Draft Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment Etc.) (EU Exit) Regulations 2019
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The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs (David Rutley)
I beg to move,
That the Committee has considered the draft Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019.
It is an honour to serve when you are in the Chair, Mrs Ryan. Veterinary medicines are tightly regulated, both here in the UK and in Europe. They are essential for the treatment of animals and ensuring animal welfare, but can also present a risk to human health and the environment. If misused, they can affect human health directly, or may enter the natural environment, causing long-lasting damage. The existing Veterinary Medicines Regulations 2013 set out the requirements for the manufacture, authorisation, supply, possession and administration of veterinary medicines in the UK. Separately, the surveillance of residues from veterinary medicines in animal produce is an important safeguard, providing assurance that any meat, eggs or milk consumed is free from harmful residues of medicines used in animals.
The Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015 provide for a surveillance programme for residues in England and Scotland. Those regulations adopt the level of permissible residues set by the EU, and prohibit the use of certain substances as growth promoters. As residue surveillance is a devolved matter, there is equivalent secondary legislation covering Wales and Northern Ireland.
The Government share the British public’s high regard for animal welfare, and understand the need for safe and effective veterinary medicines. This instrument addresses operability issues in our veterinary medicines legislation to ensure that such legislation continues to operate effectively when we leave the EU. The instrument will make sure that the legal framework continues to provide an effective regime for the regulation of veterinary medicines through which we can safeguard the wellbeing of our animals, and does not diminish the high standards of the established veterinary medicines and residues surveillance regimes. Notwithstanding the concerns raised by both the Secondary Legislation Scrutiny Committee in the House of Lords and the European Statutory Instruments Committee in the House of Commons, I emphasise that the amendments in this instrument are to ensure operability, and are very technical in nature. The high safety standards that are in place will continue, and will not be watered down.
The current UK legislation is designed to work in the context of EU membership, and therefore some existing elements will not work sensibly in a national context. Part 3 of the instrument amends the existing national legislation; for example, the mutual recognition provisions for medicine approvals between member states are no longer relevant. Similarly, as approvals of generic marketing authorisations rely on sharing of information between member states, they cannot continue to operate in the same way. Minor corrections are also made to the text to address references concerning EU membership that are no longer accurate or appropriate.
This instrument introduces one change that is necessary as a consequence of leaving the EU. It relates to the location of holders of marketing authorisations for veterinary medicines. Marketing authorisation holders must be established in the UK. As set out in the explanatory memorandum, that may result in a small increase in costs for those marketing authorisation holders currently based outside the UK, in the order of £100 initially and £40 annually. That cost increase is necessary to make sure that there are appropriate regulatory controls to ensure full compliance with UK law and standards, and that all marketing authorisation holders are treated equally.
Chris Bryant (Rhondda) (Lab)
The Minister refers to UK law, but as I understand it there is going to be separate legislation for Wales and Scotland, because this is a devolved matter. I do not quite understand how those two things match.
David Rutley
The arrangements that I am talking about are UK-wide; we are bringing what currently sits in EU law into, and across, the UK. If the hon. Gentleman wants further clarification, I can seek some inspiration, but it is a UK-wide statutory instrument.
In line with the Government’s better regulation principles, a formal impact assessment has not been carried out because the costs involved are small. The impact on businesses has been assessed as well below the threshold requiring an impact assessment. It is vital that marketing authorisation holders can be held accountable for their products, and this regulation provides for that.
Part 4 of the instrument sets out the necessary amendments to retained EU regulations that become UK law as provided by the European Union (Withdrawal) Act 2018. It is linked to another instrument: the Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019, which transfers the power to set maximum residue limits to the UK from the European Commission, and is yet to be debated in this House.
European regulation 470/2009 sets out how maximum residue limits for substances used as veterinary medicines are set. 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 a medicine before produce from that animal may enter the food chain. Without these amendments, the UK would be unable to regulate the marketing and use of veterinary medicines effectively. That would have negative impacts on businesses and our ability to protect human and animal health and the environment.
