Draft Food and Drink, Veterinary Medicines AND RESIDUES (amendment ETC.) (EU Exit) Regulations 2019

Sandy Martin Excerpts

Wednesday 20th March 2019 General Committees

[Sandy Martin (Ipswich) (Lab)]

Whether or not we protect GIs here in the UK, will that have any further effect in the rest of Europe? If we introduce new GIs in the UK, will the rest of Europe recognise them?

[David Rutley]

I will answer the hon. Gentleman’s question about new GIs later in my speech, but on the UK GIs that are currently in operation, our understanding is that the EU will continue to recognise those, because we are listed in its legislation.

In addition, the instrument will amend retained EU law on the method of analysis used to ensure that spirit drinks comply with the relevant rules. It also amends retained EU law concerning the documentation that must accompany the movement of wine and imported wine, the certification of wine and the registers that must be kept by wine operators relating to the wines handled by them.

The Government launched a public consultation in October 2018 to seek the views of stakeholders and the public about our proposed new UK GI rules. The majority of respondents supported the Government’s proposals. GIs are intellectual property and, as such, reserved. The relevant powers currently exercised by the European Commission will therefore be transferred to the Secretary of State. We have worked in partnership with the devolved Administrations on the whole of this instrument, and where it concerns devolved matters, they have given their consent.

I turn to the provisions on veterinary medicines. This is the second EU exit statutory instrument to cover veterinary medicines. The other, with which Opposition Members may be familiar, is the Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019. That instrument has already been debated in, and accepted by, both Houses.

The instrument we are debating covers three areas of veterinary medicines. It transfers powers and functions to set maximum residue limits for veterinary medicines. It provides for veterinary medicines that have been approved by the European Medicines Agency to remain on the UK market. It also makes necessary consequential changes to the fees charged by the Veterinary Medicines Directorate, as set out in the Veterinary Medicines Regulations 2013.

Maximum residue limits 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 UK MRL-setting framework is necessary to ensure the safety of produce from food-producing animals.

Veterinary medicines are devolved to Northern Ireland, so the power to set MRLs is shared between the UK Government and the Department of Agriculture, Environment and Rural Affairs. The Department for Environment, Food and Rural Affairs will be able to act on a UK-wide basis with the consent of DAERA, and the Veterinary Medicines Directorate will continue to act as the UK-wide regulator to ensure consistency. In addition, this instrument brings across from the European Medicines Agency the existing MRL application fees of £62,300 for a new MRL and £18,850 to amend an existing MRL. As stated in the explanatory memorandum, these fees will be reviewed as soon as possible.

As a cost recovery agency, the VMD recovers its assessment costs from the pharmaceutical industry. Until the data is available in a few months’ time to underpin a more accurate cost base, the VMD will administratively and significantly reduce the fee, to better reflect the actual cost of the assessment. Once a robust cost base has been established, the fee in the legislation will be amended, and that will be subject to consultation.

Medicines approved by the EMA—there are only 389 of them—account for a small percentage of all veterinary medicines in the UK, at 13%. However, they are often novel treatments and substances, so it is highly important for these medicines to remain on the UK market after we leave the EU. This instrument provides for their conversion to UK national approvals, with no charge for the conversion. Pharmaceutical companies will not need to take any immediate action to enable them to continue to market their products in the UK.

Lastly, this instrument makes minor consequential changes to the fee schedule charged by the VMD for the function it carries out. Apart from bringing over the existing MRL fees, which I have set out, these are minor corrections, and no new VMD fees are being introduced.

The amendments proposed to schedule 7 of the Veterinary Medicines Regulations 2013 are merely to correct deficiencies arising from us leaving the EU. Without these amendments, the UK would be unable to regulate the marketing and use of veterinary medicines effectively. That would have negative impacts on business, as well as on our ability to protect human and animal health and the environment. This instrument will maintain the existing high standards for the safety, quality and efficacy of veterinary medicines.

In line with the Government’s better regulation principles, and given the small costs involved, a formal impact assessment has not been carried out. The impact on business has been assessed as being well below the threshold requiring an impact assessment. Although a formal public consultation has not been carried out, 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 Association and 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. NOAH has expressed some concern that introducing a separate MRL-setting regime for the EU could increase burden and cost on industry. The Government recognise that MRLs are key to facilitating trade in animal produce, and will therefore look to align with international standards when setting MRLs.

[Sandy Martin]

In addition to the additional cost of this process, is there not a real danger that it will be difficult to carry out if there is a shortage of trained and professional staff?

[David Rutley]

The good news is that we have those trained and experienced members of staff available, and we are ensuring that, whatever the eventuality, we will have the resources available for the change. As the hon. Gentleman has intervened, it is important for me to answer his previous question about whether the rest of Europe would recognise new GIs from the UK. That would not happen automatically; new UK GIs will still need to apply for EU GI status, although the Government will support them in that. However, existing ones would be protected.

The steps I have outlined will ensure high-level protection for human health. MRLs must be based on sound science and data; the UK has a proud and growing reputation in the area of food, and GIs play an important part in that. The Government are committed to protecting and celebrating the success of those products and driving further market access to make sure that they and other great British food are enjoyed around the world. For the reasons I have set out, I commend this statutory instrument to the Committee.

[Dr David Drew (Stroud) (Lab/Co-op)]

I am delighted to serve under your chairmanship, Mr Austin, and to see the Minister in his place. We see an awful lot of each other at the moment, and will no doubt see each other again.

