On account of Brexit, the UK is no longer subject to EU single market rules or the EU legislative framework. However, under the EU–UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, Northern Ireland continues to follow EU rules. However, this was somewhat narrowed by the entry into force of the EU-UK Windsor Framework on 1 January 2025, which allows for the UK-wide licensing of novel medicines, pursuant to domestic legislation, by the Medicines and Healthcare products Regulatory Agency (MHRA). Pre-existing domestic legislation that implemented EU law continues to have effect in the UK.

UK regulation of medicinal products derives from EU legislation, principally Directive 2001/83/EC (EU Directive 2001/83) and Regulation (EC) 726/2004 (EU Regulation). The key UK legislation is the Human Medicines Regulations 2012 (SI 2012/1916), as amended (HMRs).

Similarly, UK regulation of medical devices derives from three EU Directives (the Medical Device Directives):

• Council Directive 93/42/EEC on Medical Devices;
• Council Directive 90/385/EEC on Active Implantable Medical Devices; and
• Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD).

These directives are implemented in UK domestic law through the Medical Devices Regulations 2002/618, as amended (UK Medical Devices Regulations). The more recent EU Regulations on medical devices – Regulation (EU) 2017/745 on medical devices (EU MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR) – do not apply to Great Britain, but do to Northern Ireland. The UK government intends to bring the UK Medical Devices Regulations up to date through a series of Statutory Instruments. The first of these regarding post-market surveillance requirements will come into force on 16 June 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency sponsored by the Department of Health and Social Care (DHSC). The MHRA has the statutory responsibility to apply and enforce laws governing pharmaceuticals and medical devices in the UK.

Decisions of the MHRA can be challenged by way of judicial review in the Administrative Court, King’s Bench Division or through statutory review proceedings, although this is rarely used.

For a judicial review, an application must be made promptly, and in any event within three months of the decision to be challenged, and the applicants must be able to show a sufficient interest in the matter to which the application relates.

The court’s permission is required to proceed with a claim for judicial review.

The grounds for judicial review can be summarised as:

• illegality;
• irrationality;
• procedural unfairness; and
• legitimate expectation.

There are three categories, or legal classifications, of medicinal products, which determine the level of control over supply. In part, classification rests on how much healthcare professional (HCP) input is needed to diagnose and treat the conditions for which the medicine might be used. The three legal classifications are:

• prescription-only medicines (POMs) – these have to be prescribed by a doctor or other authorised HCP and have to be dispensed from a pharmacy or from another specifically licensed place;
• pharmacy (also known as P, over the counter or OTC) – these have an intermediate level of control and can be bought only from pharmacies and under a pharmacist’s supervision; and
• general sales list (GSL) – these may be bought from general retail stores or vending machines.

Medical devices are given a classification depending on the level of risk associated with their use. This relates to the regulatory pathway for the product rather than the conditions on supply. How a medical device is classified will depend on factors such as:

• the intended purpose of the device;
• how long it is intended to be in use; and
• if the device is invasive/surgically invasive, is implantable or active, or contains a substance which in its own right is considered to be a medicinal substance.

General medical devices and active implantable devices fall within the following categories:

• Class I – low risk;
• Class IIa – medium risk;
• Class IIb – medium risk; and
• Class III – high risk.

In vitro diagnostic (IVD) medical devices in Great Britain are currently categorised differently into four main groups – namely, those which are (there are different classifications under the EU IVDR that applies in Northern Ireland):

• considered as general IVD medical devices;
• within the classifications stated in Annex II List A of the IVDD (which is referred to in UK legislation);
• within the classifications stated in Annex II List B of the IVDD; and
• for “self-test” intended to be used by a person at home.

The current UK law governing clinical trials of medicinal products is the Medicines for Human Use (Clinical Trials) Regulations 2004/1031, which transposed the EU Clinical Trials Directive 2001/20/EC into UK law, and has been amended to reflect the UK’s departure from the EU. Clinical trials must be conducted in accordance with good clinical practice (GCP), the terms of the approved protocol, clinical trial authorisation and research ethics committee (REC) approval. The EU Clinical Trials Regulation 536/2014, which came into full effect on 31 January 2022, does not apply in Great Britain but, as a result of the Northern Ireland Protocol, certain parts apply in Northern Ireland.

