Unliberated Creatures of the European Union

The European Union’s Directive of 2010 “on the protection of animals used for scientific purposes” laid down the rules and standards for animal research in all the member states. Its Article 58 required a review of the Directive’s own success to be issued no later than 10 November, 2017. So here it now is, or rather they are:  the summary Report from the Commission to the European Parliament, the Council, etc., of 10 pages or so, and the rather opaquely titled Staff Working Document, containing “more detailed analysis of the different consultation activities and other information sources used”, and covering about 145 pages.

Another mighty deposit of conscientious bureaucracy, then: important, because this represents the progressive front for animals in laboratories, setting and monitoring standards which practitioners in Europe will be expected to keep and will therefore have a professional interest in persuading institutions in other countries to adopt (and this does happen, to a modest extent); not very important, on the other hand, because the review comes too soon to be useful. The Directive itself came into force back in 2013, but the last of the transpositions into national law was not completed until 2015. Besides, compliance with some important parts of the Directive (notably “common standards for accommodation and care”) was not obligatory until January 2017. In short, the Report concludes that “trends in animal use at EU level will not be known before 2019.” And the most that can be deduced from all the “consultation activities” deployed in the Staff Working Document is that the Directive “is generally considered to be a sound foundation for the regulation of animals used in scientific research.” 

So these texts make a disappointing and laborious read. There’s a great mass of comment from nations and institutions, but most of it is digested into generalities, and all of it is anonymized. Occasional details do suddenly remind the dazed reader that behind all this de-personalized discourse are real places and experiences, and real animals. See under ‘Sharing organs and tissues’, for instance: the 2010 Directive (Article 18) stated that “Member States shall facilitate, where appropriate [every bureaucrat’s get-out-of-jail-free word], the establishment of programmes for the sharing of organs and tissues of animals killed”; so now we’re told, by way of compliance, that “announcing planned animal killing in one establishment by an internal calendar assists planning. Through the fog of abstract style you can descry a strange and telling bit of laboratory life there.

Or see under ‘Re-homing’. This is a practice authorized by the Directive (Article 19) provided that “appropriate measures” have been taken to safeguard the welfare of the animals. Yet it seems that out of all the many millions of animals that have passed through Europe’s laboratories during the review period of four years or so, this one possible way of coming out alive has been granted to “only a few dogs and even fewer rabbits”.

It’s a miserable picture, and it reminds me of a poignant scene in the 1883 novel Heart and Science by Wilkie Collins which I shall quote as a digression (also as a very fine piece of writing). It comes near the end of the story, when the vivisector Dr Benjulia, defeated as a scientist and despairing as a man, has gone into his laboratory for the last time, watched at a distance by one of his servants:

The door was opened again; the flood of light streamed out on the darkness. Suddenly the yellow glow was spotted by the black figures of small swiftly-running creatures—perhaps cats, perhaps rabbits—escaping from the laboratory. The tall form of the master followed slowly, and stood revealed watching the flight of the animals. In a moment more, the last of the liberated creatures came out—a large dog, limping as if one of its legs was injured. It stopped as it passed the master, and tried to fawn on him. He threatened it with his hand. “Be off with you, like the rest!” he said. The dog slowly crossed the flow of light, and was swallowed up in darkness.

The last of them that could move was gone.

As Collins says in his preface to the novel, “I leave the picture to speak for itself.”

Returning to the report: there are positive things to find in these documents. One reason for the delays in putting the Directive into effect is that some of the member states started off far behind the new standards. In such countries there may have been “no previous requirements or formal structures for project evaluation”. For them, even partial compliance with the EU rules for training and supervision will have meant “better animal welfare, better recognition of pain, distress and suffering, and better understanding of animal behaviours and needs.” The change effected by the EU Directive may have been slight in the United Kingdom, but its effect upon the sum total of EU animal research has been very beneficial.

Good evidence is provided, too, for the report’s claim that “the level of challenge to animal studies has increased” – i.e. that research projects and the laboratories themselves really are subject to stricter assessments – even though, as the animal rights groups quoted in the report (they do get a say in it) rightly protest, there is no record of projects failing altogether to pass the test. The evidence comes in the form of complaints from some of the institutions: “delays to projects have been observed”, “scientists try to avoid doing animal experiments because of the administrative burden”, “the process [of ethical review, etc.] has limited some research at their institutes”, and “The directive has necessitated closure of some animal units as they did not comply with the requirements.” These grievances, assuming them to be sincere, are surely significant and welcome.

In its preamble, paragraph 10, the Directive calls itself “an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so”. But as the Staff Working Document admits, so far during the period of the Directive’s authority there has been “no apparent reduction in animal use”. (And perhaps even that phrase is really a euphemism for ‘increase’, such as there has indeed been in the U.K.) Nor, even in the case of non-human primates, the most officially controversial of the animal research victims, does a reduction seem likely in the near future, for the report accepts the advice of the SCHEER ‘Opinion’ (reported in this blog on 17 July), and accordingly states that “no phasing-out timetable for the use of non-human primates is proposed.” So the Directive’s paragraph 10 optimism reappears now with a subtle re-direction: “The scientific community need to continue and improve efforts to explain why at this stage the use of animals in scientific procedures is still necessary.” Settle it with PR, then, and indeed one of the respondents (from the U.K. I would guess) mentions “significant progress in this area” on the part of the U.K.’s ‘Concordat on Openness’. Britain showing the way in modern vivisection, as usual; that it’s not yet the way forward is what one evidently has to learn from this 2017 review.

