Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019.

My Lords, veterinary medicines are tightly regulated here in the United Kingdom 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 UK’s existing Veterinary Medicines Regulations 2013 set out the requirements on 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 to provide 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. These regulations adopt the level of permissible residues set by the EU and also prohibit the use of certain substances as growth promoters. As residues 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 the need for safe and effective veterinary medicines. These regulations address technical deficiencies in our veterinary medicines legislation to ensure that it continues to operate effectively when we leave. They will ensure that the legal framework continues to provide an effective regime for the regulation of veterinary medicines through which we can safeguard the well-being of our animals. The instrument does not diminish the high standards in the established veterinary medicines and residues surveillance regimes. I emphasise that the amendments in this instrument are to ensure operability and that the high safety standards we have in place will continue. I particularly emphasise, given the reference in the Explanatory Memorandum to some concerns, that these regulations—I repeat this on the record—are for nothing other than to retain the high safety standards that we all desire and must have in this country.

My Lords, I thank the Minister for his explicit and clear explanation of these regulations. I have very little quibble with them, but just a few points. As he emphasised, a significant change is to require the holders of market authorisations to be registered in the UK. This will impose a small burden. About £100 was estimated in the Explanatory Memorandum, which seems extremely reasonable and justified, because this measure is required to bring the market authorisation holders under UK legal jurisdiction. That is clearly extremely important to protect animal health and public safety.

The monitoring of residues, to which the Minister referred, is extremely important. As he mentioned, it is devolved. Can he tell us which processes are, or will be, in place between the devolved authorities in the UK to ensure that we maintain consistent levels and standards, so as not unduly to interfere with internal trade within the UK? I was going to ask the Minister about the concerns raised by your Lordships’ Secondary Legislation Scrutiny Committee in relation to the lowering of standards, but I accept his assurance that those concerns are unfounded.

Finally, I make a plea to the Minister, which I am sure he will fully understand. These regulations will significantly increase workload for the regulatory departments in our pharmaceutical companies, which form an important industry in the UK. I ask him to ensure that at least some degree of understanding and flexibility applies to the government agencies responsible for interacting with those companies. All in all, however, this is a very satisfactory SI.

I congratulate my noble friend the Minister on introducing this SI. I am not a vet but an associate fellow of the British Veterinary Association, and I am grateful for the briefing it has given me for today’s purposes. I want to press the Minister on the question of the potential cost. Historic and current approvals will obviously remain in place, but can he put my mind at rest on what the future cost will be? Can he also assure the Committee that the SI before us this afternoon will not potentially raise a barrier to trade?

In particular, I understand that the previous harmonisation and mutual recognition of products will not necessarily go forward. It is good that we are being nice about products coming this way, but will the Minister ensure that those going the other way will be equally assured? I understand that reciprocity will not be guaranteed in the event of no deal. I do not disapprove of the SI; I understand the absolute need for it, and welcome it. But what is happening to ensure reciprocity going forward?

Can my noble friend also give a hint to the Committee—this could be in the SI; I might have missed it—of what the cost would be of placing a veterinary product from the UK across the EU? That would be most helpful to know, as I understand that there will potentially be additional costs going forward. Could this lead to some companies, which might otherwise have chosen to establish themselves in the UK, choosing not to do so? This is one of the concerns that was expressed by the Secondary Legislation Scrutiny Committee Sub-Committee A, as it could mean a reduction in the number of veterinary medicines being available after exit. I assume this is something that the SI deals with. There are two sides to the coin. One is that a new product is going to cost more to be placed in another EU member state, or potentially an EEA country, even in spite of this. The flip side is that a company that may have wished to place itself in the UK may have second thoughts about doing so. Will this cover the situation if there is no deal, as the statutory instrument before us will presumably replace what would have been a transition period?

My Lords, as a tenderfoot in no-deal SIs, I seem to have landed on my feet in a comparatively soft zone. No one I have received briefing from thinks that this, unto itself, is a bad thing. That seems to be the general consensus. Although there are going to be small rising costs—and as we have just heard, there is always the danger that we will be going into a world that is not as good for trade as Europe as it was before—that probably comes with the territory. We will have to accept that, if this SI comes into being; that is the reality of what we have here.

