Response to amending references to PHE and HSCB in the Human Medicines Regulations
Updated 25 April 2024
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This publication is available at https://www.gov.uk/government/consultations/amending-references-to-phe-and-hscb-in-the-human-medicines-regulations/outcome/response-to-amending-references-to-phe-and-hscb-in-the-human-medicines-regulations
Introduction
The aim of this consultation was to seek the views of stakeholders on proposals to amend the Human Medicines Regulations 2012 (HMRs) to remove the remaining references to organisations in England and Northern Ireland which have since been dissolved. The consultation was run jointly between the Department of Health and Social Care (DHSC) and the 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. The HMRs currently contain a small number of references to Public Health England (PHE) that need to be amended to reflect the transfer of its functions to successor agencies and departments after PHE was dissolved in summer 2020. 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 in Northern Ireland is seeking an amendment to the HMRs in order to be expressly designated as a ‘health authority’ to clarify that it is able to fulfil the legal requirements as set out in the HMRs that were formerly attributed to the Health and Social Care Board (HSCB), which was dissolved on 31 March 2022.
Details of the proposed changes are outlined in table 1, more details of which can be found in the original consultation.
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 UK Health Security Agency (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 (PDGs), 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 regulations 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 |
Table 2: changes related to Northern Ireland
| Reference 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 |
Evaluation of responses and equality assessment
We received fewer than 5 responses in total and these came from across the UK. These were from individuals sharing personal views and responses received on behalf of organisations.
Within the responses, there were no disagreements with any of the proposals consulted on as regards our proposed amendments to the HMRs. Respondents also felt that the proposals do not risk impacting people in a way that complied with our assessment of the public sector equality duty as set out in section 149 of the Equality Act 2010, or section 75 of the Northern Ireland Act 1998.
We have found nothing within the responses or otherwise that has affected our assessment and so we do not intend to update our assessment at this time. Comments were strongly in support of the changes to update legislation to accurately reflect the transfer of functions and responsibilities both in England and Northern Ireland.
Government response
We will now progress with our proposals to amend the HMRs as set out in the consultation document.
Next steps and Parliamentary procedure
We will now proceed to draft and lay a UK-wide draft statutory instrument to make the proposed amendments to the HMRs that we consulted upon. A summary of those amendments can be found in table 1 and more detail on those amendments can be found in the original consultation document.
The draft regulations are to be made using the enabling powers in part 2 of the Medicines and Medical Devices Act 2021 and will be subject to the draft affirmative Parliamentary procedure. As the statutory instrument is to be UK-wide this means that it will need to be debated and approved in both Houses of Parliament and the Northern Ireland Assembly before it can be made.
We thank everyone who took the time to respond to this consultation.