Following a public consultation undertaken by the MHRA in early 2022, new regulations (the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024) were laid before the UK parliament in December 2024 to amend the current UK framework governing clinical trials. The aim is to streamline clinical trial approvals, enable innovation, enhance clinical trial transparency, enable greater risk proportionality, and promote patient and public involvement. The aim is for these changes to come into force by early 2026.

Clinical investigations for medical devices are regulated by the UK Medical Devices Regulations. Requirements relating to clinical investigations under the EU MDR and the EU IVDR apply in Northern Ireland. The amended regulations for medical devices, when introduced by the UK government, will also amend the requirements for clinical investigations.

Before a clinical trial for a medicinal product can commence, a REC must give a favourable opinion, and authorisation must be obtained from the MHRA. A sponsor of a clinical trial must be established in the UK or in a country on an approved country list, which includes EU/EEA countries. Otherwise, the sponsor must have a legal representative.

As of 1 January 2022, applications for all new clinical trials for investigational medicinal products must be prepared, submitted and reviewed via the combined review service – a single application route with co-ordinated review by the MHRA and the REC, leading to a single UK decision on the application. Applications must be submitted via the Integrated Research Application System (IRAS). While this single application route is currently available in the UK through various schemes and pilots, it will be enshrined into law when the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 come into force.

After receipt of a valid application, an assessment will be conducted within 30 days. Following assessment, and ordinarily within 60 days of the submission, the MHRA and the REC will either:

• accept the request;
• accept the request subject to conditions; or
• not accept the request.

The MHRA will focus on the safety and scientific value of the trial, while the REC will focus on the research proposals and review certain documents relating to the trial, including the trial protocol, the informed consent form, the suitability of the personnel, investigator and facilities, and the investigator’s brochure.

The MHRA must be notified by the sponsor at least 60 days in advance of the commencement of a clinical investigation involving medical devices. Applications should be submitted via the IRAS. The MHRA will consider the documentation and assess the safety and performance of the device, as well as the design of the investigation. A letter will be sent to the sponsor within 60 days with a decision (providing either an “objection” or “no objection”). In addition, an opinion of the REC is required.

Any favourable opinion by a REC is conditional upon the clinical trial being registered on a publicly accessible database.

Since 1 January 2022, the Health Research Authority (HRA) automatically registers clinical trials submitted through IRAS with the International Standard Randomised Controlled Trial Number (ISRCTN) registry.

Information about trials (for both medicinal and devices) being conducted in the UK is made publicly available on the HRA research summaries website and on the UK “Be Part of Research” website.

In addition, the advertising code for the pharmaceutical industry published by the Association of the British Pharmaceutical Industry (ABPI) requires companies to disclose details of clinical trials in accordance with international requirements. This is not set out in the equivalent Code applicable to medical devices.

There are no restrictions on using online tools to support clinical trials or clinical investigations. However, all advertising and all materials provided or directed to subjects will be reviewed by the REC.

Data resulting from clinical trials is likely to be considered as special category (sensitive) personal health data for the purposes of the data protection legislation, even if it is in coded/pseudonymised form, and will be afforded greater protection than non-special category personal data. The Data Protection Act 2018 and the UK GDPR provide that pseudonymisation is a security measure that can be used to protect personal data, but it does not mean that the data is beyond the scope of the UK GDPR.

The resulting data can be transferred to a third party or affiliate, provided that any UK GDPR provisions governing such a transfer are complied with.

The Data (Use and Access) Bill was introduced in October 2024, and it proposes to amend the UK GDPR and Data Protection Act 2018 in various ways. In particular, it will allow for patients to provide “broad consent” to use of their personal data for scientific research, allowing use of their personal data for broad research purposes. If the Bill receives royal assent, its provisions may come into force by early 2026.

If a database contains personal or special category (sensitive) personal health data, the UK GDPR would need to be complied with. The key requirements are as follows:

• the data is processed lawfully;
• the data stored is relevant, up to date and limited to what is required;
• sufficient security measures are put in place;
• the data is not stored for longer than is necessary; and
• the relevant individuals have been informed of the use and storage of their data.

The party managing the database would also need to comply with the UK GDPR more widely.

