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 Advertising Standards Authority (ASA) has received a complaint regarding a post on Astrid Wett’s X (formerly Twitter) page, advertising a company...
The Council for Science and Technology (CST) has published a letter of advice to the UK Prime Minister on how the government can better address global...
IP analysis: The Patents Court granted Bayer an interim injunction restraining sales of generic once-daily rivaroxaban pending the possibility of a...
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new regulatory sandbox for AI as a Medical Device (AIaMD), the AI...
The Association of British HealthTech Industries (ABHI) has published its manifesto, The Plan for Health Tech, which sets out a ten-point programme...
Latest Life Sciences Practice Notes
UK Rome I—application and interpretationThis Practice Note is for use when determining applicable law where the contract was entered into on or after...
The regulation of medical software, including mHealth appsThis Practice Note discusses the regulation of medical software with an emphasis on mHealth...
mHealth—data protection considerationsDigital health developers, manufacturers and distributors of mHealth apps, and any connected software as medical...
The EU and UK General Data Protection Regulations—application in the life sciences sectorThe General Data Protection Regulation, Regulation (EU)...
Sunsetting retained EU law—essentialsRetained EU Law (Revocation and Reform) Act 2023The Retained EU Law (Revocation and Reform) Act 2023 (REUL(RR)A...
Latest Life Sciences Precedents
Privacy policy—general commercial organisation—customer-facingWe take your privacy very seriously. Please read this privacy policy carefully as it...
Consultancy agreement—individual and company—pro-consultantThis Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in...
Side letter to consultancy agreement—company and company—pro-client[To be typed on letterhead of individual][Insert name of consultancy...
Consultancy agreement—company and company—pro-consultancyThis Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in...
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
Active device (or active medical device)
Generally, active devices refer to medical devices powered by electricity or any source of power other than that generated by the human body or gravity. Examples are examination lights, surgical microscopes, gas pressure regulators or blood pumps for heart-lung machines or devices for viewing diagnostic images such as ultrasound images. Under Regulation (EU) 2017/745 (EU MDR), ‘active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device’. UK legislation compounds the definition of an ‘active’ device with implantable devices.
Generic
A medicinal product which contains the same active substances and has the same pharmaceutical form as the original branded reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies, as defined in Article 10(2)(b) of Directive 2001/83/EC.
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.
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