(1 year, 10 months ago)
Lords ChamberI 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.