The HMRs define a medicinal product as:

• any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
• any substance or combination of substances that may be used by or administered to human beings with a view to:
1. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action; or
2. making a medical diagnosis.

The UK Medical Devices Regulations define a medical device as any instrument, apparatus, appliance, software, material or other article, used alone or combined, for humans to:

• diagnose, prevent, monitor, treat or alleviate disease;
• diagnose, monitor, treat, alleviate or compensate for an injury or handicap;
• investigate, replace or modify the anatomy or a physiological process; or
• control conception.

To distinguish between medical devices and medicinal products, it is important to consider:

• the intended purpose of the product, taking into account the way the product is presented; and
• the method by which the principal intended action is achieved.

Where the assessment is not straightforward, or where disagreement arises, the MHRA’s Medicines Borderline Section is able to issue determinations. Where a product falls into more than one category, a product will be classified as a medicinal product.

A medicinal product may only be placed on the UK market if it has been granted a marketing authorisation (MA). Biological medicinal products must meet the same quality, safety and efficacy criteria to obtain an MA as those for non-biological medicinal products. However, since biological medicinal products are especially sensitive to change in starting materials or manufacturing conditions, they are subject to specific requirements, as set out in Annex I to EU Directive 2001/83, as amended by Schedule 8B of the HMRs.

MAs for medicinal products in the UK are valid for an initial period of five years. However, an MA ceases to be valid if the product is not placed on the market within three years of the date of authorisation (known as the “sunset” clause).

The renewal application should be submitted to the MHRA six months before expiry. The authorisation may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the MA will be valid for an unlimited period, unless there are justified grounds relating to pharmacovigilance to proceed with one additional five-year renewal.

The MHRA may revoke, vary or suspend a UK MA in certain situations, including if the MHRA believes that the product is harmful or that the positive therapeutic effects of the product do not outweigh its risks to the health of patients or the public, or that the product’s composition is not as described in the application for the MA or the material supplied with it.

With regard to medical devices, a UK Conformity Assessed (UKCA) mark is valid indefinitely, and the underlying conformity assessment does not require renewal unless the specifications of the device change.

The MHRA has the power to issue various notices to manufacturers (eg, prohibition notices) to ban the supply of any goods that are considered unsafe or that do not comply with the UK Medical Devices Regulations.

Medicinal Products

An application for a UK national MA must be made to the MHRA and must include the particulars and research data or justifications for exceptions that are described in the HMRs, which is based on the EU Directive 2001/83. Following Brexit, UK MAs were split into various types, depending on the parts of the UK to which they apply. In particular, applications intended to cover the marketing of a product in Northern Ireland had to comply with the requirements of EU Directive 2001/83 and EU Regulation 726/2004. This led to different types of authorisation in different parts of the UK. However, under the Windsor Framework, from January 2025, applications for a UK-wide product licence can be made to the MHRA under UK law.

Medical Devices

As of 1 January 2021, there is a new route to place a device on the Great Britain market, with an accompanying mark based on the requirements derived from the Medical Device Directives as implemented into UK law: the UKCA. EU CE marking (the acronym for the French Conformité Européenne or “European conformity”) will continue to be recognised in Great Britain, and certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market, up to June 2030, with different dates depending on the device.

EU rules will continue to apply in Northern Ireland, and EU CE marking is required. In addition, if the manufacturer chooses to use a UK Notified Body for mandatory third-party conformity assessment for purposes of the Northern Ireland market, the UKNI mark must be applied in addition to the CE mark.

As previously noted, medical devices are given a classification depending on the level of risk associated with their use. Each risk classification also has a separate conformity assessment procedure. If the relevant requirements are met, the Approved Body will issue a UKCA certificate. Only UK-Approved Bodies may conduct conformity assessments in relation to a UKCA mark. They are not able to issue CE certificates other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland.

Low-risk Class I medical devices do not need to go through a conformity assessment procedure. For all devices, once the relevant assessment has been completed successfully, the manufacturer may place a UKCA mark on their medical device and put it on the market in Great Britain.

To be placed on the Great Britain or Northern Ireland market, all devices must now be registered with the MHRA, which will only accept the registration of devices from entities based in the UK. Therefore, manufacturers based outside the UK are required to appoint a UK Responsible Person that is established in the UK.

