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What are pharmaceutical incentives? In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product. Rationale behind PIs PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the
Claims by contractors for time and/or money Requests from contractors seeking additional time and/or payment are commonplace on construction projects. A time claim seeks an extension of time (EoT) to complete the works (or achieve a contractual milestone) where a delay event has occurred, whereas a money claim typically pursues reimbursement of extra loss and/or expense incurred by the contractor due to delay or disruption to the works. Such a claim might likewise be brought by a sub-contractor under a sub-contract. These claims are usually founded on an express contractual entitlement—ie the contract specifies situations in which the contractor is entitled to time and/or money—and they are advanced and decided in accordance with the contract terms. They do not, of themselves, involve a breach of contract or require there to be a dispute between the parties, although they may ultimately give rise to
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Guarantor) ] 1 Definitions For this Deed, the terms below shall have the following meanings: Effective Date • [ today OR the date of this Deed OR [ other date on which the variation is to take effect ] ] [ Guarantor’s Obligations • the covenants undertaken by the Guarantor in [ the Lease OR a [ describe other
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When advising an administrator appointed over a company, it is usual, shortly after their appointment, for the administrator to instruct a solicitor to review the appointment papers and the surrounding circumstances and to issue a letter confirming that the appointment is valid. This confirmation provides the administrator with assurance that they are acting properly going forward. If it later transpires that they were not validly appointed, a creditor, one of the directors, or the company may bring a challenge. For further information on how to make an appointment, see Practice Notes: Out-of-court administrator appointments—who can appoint and in what circumstances? Out-of-court administration appointments by a company or its directors—the procedure Out-of-court administration appointments by a QFCH—the procedure Court appointment of administrators—who can apply and in what circumstances? How to file for administration out of court opening hours Where there is a defect in the appointment or in the...
To gauge concentration within a particular market, competition authorities often turn to the Herfindahl‑ Hirschman Index ( HHI) as a primary tool that supports and streamlines their assessment. Although the absolute HHI level provides an early signal of post‑merger competitive pressure, the movement in the HHI (the ‘delta’) functions as a practical proxy for the change in concentration directly attributable to the merger itself and its immediate effects. How to calculate the HHI The HHI is obtained by adding the squares of the individual market shares of all firms participating in the market, without omitting any active competitor......
This checklist sets out a non-exhaustive range of matters to weigh up before using the commercial rent arrears recovery ( CRAR) procedure to recover rent arrears. Initial considerations Confirm the premises are solely commercial and the lease prohibits any residential use. CRAR cannot be applied where the premises are residential or mixed-use, or where residential occupation is permitted, even if no-one is actually living there. Ensure occupation is evidenced in writing, for example by a lease or a tenancy at will. Verify there is a right to exercise CRAR. An immediate landlord may exercise CRAR, as can other parties such as an LPA or court-appointed Receiver. See Practice Note: Commercial rent arrears recovery ( CRAR)— Who can exercise CRAR? Consider whether the landlord might later wish to forfeit the lease, since exercising CRAR will waive any existing right to...
Consider the nature of the IP right From a lender’s standpoint, use this checklist to pinpoint key points when taking IP as security and the steps to implement it... Identify the IP right and applicable law; patents, trade marks, registered designs and copyright can be mortgaged or charged... Select security: a legal mortgage (assignment plus redemption and exclusive licence‑back) offers stronger control than a fixed charge; for charges, restrict disposals and hold an executed undated assignment in escrow (verify foreign recognition)... Confirm ownership, term, existing security, licences and third‑party interests; demand warranties and title evidence, especially for unregistered rights... Assess validity and maintenance: search prior rights, check renewals and genuine use, monitor infringement, review litigation; obtain professional opinions where needed... Value the right and routes on default (licensing or sale); add complementary assets if...
This checklist outlines the key obligations an insurer undertakes within an insurance policy. The duty to defend captures an insurer’s responsibility to furnish an insured with a defence to claims made under a policy. The duty to indemnify reflects an insurer’s responsibility to pay a claim for loss or damage asserted against an insured. For added insight into these concepts, see Practice Note: US—duty to defend and duty to indemnify. These duties arise under policy wording. The starting point Counsel advising clients, whether the policyholder or the insurer, should begin by obtaining the insurance contract. Insurers draft bespoke contracts, called insurance policies, that provide certain cover to insureds and set certain duties for insurers when a covered loss occurs. Covered loss is defined in each form of policy and will vary depending on the type of policy sold to an insured. The two...
