Medical Research Techniques

Question

Asked by

To ask His Majesty’s Government what steps they are taking to promote the use of human-specific medical research techniques, such as “organ-on-a-chip” and computer modelling, in place of animal testing.

The Government provide significant funding for the development of these technologies through UKRI, primarily to the National Centre for the Replacement, Reduction and Refinement of Animals in Research. We are doubling our investment in this area next year to £20 million and this summer the Government will publish a plan to accelerate the development, validation and uptake of methods to reduce reliance on the use of animals in science.

I thank the noble Lord the Minister for his Answer, but of course animal testing is not working well. Less than 6% of cancer drugs proceed past the first small phase 1 trials, and more than 99% of Alzheimer’s drugs have failed. There are some very exciting possibilities, such as the liver-on-a-chip device that correctly identified 87% of drugs that caused liver toxicity after they passed animal tests. Many other countries are racing ahead on this: the USA has passed the FDA Modernization Act, the Netherlands has a transition programme and India has new rules for drug trials. Do we not need to go much further and look towards legislative change and a much bigger injection of funds to see real progress if we are to be world-leading in the future in this biotechnology field?

That is a wide-ranging question, and I will do my best to cover some of those points. With respect to the effectiveness of clinical trials, on the whole they cannot take place without toxicology trials and most of those, sadly, have to be done on animals. We very much welcome any technology that allows for in silico methods of assessing toxicology and it is true that more of those are emerging, but they have to be validated in order to be assumed safe and usable in clinical trials.

My Lords, the Government produced a previous report on a road map for non-animal technologies from six UK government funders, including MRC, EPSRC and Innovate UK way back in 2015. How will they ensure that this new road map does not get left on the shelf again? Will DSIT set up an independent strategic advisory board with the key stakeholders to provide direction and oversight, as suggested by the RSPCA?

DSIT continues to be led on its approach to creating non-animal methods in clinical trials, toxicology trials and so on by the UK’s NC3Rs—the National Centre for the Replacement, Refinement and Reduction of Animals in Research—for toxicology and other scientific research, and that continues. There was a decrease of 10% in animal testing from the previous year, according to our most recent records, and that will continue. DSIT meanwhile has no plans to add a new oversight executive body to those already in existence.

My Lords, I express an interest as a past chairman of NC3Rs. During the time I was chairman, we saw a marked reduction in the number of animals used in research, and that continues with certain types of animals, such as dogs, cats and so on. It is essential, though, for new drugs to be tested on animals and regulatory authorities rely on that. Is there anything we can do to help those authorities relax a little?

First, let me pay tribute to the work of the NC3Rs, which is an extremely important body. Nobody feels comfortable doing a lot of animal tests; they simply are necessary for human safety in too many cases. For example, UK REACH follows the last-resort principle where, as far as possible, it is able to waive animal tests for chemicals. That kind of work will further accelerate the work of the NC3Rs.

My Lords, the noble Baroness, Lady Bennett, spoke about other countries that were looking at alternatives to animal testing. What conversations has my noble friend’s department had with other countries on how they can encourage more alternatives to animal testing?

DSIT continues to engage on life sciences research with a wide range of other countries, including countries that have tried to accelerate further. Recently, in particular, the Netherlands and the United States have not always been able to succeed in their goals of accelerating the date by which non-animal methods of research become the only way forward. On the other hand, steady progress towards the greater use of non-animal methods through the three Rs seems to be bearing fruit, albeit not as fast as anybody would like.

My Lords, we know that there is a fast-growing global market for human-specific technologies. The size of that global market in 2023 was around $2 billion, so it is huge. Does the Minister have any views on the economic potential of human-specific technologies for the UK as a leader in this field?

Yes, indeed; the economic potential is absolutely enormous. As with any medical devices, they need to be put through proper pharma-covigilance procedures, validation and testing, to make sure that by the time we are ready for clinical trials, all the toxicology testing has been properly done. Where it is possible to find an alternative to animal testing, that should always be followed. We always aim to use the minimum number of animals for the scientific benefit to be achieved and minimise the potential harm to animals for that benefit.

My Lords, in responding to me the Minister referred to the apparent necessity of animals for toxicity tests. Of course, the case I had cited was one where liver drugs had passed animal toxicity tests and then were found to have problems with a human-specific technology. Canada has passed a Bill to phase out animal-based chemical toxicity testing and the European Commission is committed to developing a road map in that direction. As the noble Baroness on the Front Bench said, human-specific technologies have enormous potential. Will the Government look at getting an Act to provide a framework so that the UK could get ahead in this area and end toxicology testing on animals, as other countries are looking to do?

The noble Baroness mentioned an Act—there are widespread protections under the Animals (Scientific Procedures) Act. We have the three-tier licensing system, including significant training and assessment for licensees, and a range of other safeguards. Different jurisdictions are taking a range of approaches to this; I am not aware of any jurisdiction that has yet been able to set a timeline for the absolute removal of animal tests because, sadly, they do remain critical for the development of medicines.