Q&As

This Practice Note sets out the core principles for securing injunctions concerning confidential information and privacy. Although other remedies exist for claimants in breach of confidence matters, stopping publication of the material by injunction is frequently the only remedy of real practical worth to the claimant. It also addresses anonymised injunctions, alongside both interim and final injunctions. In recent years, injunctions touching on confidentiality and privacy have provoked debate. So‑called ‘super‑injunctions’ have drawn media criticism for constraining free expression; yet much of this derives from misunderstanding of what a ‘super‑injunction’ actually signifies and from the false sense that such orders are far more common than they are. This Practice Note explains the overarching principles for obtaining relief in this field. For further material on privacy injunctions, see the following Practice Notes: Privacy law—misuse of private...

Changes to intellectual property ( IP) law from 1 January 2021 Before considering how IP law applies to medical devices, it is worth noting the position as at 31 December 2020 ( IP completion day). The key development concerns EU trade marks ( EUTMs) and registered Community designs ( RCDs). From 1 January 2021, proprietors of EUTMs and RCDs that were already registered and published automatically acquired equivalent, registered and enforceable UK rights ( UK comparable rights). Entries on the EUIPO register were effectively cloned onto the UKIPO register. These UK comparable rights were created automatically and at no charge to the rights holder. They preserve the filing date and, where relevant, the priority date of the original EUTM or RCD. They are independent of the EU rights and can be assigned or licensed on a...

The life sciences arena sees substantial, high-value merger and acquisition ( M& A) activity. This Practice Note outlines the factors fuelling deal flow and highlights the principal issues legal counsel should consider when advising parties to such transactions. For these purposes, the life sciences sector is taken to include pharmaceuticals, health-focused biotechnology products and medical devices. This Note concentrates on issues that recur in life sciences M& A and on matters that typically carry more significance here than in other industries. Industry-specific considerations shape almost every element of a life sciences M& A transaction, including: due diligence structuring the deal consideration the purchase agreement transition arrangements Before examining these aspects, it is useful to reflect on the elements that have supported robust deal activity in the industry in recent years. Drivers of M& A...

This Checklist flags typical issues encountered when negotiating and drafting the following agreement types: Confidentiality agreement-mutual Confidentiality agreement-one-way-pro-discloser Confidentiality agreement-one-way-pro-recipient Confidentiality letter-mutual Confidentiality letter-one-way-pro-discloser Confidentiality letter-one-way-pro-recipient Use the third column to capture observations or remarks as the Checklist is completed. Checklist | Further information | Notes (if any) Key considerations and definitions Confirm the parties to the agreement. Consider which individuals and/or entities will be party to it, and whether a single party or several parties will be providing confidential information. Confirm how confidential information will be defined. Consider: whether a general definition or a list format is suitable; if any confidential information of group companies will be supplied; if any confidential information will be shared with group...

What is digital health? Digital health is a broad umbrella describing how information and communication technologies are used to enhance prevention, diagnosis, treatment, monitoring, and the management of health conditions and lifestyle habits that influence wellbeing. Its rise reflects the coming together of healthcare and technology, and a move away from provider‑focused, ‘one size fits all’ delivery towards personalised, patient‑centred care. This Practice Note explores data protection considerations across three digital health use cases: Wearables Use of artificial intelligence ( AI) in medical diagnostics Digital health records Unlike mobile health (m Health), which is limited to care delivered via mobile devices, digital health is wider in scope. It encompasses modern care models such as digital therapeutics, telemedicine, digitised health systems and electronic health records, as well as AI, machine learning and data analytics. For more on m Health, see Practice Notes: Digital...

Data—and by extension, adherence to data protection rules—sits at the heart of clinical research, whether for clinical trials, pharmacovigilance activities or wider scientific inquiry. This Practice Note examines the data protection ramifications of running clinical research. In particular, it addresses who is accountable for compliance, the lawful bases relied upon, and how transparency should be delivered in this context... Allocation of responsibility for data protection compliance in clinical research Appropriate legal grounds for processing personal data for research purposes Transparency duties owed to participants and other data subjects Collaborative research arrangements and data sharing practices Derogations from data subject rights when processing for research A practical checklist of data protection points to consider when planning research activities The GDPR regimes On 25 May 2018, the General Data Protection Regulation, Regulation ( EU) 2016/679 ( EU GDPR) became directly...

