• Publication frequency quarterly
  • approx. 70 pages
  • ISSN 2511-7157
  • Language: English

Issue 1/2020 – The Pharma Sector in the Age of AI

Reflecting the growing impact of Artificial Intelligence on the pharmaceutical sector, Issue 1/2020 of EPLR features articles on AI as a medical device, the patentability of AI generated drugs and the EU – US Privacy Shield Regime.

In addition to the articles this issue features reports on medicine shortages and the effectiveness of therapeutic and biosimilar pharmaceutical competition. Concluding the issue we have a Case Note on Case T-733/17 GMPO which addressed problems with the orphan designation procedure.

 

View the whole table of content of EPLR 1/2020: Here


 

The European Pharmaceutical Law Review (EPLR) is seeking original research papers for a special issue on global pharmaceutical law and policy.

Please see for details our Special Call for Papers

Details of seeking for Contributions regarding Covid-19 and pharmaceutcal Law

About EPLR

The European Pharmaceutical Law Review (EPLR) identifies and analyses important legal and regulatory developments on the national, EU and international level. It is primarily concerned with pharmaceutical law, medicines law and issues related to the work of the European Medicines Agency (EMA).

Furthermore, it provides an overview of and critically examines judgments and directives that shape the interpretation and application of EU pharmaceutical law and policy, including those by the European Medicines Agency (EMA), European Courts, international courts and tribunals such as the WTO’s Dispute Settlement Body, and higher national courts.

EPLR’s Aims & Scope

In order to establish itself as a forum for dialogue between different stakeholders in pharmaceutical regulation and governance, EPLR invites contributions from academics, practitioners, regulators and civil society representatives.

Topics covered by EPLR include:

  • Pharmaceutical law and policy in all jurisdictions (regional, national, international);
  • Medicines law
  • Commission decisions (EMA opinions) and regulatory guidelines;
  • National, EU, and international jurisprudence;
  • Medical devices;
  • Borderline cases: pharmaceuticals/food/cosmetics/chemicals
  • Patents /trademarks;
  • Health technology assessment and pricing/reimbursement;
  • Digital health/big data;

All contributions will be subject to double blind peer-review before acceptance for publication and are required to conform to the author guidelines.

EPLR’s Target Audience

The quarterly journal addresses everyone who is concerned with pharmaceutical law and policy issues such as academics (in the field of medicines law, regulatory science, and other relevant research fields), legal practitioners in national and international law firms, regulators such government officials working in EU  and national public administration, judges and legal experts in domestic, European and international courts, consultancies, business people in the EU and beyond as well as stakeholder organisations representing professionals, patients, and civil society.

EPLR’s Structure

Each issue of EPLR will be a balanced mixture of original research articles, first-hand country or thematic policy reports, timely case annotations on important ECJ/GC rulings and other international/national court judgments, book reviews as well as other information material and updates, including opinions, case summaries or event reports.

Editors

Managing Editor

Sabrina Röttger-Wirtz, University of Maastricht

Editorial Board

Ulrich M. Gassner, University of Augsburg
Richard S. Goldberg, Durham University
Leigh Hancher, University of Tilburg / Allen & Overy
Isabelle Huys, KU Leuven
Tomasz Jablonski, European Medicines Agency
Els Janssens, Baker McKenzie
Trudo Lemmens, University of Toronto
Robert Madelin, Foresight International Policy and Regulatory Advisers
Timo Minssen, University of Copenhagen
Vincenzo Salvatore, University of Insubria/BonelliErede
George Peretz, Monckton Chambers
Claudia Seitz, University of Ghent
Eveline Van Keymeulen, Allen & Overy
Karin Verzijden, Axon Lawyers

Executive Editor

Jakob McKernan, Lexxion Publisher, Berlin

Cases for Annotation

We invite expert authors to submit case annotations from the CJEU and Member State Courts. Only authors who contact us in advance will be reserved a case.
To do so please send an email to the Executive Editor at mckernan@lexxion.eu.

Please note that all submitted Case Notes will be subject to peer review.

 

8. January 2020

Issue 4/2019 – Special: AI in the Pharmaceutical Field

Although we are already seeing the application of AI in the pharmaceutical field, the greatest impacts are yet to come. Whether it is in relation to drug development, the production and assessment of clinical trial data or the transparency and accountability of algorithmic decision making, there can be no doubt that AI will have profound legal, regulatory and ethical implications. In this Special Issue of EPLR, we provide an overview of the most important developments in this field and offer a detailed analysis of future challenges and opportunities.  
View the whole table of content here.   The European Pharmaceutical Law Review (EPLR) is seeking original research papers for a special issue on global pharmaceutical law and policy.  Please see for details our Special Call for Papers
25. October 2019

Issue 3/2019 – Changes, Challenges and Opportunities

With contributions on parallel imports, pharmaceutical trademarks, combination products and the SPC manufacturing waiver, EPLR 3/2019 tracks some of the most important legal and regulatory developments in the pharmaceutical sector. As usual, the issue also includes brief updates on recent judgements and policy changes.
  View the whole table of content here.
16. July 2019

Issue 2/2019 – Recent Court judgements and their implications

Issue 2/2019 of the European Pharmaceutical Law Review is very much focused on recent Court judgements and their implications: as well as two case notes, this issue’s lead article, by Peter von Czettritz and  Alexander Meier, analyses off-label use reimbursement by critically engaging with the CJEU judgement in C-29/17 Novartis v AIFA. The second article, by Gunther Herr, Alexander Natz and Robbert van Haselen provides a comprehensive comparative overview over the regulation of homeopathic medicinal products in the EU and the Eurasian Economic Union (EAEU). Meanwhile the aforementioned case notes look at how recent judgements have impacted  the regulation of ‘pay for delay agreements’ and the current SPC regime. The issue is rounded off with a report on clinical trials and the GDPR.   View the whole table of content here.  
4. April 2019

Issue 1/2019 – AI and Pharma: What are the legal Challenges?

