Intellectual Property Law and Practice, October 2012

How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?, Pharmaceutical Patent Analyst, September 2012

Fashionably Late, IP Magazine, December 2011

Belgium, Life Sciences Handbook, edition 2009, 2011, and 2012