Legal Practice Notes

What is an intrusive site investigation? An intrusive (phase 2) site investigation involves geotechnical and geo-environmental specialists collecting detailed and reliable information on a site’s physical and chemical ground conditions. These findings are then applied to: the design of earthworks and foundations, and determining whether contamination is present The UK follows a risk-based framework for the identification, assessment and management of contaminated land, based on the idea of a contaminant linkage (once called a pollutant linkage), ie contaminant-pathway-receptor. For further information, see Practice Note: Contaminated land—risk assessment. Site characterisation is generally carried out in a clear staged manner: screening phase: an initial investigation consisting of a desk study phase 1: a site walkover and qualitative risk assessment phase 2: intrusive site investigations involving the analysis of soil, groundwater and/or gas samples and a quantitative risk assessment For further information on desktop studies and phase 1 assessments, see Practice Note:...

What is a phase 1 audit? A Phase 1 environmental audit is an impartial appraisal by external environmental consultants of an organisation’s adherence to environmental legislation and its management systems. The purpose is to methodically and precisely examine site activities and the local environmental context to identify breaches and the likelihood of contaminated land liabilities. By flagging environmental risks, their potential impact can be gauged and suitable remediation actions proposed. When will a phase 1 audit be instructed? The need for, and extent of, any audit will vary according to several considerations, such as: the terms governing a transaction current and historic operations site characteristics and environmental sensitivity the client’s risk appetite and available budget In most cases, a Phase 1 audit is commissioned because of: potential environmental liabilities highlighted by an initial desktop review (see:...

Pharmaceutical patents This Practice Note examines pharmaceutical patents and the implications of regulatory regimes governing the authorisation of new medicinal products. Pharmaceutical patents (pharma patents) typically address: chemical compounds that are effective in treating disease therapeutic uses of those compounds in managing illnesses formulations that present the compounds as medicines processes for manufacturing the compounds For detail on patents covering new chemical entities and small molecules, see Practice Note: Patents for new chemical entities and small molecules; for biotechnology-focused protection, see Practice Note: Biotechnology patents. Notwithstanding Brexit, the UK remains within the European patent architecture because the European Patent Office ( EPO) and the European Patent Convention ( EPC)—the treaty that sets out the procedure for granting European patents via the EPO—operate independently of the EU. The UK is now simply another non‑ EU EPC contracting state, alongside Norway,...

This Practice Note explores the principal parties commonly engaged in a PFI or PF2 project. It outlines the functions of public sector participants, private sector counterparts, finance providers and sub-contractors, together with support providers and other professionals involved. In the 2018 Budget (delivered on 29 October 2018), the government confirmed it would cease using PF2 for new schemes (see News Analysis: Budget 2018—what does it mean for infrastructure and housebuilding?). Nonetheless, live PFI and PF2 arrangements remain in operation and, given the usual duration and lifespan of these schemes, are expected to do so for many years to come. Public Sector Authority/ Trust This is the public sector organisation that originates and procures the PFI scheme in question and seeks to have the asset constructed and properly maintained (the label ' Trust' applies only to NHS schemes). The public body will typically be a local...

This Practice Note explores the Compensation Event and Relief Event frameworks in the Project Agreement for a PFI or PF2 scheme. It examines the key features of each framework and the differences between them under PFI and PF2 (also occasionally called PFII). In the 2018 Budget, presented on 29 October 2018, the government confirmed that PF2 would no longer be used on new projects (see News Analysis: Budget 2018—what does it mean for infrastructure and housebuilding?). Nevertheless, existing PFI and PF2 projects will continue to operate and, given the typical lifespan of such arrangements, are likely to remain in place for many years to come. Context Compensation Events and Relief Events are categories of 'supervening events'; circumstances in which some contractual relief is appropriate and justified. The objective is to manage the allocation of risks between the parties arising from unintended...

Background to the Construction Sub-contract PFI structure—diagram sets out the basic structure of a PFI project This Practice Note considers the Construction Sub-contract linking Project Co with the Construction Sub-contractor (also known as the Construction Contractor) within a PFI or PF2 arrangement. In the 2018 Budget, presented on 29 October 2018, the government confirmed it would cease using PFI and PF2 for new schemes (see News Analysis: Budget 2018—what does it mean for infrastructure and housebuilding?). Nonetheless, live PFI and PF2 schemes will continue, and, given their usual duration, are expected to operate for many years... Where a project involves a built asset (as is commonly the case), a Construction Sub-contract (also termed the ‘ Construction Contract’) is entered into between Project Co and the Construction Sub-contractor. Under it, the Construction Sub-contractor undertakes the construction stage of the project (the period when the assets are...

