Lexis®PSL 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.
Our content is written and structured to cover each stage in the life-cycle of a Life Sciences product from research and development to manufacturing, marketing and sale, including analyses of sector specific IP and data protection issues.
Our practice notes set out key principles supported by relevant authority and links through to in-depth commentary and underlying sources in Lexis®Library, all of which are designed to speed up the task of advising in this fast-moving and innovative sector.
LexisPSL Life Sciences is supported by an in-house legal team with extensive experience in practice and dedicated to producing content specifically for busy practitioners. This experience, combined with extensive customer research, has shaped our practical guidance on issues affecting the UK’s Life Sciences sector. We have built and continue to develop our product with the assistance of leading experts in the field.
In May 2016, the General Data Protection Regulation, Regulation (EU) 2016/679, (GDPR) came into force, introducing a number of changes in EU data protection law. The GDPR...
Data, and consequently data protection compliance, is central to conducting clinical research whether in the context of clinical trials, pharmacovigilance activities...
The purpose of clinical trials A clinical trial is an investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a...
This new starter guide provides an introduction to the life sciences practice area, the legislative and regulatory framework which governs the life sciences sector and...
What is a medical device? ‘Medical device’ is a broad term that covers a wide range of products involved in human or animal health and encompasses very simple devices,...
This Practice Note introduces and considers the general principles that apply to the advertising and promotion of medicinal products as well as the accompanying rules on...
An introduction to unlicensed medicinal products and off-label use of medicinal products In the EU, Article 6 of Directive 2001/83/EC (consolidated version 28.01.2019),...
Background to medical use claims Second (and subsequent) medical use patent claims are specific to the pharmaceutical/biotechnology industry and are used to define the...
This Practice Note provides an introduction to: • what is a patent? • applying for and maintaining patents • dealing with patents in agreements • patent assignment and...
Patent systems are intended to foster innovation, not to impede it. For this reason, the patent laws of many jurisdictions contain exemptions to infringement for...
No medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions...
What is biotechnology Biotechnological inventions are defined in Rule 26(2) of the European Patent Convention (EPC) as: ‘inventions which concern a product consisting of...
European level rules on pricing and reimbursement of medicinal products The pricing and reimbursement of medicinal products and medical devices is not harmonised across...
What is mHealth? ‘mHealth’ (ie mobile health) is a subset of eHealth (ie the use of information and communication technologies for health) and refers to the use of mobile...
Introduction Patent claims may be separated into two broad categories: product claims and process claims. Product claims and process claims are recognised as having a...
What are e-cigarettes? Electronic cigarettes (commonly known as ‘e-cigarettes’, ‘vapourisers’ or ‘vapes’) are products that can be used to consume nicotine-containing...
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