Medicinal Labelling Bill [HL]
Lord Winston (Lab)
My Lords, first, I am so pleased to see the noble Baroness sitting on the Front Bench, but so sad that the noble Earl, Lord Howe, is not fit at the moment. We agree that he is a most loved and respected Member of this House and wish him well. We fully understand that it is far more important that he recovers completely to good health than that he deal with the issues that I want to raise in the Bill. I know that the noble Baroness will give an excellent answer to the questions that I will raise. Secondly, it is rather sad that the Bill is being read on a Friday. A large number of Members of the House have told me personally that they support it, and many of my scientific friends, who are working, have been unable to come in on a Friday but have certainly been very supportive.
Why do we need a Bill of this kind? There is no question but that animal research in the United Kingdom has been considerably under threat repeatedly for a long time. Experimenters such as me who hold licences often find it difficult to do research which we regard as an ethical necessity. The biggest single area where animal research is needed is in the development of pharmaceuticals and, to a lesser extent, the development of vaccines. It is true, of course, that with reverse vaccinology and the ability to use genomic medicine, we can often design vaccines on a piece of paper, without the need for such research, but even there, vaccines have always been tested using at least eggs, so anyone using a vaccine is effectively benefiting from that research. As your Lordships will be aware, in terms of public health, the area in which we often lag behind in this country, despite the excellence of our research, vaccines are one of the most important means of protection of ourselves, our children and the population. They will always be particularly important with the rising risk of pandemic infections across the globe. Indeed, many people feel that that is a more serious threat than that of climate change.
It is a fact that virtually every drug, every medicine that we take, with the possible exception of aspirin and digitalis for the heart, which is hardly ever used nowadays, was developed as a result of animal research. The pharmaceutical industry in this country is one of our most important and critical industries. It is under considerable threat. We have seen a diminution of the pharmaceutical companies in this country. For example, it is very sad for the United Kingdom that Pfizer has moved offshore its research establishment in Sandwich, in Kent. We have lost a great deal of R&D, which is important for that work, and, with it, the trials that might be done.
I fear that one issue is that although the pharmaceutical companies desperately need that work, they have been very reluctant to put their heads above the parapet. Despite repeated suggestions to the Association of British Pharmaceutical Industries that the industry should engage the public much more readily to say why that research is necessary, on the whole it has been reluctant to make any waves which might cause more public concern about what is going on with drugs. I have to say that in medicine in general, as I am sure that your Lordships are aware, a huge number of developments could not have been possible without animal research. I am sure that everyone in the Chamber agrees that it would have been unthinkable for us to have transferred a human embryo to the uterus of an infertile patient without first making sure that an embryo transferred in the mouse and then in other mammals was not made abnormal by the culture in vitro. That is a given and we accept it and benefit from it in all sorts of ways. Medicine has always benefited from that.
The work that is done in this field is very strictly regulated by the Home Office. It is increasingly difficult to obtain a licence. I have just had a letter from the Home Office to renew my licence and I am told by my institution that unless I sign up very quickly for that process it will take me at least six months to get a licence. That is a problem for research in universities, particularly when a PhD student wants to start a project.
Of course, we all espouse the idea of the three Rs—reduction, refinement and replacement of animals—but the truth is that the figures show that the number of transgenic mice used in research is increasing, and has been steadily over some years, as it must continue to do. A transgenic mouse is a mouse that has been genetically modified in a humane way, usually by tampering with the embryo, although there are other ways to do it. These mice are important models used in the drug industry and every research establishment where animals are used in biology. The need for animal research in drugs will probably increase rather than decrease. Often we do not state that clearly enough.
Let me give one example. The most successful area in drug development at the moment is unquestionably in the treatment of cancer. It is a fact that at least one-third of us in this Chamber will eventually develop cancer as we age—unless we are thrown out of the Chamber in due course by a cull. The incidence of cancer will rise. As a result of genomic medicine, we are now able to make targeted therapies that are specific to the individual genome of that particular cancer.
