Consultation outcome

Making amendments to the references to Public Health England and the Regional Health and Social Care Board within the Human Medicines Regulations 2012

Updated 25 April 2024

Summary

The aim of this consultation is to seek the views of stakeholders on proposals to amend the Human Medicines Regulations 2012 (HMRs) to remove remaining references to organisations in England and Northern Ireland which have since been dissolved.

The consultation is run jointly between the:

• Department of Health and Social Care (DHSC)
• Department of Health in Northern Ireland

The proposed changes are technical in nature and will ensure legislation reflects recent changes within the healthcare systems in England and Northern Ireland.

In summer 2020, the Secretary of State for Health and Social Care announced that Public Health England (PHE) would be replaced by the UK Health Security Agency (UKHSA) and the Office for Health Improvement and Disparities (OHID). From 1 October 2021, PHE transferred their health protection function into UKHSA and their health improvement and public health functions into OHID, NHS England and Improvement and NHS Digital. NHS England and Improvement and NHS Digital have since merged into a single organisation.

UKHSA is an executive agency, sponsored by DHSC. OHID is a part of DHSC.

In light of the organisational changes taking place as a result of PHE’s dissolution, and the subsequent transfer of their functions, amendments need to be made to the HMRs to remove the small number of references to PHE that they contain. These amendments are technical changes which reflect that, where appropriate, the functions that PHE carried out have been transferred to the relevant agency or department.

The amendments being proposed in this consultation are consequential to the dissolution of PHE. PHE has already been dissolved and the transfer of their responsibilities and functions has already taken place. There have not been any practical or operational impacts of PHE continuing to be referenced in the HMRs, but these changes are required in order to keep legislation current and accurate and to reflect that UKHSA or DHSC, as appropriate, carry out functions previously carried out by PHE.

In Northern Ireland, as part of a major programme of work to transform their health and social care system, as set out in Health and Wellbeing 2026 - Delivering Together, the Regional Health and Social Care Board (HSCB) dissolved on 31 March 2022 as a result of the coming into force of section 1 of the Health and Social Care Act (Northern Ireland) 2022 (‘2022 Act’) and its commissioning functions were transferred to the Department of Health (NI). 

The Department of Health (NI) is seeking an amendment to the HMRs in order to be expressly designated as a ‘health authority’ to clarify that it is able fulfil the legal requirements set out in the HMRs that were formerly attributed to HSCB. A transitional provision in the 2022 Act means that this is not strictly necessary (see below), although it would be helpful to readers of the HMRs in isolation.

The Medicines and Medical Devices Act 2021 (MMDA) provides the powers required to amend the HMRs. The MMDA requires that a public consultation is held before any changes are made to medicines law when using the powers under the act. This consultation is to seek views on our proposals to amend the references to PHE and HSCB in the HMRs, and to replace them with the appropriate successor agencies and departments to enable them to carry out the functions previously carried out by PHE and HSCB.

Both sets of changes are of a similar technical nature. We are therefore running the consultation jointly with the Department of Health (NI) as provided for under the MMDA.

Policy objectives

The proposed changes to the HMRs are technical in nature; the HMRs currently contain a small number of references to PHE that need to be amended as a consequence of PHE’s dissolution and the transfer of their functions to successor agencies and departments. Our proposals are to clarify legislation and to reflect this transfer of functions as a consequence of the dissolution of PHE, by amending the remaining references to PHE within the HMRs.

The Department of Health (NI) is seeking an amendment to the HMRs in order to be expressly designated as a ‘health authority’ to clarify that they are able to fulfil the legal requirements as set out in the HMRs that were formerly attributed to HSCB, which was dissolved on 31 March 2022.

Overview of all the proposed regulatory changes

Details of the proposed changes are set out in the below sections, including a table outlining all the references to PHE in the HMRs (Table 1) which are to be amended. The table also includes the single reference to HSCB that we are proposing to amend.

The HMRs include a definition of PHE which we propose removing. We also propose inserting a definition for UKHSA.

There are also several references to PHE within the HMRs that relate to the supply of medicines in accordance with a patient group direction (PGD) and 2 references that relate to the lawful supply of naloxone.

Where the reference relates to PGDs, we are proposing substituting ‘PHE’ with ‘UKHSA’ and where the references relate to naloxone, we propose substituting ‘PHE’ with ‘DHSC’. We do not expect these changes to have any impact on patients.

There are a further 2 references to PHE in the HMRs, related to a review provision and wholesale dealing, which we are also proposing to amend and are included in Table 1 below.

