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

Lord Trees Excerpts

Wednesday 27th February 2019 Grand Committee

[The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Gardiner of Kimble) (Con)]

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.

The UK’s regulator, the Veterinary Medicines Directorate, is already established as one of the leading regulators in Europe for veterinary medicines and will continue to lead on the international stage. The current legislation is designed to work in the context of EU membership. Some elements will therefore not work sensibly in a national context. Part 3 of this instrument amends the existing national legislation. For example, the mutual recognition provisions for medicine approvals between member states are no longer relevant. Similarly, approvals of generic marketing authorisations rely on the sharing of information between member states, and cannot continue to operate in the same way. Minor corrections are also made to the text to address references concerning EU membership which are no longer accurate or appropriate.

The instrument introduces a change in relation to the location of holders of marketing authorisations for veterinary medicines, which is needed as a consequence of leaving. Marketing authorisation holders must be established in the UK. As set out in the Explanatory Memorandum, this may result in a small increase in cost to those marketing authorisation holders currently based outside the United Kingdom. This is necessary to ensure that there are appropriate regulatory controls to ensure full compliance with UK law and standards, and that all marketing authorisation holders are treated equally. It is vital that marketing authorisation holders can be held accountable for their products, and these regulations provide for that.

Part 4 of the regulations sets out the necessary amendments to retained EU regulations. Regulation 470/09 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.

The Government have proactively engaged with the animal health industry to ensure that the regulatory regime continues to function effectively after exit day. I have 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. Industry has welcomed our proactive and continued engagement with them. We have also worked comprehensively with the devolved Administrations on this instrument where it relates to devolved matters, and they have given their consent to this instrument being made on a UK-wide basis.

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 products on the market; and ensuring UK businesses and individuals can continue to access a range of veterinary medicines. This instrument will help to maintain the established veterinary medicines and residues surveillance regimes, and ensure that an effective regulatory framework for veterinary medicines is in place. It remedies deficiencies in the law to enable that operability and I beg to move.

[Lord Trees (CB)]

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.

[Baroness McIntosh of Pickering (Con)]

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?