As we go through life and as we age, from the egg through to the final stages of life, cell division results and more and more mutations. There are at least 100,000 mutations believed to be responsible for cancer in different cells. So far, the drug companies have managed to manufacture and target therapies for about 297 mutations. They are greatly accorded but in fact they do not work particularly well because we need to do more research. However, they often work better than any other therapy, and of course they are much more humane to the patient because the side effects are much more controlled; they do not cause the severe injury that patients suffer from. This is a very important example of where mouse models will be essential in medicine and in drug companies in future.
In my view, a packet that is clearly labelled so that the public understand that animal research is necessary for the development of the drug that they are taking or the vaccine that they are using is really important as a part of public debate, and as a recognition that this research is not only necessary but that it is done properly and humanely and is entirely ethical. The alternatives, I think, are not.
What are those alternatives? Cell culture has been posited but it does not work because it does not have the intact animal, the cell signalling is quite different in cell cultures and we cannot replace the sort of work that we do in physiology by culturing cells. Computer modelling has also been posited but is a way off what is required. Organ culture is slightly better, but often the best way of doing organ culture might well be with modified organs from animals, which would of course require animal research where we had modified the genes in those organs so that they could mimic what was going on. For example, the piece of research that I am doing at Imperial College involves modifying kidneys, livers and hearts so that we can potentially look at organs that have been humanised—for example, from the pig. That area will be increasingly important, as xenotransplantation might possibly be in due course.
I am afraid that we have failed to recognise just how humane our laws actually are. Last night I got home at about 1.30 am from a visit to Keele University, whose medical school uses animal research. The vice-chancellor said, “Of course, we keep quiet about our animal house. It has only small animals”. However, every institution should be saying that these animal houses are essential to the progress of the research that is needed for humanity. At Imperial College, where I work, there is a very large animal facility, but pretty well every university that has biological research going on must and does use animal models, as does the entire pharmaceutical industry. It makes sense that we are open about that, but for far too long we have sheltered behind the parapet because we have been frightened of threats. My friend Colin Blakemore has had firebomb threats; indeed, so have I in the past. However, although I am in the public eye and am known to be doing animal research, in the past few years I have not seen any evidence of antagonism from the public. That openness is an advantage, because if you do it properly you will be trusted.
What are the disadvantages of a Bill such as this? First, there is the question of what the attitude of the drug companies might be. Will this be costly to add to the packet? Given that, for example, for a cancer drug it might cost £600 million to £900 million to develop a single targeted molecule, it does not seem unreasonable to put a message on the packet for a few extra coppers. So why should the drug companies not do that? If you talk to scientists at these drug companies, which I have done in various companies throughout the country, they universally applaud this measure; they think that it is a good thing to be considered. What about patients? Would it actually prevent them taking their medication? I do not think so. We eat meat but people do not destroy butchers’ shops. In fact, when you think about it, animal farming is a good deal less humane than the restrictive and thoroughly humane work done in laboratories looking at animal research. Indeed, those noble Lords who have visited an abattoir will know full well how unpleasant that is compared with the cleanliness and scrupulousness of how we conduct our work with animals—for example, in a university.
The issue is therefore not only the attitude of patients, who I do not believe would present a problem, but also the attitude of researchers. In my view, it is very important for young people not to feel that the work they are doing is reprehensible. Noble Lords may not always understand this, not being in that community, but it is amazing that so many researchers who I have had as junior staff have felt very threatened—for example, by authorities who argue that their work is reprehensible or unethical. For example, I do not want to rail against the Human Fertilisation and Embryology Authority, but it is extraordinary how many of my staff were reluctant to work with human embryos because they felt that somehow that work was not regarded as being proper and appropriate. That is certainly true of animal research.
The Bill is being introduced because I believe that in our society we need more transparency in, and recognition of, the need for this valuable activity, which is essential for human health and in my view will remain so in the future. I beg to move.
Lord Willis of Knaresborough (LD)
My Lords, I rise with a little trepidation following the noble Lord, Lord Winston. I think that all of us who heard that remarkable speech recognise someone who has a real passion not only for his Bill but also for the whole of the medical science that he has been involved with. We are very grateful indeed to him for introducing the Bill.