Launched in 1992, the Private Finance Initiative ( PFI) is a form of public–private partnership, later followed in 2012 by the ‘ PF2’ variant. See Practice Notes: Introduction to PFI and PF2, Key parties in a PFI/ PF2 project, and PFI structure—diagram. This Practice Note concentrates chiefly on disputes arising on PFI projects (rather than PF2), as PFI projects are far more numerous. In 2018, the government confirmed it would cease using the PF2 model for new projects. Nonetheless, existing PFI and PF2 projects will continue in operation. Given the usual 25–30 year term, existing projects—and any disputes they generate—are expected to persist for many years to come. The contractual context of PFI disputes Disputes on PFI projects are not unusual: the governing documentation is voluminous, the projects are complex and high‑value, and numerous interested parties are involved. Broadly, PFI projects progress through three...

This Practice Note outlines the obligations under the Petroleum ( Consolidation) Regulations 2014 (2014 Regulations), SI 2014/1637, requiring operators of petrol filling stations to hold a petroleum storage certificate from the Petroleum Enforcement Authority, and requiring non‑workplace premises storing petrol to obtain a licence for storage. It also reviews the applicability of other health and safety legislation, and the environmental permitting regime, to the unloading of petrol into storage at petrol stations. Petroleum ( Consolidation) Regulations The 2014 Regulations, SI 2014/1637, which took effect on 1 October 2014, apply to: workplaces that keep petrol where petrol is dispensed directly into vehicles, ie petrol filling stations non‑workplace premises storing petrol, ie at private homes, or at clubs/associations General prohibition on the keeping of petrol No person may keep petrol except in accordance with the 2014 Regulations, SI 2014/1637, reg 5 or 13. Regulation 5 provides that...

Petrol stations in the UK From a high of 39,958 in the late 1960s, the UK now has roughly 8,400 petrol forecourts. When assessing environmental liabilities linked to these sites, attention should cover locations that are: active forecourts forecourts approaching closure and earmarked for redevelopment, and former forecourts that have already been redeveloped Given their (often) central urban positions, redevelopment frequently targets housing. While fuel is branded by the oil majors, many sites are operated by smaller owners. Rising land values linked to redevelopment have prompted numerous closures, particularly where small operators have struggled to remain viable. Potential environmental liabilities associated with petrol stations Petrol stations can create environmental harm through: leaks from underground storage tanks ( USTs) and connecting pipework to pumps failures in drainage, run-off from spills, or poor performance of interceptors, and vapours during tank...

What are petrol filling stations? Traditional filling stations retail petrol, diesel and paraffin, typically stored in underground tanks of varying sizes. Sites range from small urban or rural forecourts with only one or two pumps to larger garages that also operate full workshops providing repair and maintenance services. The overall number of forecourts has decreased since the 1960s, and many locations have shifted from oil company ownership to dealer operation. Activities Petrol is a blend of volatile hydrocarbons with chemical additives. Oxygenates are included to improve stability and deliver anti-knock properties; the amounts of anti-knock compounds are regulated by legislation and have been progressively reduced. In unleaded petrol, these have been replaced with other substances, such as methyl tertiary butyl ether ( MTBE), which acts as an octane booster. Detergents are also added to help keep carburettors, fuel injectors and inlet valves free from carbon...

Note—check Where to Notify to confirm whether notification thresholds in Peru and worldwide are satisfied. 1. Have there been any recent developments regarding the Peruvian merger control regime and are any updates/developments expected in the coming year? Are there any other 'hot' merger control issues in Peru? On 30 December 2020, Peru’s Congress enacted the Merger Control Law 2021 ( MCL 2021). Following the publication of supplementary regulations, it entered into force on 14 June 2021. Before this, under the Antitrust and Antioligopoly Law for the Electricity Sector 2009 (as amended) ( AAL 2009), Peruvian rules required compulsory pre-notification and clearance solely for vertical or horizontal concentrations within electricity generation, transmission, or distribution. Once the MCL took effect, the AAL and Urgency Decree No 13/2019 were repealed. Among other modifications, the MCL allows the authority to review a concentration ex...

What is meant by ‘personalised medicines’? The expression ‘personalised medicine’, sometimes called ‘targeted medicine’, commonly refers to therapies aimed at rare conditions. As outlined in this Practice Note, these medicines often involve small‑molecule products repositioned for fresh indications or for subsets of existing patient cohorts that share a predictive biomarker of disease. They can also be biological medicines characterised by functional attributes. Such products present distinct challenges for securing patents and for patent enforcement, some of which are yet to be determined by the English courts. This Practice Note also sets out the limits of patent protection and supplementary protection certificates ( SPCs) for these approaches, and signposts other rights relevant to research in this field, including the protection afforded by data and market exclusivity. What are rare diseases? Rare diseases are conditions that affect a small minority of the population. In the US, a rare...

What is personalised medicine Personalised medicine has been part of clinical practice for quite some time. Clinicians have, to differing degrees, tailored care to individual patients using information gathered about them. Over the last decade and a half, however, the emergence of systems biology has markedly broadened its scope; in contemporary practice it depends on collecting as much data as possible about a specific biological system under study. The aim is to interpret these collected datasets in ways that enhance understanding of a living system and its pathologies, ultimately enabling targeted interventions that are responsive to an individual patient or to groups of patients. It is often characterised as care that is ‘custom‑made’, set against the more traditional, ‘one size fits all’ model. Although many cell therapies, gene therapies and other advanced therapy medicinal products ( ATMPs) are regarded as...

