Instruments of interest
Draft Veterinary Medicines (Amendment etc.) Regulations 2024
37.This instrument proposes extensive changes to the way veterinary medicines are marketed, manufactured, supplied and used in Great Britain (GB).20 According to the Department for Environment, Food and Rural Affairs (Defra), the aim is to modernise the current regulatory regime for veterinary medicines (VMR), which was introduced in 2013, in line with technical advances and other developments. There is a particular focus on reducing the risk of development and spread of antibiotic resistance, including by increasing restrictions on the use of antibiotics. The proposed changes also seek to encourage applications for and marketing of new and innovative veterinary medicines and to update the fees charged to industry by the regulator, the Veterinary Medicines Directorate (VDM), in line with the cost recovery principle. Defra has provided a helpful summary of how the proposals have been adapted in response to the feedback received during public consultation,21 and the VDM is revising its guidance to support the changes.22
38.We note that the Explanatory Memorandum refers to an estimated equivalent annual net direct cost to business of £2.5 million per year. Asked whether this could lead to higher prices for veterinary medicines, the VDM told us that:
“The regulatory changes to the Veterinary Medicines Regulations do not impose any direct cost implications for the pricing of veterinary medicines. Veterinary medicine is a private service including the supply of medicinal products; the costs charged by individual veterinary practices vary widely due to the variable levels of overheads incurred. The Government is not informed of the costs of individual products and the pricing structure of veterinary medicines is not subject to legislative controls. Therefore, the cost of a veterinary medicine is controlled by the market rather than legislation.”
39.While the original VMR applied to the whole of the UK, under the Windsor Framework, EU law on veterinary medicines and medicated feed applies in Northern Ireland (NI). We note that the House of Lords Sub-Committee on the Windsor Framework has launched an inquiry into veterinary medicines and the Windsor Framework.23 Asked about potential divergence between GB and NI in this policy area as a result of this instrument, and in particular after a grace period for the import of veterinary medicines from GB into NI expires at the end of 2025, the VDM replied:
“The Veterinary Medicines Regulations set out the requirements that each pack of veterinary medicines must meet. The changes introduced by this SI mirror the requirements in EU law, which will enable pharmaceutical companies to share common packs/labels between GB and NI and provide for the ability to market veterinary medicines on a whole UK basis should a company wish to do so. Such changes relate for example to the wording and information that needs to be included on the pack/label. This further reduces the current levels of UK-EU divergence in relation to labelling of veterinary medicines.
The SI makes more than 200 changes to the Veterinary Medicines Regulations 2013 in respect of GB. A large portion of these changes mirror recent changes to EU law (which we negotiated for and supported when we were part of the EU). Some regulatory changes introduced by this SI do introduce a slight divergence from the law that applies in NI, but none of these will affect the supply of products from GB to NI. Examples are changes to ease processes for certain businesses (for example to safeguard the provision of medicated feed), or to allow for a more flexible approach (for example to help encourage submission of applications for new and innovative veterinary medicines to the market and to enable us to better support development of novel therapies).
The Government is committed to securing a long-term sustainable solution ahead of December 2025 that will properly support the flow of veterinary medicines into NI from GB on an enduring basis. It remains the Government’s priority to find a solution that removes the barriers to supply of veterinary medicines into NI through technical talks with the EU. The Government is very clear that in all scenarios it is imperative to safeguard the supply of veterinary medicines to NI, and if necessary, we will deploy all available flexibilities in line with our legal obligations.”
National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2024 (SI 2024/302)
40.These Regulations amend “the Standing Rules”24 imposed on NHS England and Integrated Care Boards (ICB) in particular to:
- increase by 7.4% the rates for NHS-funded nursing care payable by NHS England or an ICB to care homes where patients require care by a registered nurse. The rate increases from £219.71 to £235.88 per week for the flat payment and from £302.25 to £324.50 per week for the high band;
- substitute regulations 52 and 53 with a new duty from 1 April 2024 to ensure that the waiting period to diagnose or rule out cancer does not exceed 28 days in at least 75% of cases (“the Faster Diagnosis Standard”). This replaces the current two-week standard from referral to first appointment with a specialist, in order to focus more on diagnosis than process; and
- include a saving provision to provide an appointment with a specialist, and offer an alternative provider, for those people urgently referred for treatment for suspected cancer before 1 April 2024.25
Infrastructure Planning (Examination Procedure) (Amendment) Rules 2024 (SI 2024/317)
Infrastructure Planning (Miscellaneous Provisions) Regulations 2024 (SI 2024/332)
Infrastructure Planning (Fees) (Amendment) Regulations 2024 (SI 2024/333)
41.These three instruments are part of a package of operational reforms to the consenting process for Nationally Significant Infrastructure Projects (NSIP), as set out in the Government’s NSIP Action Plan from February 2023.26 According to the Department for Levelling Up, Housing and Communities (DLUHC), the aim is to ensure the process “is better at meeting statutory timescales, faster where environmental and community concerns can be addressed before examination, greener for the environment, fairer for communities, and more resilient in resourcing”. The changes will apply in England and Wales and, in very specific circumstances, to Scotland in relation to the construction of oil or gas cross-country pipelines.