The HMRs state that a person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product, or a medicinal product other than in accordance with the terms of an MA. However, there are exceptions whereby a product can be placed on the market without an MA. The main exception is often called “named-patient supply” and applies if the medicinal product is:

• supplied in response to an unsolicited order;
• manufactured and assembled in accordance with the specification of a person who is authorised to prescribe; and
• for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient.

Certain conditions set out in the HMRs must also be met.

When named-patient supply of medicinal products is offered to a co-ordinated patient group, this is referred to as a “compassionate-use scheme”. However, the legislative provisions of named-patient supply continue to apply.

The Early Access to Medicines Scheme is a voluntary scheme that allows patients to access innovative unlicensed medicines earlier than the current MA procedures permit, but applies only to medicines that target life-threatening or seriously debilitating conditions for which there are no existing satisfactory treatments.

In relation to medical devices, it is also a requirement that all devices placed on the market must have a UKCA or EU CE mark. However, devices that are custom-made for individual patients do not need a UKCA mark. Custom-made medical devices are defined as devices manufactured specifically in accordance with a duly qualified medical practitioner’s written prescription that gives specific design characteristics, under their responsibility, and is intended for the sole use of a particular patient. The manufacturer of a custom-made medical device must meet the requirements of the UK Medical Devices Regulations that relate to custom-made devices.

The MHRA may also approve exceptional use of a non-compliant device on humanitarian grounds. These devices do not need a UKCA mark. A manufacturer can apply to the MHRA to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. The same provision may be made for custom-made devices that have not complied with the standard conformity assessment procedure.

MA holders must operate a pharmacovigilance system to monitor the safety of their product’s life cycle, and to detect any change to their risk-benefit balance for the medicinal product. They must:

• have an appropriately qualified person (QP) responsible for pharmacovigilance located in the EEA (however, where this person does not reside and operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK);
• maintain a pharmacovigilance master file;
• operate, monitor and update a risk management system for the product;
• record and report all suspected adverse reactions occurring in relation to their products; and
• submit periodic risk-benefit evaluation reports for their products.

The MHRA may grant an MA subject to one or more conditions, including post-marketing obligations such as the requirement to conduct post-authorisation safety and efficacy studies. The MA holder must incorporate any such condition into the risk management system for the product.

Once a medical device has been placed on the UK market, the MHRA requires the manufacturer to monitor and report to it any serious adverse incidents associated with the product. The manufacturer must also take appropriate safety action when required.

Requests for information about MAs and pending MAs for medicinal products may be submitted to the MHRA under the Freedom of Information Act 2000 (FOIA).

The MHRA releases very little information in relation to pending applications.

Following the grant or refusal of an MA, the MHRA generally releases detailed information about the application and authorisation, both proactively via disclosures on its website and also in response to third-party information requests. The FOIA provides mechanisms whereby personal data, confidential information and commercially sensitive information may be withheld or redacted from documents requested by third parties, and the MHRA typically allows MA holders to comment on any proposed redactions prior to their release.

For medical devices, Approved Bodies are private entities. Therefore, access to information provisions that apply to public bodies do not apply. As such, both before and after UKCA marking, the information pertaining to the device remains the property of the manufacturer. Once registered with the MHRA, a manufacturer’s details will be added to the Public Access Database for Medical Device Registration. Other information held by the MHRA could be requested under the FOIA, but will only be provided where no exceptions under the FOIA apply.

The UK operates a national accelerated procedure for medicinal products, which took effect in January 2021. Under this route, the MHRA evaluates all high quality UK MA applications and reaches an opinion within 150 days of application validation, with the aim of accelerating market access.

The assessment period is split into two phases. Phase I involves an 80-day period, during which the MHRA will consult with the Commission on Human Medicines (CHM) and/or therapy area experts. Any concerns arising after this initial assessment will be raised in a request for further information letter to the applicant. The applicant has 60 days (a clock-stop period) to address and respond to the concerns (an extension is available in exceptional circumstances only). Phase II begins following MHRA’s receipt of the applicant’s responses, following which the MHRA will provide an opinion on approvability. If the MHRA refuses an application upon the advice of CHM, an appeal can be made.

