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
Planning conditions and planning obligations often limit both what development may take place and the way it is carried out on the land or buildings to which they apply. See Practice Notes: Planning conditions—key points and Planning obligations—key points. Planning obligations Agreements made under section 106 of the Town and Country Planning Act 1990 (commonly called section 106 agreements, or planning obligations) control the use of land and bind successors in title. They are recorded as local land charges. The agreement should specify the land it binds by reference to an attached plan, which will usually mirror the planning application site boundary for the related development. A section 106 agreement is typically concluded before the decision notice granting planning permission is issued. How are planning obligations revealed? Review the outcome of the local land charges search ( LLC1). Planning obligations are registrable as local land charges. From 12 April...
Is listed building consent required? Section 7 of the Planning ( Listed Buildings and Conservation Areas) Act 1990 ( P( LBCA) A 1990) in England, and section 88 of the Historic Environment ( Wales) Act 2023 ( HE( W) A 2023) in Wales from 4 November 2024, provide that no person may carry out, or cause to be carried out, any works comprising: the demolition of a listed building; or its alteration or extension in any way that would affect its character as a building of special architectural or historic interest, unless those works are authorised by listed building consent. Whether proposed works affect the building’s character is a matter of individual judgement, and opinions may vary between the owner, interested parties and the local planning authority ( LPA). Alterations that do not require planning permission may still need listed building consent; for instance, internal changes that are not...
Section 57 of the Town and Country Planning Act 1990 ( TCPA 1990) requires planning consent for any material change in the use of buildings or land. Any limitations or conditions attached to a permission must likewise be adhered to. Liability for any existing breach will transfer to the purchaser. It is therefore essential to verify that the current use of the entire property is properly authorised and that all related conditions are being complied with, or to establish whether any unauthorised use or breach has become immune from enforcement. For further information, see Practice Note: Material change of use. Is the use authorised? Confirm the permitted use of the property, or, where relevant, each planning unit, and determine whether that use is authorised by: an explicit planning permission a certificate of lawful use, or permitted development rights If the permitted use does not...
This Checklist supports planning for a print marketing campaign. It concentrates on marketing-specific needs, excluding wider transactional matters (eg contract formation, distance selling). Scope includes targeting and placement, agency agreements, data protection, advertising compliance, and prize or price promotions. It also addresses conformity with the UK’s legislative and self-regulatory framework, notably the unfair commercial practices rules in the Digital Markets, Competition and Consumers Act 2024 ( DMCCA 2024) and the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing ( CAP Code). Print ads remain pivotal to big-brand activity, across billboards, posters, brochures, leaflets, newspapers and magazines. In the UK, print advertising is overseen through a blend of industry self-regulation and statute. For a wider briefing on the UK advertising environment, see Practice Note: Advertising law and regulation. See also: Advertising copy...
How to use this Checklist Use this Checklist when mapping out a digital marketing campaign. The emphasis is on marketing‑specific requirements, and it does not deal with general matters connected to transactional activity (eg contract formation and distance selling). It spans media selection, territorial targeting, agency contracts and agreements, data protection and safeguarding, advertising compliance, user‑generated content and material, influencer engagement and partnerships, prize and price promotions, and behavioural advertising. It also looks at adherence to the legislative and self‑regulatory regime in the UK, including the unfair commercial practices provisions in the Digital Markets, Competition and Consumers Act 2024 ( DMCCA 2024) and the UK Code of Non‑broadcast Advertising and Direct & Promotional Marketing ( CAP Code). Digital marketing can reach consumers at home, at work and, via their mobiles, tablets and video game consoles, almost everywhere else. Alongside unrivalled potential audience numbers, it gives brands the...
This Checklist This Checklist explains the actions property solicitors must take to perfect security in a real estate finance transaction. Real estate finance lenders will typically seek a comprehensive security package over all assets connected with the real estate. A real estate solicitor within a multi-disciplinary team will commonly arrange or contribute to the following securities and documentation: security over the land, rental income, insurance proceeds, development and construction, and contractual rights reviewing the management agreement and negotiating a duty of care agreement (although in a multi-disciplinary team, this is sometimes handled by the banking and finance lawyer) dealing with completion undertakings and post-completion registration of the legal charge at Companies House and HM Land Registry, as well as giving third party notices regarding rent payment, notice of charge and, where necessary, assignment of contractual rights or...
