2

The Use of Legislative and Other Controls on Animal Research to Meet Public Expectations and Improve Animal Welfare

It is generally accepted that there should be controls on how research on animals is carried out in order to limit harm caused to them. In this chapter I describe various ways in which controls at various levels (e.g. super-national, national, local) can be used to enforce or ensure minimum standards of animal welfare.

2.1 Introduction

Legislative controls are an obvious and attractive option when considering how to best protect the welfare of animals used in research. Legislative controls aimed at minimising harm to animals during their breeding, transport and use in research provide a clear and strong message to those involved of the concern that society has about the practice. Legislation provides a means of monitoring and controlling the activity, and if research is not carried out properly so as to minimise harm, there is the ultimate recourse of penalties and other sanctions. So it is surprising that, in many parts of the world, legislative controls on animal experimentation have been a long time coming. The first law regulating experiments using animals was passed by the UK in 1876; in Australia, Victoria introduced legislation in 1883, but other Australian states did not follow suit until considerably later. Denmark passed animal welfare legislation in 1891, Germany in 1933 and Sweden in 19441, but the legislation of many other countries is much more recent.

To provide just a few examples: in the USA, the Laboratory Animal Welfare Act was first passed in 1966, with important additions being made in 19872; Brazil passed the Arouca law in 2008; Chile passed the Animal Protection Law in 2009, although at the time of writing in 2012 it was still not yet properly implemented with respect to animal procedures as the National Bioethics Committee had not been constituted3; in Japan, despite the large number of animals used in research, there is no specific legislation to protect animals, although the government has produced guidelines; and a proposal for animal welfare legislation in China was produced in 2009 but as yet there is no law. While many countries do now have legal controls, there are significant national differences in both the regulations and their implementation4. In some countries, for example, legislation has been specifically enacted to address the issue of the use of animals in research, while in others research is covered as part of more general animal welfare legislation.

Legislation, however, is not a panacea for solving animal welfare and other ethical issues involved in research. By their nature, legislative provisions enforce minimum standards rather than current best practice. Higher standards are often possible, and the decision as to whether to adopt higher standards lies with the researchers, and the institutions in which research is carried out. So, paradoxically, those who carry out research on animals are often in the best position to have a positive impact on the animals’ welfare. Researchers in particular are key. They are the ones who make the initial choice to use animals and decide on the types of technique or procedure used on the animals. It follows that they are well placed to take available steps to avoid or reduce animal use, or to minimise or ameliorate any distress, pain or suffering that may result from their research. And researchers often do succeed in making such improvements. There are plenty of examples of animal users who, by developing replacements to animal use or better methods that result in less suffering, have improved the welfare, not just of their own animals, but also of those used by other researchers5.

However, it is obvious that responsibility for minimising suffering and ensuring good welfare should not lie just with the researcher. Most researchers want to carry out high-quality science while minimising any suffering that may occur, but animal welfare may not be their speciality and they are not disinterested parties. Financial and other constraints can also conspire against the best interests of the animals. External controls, particularly legal controls, can provide animal care staff with persuasive arguments to convince higher management that certain actions are necessary. I once carried out a mini-survey on managers of facilities that bred or carried out research on marmoset monkeys, asking what their priorities were when planning new housing (Table 2.1). The respondents were asked to rank the choices but, as is common with surveys, ignored the instructions and ticked the categories instead. Moreover, all but one ticked two of the categories. While this survey was carried out some considerable time ago now, and undoubtedly could have been done better, it appeared that legislation was a powerful driver of decisions, far outranking the respondents’ own views as to what might be in the best interests of the animals in their care.

Table 2.1 Priorities of respondents when asked what factors affected their choice of marmoset caging.

Source: Hubrecht (1997).

Finally, as discussed in Chapter 1, one very important function of legislative controls is to provide reassurance to the public that research is being carried out with proper checks and balances. These need to be comprehensive, as illustrated in an Australian senate committee report which suggested that if public confidence and support for the use of animals in research was to be maintained, it was essential that the animals’ welfare was protected and promoted, that there was transparency of process, public participation in ethical decision-making and that there were mechanisms for accountability6.

So, legislative controls on the breeding, supply and use of animals in research are useful and arguably essential, but care has to be taken to find a balance between the sometimes conflicting needs of the various parties involved, namely the researchers, the animals used in the research, and any of the general public who have concerns about the research. To achieve this balance, legislation must ensure minimum standards of good welfare and must provide reassurance to the public that things are being done properly, but should not be overly restrictive or bureaucratic.

Other authors have described and contrasted the many different ways that legislation has been used to control animal research in different jurisdictions7. Moreover, legal controls are not the only way of ensuring animal welfare and developing higher standards. Codes of practice and non-statutory recommendations have also played a part and deserve to be discussed alongside legal controls. So, in this chapter I will concentrate on the principles of control and oversight of research, looking at what can be controlled and the different means by which it can be achieved, using examples predominantly from the USA and Europe.

2.2 Levels of Control

Controls on animal experimentation can be, and are, applied at a number of different points in the process of planning, carrying out, and reporting of animal experimentation. National or in some cases international controls and regulation can be applied through the legal system. However, other bodies can also play a role in regulating animal research. Funding bodies, regulatory agencies, research institutions, sectors of industry and professional associations can all set their own controls, publishing expectations and requirements on minimum standards, or through systems of accreditation.

2.2.1 Local controls

The ultimate responsibility for the animals used in the research, and thus the first level of local control, lies with the researcher who devises the study. Researchers, like any other group of people, vary in both what they think is ethical and in what they are personally prepared to do. So while the researcher’s decisions on the nature of their research are important, many establishments have also developed controls at an institutional, corporate, or group of institutions level, limiting what can be done and specifying how it should be done. Local controls can cover almost any aspect of animal use, from controlling how specific procedures should be carried out to establishing institutional standards on issues such as animal husbandry (i.e. enclosure dimensions and enrichment provision) or staff training.

One might ask why local controls are necessary if the research is carried out in a jurisdiction where there are legislative controls that set minimum standards. In some cases local controls may be required by legislation, but whether they are mandated or voluntary, their importance lies in the fact that they allow establishments to set their own limits as to what is acceptable in their institution. For example, some institutions might decide not to carry out primate research, or perhaps only allow research that causes no more than moderate suffering. It might seem odd that institutions should wish to limit their operations in this way, but there are various reasons why it might be beneficial for them. A desire to operate, and to be seen to operate, ethically is one. An example of a sector where there is a particular need to keep a close eye on public profile vis-à-vis the use of animals is the pet food industry. Pet food manufacturers need to research into and test various aspects of the diets they produce to ensure that they are safe and meet the animals’ needs, but for commercial as well as ethical reasons might well wish to limit the types of animal research they do. Similarly, charitable organisations researching cures for human disease depend on public support and thus might wish to keep an eye on the public...