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
EU Law: Ravi Srinivasan and Graham Lewis, partners, and James Egleton and James Smythies, associates, at J A Kemp discuss the decisions in Joined...
The European Commission has introduced new EU-wide rules on Health Technology Assessment (HTA), effective from 12 January 2025. The regulation...
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on the International Council for Harmonisation (ICH)...
IP analysis: The European Patent Office (EPO) regularly applies the problem and solution approach when deciding whether an invention involves an...
The European Federation of Pharmaceutical Industries and Associations (EFPIA), along with AESGP and Medicines for Europe, has proposed a phased...
Latest Life Sciences Practice Notes
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Brexit—implications for data protection [Archived]ARCHIVED: This archived Practice Note provides information on the Data Protection, Privacy and...
Data protection principlesThis Practice Note covers the principles for handling personal data that form the core of the United Kingdom General Data...
Introduction to the EU GDPR and UK GDPRThis Practice Note provides an introduction to both the EU’s General Data Protection Regulation, Regulation...
Conditions precedent in commercial contractsThis Practice Note considers the meaning and use of conditions precedent in commercial arrangements. It...
Latest Life Sciences Precedents
Confidentiality letter—private M&A—asset purchase—corporate sellerStrictly private and confidentialTo: [insert buyer name][insert buyer address]Date:...
Confidentiality letter—private M&A—share purchase—corporate sellerStrictly private and confidentialTo: [insert buyer name][insert buyer address]Date:...
Confidentiality agreement—corporate joint ventureThis Agreement is made on [insert day and month] 20[insert year]Parties1[Insert name of first...
Confidentiality letter—mutual[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][Insert address of recipient]Date:...
Consultancy agreement—company and company—pro-clientThis Agreement is made on [date]Parties1[Name of Company], a company incorporated in England with...
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
Bioequivalence
Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.
Biosimilar
A medicinal product that is similar to a biological medicinal product (the originator or ‘reference’ product) that has already been granted a authorisation'>marketing authorisation in the EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes.
Regulatory data protection
Refers to the data exclusivity period granted by Article 10(1) of Directive 2001/83/EC, in which pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation for a generic product.
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