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 published findings from its evaluation of Commission Regulation (EU) No 316/2014 (the Technology Transfer Block Exemption...
This week's edition of Life Sciences weekly highlights includes analysis by Taylor Wessing of the new UK post-market surveillance statutory instrument...
Life Sciences analysis: Alison Dennis, partner, and Alice Matthews, associate, at Taylor Wessing discuss the draft Medical Devices (Post-market...
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposed changes to pre-market regulatory requirements...
The Heads of Medicines Agency (HMA) and the European Medicines Agency (EMA) have published a report that focuses on the use of social media data in...
Latest Life Sciences Practice Notes
Sub-licensing intellectual property rightsAn IP owner may choose to license its IP to a third party. This can be an effective route to generating...
Product liability and defective productsThis Practice Note summarises the law on product liability and defective products under the Consumer...
Conditions precedent in commercial contractsThis Practice Note considers the meaning and use of conditions precedent in commercial arrangements. It...
SubcontractingThis Practice Note examines the following legal and practical matters in relation to entering into a subcontract or when granting...
Tax considerations for the life sciences sectorThis Practice Note provides an overview of some of the tax issues that are particularly relevant to a...
Latest Life Sciences Precedents
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
Trade mark—letter of consent[insert address of trade mark proprietor]Our ref: [insert reference]Your ref: [insert reference][insert address of...
Retained EU law—training materials [Archived]ARCHIVED: This Precedent has been archived and is not maintained.These training materials consist of...
Personal data sharing clause—controller to controller—pro-receiving partyDefined terms: This Precedent clause uses the additional defined terms...
Personal data sharing schedule—controller to controller—pro-disclosing partyDefined terms: This precedent schedule uses the additional defined terms...
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
Orphan medicinal product
A medicinal product that is used to prevent, diagnose or treat a rare medical condition or disease. In the EU, according to Regulation (EC) 141/2000, a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU.
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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