Although a formal public consultation has not been carried out, and has not been required under existing guidelines, the Government have proactively engaged with the animal health industry to discuss how we ensure that the regulatory regime continues to function effectively after exit day. 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. We have worked closely with the devolved Administrations on this instrument, and where it relates to devolved matters they have given their consent.
Liz Twist (Blaydon) (Lab)
I would like to ask about the different standards in different UK devolved areas and when it comes to trading with other countries. Is there not a risk that we will have different standards as time goes on? We therefore need co-operation to ensure that we can continue to trade effectively.
David Rutley
Well, we will be leaving the EU, so we need our own mechanisms in place to validate veterinary medicines. That is primarily what we are talking about here. We are bringing back to the UK powers by which medicines are authorised. We will carry on doing that. As it happens, most authorisations already take place in the UK. Unlike for some medicines used for humans, veterinary medicine authorisations often take place in the national states themselves. It will be important to maintain high standards. The hon. Lady and I have exchanged views on that matter in other situations, and I know that she will continue to hold me and the Government to account on these matters. The steps that we are taking in this legislation will bring across powers that are currently in the EU so that we can do what currently takes place. The only thing that is different is the market authorisations. We are requiring those entities to have a market presence in the UK, but at a very low cost. That is the approach we felt was most appropriate to get the balance right.
The Government are committed to ensuring continued levels of protection for human and animal health, as well as making it straightforward for businesses to put medicines and relevant food products on the market, ensuring that UK businesses and individuals continue to have access to a range of veterinary medicines. This instrument will help to maintain the established veterinary medicines and residues surveillance regimes, and will ensure that an effective regulatory framework for veterinary medicines is in place. This instrument does no more than is appropriate to remedy deficiencies in law arising from leaving the EU. For the reasons I have set out, I commend this statutory instrument to the Committee.
David Rutley
I thank the hon. Member for Workington for her contribution, which as usual was thoughtful and thorough. I will respond to some of the points she made. It is obviously vital that we continue to access science. The good news is that the Veterinary Medicines Directorate is regarded as an EU leader in veterinary medicines assessment and has considerable expertise already. We will make sure that it continues to meet that high standard—regardless of what we decide in Parliament today, or over the next few days—so that we have access to the very best.
It is also important to recognise antimicrobial resistance, which the hon. Lady rightly highlighted. As she knows, because we have talked about this in other debates, there will have been an overall reduction in antibiotics sales of 25% between 2016 and 2020, owing to the implementation of livestock-specific targets, which is good. New objectives will be defined by 2021, to sustain longer-term progress. Good progress is being made there.
The hon. Lady asked some challenging questions about the effect of all the legislative changes. I have to say that I do not have the answers to all of them.
Sue Hayman
Is the Minister prepared to write to me, to reassure me on certain issues I have raised? I am happy to receive that information in writing if he does not have it now.
David Rutley
I will do my very best to give the best possible estimates in answer to those questions. I was going to say that a lot of different factors need to be brought into play here. It is not just about the legislation but about market risk and people’s appetite for the changes that are going on and for the things that we will vote on in just a few hours’ time.
However, I assure the hon. Lady that I have been working closely with the Department for Transport and other Government Departments to ensure the continued supply of vet meds, which will be vital not only for pet owners but for agriculture as well. In the prioritisation that has taken place, medicines for human consumption stand out as key, but right next to that is veterinary medicines. They have a strong place in our priorities, and the Government have been working to ensure their continued supply, which I hope reassures the hon. Lady and many others. Again, we will have to wait and see what the House decides today, which will have quite an influence on what goes on.
I hope I have dealt with most of the issues that the hon. Lady raised. With her permission, I will come back to her on the wider concerns and with an estimate of the wider costs. I hope that Committee members now more fully understand the need for the draft regulations and the need to maintain the operability and consistency of our legislation after leaving the EU. For the reasons I have set out, I once again commend the draft instrument to the Committee.
Question put and agreed to.