Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019
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Lord Gardiner of Kimble
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.
Relevant document: 14th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee A)
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.
Lord Gardiner of Kimble
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.
Lord Gardiner of Kimble
This may well come into the trade and animal-related products SI.
Baroness Jones of Whitchurch (Lab)
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?
Can the Minister also respond to concerns that if we banned products from EU companies that did not have a base in the UK, the EU could retaliate and ban UK-authorised products in the EU? Can he clarify whether products authorised by UK marketing companies will still be valid in the EU after exit? This is particularly concerning given that mutual batch testing would cease after Brexit. This would mean that additional checks for veterinary medicines manufactured in the UK and exported to the EU would have to apply. Is any dialogue taking place to ensure that these trade issues are resolved? Has an assessment of the risks to UK research and business been carried out?
The EM gives the reason for requiring a UK base as being to facilitate enforcement, as the Minister said. It goes on to say:
“The ability to prosecute a holder in appropriate circumstances is an important deterrent to bad practice”.
Can the Minister explain what these bad practice risks are? Which UK agency would prosecute the companies if bad practice continued to exist? Have there been any prosecutions in recent memory? I am trying to get to the bottom of where that concern really lies.
The Scrutiny Committee also raised concerns about the potential lowering of safety standards in respect of certain amendments. Clearly this is a scenario we would want to avoid at all costs. The SI appears to retain many of the standards currently in operation within the EU. Can the Minister confirm that we will comply with EU regulatory standards or standards at least as stringent as those currently in place?
We will no longer have the checks and balances on standards which the EU offers. Responsibility for some decisions will now be delegated to the Secretary of State. For example, under Paragraph 22, the veterinary medicines regulations are amended to say that before placing an immunological product on the market, written approval must be sought from the Secretary of State. Can the Minister clarify which agency or department will be authorised to give this approval and what scientific evidence will be required?
With regard to applications for new or amended residue limits, page 9 refers to an appropriate authority producing an assessment report with a risk assessment. In this case the appropriate authority is again defined as the Secretary of State, so will he, in effect, be making a recommendation to himself? Can the Minister clarify how the responsibilities will be defined so that there is a separate assessment and decision-making function?
There are several references to exporting countries having,
“equivalent medicines regulation standards to those of the United Kingdom”.
Can the Minister clarify who will determine whether those standards are equivalent?
For the avoidance of doubt, can the Minister state categorically that there is nothing in this SI that would enable the USA to start exporting hormone-injected beef to the UK? He will know that this is a matter of great concern to the British public. I look forward to his response.
Lord Gardiner of Kimble
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.
My noble friend Lady McIntosh raised the issue of UK companies wishing to market products in the EU. At this stage, the European Medicines Agency has been clear on its expectations. Marketing authorisation holders, final manufacturing certification and post-authorisation surveillance must all be located in the EU. As I have said, our approach has been somewhat different. We have intentionally intended to be pragmatic. We think that is the right way forward. On whether there will be any changes in the arrangements, this is the position as we understand it at the moment. I think this is an area where continuing collaboration is important.
I profoundly agree with the noble Baroness, Lady Jones of Whitchurch, about the imperative of reducing the use of antibiotics in livestock. We must reduce it in humans too. In livestock, there has been a 40% reduction already. We need to go further for all the reasons we understand about animal and human resistance.
Lord Gardiner of Kimble
I am most grateful to the noble Baroness. The EU knows about our arrangements. The way in which we have set out the market authorisation holders could not be a stronger signal to our European friends that we have found what we think is an appropriate way of ensuring that we have the protections we believe we need. We are not being draconian or difficult; we believe that it is important to have an international trade in good animal medicines. That is what we seek. For those reasons, I will look at Hansard for any other points to address. In the meantime, I commend the regulations to the Committee.