The UK is also part of an access consortium work-sharing procedure. This allows for simultaneous submission to the UK, Australia, Canada, Singapore and/or Switzerland, for an internationally co-ordinated review. The standard procedure takes 180 days (excluding stop-clocks).

In addition, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines and medicine-device combinations to the UK market more quickly. It was first launched in January 2021, and was re-launched in January 2025. Successful applicants are awarded an Innovation Passport, which enables developers to work collaboratively with the national health services (NHS), MHRA, and UK Health Technology Assessment (HTA) bodies to bring products to the UK market in a more streamlined and efficient way.

In relation to medical devices, the UK has launched the Innovative Devices Access Pathway (IDAP) pilot that is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. Eight technologies were selected that will receive tailored regulatory and access support.

On 1 January 2024, an International Recognition Procedure (IRP) for medicinal products came into force in the UK, which enables the MHRA to consider the expertise of regulatory partners in other countries and utilise pre-existing approvals to speed up authorisation in the UK, including (but not limited to) approvals in the EU. Such partners are referred to as reference regulators (or RR). The product must be classified as a medicinal product in accordance with the HMRs and the IRP application must relate to the same product for which authorisation has already been granted by an RR. The IRP can be used for multiple types of MA applications, including chemical and biological new active substances, known active substances, generics, hybrids, biosimilars and new fixed combination products.

There are two recognition routes under the IRP: Recognition A (60 day timetable) and Recognition B (110 day timetable), to which different eligibility criteria apply. The main criteria for Recognition A are that the RR approval was granted within the previous two years and manufacturing processes are the same, with evidence of GMP compliance. For Recognition B, possible applicable criteria are more numerous, but the main criterion is that the RR approval has been granted in the previous ten years, subject to exceptional circumstances. While MHRA will conduct a targeted assessment of IRP applications based on the assessment by the RR, it may reject applications on the basis that evidence supplied by the applicant is not sufficiently robust.

For medical devices, as discussed above, EU CE marks are recognised in Great Britain until 30 June 2030 at the latest depending upon the type of device.

The UK Medical Devices Regulations are currently under review and part of the consultation process included considering alternative routes to market. In 2024, the MHRA published a statement of policy intent for international recognition of medical devices, which describes MHRA’s intentions for recognition by the UK of international regulators’ approvals for medical devices. It is anticipated that comparable regulator countries will be (at least initially) the EU, as well as Australia, Canada and the USA, and various criteria will need to be fulfilled. The proposed framework would provide a certificate of international recognition that will grant devices access to the Great Britain market. It is anticipated that certain devices, for example custom-made and certain software devices, will be excluded from eligibility.

A manufacturer licence issued by the MHRA is required in order to manufacture, assemble or import licensed, unlicensed or investigational medicinal products. The process involves the submission of an application and the inspection of the designated manufacturing site by the MHRA to verify compliance with good manufacturing practice (GMP). A manufacturer licence remains in force until it is revoked or surrendered.

Manufacturers of medical devices are not required to obtain a specific authorisation for the manufacture of their products, but are required to register the medical devices with the MHRA in order to place them on the market in Great Britain and (for certain medical devices, including IVD medical devices) Northern Ireland. As previously noted, the MHRA will only register medical devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK.

A wholesale distribution authorisation (WDA) issued by the MHRA is required in order to:

• sell, supply, offer for sale, procure, hold or export POM, P/OTC, traditional herbal and GSL medicines on a wholesale basis in the UK;
• import QP-certified medicinal products into Great Britain from EEA countries; and
• export medicinal products to EEA and non-EEA countries.

WDA holders located in Northern Ireland can still bring medicinal products into Northern Ireland from Great Britain, provided certain additional conditions are met.

The facility involved in wholesale distribution is subject to inspection by the MHRA before a licence is granted. A WDA remains in force until it is revoked or surrendered.

Distributors of medical devices are not required to obtain an authorisation to engage in wholesale trade.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The importing and exporting of medicinal products are governed by the HMRs (or EU Directive 2001/83 in relation to Northern Ireland). A Certificate of Pharmaceutical Product may be required. The importing of medical devices is governed by the UK Medical Devices Regulations (or the relevant EU Directive in relation to Northern Ireland). The UK government plans to introduce new regulations for medical devices over the course of 2025 and 2026. These regulations are expected clarify the requirements for economic operators, including importers. There are no specific rules regarding the exporting of medical devices except that a Certificate of Free Sale may be needed depending on the importing country.

