About Life Sciences Law
Lexis®+ Life Sciences is an online practical guidance product for contentious and non-contentious lawyers providing advice to and supporting the UK’s Life Sciences sector.
Research and development
Highly regulated, with strict compliance rules, work can be in-house or in collaboration with another entity. Guidance includes practice notes on UK and EU regime for clinical trials and various precedents.
Intellectual property
Patents and supplementary protection certificates are significant to many life sciences businesses. We have practice notes on pharmaceutical patents, biotechnology patents, IP protection for medical devices and more.
Medicinal products
This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.
Medical devices
Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.
Topics We Cover
Latest Life Sciences News
The Medicines and Healthcare products Regulatory Agency (MHRA) has collated the information on the Human Medicines (Amendment) (Modular Manufacture...
The Board of the National Institute for Health and Care Excellence (NICE) has approved changes to the criteria used to decide which treatments for...
This week's edition of Life Sciences weekly highlights includes news that the MHRA and NICE outlined new regulatory processes that MHRA will permit...
MedTech Europe has published guidance on the implementation of the European Health Data Space (EHDS) Regulation ahead of its publication in the...
The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) outlined new regulatory...
Latest Life Sciences Practice Notes
Drafting a jurisdiction clause—commercial B2B contractsThis Practice Note provides practical guidance when drafting a jurisdiction clause in a...
Executing deeds and documents in property transactions—charitiesIncorporated v unincorporated charitiesThere are currently a number of incorporated or...
Arbitration—an introduction to the key features of arbitrationSTOP PRESS: This Practice Note has been updated in light of the new Arbitration Act 2025...
Life sciences cases tracker—UKThis Practice Note is intended to be used to track the progress of UK cases relevant to the life sciences sector.Jump...
Execution formalities—incorporated charitiesThis Practice Note provides practical guidance on the execution of documents by incorporated charities,...
Latest Life Sciences Precedents
Mergers and acquisitions in the life sciences sector–training materialsThese training materials consist of template PowerPoint slides that can be used...
Personal data processing schedule—short form—pro-controllerThis Precedent is drafted in contemplation of arrangements where the parties wish to insert...
Personal data processing schedule—short form—pro-processorThis Precedent is drafted in contemplation of arrangements where the parties wish to insert...
Retained EU law—training materials [Archived]ARCHIVED: This Precedent has been archived and is not maintained.These training materials consist of...
Process agent agreementThis Agreement is made on [date]Parties1[insert name of Principal] [of OR a company incorporated in [insert jurisdiction] under...
Latest Life Sciences Q&As
Featured Life Sciences content
The regulation of medical devices in the UK
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
Regulation of e-cigarettes
Regulation of e-cigarettes31 December 2020 marked the end of the Brexit implementation period following the UK’s decision to withdraw from the EU. At...
Clinical evaluation and performance evaluation of medical devices in the EU
Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...
Unlicensed medicinal products and off-label use of medicinal products
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
Second and subsequent medical use patent claims
Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
Post-market surveillance of medical devices in the EU
Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...
Intellectual property protection for medical devices
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Medicines and Medical Devices Act 2021
Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
Introduction to borderline products
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
Clinical Research Organisation (CRO) master services agreement
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
Pharmacovigilance
PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...
The UK medical devices regime and the impact of the Northern Ireland Protocol
Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osborne Clarke discuss how the medical device industry is...
Medical devices due diligence questionnaire
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Life Sciences weekly highlights—11 August 2022
This week's edition of Life Sciences weekly highlights includes analysis of the English court’s jurisdiction to decide COVID-related business...
The regulation of advanced therapy medicinal products
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
The experimental use and Bolar-type exemptions to patent infringement
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
Life Sciences weekly highlights—18 August 2022
This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for...
Pharma and medical device regulation—Colombia—Q&A guide
Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device...
Associated legal terms
Compassionate use
Making a medicinal product that would normally require authorisation'>marketing authorisation available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product.
Medical device
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for a medical purpose, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body.
Off label
The intentional use of an authorised medicinal product outside the terms of its authorisation'>marketing authorisation (e.g. for a different indication, different dose or in a different patient population). It is considered off-label use of a medical device if the device is used differently from how the manufacturer has instructed.
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