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R (Greyhound Board of Great Britain Ltd) v Welsh Ministers [2026] EWHC 670 (Admin) What are the practical implications of this case? The ruling reinforces the constitutional divide between the courts and the legislature. It explains that the scheme and framework of the Government of Wales Act 2006 (GWA 2006) embody that separation of powers, and that any judicial attempt to recognise and enforce a common law obligation on Welsh Ministers to consult prior to introducing legislation in the Senedd would trespass upon that boundary. This is not a departure from established principle; case law has already upheld comparable rules for lawmakers in Scotland and at Westminster. However, this is the first express confirmation of the position for Welsh lawmakers, and the first time this dimension of the GWA 2006 has been analysed in such depth. The court examined earlier
The solution arrived through the United Nations Compensation Commission (UNCC), a quasi‑judicial body handling mass claims, created under UN Security Council Resolution 687. By addressing environmental harm—most notably via its ‘F4’ claim class—the UNCC set a seminal benchmark shaping how international law and contemporary arbitral panels allocate financial responsibility for wartime ecological devastation. With present-day wars in areas such as Eastern Europe and the Middle East bringing dam breaches, strikes on chemical facilities, and the burning of farmland, the UNCC’s legacy endures as an essential reference point for states, global investors, and companies engaged in post‑conflict arbitration. The F4 claims: Quantifying the unquantifiable Prior to the 1990s, mechanisms in international law for war reparations overwhelmingly favoured property loss, foregone earnings, and bodily injury. The natural world was commonly treated as a mute, non-compensable victim of armed hostilities...
Understanding the farming business as a business Many farms still use long-standing structures that arose by habit, not strategy. Sole traders, informal partnerships and outdated partnership deeds are common. While once effective, such setups can cause major issues around succession, tax planning and involving the next generation. A corporate team can take a fresh, business-led view of the farm, asking: Who owns the land and other critical assets? Who manages daily operations? Who carries the risk and who enjoys the return? What is the enduring plan for succession? From this review, the team can confirm whether the current setup is fit for purpose or if an alternative — for example an updated partnership agreement, a company, a limited liability partnership, or a blended model — would better meet the family’s aims. Tax efficiency through joined-up advice Tax sits at the centre of most
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In this issue: Pharmaceuticals—regulatory framework Competition in life sciences Medical devices Intellectual property Commercialisation Research and development Data protection and life sciences Advertising of medicines Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Pharmaceuticals—regulatory framework MHRA publishes its strategic approach to AI The Medicines and Healthcare products Regulatory Agency ( MHRA) has set out its strategy for artificial intelligence, mirroring the government’s white paper, ‘ A pro-innovation approach to AI regulation’, and its guiding principles of safety, security, fairness and accountability. It evaluates AI’s opportunities and risks in three roles: as the regulator of AI products, as a public service making time-critical decisions, and as an organisation that bases decisions on evidence. See: LNB News 30/04/2024 78. EFPIA publishes circular economy white paper for pharmaceutical industry The European Federation of Pharmaceutical Industries and Associations ( EFPIA) has unveiled a white paper on the circular economy in response to the...
In this issue: Medical devices Data protection and life sciences Research and development Commercialisation Advertising of medicines Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Government reaction to Whitehead Review on systemic bias in UK medical devices Harriet Hanks, counsel, Sanjana Canumalla, associate, and Matt Allison, trainee, at Freshfields Bruckhaus Deringer, examine and reflect on the findings of the Whitehead Review into equity in medical devices, published on 11 March 2024. See News Analysis: UK government responds to Whitehead Review’s findings of systemic bias in UK medical devices. Guidance on content of Investigator’s Brochure for clinical investigations of medical devices issued The Medical Device Coordination Group ( MDCG) has published guidance on the Investigator’s Brochure ( IB) for clinical...
Austen Hays announced it has filed a claim in the High Court, asserting that Grindr violated data protection rules by unlawfully handling and disclosing users’ 'highly sensitive' medical information to third parties without permission. According to the firm, advertising partners including Localytics and Apptimize received private data from Grindr’s users between May 2018 and April 2020, and potentially for a longer period, the firm added in its claim. Founded in 2009, the app calls itself 'the largest social networking app for gay, bi, trans and queer people', claiming 'millions of daily users' who use its location-based technology to connect across more than 190 countries. Austen Hays said the breaches enabled a 'potentially unlimited number' of third parties to direct advertisements at users and tailor those promotions. These third parties either delivered adverts themselves or operated as so-called adtech intermediaries, with the potential to pass data on to...