Table 1: all references to PHE within the HMRs, and the proposed amendments

Reference in HMRs	Proposed amendments
Regulation 213(1) - Interpretation	Remove the definition of PHE and insert a definition for UKHSA
Regulation 229 (1)(db) - Exemption for supply by national health service bodies and local authorities	Substitute the reference to PHE with UKHSA
Regulation 233 (1)(a)(ivd) - Exemption for supply etc under a PGD by person conducting a retail pharmacy business	Substitute the reference to PHE with UKHSA
Schedule 16 - Patient Group Directions, Part 2 - person on whose behalf a PGD must be signed	- Substitute the references to PHE with UKHSA - Substitute the reference to ‘Chief Executive of PHE’ with ‘Chief Executive of UKHSA’
Regulation 346 (2)(d)(ivza) and (ivb) - Review - Requirements for the Secretary of State to review certain provisions from time to time	Substitute the references to PHE with UKHSA
Schedule 17, part 2, paragraph 1, row 4a (c) - Exemption for sale, supply or administration by certain persons - exemption from the restriction on supply of prescription only medicines	Substitute the reference to PHE with DHSC
Schedule 17, part 5, paragraph 1, row 7a (c) - Exemption for sale, supply or administration by certain persons - exemptions from the restrictions in regs 220 and 221 for certain persons who supply certain medicinal products	Substitute the reference to PHE with DHSC
Schedule 22, paragraph 1 - Classes of person for the purposes of regulation 249 (restrictions of persons to be supplied with medicinal products)	Substitute the reference to PHE with UKHSA

Change related to Northern Ireland

There is one reference to HSCB within regulation 213 of the HMRs, which is an interpretation provision for part 12 of the HMRs. The reference is in relation to the definition of a ‘health authority’, which is defined, for the purposes of Northern Ireland, as HSCB.

HSCB had been the commissioning body in Northern Ireland, responsible for general practitioner (GP) services and community pharmacy (CP) services. These commissioning functions moved to the Department of Health (NI) on 1 April 2022. It was noted that it is a legal requirement for a PGD to have authorisation by the appropriate organisation, which must be specifically designated within the HMRs. Part 12, chapter 1, regulation 213 states that in Northern Ireland the ‘health authority’ is defined as HSCB. Therefore the Department of Health (NI) is seeking an amendment to the HMRs in order to be expressly designated as a ‘health authority’.

Table 2: reference to HSCB within the HMRs, and the proposed amendments

References in HMRs	Proposed amendments
Regulation 213(1) - Interpretation	Substitute the reference to HSCB with the Department of Health in the definition of ‘health authority’ for the purposes of Northern Ireland

Detailed description of individual legislative changes

Removing the definition of PHE and replacing with UKHSA

In the summer of 2020 the Secretary of State for Health and Social Care announced that PHE would be replaced as an executive agency by UKHSA. From 1 October 2021, PHE transferred their health protection function to UKHSA.

Within the HMRs (regulation 213: Interpretation) there remains a definition of PHE which we propose removing:

‘Public Health England’ means the executive agency of that name of the Department of Health [and Social Care]

We also propose inserting a definition for UKHSA:

‘The United Kingdom Health Security Agency’ means the executive agency of that name of the Department of Health and Social Care

This amendment will ensure the HMRs accurately reflect the dissolution of PHE and the implementation of UKHSA.

Question

Do you agree or disagree with our proposals to remove the definition of PHE and to insert a definition for UKHSA in the HMRs?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Supply of medicinal products by or pursuant to an agreement with PHE including under a PGD

PGDs provide a legal framework that allows some registered health professionals to supply and/or administer specified medicines to a pre-defined group of patients, without them having to see a prescriber (such as a doctor or nurse prescriber).

For a PGD to be legally compliant, it must be developed and approved by a doctor (or dentist) and a pharmacist. It must also be approved by the agency that has commissioned the service. The organisations are specifically designated within the HMRs.

There are a small number of amendments to the HMRs that we are proposing, as a consequence of PHE’s dissolution, to reflect the transfer of PHE’s functions in relation to the sale, supply or administration of medicines by PHE, or by a person who supplies pursuant to an arrangement with PHE, both under the written directions of a specified healthcare professional (known as patient specific directions) or under a PGD.

