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Draft Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020

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

Debated on Wednesday 25 November 2020

The Committee consisted of the following Members:

Chair: David Mundell

† Brereton, Jack (Stoke-on-Trent South) (Con)

† Britcliffe, Sara (Hyndburn) (Con)

† Buchan, Felicity (Kensington) (Con)

† Coyle, Neil (Bermondsey and Old Southwark) (Lab)

† Davison, Dehenna (Bishop Auckland) (Con)

Grady, Patrick (Glasgow North) (SNP)

Hillier, Meg (Hackney South and Shoreditch) (Lab/Co-op)

† Jenkinson, Mark (Workington) (Con)

Johnson, Dame Diana (Kingston upon Hull North) (Lab)

† Mann, Scott (North Cornwall) (Con)

† Moore, Damien (Southport) (Con)

† Morris, James (Lord Commissioner of Her Majestys Treasury)

Nichols, Charlotte (Warrington North) (Lab)

† Prentis, Victoria (Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs)

† Smith, Jeff (Manchester, Withington) (Lab)

† Sunderland, James (Bracknell) (Con)

† Zeichner, Daniel (Cambridge) (Lab)

Seb Newman, Committee Clerk

† attended the Committee

Sixth Delegated Legislation Committee

Wednesday 25 November 2020

[David Mundell in the Chair]

Draft Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020

With this it will be convenient to discuss the 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.

It is a great pleasure to serve under your chairmanship, Mr Mundell, particularly—if I may say so—in your new slimline state. I have been gripped by social media—

That is all I needed to say. The draft regulations were laid before the House on 2 November. Turning first to the veterinary medicines and residues regulations, veterinary medicines are tightly regulated in the UK. They are essential for the treatment of animals and ensuring animal welfare, but they 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 UK Veterinary Medicines Regulations 2013 set out the requirements on the manufacture, authorisation, supply, possession, and administration of veterinary medicines in the UK. The statutory instrument before us addresses technical deficiencies in our veterinary medicines and residues surveillance legislation to ensure that it continues to operate effectively at the end of the transition period. For example, minor corrections are being made to the text to address references to EU membership, which are no longer accurate or appropriate. The changes are also needed to reflect the requirements of the Northern Ireland protocol, as well as to implement the Government’s commitment to ensuring unfettered market access for Northern Ireland businesses in relation to veterinary medicines.

The legal frameworks will continue to regulate veterinary medicines and to safeguard the wellbeing 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 the instrument are to ensure operability and that the high safety standards we have in place will continue.

The second SI is a composite one, covering seven policy areas—aquatic animal health, transmissible spongiform encephalopathies and animal by-products, livestock, zoonotic diseases, pet travel, alien and locally absent species in aquaculture, and seed, plants and propagating material. They have been grouped together purely to speed up the passage of these affirmative SIs before the end of the transition period.

The regulations transfer functions carried out by EU legislative bodies to the appropriate UK authorities. They also amend previously made EU exit statutory instruments to reflect the changes that took place at the end of last year and to implement the Northern Ireland protocol. The SI makes no major policy changes.

The instrument makes operability amendments to several pieces of secondary legislation. In particular, it will continue our robust sanitary and phytosanitary safeguard regimes in several crucial areas, give effect to our obligations under the Northern Ireland protocol and allow our new systems to operate at the end of the transition period. It will allow for the continued movement of pet animals and assistance dogs into Great Britain in a manner that protects our biosecurity as well as the health and welfare of the animals being moved.

We have taken the decision to list the EU to import live animals and animal products because, in biosecurity terms, we do not believe the risk will change on 1 January 2021. The SI will allow for decisions to be made about a country’s certification processes for plant reproductive material and whether they are equivalent to our own.

We have amended our legislation so that by the end of the transition period, the EU will become Part 1 listed for the non-commercial movement of pets into Great Britain. Practically, that means no change for EU travellers. We are maintaining the current health requirements on pet movements from the EU based on the unchanging disease risk at the beginning of next year, and to ensure that there is minimal impact on pet owners and users of assistance dogs who travel with their pets into GB under the EU pet travel scheme.

The instruments will make sure that legislation to ensure our biosecurity will continue to function in Great Britain after the transition period, and that we will continue to have a functioning pet travel scheme and imports system that guarantees our high standards of food and animal safety while ensuring frictionless trading and movements. For the reasons I have set out, I commend the draft regulations to the Committee.

It is a pleasure to serve with you in the Chair, Mr Mundell, and to be with the Minister again today. There is something rather important about the statutory instruments before us. I am not sure that anyone thinks that considering them is soporific because most Members, in my experience, are quite keen on knowing what they will have for tea later. Somewhere down the line, this could well affect what we find being served up in the Members’ Tea Room, so it is important stuff. [Laughter.] I will come to it—do not worry. I also have a direct interest in the sense that I chair the all-party parliamentary group for life sciences. I have many life science researchers in and around my constituency, so I know quite a lot more about this issue than I did when I came to Parliament a few years ago, and it is important.

