Instruments of interest
Draft Aquatic Animal Health and Alien Species in Aquaculture, Animals, and Marketing of Seed, Plant and Propagating Material (Legislative Functions and Miscellaneous Provisions) (Amendment) (EU Exit) Regulations 2020
54.This instrument ensures that legislative functions of the EU can be exercised by the appropriate authorities in Great Britain (GB) after the end of the Transition Period (TP). The instrument also amends earlier EU Exit instruments in order to reflect recent changes in EU law and to implement the Withdrawal Agreement and the Northern Ireland (NI) Protocol (“the Protocol”). The instrument covers seven policy areas: seed, plant and plant propagating material; aquatic animal health; Transmissible Spongiform Encephalopathies (TSEs) and Animal By-Products; livestock; zoonotic diseases; pet travel; and the use of alien and locally absent species in aquaculture.
55.Amongst other changes, the instrument ensures that in relation to the movement of non-commercial pets, EU Member States are considered to be a ‘Part 1’ listed third country for the purposes of the Pet Travel Scheme and that pets travelling to GB can continue to use their current EU-issued Pet Passport. The Department for Environment, Food and Rural Affairs (Defra) says that currently around 300,000 pets move into the UK every year through the Pet Travel Scheme. We asked the Department about the requirements for pets moving from GB to the EU and between GB and NI after the end of the TP. Defra told us that:
“The health and documentary preparation required to enter the EU from GB will be dependent on the category of third country that GB becomes after the transition period, although we have submitted an application to become a ‘Part 1’ listed third country. The EU are now considering our application. On pet travel between Great Britain and Northern Ireland, we believe that there is no animal health-related justification for significant changes to pet movements between Great Britain and Northern Ireland and that they should continue in a very similar way to as they do now.”
56.We note that it is not clear at this stage what the process and requirements will be for moving pets from GB to Ireland via NI after the end of the TP.
57.We also asked the Department about the practical impact of having separate regimes in areas such as TSEs and zoonotic diseases on the trade between NI and GB. Defra explained that under the Protocol:
“Moving goods from Northern Ireland to Great Britain should take place as it does now — there will be no additional process, paperwork, or restrictions on Northern Ireland goods moving to Great Britain, delivering unfettered access.
Changes for goods moving from Great Britain to Northern Ireland will be kept to an absolute minimum, but there will be a requirement for export health certification. A new Trader Support Service, available to all traders at no cost, will be established to provide wraparound support, alongside guidance on the processes for food and agricultural products designed to uphold the longstanding status of the island of Ireland as a single epidemiological unit.”
Draft Protocol on Ireland/Northern Ireland (Democratic Consent Process) (EU Exit)) Regulations 2020
58.This instrument inserts into the Northern Ireland Act 1998 (which establishes the devolution arrangements) a schedule setting out the process by which the Northern Ireland Assembly will decide whether to continue with the special provisions set out in the Protocol to the Withdrawal Agreement. Article 18 of the Protocol requires the Northern Ireland Assembly to consent to the continued application of Articles 5 to 10 of that Protocol every four or eight years depending whether it is given on a simple majority or cross-community basis. The first consent process will need to be completed by the end of December 2024 and the Explanatory Memorandum also identifies the specific dates on which certain actions must be taken.
Draft Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020
59.This instrument ensures that the regulatory regimes for veterinary medicines and residues surveillance remain operable and enforceable in the UK after the end of the Transition Period (TP). It also implements requirements of the Northern Ireland (NI) Protocol. The Department for Environment, Food and Rural Affairs (Defra) explains that in order to facilitate unfettered market access for veterinary medicines from NI to Great Britain (GB), the instrument introduces “light touch regulatory controls” on medicines that are approved in NI but not GB. As the Explanatory Memorandum does not provide further information, we asked Defra about the nature of these controls.
60.The Department told us that a medicine with a valid marketing authorisation in NI but not in GB may benefit from unfettered market access if the Marketing Authorisation Holder has a “dedicated place of establishment” in NI and has provided the same application dossier and supporting information to the Veterinary Medicines Directorate as they would have provided to the European Medicines Agency or the relevant authority in an EU Member State. In addition, access must be provided to any “EU based pharmacovigilance system” that the Marketing Authorisation Holder has in place.23 Defra says that if these conditions are met and there are no safety concerns, a certificate will be issued to allow the product to be marketed in GB.
61.We received a submission from Friends of the Earth which raises a number of concerns about the instrument. We are publishing the submission and Defra’s response on our website.24 As highlighted by Friends of the Earth, we note that the instrument omits a requirement from EU law which will come into effect in November 2022 and updates Reference Points for Action for certain antibiotics and antimicrobials.25 Defra responded that the provision was omitted because it will not have effect until after the end of the TP, but that the “UK Government is committed to maintaining standards”.
23 A pharmacovigilance system enables the collection, monitoring, assessment and evaluation of information related to adverse events. Under EU law, Marketing Authorisation Holders are required to develop a pharmacovigilance system and provide a detailed description of it as part of their marketing authorisation application.
24 Secondary Legislation Scrutiny Committee, scrutiny evidence page: https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/publications/8/scrutiny-evidence/.
25 Food of animal origin containing residues of certain substances at or above the Reference Points for Action is considered as not complying with relevant legislation.