Open call for evidence

Private (non-NHS) prescribing: call for evidence document

Published 12 August 2025

Foreword

The UK can be proud of its reputation as a country where prescription medicines are held to the highest standards of regulation, prescribing and use. 

Over time we have expanded the legal routes by which people can access the medicines they need to live independent, healthy lives. These routes have developed to improve access to, and the timeliness of, treatment while also maintaining safety and reflecting changing societal preferences and technological developments. They provide people with a range of different options for accessing medicines that better fit with their lifestyles and preferences. However, as accessibility increases, we need to ensure all the ways people access medicines legally continue to be safe and effective.   

With this in mind, the Department of Health and Social Care (‘the department’) has developed this UK-wide call for evidence to give the public, healthcare professionals and providers, and other interested parties the opportunity to share their views on how the current medicines prescribing and supply mechanisms are meeting their needs.

This call for evidence does not consider NHS prescribing, which is underpinned by a range of checks and balances to promote access and maintain safety, rather it focuses on:  

• prescriptions written by prescribers registered in the European Economic Area (EU countries, Iceland, Liechtenstein and Norway) and Switzerland, that are dispensed in the UK
• private prescriptions written by UK prescribers
• medicines accessed through patient group directions (PGDs) outside of the NHS

We know that these routes can offer convenience, flexibility and choice to people when accessing an increasing range of medicines. However, we want to ensure that improving convenience and choice does not inadvertently reduce safety or quality of care.   

This call for evidence seeks your views on the effectiveness of clinical governance, oversight and regulation of each of the 3 existing mechanisms listed above. We would like to use the call for evidence to explore what impact these routes of prescribing and supply have on:

• the safety of people accessing medicines
• the quality of care that people receive

Your views will help us in shaping how we continue to ensure that the medicines people need are available conveniently and promptly, while also maintaining the highest standards of safety across the UK.   

In preparing the call for evidence, the department has engaged closely with a range of stakeholders from across the NHS, private healthcare providers, academia, regulators and the public. The devolved governments in Wales, Scotland and Northern Ireland have inputted heavily in the development of this work. 

As the chief pharmaceutical officers of all 4 nations, we are pleased to be supporting this call for evidence. 

David Webb, Chief Pharmaceutical Officer for England

Andrew Evans, Chief Pharmaceutical Officer for Wales

Professor Alison Strath, Chief Pharmaceutical Officer for Scotland

Cathy Harrison, Chief Pharmaceutical Officer for Northern Ireland

Overview

The prescribing environment must support patients to safely access high-quality medicines in the UK through all legal routes.

This call for evidence considers how the current system operates in relation to patient access to medicines through private (non-NHS) routes. This includes:

• prescriptions written by prescribers registered in the European Economic Area (EEA) (EU member states, Iceland, Liechtenstein and Norway) and Switzerland whose prescriptions are dispensed in the UK
• private prescriptions written by UK prescribers
• medicines supplied through other legal mechanisms such as PGDs, outside of the NHS (‘private PGDs’)

We want to ensure that the current system remains fit for purpose and enables patients to:

• be treated by the most appropriate healthcare professional
• safely and quickly access high-quality medicines they need through all legal routes in the UK

Anyone can respond to this call for evidence. However, we are particularly interested in the views of health and social care professionals, regulators, academics, providers, employers and stakeholder organisations. Rather than a formal consultation, this is a request for ideas and evidence in relation to how the current systems are operating, and for suggestions as to how it might be improved.

The call for evidence is seeking views on private prescribing and the use of private PGDs, and includes questions on:

• oversight and regulation
• patient safety and access to medicines
• quality of care

This call for evidence is being undertaken by the Secretary of State for Health and Social Care. Any action taken following this call for evidence may have UK-wide implications, therefore devolved governments have been closely engaged in its development.

Introduction

The government has set out an ambitious programme of reform for the NHS. The health mission has set the clear goals of achieving:

• an NHS that is there when people need it
• fewer lives lost to the biggest killers, such as cancer and cardiovascular disease
• a fairer Britain where everyone lives well for longer

To deliver this vision, the 10 Year Health Plan will fundamentally reform the NHS through 3 shifts, from:

• sickness to prevention
• hospital to community
• analogue to digital

The findings of this call for evidence will form part of this programme of reform and ensure that private prescribing remains responsive to patients’ needs. It will also investigate whether appropriate safeguards and mechanisms are in place to make sure patients in the UK can safely access high-quality medicines through all legal routes.

