Bio-Science Law Review - Volume 14 - Issue 5

Supplementary Protection Certificates for biologicals - some guidance from Pharmaq v Intervet
John Miles and Michael Pears Potter Clarkson LLP

The Pharmaq v Intervet case considers, in the context of a salmon virus vaccine, the important issues of what types of marketing authorisations count for the purposes of determining whether a supplementary protection certificate (SPC) is available and what its duration is, and whether an SPC based on a particular authorised biological product can validly extend protection to an authorised variant of that product. Possible implications with respect to SPCs for human biological medicines are also discussed.

Enforceability of NICE Guidance and Guidelines
Paul Ranson
Pinsent Masons, and Christian Hill MAP BioPharma

This article outlines the background to NICE guidance and guidelines and considers the implications of R (Rose) v Thanet CCG where the CCG failed to offer sufficient rationale for not following the guidance and for questioning its efficacy.

Humming a Different Tune? Commercial cultivation of GM Crops in Europe
Robert G. Lee Professor of Law, University of Birmingham

This article examines the amendment to Directive 2001/18 on deliberate release of GMOs that will allow Member States to opt out of growing EU-approved GM crops. Existing EU risk assessment and decision-making processes remain in place but Member States will be permitted to refuse to implement authorisations and ban a GM crop on limited grounds including: environmental policy objectives; town and country planning; land use; socio-economic impacts; agricultural policy; and public policy. This article will argue that, in leaving in place and untouched centralised approval systems for GM, the amendment is by no means guaranteed to appease either those Member States resistant to GM crops or those ready to exploit the potential of the technology. The article begins with a review of why controversy has surrounded the commercial growing of GM crops before reviewing the existing approval processes for GM crops in Europe. The recent reform and the reasons behind it are then explained and finally a critique is offered of the compromise proposal and its consequences are considered.

CJEU rules again on combination SPCs - Actavis v Boehringer
Katie Hutchinson and Laura Reynolds

This comment considers the latest judgment from the CJEU on combination SPCs. It summarises earlier cases from the court in order to build up a picture of the position the CJEU is now taking.