November 28, 2014, by Carmen McLeod
Will a spoonful of ‘awareness’ help the medicine go down?
Lord Robert Winston, well-known scientist and professor of fertility studies, would like the public to be made aware that experiments on animals are involved in the development of all medicines, vaccines, and drugs for human use. To this end, he introduced the Medicinal Labelling Bill in October 2013 which, if passed, would make it mandatory for pharmaceutical companies to label all their medicinal products with a message along these lines: “This pharmaceutical product has only been made possible by the use of research in animals”. By raising public awareness about the role of animal research in the development of medicines, Lord Winston predicts there will be a corresponding rise in public appreciation of biomedical research on animals. But raising awareness can have unpredictable results, and is not the same as providing members of the public with the opportunity to really engage with the complex issues associated with animal testing.
Medicinal Labelling Bill
The Medicinal Labelling Bill was read a second time in the House of Lords on 25 October 2013, and is currently at the Committee review stage. At the second reading of the Bill, Lord Winston argued that animal research has been under threat for a long time, and that greater transparency was necessary in order to engender public trust, and that this Bill would contribute towards this goal. In the subsequent debate following Lord Winston’s opening remarks, a number of concerns were raised. Some of these related to the complications of dealing with medicines under the EU regulatory framework which already requires around 14 different items of information to be included on labels. Mandating a statement about the role of animal research in the development of a medicine would be challenging on “small packages, already crowded”, and could potentially impact on the legibility of the text. Another concern that was raised, related to the potential impact on the workload of healthcare professionals, who might be required to provide reassurances and explanations to patients about their medicines in connection with the animal testing labelling. Two of the peers contributing to the debate also highlighted that some patients might refuse to take their medicines, if information about animal research was added to the product packet.
Will more public awareness lead to greater public support?
Professor Michael Balls also has reservations about the Bill, and in an editorial for Alternatives to Laboratory Animals (ATLA), he argues that there is a discrepancy between Lord Winston’s “laudable aim” of promoting openness, and the limited information proposed to be included on pharmaceutical product labels. Even taking into account the practical restrictions of limited space on medicine labels, the information that is proposed in the Medicinal Labelling Bill is not a neutral statement. Indeed, Lord Winston makes it clear in his introduction to the second reading of the bill, that the only take-home message the public should have after reading a medicine label, is that all animal research is necessary and there are no alternatives:
“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… 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”.
But not everyone thinks members of the public would necessarily be more supportive following raised awareness about animal testing on medicine labels. Dr Laura Waters, a scientist who works in pharmaceuticals development, is opposed to animal testing. However she actually agrees in some ways with the idea of the Medicinal Labelling Bill, as she predicts more information would decrease public support for animal experimentation, and increase support for alternatives.
The devil is in the detail
The development of all new medicinal products in the UK is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). Before a drug can be given to human volunteers in a clinical trial, it must first pass through mandatory toxicology safety tests on rodents (usually rats), and then on a larger non-rodent mammal species (most frequently dogs). Other species of animals may also have been used in earlier research development of a pharmaceutical medicine, and this work is regulated by the Animals (Scientific Procedures) Act 1986. Animal research also involves ‘basic’ research which seeks to understand fundamental biological processes and may not directly lead to the development of a medicine, or be obviously connected to a major breakthrough. Therefore any individual medicinal product may involve a complexity of animal species and procedures in the development process, and will be covered by a number of different regulatory instruments. Over the past few decades there have been increasing calls from groups critical of animal testing for more information to be made available about this complex (and controversial) scientific work. In the last couple of years, members of the ‘pro’ animal research lobby have also started to articulate the need for greater openness and transparency about biomedical research on animals.
‘Opening up’ animal research?
Earlier this year, a Concordat on Openness on Animal Research was announced, with over 40 signatories from universities, industry and funding bodies. The Concordat focuses on the need to provide more nuanced and detailed information to members of the public about animal research. It is clear from the Concordat that there is hope that greater openness will lead to greater understanding and acceptance of animal research. It is less clear however, whether there will be opportunities provided for scientists and citizens to have a constructive dialogue about the experimental use of animals. Nonetheless, there is a commitment in the Concordat to provide “accurate descriptions of the benefits, harms and limitations” of animal research.
This commitment to making more information available about the complexities of animal research (and perhaps revealing some of the uncertainties), seems at odds with Lord Winston’s Medicinal Labelling Bill. The proposed statement that all pharmaceutical medicines are only ‘possible’ because of animal research seems to obfuscate the multifarious ethical and scientific dimensions that underlie biomedical research and pharmaceutical testing which uses animals. In an article in Nature, Lord Winston explains that the object of this Bill is: “to encourage discussion and to ensure awareness and openness about animal testing”, even if it is ultimately unsuccessful in passing. However, like the space limitations of a small label on a medicine bottle, it is difficult to see how this Bill can open up any genuine opportunities for citizens and scientists to have meaningful discussions about animal research. It seems increasingly unlikely now that the Medicinal Labelling Bill will be passed, and we will have to wait and see whether there are any other positive outcomes from this initiative, as Lord Winston hopes.
Dr Carmen McLeod is a Research Fellow in the Leverhulme Trust Programme: Making Science Public: Challenges and Opportunities at University of Nottingham. She is working on a project called ‘Animals and the Making of Scientific Knowledge’, which is exploring the relationship between science and society in the context of the governance of animal experiments. Carmen is currently working on several publications relating to: transparency and animal research; RRI and the 3Rs; and the role of stakeholders in a HO consultation on animal experiments.