Patient access to medicines

Currently, patients residing in the UK can legally access medicines through:

• NHS prescribers
• UK-registered private prescribers
• prescribers registered in the EEA

Patients may also access some medicines under PGDs. These routes are described in more detail below.

Information about the legislation relevant to medicines regulation is included in annex A, and relevant regulators and other public bodies in annex B.

NHS prescriptions

Patients may seek medical support from an authorised NHS prescriber. In general, an authorised NHS prescriber must be a healthcare professional that is regulated by a UK professional regulator and providing NHS services.

All NHS prescribers are expected to take national clinical guidance (for example, provided by the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA)), and to take local guidance and commissioning decisions fully into account when making prescribing decisions. However, while there are limitations on the range of medicines some non-medical prescribers may prescribe, in general prescribers can use clinical discretion to prescribe whatever medicines they believe are required for the patient. 

UK private prescriptions

Patients may opt to access treatment through a private provider based in the UK. This may be a clinic, hospital or online service. All UK prescribers operating in a private capacity must be a healthcare professional regulated by a UK professional regulator such as the:

• General Medical Council (GMC) for doctors
• General Pharmaceutical Council (GPhC) for pharmacists in Great Britain
• Pharmaceutical Society of Northern Ireland
• respective regulatory bodies for other non-medical prescribers

UK private prescribers are subject to the same professional standards and expectations as their NHS counterparts and are expected to abide by the policies their employing provider may have, as well as take account of national clinical guidance. The provider within which they operate may also need to be registered with an appropriate UK regulator. 

EEA prescriptions

Patients may decide to access prescriptions from an EEA-registered prescriber. This may be through an online service or a clinic or hospital based outside the UK. Their prescription should be dispensed by a UK-registered pharmacy, either in-person or through post so that the quality of the products received can be assured.

Since 1 January 2021, the UK has recognised and dispensed prescriptions issued in an EEA member state or Switzerland, if the prescriber is from a recognised profession that is legally entitled to issue a prescription of that kind in the country in which the prescription is issued. ​Regulation 214(6A) of the Human Medicines Regulations (HMRs) (see Annex A: relevant legislation) refers to a list of approved countries and professions for the purpose of the definition of ‘approved country health professional’.

EEA-registered prescribers may only prescribe controlled drugs in schedule 4 and 5 of the Misuse of Drugs Regulations 2001 (MDRs). They sit outside of UK regulations and do not have to comply with the practice standards of a UK regulatory body. EEA-registered prescribers may not be subject to the same standards and expectations as either NHS or UK-registered private prescribers and may be employed by a UK business or overseas online provider that is registered by the relevant regulatory body.

Prescriptions written by UK prescribers are not recognised or dispensed in EEA member states or Switzerland. Prescriptions written by UK medics, dentists and nurse prescribers may be lawfully dispensed in Ireland.

Prescriptions from prescribers who are not UK prescribers or approved country health professionals may not be dispensed in the UK.

In the questions below, we refer to both EEA-registered prescribers and overseas providers. This is because an EEA-registered prescriber may be employed by a business operating from any country outside the UK.

Patient group directions

PGDs provide a legal framework that allows the supply and administration of a specified medicine or medicines, by named, authorised, registered health professionals, to a pre-defined group of patients for treatment of a condition described in the PGD, without the need for prescription or an instruction from a prescriber. They are written instructions for the supply or administration of medicines to groups of patients who may or may not be individually identified before presentation for treatment.

They are not a form of prescribing but are routinely used in both the NHS and private practice as a legal mechanism enabling healthcare professionals to supply and administer medicines without them having to be a qualified prescriber.