HM Revenue and Customs is responsible for border control. The MHRA Enforcement Group is responsible for applying and enforcing the HMRs and the UK Medical Devices Regulations.

Importers of pharmaceuticals and medical devices require an Economic Operator Registration and Identification number, which is entered onto all UK customs declarations. Importers must be a UK-resident business for certain UK customs issues, including the declarations.

The designation of a particular entity as the importer of record for customs purposes will not be conclusive in determining who should hold any required import authorisations from a regulatory perspective.

Importing medicinal products into the UK from countries outside the EEA for use in the UK or to supply to an EEA country requires a manufacturer’s import authorisation granted by the MHRA. Importing QP-certified medicines into Great Britain from the EEA may be performed under a WDA that authorises import.

No authorisation is required to import medical devices, but importers should notify the UK Responsible Person or the Northern Ireland-based Authorised Representative (as described in 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceutical and Medical Devices), as they are required to provide the MHRA with a list of device importers.

Details of specific tariff duties and measures that apply to particular goods in the UK are contained in the Integrated Tariff of the UK. An importer or exporter is responsible for the correct tariff classification of goods. His Majesty’s Revenue and Customs (HMRC) has developed an online trade tariff tool to assist in product classification.

Under the EU–UK Trade and Co-operation Agreement, and the UK’s free trade deal with Norway, Iceland and Liechtenstein, there are no tariffs or quotas on trade in medicinal products and medical devices between the UK and the EU and EEA countries, and mutual recognition of GMP inspections and certificates. The UK has also entered into an economic partnership agreement with Japan, which provides for mutual recognition of conformity assessments for GMP. The UK has entered into free trade agreements and mutual recognition agreements (MRAs) with Australia and New Zealand which provide for no tariffs or quotas on trade in most medicinal products and medical devices as well as mutual recognition of conformity assessment of medical devices and GMP. The UK-USA MRA provides for mutual recognition of conformity assessments for GMP of pharmaceuticals. The UK-Switzerland Trade Agreement provides for mutual recognition of GMP inspections and certifications. The UK-Canada Trade Continuity Agreement includes a protocol relating to mutual recognition of conformity assessments for GMP of pharmaceuticals. The UK-Israel Trade and Partnership Agreement provides for mutual recognition of GMP inspections and certifications. The UK-Singapore Free Trade Agreement provides preferential tariffs and a reduction of non-tariff barriers for medicinal products and medical devices. The UK remains a member of the World Trade Organization.

Statutory controls on pharmaceutical pricing are set out in the National Health Service Act 2006 and subordinate legislation. There are currently two schemes for controlling prices of branded medicines purchased by the national health services in the UK: (i) a Voluntary Scheme; and (ii) the Statutory Scheme.

The Voluntary Scheme for Branded Medicines Pricing and Access (VPAG or the “Scheme”) is an agreement, which is non-binding under the laws of contract, negotiated between DHSC, NHS England and the ABPI. It controls the prices of branded health medicines by:

• limiting the profits made by scheme members from their NHS business;
• controlling the maximum prices which may be charged for medicines within the Scheme;
• establishing a budget cap on the total expenditure by the NHS on branded health service medicines, with member companies making scheme payments to the DHSC as quarterly rebates (calculated as a percentage of eligible net sales) to cover excess expenditure.

New branded health services medicines that contain a new active substance and are supplied by VPAG member companies are subject to free pricing at launch, as are line extensions of such medicines launched within 36 months of licensing of the initial indication in the UK. The prices of such products must be notified to the DHSC prior to launch. The price for all other branded health service medicines supplied by VPAG member companies must be agreed with the DHSC.

If a company is not a member of the VPAG, it is regulated by the parallel Statutory Scheme. The Statutory Scheme is applicable only to branded health service POMs. Since 1 April 2018, it has involved a payment scheme calculated as a percentage of net sales, and from 1 January 2025, the Scheme has differentiated between older and newer medicines in a manner similar to VPAG. The maximum price that may be charged for a branded health service medicine within the Statutory Scheme is that directed by the Secretary of State. The DHSC has stated that it aims for broad commercial parity between the schemes and has in recent years made various amendments to the Statutory Scheme to bring it in line with changes in the Voluntary Scheme, including harmonising certain exemptions from the requirement to make Statutory Scheme payments, with those applicable in the Voluntary Scheme.

