Bio-Science Law Review - Volume 13 - Issue 5
LEGAL CONSIDERATIONS RELATED TO THE AUTHORISATION, IMPORT AND CULTIVATION OF GM CROPS IN THE EUROPEAN UNION: A PRECEDENT FOR OTHER REGULATED INDUSTRIES?
Barrister, Partner at Steptoe & Johnston LLP, Brussels
The EU system for the authorisation of GM products is not being applied correctly. Several Member States and the European Commission have been condemned by the Court of Justice for failure to implement legislative. In the recent judgment of the General Court in the Pioneer Hi-Bred International, Inc v Commission case regarding 1507 maize, the Court signalled that it will not tolerate reliance on political considerations over binding legal procedures and independent science.
The GMO authorisation experience offers four lessons for other industries whose products undergo EU authorisation processes. 1)Legal action can work, as illustrated by Court rulings in a number of cases. The implications of the 1507 maize case go far beyond GMOs – the case shows that there where the Commission fails to meet its legal requirements, it will be condemned by the CJEU and damages actions will likely follow. 2) The growing trend of politicisation of product authorisation processes has made it increasingly challenging to see the fair, workable and predictable processes as described in EU law. 3) Legal action against the Commission is considered a legitimate tool in an over-politicised regulatory environment. 4) The effect of unpredictable decision-making makes investment in the EU significantly less attractive.
INSTRUCTING EXPERTS IN PATENT LITIGATION
SIMON COHEN AND PAUL ENGLAND
Taylor Wessing LLP, London
The justice system and scientific method are both designed to get to the truth. It is in the nature of patent actions that most evidence will consist of the opinions of expert witnesses on technical subject-matter ranging from the biological and the chemical to the electronic and mechanical. Hence, rarely a day goes by in which the worlds of science and law do not meet in the English Patents Court. For the experts giving evidence, whether they are from academia, industry or private consultancy, the different approaches to finding the truth that science and justice take in this context can be a culture shock. For this reason there are strict rules in place to govern the duties of experts and to protect them, and to ensure that the process of preparing evidence is as transparent as possible. These are complemented by judge made rules in case law, some of which are still developing. This article examines the approach of the English Patents court to a number of these issues: the role of the expert; the correct approach to instructions; the difference between a ‘Part 35’ expert and a ‘behind the scenes expert’; the expert’s role in experiments; and,the likely impact on the preparation of Jackson LJ’s recent reforms.
SHOULD COST PREVAIL OVER SAFETY? THE RISKS OF OF PROMOTING UNAUTHORISED PHARMACEUTICALS AND OFF-LABEL USE FOR BUDGETARY CONSIDERATIONS
JAMES KILLICK AND PASCAL BERGHE
White & Case LLP, Brussels
In Europe, medicines can only be introduced once they have passed through a strict regulatory process, which aims to protect patient safety, and can only be used outside the limits of their indications under a few narrow exceptions. However, in recent years, a trend has emerged whereby a
number of Member States have adopted or considered adopting regulatory measures to promote unauthorised medicines or medicines used outside the limits of their marketing authorisation on the ground that they are cheaper than the duly authorised drug.
We submit that Member States’ promotion of unauthorised pharmaceuticals for short-term budgetary considerations is raises serious public policy concerns and their legality is dubious under EU law. The encouragement of unauthorised medicines or medicines used outside the limits of their authorisation for budgetary reasons violates the fundamental principle that public health takes precedence over economic considerations. It is also a short-sighted policy as it could have long term consequences not just on public safety but also for innovation. Finally, Member States’ unilateral deviations from EU law can lead to a fragmentation of the EU regulatory framework for medicines. Ultimately, this could impact Europe’s attractiveness and the perspective of growth for new, emerging companies in Europe.
RECENT EUROPEAN DEVELOPMENTS REGARDING SUPPLEMENTARY PROTECTION CERTIFICATES
GERTJAN KUIPERS, TJIBBE DOUMA AND MARGOT KOKKE
De Brauw Blackstone Westbroek, Amsterdam
UNIFORM TRADE SECRETS PROTECTION FOR EUROPE?
Taylor Wessing LLP, London