 

Notes and references:

The Report can be read here:   http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510252227435&uri=COM:2017:631:FIN

and the Staff Working Document here:   http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510252227435&uri=SWD:2017:353:FIN

and the EU Directive 2010/63 here:     http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF

The passage from Heart and Science, a Story of the Present Time (1883) comes in Chapter 62. The novel was discussed in this blog on 21 November 2015 at https://voiceforethicalresearchatoxford.wordpress.com/2015/11/21/the-real-benjulia/

The SCHEER report is reviewed in this blog at

https://voiceforethicalresearchatoxford.wordpress.com/2017/07/17/brothers-and-cousins/

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Brothers and Cousins

Statistics of the animal research done in Britain during 2016 have now been published. They show a decrease of about 5% or 206,000 in the annual total of ‘procedures’ (down, but not very far down, to 3.94 million). The Home Office press release announcing the statistics was headed with that notable news – notable not so much because the achievement is very great (after all, the 2015 figure had been the highest number of ‘procedures’ ever recorded), but because it represents only the second time in about fifteen years that the numbers have not gone up. And the total in 2016 is still larger than it was in 1986, when the present Animals (Scientific Procedures) Act was introduced with the aim and expectation (for a time actually realised) of pushing the numbers steadily down.

Now is a good moment to recall that aim, because the European Union’s Directive 2010/63, which has been co-ordinating the laws on animal research in all 28 member states, is about to be revised. Although the U.K. will probably not belong to the Union by the time any revisions come into effect, its own practice will certainly be influenced by them. In fact, because science is an internationally collaborative business, published in international journals, the rules and standards established in the Union are certain to have some influence in all countries where animals are used in research.

Article 58 of the Directive requires the European Commission (the E.U.’s executive) to “review” its contents no later than 10 November 2017. In doing so, the Commission must take into account “advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates”. Specifying OU primateprimates in this way, the Directive’s authors no doubt had in mind a ‘declaration’ which the European Parliament had adopted back in 2007, urging the Commission “to establish a timetable for replacing the use of all primates in scientific experiments with alternatives”. Anyway, by way of limbering up for the review, the Commission asked one of its advisory committees, the Science Committee on Health, Environmental and Emerging Risks (SCHEER), to set up a Working Group to study and report on “the need for non-human primates in biomedical research, production and testing of products and devices”. Under this same title, with its ready-made implication that such a need really does exist, SCHEER accordingly published its conclusions (formally an ‘Opinion’) a few weeks ago. These conclusions, on such an especially controversial aspect of animal research, may be taken as indicative of what animals have to hope for from the coming review.

We’re deep inside the E.U. machine here: a working group reporting to a standing committee commissioned to advise the executive on the revision of a parliamentary directive setting the parameters for (and here we at last come out into the open) actual laws in the 28 member states. And the advice itself frequently does have a machine-generated feel to it, of truth made out of words rather than real things, and all the more conveniently incontrovertible for that. “It is indeed important to consider the limitations of the NHP when choosing which species to use in a drug-safety test: the use of an appropriate species or combination of species/models is essential to obtaining the most reliable and translatable information.”[p.63] Has anything been said here that isn’t necessarily true? Is anyone arguing, for instance, that an inappropriate species would produce more reliable information? This key word ‘appropriate’, with its built-in wisdom, is much used in the authors’ proposals: “appropriate training”“appropriate standards”, and of course “appropriate use of NHPs”.

Another such passe-partout word is ‘robust’: the authors variously recommend “robust scrutiny”, “robust peer review procedures”, “robust study design”, and so on. One wonders why scientists hadn’t thought of the great merits of robustness before. Anyway, everything will surely be better in this robust and appropriate new world.

But not very much better. Distinctly this is a technical account of the subject: how to make things as they are work properly (the machine again). There are some good suggestions to that end, certainly. For instance the authors recognize, as one of the barriers to progress in animal-free research, the weight of professional habit and institutionalized practice; they advise that training courses for animal researchers should include “non-animal technologies”, so that transition is easier and more acceptable [p.64]. Also I must concede that, for all the tautologies and self-evident truths, there’s a 12-page bibliography to back up what the committee says. But the rationale for all this attention, why it matters whether there’s a ‘need’ for NHPs in science or not – in short, the morality of it – is almost untouched. Two pages (out of 66 in the main text) make a hurried tour of the topic, though it is of course alluded to from time to time elsewhere. But then all members of the Working Group were scientists. Accordingly, the page headed ‘Minority Opinion’, which looks rather promising with the whole of page 23 to itself in the table of contents, proves, when one reaches it, to be blank, apart from the word “None”.