This Checklist sets out, in chronological order, the actions required to implement a pension sharing order from the standpoint of trustees of an occupational pension scheme. It does not cover pension attachment orders, which are uncommon; see Practice Note: Pension attachment orders. In particular, the Checklist outlines the process where the application for a pension sharing order is made on Form A, rather than via Form D50F for financial relief following an overseas divorce (a rarer route), though the sequence is broadly comparable in that case. For guidance on implementation challenges that trustees may encounter in this context, refer to Practice Note: Pensions on divorce—issues for pension trustees. Action step Comment Source Trustees are sent a copy of Form A ( Notice of intention to proceed with a financial application to which the standard procedure applies) that includes an application for a pension sharing order....
This flowchart explains the actions required from the issue of a pension sharing order, following the court’s final order/decree of divorce, dissolution or nullity, through to the execution of that pension sharing order in due course......
This flowchart outlines the actions required, from filing an application through to ultimately securing a pension sharing order, where the court then issues a final order or decree of divorce, dissolution, or nullity......
Planning of merger Secure an 'in principle' commitment from the trustees and employers of both the transferring and receiving schemes to proceed with the merger. Examine the governing provisions for each scheme to verify that the transfer of assets, liabilities and members can take place; amend those provisions where necessary and practical. Confirm whether the schemes' benefit structures align and are compatible. Assess if the contracted-out status of either scheme creates any issues. Review the funding positions of both schemes and obtain actuarial advice; determine whether an employer top-up contribution is required. ......
This checklist sets out the requirements for the content of schemes’ annual reports and accounts under the Occupational and Personal Pension Schemes ( Disclosure of Information) Regulations 2013, SI 2013/2734. For fuller guidance on the duty on occupational pension schemes to produce annual reports and accounts, see Practice Note: Pension scheme annual reports and accounts. Requirement to prepare and disclose a pension scheme annual report Trustees of an occupational pension scheme meeting the conditions in the Occupational and Personal Pension Schemes ( Disclosure of Information) Regulations 2013, SI 2013/2734, Sch 1, Para 1 must produce an annual report no later than seven months following the close of each scheme year. For further details, see: Disclosure requirements for occupational and personal pension schemes—the 2013 disclosure regulations— Scope of the 2013 Disclosure Regulations. The annual report must be provided to any relevant person (that is, a member,...
Within this Checklist, the expression ‘transferring employees’ denotes employees of an undertaking or service provider whose employment is intended to transfer under the operation of the Transfer of Undertakings ( Protection of Employment) Regulations 2006, SI 2006/246 ( TUPE). When does TUPE apply? The Transfer of Undertakings ( Protection of Employment) Regulations 2006, SI 2006/246 ( TUPE), in force since 6 April 2006, apply where there is a ‘relevant transfer’. This includes: business transfers—the transfer of an undertaking, a business, or part of an undertaking or business, situated in the United Kingdom immediately before the transfer, to another person, where an economic entity is transferred and it retains its identity a service provision change—involving a change in the provider of a service, ie a client ‘outsourcing’ work to a contractor (first generation outsourcing), bringing that work back in-house (‘insourcing’) or re-assigning that work to a...
Statutory minimum increase rates The summary below sets out the current statutory minimum uplift that occupational pension schemes must apply each year to each tranche of pension. Period of pensionable service to which the pension relates (or, for money purchase benefits, the period in which contributions were paid): Before 6 April 1997 — no statutory minimum increase. However, to refund surplus assets to a sponsoring employer under the Social Security Pensions Act 1975, s 58A, it was necessary (until 5 April 2006) to revalue all pensions in payment (excluding GMPs and money purchase benefits) annually in line with RPI, capped at 5%. Despite the absence of a statutory minimum, most defined benefit schemes provide some pre-1997 indexation under scheme rules or as a discretionary benefit. As at March 2023, research indicates that only 17% of members of private sector defined benefit...
THIS CHECKLIST APPLIES TO TRUSTEES OF DEFINED CONTRIBUTION ( DC) OCCUPATIONAL PENSION SCHEMES This Checklist has now been archived. It sets out the actions DC trustees were required to undertake both before and after 6 April 2015, concerning the pension flexibilities/pension freedoms that came into effect on 6 April 2015. For further detail on the scope and nature of those reforms, refer to Practice Note: Pension freedoms—an introduction [ Archived]. Within this Checklist, ' DC trustees' refers to trustees (or managers) of pension arrangements providing flexible benefits, ie: money purchase arrangements cash balance arrangements other arrangements which typically require an individual to purchase an annuity Step 1—preliminary steps familiarise yourself with the pension flexibilities in detail......