The highly regulated nature of the life sciences industry Intense regulation within life sciences creates countless avenues for enforcement where ethical standards or legal duties are breached. Organisations must understand and meet their compliance responsibilities, and, at times, those affected by regulatory action may seek to contest the outcome. Sanctions can compel a life sciences company to undertake expensive remediation, pay heavy penalties and endure damaging negative press. They can also strain contractual and trading arrangements; moreover, those under supervision must manage continuing relationships with regulators with care. Operators spanning the UK and EU require insight into domestic requirements and the stance adopted by local authorities. Clients now encounter escalating enforcement exposure, intersecting frameworks and tangible individual and corporate liability. Enforcement risk in life sciences is no longer compartmentalised. If matters unravel, the fallout is rapid, visible and costly....

This Practice Note outlines and explores the overarching principles that govern the advertising and promotion of medicinal products, together with the associated rules on how the pharmaceutical industry engages with healthcare professionals ( HCPs). Introduction to the advertising and promotion of medicinal products To safeguard public health, the advertising and promotion of medicinal products is subject to strict regulation and close oversight. The general rules for advertising and promoting medicinal products are: it is forbidden to advertise any medicinal product that does not hold a marketing authorisation ( MA) promotion of an authorised medicinal product must align with the particulars in the summary of product characteristics ( Sm PC) linked to the MA promotion of authorised medicinal products must not mislead and should foster the rational use of the product, presenting information objectively and without overstating its...

Introduction to the medicines advertising enforcement landscape Directive 2001/83/ EC, the Community code for medicinal products for human use (the Pharmaceutical Code), sets the standards for the advertising and promotion of medicinal products across the EU. It obliges Member States to ensure there are adequate and effective arrangements to supervise medicines advertising. These arrangements must include legal routes enabling persons or organisations considered to have a legitimate interest in stopping any advertisement that breaches the Pharmaceutical Code to: bring legal proceedings against the advertisement, or submit the advertisement to an administrative authority empowered either to determine complaints or to start appropriate legal proceedings In the UK, Part 14 of the Human Medicines Regulations 2012 ( HMR 2012), SI 2012/1916 implements the Pharmaceutical Code’s rules on the advertising of medicinal products. Notably, HMR 2012, Part 14, Chapter 3 sets out the...

Developers, manufacturers and distributors in digital health—spanning m Health apps and any associated Software as Medical Device ( Sa MD), artificial intelligence ( AI) system or Artificial intelligence as a Medical Device ( AIa MD)—must meet stringent data protection regulations in tandem with regulatory compliance across the entire lifecycle, from development through to commercialisation This Practice Note concentrates on data protection and privacy issues for m Health (mobile health) and also considers the tighter safeguards governing the collection of an individual user’s health data. It does not cover broader life sciences regulatory matters, such as those relating to medical devices What is m Health? For related guidance, see: Practice Note: Digital health—regulation of m Health apps and medical software. Practice Note: Mobile app development and data protection. Practice Note: Digital health—data protection and privacy case studies, including wearables and AI...

What is Alternative Dispute Resolution? Alternative Dispute Resolution ( ADR) is an umbrella label for methods that settle disputes without resorting to litigation. ADR is increasingly chosen to address life sciences conflicts. This Practice Note will set out the key benefits and limitations of different ADR models for disputes arising in this field and offer practical guidance on making the most of each route. For broader guidance on ADR, as well as a detailed comparison of processes, see Practice Note: What is ADR? The advantages of ADR for life sciences disputes Life sciences disputes are diverse and often turn on complex, highly technical topics. Even so, several recurring characteristics mean ADR can be well-suited in the right circumstances. Disputes are multi-jurisdictional The life sciences industry frequently involves cross-border collaborations, with participants across Asia, Europe and North America. Clashes may emerge from differing corporate cultures and/or divergent legal...

The criminal regulatory landscape How does criminal law intersect with the life sciences industry? The points of contact are numerous. Beyond offences against the person and controlled drugs offences, a range of corporate or ‘white collar’ crimes can affect both individuals and companies, such as counterfeiting, criminal cartel offences, money laundering, fraud and bribery. Breaches of the sector’s regulatory framework-including rules on medical devices, and on inducements and hospitality-can equally give rise to criminal liability. Criminal investigations and prosecutions may, though do not invariably, follow. This Practice Note outlines how criminal law may operate in the life sciences arena. It addresses corporate crime liability, money laundering, fraud, anti-bribery, and inducements and hospitality in the promotion of medicinal products and medical devices, as well as enforcement. It also examines the effects of, and duties created for, life sciences businesses by the Economic Crime and...

