United Kingdom

MHRA provides further guidance on no-deal Brexit plans

Jacqueline Bore

The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the United Kingdom leaves the European Union on 29 March 2019 without any agreement on its future relationship with the EU and, therefore, without any transitional period. The guidance reflects responses to Read More

New formulations of existing active substances are not entitled to an SPC according to Advocate-General

Toby Sears

The Opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience (Case C-443/17) was delivered on 13 December 2018.  The Advocate General concluded  that the UK Intellectual Property Office had been  correct in declining to grant a Supplementary Protection Certificate (SPC)  to Abraxis for a novel formulation of an active substance which had already been the Read More

Rethinking the Growth Capital Challenge in UK Life Sciences

Matthew Appleton

Investors, entrepreneurs and deal makers in the UK Life Sciences industry met on the 28 September 2018 to share ideas on how to close the funding gap which exists for UK businesses in the period between early stage investment and IPO. At a lively panel discussion sponsored by LSX Connect and hosted by Allen & Read More

UK Department for Health and Social Care publishes an initial code of conduct for use of digital technology

Emma Keeling

As big data continues to be big news and data protection law continues to evolve, it is timely that the Department for Health and Social Care (the Department) has published a code of conduct relating to the use of data-driven health and care technology (the Code). Published in its initial form on Wednesday, the code Read More

UK government publishes plans for the Life Sciences sector in the event of a no-deal Brexit

Jacqueline Bore

The UK government has published a series of guidance documents setting out how it plans to regulate the Life Sciences sector if the UK leaves the European Union on 29 March 2019 without an agreement with the remaining EU-27 Member States. The UK government emphasizes that significant progress has been made in negotiations with the Read More