Publications
A&O alerts
EMA Transparency Policy upheld by General Court: Companies unable to show that submissions to European Medicines Agency are confidential in their entirety – 23 February 2018, by Eveline Van Keymeulen, Marco de Morpurgo and Jacqueline Bore
Recent developments on China IP and Regulatory – 5 February 2018, by David Shen
China Further Encourages the Marketing Authorisation Holder Regime – 12 September 2017, by Victor Ho and David Shen
“Sunshine” in Belgium: New Statutory Transparency Requirements for Life Sciences Companies – 5 September 2017, by Geert Glas, Eveline Van Keymeulen and Tine Carmeliet
Regulating CRISPR genome editing in humans: where do we go from here? – 31 August 2017, by Eveline Van Keymeulen, Erin Currie, Rafi Allos, Marco de Morpurgo and Audrey Aboukrat
Government Registration Requirement for Medical Representatives in Shanghai – 31 August 2017, by David Shen
Falsifying Drug Regulatory Submission May Be a Criminal Offence in China – 28 August 2017, by David Shen
Generic Consistency Evaluation in China: The Coming Paradigm Shift in Drug Pricing and Patent Cliff – 18 April 2017, by David Shen and Jill Ge
China issues bill amending Law Against Unfair Competition – 22 March 2017, by David Shen
Importance of patents in Chinese pharmaceutical tendering – 14 March 2017, by David Shen
Round one of the the U.S. CRISPR patent battle is over – but what does the PTABS’s no interference-in-fact decision really mean?– 1 March 2017, by Daniel Lim, Dr Joachim Feldges and Nicola Dagg
How the legislator restricted the export of medicinal products – November 2016, by Juraj Gyarfas
EU Court of Justice Outlaws German Fixed Retail Pricing System for Prescription Medicines – 25 October 2016, by Marco de Morpurgo and Alexandre Rudoni
Excessive prices in the pharmaceutical industry: the Aspen case – 25 October 2016, by Emilio De Giorgi
Cybersecurity in life sciences: what is your duty of care? – 26 July 2016, by Nicola Dagg, Filip Van Elsen, Alexandre Rudoni, Mark Ridgway and Mark Mansell
Big Brother wants to see you: Obligatory disclosure of monetary and non-monetary considerations – 18 December 2015, by Juraj Gyarfas
EMA Consults Stakeholders on the Practical Application of Clinical Trial Data Transparency – 10 September 2015, by Laëtitia Bénard, Eveline Van Keymeulen and Marco de Morpurgo
Ensuring data protection in the implementation of the EFPIA Disclosure Code: Key challenges and how pharmaceutical companies are addressing them – 27 February 2015, by Nigel Parker and Eveline Van Keymeulen
New Clinical Trial Rules in the EU: A First Overview – 3 June 2014, by Laëtitia Bénard, Eveline Van Keymeulen and Marco de Morpurgo
Biosimilar Substitution in France: No Way Back? – 8 January 2014, by Laëtitia Bénard, Alexandre Rudoni and Eveline Van Keymeulen
Pharmaceutical companies face new pharmacovigilance obligations in the EU – 10 November 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen
The EFPIA transparency initiative: Making hay while the sun shines? – 10 October 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen
France issues “good dispensing practices” for online sales of medicines – 19 July 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen
Transparency requirements under the French Sunshine Act: Life sciences companies in the dark? – 11 June 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen
Published work
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 (EPLR), February 2018, by Eveline Van Keymeulen and Jacqueline Bore
Italy Reforms Clinical Trial Rules – European Pharmaceutical Law Review (EPLR), February 2018, by Marco de Morpurgo
Crowded field – Intellectual Property Magazine, 5 December 2017, by Daniel Lim
From Takeda to Teva v Merck: Are We Treading the Right Path on Combination Product SPCs? (Part 2) – (2017) 39 (11) E.I.P.R. 697-704, by Nicola Dagg, Steven Baldwin and Dr Tony Rollins
‘Sunshine’ in Belgium: New Statutory Transparency Requirements for Life Sciences Companies – European Pharmaceutical Law Review (EPLR), October 2017, by Eveline Van Keymeulen and Tine Carmeliet
The revised French transparency regime: additional disclosure obligations for life sciences companies – Practical Law (Thomson Reuters), October 2017, by Eveline Van Keymeulen and Laëtitia Bénard
The definition of product in the SPC Regulation: (Part 1 of 2) What’s in a name? – (2017) 39 (9) E.I.P.R. 555-564, by Nicola Dagg, Steven Baldwin and Dr Tony Rollins
The European Court to rule on milestone in European GMO legislation: the legal classification of mutagenesis in plant breeding – Bio-Science Law Review, June 2017, by Geert Glas and Tine Carmeliet
The expected future ubiquity of consumer virtual reality equipment and consequent legal and regulatory challenges – Lamy magazine, December 2016, by Alexandre Rudoni and Emil Albihn
The Nutrition and Health Claims Regulation Applies to Commercial Communications Addressed to Health Professionals – European Journal of Risk Regulation, October 2016, by Marco de Morpurgo and Patricia Carmona Botana
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, by Eveline Van Keymeulen
Brexit: Time is of the essence for life sciences innovators – Life Sciences Intellectual Property Review, 30 June 2016, by Laëtitia Bénard
Parallel Trade in the Slovakian Pharma Sector: Between Hammer and Anvil – CEE Legal Matters, 3 September 2015, by Martin Magal and Juraj Gyarfas
Digital Health in the EU: Moving “beyond the pill” – mHealthNews, January 2015, by Filip Van Elsen, Eveline Van Keymeulen, Quentin Van Peteghem and Julie Bossaert
La vente des lunettes “sous la loupe” (The sale of glasses “under the magnifying glass”) – Le Monde du Droit, May 2014, by Eveline Van Keymeulen and Alexandrine Ananou
France’s biosimilar law may set trend inside the EU – LAW 360 (a LexisNexis company), February 2014, by Laëtitia Bénard and Eveline Van Keymeulen
The proposed EU device regulation: A look on the – possibly – bright side – SCRIP Regulatory Affairs, June 2013, by Eveline Van Keymeulen
Specific provisions for medicines – in J. Ysewyn, M. Van Schoorisse a.o., The Belgian Competition Act 2013 (in Dutch), Antwerp, Intersentia, 2013, by Eveline Van Keymeulen