I welcome my noble friend to the Front Bench. This is the first time that she has replied to a debate that I have taken part in. She always agreed with me when she was on the Back Benches; I trust that she will do the same on this occasion.
I speak in the debate not as a scientist—indeed, I think that all of us here feel rather humble and inadequate compared with the noble Lord, Lord Winston—but as chairman of the Association of Medical Research Charities, which represents some 127 medical research charities. Our members raise about £1.3 billion a year for medical research, which is roughly equivalent to what the Government put into medical research. This is therefore an incredibly pertinent subject for our members. If people are going to donate to medical research charities, they need to have an understanding of what it is that they are donating to, and to have confidence that their donations are going to ethical research.
As a group of charities, we are spending a significant amount of our time at our board meetings and with our members discussing the whole question of the use of animals in science, and what the grants we are making to researchers are being used for. While we are hugely supportive of the three Rs, the reality is that that is not enough. A campaign by Animal Aid, an organisation aimed at disrupting medical science, has not been effective but has been disturbing. Targeting major charities like Cancer Research UK, Diabetes UK, the British Heart Foundation and the Alzheimer’s Society, it has tried to persuade individuals that donating to these charities means donating to the evil vivisection of animals, and it is therefore wrong and they should stop donating. That is an important issue, because if we were to cut off a significant supply of resources, we would be doing a lot of damage.
The noble Lord has introduced an innovative idea in his Bill, which I am very supportive of, but there are a couple of major questions. First, would it raise awareness about animal research? Secondly, would it have any other impacts that we might not want, such as the ones the noble Lord referred to?
Labelling is not new. In fact, successive Governments have supported the labelling of tobacco products. When they brought that in, they must have thought that it was an effective way of communicating to the public that there are some pretty harmful effects when you buy a packet of cigarettes or cigars. If you are taking a drug that has been prescribed by your GP, approved by NICE and funded by the Government, there is an undeniable logic in having a simple message on it which states, “This is not only okay but has been appropriately tested on animals”. That must be right. But the reality is that simply having a message on the packet is not enough. You need to know what is behind that, and we need to do a great deal more. I am pretty sure that the noble Lord, Lord Winston, would agree with that.
The second issue is whether the provision would have any other impact. Quite frankly, that issue worries me more than the first one. There is a real problem here. The NHS spends around £9 billion a year on its drug bill but hundreds of millions of pounds is wasted because people do not take the drugs they are prescribed or do not complete the course. There is a real challenge as to whether this labelling would lead to people saying, “I will not take that because it has been tested on animals”. You would have to do some market research on the issue. I suspect that it would have a pretty low impact but the research would need to be done.
Are the public attuned with this issue? BIS, using Ipsos MORI, regularly looks at the public’s attitude to using animals in medical research. The majority of the public seem to accept that research using animals is necessary. However, the latest poll, in April 2012, shows a slight drop in public support for research. The last time the research was done, in 2010, about 73% said that they supported the use of animals in research if certain conditions were met. That number dropped to 63% in 2012, with the number of those objecting to the use of animals in medical science increasing from about 35% to 37%.
I support the Bill introduced by the noble Lord, Lord Winston, because of those figures. There is clearly a slight shift in the public’s attitude which needs to be addressed; it cannot simply be ignored as a blip. Although the number of those wanting an outright ban has consistently decreased every time a new poll is taken, the number of those who want to know more is nevertheless increasing. I think that that is healthy. If people are saying, “I don’t know how to answer your question because I don’t know what animals are being used for”, it is an important statement.
It is important that all of us involved in this area of science—whether we be scientists or charitable funders, as in my case—try to do more. The public are very supportive of medical research charities but our members have to do more. It is not good enough simply to give grants to scientists to carry out important research; we should also be telling our members what those grants are being used for. In fact, many of our grants are being used to research key conditions such as cancer and Parkinson’s and to find cures for arthritis. We are funding all those key areas. We have therefore been encouraging our charities to be much more open and to ensure that they explain their role, and they have been very effective indeed in doing so.
