Baroness Parminter:

Moved by Baroness Parminter

22: Leave out Clause 14 and insert the following new Clause—“Precision bred animal marketing authorisations: reporting obligations(1) Before issuing a precision bred marketing authorisation for the first time, the Secretary of State must establish a monitoring system for the reporting of potential adverse effects on the health or welfare of such animals or their progeny which must enable—(a) the voluntary reporting to the Secretary of State by keepers of animals, animal health and veterinary professionals, or others, of adverse effects,(b) the mandatory reporting to the Secretary of State by the marketing authorisation holder of adverse effects, and(c) relevant information to be available to support future research.(2) Regulations under subsection (1) may—(a) define what is meant by adverse effects on health and welfare,(b) prescribe information to be required from the notifier for reporting adverse effects to the Secretary of State,(c) make provision for requiring the recipient of marketing authorisation to take prescribed steps, in connection with supplying such an animal to another person, to secure that prescribed information about the subsequent health and welfare of that animal or its progeny, is provided by, or can be collected from that other person, and(d) determine the period after marketing authorisation that such reporting of adverse effects on the health and welfare of animals or their progeny of a given precision bred technique is to be required.(3) Regulations under this section are subject to the affirmative procedure.”Member’s explanatory statementThis amendment requires that, before precision bred animals are marketed, there be mechanisms established for reporting possible adverse effects on the animals’ health and welfare or that of their progeny. Regulations shall define adverse effects, details of the information required, and the time period over which it is required for any given precision breeding technique and application.

My Lords, Amendments 22 and 23 are in my name and that of the noble Lord, Lord Trees. My name is at the head, but they are really joint amendments, and we grateful for the support of the noble Baroness, Lady Hayman, on the Labour Front Bench and my noble friend Lady Bakewell of Hardington Mandeville from the Liberal Democrats. The aim of the amendments is to ensure that a very clear monitoring system is set up in advance of when gene-edited animals are marketed. This is to ensure that the lessons can be learned about any adverse, or indeed positive, effects on animal welfare so that, throughout the process, we can make those learnings available to others so that animals can benefit in the future.

The provisions in Clause 14, which we are proposing this amendment as a replacement for, say that the Government “may” do this—but this is a fundamental issue about whether or not we are ensuring that a proper surveillance and monitoring system is in place right from the beginning. We would certainly concede that it is appropriate that the regulations to implement such a provision were in secondary legislation, but that is not what Clause 14 says: it basically says that the principle of undertaking a monitoring system is only a “may”, not a “must”. As was referred to earlier this evening, in comparable legislation—the Human Fertilisation and Embryology Act—the principle of having a surveillance and monitoring system in the Act and the regulations for how to deliver it are in secondary legislation. This seems to be a reasonable position.

The Minister talked on a number of occasions this evening about the research project with a Scottish university on how these regulations might work in practice. If you have the provisions on how they will be delivered in secondary legislation, that seems to be appropriate. But our amendment would put in the Bill a provision that the Government will introduce a surveillance and monitoring system and that the information will be recorded and available to inform decisions in the future to guarantee animal welfare— which is a common theme that we have covered this evening.

I am grateful to the Minister and the Bill team for their meetings with me, the noble Lord, Lord Trees, and others on this matter between Committee and Report. I do not wish to put words into the Minister’s mouth, but I can guess what he will say in response to our amendment, given the email that the noble Lord, Lord Trees, and I received from the Bill team on 13 January. The objections were that what was in the Bill was proportionate and what we were asking for was not a proportionate form of regulation. The exact words were that our amendment

“could be seen as being too burdensome a requirement for industry and would remove our ability to scale back reporting requirements in the future if we have a scientific basis for doing so”.

To be clear, our amendment is about putting in the Bill a requirement that there is scientific monitoring; we are not saying that the regulations need to go in the Bill. But the Bill team basically says that making it effectively something that the Government must do— putting it in the Bill—is too “burdensome” a requirement for industry. That does not seem a proportionate approach to a regulatory process, where you are balancing the rightful requirements of people going into this new industry against public benefit and animal welfare. This gets the scales wrong.