The role of personal representatives Applications for reasonable financial provision from an estate under the Inheritance ( Provision for Family and Dependants) Act 1975 ( I( PFD) A 1975) appear to be increasing. Consequently, it is more likely that personal representatives ( PRs)—whether executors or administrators—will need to address such a claim during the administration of the estate. This can be challenging, as PRs may feel caught between opposing sides, namely the claimant and the beneficiaries taking under the Will or the intestacy rules. This Practice Note explores the position of PRs in relation to I( PFD) A 1975 claims. Although it is well understood that, when faced with an I( PFD) A 1975 claim, PRs should remain neutral, that approach raises practical queries, such as: how PRs should respond to requests for information from someone threatening to bring an I( PFD) A 1975...

Why indemnities and security are required When an insolvency practitioner takes office, they owe creditors a duty of care to act bona fide and in their best interests. Depending on circumstances, an office-holder may continue trading for a time or complete or take on contracts, and must shield themselves from personal exposure while doing so. In most cases, office-holders seek to exclude personal liability within contracts and ensure all documents are executed in their capacity as office-holder, not in a personal capacity. Nevertheless, a complete exclusion may not be possible, so they may need to rely on statutory indemnities, where available, alongside extra creditor indemnities. The importance of indemnities differs according to the office held and the actions required during the appointment. Personal liability The degree of personal liability for an office-holder depends on the specific office and the extent to which the role carries...

UK status From 31 January 2020 (exit day), the UK ceased to be a member of the EU. Under the Withdrawal Agreement there followed an implementation period, during which EU law continued to apply to the UK. From 1 January 2021, however, the core provisions of Regulation ( EU) 2015/848 ( OJ L141 5.6.2015 p 19)—the Recast Regulation on Insolvency ( EU Recast Regulation on Insolvency)—concerning automatic recognition no longer extend to the UK (see Practice Note: Brexit—impact on Recast Regulation on Insolvency). Other Member States nonetheless still apply the EU Recast Regulation on Insolvency where its conditions are met, and this Practice Note considers its operation between those Member States. EU Recast Regulation on Insolvency The EU Recast Regulation on Insolvency introduced significant amendments to the EC Regulation on Insolvency, Regulation ( EC) 1346/2000 ( EC Regulation on Insolvency). For the complete text of the EU...

Inheritance tax and personal injury trusts Many advisers mistakenly assume that choosing one form of personal injury trust over another delivers an inheritance tax ( IHT) benefit, with discretionary trusts often singled out. In truth, for a self-settled personal injury trust, the structure chosen makes no difference. The gift with reservation of benefit rules bite, so the trust fund’s value is treated as part of the settlor’s estate for IHT purposes, whether or not it actually falls back into the estate on death. This remains the position even for disabled trusts... From an IHT perspective, a poorly planned personal injury trust can be positively harmful. If an amount exceeding the nil rate band (£325,000 for England and Wales 2025–26) is placed into a relevant property trust—such as a discretionary or life interest trust—that does not qualify as a disabled persons trust, there is an...

Types of personal injury trust How to choose between the different types of trust Consideration of the various personal injury trust options commonly proceeds on the basis that the injured individual has full capacity and acts as settlor. Yet a trust may equally be created by court order, whether during the litigation or once a personal injury claim concludes. In those circumstances, the trust is put in place for the injured person, irrespective of whether their capacity is impaired. Watt v ABC (see Practice Note: The Court of Protection versus personal injury trusts) indicates that such orders can be made either by the court determining the claim and granting the award, or by the Court of Protection, whilst acknowledging that some jurisdictional questions remain unresolved. Although these notes proceed on the footing that the injured person is capable of setting up the trust, the...

Security Where compensation is paid as a lump sum only, once damages and costs have been settled, the claimant need not be concerned about future payment security. Conversely, if a periodical payments order is made, the claimant will depend on that security for the rest of their life. The court treats security of payment as essential and will not make a periodical payments order unless satisfied that the ongoing payments are reasonably secure. Payments are automatically treated as reasonably secure where: the payer is a government or health service body the insurer benefits from protection under the Financial Services Compensation Scheme ( FSCS) a ministerial guarantee applies The first two situations are commonplace, while the third is relatively rare. Government or health service body There are many government or health service bodies listed in the Damages ( Government and Health Service Bodies) Order 2005, SI...

Assessing the limitation date When you are instructed on a personal injury matter, the question of limitation ought to be among your earliest checks and priorities. The default position is fairly simple in principle — there is a three-year period, starting from the date on which the cause of action arises or, if later, when the claimant becomes aware of it — yet numerous exceptions set different time limits, and, in many instances, the deadline is markedly shorter than the three years provided by the Limitation Act 1980 ( LA 1980). At the outset, when addressing limitation, ask yourself: does the case involve a claim for damages for personal injury suffered by an individual? if it does, what is the date of the incident (or the date on which the cause of action arose)?......