The proposals also reflect the transfer of PHE’s functions in relation to the sale, supply or administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business, under a PGD, pursuant to an arrangement with PHE. As these functions have been transferred to UKHSA, we propose substituting the references to PHE in the HMRs with UKHSA, and the reference to ‘Chief Executive of PHE’ with ‘Chief Executive of UKHSA’ in the following areas:

• regulation 229(1)(db): restrictions relating to the sale and supply of medicines do not apply to a medicinal product supplied by PHE, or by a person who supplies pursuant to an arrangement with PHE, provided that it is either supplied for the purpose of being administered to a person in accordance with the written directions of one of the specified healthcare professionals (a patient specific direction) or the product is supplied for the purpose of being administered to a person in accordance with a PGD

• regulation 233(1)(a)(ivd): restrictions relating to the sale and supply of medicines do not apply to the sale, supply or administration of a prescription only medicine (POM) by a person lawfully conducting a retail pharmacy business if the supply was made pursuant to an arrangement with PHE and was sold, supplied or administered in accordance with a PGD and the remaining conditions as set out in the regulation

• schedule 16, part 2: this sets out this if a medicine is supplied under a PGD by PHE, or pursuant to an arrangement with PHE, the PGD must be signed on behalf of the Chief Executive of PHE

Question

Do you agree or disagree with our proposed amendments to substitute the references to PHE with UKHSA in regulations 229(1)(db) and 233(1)(a)(ivd) of, and part 2 of schedule 16 to, the HMRs?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Question

Do you agree or disagree with our proposed amendment to substitute the reference to ‘Chief Executive of PHE’ with ‘Chief Executive of UKHSA’ in part 2 of schedule 16 to the HMRs?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Allowing the supply of prescription only medicines (POMs) and pharmacy (P) medicines to PHE by way of wholesale dealing

Schedule 22 to the HMRs read with regulation 249 provides that the holder of a relevant authorisation or a person who carries on a business consisting of manufacturing medicines or selling medicines by way of wholesale dealing, is permitted to sell a POM or a P medicine by way of wholesale dealing to:

• PHE
• a person other than an excepted person who carries on a business consisting (wholly or partly) of supplying medicinal products in circumstances corresponding to retail sale, or of administering such products, pursuant to an arrangement made with PHE

We propose substituting the references to PHE within schedule 22 to the HMRs to UKHSA to accurately reflect the transfer of function and responsibility.

Question

Do you agree or disagree with our proposed amendments to schedule 22 to the HMRs which substitutes the references to PHE with UKHSA?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Review requirements

Regulation 346 of the HMRs provides a review requirement that sets out that the Secretary of State must from time to time carry out a review of certain provisions. Two of these provisions contain references to PHE. We propose amending those references to PHE, within regulation 346 of the HMRs, to UKHSA, to accurately reflect the appropriate transfer of functions and responsibilities. The provisions to be amended are:

• regulation 346(2)(d)(ivza) - which requires that the Secretary of State review from time to time the entries in part 2 of schedule 16 to the HMRs that relate to PHE. Our proposed amendments to part 2 of schedule 16 to the HMRs have been discussed in more detail above in the section ‘Supply of medicinal products by or pursuant to an agreement with PHE including under a PGD’
• regulation 346(2)(d)(ivb) - which requires that the Secretary of State review from time to time the entries in schedule 22 to the HMRs that relate to PHE. Our proposed amendments to schedule 22 to the HMRs have been discussed in more detail in above in the section ‘Allowing the supply of prescription only medicines (POM) and pharmacy (P) medicines to PHE by way of wholesale dealing’

Question

Do you agree or disagree with our proposed amendments to substitute the references to PHE with UKHSA in relation to the review requirements of regulation 346 of the HMRs?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Supply of naloxone

Naloxone is a drug that reverses the effects of an opioid overdose and can help to prevent overdose deaths. It is a POM.

Provisions within the HMRs enable naloxone to be lawfully supplied without a prescription or other written instruction by people working for a drug treatment service that is provided by, on behalf of, or under arrangements made by a list of bodies that includes PHE, where required for the purpose of saving life in an emergency. For awareness, these drug treatment services can also be supplied by the NHS and local authorities under separate provisions. Naloxone supplied by a drug treatment service under these provisions would not need to be dispensed at a registered pharmacy business.

We propose amending the HMRs by substituting the references to PHE within parts 2 and 5 of schedule 17 with DHSC, thus supporting DHSC to carry out this commissioning function previously carried out by PHE.

These references concern PHE’s potential involvement in commissioning drug treatment services, enabling such services to supply naloxone without prescription or other written instruction. At present no drug treatment services are commissioned in this way. The proposed amendments would mean that any drug treatment services that might be commissioned by DHSC in the future would be able to supply naloxone without a prescription or other written instruction. There are no plans to commission drug treatment services in this way. These provisions are solely a wording update to reflect the transfer of these responsibilities to DHSC following the dissolution of PHE.