This is compounded when the email goes on to say:

“Introducing a requirement on the face of the bill to require and publish data from clinical outcomes from research would also curtail our flexibility and could lead to issues with commercial sensitivity”.

Again, it is not beyond the wit of man for Governments to produce regulations in secondary legislation that ensure that legitimate issues of commercial sensitivity are handled—but that should not preclude the duty on companies to supply that information so that lessons can be learned for the benefit of both animal welfare and public confidence, which is an issue that I think the noble Lord, Lord Trees, will address in some detail.

So I look forward to what other noble Lords will say and how the Minister will respond to both our amendments. I reserve our position on moving to a vote. But we think that this is a really important way of doing what the Government say they want to do: move ahead with this in a step-by-step way, while ensuring that the evidence is retained from the relevant companies and available to inform future research.

I am grateful for the excellent introduction of the noble Baroness, Lady Parminter, which carries my name and those of two other noble Baronesses. I am also very grateful to the Minister for our meetings. As he and others in the House will be aware, I strongly support the Bill, and I commend the Government on including animals in it. Alongside existing animal welfare legislation, the new breeding technologies promise great benefits to animal health and welfare by reducing the burden of disease, thereby maintaining food production with potentially fewer animals, and reducing land use, the use of drugs and chemicals, the carbon dioxide footprint and greenhouse gas emissions.

I will expand on the productivity issue. Productivity goes both ways: you improve productivity by producing the same amount from fewer animals. Reducing the disease burden will enable us to produce the same amount with fewer animals, with concomitant advantages.

I thank the Minister for the amendments he introduced earlier. Although I have great enthusiasm for the modern technologies and for this Bill, which will facilitate the uptake of those technologies, this enthusiasm—and I note that in Committee the noble Baroness, Lady Hayman, referred to mine as “gung-ho”, which I take as a compliment—is not shared by everyone. If we want these technologies to be applied and the benefits to be realised, it is going to be essential to take the public with us and ensure public confidence so that they take them up and accept them. This amendment, as the noble Baroness, Lady Parminter, has elegantly said, basically makes it mandatory in the Bill that there shall be a reporting process for potential adverse effects post marketing. So it differs in that respect from Clause 14, but much of the rest of our amendment is copied from Clause 14.

What we are suggesting is also a two-tier reporting system. The first tier is a voluntary system, proposed for individuals such as farmers, keepers of animals, veterinary surgeons and animal health professionals. But for the commercial bodies that hold a marketing authorisation, there should be a mandatory requirement to collect data about the possible adverse effects on PB animals’ health and welfare and to submit that data at periodic intervals.

I will make a number of key points on the amendments. First, they mirror precisely current regulations with regard to possible adverse effects of drugs marketed for veterinary use, and indeed for human use, both of which have voluntary as well as mandatory reporting systems in place.

Secondly, we submit—and I reinforce the points the noble Baroness, Lady Parminter, made—that we do not feel that what we are asking is disproportionate, in that only the commercial sellers of these animals, the people making money, have the legal obligation to collect adverse effects reports and notify of them. But there is a provision for others to do so voluntarily, which could be a sort of check that the notifiers are not ignoring potential problems.

Thirdly, surely it is in the interests of the developers of a new product to safeguard the reputation of that product by seeking and surveying and monitoring the possible outcomes of the development when used in the real world.

Fourthly, the definition of an adverse effect can be made in regulations, and indeed that is already provided for in Clause 25. But I suggest it should refer to issues over and above the expected health issues that might affect any conventionally bred animals but might reasonably be associated with a particular breeding technology. But this requirement can be time-limited under regulation for any given precision-breeding method.

Fifthly, this can be quite a light-touch system. For example, the reporting of adverse effects of veterinary medicines requires an online pro forma which can be sent in digitally to the Veterinary Medicines Directorate, which assesses it. That directorate, of course, already exists. The marketing authorisation holders could also submit their reports in the first place to something like the VMD, which could triage them and then pass them to the Secretary of State for consideration by the animal welfare advisory body, which is already set up —we are not asking for new bodies to be set up.