I start with our usual caveat: this is an incredibly complicated bit of legislation and, to be honest with the Committee, I have not completely got my head around it yet. It is very complex, bringing together a number of different issues that, in a normal state of affairs, we would look at separately and scrutinise in some detail. To make sure that we are all on the same page, GI refers not to an American serviceperson, but to geographical indication. That is quite important, because we will not have Cheddar cheese or various ciders if we do not get this right. We have to do our bit as an Opposition, despite the problems posed by the number and complexity of these SIs.

For this SI, I will start with something slightly different, and ask some quite complicated questions that I hope the civil service will be able to answer for the Minister or in tandem with him. If not, I hope that the civil servants will be able to write to me in due course through the Minister. Some quite separate issues have been conflated in this SI, so I am doing the best I can. I will start with some fairly complex, but nevertheless important, issues.

Paragraph 6.4 of the explanatory memorandum states that the maximum residue limits

“are set to protect consumers from residues of medicines in produce. These limits are used to establish withdrawal periods (the period that must elapse after the last administration of the medicine before produce from that animal may enter the food chain).”

My question is quite simple: how long are the withdrawal periods, and will those periods be the same length regardless of what happens next week?

Paragraph 6.5 states:

“This instrument provides for the conversion of veterinary medicines issued by the European Medicines Agency (EMA) to UK approvals in order for these products to remain on the UK Market.”

My question is whether UK approvals will be recognised in the EU market, or whether we will have to go through a different process.

My hon. Friend the Member for Ipswich has already picked up on the issue of costs. As NOAH has intimated, there is certainly some concern about the fee structures, because we are changing the mechanism by which these medicines are being regulated. If there are additional costs, are the Government aiming to defray those in any way? Again, we received no regulatory impact assessment, which is always very sad, because those assessments are supposed to provide that kind of information. We therefore have to rely on the Government to give us some indication of what those additional costs may be; there is certainly no such indication in the explanatory memorandum.

Paragraph 7.7 of the explanatory memorandum states:

“All GI applications will go through a single UK scrutiny and opposition process, rather than the two-stage process for applications”

that currently exists under the EU scheme. Will the Minister say something about whether that is sufficient? Could it limit scrutiny for geographical indications? Again, it is a matter of not just what is allowed, but what is not allowed. We all know the arguments about who claims Cheddar cheese and so on. These things can get terribly complicated if we are not careful. Producers get very hurt when their particular product is undermined by something that claims to be something that it clearly is not, yet people are able to sell it.

[Sandy Martin]

Does my hon. Friend agree that where such controversies arise around geographical indications, we currently have recourse to debate, consultation and reconciliation processes in the EU, but we will no longer have recourse to them once we have left?

[Dr Drew]

Of course. At the moment, I am not quite sure what is in place and what is not. That brings me to my next point, about the appeals provisions for those who have made an application. The provisions say that those who have a legitimate interest can appeal to a first-tier tribunal. Is that tribunal set up, and who will be part of it?

Then we come to the logos. Logos matter here because they are the only way the general public can tell exactly what they are buying. Currently, the Government intend to introduce a new UK process, whereby geographical indications for a product will be clearly labelled in this country, but what ability does this country have to then negotiate with the EU over the acceptability of those logos in what will be a different marketplace?

I could go on at great length, but I am trying to get to the kernel of what the Government are trying to do with this legislation, albeit that it is largely a cut and paste from existing EU regulations. Paragraph 10.3 of the explanatory memorandum states:

“Respondents were happy with the proposed three year adoption period until logo use becomes mandatory on food and agricultural products.”

Why was a period of three years chosen, and will that period begin on 29 March or some date thereafter?

Finally in terms of my detailed questions, paragraph 12.2 states that changes to packaging requirements are the only ones

“introduced by this instrument that present significant cost implications”.

That brings us back to the issue of cost. Clearly, if we are changing logos and the way in which those logos are regulated, an additional cost is implied, at least in terms of the logo and the packaging. Why is there no mention of that in the legislation?

As the Minister rightly said, my friends at the National Office of Animal Health will be the ones mainly concerned with this legislation, because they are the representative body for veterinary medicines. I have to say that they are largely happy with it and with the way it is being carried through. The Minister was right that they had some questions about how it is going to work in practice. I certainly looked at the time periods, which is where NOAH is most quizzical regarding the changes in our relationship with not only the EU but third countries. Clearly, products will come to this country that will then be sold on to the EU. It would be interesting to know what discussions the Government have had, within and without this country, to ensure that this process is as seamless as possible.

This is one of those complicated SIs. Trying to struggle through it is very difficult. In terms of what it does, it is very important to so much of our agricultural produce, because that produce will be branded—it will have its own logo and its own statement of what it really stands for. We have to hope that the disruption is as limited as possible, but it is something we will have to watch.

It would be interesting to know what scrutiny the Government intend to carry out when and if there are complaints, and how they will handle those complaints. How can we be sure that food products, and particularly veterinary medicines—which are the bit that is most about safety—are being properly regulated? If there is a new system, such as a tribunal to which appeals will go, we will need to know that it is transparent and up and running. Those involved in making food products and veterinary medicines need to be sure that they will be able to sell them as far afield as they have in the past. That is something that has to carry on, rather than being threatened by huge disruption.