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