In 2021, a consultation was held on proposals to widen access to naloxone by expanding the list of services and individuals that can give it out without a prescription or other written instruction. Those proposals are separate to the changes described in this consultation.

Question

Do you agree or disagree with our proposed amendments to parts 2 and 5 of schedule 17 to the HMRs which substitute the references to PHE with DHSC in relation to the lawful supply of naloxone by drug treatment services?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Amendment of the definition of ‘health authority’ in Northern Ireland

This section of the consultation focuses on a proposed amendment to the HMRs related to Northern Ireland and references below to the Department of Health are to the government department in the Northern Ireland Executive.

Regulation 213(1) of the HMRs defines ‘health authority’ for the purposes of part 12 of the HMRs and includes HSCB in that definition. HSCB had been the commissioning body in Northern Ireland, responsible for GP services and CP services. These commissioning functions moved to the Department of Health on 1 April 2022.

It was noted that there is a legal requirement for a PGD to have authorisation by an appropriate organisation, which is specifically designated within the HMRs. Therefore, the Department of Health (NI) is seeking an amendment to the HMRs in order to be expressly included in the definition of a ‘health authority’ for the occasions when it will authorise PGDs as such.

The Department of Health (NI) took forward a Northern Ireland public consultation in December 2021 on the proposals to amend the HMRs to allow the Department of Health (NI) to be designated as a ‘health authority’. The consultation closed on 14 January 2022.

The Department of Health decided not to take forward a single Northern Ireland statutory rule to make any expressed amendments prior to HSCB being dissolved at the end of 31 March 2022. Although support was given to the proposals from those who responded to the consultation, further consideration needed to be given to the administrative arrangements. These administrative arrangements are now detailed in the Department of Health (NI)’s response document (available on the consultation page).

The transitionary provision schedule 4, part 2, paragraph 1 of the Health and Social Care Act (Northern Ireland) 2022 is being used to enable the department to act as the health authority to sign off PGDs until the department has an appropriate opportunity to take forward a formal amendment. By virtue of this paragraph, remaining references in statutory provisions to HSCB are read as references to the department.

The Department of Health in Northern Ireland is therefore seeking an amendment to the HMRs in order for it to be expressly designated as a ‘health authority’ to clarify, for the benefit of readers of the HMRs in isolation, that it is able to fulfil the legal requirements as set out in the HMRs that were formally attributed to HSCB.

Question

Do you agree or disagree with our amending regulation 213(1) of the HMRs to include the Department of Health in Northern Ireland in the definition of a ‘health authority’ for the purposes of part 12 of the HMRs, in place of HSCB?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

Equality assessment and rural screening

When exercising functions, such as designing policies, the Secretary of State must comply with the public sector equality duty, which is an obligation to have due regard to the need to:

• eliminate unlawful discrimination under the Equality Act 2010
• advance equality and opportunity
• foster good relations between different groups

In Northern Ireland new policies must be screened under section 75 of the Northern Ireland Act 1998, which places a statutory duty on public authorities to maintain equality in all its functions - so that equality of opportunity and good relations are central to policymaking and service delivery. In addition, new or revised policies must be ‘rural proofed’ in line with the Rural Needs Act (Northern Ireland) 2016, which requires public authorities to have due regard to rural needs.

We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in NI. We welcome views on this point.

Question

Do you agree or disagree with our assessment that the proposals do not risk impacting people in any way that would affect compliance with the public sector equality duty set out in section 149 of the Equality Act 2010 or section 75 of the Northern Ireland Act 1998?

• Agree
• Disagree
• Don’t know

If you said ‘agree’ or ‘disagree’, please explain your answer.

How to respond

The consultation will close at 11:59pm on 22 February 2024.

Please respond by completing the online survey.

The consultation will only be open for 4 weeks rather than the standard 12. Due to the nature of the proposals, in that they only suggest small technical amendments to the HMRs as a consequence of the dissolution of PHE, the government considers a 4-week consultation appropriate and proportionate in the circumstances.

When responding, please say if you are a business, individual or representative body. In the case of representative bodies, please provide information on the number and nature of individuals or firms you represent.

Annex: legislative basis and the assessment of the matters set out in section 2 of the MMDA

The MMDA received Royal Assent on 11 February 2021. We propose to make the legislative changes consulted upon in this document, using the powers under part 2 of the act, which allows regulations to be made in relation to human medicines.