THIS CHECKLIST APPLIES TO TRUSTEES OF PRIVATE SECTOR DEFINED BENEFIT OCCUPATIONAL PENSION SCHEMES This Checklist has been archived. It summarises the actions DB trustees needed to take in the run-up to 6 April 2015, and afterwards, to accommodate the pension flexibilities (also called pension freedoms) introduced on 6 April 2015. For more about the nature of those reforms, see Practice Note: Pension freedoms—an introduction [ Archived]. In this Checklist, ‘ DB trustees’ denotes the trustees (or managers) of arrangements other than those providing flexible benefits, i.e. excluding: money purchase arrangements cash balance arrangements other arrangements that typically require an individual to buy an annuity Note that the additional voluntary contribution ( AVC) facilities of defined benefit schemes do, in effect, amount to arrangements offering flexibilities. The issues set out in Pension flexibilities: steps for DC trustees to...
THIS CHECKLIST APPLIES TO OCCUPATIONAL AND PERSONAL PENSION SCHEMES Is there a requirement to consult employees? Confirm if the scheme operates as a trust-based occupational pension arrangement. Determine whether there are 50 or more employees. Establish if the employer is an excluded employer. Ascertain whether the proposal involves a change that triggers consultation. Consider if the change is to comply with statute (eg age discrimination legislation). Evaluate whether the alteration has a lasting impact on members' benefits. If unsure whether consultation is required, consider checking with the Pensions Regulator. Identify whether there are any affected members. If swift action is necessary (eg to avoid the risk of insolvency), contact the Pensions Regulator to request a waiver of the consultation requirement......
The original Payment Services Directive, 2007/64/ EC ( PSD1), took effect on 25 December 2007, with all Member States obliged to transpose it by 1 November 2009. In the UK, it was given effect via the Payment Services Regulations 2009, SI 2009/209 (the PSRs). Its purpose was to regulate payment service providers ( PSPs) and bring greater harmonisation to the EU payments market. Yet developments in payment technology outpaced PSD1, leading the European Commission ( Commission) in July 2013 to table a proposal for a successor measure, the second Payment Services Directive ( PSD2). PSD2, Directive 2015/2366, formally came into force on 13 January 2016. Member States were required to implement most of its provisions by 13 January 2018. PSD2 both absorbed and repealed PSD1......
ARCHIVED: This Practice Note is archived and is no longer maintained. The Payment Accounts Directive ( Directive 2014/92/ EU) ( PAD) is designed to improve clarity and comparability for consumers in relation to payment accounts across the EU. Specifically, the PAD: simplifies comparison of charges levied by banks and other providers throughout the EU helps customers to switch payment accounts with ease, and gives every EU consumer the right to open a payment account enabling them to carry out essential functions such as receiving their salary and paying bills The PAD stems from the European Commission’s consultation on retail bank accounts, launched in March 2012, which evaluated the need for action in the areas of fee clarity and comparability, account switching, and access to basic payment accounts. This was preceded by a 2007 inquiry into the retail banking sector that...
Checklist This Checklist outlines the factors to consider when arranging payments to summoned witnesses under CPR 34.7 and to deponents under CPR 34.8, often described as ‘conduct money’. It explains when payments must not be made, how and when they should be processed, and the sums that are payable... Situations in which no payment should be provided The timing and method for making payments The amounts that are due A witness served with a witness summons ( CPR 34.7) or an order for a deposition ( CPR 34.8) must be offered, or reimbursed for, specified expenses and for loss of time, collectively referred to as ‘conduct money’. Professional conduct obligations, in particular rules 2.2 and 2.3 of the SRA Code of Conduct for Solicitors, registered European lawyers ( RELs) and registered foreign lawyers ( RFLs), are pertinent to the payment of...
This Checklist sets out the principal terms ordinarily found within an assignment of patents or patent applications. It functions as a checklist of points to consider and address when preparing, reviewing, or negotiating an assignment of patents or patent applications. It may likewise be tailored as heads of terms to capture the basic points agreed while a formal assignment is still being negotiated. How to use this Checklist This Checklist aims to flag issues that regularly surface during the negotiation and the drafting of the following types of agreements: Patent assignment—pro-assignor Patent assignment—pro-assignee For more detailed information on matters raised by this Checklist, see Practice Note: Assigning intellectual property rights. This Checklist can also, where appropriate, form the basis of a simple non-binding heads of terms. For guidance on how to do this, see Precedent: Heads of...
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 ]...