Sixthly, and perhaps most importantly, the public acceptance of precision-bred animals is hugely important if the Bill is ultimately to be of value, and I submit that it will be a considerable reassurance for the public to know that the sale and commercial breeding of precision-bred animals will be monitored for unforeseen negative effects post-marketing to complement the pre-marketing reporting requirements under Clause 12.

Seventhly, such post-marketing monitoring will also provide both the animal welfare advisory body and the marketeers with essential feedback on the robustness, validity and safety of their pre-marketing assessments. That would be important to inform them and help them develop, if necessary, better systems.

Eighthly and finally, the Minister has assured us that the use in animals will be phased in. Surely, if one is phasing in, one would want to monitor what was happening to the first group in the real world when it is being sold and used by farmers. Only then, by collecting that information, could you be assured, at the end of whatever length of time that phase is, that it is safe and appropriate to proceed to subsequent phases. I would argue that phasing in automatically suggests that one needs to be monitoring what is happening in that first phase, which will involve thousands of animals but will be a real-world experiment to prove or disprove the safety of the system. I do not expect there to be major problems, but it will give assurance to the public. On these collective grounds, I support Amendments 22 and 23.

My Lords, I thank the noble Baroness, Lady Parminter, for her thorough introduction to her two amendments, to which I am very pleased to have added my name. We strongly support what she is trying to achieve. We believe that there does need to be a reporting process for the adverse effects on the health and welfare of animals and, of course, their progeny. The noble Baroness, Lady Parminter, talked about the importance of evidence being retained to inform future research, as did the noble Lord, Lord Trees. This is also about public benefit; we discussed public benefit a lot in Committee, and it does need to be central to the Bill.

As the noble Baroness also said, we need to understand any lessons that can be learned. The noble Lord, Lord Trees, put it very clearly and succinctly when he talked about “robust” feedback. When we look at the first tranche of animals, we need to have the confidence that the industry is acting appropriately, that the outcomes are what we would hope to see and that we can catch anything that perhaps is not what we hoped for.

The noble Lord, Lord Trees, talked, importantly, about public confidence, as did the noble Baroness, Lady Parminter. If we are to carry the public with us, the future monitoring of animal health and welfare, consequences and outcomes is really important. Understanding adverse events is therefore terribly important. The noble Lord talked about drug introductions in the veterinary field, and we should have the same principles here, I believe, if we are to carry the public with us.

It does not seem to me that this amendment is disproportionate in any way. Instead, it would bring in some really important checks and balances and underpin what the Government are trying to achieve. I urge the Minister to consider very carefully what noble Lords have said. If the noble Baroness wishes to test the opinion of the House, she will have our support.

My Lords, I repeat, again, that I am a very strong supporter of this Bill and everything it stands for. However, again, as I have said at every stage and indeed a moment ago on the previous grouping, the one weakness of the Bill is around animal welfare. Anyone reading the Hansard of the passage of this Bill through the Commons will note that it was the greatest concern of MPs too, but they failed to make even a dent in the Government’s protective carapace on this issue.

In Committee, many noble Lords from all sides of the House—myself included—put down amendments to try to minimise the possibility of any genetic change being proposed or implemented that could result in the future suffering or discomfort of, or distress to, animals or their progeny involved in the process. However, none of these amendments was put to the vote. We now have a well-thought-out amendment—or two—which precisely covers the worries that we all had and attempts to avoid them. The Government should think seriously before they reject them.

I thank noble Lords for their engagement on this important issue. I am grateful for the meetings that I have had with noble Lords from across the House on this and for them taking the time to share their thoughts with me and with the House on this occasion. I have found it constructive and enlightening.

We recognise that there is a need to safeguard animal welfare in the new regulatory regime; we are all united on this. That is why we are taking a step-by-step approach with regulatory changes for plants first, followed by animals. The measures in this Bill in relation to precision-bred animals will come into force, as I said before, only when safeguards for animal welfare are in place. This will include a monitoring and reporting system for the precision-bred animals once they are placed on the market.