In March 2024, the independent review into equity in medical devices, led by Professor Dame Margaret Whitehead, released its much-anticipated final report (see: LNB News 11/03/2024 90), setting out wide-ranging proposals to confront present and future risks of bias in devices on the UK market. At the same time, the government published a policy paper responding to those proposals. Here, we consider several themes arising from the Report and the government’s response (the Response). The equity in medical devices review: brief background and scope In 2021, the Department of Health and Social Care ( DHSC) commissioned an independent ‘equity in medical devices’ review to examine potential systemic bias affecting devices used in the UK. The immediate catalyst was concern about pulse oximeters—widely relied upon during the coronavirus ( COVID-19) pandemic to measure blood oxygen saturation—and whether readings were accurate in patients with darker skin tones. Once...
In this issue: Pharmaceuticals—regulatory framework Borderline products Business transactions Intellectual property Data protection and life sciences Advertising of medicines Medical devices Competition in life sciences Post-market Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Pharmaceuticals—regulatory framework European Parliament adopts proposal to revise EU pharmaceutical legislation The European Parliament has backed a plan to modernise EU medicines law, featuring a Directive updating the Union code for medicinal products for human use—repealing Directives 2001/83/ EC and 2009/35/ EC—and a Regulation that replaces Regulation ( EC) 726/2004 and Regulation ( EC) 141/2000 ( Orphan Regulation), while repealing and incorporating relevant parts of Regulation ( EC) 1901/2006 ( Paediatric Regulation), to drive innovation and improve the supply, accessibility and affordability of medicines. This is the first...
Law360 spoke with the general counsel at three venture capital groups ( Sofinnova Partners, RA Capital Management and Bain Capital) active in life sciences and healthcare. They outlined the key issues foremost in their minds amid a complicated regulatory landscape and a shifting economy. ‘ I’d say the dominant theme is more rules on everything,’ said Armance Bordes, general counsel at Sofinnova Partners. Bordes noted that tighter oversight of foreign investment controls, in particular, has started to influence how the firm arranges transactions. Whereas the firm had previously either declined certain opportunities or tackled the rules directly when it wanted to back a specific company, Bordes said one particular deal with a UK business about six months ago prompted it to begin altering how it put deals together, with those requirements in view. ‘ It made us think, “ Look, we really want to...
FDA Commissioner Dr Robert Califf delivered his comments during a five-hour appearance before the US House of Representatives Oversight Committee, which ranged across subjects such as seafood inspections, shortages of infant formula, abortion rights, flavoured tobacco, lead in food and foreign-made vaping products, and featured questioning from several Republican members on whether the antiparasitic medicine ivermectin works against coronavirus ( COVID-19) during the proceedings. Regarding oversight of CBD, a non-psychoactive hemp derivative, Califf restated the FDA’s January 2023 position that it would not craft regulations permitting CBD to be marketed in foods or dietary supplements for sale. He said CBD does not sit within any current regulatory framework at the agency, and added that the FDA would very much like Congress to create a regulatory pathway for CBD through legislation. The session took place as lawmakers weigh various possible changes to federal hemp rules, now...
In this issue: Commercialisation Medical devices Regulatory framework for medicinal products Intellectual property Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Commercialisation European pharma industry responds to HTA consultation calling for JCA process reforms The European Federation of Pharmaceutical Industries and Associations ( EFPIA) has replied to the consultation on the draft implementing act for Joint Clinical Assessment ( JCA) of medicinal products under the Health Technology Assessment Regulation, Regulation ( EU) 2021/2282. Although EFPIA broadly endorses the initiative, it raises significant worries that the current draft would make the JCA system unworkable and drive unnecessary duplication. It particularly objects to the near exclusion of manufacturers from JCA procedures except in rare cases, and deems the proposed timelines unmanageable. EFPIA concludes that insufficient involvement and a lack of clarity at the...