Section 45(1) of the act includes a statutory requirement for the appropriate authority (here, the Secretary of State for Health and Social Care and the Department of Health (NI)) to carry out a public consultation before making amendments to the HMRs. This consultation is conducted in line with that requirement.

Section 2(2) of the act states that safeguarding public health must be the overarching objective of the appropriate authority when making regulations under section 2(1). Section 2(3) requires that when assessing whether those regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to the following:

• the safety of human medicines
• the availability of human medicines
• the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to:
  • carry out research relating to human medicines
  • conduct clinical trials
  • manufacture or supply human medicines

Section 2(4) of the MMDA specifies that where the regulations may have an impact upon the safety of human medicines, the appropriate authority may only make the regulations if the benefits outweigh the risks. In conjunction, section 45(3) requires that the consultation carried out by the appropriate authority must include a summary assessment of how proposed changes contribute to the overarching objective of safeguarding public health, including whether there is an impact on the safety of medicines.

We have assessed the proposals as outlined below.

Patient safety considerations

The functions to which these changes relate are all pre-existing functions. In the case of the HSCB change, the consequence will be no change to the law but a clarification of it for readers of the HMRs in isolation. In the case of the PHE changes, these proposals reflect machinery of government changes in function and responsibilities as a consequence of the dissolution of PHE. They enable either UKHSA or DHSC, as appropriate, to carry out certain functions previously carried out by PHE. The functions in question are all functions that are or could be carried out by other commissioners of services.

By clarifying this change of responsibility in legislation, it is ensuring that the responsibility for patient safety is clear and supports centralised arrangements in England, where appropriate. We do not consider there to be an impact on patient safety from the proposed amendments.

Availability

These proposals aim to reflect the change in function and responsibilities following the dissolution of PHE, including access of medicines dispensed using PGDs and the lawful supply of naloxone by drug treatment services for use in life-saving emergencies. We do not consider there to be an impact on the availability of medicines as a consequence of the proposed amendments.

Favourability of the UK

The third point relates to the likelihood of the relevant part of the UK being seen as a favourable place in which to carry out research relating to human medicines, conduct clinical trials, or manufacture or supply human medicines.

These proposals seek to reflect the change in function and responsibilities following the dissolution of PHE and therefore we do not expect them to impact on the favourability of the UK as a place to carry out research relating to medicines, conduct clinical trials, or to manufacture or supply human medicines.

Considerations

The appropriate authority will continue to assess the matters set out in section 2(2) to (4) before making any regulations under section 2 to give effect to the policy proposed in this consultation.

Privacy notice

Summary of initiative or policy

This is a public consultation regarding making amendments to the references to PHE and HSCB, both of which dissolved in 2020, to update them to reflect the transfer of their functions within the HMRs. This is not regarding the transfer of the functions themselves, as this took place in 2020 along with the dissolution of these organisations. The statutory instrument to amend these regulations will be made using the powers of the MMDA, which contains a statutory requirement to consult on all regulations being made.

Data controller

DHSC is the data controller.

What personal data we collect

We will be collecting your geographical location or the geographical location your organisation covers, organisational name and activities (if responding on behalf of your organisation) to aid our analysis of respondents.

We will also be collecting your email address in case of the need to follow up on any of your responses.

How we use your data (purposes)

This information will be collected via the survey attached to this consultation. It will be retained in line with our data retention policy outlines below, and will be used only for analysis or, in the case of your email address, to follow up with further questions if needed.

Legal basis for processing personal data

Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful basis we rely on for processing this information is:

• (e) necessary task in the public interest or controller’s official authority

Data processors and other recipients of personal data

Your information will be shared with DHSC’s third party supplier (SocialOptic), which is responsible for running and hosting the online survey.

We will be sharing your anonymised feedback with officials in the Department of Health in Northern Ireland only, as this consultation also relates to the now dissolved organisation HSCB, which previously existed in Northern Ireland.

International data transfers and storage locations

The data will be held on secure servers by DHSC. There will be no international data transfers of your personal data.

Retention and disposal policy

Data will be retained for 12 months after the stakeholder consultation period closes. The data will be held for 12 months in case of the need to revisit any of the responses.

How we keep your data secure

This information is held on secure servers by DHSC.

Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

1. The right to get copies of information - individuals have the right to ask for a copy of any information about them that is used.

2. The right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected.

3. The right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted - for example, if they think inaccurate information is being used.

4. The right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

5. The right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision-making or profiling

No decision will be made about individuals solely based on automated decision-making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 25 January 2024.