For instance, Alzheimer’s Research UK has produced an interesting leaflet, Why Research using Animals can help defeat Dementia, which clearly states:
“Flies and mice bred to develop amyloid and tau in their brains have been vital for helping scientists understand these hallmark Alzheimer’s proteins, tracking how they build up and finding clues to why this could be so damaging in people”.
Almost every family in the land who includes an elderly person will have somebody involved with dementia or Alzheimer’s. It is important to tell people that by using animals we are on a journey to finding at least amelioration, which we hope will lead to cures at some time in the future.
The British Heart Foundation has produced some marvellous publicity showing how vital medicines using ACE inhibitors are allowing people to live longer. Again, that is directly relevant to the reasons for using it on animals. The foundation also had a marvellous campaign using zebra fish. It had large billboards illustrating that the use of zebra fish has had a significant impact in improving our understanding of how the heart works; indeed, it has been able to look at regrowing proteins to effect cures. A significant number of our members have had similar campaigns that I could mention.
AMRC can, however, do more. We have established an animal research working group of all our members to ensure that every one of them that funds animal research talks about it and makes clear to their members what they are doing. We also recognise that we have to work with the bioscience industry to develop openness. In 2012, some 40 organisations within the charitable sector of the bioscience industry that are involved in funding animal research for medical science came together to launch their Declaration on Openness on Animal Research, which committed all signatories to agreeing principles and practical steps for the whole community.
All these steps are important in driving forward the idea. Interestingly, over the past few months the International Debate Education Association has been posing the question in universities on whether, “This House would ban all forms of animal research”. I think that the debating society at the university where the noble Lord is the chancellor debated that target. Of the 24 universities that held a debate among their young, intelligent people, every single one rejected the proposal that we should ban animal science. If you bring this debate to people and give them proper, educated, adult reasoning, the result is a buy-in and understanding of what you are trying to do.
I am sad to say, however, that there is a real issue with the Department of Health. I understand that the department does not itself fund research using animals. At this point, I should say that I could not compliment the Government more for their funding of science, particularly medical science. The Medical Research Council had an above-inflation grant from the last spending round while the NIHR, which looks at medical research within the NHS, has constantly had increased funding. I have no gripes at all in that area. When it comes to recognising that animals are used to develop scientific cures both in pharmaceuticals and in the procedures used in the NHS, however, the NHS is silent. There is nothing on the NIHR website which supports the use of animals in science but there is a bold statement which basically says, “We do not use and do not fund the use of animals in science”.
In order for the noble Lord’s Bill to have real success, it needs a buy-in from the department. The department must lead on this. It cannot simply say that it is BIS or another department that does science using animals and that, “It’s nothing to do with us, gov”. It has to be a standard bearer and say that patients are treated because animals have been used quite humanely and quite superbly in terms of finding cures for a host of diseases. I hope that the Bill receives a Second Reading and that the Government will give it a fair wind as it moves through the House.
Lord Turnberg (Lab)
My Lords, I am very pleased to support my noble friend’s Bill. I believe it is timely and important. He introduced the Bill with his usual panache which I find difficult to emulate. It is a pleasure to follow my friend the noble Lord, Lord Willis. I welcome coming after him, even though he has stolen much of what I had to say. It will not stop me, of course, but I enjoyed listening to him.
I should express my interests as a medical researcher in a previous life and now as scientific adviser to the AMRC, in which organisation I work very closely with the noble Lord, Lord Willis. In the more recent past, I was chairman of NC3Rs—the National Centre for the Replacement, Reduction and Refinement of Animals in Research. All the 120 or so members of the AMRC sign up to support animal research where that is essential to improve human health and cure disease and where it is performed under strictly regulated conditions. It is worth remembering that AMRC members represent a huge variety of patient groups, from Parkinson’s disease to cancer, from Alzheimer’s disease to asthma and from diabetes to leukaemia. So a very wide section of society who suffer these diseases or care for those suffering from them recognise the value of animal research where that is essential for improvements in their care.