ARCHIVED: This archived Checklist outlines the matters trustees would have needed to assess when revising their scheme rules to reflect the legislative changes that took effect on 6 April 2006 ( A‑day). It is provided for background purposes only. For more detail, see Practice Note: Updating your rules to reflect A‑day changes [ Archived]. A-day—an overview On 6 April 2006, the Finance Act 2004 ( FA 2004) commenced, bringing in a new framework for taxing UK pension schemes. The principal reforms were: the former tax approval regime was replaced with registration by HM Revenue & Customs ( HMRC) in place of strict caps and limits on benefits, a more flexible approach was adopted, applying tax charges to ‘unauthorised payments’ and where members’ benefits exceed the annual and lifetime...
ARCHIVED: This Practice Note is archived and is no longer maintained. UCITS is the acronym for undertakings for collective investment in transferable securities. The expression derives from Directive ( EC) 85/611 concerning the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (the Original UCITS Directive), which was adopted in 1985. The purpose of the Original UCITS Directive was to establish a single market for open-ended retail investment funds that offered enhanced protection for investors. The UCITS framework has been updated on several occasions, with the Management Company Directive 2001/107/ EU adopted in 2002 and the Product Directive 2001/108/ EU implemented in 2005 (together referred to as UCITS III); followed by implementation in 2011 of Directive 2009/65/ EC (the UCITS Directive, also called UCITS IV), which repealed and replaced the Original UCITS Directive; and Directive 2014/91/ EU ( UCITS V),...
In everyday workplace conversations, we focus heavily on process enhancement, technological solutions, productivity and performance; yet that is the automated, production-line lexicon of machines rather than humans. For a well-rounded and contributory culture, we ought also to speak of imagination, consideration and care. This Checklist is intended to support in-house lawyers through the process of setting objectives and carrying out appraisals too......
This Checklist, although not exhaustive, sets out the key steps and issues to consider when acting for a landlord in relation to a tenant’s application for a licence to underlet the demised premises. Does the lease permit underletting? First, review the relevant provisions in the lease to confirm whether the tenant may underlet the demised premises and, if permitted, the conditions and terms that would apply. Where there is an absolute covenant against underletting (ie a total ban), the landlord is under no duty to consent or to entertain the application, although they might choose to accommodate the tenant’s request. Take instructions on that basis; ensure the landlord understands that consenting to an otherwise prohibited act could breach obligations in other leases requiring enforcement of the covenant, and proceed as advised as necessary. If instead the lease has a qualified covenant (ie no...
Flowchart It outlines the steps for divorce or civil partnership dissolution proceedings lodged with the court on or before 5 April 2022, where case is undefended, whether an application for a matrimonial order or a civil partnership dissolution, brought under the Matrimonial Causes Act 1973 ( MCA 1973) or the Civil Partnership Act 2004 ( CPA 2004)......
Before commencing the arbitration Review relevant limitation deadlines and contractual time limits under the substantive law governing the dispute (a general matter outside the UNCITRAL Arbitration Rules) Examine the claims you intend to advance in an UNCITRAL arbitration, confirming they fall within the arbitration clause that refers disputes to arbitration under the UNCITRAL Arbitration Rules ( Article 1(1)) (ad hoc) Decide whether to accept or suggest an appointing authority to handle the appointment of arbitrators and related challenges in accordance with the Rules ( Article 6)......
Under the Finance Act 2004 ( FA 2004) and its associated regulations, payments made by a registered pension scheme to, or on behalf of, a member or an employer are categorised as either: authorised payments unauthorised payments Any payment that is not an authorised payment will be treated as unauthorised, unless it falls within a statutory exception; moreover, certain types of payment are expressly identified as unauthorised. Unauthorised payments—consequences Subject to their own rules, registered pension schemes may make unauthorised payments Unauthorised payments typically trigger tax charges for both the recipient and the scheme, and can in the end result in de-registration, causing the loss of the scheme’s tax-privileged status Reporting obligations apply to schemes where unauthorised payments have occurred Benefits offered under registered pension schemes are generally designed to prevent unauthorised payments arising......
FORTHCOMING CHANGE relating to the modernisation of stamp taxes on shares framework: In 2027, stamp duty and SDRT are set to be replaced by a single, self-assessed charge on securities—the securities transfer charge ( STC)—to be paid and reported via a new online portal. The STC’s core features are expected to broadly align with the proposals consulted on in 2023. Finance Bill 2026 ( FB 2026) provides a power, effective from Royal Assent, to introduce secondary legislation so taxpayers can test the digital service by self-assessing their stamp taxes on securities obligations and reporting transactions electronically through that service. For more on the modernisation of stamp taxes on securities, see: News Analyses: Budget 2025— Tax analysis— Stamp and transfer taxes Tax update spring 2025— Stamp taxes on shares modernisation Tax update spring 2025— Tax analysis— Stamp and transfer taxes TAMD 2023— Stamp taxes on...