42.SI 2024/317 provides that the date by which a written representation must be received by the Examining Authority is no longer subject to a 21-day minimum period. It also replaces the current 21 days’ notice to be given by the Examining Authority with a more flexible “reasonable notice” when setting deadlines for making a request for compulsory purchase or open floor hearings, and when notifying interested parties and affected persons of those hearings. The instrument also allows the notice of a hearing to be published on the applicant’s website in addition to publication in a local newspaper, and allows representations, notices and other documents to be transmitted digitally without having to obtain consent from the recipient.
43.SI 2024/332 expands the requirement for the information that must be included in a relevant representation registration form which is used to register as an interested party and submit views to the Planning Inspectorate. The aim is to ensure that Examining Authorities receive more detailed information earlier in the process.
44.The instrument also allows inspectors who give pre-application advice on proposed applications to also be appointed to examine applications once they have been accepted. This is to give the Planning Inspectorate more flexibility in deploying resources. DLUCH says that while 39% of those who responded to the consultation supported this change, 8% were opposed, with concerns being raised about potential bias from an inspector providing pre-application advice on a proposed NSIP application and then being appointed to the Examining Authority Panel. The Department acknowledges this concern in the Explanatory Memorandum and says that new guidance will provide transparency regarding any pre-application involvement by inspectors. Asked about potential conflicts of interests, DLUHC told us that:
“the Planning Inspectorate will take a balanced judgement on the input a Planning Inspector has had in the provision of pre-application advice, before considering whether that Inspector could then be deployed onto the Examining Authority. For example, the Planning Inspectorate may decide against appointing a person onto the Examining Authority if they have given advice on sensitive topics, in order to reduce the risk of a conflict of interest arising.”
45.SI 2024/333 makes provisions to enable the Secretary of State and certain public authorities to charge fees to applicants for the provision of some services.
46.We note that during public consultation, concerns were raised that moving to digital documents should not exclude people from the planning process.27 We therefore asked the Department how it would ensure that people without digital access or with poor internet connection, for example in rural areas, would still be able to access all relevant information and would not be disadvantaged in the planning process. DLUHC replied:
“The new National Infrastructure Planning Guidance will set an expectation that, where necessary, applicants will make alternative arrangements to make documentation available on request where it is not possible to view the material online, for example by providing copies of documents on a USB flash drive where parties have access to a computer but have limited or no internet access or, where reasonably practicable, by making paper copies of documents available for inspection free of charge where a person is unable to access the documentation electronically or finds it difficult to do so.
Applicants also make application information available to view in local libraries and make communities aware of this during the pre-application stage through the preparation of a Statement of Community Consultation (SoCC) which is prepared in liaison with the local planning authority. The SoCC sets out the most effective ways for making local stakeholders aware of how the applicant will communicate with communities–this can include digital means (including the applicant’s website, PINS [Planning Inspectorate] website, and local news websites) and paper means (e.g. local newspaper, mail, and site notices). A document is then published online which sets this out for the public to read so that that they are aware of the various forms of communication which the applicant will use.”
20 As set out in the Veterinary Medicines Regulations 2013 (SI 2013/2033), as amended.
21 Department for Environment, Food and Rural Affairs, ‘Review of the Veterinary Medicines Regulations 2013’ (2 February 2024): https://consult.defra.gov.uk/vmd/review-of-the-veterinary-medicines-regulations-201/ [accessed 18 March 2024].
22 Veterinary Medicines Directorate, ‘Veterinary medicines guidance’ (October 2022): https://www.gov.uk/government/collections/veterinary-medicines-guidance-notes-vmgns [accessed 18 March 2024].
23 Sub-Committee on the Windsor Framework, ‘Veterinary medicines and the Windsor Framework Inquiry’: https://committees.parliament.uk/work/8125/veterinary-medicines-and-the-windsor-framework/
24 See the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (SI 2012/2996).
25 The new guidance is available at: NICE, ‘Suspected cancer: recognition and referral’ (2 October 2023): https://www.nice.org.uk/guidance/ng12 [accessed 18 March 2024] and NHS England, ‘National cancer waiting times monitoring dataset guidance’ (17 August 2023): https://www.england.nhs.uk/publication/national-cancer-waiting-times-monitoring-dataset-guidance/ [accessed 18 March 2024].
26 Department for Levelling Up, Housing and Communities, ‘Policy paper: Nationally Significant Infrastructure: action plan for reforms to the planning process’ (23 February 2023): https://www.gov.uk/government/publications/nationally-significant-infrastructure-projects-nsip-reforms-action-plan/nationally-significant-infrastructure-action-plan-for-reforms-to-the-planning-process [accessed 18 March 2024].
27 Department for Levelling Up, Housing and Communities, ‘Consultation outcome: Operational reforms to the Nationally Significant Infrastructure Projects consenting process: government response’ (6 March 2024): https://www.gov.uk/government/consultations/operational-reforms-to-the-nationally-significant-infrastructure-project-consenting-process/outcome/operational-reforms-to-the-nationally-significant-infrastructure-projects-consenting-process-government-response [accessed 18 March 2024].