Call for evidence areas of focus

We want to assess the extent to which the existing arrangements support and prioritise patient safety and access to medicines. To inform this, we are using this call for evidence to gather information on:

• the efficacy of existing mechanisms for the oversight and regulation of private prescribing by UK and EEA registered healthcare professions and supply and administration of medicines under private PGDs
• what impact the existing arrangements for private prescribing and supply of medicines have on patient safety and access to medicines
• how private prescribing by UK and EEA registered healthcare professions and the use of private PGDs affect the quality of care received by patients

Any further action taken will have a strong focus on how we can ensure patient safety is maintained across all legal medicines access routes in the UK. This call for evidence is also looking to build the evidence base around other associated themes:

• misuse of medicines
• counterfeit medicines
• inappropriate advertising

We want to make sure that all patients in the UK, regardless of legal route taken, can safely access the high-quality medicines they need, at the time and place they need them. 

About the survey

Given the breadth of topics contained in this call for evidence, the survey consists of 3 sections. You do not need to respond to every section or every question to submit a response. You will be able to save your progress and return later as you progress through the survey. The 3 sections of the survey are focused on:

• oversight and regulation
• patient safety and access to medicines
• quality of care

To support responses to each section, references to:

• ‘prescribers’ means a healthcare professional who has the legal authority to issue prescriptions for medicines
• ‘providers’ means businesses that employ prescribers to deliver prescribing services
• ‘private providers’ means providers based in either the UK or overseas who deliver a private service
• ‘patient group directions’ or ‘PGDs’ means written instructions to authorised healthcare professionals to supply or administer medicines to patients, usually in planned circumstances

How to respond

Please respond using the online survey.

You do not need to respond to every section or question. However, you do need to reach the end of the survey and select ‘submit’ to ensure your response is recorded.

When answering the questions, where possible please provide evidence and examples to support your answers.

Do not provide personal data when responding to questions or giving evidence or examples. Any personal data included will be removed prior to analysis of these responses and will therefore not be considered in our analysis.

This call for evidence is open for 12 weeks and will close at 11.59pm on 4 November 2025. If you respond after this date, your response will not be considered.

If you have any queries relating to this call for evidence, email prescribingpolicy@dhsc.gov.uk. Do not use this email address to submit your responses.

Call for evidence questions

About you

In what capacity are you responding to this survey?

• On behalf of an organisation
• As a healthcare professional sharing my personal views and experiences
• As a member of the public sharing my personal views and experiences

Questions for organisations

What is the name of your organisation? (Optional)

Questions for healthcare professionals

Do you work in a healthcare role that requires you to either prescribe medicines, or work with prescriptions and/or prescription-only medicines?

• Yes
• No

What profession do you belong to?

Are you registered in the UK or European Economic Area (EEA)?

• UK only
• EEA only
• Both the UK and EEA
• Other location, please specify
• None of the above

Considering the total number of non-NHS UK private prescriptions you receive and dispense, what proportion are for patients under the age of 18? (Optional)

• Less than 25%
• 25 to 49%
• 50 to 75%
• More than 75%
• Not applicable

Considering the total number of EEA prescriptions you receive and dispense, what proportion are for patients under the age of 18? (Optional)

• Less than 25%
• 25 to 49%
• 50 to 75%
• More than 75%
• Not applicable

Questions for both organisations and healthcare professionals

Which of these prescribing or dispensing services do you provide? Select all that apply.

• In person
• Online
• Telephone
• Other, please specify
• None of the above

Do you provide NHS or private services?

• NHS only
• Private only
• Both NHS and private
• Not applicable

Where do you work? Select all that apply.

If you offer international services or work internationally, please select ‘other’ and provide details.

• England
• Northern Ireland
• Scotland
• Wales
• Other, please specify
• Prefer not to say

Section 1: oversight and regulation

This section of the call for evidence is focused on the effectiveness of existing mechanisms to oversee and regulate private prescribing.

