Europe to Stay Open for Non-Human Primate Research


Applied Clinical Trials

Peter O’Donnell discusses the argument on whether or not European researchers should be allowed to continue using non-human primates in their research.

It's a battle that's been going on for years in Europe. Should European researchers be allowed to continue using non-human primates (NHP) in their research? This is an argument that goes beyond the familiar territory of fundamentalist objections to any animal testing at all, for any purpose-a position already widely supported in Europe. But the NHP issue divides even those who recognize the legitimacy of some use of animals, but baulk at the use of animals so closely related to homo sapiens.

For the moment at least, work with NHPs should remain permissible, according to an influential European Union advisory committee. The scientific committee on health and environmental risks has just concluded that “there is consensus within certain sections of the scientific community that, where alternatives do not exist, appropriate use of NHPs remains essential in some areas of biomedical and biological research and for the safety assessment of pharmaceuticals.”

The committee was tasked with updating its earlier opinion-reached in 2009-on this issue. Back then, it took the view that NHPs were essential for scientific progress in important areas of disease, biology, research, and safety testing-but it also insisted on the need for a regular review of this position. Since then, public concern over all animal testing has remained high in Europe, and given rise to new and more constraining legislation. Many pressure groups have increased their focus on the most sensitive aspects of animal use, including, notably, the use of NHPs.

But it is happening, and it is happening a lot. In 2014-the most recent year for which figures are available-8,898 procedures on NHPs were reported in the EU, predominantly for development and safety testing of pharmaceuticals and medical devices, treatment and prevention of infectious diseases, neuroscience, ophthalmology and (xeno)transplantation. In its new opinion, the committee sees “an urgent need to conduct systematic reviews and meta-analysis of all areas of NHP use”-to cut the number of NHPs used in unsuitable models or where they have contributed little to current knowledge. A review should also provide evidence for “more targeted use of NHPs, which is important for ethics committees and funders of research.”

“Research in NHPs represents a serious ethical dilemma which gives rise to a high level of concern from EU citizens,” the committee says. “Therefore, human interest in potential benefits for mankind must be balanced against avoiding harm to NHPs and adopting ethical limits or boundaries on NHP use.”

But complete replacement of NHPs in drug safety testing will require new insights into molecular biology, including a better understanding of signaling pathways, modeling and bioinformatics and further research into integrated testing strategies, including the identification of Adverse Outcome Pathways leading to human diseases. And new demands are being made for NHP use in science, such as emergence and re-emergence of infectious diseases where NHPs are the only relevant model.

So, in the end, the committee comes down firmly in favor of keeping the door open to NHP use. It is necessary, and if Europe bans it, then it will be done elsewhere in any case, and under arguably less caring conditions than Europe imposes.

“The close phylogenetic relationship of NHPs with humans makes them the best available animal models for addressing particular research questions,” it concludes. A total ban would make further progress impossible in research into immune-based diseases, neurodegenerative disorders, infectious diseases, and serious diseases.

And “tightening of the existing strict EU regulations for NHP use may lead NHP research to transfer to other countries to the detriment of animal welfare,” says the committee. Since animal welfare standards for laboratory NHPs are on average higher in many

European countries than in other parts of the world, it follows that if NHP research is forced outside of Europe then there would likely be a net decrease in animal welfare, it argues. And the committee adds a warning that the departure of research from EU territory could “impact on the quality of the research, on public health and accessibility of treatments developed under different standards, and on local economy.”

So, for the moment, NHP research stays.

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