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 National Institute for Health and Care Excellence (NICE) has published a modular update to its health technology evaluations manual, introducing...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded to proposed EU legislation that would require...
This week's edition of Life Sciences weekly highlights includes two analyses by Gill Jennings & Every LLP: one regarding the EU landscape of...
IP analysis: In a significant UK ruling in Generics (UK) Ltd v AstraZeneca AB, the High Court of England and Wales provided a comprehensive...
The European Medicines Agency (EMA) has developed the European Shortages Monitoring Platform (ESMP) in accordance with Regulation (EU) 2022/123 to...
Latest Life Sciences Practice Notes
Declaration of a director's interests—the statutory provisionsA director who is in any way, directly or indirectly, interested in:•a proposed...
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
Data protection, privacy and confidential information case law trackerThis Practice Note tracks noteworthy High Court, Court of Appeal and Supreme...
Trade secrets and confidential information—protection and enforcementThis Practice Note sets out the protection available for trade secrets and...
Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...
Latest Life Sciences Precedents
Patent licence—pro-licensorThis Agreement is dated [insert date]Parties1[insert name] [of OR a company incorporated in [insert jurisdiction, eg...
Privacy policy—general commercial organisation—customer-facingWe take your privacy very seriously. Please read this privacy policy carefully as it...
Sustainability glossary terms (The Chancery Lane Project)These Precedent sustainability definitions, produced by The Chancery Lane Project (TCLP) as...
Power of attorney for commercial transactions1Appointment and powersWe, [insert name of company] a company incorporated in [England and Wales] under...
Board minutes approving a proposed commercial agreementCOMPANY NUMBER:[ insert company number][insert company name] [LIMITED OR PLC]Minutes of a...
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...
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.
Notified body
An organisation that has been appointed by the authorities'>competent authorities of a Member State to conduct conformity assessment procedures in respect of medical devices and verify the conformity of the manufacturer with the requirements of the medical devices legislation. The Notified Bodies are listed on the Commission website.
Originator
Another term for reference medicinal product, which has been granted a authorisation'>marketing authorisation (MA) on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, and to which the application for MA for a generic medicinal product refers, by demonstration of bioequivalence.
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