EPLR Journal

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Issue 4/18 of EPLR - European Pharmaceutical Law Review

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.


Please have a look at the latest issue: here.

Are you interested in contributing to the journal? View our Call for Papers.

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

Annual subscription
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European Pharmaceutical Law Review - EPLR

The European Pharmaceutical Law Review (EPLR) identifies and analyses important legal and regulatory developments on the national, EU and international level. Furthermore, it provides an overview of and critically examines judgments that shape the interpretation and application of EU pharmaceutical law and policy, in particular those by the European Courts, international courts and tribunals such as the WTO's Dispute Settlement Body, and higher national courts.

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);
  • 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 law, pharmacy and medicine, 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.

 

Managing Editor

Sabrina Röttger-Wirtz
Tilburg University

Reports Editor

Eveline Van Keymeulen
Allen & Overy

 

Editorial Board



Ulrich M. Gassner
University of Augsburg

Richard S. Goldberg
Durham University

Leigh Hancher
University of Tilburg

Isabelle Huys
KU Leuven

Trudo Lemmens
University of Toronto

Robert Madelin
Foresight International Policy and Regulatory Advisers

Timo Minssen
University of Copenhagen

George Peretz
Monckton Chambers

Vincenzo Salvatore
University of Insubria/BonelliErede

Claudia Seitz
University of Basel

Karin Verzijden
Axon Lawyers

 
 
 
Event KST Banner Big Data in the Pharmaceutical Sector Between Protection and Transparency Lexxion Basel 27 February


EXECUTIVE EDITOR

0 JMcK Photo Jakob McKernan
Tel.: +49 30-81 45 06-10
mckernan@lexxion.eu

CUSTOMER SERVICE

  (orders, enquiries, returns)

 CG

Cristina Gîrloanƫă
Tel.: +49 30-81 45 06-12
mail@lexxion.eu



mckernan@lexxion.eu

EStAL
Journal
Publication frequency: quarterly
Subscription: € 442,-
ISSN 16 19-52 72

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