In chairing the NC3Rs, it has become clear that it is also important in the context of this Bill. NC3Rs was set up by the Government to support research that would lead to ways of replacing animals in research by the use of non-animal techniques, such as those that my noble friend Lord Winston described, or if that is not possible, to reduce the number of animals needed to do a piece of research and in all circumstances to refine research to minimise the suffering of animals. Chairing that body was an interesting experience since it had representatives from not only the scientific community but industry, animal welfare organisations and the Home Office animal inspectorate. Despite those different backgrounds, there was unanimity of purpose in what we did. It turned out that neither the pharmaceutical industry nor the basic scientists were at all resistant to the idea of replacing animals or reducing the numbers of animals used. In fact, the pharmaceutical industry would be relieved of the considerable expense of animal research and would be able to avoid the opprobrium that is sometimes heaped on it for doing it.
The fact is that animal research is absolutely essential in many circumstances, and although we in NC3Rs supported some excellent work that had an impact on the use of animals, as I will describe in a moment, it remains the case that research in animals is vital in the basic science, the discovery of new treatments and the testing safety of drugs before they can be given to patients. A very high proportion of all animal research is done to test the toxicity of new treatments. Huge numbers of animals are used. The industry does not like doing it. The expense and the unpleasant publicity surrounding it does not make it easy, but it has to do it because of the strict rules of the regulators. The MHRA in the UK, the EMA in Europe and the FDA in the USA would not allow a drug to be sold unless they were convinced that it was safe for human use, as demonstrated by toxicity studies in animals. We, in NC3Rs, were able to show how the number and the range of animals used in these tests could be reduced, and the industry was very happy to take those recommendations on board, but at the end of the day the regulators have to be satisfied, quite rightly, that any new drug is safe. Of course, Home Office inspectors make sure that the conditions under which animal research is carried out are strictly controlled and standards of animal care are maintained, but it has to be accepted that research in animals is essential.
In any debate on animal research there is always going to be a wide range of views from the extreme animal rights groups at one end to the scientific community at the other, but the vast majority of people somewhere in the middle will always be concerned for the welfare of animals and be unhappy if they are treated badly or inhumanely. They certainly are concerned if there are reports of animal maltreatment and want to be reassured that systems are in place to minimise suffering and that animal use is essential for the discovery and use of new cures for their ills.
I believe that labelling all drugs with a note indicating that animals have been used in their testing, as they always have been used, would go a considerable way to opening up the public’s knowledge of how drugs have to be tested for their safety and, equally importantly, point to the care and attention that is given to controlling the conditions under which such research is carried out. I cannot see that any rational person would be put off taking their medicines by such a provision.
This Bill is one step, but I hope it will open up the discussion and bring some sense and reality to a debate that is too often surrounded by misinformation.
Baroness Wheeler (Lab)
My Lords, on behalf of these Benches, I send our best wishes to the noble Earl, Lord Howe, and welcome the noble Baroness, Lady Jolly, to the government Front Bench role. We welcome the opportunity presented by my noble friend Lord Winston in this Bill to address the important issue of animal research. There are high levels of general acceptance among the public for scientific animal research which leads to vital breakthroughs and improvements in the understanding and treatment of a wide range of human diseases and conditions.
This public support depends on the humane treatment of animals and research being carried out only if there is clear benefit and there are no other means of achieving it. It is therefore right that today’s focus is on both what information is supplied to the public to raise awareness and its possible impact and how we assess and step up progress on the overall work the Government are undertaking in this area.
My noble friend Lord Winston argues his case, in his usual fascinating and expert way, for the need to make clear to the public the important, indeed vital, role played by animal research in physiological medical research in almost every field. He is absolutely right in citing developments in his own field of in vitro fertilisation and reproductive biology and in other key areas such as cancer treatments and vaccines. We heard of other convincing examples from the other noble Lords who spoke.
My noble friend’s Bill proposes, as a key way of raising public awareness and understanding, making it mandatory for medicines to make it clear on the label that a drug has been made possible for human consumption only because of animal testing. We believe there is a compelling case for looking at how the information on drugs supplied to the user can be improved in this respect and in a number of ways. The MHRA guidance on labelling and packaging of medicines needs to be reviewed and updated. Can the Minister advise the House on the work that is being undertaken on this?