The Bill will give us the ability to place a time-limited and proportionate duty on breeders and developers to monitor for significant health and welfare outcomes in animals that could be linked to their new traits and to report such outcomes to Defra. This monitoring and reporting system will be informed by research that we intend to carry out—which I have already spoken about—to help us identify the specific outcomes that must be reported, as well as appropriate timeframes and numbers of generations that must be monitored for each species or type of animal.

We believe that the powers in the Bill are sufficient to enable us to put this monitoring system in place. Clause 14 sets out that regulations may require the notifier, or any other person specified, to provide information to the Secretary of State about the welfare of the relevant animal and its qualifying progeny. The regulations may set requirements on the information that must be collected, and they allow the Secretary of State to apply reporting requirements in a bespoke manner. This flexibility is essential to ensure that any obligations placed on businesses are proportionate to risk—this is the key point that I hope I may be successful in getting across.

For example, proposed subsection (1)(c) of the alternative clause proposed by the noble Baroness, Lady Parminter, and the noble Lord, Lord Trees, would require the Secretary of State to mandate developers to share additional information for the benefit of other developers and researchers. It may be difficult to reconcile these requirements with the right of businesses to keep commercially sensitive information out of the public domain. I understand that there is a difference of opinion here, but I am led to believe, by people who understand the legal parameters within which we operate, that this really is important.

Clause 18 already provides adequate powers to share relevant information about marketing authorisations as required, while making sure that sensitive information is suitably protected. These powers will work alongside the powers under Clause 15, which enable the Secretary of State to make regulations setting out the circumstances in which an animal marketing authorisation should be suspended or revoked, such as on health and welfare grounds.

I turn now to Amendment 23, for which I thank the noble Baronesses, Lady Parminter, Lady Hayman of Ullock and Lady Bakewell of Hardington Mandeville, and the noble Lord, Lord Trees. This amendment would allow regulations under Clause 18 to require records of clinical outcomes, and any adverse effects and outcomes, of precision-bred animals and their qualifying progeny to be published on the register of precision-bred organisms. I think that this is there in the Bill—Clause 18(1)(j) already allows for regulations to prescribe additional matters relating to this Act to be included on the register.

I just reiterate that, before applying for a precision-bred animal marketing authorisation, the notifier will need to carry out an assessment of whether the health and welfare of a precision-bred vertebrate animal and its qualifying progeny are expected to be adversely affected by any trait resulting from a feature of the animal’s genome that results from precision breeding. This part of the application is not intended to be a tick-box exercise but, rather, a substantive assessment of risks to animal health and welfare that may result from the precision-bred trait. It will require a substantive assessment backed by a submission of data to show how a range of relevant criteria have been assessed.

I hope that, in the light of these points, I can persuade the noble Baroness and the noble Lord to consider not pressing their amendments.

I thank the Minister for that reply. Sadly, it is quite clear, in the almost immortal words of the noble Lord, Lord Cameron, this evening, that we have not yet managed to make a dent in the Government’s protective carapace on this Bill—it is a great phrase—which is a disappointment, as a number of other amendments earlier in the evening led up to this amendment.

I do not want to spend much time. I just want to make two points to the Minister. He did not answer the fundamental question that Clause 14 says only that regulations “may” make provision. There is absolutely nothing to stop a future Government—and I do not wish to impugn the Minister’s character or motives—not doing anything at all. It is not about the regulations in future; they do not need to introduce a surveillance monitoring system in the future because all that is in the Bill is that regulations “may” make provision. If it was regulations “must” make provision, that might have made a difference, but the Minster was not prepared to concede that.

Secondly, we have a difference of opinion on the issue of commercial sensitivity. I referred to other legislation in comparable fields of human research where this issue has been overcome, and the noble Lord, Lord Trees, outlined other legislation in the veterinary field where this commercial sensitivity issue has been addressed with wording in legislation to that effect.

So I am not content with what the Minister has said. I have seen where we have been heading this evening, but I think it is a matter of principle. For those of us who feel strongly about this, this was a solid amendment seeking to do a good job to help this Bill from both sides of the House, and I wish to press it to a vote.

Ayes 161, Noes 176.

Amendment 22 disagreed.

Clause 18: Precision breeding register

Amendment 23 not moved.