My Lords, most of this instrument corrects retained EU law on geographical indication—or GI—schemes. The remainder makes a small number of amendments relating to wine and spirit provisions and on veterinary medicines.
I turn first to the provisions on GIs. GI schemes provide legal protection from imitation for both local and traditional food and drink specialities. The purpose of the instrument is to enable the Government to administer and enforce GI schemes in the UK after exit. This will ensure that our GIs remain protected against imitation in the UK. Together with other legislation on GIs, it will ensure that the UK continues to comply with World Trade Organization obligations after exit, specifically the TRIPS agreement on intellectual property. Currently, we comply with the TRIPS agreement through our membership of the EU’s GI scheme. We will remain compliant with these obligations through this new domestic legislation, which makes provision for the protection of GI products within the UK and empowers the relevant agencies to enforce the rights granted to GI holders.
The instrument also provides a UK framework to administer and enforce GI schemes for agricultural products and foodstuffs, aromatised wines and spirit drink products throughout the UK. It will enable applicants from the UK and third countries to apply for UK GI protection, and it will allow the number of UK-recognised GIs to continue to grow following EU exit.
The UK Government are working with their global trading partners to transition EU free trade agreements and other sectoral agreements, and this includes commitments on the recognition and protection of UK GIs. In addition, the instrument will amend retained EU law on methods of analysis used to ensure that spirit drinks comply with the relevant rules. It also amends retained EU law concerning the documentation that must accompany the movement of wine and imported wine, the certification of wine, and the registers that must be kept by wine operators relating to the wines handled by them.
The Government launched a public consultation in October 2018 seeking stakeholders’ and the public’s views on our proposed new UK GI rules. Under EU rules, we are required to consult on amendments to food law. As we had to do this for wines and spirits sector standards, we also took the opportunity to consult on the wider GI aspects. We received 92 responses from a range of stakeholders, including the Scotch Whisky Association, the UK Protected Food Names Association and Quality Meat Scotland. Furthermore, the majority of respondents—68%—supported the Government’s proposals. This included our proposals to have a three-year implementation period for the new logos and our recommended appeals process using the First-tier Tribunal.
GIs are intellectual property and, as such, this is a reserved matter. The relevant powers currently exercised by the European Commission will therefore be transferred to the Secretary of State. We have worked with the devolved Administrations on the whole of this instrument and, where it concerns devolved matters, they have given consent.
I turn to the provisions on veterinary medicines. This is the second EU exit instrument covering veterinary medicines. The other instrument, the Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residues Limits) (Amendment etc.) (EU Exit) Regulations 2019, has already been debated in and accepted by both Houses.
This instrument covers three areas. It transfers powers and functions to set maximum residue limits for veterinary medicines. It provides for veterinary medicines that have been approved by the European Medicines Agency to remain on the UK market. It also makes necessary consequential changes to the fees charged by the Veterinary Medicines Directorate, as set out in the Veterinary Medicines Regulations 2013.
MRLs are the maximum safe limit of a particular substance in produce from animals. These limits are used to establish withdrawal periods: the period that must elapse after the last administration of the medicine before produce from that animal may enter the food chain. A UK MRL-setting framework is necessary to ensure the safety of produce from food-producing animals. Veterinary medicines are devolved to Northern Ireland, so the power to set MRLs is shared between the UK Government and the Department of Agriculture, Environment and Rural Affairs. Defra will be able to act on a UK-wide basis with the consent of DAERA and the VMD will continue to act as the UK-wide regulator to ensure consistency.
This instrument brings across the existing MRL application fees from the EMA of £62,300 for a new MRL and £18,850 to amend an existing MRL. However, as stated in the EM, these fees will be reviewed as soon as possible. Until the data is available to underpin a more accurate cost base, the fees will be administratively reduced to better reflect the actual costs incurred as part of the assessment.
Medicines approved by the EMA account for a small percentage of all veterinary medicines in the UK—about 13%. However, they are often novel treatments and substances and it is highly important that these medicines remain on the UK market. This instrument provides for their conversion to UK national approvals, with no charge for the conversion. Pharmaceutical companies will not need to take any immediate action to enable them to continue to market their products in the UK.
Lastly, this instrument makes minor changes to the fees charged by the VMD for the functions it carries out. I must be clear; apart from bringing over the existing MRL fees I have set out above, these are minor corrections and no new fees are being introduced. The amendments proposed to Schedule 7 to the Veterinary Medicines Regulations 2013 are merely to correct deficiencies arising from us leaving the EU.
Although a formal public consultation has not been carried out, the Government have proactively engaged with the animal health industry to discuss how we can ensure that the regulatory regime continues to function effectively after exit day. My noble friend Lord Gardiner of Kimble has met the veterinary pharmaceutical industry association—the National Office of Animal Health—on a number of occasions as part of our extensive engagement. Officials from the Veterinary
Medicines Directorate continue to hold regular meetings with key industry representatives. The industry has welcomed our proactive and continued engagement with it. NOAH expressed concerns that introducing a separate MRL-setting regime to the EU could increase burden and cost on the industry. The Government recognise that MRLs are key to facilitating trade in animal produce and will therefore look to align with international standards when setting them. To ensure a high level of protection for human health, MRLs must be based on sound science and data.
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A final point to note is that the SLS Committee has drawn this instrument to the special attention of the House. However, this was on the grounds that the policy areas were likely to be of interest to the House. The committee adviser confirmed this was on a neutral basis and concerns about the instrument were not raised in this case. I beg to move.