To what extent do you agree or disagree that existing mechanisms enable the effective oversight and regulation (including enforcement) of UK registered private prescribers? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree that existing mechanisms enable the effective oversight and regulation (including enforcement) of EEA registered prescribers (with medicines dispensed in the UK)? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree that existing mechanisms enable the effective oversight and regulation (including enforcement) of medicines supplied under private PGDs? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

What are the strengths of the current regulatory regime for medicines accessed through private providers? (Optional, maximum 500 words)

What are the limitations of the current regulatory regime for medicines accessed through private providers? (Optional, maximum 500 words)

How could the current regulatory regime for medicines accessed through private providers be strengthened? (Optional, maximum 500 words)

If you are aware of any data captured on medicines accessed through private providers, please provide details on the source of the data and how it is currently used. (Optional, maximum 500 words)

To what extent do you agree or disagree that this data is sufficient to appropriately monitor this activity? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know
• Not applicable

To what extent do you agree or disagree that medicines advertising in the UK is effectively regulated? (Optional)

Please consider both digital advertising (for example, websites and social media) and traditional advertising (for example, leaflets and print advertisements).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please share any additional evidence you would like to contribute regarding the effectiveness of existing mechanisms to oversee and regulate private prescribing. (Optional, maximum 750 words)

Section 2: patient safety and access to medicines

This section of the call for evidence seeks to understand the impact of private prescribing on patient safety and access to medicines.

What do you understand to be the main reasons for patients to access medicines from private providers? (Optional, maximum 500 words)

What do you understand to be the main reasons for patients to access medicines from healthcare professionals under private PGDs? (Optional, maximum 500 words)

To what extent do you agree or disagree that patients can safely access medicines from UK private providers? This includes access under private PGDs. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree that patients can safely access medicines from EEA providers? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

What are the risks of patients accessing medicines through private providers? This includes access through online platforms. (Optional, maximum 500 words)

What are the benefits of patients accessing medicines through private providers? This includes access through online platforms. (Optional, maximum 500 words)

How can the risks to patients from accessing medicines through private providers be mitigated? (Optional, maximum 500 words)

To what extent do you agree or disagree that sufficient safeguards are in place to prevent harm caused by medicines accessed through private providers? (Optional)

Please consider medicines accessed for their licensed indication (what they have been approved to treat), medicines accessed off-label (prescribed in a different way than that stated in its licence), controlled drugs (medicines that are closely regulated due to their potential to be abused or cause addiction) and medicines accessed that are not authorised for use in the UK.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree that appropriate safeguards are in place to protect patients against counterfeit (fake) medicines? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

How easy or difficult is it for dispensers (pharmacists) and other healthcare professionals to verify the authenticity of prescriptions from UK private prescribers? (Optional)

• Very easy
• Easy
• Neither easy nor difficult
• Difficult
• Very difficult
• Don’t know

How easy or difficult is it for dispensers (pharmacists) and other healthcare professionals to verify the authenticity of prescriptions from EEA prescribers? (Optional)

• Very easy
• Easy
• Neither easy nor difficult
• Difficult
• Very difficult
• Don’t know

What are the risks associated with prescriptions received electronically from private providers, compared to on paper? (Optional, maximum 500 words)

In your experience, what medicines are patients seeking to access through alternative legal routes (non-NHS), and why? (Optional, maximum 500 words)

In your experience, what is the impact on patient safety of medicines supplied under private PGDs? (Optional, maximum 500 words)

To what extent do you agree or disagree that private prescribing improves medicines access for people with protected characteristics within the meaning of the Equality Act 2010? (Optional)

The protected characteristics under the act are age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, and sexual orientation.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please describe any benefits or barriers related to inequalities you’ve observed that have been caused by private prescribing. (Optional, maximum 500 words)

To what extent do you agree or disagree that sufficient training and education on private prescribing is available to healthcare professionals? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please share any additional evidence you would like to contribute regarding the impact of private prescribing on patient safety and access to medicines. (Optional, maximum 750 words)

Questions about recent restrictions on the sale and supply of puberty-suppressing hormones

In 2025, following 3 temporary emergency orders, the government introduced indefinite legislation placing restrictions on the sale and supply of puberty-suppressing hormones for under 18s with gender incongruence and/or gender dysphoria through private prescriptions, and for any indication for under 18s through EEA prescriptions. This followed in the wake of findings from the Cass Review about the safety of these medicines and advice from the Commission on Human Medicines about the current prescribing environment.

We are seeking evidence to understand the impact of this change.

Do you wish to answer questions regarding placing restrictions on the sale and supply of puberty-suppressing hormones?