Paragraph 2.2 of the explanatory memorandum explains what the instrument does, which is pretty much what the Minister said:

“In England and Scotland, the Residues Regulations prohibit the use of certain substances as growth promoters and provide for a surveillance programme for residues of veterinary medicines…Regulation 470/2009 establishes maximum residues limits for pharmacologically active substances in foodstuffs from animal origin.”

That is, of course, quite salient to many of the debates that we have had in recent times. Paragraph 7.2 states:

“The policy objective is to maintain existing laws.”

We agree with that overall objective; the question is whether it will be achieved. Paragraph 7.3 talks about

“light touch regulatory controls on medicines that are approved in Northern Ireland and not Great Britain and that move from Northern Ireland onto the Great Britain market.”

Could the Minister elaborate a bit on what those light-touch regulatory controls actually mean?

I am grateful to the British Veterinary Association, whose members obviously deal with such matters on a day-to-day basis, for giving us some advice. The BVA said:

“In the medium term there may be concerns about the availability of medicines in Northern Ireland. Today, medicines are often shipped from the EU and warehoused in GB. They are then moved in smaller quantities to NI. Friction in the Irish Sea could make this difficult. For example, there could be a requirement for batch testing once medicines enter Northern Ireland. Northern Ireland is a small market. Similarly, if there are additional costs associated with sending medicines to Northern Ireland companies may choose to exit the Northern Ireland market.”

It is therefore very important that we get this right. I am frequently accused by Ministers of being unduly pessimistic about the future, so here is a note of positivity from the BVA, which says that

“an agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed”.

That is good news, and it came from the Ireland/Northern Ireland Specialised Committee, which apparently met on 5 November, but it leaves some longer-term questions in the air. The BVA concludes:

“The concern is that there may be a requirement for a standalone authorisation process for Northern Ireland. As a result of the small market, this could see medicines companies choose to forgo the market.”

It is important that we get these things right in the future.

I am also grateful to the Secondary Legislation Scrutiny Committee in the House of Lords, which often does excellent work in this area. There is some correspondence between that Committee and Friends of the Earth, which had asked very detailed questions that the Department answered. It showed me the level of complexity in all this. With the best will in the world, I am not sure that any of us has the capacity, knowledge or time, frankly, to dig through the levels of complexity to be absolutely sure that nothing has been either overlooked or, if one were being unduly negative, passed through the back door in some way. The questions from Friends of the Earth certainly bear looking into. I will not trouble the Committee with the fine detail of each part, but I would be grateful if the Minister wrote in response to one or two of their points.

There is a detailed legalistic discussion about whether the analysis of animal product samples is subject to two pieces of legislation, one of which is removed in the first SI. The Department argues that it is replicated elsewhere, but I do not think Friends of the Earth are entirely convinced by that, though I am not in a position to judge.

The second question is more serious. Friends of the Earth argue that within the regulations there are so-called reference points for action. That essentially means points at which the standards are reconsidered. There are some to come in future, prompting a discussion between Friends of Earth and the Department as to whether we would replicate that process. The answer from the Department is only that we are committed to maintaining high standards. Frankly, that is not an answer. I would read that answer to mean that there is no guarantee, which potentially weakens the position we would have been in if we were not taking this course of action. On that basis alone, it gives me cause for concern.

What gives me more concern when I think about what might be in the Tea Room later—or many years hence—are maximum residue levels. That is the vexed question of what is still left in the animal when we come to eat it. There is a complicated series of questions posed about whether to shift to an administrative process rather than a legislative one. I would argue that the Department has not put our minds at rest on that process. That again suggests a potential weakening of our protections.

Some may ask why any of that matters. I will quote my good friend, the learned Lord Whitty, speaking in the House of Lords. Members will appreciate that much of this has been discussed before, when we were going through the process last year. Lord Whitty put the case very well. He said:

“MRLs are ultimately there to protect the human and, in some cases, animal consumer. They are there for a health reason. It is very important that we do not go backwards. The withdrawal period specified in the EU legislation—the period since the animal last received those medicines—is important to preserve but does not exist in the same way in other jurisdictions around the world. If we are entering new trade agreements with, say, America or Brazil, they will be operating on different systems. We must be careful.”

Lord Whitty asked that we check on one particular protection. He said:

“The Americans portray hormone injections as medicine but they are really there for growth.”—[Official Report, House of Lords, 20 March 2019; Vol. 796, c. 301GC.]

I suspect the Minister knows where I am going with this discussion, as all roads in these debates tend to lead ultimately to chlorine-washed chicken and hormone-fed beef. My concern is that deep in the intricacies of the legislation there are potential back doors opening to allow lower standards. That is something the Opposition are not prepared to allow.

The other SI deals with a range of issues. As the Minister said, it covers seven policy areas: seed, plant and plant propagating material; aquatic animal health; transmissible spongiform encephalopathies and animal by-products; livestock; zoonotic diseases; pet travel and the use of alien and locally absent species in aquaculture. That is very wide ranging and there is some question about how those issues are grouped. Some of the things we are discussing this afternoon were previously grouped with some of the things we discussed this morning, which adds to the confusion, I am afraid. No one ever said this was going to be easy.