As in previous issues of EPLR, Issue 1/2019 tracks the latest legal and regulatory developments in the pharmaceutical sector. When it comes to developments in the industry, few offer as many opportunities as AI. With this in mind, the lead article of the first issue of the year tackles the legal challenges brought about these technological advances and offers practical advice on how companies should approach them. With contributions on Brexit, new developments in Denmark and in the Ukraine, our Reports section is also required reading for those who want to keep up to date on crucial legislative and policy developments. The issue concludes with a fascinating case note on the Courts interpretation of Articles 11(2) and 21(3) of Directive 2001/83/EC concerning carve outs.   View the whole table of content here. Become an Author for EPLR and view our Call for Papers.
20. December 2018

Issue 4/2018 – Challenges in Pharmaceutical Law and Policy

With contributions on the orphan drug regulation, the recent ruling on genome editing and on transparency rules,  the final issue  of the European Pharmaceutical Law Review in 2018 again reflects the current ‘hot topics’ and challenges in pharmaceutical law and policy. In our lead article Eveline Van Keymeulen, Laëtitia Bénard and Jaqueline Bore critically examine the EU’s regime incentivising research and development of medicines for patients with rare diseases. Reporting on the Italian Sunshine Act Proposal, Marco de Morpurgo criticizes that the low threshold of the proposed reporting obligation and argues that it might actually lead to less transparency. Writing on developments in Greece, Vicky Kriketou examines the changes in the Greek drug distribution network, where the pharmaceutical industry is making an effort to decrease the comparatively high fragmentation of the wholesale structure. And in their report from France, Alexandre Regniault and Aurélia Maurer present a ‘Practical guide on French health product liability law’, discussing the action mechanisms available to an individual liability claimant as well as class actions. The issue is concluded with two case notes on the recent judgments in regard to gene editing and excessive pricing respectively. View the whole table of content here.
20. November 2018

Issue 3/2018 – Core Regulatory Challenges in the Pharmaceuticals Field

Policy makers and courts tend to slow down their output during the summer, and this is no different for those working in the pharmaceutical community. With EMA focused on moving their headquarters to Amsterdam in the wake of Brexit, this trend is particularly pronounced. However, this does not mean that there were no legal and regulatory developments which merit our attention. Indeed, issue 3/2018 of EPLR features two articles on core regulatory challenges in the pharmaceuticals field: allegations of excessive pharmaceutical pricing and the contentious topic of off label use. In addition, we have also included reports from Germany and the United Kingdom and a topical report on biosimilar authorisation. The issue concludes with a timely Case Note by Minssen and Bostyn who criticise the Court of Justice for failing to clearly determine ‘when a product is protected by a basic patent’. View all articles of EPLR 3/2018.
17. July 2018

Issue 2/2018 – Innovation and Transparency in the Field of Pharmaceutical Law

The new issue 2/18 of our journal European Pharmaceutical Law Review (EPLR) identifies and analyses important legal and regulatory developments on the national, EU and international level. Reflecting EPLR’s position as a forum for discussion in the field of pharmaceutical law, this issue includes contributions from a number of critical stakeholders on innovation and transparency as well as reports on developments in Denmark and the Netherlands. It also includes a case annotation on the recent Hoffman – La Roche v AGCM case and analysis of a number of cases involving EMA’s Access to Documents Policy. As always, the issue concludes with an update on legislative and policy developments in the pharma sector. View all articles of EPLR 2/2018.
13. February 2018

Issue 1/2018 – Pharma Law Convention in Berlin

The European Pharmaceutical Law Review (EPLR) identifies and analyses important legal and regulatory developments on the national, EU and international level. Reflecting the comprehensive nature of the EPLR, Issue 1/2018 features an article on transparency and clinical trials data, as well as reports on online sales regulations in Austria, the reform of clinical trials rules in Italy and the advertising of pharmaceuticals in Sweden. In addition, this issue also includes a case annotation on the Snitem and Philips France case, updates on legislative and policy developments and a report from the recent Pharma Law Convention in Berlin. View all articles of EPLR 1/2018.

Do you want to make your contribution freely available to the public?

This journal offers the option to publish open access (OA). Contributions published under the OA policy must still successfully pass peer review in accordance with the journal’s Author Guidelines (view them under the section ‘For authors’ on this website). Please contact us for the current OA fee per contribution at info@lexxion.eu.

Read some of the open access contributions for free here:

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Schedule 2020

Issue Date of Publication Advertising Deadline
EPLR 1/2020 30.03.2020 02.03.2020
EPLR 2/2020 30.06.2020 02.06.2020
EPLR 3/2020 21.09.2020 24.08.2020
EPLR 4/2020 21.12.2020 23.11.2020

(Changes excepted.)

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