BTS response to enquiry on use of NHPs

11
Jul

The European Commission has asked the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to update its 2009 report on “The need for non-human primates in biomedical research, production and testing of products and devices. The BTS has responded to the call from SCHEER for information to aid this process.

Please the Response from British Toxicology Society below:

1. The areas of research (fundamental, translational and applied) and testing of products and devices in which non-human primates continue to be used today;

Comment:
The principal areas in which non-human primates (NHPs) continue to be used in 2016 are in translational research & testing for serious, life-threatening medical conditions where there is unmet medical need, such as viral infections including AIDS (HIV), some degenerative neurological conditions, sickle cell disease, autoimmune disease, and serious inflammatory diseases. For antibody based medicines, which are used extensively to treat cancer, the NHP is often the only human relevant species. Such studies include assessment of safety, such as the potential for a new medicine to harm a developing fetus – click HERE to see the  International Guidance for the safety testing of new biotechnology medicines: 2011 Addendum, Section 5, p13-16.

2. The currently available possibilities by type of research or testing to replace their use either with methods not entailing the use of animals or by using other species of animals including those genetically altered;

Comment:
The uses mentioned in Comment 1 are examples where currently there is no adequate alternative to use of NHPs. Nevertheless, the use of NHPs should be justified in every case by well developed arguments that
(i) the scientific question is of sufficient importance to justify the use of NHPs and
(ii) other experimental approaches would not be capable of achieving the scientific objective.

3. The scientific viewpoint on when their use would no longer be necessary, considering the type of research and areas of testing with a view to the establishment of a specific phasing-out time-table where possible;

Comment:
It is not possible to predict with any degree of assurance when the use of NHPs will no longer be necessary for the uses outlined above. The rate at which scientific knowledge advances is not linear on a temporal scale. Therefore, we feel it is inadvisable to speculate as to when human knowledge would be sufficiently advanced, that the use of NHPs in particular (or animal models in general) would be no longer necessary. Speculation risks either raising expectations that may be dashed, or might serve to underestimate the speed of progress through breakthroughs that are currently unanticipated.

4. The opportunities for the reduction and refinement of their use in areas where no replacement can be foreseen in medium or long term as per the principles of the Three Rs.

Comment:
All NHP studies require a clear scientific rationale as to why the work could only be done in primates. For safety studies of a potential new medicine, this evaluation takes into account factors such as pharmacology, the presence of human-relevant epitopes or receptors and the absorption, distribution, metabolism and elimination of the product.

5. Identification of specific research areas where effort should be made to advance replacement, reduction and refinement of the use of non-human primates in scientific procedures.

Comment:
Genetically engineered (humanized) rodent strains are suitable to replace NHPs for some types of experimental study. This is an area which should be pursued to expand the possibilities for replacement of NHPs (as has been the case in the UK under the auspices of the National Centre for the 3Rs) www.nc3rs.org.uk

6. Potential implications for biomedical research (e.g. immune based diseases, neuro-degenerative disorders, infectious diseases and serious diseases) should the use of non-human primates be banned in the EU

Comment:
A ban on the use of NHPs, despite a strong ethical and scientific justification for the work and in the absence of viable alternatives, would constrain the ability of the scientific community to expand the present state of biomedical and scientific knowledge, and may well delay the provision of important new therapies to seriously ill patients. There is also a risk that a ban in the EU would lead to the transfer of some experimental studies, from being conducted in highly regulated and welfare conscious laboratories in Europe, to other countries of the World, where animal welfare is less thoroughly regulated. If data from NHP studies conducted outside the EU was of uncertain quality for safety evaluation and human risk assessment, then additional studies may be required.