I gently suggest that anything relating to spongiform encephalopathies and salmonella will cause politicians of a certain age to be on alert. Of course, that dispute ran for years and years. It strikes me as astonishing that people talk about how easy everything is to sort out when we spent a decade having an argument with the European Union, with all those “Dad’s Army” posters on the front of The Sun and all the rest of it, over one item of dispute. Goodness knows what lies ahead, but that is for another day, sadly. These are important issues and they need to be resolved properly.

Finally, I come to the subject that probably concerns the most people: the pet travel issues. As the Minister said, these SIs touch on that. As I understand it, something like 300,000 pets come into the UK at the moment. There are some concerns about those numbers and about puppy smuggling. Anything the Minister might want to say about that would be welcome. I again welcome the work of the Secondary Legislation Scrutiny Committee in the House of Lords, because it has asked some serious questions about that, and again I will refer to the Government’s answers. It is all about which direction we are going in, basically. We can make our decisions, but it is not so easy for us to take pets into the EU. The EU is apparently now considering our application to be a Part 1 listed third country, and the Lords Committee rightly said:

“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”

transition period. Anything the Minister can tell us about that would be extremely helpful.

The Secondary Legislation Scrutiny Committee also asked about the practical impact of having separate regimes in areas such as TSEs and zoonotic diseases. DEFRA’s explanation was:

“Changes for goods moving from Great Britain to Northern Ireland will be kept to an absolute minimum”—

oh, joy—

“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”.

Frankly, that is the same old magical thinking and we are not convinced by it. On that basis, we are not convinced by either of these pieces of legislation, but we will divide the Committee only on the first.

The hon. Gentleman asked a large number of questions, and I will try to answer them as best I can. He asked about the light-touch transparency arrangements in veterinary medicines. A medicine that is legally on the market in Northern Ireland but not in GB may benefit from unfettered market access, providing that the following conditions are met. The marketing authorisation holder, if it is not already based in Northern Ireland, must have a dedicated place of establishment in Northern Ireland. The holder must provide the same application dossier and supporting information to the Veterinary Medicines Directorate as it would have provided to the European equivalent. The Northern Ireland dedicated place of establishment must provide access to any EU-based pharmacovigilance system that the marketing authorisation holder has in place. If the conditions are met and there are no safety concerns, a certificate will be issued to allow the product on to the GB market. In brief, we are trying to work in a joined-up, sensible and proportionate way as we come to the end of the transition period.

I am also grateful to the scrutiny Committee in the House of Lords. As the hon. Gentleman knows, I love secondary legislation, which is good because we spend a lot of our time doing it at the moment, and I spent many happy years on the Joint Committee on Statutory Instruments. I feel that the questioners on the scrutiny Committee in the House of Lords did not completely understand the purpose of this statutory instrument, but I am happy to answer those points in any event.

As we said many times during the passage of the Agriculture Act 2020, any future trade agreements must respect the retained regulatory autonomy that we have brought over as a result of the withdrawal agreement. We will continue to protect public, animal and plant life and health, and reflect our existing high standards. The EU law banning the import and production of hormone-treated beef has been transposed into domestic law and will continue to operate in the UK at the end of the transition period. That will apply in all parts of the UK. Any changes would require legislation to be brought to Parliament. After the transition period, the Food Standards Agency and its equivalent in Scotland will continue to oversee food safety to ensure that all food imports comply with the UK’s high safety standards. You will be aware, Mr Mundell, of the changes made recently to the Agriculture Act that add an extra layer of scrutiny to that.

All current EU maximum residue levels will continue to apply in the UK from the end of the transition period. The methodology is set out in Commission regulation 2018/782, which now forms part of our retained EU law, with only very minor amendments for operability. There is nothing—I do love secondary legislation—that concerns me about our new regulatory system. I accept that it is complex, but it is also comprehensive.

The Veterinary Medicines Directorate—this may be of assistance to Committee members—has published extensive guidance on its information hub, which will help businesses prepare for the end of the transition period. This hub has, broadly, been very well received by the veterinary medicines industry. I recognise that this legislation, especially where it amends other legislation, is not always easy to read, or to follow. I suspect that that is one of the reasons why the VMD has engaged so strongly with its stakeholders to ensure that they understand it.

The hon. Gentleman’s question on pets is not exactly within the scope of this instrument, which relates to inbound travel of pets and guidance dogs to the UK, but as he has asked, I will answer. DEFRA has submitted its application for the UK to become a Part 1 listed country under Annex II of the EU pet travel regulations; we are currently in technical negotiations with the EU about this. We will do what we can, and we intend to make sensible, proportionate and biosecure changes in the regulations.

We have had a constructive and useful debate, and I commend the regulations to the Committee.

Question put.


That the Committee has considered the draft Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020.

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


That the Committee has considered the 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.—(Victoria Prentis.)

Committee rose.