If you select ‘no’ you will go straight to section 3 which is focused on quality of care.

• Yes
• No

To what extent do you agree or disagree with the following statements?

Restrictions on the sale and supply of puberty-suppressing hormones to under 18s for gender incongruence and/or gender dysphoria have been effective in limiting prescribing by UK private prescribers. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Restrictions on the sale and supply of puberty-suppressing hormones to under 18s for gender incongruence and/or gender dysphoria have been effective in limiting prescribing by EEA registered prescribers. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The prescribing of cross-sex hormones to under 18s for gender incongruence and/or gender dysphoria is undertaken in accordance with NHS guidelines (offered with extreme caution and with a clear clinical rationale) by UK private prescribers. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The prescribing of cross-sex hormones to under 18s for gender incongruence and/or gender dysphoria is undertaken in accordance with NHS guidelines (offered with extreme caution and with a clear clinical rationale) by EEA registered prescribers. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Government and NHS guidance on the sale and supply of medicines for gender incongruence and/or gender dysphoria to under 18s (puberty-suppressing hormones and cross-sex hormones) is sufficiently clear for frontline practitioners. (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Is there anything else you would like to tell us about the recent restrictions on the sale and supply of puberty-suppressing hormones? (Optional, maximum 500 words)

Section 3: quality of care

This section of the call for evidence seeks to understand the impact of private prescribing on quality of care.

In your experience, what impact does patient access to UK private prescribers typically have on the quality of care received? (Optional)

• Positive
• Negative
• No impact
• Don’t know

In your experience, what impact does patient access to healthcare professionals operating under private PGDs typically have on the quality of care received? (Optional)

• Positive
• Negative
• No impact
• Don’t know

In your experience, what impact does patient access to EEA registered prescribers have on the quality of care received? (Optional)

• Positive
• Negative
• No impact
• Don’t know

How can the quality of patient care received from private providers be strengthened? (Optional, maximum 500 words)

To what extent do you agree or disagree that patients receive appropriate consultation and clinical advice when prescribed or supplied medicines by private providers? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree that patients are routinely monitored by an authorised healthcare professional when prescribed or supplied medicines by private providers? (Optional)

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If there is anything else you would like to tell us about patient consultation and monitoring when accessing medicines through private providers, please include it here. (Optional, maximum 500 words)

In your experience, what patient medical information is relied upon when prescribing privately? (Optional)

Select all that apply.

• Patient supplied
• NHS GP supplied
• Core NHS record
• Private provider’s own records
• Other, please specify

How effectively is patient medical information shared between NHS and private prescribers, and vice versa? (Optional, maximum 500 words)

If there is anything else you would like to tell us about private prescribing data, please include it here. (Optional, maximum 500 words)

What impacts does private prescribing have on the wider healthcare system? (Optional, maximum 500 words)

Please share any additional evidence you would like to contribute regarding the impact of private prescribing on quality of patient care. (Optional, maximum 750 words)

Submitting further evidence

We welcome contributions of data, research and other reports relating to:

• the efficacy of existing mechanisms for the oversight and regulation of private prescribing by UK and EEA registered healthcare professions, and supply and administration of medicines under private PGDs
• the impact the existing arrangements for private prescribing and supply of medicines have on patient safety and access to medicines
• how private prescribing by UK and EEA registered healthcare professions and the use of private PGDs affect the quality of care received by patients

Documents of up to 5 pages will be accepted. You may upload up to 3 files.

Would you like to upload a contribution of data, research or other reports?

• Yes
• No

Which themes does your evidence best relate to?

Select all that apply.

• The efficacy of existing mechanisms for the oversight and regulation of private prescribing by UK and EEA registered healthcare professions, and supply and administration of medicines under private PGDs
• The impact the existing arrangements for private prescribing and supply of medicines have on patient safety and access to medicines
• How private prescribing by UK and EEA registered healthcare professions and the use of private PGDs affect the quality of care received by patients

The efficacy of existing mechanisms for the oversight and regulation of private prescribing by UK and EEA registered healthcare professions, and supply and administration of medicines under private PGDs

Please upload your contribution of data, research and other reports. For this section, we are particularly interested in:

• your views on the strengths and weaknesses of the existing oversight and regulatory mechanisms, and any changes you would suggest making to them
• your insights into what action is needed to ensure effective enforcement of existing regulations
• examples of good or bad behaviours from UK private and EEA prescribers
• case studies of effective enforcement, or how regulations have limited enforcement activity
• any gaps in research and evidence

Do not include any personal information in your response.