The noble Lord, Lord Willis, and my noble friend Lord Turnberg referred to the Association of Medical Research Charities of which they are leading members. AMRC is clear and up front about why its members support the use of animals in research, where it is necessary and there is no alternative, and strongly encourage as best practice the widespread use of leaflets and blogs when members talk about research breakthroughs where animals were used.
We are also having this debate hotfoot on the inclusion in the Care Bill earlier this week of a key government amendment on promoting transparency in research. That was essentially about clinical trials, but the principles of transparency in the registration, publication and dissemination of research findings and data access apply to what we are discussing today.
My noble friend Lord Winston expressed his concern and disappointment at the reluctance and failure of the pharmaceutical industry and many of the research universities to engage in raising public awareness. I am sure that he is right that much more has to be done by them to move this agenda forward. However, we share the AMRC’s cautions, as set out by the noble Lord, Lord Willis, that before a big step such as labelling medicines is taken we need to have clearer evidence about what the impact on public opinion and awareness would be, and how any negative impacts on patients and their health are to be addressed.
The Government are committed to reducing the use of animals in scientific research and ending the testing of household products on animals. We know that this is a complex issue, and I look forward to hearing from the Minister on the progress being made, although I realise that we are ranging across the responsibilities of both the Department of Health and the Home Office, and those of other departments, in this debate and the issues arising from it. The recent article from the NC3Rs chief executive, Dr Vicky Robinson, shows just how difficult it currently is to measure progress on the three Rs principles on animal research, and how we need to look behind Home Office headline animal testing figures, as well as to measure key other areas such as improvements to the welfare and care of animals that are used—surely vital information that the public want to be reassured about. They want to know how research animals are housed, cared for and treated.
Can the Minister tell the House how the Government will ensure that the data collected across departments measure the information that is needed to assess the overall picture, not just the numbers of animals tested? Are there plans to change the way data are collected in the future?
It is also worth reminding ourselves in the context of today’s discussions about the new EU directive covering animal research. I hope that the Minister will be able to advise the House on how the consultation on the directive is progressing following transposition, and how the Department of Health and the Home Office in particular are working together on the issues covered in this debate. That is, again, particularly important given the reference of the noble Lord, Lord Willis, to the Department of Health’s position on research funding.
The Government have given welcome assurances that they want the new regulations in the directive to be transposed in a way that will promote public confidence in humane animal research, and maintain and improve existing standards and rigour of inspections of research premises and laboratories. Do the Government remain committed to this? What is the implementation timetable and when will the results of the consultation be published?
The aim of my noble friend’s Bill, as he has made clear today and in press interviews, is to emphasise that animal research is an essential part of producing safe and effective ethical medicine. It gets to the heart of the debate about animal research and the need to maintain public consensus on its use, which will only continue if we ensure that it is effectively regulated, transparent about research methods and data, and that animals are treated humanely and well and are not subject to unacceptable levels of cumulative suffering. We must also ensure that the vital work of the NC3Rs in funding innovation and technological development that replace or reduce the need for animals in research testing continues to have our full support. I was grateful to my noble friend Lord Turnberg for underlining the importance of its work.
Baroness Jolly (LD)
My Lords, I congratulate the noble Lord, Lord Winston, on securing a Bill that draws attention to the important information contained on the labelling and packaging of medicines. I need to reassure him that, although the noble Earl, Lord Howe, is not here, he and I were exchanging e-mails late last night as to the content of this speech. He is here in spirit if not in person.
The noble Lord’s reputation as one of the world’s foremost medical scientists is acknowledged both in academia and in the nation’s sitting rooms. I was fascinated by his contribution today. He recognises that the importance of information which accompanies medicine is all too often underestimated, so I am grateful to him for providing the opportunity to highlight this important subject and for finding the time to talk to me yesterday about the issue. As noble Lords would expect from the contributors to the debate, it has been commendable in terms not only of standard but of breadth and depth, for which I am grateful.
I should start by making clear that the Government’s commitment to a continuing need for properly regulated and ethically conducted research using animals where no practicable alternative exists is strong. The coalition agreement included a commitment to work to reduce the use of animals in scientific research. We believe that scientific advances present significant opportunity. All noble Lords have mentioned the three Rs: replace, reduce and refine.