In this issue: Regulatory framework for medicinal products Commercialisation Research and development Competition in life sciences Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Regulatory framework for medicinal products Court of Justice finds that scientific experts’ conflicts of interest meant refusal of marketing authorisation was unlawful On 14 March 2024, the Court of Justice handed down its ruling on the appeal brought by Debrégeas et associés Pharma SAS ( D& A Pharma) against the earlier judgment of the General Court of the EU (the General Court), which had dismissed its action challenging the European Commission’s refusal to grant a conditional marketing authorisation ( CMA) for D& A Pharma’s medicine, Hopveus (sodium oxybate). The Court of Justice set aside the General Court’s...
Justice Secretary, Alex Chalk, has said the move is intended to end the 'murky world of non-disclosure agreements' Under plans to curb misuse of NDAs, those bound by confidentiality clauses would still be free to raise alleged criminality with key professionals and crime-fighting bodies. On 28 March 2024, Alex Chalk set out an ambition to end the ‘murky world’ where such agreements are used to conceal wrongdoing, adding that the reforms will make clear in law that gagging orders cannot lawfully be wielded against victims to block justice or silence them. Lawyers and the police Medical practitioners and counsellors Advocates and other organisations that investigate crime The change will not bite immediately; legislation will be brought forward ‘when parliamentary time allows’, the Ministry of Justice said. The Mo J also confirmed the bill will not capture NDAs signed before it secures royal...
What are the practical implications of the case? The case offers significant clarification of the impartiality obligations under Article 41 of the Charter and confirms that substantive links between an expert and the pharmaceutical industry, for example consultancy arrangements or acting as principal investigator in clinical trials, could compromise such impartiality when assessing an application for a marketing authorisation concerning a potentially rival medicinal product, even where no demonstrable bias on the part of the expert can be shown. The judgment provides reassurance for industry in a context where a narrow reading of conflicts of interest has long been regarded as unsatisfactory and proof of actual bias is frequently hard to secure. However, the Court of Justice’s decision appears likely to create difficulties for the EMA and comparable bodies, particularly in rare diseases where there are few well qualified experts and most of these...
In this issue: Research and development Disputes and regulatory enforcement Medical devices Advertising of medicines Regulatory framework for medicinal products Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Research and development UK AI regulation Bill advances after House of Lords second reading The United Kingdom's Artificial Intelligence ( AI) regulation Bill has finished its second reading in the House of Lords. A wide-ranging debate on the Bill occurred on 22 March 2024. It now proceeds to the committee stage, where a clause-by-clause review will be conducted when timetabled. See: LNB News 26/03/2024 24. EFPIA and IHI invite proposals to enhance patient outcomes The European Federation of Pharmaceutical Industries and Associations ( EFPIA) and the Innovative Health Initiative ( IHI) have issued two calls for proposals aimed at improving patient...
In this issue: Regulatory framework for medicinal products Research and development Data protection and life sciences Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Regulatory framework for medicinal products Commission releases Communication to boost biotechnology and biomanufacturing The European Commission has issued a Communication on building the future with nature, outlining the obstacles and constraints in the EU’s biotechnology and biomanufacturing arena and setting out a suite of targeted measures to invigorate biotechnology and biomanufacturing across the EU. The European Federation of Pharmaceutical Industries and Associations ( EFPIA) welcomed the Commission’s Communication and urged the Commission to bring forward, in its next mandate, a comprehensive health and life science strategy so that European patients can access innovative new treatments and technologies. See: LNB News 20/03/2024 81. MEPs adopt proposal to improve EU pharmaceutical legislation The Environment, Public Health and Food Safety Committee has adopted its proposals to enhance EU...
The Competition and Markets Authority ( CMA) stated on 8 March 2024 that it strongly disputes a judgment delivered the same day by the Competition Appeal Tribunal ( CAT), which concluded that enforcement officials had not put crucial questions to a witness during the drugmakers’ appeal hearings. In July 2021, the CMA levied fines over alleged deals involving two companies now part of Accord Healthcare, together with their former parent Allergan plc, said to have postponed the launch of generic versions of the medicine produced by Waymade and AMCo, now Advanz Pharma. On 8 March 2024, Sarah Cardell, the CMA’s chief executive, said the authority had imposed substantial penalties after determining the firms took part in a market‑sharing arrangement that deprived the NHS of possible “savings from competition for this essential medicine”. Cardell added that the CAT’s decision to allow the appeals is...
