Bio-Science Law Review - Volume 15 - Issue 2
Blurred Lines? Patents and Plausibility
King + Wood Mallesons LLP
Experts in the Unified Patent Court
Nanomaterials in the EU Regulatory Framework on Chemical Products
ARATZ RAMIREZ DE LA PISCINA
University of the Basque Country
Nanotechnologies, groups of technologies that manipulate matter at nanoscale (10-9), have spread fast in the last decade. The technical exploitation and commercialisation of products containing manufactured nanomaterials is constantly growing and evolving, despite the fact that the scientific knowledge of the properties, behaviour and potential health and environmental hazards of these materials throughout their lifecycle is still dominated by widespread uncertainty. In this context, the European Union regulatory framework on chemical products, based on the Regulation 1907/2006 and Regulation 1272/2008, set out an integral control system which ensures the traceability of the chemical substances from the first to the last stage of their lifecycle. Even though this control system is applicable to nanomaterials, there are no express legal provisions dealing with them. Consequently, the main purpose of this article is to examine the implementation and the possible deficiencies of the EU chemical products control system with regard to nanomaterials.
The Nexus between Inspection and Enforcement
R (Roche Registration Ltd) v Secretary of State for Health
CHRIS WARBURTON and JOHN COOPER
Gowling WLG, Birmingham
The Court of Appeal of England and Wales has considered the nexus between two distinct parts of the European regulatory regime for centrally authorised medicinal products - the pharmacovigilance system (which is overseen by national competent authorities) and the penalties regime for breach of that system (which is operated by the European Medicines Agency). It was complained that information gathered through routine inspections at national level had unfairly been passed to the EMA for use as part of penalty proceedings. The court explored the proper legal relationship between these two parts of the system, and the responsibilities that well-resourced and sophisticated businesses had to understand it.
GSK and Others fined as CMA concludes investigation into paroxetine 'pay for delay' settlements
DERVLA BRODERICK Olswang, London
In February 2016, the UK Competition and Markets Authority ('the CMA') imposed fines totalling £45 million on three companies which were found to have infringed European Union and UK competition law by entering into agreements to delay the market entry of generic versions of paroxetine in the United Kingdom. GSK has shouldered the bulk of the fines, with the remainder going to generic producers, Generics (UK) Limited and Alpharma Limited. This comment looks at the background to the case and the legal basis for the infringement findings, providing some insight into the wider EU law context of the CMA's decision.
The Implications of the TPP Agreement on Exclusivity for Biologics and Biosimilars in Australia
KIM O'CONNELL AND ANNA SPIES King Wood Mallesons
What's all the Buzz about GM Insects?
UK House of Lords Science and Technology Committee Report on GM Insects
Helen Cline Pinsent Masons, London