To this end, we are pressing ahead with a delivery plan to work towards reducing the use of animals in research which has three strands: a domestic programme, an international programme and a programme to promote understanding and awareness about the use of animals where no alternative exists. This last strand would therefore seem to be entirely aligned with the aims of the noble Lord, Lord Winston.
Central to the Government’s work on openness and transparency is the review of Section 24 of the Animals (Scientific Procedures) Act 1986. This provides for the protection of confidential information provided in connection with regulatory activities. A breach of Section 24 can result in criminal sanctions. The requirements of Section 24 are now completely out of step with our policy on openness and transparency, and with the approach taken in other legislation such as the Freedom of Information Act 2000. The solution we develop will improve the overall transparency surrounding research using animals while protecting personal identities, intellectual property and commercial competitiveness. The principle is of fundamental importance to the life sciences sector; we have heard this today. Factors such as the rapid pace of global travel, the looming threat of widespread antimicrobial resistance and an increasingly ageing world population all present challenges in dealing with many conditions which noble Lords have mentioned today.
Improved research models will be required to deal with these challenges, and animal research will play a vital role in their delivery. To retain public confidence in our work we must be open and transparent about our use of animals. In relation to the labelling of medicines, the House might find it helpful if I explain the rationale for requirements for information which accompanies medicines, particularly labelling, and the legislation which pertains to these requirements. The label on the medicine, along with the packaging and the product information are the public face of the product. The law governing the labelling of medicines is set out in European law, in title 5 of council directive 2001/83/EC, which specifies what information must appear on the label. This is replicated within Part 13 of the Human Medicines Regulations 2012, which recast the Medicines Act 1968. This European and national framework requires that some 14 items of information must appear on what are often small packages, already crowded. The legislation also states that where the information provided complies with the requirements, member states cannot refuse to authorise such packaging. A statement on animal research is not currently required as part of the information set.
The primary purpose of the medicine label is to identify unambiguously the product and to alert users to any important safety messages. Clear labelling ensures that healthcare professionals and patients can select and use medicines safely and to best effect. Although no particular size of text is specified in legislation as regards information on the label, the European Commission has published guidance which recommends text of a size not smaller than 7-point. Those of us who are ageing will appreciate that, but also note that they often miss it by a mile.
Many pharmaceutical companies struggle with three considerations: legibility of information on the packaging; keeping packaging to a minimum; and supplying packs which are easy to read. Increasing the amount of information which is required to appear on the label and the packaging is likely to have a detrimental effect on text size. This would result in all the information appearing in a smaller text size on the package, having a negative impact on users’ ability to find and assimilate key messages. In high-pressure environments such as pharmacies, this could make safe selection of the correct medicine difficult to carry out quickly.
I certainly have a personal anecdote about this. A pharmacist was unable to read clearly the different labels on two medicines that were side by side on the counter. My mother was not given the medicine prescribed for her but the neighbouring one, and as a consequence she was very poorly for a very long time. Of course, more information can be and is accommodated within the patient information leaflet that comes in the packaging of all medicines. However, again, the legislation covering those does not specify the need to include anything about whether the product or its ingredients have been subject to animal research. The focus here is safe and effective use of the product to help patients manage their disease. Where the patient information meets the legislative provisions, national competent authorities in the UK and the Medicines and Healthcare products Regulatory Agency cannot refuse to accept these.
On the key issue of European medicines licensing, there are more fundamental points at issue here than the problem of adding more material to the packaging of medicines. These are to do with the way we regulate medicines to safeguard public health. More and more medicines are now authorised through European licensing procedures. These arrangements enable a pharmaceutical company to market a product in all member states across the Community. As part of this licensing arrangement, the labelling and product information, which is approved, must be identical across the Community. This leaves no opportunity for the United Kingdom to require specific labelling statements concerning animal testing to appear. Therefore the UK is not able to act unilaterally in seeking to add new labelling requirements in an area covered by EU legislation—which is a key point. Legislative obstacles to the inclusion of this information were previously explored at European level, but proposals in this area were rejected.