In this issue: Competition in life sciences Disputes and regulatory enforcement Regulatory framework for medicinal products Medical devices Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Competition in life sciences CAT publishes decisions on Allergan PLC v CMA cases The Competition Appeal Tribunal ( CAT) has released two judgments on the Competition and Markets Authority’s ( CMA) conclusion that Auden/ Actavis UK paid AMCo/ Advanz to keep its own 10 mg hydrocortisone tablets off the market. In the first, the tribunal upholds the decision on the facts and dismisses every ground of appeal. In the second, it allows the appeals because the CMA failed to put its case fully to a witness during a two‑day...
A three-judge panel affirmed a Manhattan district judge’s ruling to refuse Bon Sens.org ( Bon Sens)’s application for discovery intended for use in a foreign proceeding. The organisation also sought the communications to use in its lawsuit against the Government of France, in which it alleged that France and several other countries had unlawfully granted Pfizer immunity from liability linked to the coronavirus vaccines. Bon Sens says it is a collective of ‘citizens, artisans, entrepreneurs, farmers, doctors [and] teachers’, adding that ‘people of good will and common sense have decided to act to face the health and ecological challenges that the world will face in the coming decades.’ According to its website, it also backs scientific studies and pursues legal actions against the French Government in the name of transparency......
In this issue: Research and development Intellectual property Regulatory framework for medicinal products Medical devices Post-market Data protection and life sciences Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Latest Q& A Useful information Research and development Spring Budget 2024— Key Life Sciences and Research & Development announcements On 6 March 2024, as part of the Spring Budget 2024, the Chancellor of the Exchequer, the Rt Hon Jeremy Hunt MP, outlined proposals to drive growth across the life sciences and research and development ( R& D) sectors. The plans include commitments to overhaul public spending, accelerate technological and digital transformation within the NHS, and progress the UK’s growth plan by establishing the UK’s first investment zones in North England and the...
Your Lawyers Ltd v Capital Interchange Ltd & Therium Capital Management Ltd; Your Lawyers Ltd v Capital Interchange Ltd & Therium Capital Ltd [2024] EWHC 287 ( Ch) What are the practical implications of this case? This was a lengthy, fact‑heavy judgment, and its chief value for practitioners lies in the court’s appraisal of the prospects of success in some less commonly encountered causes of action. The judge was able to rely on Court of Appeal decisions arising from prior litigation between the Claimant and another party said to be involved in the alleged breach of its confidence, Harcus Sinclair. It was common ground that the Second Defendant had passed on the contents of a ‘ Litigation Pack’ prepared by the Claimant to Harcus Sinclair; the contested issue was whether that pack contained sufficient detail to attract the necessary quality of...
In this issue: Medical devices Regulatory framework for medicinal products Data protection and life sciences Research and development Intellectual property Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices MHRA sets out its Roadmap towards updated medical device rules. Harriet Hanks, counsel, Andrew Austin, partner, Sofia Schaffgotsch, associate, and Honor May, trainee, at Freshfields Bruckhaus Deringer, examine the MHRA’s plans for the future regulatory framework for medical devices, released on 9 January 2024. See News Analysis: MHRA issues Roadmap towards new medical devices rules. Medical Devices ( In Vitro Diagnostic Devices etc) ( Amendment) Regulations 2024 SI 2024/221: made under legislative powers in the European Union ( Withdrawal) Act 2018 relating to assimilated law. The Regulations amend three pieces of primary legislation, nine pieces of...
Legal Service Board report: The misuse of non-disclosure agreements: call for evidence themes and summary of evidence The LSB reported that clients and their legal advisers deploy these binding agreements to hide conduct that is lawful yet unethical, including bullying, settlements involving consumer products, and conflicts in construction and building. Numerous respondents also indicated NDAs are used across workplaces to conclude employment disputes. Matthew Hill, the LSB’s outgoing chief executive, voiced his gratitude to those who contributed to the review, which ran from May to July, noting that the exercise helped to illuminate a corner of legal practice that is, by its very nature, hidden. He further observed that the recurrent patterns set out in the report demonstrate that, when NDAs are misused, the consequences for people’s lives can be devastating......
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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...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...
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