The impact the existing arrangements for private prescribing and supply of medicines have on patient safety and access to medicines

Please upload your contribution of data, research and other reports. For this section, we are particularly interested in:

• your insight into the factors driving patients to seek medical treatment from private providers
• your suggestions on what safeguards are needed to better support patient safety when accessing medicines online through private providers.
• any gaps in data or evidence in these areas

Do not include any personal information in your response.

How private prescribing by UK and EEA registered healthcare professions and the use of private PGDs affect the quality of care received by patients

Please upload your contribution of data, research and other reports. For this section, we are particularly interested in:

• your views as to how private prescribing is currently meeting the needs of patients
• your views as to how private prescribing is currently impacting the wider healthcare system
• examples of solutions that have improved or hindered patient access to high-quality medicines
• recommendations for how regulations can improve how we interact with private prescribers
• any gaps in data or evidence

Do not include any personal information in your response.

Annex A: relevant legislation

In the UK, medicines regulation is a reserved matter in relation to Scotland and Wales. It is a transferred matter in Northern Ireland. Medicines are primarily regulated through the following legislation.

Human Medicines Regulations 2012

The Human Medicines Regulations 2012 (HMRs) are the main UK- wide legislative framework covering the manufacture, importation, distribution, advertising, labelling, sale and supply of medical products for human use and pharmacovigilance. Under these regulations, the eligibility of individuals to prescribe, supply or administer medicines, relies upon both profession and medicine-specific provisions.

Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 (MMDA) became law in February 2021. The act provides the Secretary of State for Health and Social Care and the Department of Health in Northern Ireland (in relation to Northern Ireland) with powers to amend the existing regulations on human and veterinary medicines, as well as medical devices, in the UK. The MMDA allows the UK to change the regulatory landscape for medicines and medical devices following our departure from the EU. It requires that public consultations are held on any proposed changes to the HMRs.

Misuse of Drugs Act 1971, Misuse of Drugs Regulations 2001 and Misuse of Drugs (Northern Ireland) Regulations 2002

The Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 (MDRs) apply only to England, Wales and Scotland; the Misuse of Drugs (Northern Ireland) Regulations 2002 (MDR(NI)) apply in Northern Ireland.

The misuse of drugs regulations allows for the lawful possession and supply of controlled drugs for legitimate purposes. They cover prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of controlled drugs to prevent diversion for misuse. Controlled drugs (CDs) are listed in one of 5 schedules contained within the MDRs and the MDR(NI). Substances are scheduled according to their therapeutic use and need for legitimate access, as well as potential for misuse and harm caused to both individuals and society. Schedule 1 CDs are subject to the greatest restrictions and schedule 5 the least. Any changes to the MDRs would require consultation with the Advisory Council on the Misuse of Drugs (ACMD).

Online Safety Act 2023

The Online Safety Act 2023 (OSA) applies to England, Wales, Scotland and Northern Ireland.

The OSA is a regulatory framework which lays the foundation for strong protections from illegal content for all users and harmful content for children online. These new laws apply to search services and all companies that allow users to post content online or to interact with each other. Under the OSA, in-scope services are required to implement robust measures designed to mitigate the risks of their service being used for illegal activity. They must also tackle criminal activity on their platforms as soon as they are alerted to its presence.

Under the OSA, encouraging suicide and drug-related offences are both priority offences. Priority offences reflect the most serious and prevalent illegal content and activity, against which services must take proactive measures, as well as ensuring their services are not being used to facilitate or commit a priority offence.

The strongest protections in the OSA are for children, and in-scope services likely to be accessed by children need to take steps to protect them from harmful content even when it does not meet the criminal threshold.

