The Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

The final Brexit agreement, the Trade and Cooperation Agreement was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK. Read more

Bundesrat passes UPC legislation – UPC could open its doors in 2022

Today, the German Bundesrat (the upper house of the German Parliament) passed the Unified Patent Court (UPC) legislation, bringing us one step closer to the start of the UPC. To come into force, the law will now have to be signed by the Federal Government, the Federal President and, finally, published in the Federal Law … Read more

Trust on a plate: consumer confidence and food safety

Consumer confidence in the origins and safety of the food they purchase and consume is a significant aspect of food brand protection and longevity. Maintaining that confidence involves the use of many different strategies, rights and regulatory controls at national and international level. In Trust on a plate: consumer confidence and food safety, the latest briefing in our Future of Consumer series, contributors Italy, Australia, the UK, China, Indonesia and across the EU cover food trust issues including geographical indications, labelling, supply chain transparency and food crime. Read more

Paediatric medicines in the post-Brexit world

Paediatric Investigation Plans The legal requirements for UK Paediatric Investigation Plans (PIPs) from 1 January 2021 are set out in the Human Medicines Regulations 2012, as amended by the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. Under the Human Medicines Regulations, results from an agreed PIP must be included in an application for … Read more

Orphan designations in the post-Brexit world

The UK government guidance How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (1 October 2020) confirms that the MHRA will offer incentives in the form of market exclusivity and refunds of MA fees for medicines to treat rare diseases. Read more

Clinical trials in the post-Brexit world

Once the UK leaves the EU, it will cease to participate in the European regulatory network for clinical trials, and regulatory responsibilities would shift to the MHRA. The UK government guidance Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021 (1 September 2020) and Guidance on substantial amendments to a clinical trial from 1 January 2021 (1 September 2020) set out the latest position in relation to clinical trials after the transition period ends. Read more