At a meeting of the Pharmaceutical Committee, the European Commission’s senior pharmaceutical policy body, the UK sought clarification of the labelling provisions. The outcome was that there should be no additions to the labelling spec. Any additional information on the label included even that added voluntarily by pharmaceutical companies, and is unlikely to be acceptable. Indeed, such a voluntary arrangement could not be enforced, and a level playing field could not be ensured. This could cause confusion and uncertainty to patients and healthcare professionals alike.
Let us take into consideration the patient. Including a statement about animal testing on medicines labelling could impact adversely on patient compliance and health outcomes. Prescribers must weigh up the fine balance between the possibility of benefit from a particular medicine against any possibility of harm. The inclusion of a statement about animal testing could inadvertently shift this balance and would require additional explanation. Doctors, pharmacists, nurses and other healthcare professionals might see a significant impact on their workload, as they would need to take time to explain and reassure patients about the safety of the medicine and their rationale for prescribing a product.
A further difficulty in ensuring compliance with such a legal responsibility would be to define the extent of animal research that would require relevant labelling. It is likely that all medicines currently on the UK market will have one or more ingredient that has at some point in its development been the subject of animal research. This begs the question of how to make any such requirement meaningful, whether a timescale or threshold should be used, or a proportion of the active ingredient and/or any excipients. That challenge is likely to make the framing of any such requirement extremely difficult. In conclusion, I am grateful to the noble Lord for raising the issue, and to those noble Lords who spoke so thoughtfully in today’s Second Reading debate.
I will respond to questions from noble Lords. The noble Lord, Lord Willis, raised the issue of Department of Health funding of research. As the noble Lord will know, BIS funds annual research, but the National Institute of Healthcare Research, which is in fact an arm’s-length body of the Department of Health, builds upon that initial research, and the Department of Health is fully supportive of this. The noble Baroness, Lady Wheeler, asked about guidance on packaging and labelling. The MHRA guidance on packaging and labelling is updated regularly to reflect the latest research and learning on how the risks and benefits of medicines are communicated.
While I share the view that it is important to explain the need for and the value of research on animals and what the Government are doing to play their part, I cannot share the view that the labelling of medicines is the right vehicle to achieve those ends. The legislation on medicines labelling, which is European in origin, does not require such a statement. The UK cannot act alone in the area of medicines labelling. The potential for a statement about animal testing causing worry to patients and resulting in them failing to take their medicines as intended could lead to treatment failure and disease progression. For these reasons the Government cannot support the Bill. However, I sincerely hope that noble Lords may find a way to help the Government’s programme to promote a national understanding and awareness of the use of animals in testing where no such alternatives exist.
Lord Winston
My Lords, I am very grateful to all Members of the House who have been kind enough to speak in this debate. I am not entirely convinced by the arguments that I have heard; I will need to read the Minister’s response to my Motion in more detail before I make a considered reply to it. I am a little unhappy with my noble friend on the Front Bench on this side, who seemed to imply that it is better not to discuss things that should be open and transparent. That is a real risk here. If animal research is being used, we should state it clearly; that is a very important ethical consideration. To know that will not put people off taking their drugs; there is no evidence for that.
The noble Lord, Lord Willis, made a very cogent point about the support or lack of it in some aspects of the Department of Health, and the concern. The Department of Health has not, at the moment, shown the right way forward. It has certainly not been helpful to people such as myself, who do this research and are in the firing line. Far too often we have seen evidence that, for example, companies that supply or transport animals have been under great threat because they have not been thoroughly supported in the way they should have been.
It is important that this measure is considered seriously. I very much take the point made by the noble Lord, Lord Willis, with his usual accuracy, about the need for research about public opinion. Governments do not do that very well. It is, for example, rather shocking that social science is not very prevalent in the Department of Health. We should think about that very clearly, along with the assessment of these issues.
I am obviously very grateful to my noble friend Lord Turnberg. Both he and the noble Lord, Lord Willis, have spoken from the aspect of the medical research charities, which do such valuable work in supporting the sort of things that we are trying to do. I am very grateful for this debate; I do not intend to detain the House any longer on a Friday afternoon, as it now is. I ask the House to give the Bill a Second Reading.