General Data Protection Regulation ( EU GDPR) and UK GDPR The General Data Protection Regulation, Regulation ( EU) 2016/679 ( EU GDPR), became enforceable across the EEA (which then included the UK) on 25 May 2018. Life sciences organisations frequently collect and/or process substantial amounts of personal information, including health-related data, about individuals (or ‘data subjects’) such as patients and clinical trial participants. As a result, the relevance of the EU GDPR and the United Kingdom General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR) (which applies after the UK’s withdrawal from the EU) for life sciences companies cannot be underestimated. Assimilated law is the term used for retained EU law ( REUL) that remains operative after the end of 2023. The reclassification of REUL (and related terminology) as assimilated law marks a change in its status and handling under UK law, in that it is...

In recent years, interest in information on medicines has risen steadily among a wide range of stakeholders, including the general public, patient associations, physicians, the pharmaceutical industry and academia. In response, legislators and medicines regulators have embraced a more open stance, enabling access to a broader set of documents and data on the quality, safety and efficacy of medicinal products than at any time before. Within the EU, the European Medicines Agency ( EMA) is the authority charged with protecting and promoting human and animal health. Among the EMA’s core duties are the scientific assessment of applications for marketing authorisation ( MA) via the centralised procedure, and the co-ordination of the EU pharmacovigilance system to monitor the safety of medicinal products. Consequently, the EMA holds extensive scientific and clinical data on medicines. There are multiple channels through which documents and information on medicinal products can be...

STOP PRESS : This Practice Note is being refreshed to capture the effects of reforms and developments affecting the UK voluntary and statutory schemes for branded medicines. In particular, forthcoming updates will expand on the practical considerations and industry perspectives arising from: the consultation on the statutory scheme that concluded in April 2025; the ongoing 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth ( VPAG) commitment; and the updated commercial framework for new medicines and its related consultations. While these revisions are prepared, to follow progress and the discussion of these matters, please refer to: Life sciences tracker— UK — Government initiatives and proposed reforms and its Consultations section. This Practice Note examines the rules on pricing and reimbursement for medicinal products and medical devices in the UK......

What are the legal implications of audiovisual manipulation and deepfakes and what challenges do they pose to intellectual property rights, rights in personal information and image rights? ‘ Deepfake’ describes a face-swapping method in which AI-driven tools process images of a person to create a digital double, then overlay that likeness onto other bodies in video or stills. Creations built from a lone source image are usually easy to dismiss, but those trained on thousands of photos or clips can appear highly convincing. In contrast, audiovisual edits that do not employ AI are often labelled ‘shallow fakes’ or ‘cheap fakes’. Deepfakes present broad socio-political threats: they can skew public debate, disrupt elections and national security, and undermine confidence in journalism and public institutions. The risks to individuals and organisations are just as significant, ranging from fake endorsements and forged documentary evidence to loss of creative control over...

This Practice Note delivers a succinct overview of cybersecurity challenges for life sciences businesses, coupled with practical guidance for EU-based organisations. It charts the EU regulatory landscape for cybersecurity, including the NIS 2 Directive, Medical Devices Regulations ( MDR and IVDR), the EU AI Act, the EU Cyber Solidarity Act, the EU Cyber Resilience Act, and the European Health Data Space Regulation ( EHDS), and outlines compliance duties alongside the sanctions or enforcement outcomes for non-compliance. It also identifies key regulatory authorities and industry bodies, and closes with insights into legislative trends and the likely direction of travel... The cybersecurity landscape in the life sciences sector The life sciences sector—covering R& D of pharmaceuticals, medical devices and biotechnology; clinical trials; and healthcare services—now embeds digital technologies such as telemedicine, health apps and artificial intelligence to enhance operations and drive innovation. This digital shift, however, brings...

The Court of Appeal has set aside the Competition Appeal Tribunal’s decision that had scrapped the penalties, finding the tribunal misconstrued the regulator’s case about a market‑sharing arrangement that pushed up prices of life‑saving hydrocortisone tablets. According to the appeal judges, the tribunal erred in thinking the CMA alleged the companies had knowingly broken competition law. Because the tribunal misread the case advanced by the CMA, the two were, as the judgment put it, largely ‘passing each other like ships in the night’. The judgment stresses that the CMA’s case contained no accusation of misconduct or dishonesty by any party or witness. Requiring the authority to prove dishonesty would make enforcement unworkable; the legislation does not demand it and, consequently, neither should the tribunal. The Court of Appeal further held that the regulator properly tested the companies’ witnesses in...

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

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