Annex B: regulators

Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency (MHRA) is the designated authority that regulates and enforces the law relating to medicines in Great Britain. It holds a range of regulatory, investigatory and enforcement powers to ensure medicines safety and quality across the entirety of a medicine’s lifecycle. MHRA operates in a statutory framework set by HM Government, working within government and the wider health system to direct overall policy within their regulatory field.

General Medical Council

The General Medical Council (GMC) is the independent regulator for doctors, physician associates (PAs) and anaesthetic associates (AAs) in the UK. It is responsible for protecting, promoting and maintaining the health and safety of the public by ensuring doctors, PAs and AAs are fit to practice. The GMC’s role encompasses setting standards for medical practice, overseeing medical education and training, and taking action when the conduct or performance of a doctor, PA or AA puts patients at risk.

General Pharmaceutical Council

The General Pharmaceutical Council (GPhC) is the regulator for pharmacists, pharmacy technicians and pharmacies in Great Britain. Its main job is to protect, promote and maintain the health, safety and wellbeing of members of the public by upholding standards and public trust in pharmacy. It is a statutory organisation set up by the UK and Scottish parliaments, and is independent from government and those it regulates. Its role and functions are set out in the Pharmacy Order 2010.

Pharmaceutical Society of Northern Ireland

The Pharmaceutical Society of Northern Ireland (PSNI) is the primary regulatory body for pharmacy professionals in Northern Ireland. The PSNI regulates pharmacy practice, sets standards, maintains a register of pharmacists and handles complaints. The Medicines Regulatory Group (MRG), within the Department of Health (Northern Ireland), works with the PSNI to ensure pharmacists meet standards and obligations. They conduct routine inspections of pharmacies and take action when standards are not met. 

Care Quality Commission

The Care Quality Commission (CQC) is the independent regulator of health and social care in England. Regulated activities include:

• treatment, care and support provided by hospitals, GPs, dentists, ambulances and mental health services
• treatment, care and support services for adults in care homes and in people’s own homes (both personal and nursing care)
• services for people whose rights are restricted under the Mental Health Act

CQC acts to ensure health and social care services provide people with safe, effective, compassionate, high-quality care. It monitors, inspects and regulates services and uses its powers to enforce against, and take action, where poor care is identified.

Healthcare Improvement Scotland

Healthcare Improvement Scotland (HIS) is a public body that works to improve the quality of healthcare across the NHS and its partners in Scotland. It provides evidence and quality assurance, and supports public and community engagement. Though it operates independently, it works in partnership with other stakeholders. HIS’s scrutiny activity is split into 3 categories:

• inspections
• regulation
• reviews (including ad hoc investigations)

It regulates independent healthcare services in Scotland and is responsible for regulating independent hospitals (including voluntary hospices), independent clinics and independent medical agencies

Healthcare Inspectorate Wales

Healthcare Inspectorate Wales (HIW) is the independent inspectorate and regulator of healthcare in Wales. It is responsible for inspecting, reviewing and investigating NHS services and independent healthcare services throughout Wales. It acts to inspect NHS services and regulates independent healthcare providers against a range of standards, policies, guidance and regulations to highlight areas requiring improvement.

Regulation and Quality Improvement Authority

The Regulation and Quality Improvement Authority (RQIA) is the independent health and social care regulator in Northern Ireland. The Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 (the order) and its supporting regulations, requires it to inspect, monitor and drive improvement in the quality of health and social care services in Northern Ireland. For those services that fall to be registered under part 3 of the order, the frequency of inspections is set out within the Regulation and Improvement Authority (Fees and Frequency of Inspections) Regulations (NI) 2005, as amended. 

It acts to assure public confidence in health and social care through their independent, proportionate and responsible regulation. Through inspections, reviews and audits, RQIA provides assurance about the quality of care, challenges poor practice, promotes improvement and safeguards the rights of service users.

Every year RQIA inspects around 1,500 health and social care services. These include almost 500 nursing and residential care homes in Northern Ireland as well as:

• children’s homes
• domiciliary care
• nursing agencies
• adult day care services
• private dental clinics
• independent hospitals and hospices and clinics

RQIA also inspects the quality of care in acute hospitals, mental health and learning disability wards and in places of detention including prisons.

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