The committee recognises, as a political fact, that “polls of the European public repeatedly show low levels of acceptance of the use of NHPs in research” [p.24]. Approval for the use of NHPs in the U.K., for instance, was about 17% when last canvassed (see, in this blog, ‘Animal Pains and Human Attitudes: the new Ipsos Mori survey’, 26 September 2016). However, there is at least “greater acceptance of animal research where animal use and suffering are minimised in line with the 3Rs principle” [i.e. Replacement, Reduction, Refinement: p.25]. This is no doubt true, although it’s a somewhat disingenuous way of putting things: where acceptance has not been ‘great’ in the first place, it shouldn’t really be said to become “greater”. And I suspect that approval would actually have been even lower if the respondents had known, as this SCHEER report records, that nearly three quarters of ‘procedures’ conducted on NHPs in the E.U. are for “regulatory use and routine production” [p.15].

What these quotations illustrate is how the “3Rs principle” is seen by scientists as a sort of ethical machine labouring away to turn expediency into good conduct, rather as the “invisible hand” of the free market was supposed by Adam Smith to convert self-interested actions into social good. In this capacity, it’s expected to satisfy or at least placate opponents of animal research. That it does not do so, and that the whole managerial attitude to “ethical considerations” understates their seriousness, is evident in the consultation document which is published alongside the SCHEER report (but which came before it in time, of course).

I must say that this 234-page consultation document is conspicuous proof at least of the diligence and fair-mindedness of the committee, which here records in the left-hand column, and replies to in the right, hundreds of queries and comments. It wasn’t in the committee’s remit to deal with ethics except as a general premise, but at least the moral passion is now allowed printed expression in raw, ungentrified form: “cruel”, “inhuman”, “abhorrent”, “nearest cousins”, “brothers”, “freedom”. True, the committee makes little attempt to address this sort of complaint (there being plenty of other more strictly scientific representations). “Stop this insane abuse!!” says one contribution (well yes, two exclamation marks, but then, as the great Aneurin Bevan used to say, “In public life, those who would change things must shout to be heard”). To such, the committee can only reply with a slightly pompous set formula: “This is a personal opinion. The comment does not provide any suggestions for improvements of the scientific basis of the SCHEER preliminary Opinion and/or any scientific evidence.” Still, such remonstrations, earnest and unscientific, are at least recorded here. Thank you to those who did speak up with this authentic human indignation.

When it issued its previous ‘opinion’ on animal research, just prior to the making of the 2010 Directive, this same science committee was called SCHER. The second ‘E’, recently added, stands for ‘emerging’, and refers to novel or reappearing infectious diseases. It’s an ominous alteration for NHPs, because this is one of the areas of research in which the committee, so far from sketching out a diminution in their use, foresees an increase. NHPs, so SCHEER claims, “provide essential models for understanding and combatting (re)emerging infectious pathogens.” Thus, for recent research into whooping cough, “a new baboon model was developed” [p.47]. That rather euphemistic phrase actually means that research was conducted, for the first time, on juvenile baboons (from two to six months old): the opposite of the 3Rs, then. SCHEER justifies such retrogressions by speaking of “realistic dangers” [p.47]. Danger, which might properly be seen as a test and validation of our ethics, is evidently expected to frighten them away. And after all, even the great apes (gorillas, chimpanzees, orangutans, bonobos), whom the E.U. Directive in principle protects absolutely from scientific exploitation, may be used “in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings” [Article 55.2].

So, shall a timetable be drawn up for ending the use of NHPs in European research, as the E.U. Parliament was dreaming ten years ago? SCHEER’s 12,000 word answer resembles the one being given in a famous Saul Steinberg cartoon from 1961. A well-fed manager of some sort, comfortably leaning back at his desk, addresses a petitioner with a mass of words, illegible but obviously full of patronizing civilities and bureaucratic reassurances. The words coalesce, above the petitioner’s head, into a giant ‘NO’.

 

Notes and references:

The 2016 statistics can be viewed here:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/627284/annual-statistics-scientific-procedures-living-animals-2016.pdf

These new statistics record about 3,600 procedures using NHPs. The SCHEER report uses the all-E.U. figure of 8898, which was the total in 2014. Note that the Home Office numbers don’t include Northern Ireland: i.e. they cover animal research in Great Britain rather than the U.K.

The 2007 Declaration of the European Parliament on primates in scientific experiments is published online at http://ec.europa.eu/environment/chemicals/lab_animals/pdf/fische_suite.pdf

The SCHEER report is at https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_004.pdf

The results of the public consultation are published at https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/followup_cons_primates_en.pdf

Aneurin Bevan is quoted in Michael Foot, Loyalists and Loners, Collins, 1987, p.36. Among other political achievements, Bevan was the Minister of Health from 1945 to 1951, therefore the man responsible for establishing the U.K.’s National Health Service.

The photograph is of a rhesus macaque monkey in Oxford University’s Biomedical Sciences Building, and is used here by permission of the University’s Public Affairs Office.