Prices may also be limited as a result of competition, including through tenders. In primary care, the price of some medicinal products may be indirectly controlled by the reimbursement price, as set out in the Drug Tariff (a monthly publication specifying the amounts to be paid to contractors for providing relevant goods and services). These prices are calculated based on sales information provided by pharmacies, manufacturers and wholesalers. Where the Drug Tariff does not list a reimbursement price for a medicine, or where a product is prescribed by brand name, it will be reimbursed at the manufacturer’s NHS list price.

Medical devices will only be routinely dispensed in primary care through the NHS if they are included in the Drug Tariff. The DHSC/NHS Business Services Authority (NHSBSA) agrees the reimbursement price of the medical device with the manufacturer at launch, and this is principally determined by comparing the device with similar products on the market and their respective prices. If there are no comparable devices or if the applicant submits evidence to support a different price, the reimbursement price is determined by negotiation between the parties.

There is no formal system of international reference pricing, although the cost of the presentation in other markets is specifically listed as a relevant criterion to which the DHSC should have regard when agreeing or directing a price under the VPAG or the Statutory Scheme.

All authorised medicines validly prescribed on an NHS prescription may in principle be reimbursed from public funds, unless expressly excluded.

In primary care, patients receive medicines prescribed by their GPs from community pharmacies. Patients in England must pay a fixed price for NHS prescriptions, unless exempt. Prescription charges have been abolished in Northern Ireland, Scotland and Wales.

Medicinal products used in NHS hospitals are funded by commissioners in accordance with the “national tariff”, a set of prices for defined procedures and items of care (currencies) established under the Health and Social Care Act 2012. Hospitals are paid for procedures performed or care provided (including the costs of associated medicines and devices), based on amounts fixed in the national tariff. Certain new and high-cost medicines and medical devices are reimbursed outside the tariff system, and enhanced payments may be made for some patients.

In England, most new medicines (and new indications for existing products) undergo health technology appraisal by the National Institute for Health and Care Excellence (NICE), which issues recommendations on NHS use based on its assessment of clinical effectiveness and cost effectiveness. NHS bodies in England are required by regulations to make funding available so that patients can access treatments recommended by NICE. NICE assesses some medical devices and diagnostic tests through parallel procedures.

The All Wales Medicines Strategy Group (AWMSG) issues guidance in Wales on new technologies immediately following launch. In Scotland, the Scottish Medicines Consortium (SMC) assesses all new medicines and new indications for existing medicines and issues guidance close to the product launch. In Northern Ireland, its Department of Health (NI DoH), considers NICE guidance and reviews it for legal, policy and financial consequences only, before deciding on implementation.

In theory, NHS prescribers may prescribe any medicine considered clinically appropriate for their patients but, in practice, NHS commissioners control which medicines may be prescribed through local or national formularies, largely determined by the cost-effectiveness of individual products. Treatments recommended by NICE should be included automatically in NHS formularies in England; products not recommended by NICE are generally not funded on a routine basis. An equivalent approach is taken to products recommended by the AWMSG, the SMC and the NI DoH.

Community pharmacists purchase products from manufacturers or wholesalers and are reimbursed by the NHSBSA at the rate specified in the Drug Tariff, or, where no reimbursement price is set in the Drug Tariff, at the manufacturer’s list price. When the price paid by the pharmacist is less than that reimbursed by the NHSBSA, the pharmacist makes a margin of profit. The extent of this margin is monitored by the NHSBSA, and claw-backs are imposed to ensure that pharmacy profits do not exceed defined limits.

There is no generic substitution by community pharmacists in the UK, and the Medicines Act 1968 requires the particular product prescribed to be dispensed. However, in general, doctors are encouraged to prescribe products using their international non-proprietary name (INN). Where a product is prescribed by its INN, the pharmacist may dispense any product that meets the specifications/INN described, and is likely to select the lowest-cost product. Generic substitution is standard practice in the hospital context.