• Erscheinungsweise vierteljährlich
  • ca. 70 Seiten
  • ISSN 2751-3971
  • Sprache: Englisch

About EHPL

The EHPL – European Health & Pharmaceutical Law  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.

EHPL’s Aims & Scope

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

Topics covered by EHPL 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.

EHPL’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.

EHPL’s Structure

Each issue of EHPL 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.


Managing Editor

Jakob Wested, University of Copenhagen

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
Marco de Morpurgo, DLA Piper / HEC Paris
Vincenzo Salvatore, University of Insubria/BonelliErede
Florian Schmidt, European Commission
Santa Slokenberga, Uppsala University
George Peretz, Monckton Chambers
Claudia Seitz, University of Ghent
Eveline Van Keymeulen, Latham & Watkins LLP

Executive Editor

Jakob McKernan, Lexxion Publisher, Berlin

Latest Articles

Issue Article
4/2021 Are You AI’S Favourite? EU Legal Implications of Biased AI Systems in Clinical Genetics and Genomics
4/2021 A Case of Unforeseen Adverse Side-Effects? The Ireland/Northern Ireland Protocol and Medicines Regulation
3/2021 Reconsidering Repositioning Incentives: An Empirical Legal Analysis of Market Protection for New Therapeutic Indications
3/2021 Medicinal Products and the Screening of Foreign Direct Investment
2/2021 ‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19
1/2021 Targeted Review of EU Pharmaceutical Legislation – The Community Code on Medicinal Products Needs to Remain a Directive
1/2021 Creating a European Health Data Space: Obstacles in Four Key Legal Areas
1/2021 Access to Medicines: The Interplay between Parallel Imports, Compulsory Licensing, and Voluntary Licensing
4/2020 Accelerated Access to Medicinal Products
3/2020 Duplicate Marketing Authorisations in the EU: Evolution of the Regulatory Framework and Practical Implications
3/2020 Lost on the High Seas without a Safe Harbor or a Shield? Navigating Cross-Border Transfers in the Pharmaceutical Sector After Schrems II Invalidation of the EU-US Privacy Shield
3/2020 Stem Cell Based Products in Europe and in China: Where are We and Where Should we Go?
3/2020 The Impact of the Medical Devices Regulation on the Pharmaceutical Industry: A Focus on Combination Products and Digital Health Technologies
2/2020 Price Control of Publicly Financed Medicinal Products – The Slovenian Example
1/2020 AI as a Medical Device: Is it Enough to Ensure Performance Transparency and Accountability?
1/2020 Patentability of AI Generated Drugs
1/2020 The EU-US Privacy Shield Regime for Cross-Border Transfers of Personal Data under the GDPR
4/2020 Homomorphic Encryption: The ‘Holy Grail’ for Big Data Analytics and Legal Compliance in the Pharmaceutical and Healthcare Sector?
4/2020 The Secondary Use of Paediatric Data Under GDPR: Looking for New Safeguards for Research
4/2020 AI, Big Data and The Protection of Personal Data in Medical Practice

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.

We are currently seeking notes on the following judgments:

Case Number Case Name/Parties
C-650/17 Royalty Pharma Collection Trust

This list is updated frequently. Feel free to propose annotations on other cases of relevance as well.

4. Juni 2021

EPLR 1/2021 Out Now

18. November 2020

EPLR 3/2020 is out now

The third issue of the European Pharmaceutical Law Review in the 2020 is now available. The issue features articles on: As well as updates on the most recent court decisions and the latest policy developments.  

View the whole table of content of EPLR 3/2020: Here Become an Author for EPLR and view our Call for Papers
3. August 2020

EPLR 2/2020

The second issue of the European Pharmaceutical Law Review in the 2020 is now available. The issue features an article on the price control of publicly financed medicinal products in Slovenia as well case notes on the recent Avastin decision and the judgment concerning the legitimacy of patent settlement agreements within the EU competition law framework. The issue also features our special series on the regulatory response to the Covid – 19 pandemic:   As well as updates on the most recent court decisions and the latest policy developments, the issue also features a review of Matthias Herdegen’s book on the international law of biotechnology.

View the whole table of content of EPLR 2/2020: 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
30. April 2020

AN EPLR SERIES: COVID-19 and European Pharmaceutical Law

In the wake of the COVID-19 pandemic, the European Pharmaceutical Law Review (EPLR) has establish a series for expert insights into the EU and Member State responses to this public health crisis, focussing on pharmaceutical and medical device law and policy: Responses to Medical Device Shortage: An Italian Perspective by Giuseppe Ragucci* COVID-19, Vaccines, BREXIT and Vaccine Damage Claims by Adam Heppinstall* The Road ta a Vaccine for COVID-19: Regulatory & Policy Infrastructure, Incentives and Obstacles by Marco Rizzi* Does EU Medical Devices Directive Apply to Contact Proximity Tracing Apps? by Erik Kamenjasevic & Elisabetta Biasin* * All contributions will be published in a later edition of the European Pharmaceutical Law Review (EPLR). Call for Papers    
26. März 2020

EPLR 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
8. Januar 2020

EPLR 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.
25. Oktober 2019

EPLR 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. Juli 2019

EPLR 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

EPLR 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.  
20. Dezember 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.
4. Oktober 2018

EPLR 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. Juli 2018

EPLR 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. Februar 2018

EPLR 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). The standard Open access fee for EPHL is 890,00 € per contribution. If you have any questions please get in touch with our colleagues at info@lexxion.eu

Read some of the open access contributions for free here:


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Schedule 2022

Issue Date of Publication Advertising Deadline
EPLR 1/2022 14.03.2022 21.02.2022
EPLR 2/2022 27.05.2022 02.05.2022
EPLR 3/2022 02.09.2022 12.08.2022
EPLR 4/2022 30.11.2022 03.11.2022

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