My only question is—and the briefest of thumbnail sketches is all I would require—what would be the alternative? Some idea about what might be happening or what might be the other way might put in context whether this is necessary at the moment. Most of the time, everybody says it is good, but if we do not do this, what else would be available? We had a brief look at the briefing meeting which the noble Lord very kindly arranged. A little hint at what else is available might let us stare a little closer into this pool of reality that comes with these documents.

My Lords, I declare an interest as I have horses. One issue of particular concern relates to the deletion of the requirement to retest horses entering the UK for disease when initial test results are inconclusive. The omission of this requirement suggests diseased horses will potentially be allowed to enter the UK without adequate care or protection for other animals and human health after the UK leaves the EU. Does this mean that we—

May I help the noble Baroness? I have a slight feeling that this might be in tune with the next SI, on the animal products and arrangements, rather than veterinary medicines, but I may have got that wrong.

I had 2019.

They are all 2019.

Just to make it easy.

This may well come into the trade and animal-related products SI.

I will repeat it then.

Thank you for the forward notice.

My Lords, I thank the Minister for his introduction to this SI and his helpful briefing beforehand and all noble Lords who have spoken. As the EM set out, this is an important issue for animal welfare, the safety of treated animals, the people handling the medicines, consumers and the environment. It is important that we get the regulation of veterinary medicines right for the future. We know, for example, that the overuse of antibiotics in animals is contributing to a developing public health crisis, as resistance and immunity to their impact becomes more widespread. It is very important that we are able to continue to harness the best and latest scientific advice to control the use of veterinary medicines.

The EM also made it clear that a partner SI will set the future maximum residue limits. Unfortunately we do not have before us today. We have debated why that happens on many occasions, and I will not repeat those arguments.

Both the Lords and Commons Scrutiny Committees recommended that this SI should be upgraded from a negative to an affirmative procedure. They did so for two reasons, which I would like to explore in more detail. First, they had concerns about the new requirement on holders of marketing authorisations for veterinary medicines to be based in the UK. The Minister has already explained in a little detail why this is necessary. The Explanatory Memorandum states that 90 companies would have to establish a UK base. Can the Minister say whether we have concerns about the quality of any authorisations currently being carried out by these 90 companies? The cost of registering a UK base seems insignificant, but, as the noble Baroness, Lady McIntosh, and others have said, the Scrutiny Committees were concerned that some of the companies would not simply bother to register and would therefore not be able to authorise EU veterinary products being imported to the UK. Can the Minister explain the consequences for animal health if this were to happen? Could there be a shortage of products? Has any risk assessment been carried out to ensure that this will not be the case?

I am most grateful to all noble Lords for their contributions. We will consider another SI which is yet to clear JCSI. I want to put on record that I am fully seized of the point that statutory instruments should be grouped together wherever possible, appropriate and helpful to your Lordships in scrutinising regulations.

Although I mentioned it in my opening remarks deliberately, I emphasise again that this SI is absolutely about continuing existing high standards for veterinary medicines and ensuring that UK businesses and individuals can continue to access as wide a range of veterinary medicines as possible. I specifically reassure the noble Baroness, Lady Jones of Whitchurch, that there is no way that this statutory instrument can do anything to unpick the existing ban on hormone growth promoters, as it is already in UK law. I repeat emphatically that this is not the purpose or intent of these regulations.

A number of your Lordships mentioned the requirement for marketing authorisation holders to be established in the UK, which will result in a small additional cost—there are references to £100 and a further annual fee of £40. We believe it is necessary to ensure the safety and effectiveness of UK medicines and that all companies can be held accountable for the medicines they market. We have endeavoured to make this process as simple and robust as possible. The cost of establishing a UK presence is small compared with the overall cost of developing a medicine and bringing it to market. We do not believe that companies will be discouraged from bringing their products to the UK market. All new companies wishing to market products in the UK may continue to manufacture medicines in Europe and elsewhere, but as a company they must be established here in the UK.

The noble Lord, Lord Addington, is right that we considered alternatives when preparing this in order to provide the same assurance that the products in question are safe and effective. Final manufacturing and product surveillance assurance processes would have been required to take place in the UK under that alternative. That would mean moving manufacturing processes and staff and would certainly have resulted in significant increases in costs to industry. This is why we chose the option that we believe provides the necessary assurances that we would require with the least impact on and cost to business. As the noble Lord, Lord Trees, said, it is a reasonable and proportionate response to what these instruments intended.