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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.

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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.

Animal testing

Animal testing refers to the use of live animals in experiments or procedures for scientific, medical, cosmetic, educational or regulatory purposes, often in the context of product safety or biomedical research. In UK law, the practice is primarily regulated by the Animals (Scientific Procedures) Act 1986 (ASPA), which requires a project licence, personal licence and establishment licence, and imposes controls on the care, use, pain relief and euthanasia of “protected animals”. The concept overlaps with statutory terms such as “regulated procedures” under ASPA.

In Ireland, animal testing is governed by legislation implementing Directive 2010/63/EU, with a similar licensing and inspection regime, and parallel concepts such as “procedures” on protected animals. Across England & Wales, Scotland, Northern Ireland and Ireland, animal testing law is underpinned by the Three Rs (replacement, reduction, refinement) and engages administrative, criminal and regulatory law.

The term is significant in advising on compliance, challenging or defending enforcement action, drafting research protocols, procurement and ethics policies, judicial review of licensing decisions, and navigating overlapping regimes on medicines, chemicals, veterinary products and cosmetics.

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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