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 European Commission has launched a call for evidence on its new circular bioeconomy initiative, open from 31 March 2025. The initiative, presented...
Law360, London: The Unified Patent Court (UPC) has now doubled down on its authority to hear claims involving UK patents, a move that is likely to...
Law360, London: The EU has taken a significant step forward in modernising its liability framework with the adoption of a new Product Liability...
Life Sciences analysis: The Court of Justice provided clarification of the meaning of ‘advertising of medicinal products’ under Directive 2001/83 (the...
Private Client analysis: This is a landmark decision of the Supreme Court on the liability of trustees and other fiduciaries to account for...
Latest Life Sciences Practice Notes
DeedsUnder English law, legally binding agreements can be made orally, in writing or by deed.This Practice Notice considers the circumstances in which...
Brexit timelineOn 23 June 2016, the UK held a referendum on its membership of the EU, with a majority voting in favour of the UK leaving the EU. On 29...
Brexit legislation trackerThis Practice Note tracks the progress of UK legislation introduced as part of the legislative project associated with the...
Hague Convention on Choice of Court Agreements—scopeThis Practice Note considers the Hague Convention on Choice of Court Agreements which applies to...
Hague Convention on Choice of Court Agreements—jurisdictionThis Practice Note considers the application of the Hague Convention on Choice of Court...
Latest Life Sciences Precedents
Retained EU law—training materials [Archived]ARCHIVED: This Precedent has been archived and is not maintained.These training materials consist of...
Consultancy agreement—company and company—pro-consultancyThis Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in...
Consultancy agreement—individual and company—pro-consultantThis Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in...
Data protection schedule—Life SciencesParties1[Insert the company name (the name of the sponsor)] with a registered office at [insert address]...
Patent licence—pro-licensorThis Agreement is dated [insert date]Parties1[insert name] [of OR a company incorporated in [insert jurisdiction, eg...
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
Active pharmaceutical ingredient (API)
Also referred to as a ‘drug substance’, this term refers to any substance or mixture of substances intended to be the biologically active ingredient (or ‘active substance’) contained in a final medicinal product and intended to provide pharmacological activity or other direct effects. It is internationally defined as: ‘…any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.’ Medicinal products are usually composed of several components: the primary biologically active ingredient(s) which form the active pharmaceutical ingredient (API) plus other non-active ingredients known as ‘excipients’. The procedure for optimising and compositing this mixture of components, often producing ‘pharmaceutical intermediate’ byproducts as synthesising the API, and excipients into a final medicinal product is referred to as drug ‘formulation’. APIs are legally required to be registered with drug regulatory authorities (eg MHRA, FDA, EMA) and manufactured in compliance with good manufacturing practice (GMP) regulations and licensed facilities.
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.
Specials
Unlicensed medicinal products for human use which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients in order to fulfil the special needs of an individual patient.
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