New legislation on the use of animals in experimentation looms ever larger in Europe, as officials in Brussels squabble over
the final draft of a proposal to update the rules in place now for more than 20 years. There are strong pressures from animal
protection groups in Europe for stricter regulation. Without doubt, the controls that will be put in place over the coming
months—or rather years, given the pace of the European Union's legislative machinery—will be tighter than at present, with
provisions on everything from allowable species to record keeping and husbandry. Equally inevitable, any restrictions on the
scope for testing in animals will have their impact on first-in-man trials.
The challenges were discussed at a workshop organized during the summer by the ethics working party of the European Forum
for Good Clinical Practice (EFGCP), with the support of the European Commission and the European Federation of Pharmaceutical
Industries and Associations. The unusual gathering brought together a broad range of interests—researchers, clinicians, patients,
policy makers, regulators, ethicists, and proponents of animal welfare. The focus was how best to reach a decision on when
there is enough animal data to justify going into man, while taking account of animal protection needs. The aim was to reflect
on possible ethical guidance or principles that can be used in this ethical dilemma by investigators, ethics committees, and
competent authorities—in other words, the best balance between reducing animal testing while offering the highest possible
safety for trial subjects.
Views from all sides
Tim Hammond from AstraZeneca underlined that preclinical studies in animals may be imperfect, but still represent the best
way currently available to identify toxicity and to guide dose selection for first-in-man studies. "We would still conduct
these studies even without regulatory requirements," he said. And for assessing reproductive toxicity and carcinogenicity,
preclinical studies remain the only available means to assess risk, despite advances in alternative methods. 
Peter O'Donnell
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From the perspective of the ethics committee, John Hudson of the UK Association of Research Ethics Committees noted the "increasingly
uncomfortable" challenge of reaching decisions on the basis of increasingly complex—and voluminous—data, and deriving meaningful
information for ethics committees and human volunteers to use in the process of informed consent. But in the end, he said,
there is always a decision to be taken. "It has to be taken in as objective a fashion as possible, but ethical decisions will
always be subjective decisions."
Penny Hawkins from the UK Royal Society for the Prevention of Cruelty to Animals pointed to "a significant conflict of interest
between animals and science." She insisted that the goal must be to alleviate human suffering without causing animals suffering.
"That goal is a long way off, but we have to have a positive approach to achieving it," she said.
From the patient perspective, said Cees Smit of the Dutch Genetic Alliance, what matters is the results of good research:
"If that can be done without the use of animals, that's perfect. If animal experimentation is necessary, it must be humane
and careful."
Smit argued for greater involvement of patient groups in ethics committees, as well as an international research agenda that
would reduce the number of animals used, with agreed methods so that alternatives to animal testing could be validated and
internationally recognized.
Common ground
There was satisfaction at discovering some common ground among researchers, patients, and animal rights advocates, and between
industry and policy makers, around the ethical principles of doing no harm to study participants, and of using animals only
when unavoidable in the research and development of new medicines.
While no "majority view" emerged, there were some useful contributions to thinking on the subject, and at least a list of
items for further discussion in structuring the ethical agenda. Even the fact that it was possible to discuss such a controversial
subject in such a broad, deliberately heterogeneous forum was greeted as something of a breakthrough—in itself an interesting
measure of the almost febrile atmosphere in which medicines development takes place in Europe.