STOP PRESS: Short Selling Regulations 2025 SI 2025/29 was made and published on 13 January 2025, together with an Explanatory Memorandum. This instrument replaces the assimilated regime and establishes a new statutory framework for UK short selling, creating designated activities and granting the Financial Conduct Authority ( FCA) rulemaking powers for those activities, plus powers to intervene in exceptional situations. It reiterates that firms must notify the FCA when net short positions exceed 0.2% of issued share capital; while HM Treasury keeps the ability to adjust this level, the FCA may mandate notifications at a different threshold in exceptional circumstances. Some provisions took effect on 14 January 2025, with the remainder commencing on the date the revocation of the UK Short Selling Regulation takes effect under the Financial Services and Markets Act 2023. For a summary of the background to the new UK regime, see...
This timeline shows key developments relating to the UK securitisation regime from January 2024 onwards For earlier milestones, see EU and UK Securitisation Regulations—timeline [ Archived]. On 1 November 2024, Assimilated Regulation ( EU) 2017/2402 (the UK Securitisation Regulation) no longer applied in the UK, and new securitisation rules issued by the Financial Conduct Authority ( FCA) and Prudential Regulation Authority ( PRA) came into effect. For insight into the revised UK framework, see Practice Note: The UK securitisation regime. 2026 17 February 2026 — PRA/ FCA CP2/26 – Reforms to securitisation requirements; CP26/6: Rules for reforming the UK Securitisation Framework; Applying the FSMA 2000 model of regulation to the Capital Requirements Regulation The PRA and FCA have opened consultations on changes to the UK securitisation framework. The FCA suggests...
This table outlines the tests and conditions that need to be satisfied before any counteraction applies across the different chapters of the UK hybrid rules. For fuller guidance in detail on the hybrid rules in force from 1 January 2017, and on the many amendments made to them since then, refer to Practice Note: Hybrid mismatches—introduction to the rules......
This timeline outlines key developments in the UK regulation of central securities depositories, including under Assimilated Regulation ( EU) 909/2014 (the UK Central Securities Depositories Regulation), from 2024 onwards. For earlier milestones, see Central Securities Depositories Regulation ( CSDR)—timeline ( Archived). 2026 26 January 2026 — IA: The Investment Association presents a roadmap for the move to T+1; IA: T+1 Settlement: Navigating the UK, EU and Swiss Transition [ PDF]. UK Accelerated Settlement Taskforce Quarterly Review — Q4 2025: FCA welcomes the Accelerated Settlement Taskforce’s 2025 update on T+1 progress. The T+1 Accelerated Settlement Taskforce has issued its Q4 2025 progress review, detailing advances towards adoption of a trade-date-plus-one ( T+1) settlement cycle, with 11 October 2027 as the current target. In tandem, the Investment Association ( IA) released T+1 Settlement: Navigating the UK, EU and Swiss Transition, which sets out a proposed roadmap for...
This timeline highlights key developments within the UK prudential framework for banks and designated investment firms from January 2024 onwards. For earlier milestones, see: Capital Requirements Directive IV ( CRD IV) and Capital Requirements Regulation ( CRR)—timeline [ Archived]... 2026 17 March 2026 — Prudential Regulation Authority ( PRA) Speech: Phil Evans on modernising the liquidity framework for banks and building societies PRA unveils liquidity reform proposals Document: CP5/26— Modernising the liquidity policy framework The PRA has issued consultation paper CP5/26— Modernising the liquidity policy framework, outlining measures to ensure banks can rapidly monetise high-quality liquid assets during swift stress episodes, such as the 2023 Silicon Valley Bank collapse. Comments are requested by 17 June 2026. In remarks on the plans, the PRA’s Phil Evans said the...
This timeline outlines key milestones concerning the UK measures that gave effect to recast Markets in Financial Instruments Directive 2014/65/ EU ( Mi FID II) and Assimilated Regulation ( EU) 600/2014 ( UK Mi FIR) (collectively, the UK’s Mi FID II regime). For earlier events, see: Markets in Financial Instruments Directive ( Mi FID II) and Markets in Financial Instruments Regulation ( Mi FIR)—timeline (2007–2023) [ Archived]. For principal updates relating to the EU’s Mi FID II regime, see: EU Markets in Financial Instruments Directive ( Mi FID II) and Markets in Financial Instruments Regulation ( Mi FIR)—timeline. 2026 Date Source Document Description 28 January 2026 FCA Next steps for setting up a bond consolidated tape provider ETS: Knowledge Centre Timeline The Financial Conduct Authority ( FCA) confirmed it has entered into a contract with Etrading Software ( ETS) to provide the UK bond...
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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...
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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