Post the adoption of Directive 2010/63/EU in September 2011, this law is now being translated and implemented at national level, across Europe.

Take a look at the current status in your country and if you think it’s not up to date, and the process has moved to another stage, we’d love to here from you.

The new directive, Directive 2010/63, will come into effect at the beginning of 2013. Being new to this legislation, I wanted to get a better understanding of the impact it would have, particularly on lab animals. So I’ve tried to summarize key elements and the thinking behind the new policy.

Revising Directive 86/609
After being in use for 20 years, the 1986 directive no longer reflected all the scientific changes that have taken place, including today’s use of transgenic animals, more sophisticated science and more non-animal research methods (alternatives).  There was also no mention of appropriate care and handling of different types of animals or any enforcement of good practice.

From a research point of view, authorization of a research study varied greatly from country to country, ranging from 30 days to more than 200 days.

So in summary there was a need to adapt to new thinking and technology, to set European standards that would help to create a level playing field across Europe and enforce good management of animal care.

Key objective of Directive 2010/93
The new legislation ensures that animals are used according to certain standards, and only as a last resort only because there isn’t a viable alternative method. Researchers must always apply the 3Rs principles – the least possible distress and pain, the lowest numbers and sound justification that the animals are really necessary.

Target audience of the directive
This directive governs virtually every sector that uses animals for research and development of products such as chemical and pharmaceutical industries as well as those developing cosmetic and consumer goods. Not only does this legislation affect the researchers, it also gives legal direction to lab animal breeders and transporters of lab animals.

Key legislative changes
The biggest shift in the text appears to be the move from optional best practice, to mandatory procedures. Below are some of the key changes:

Improved legislation:

• Each research project must pass a project (ethical) review. The proposed research must prove that it’s scientifically justified, and the researcher has applied the 3Rs principle of reduction, refinement and replacement. Part of the review now includes a cost/benefit assessment; showing the benefit to the patient or consumer, versus the harm done to the animal.
• The authorization system is now mandatory however most member states had this system in place already.
• The text has become clearer about the use of alternatives where they are available.
• The use of non-human primates has been restricted to essential biomedical research only.
• Some animal welfare staff are now mentioned and the role of the veterinarian and the animal welfare officer have been strengthened. There is now a requirement to have an animal welfare body within the research organization, which provides ongoing advice about, among other things, the 3Rs principles, accommodation, care and welfare of the animals and review of procedures.

New legislation:

• Member states must perform a certain number of inspections per year, some of which are unannounced.
• There are new detailed standards on caging and housing.
• The 3Rs principles are now very clearly referenced throughout the legislation, which removes any ambiguity.
• To increase transparency, research application must now include a non-technical summary outlining the process and objective of research project in layman’s terms. If the application is approved this lay summary will be published on the Internet.

All up, the legislation is much stronger than before and includes penalties for non-compliance.

Next steps
Right now all 27 member states are in the process of translating the new directive for national implementation on 1 January 2013. Over the coming months Animal Testing Perspectives will be following the activity at national level to see how the legislation is being adopted.

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What if I told you that these technologies already exist and the trick now is to pull them together, apply them and have them accepted by authorities? Well, it’s true.

Some of these tools can be used by themselves, others can be combined to find innovative approaches to research and testing.

By using so-called Integrated Testing Strategies (ITS), major progress could be made in moving towards the 3Rs.  This approach means using tailor-made combinations of animal and non-animal research methods in developing and testing new medicines, although hurdles remain before Europe makes the leap into this new era.

As we mentioned recently, the European Partnership for Alternative Approaches to Animal Testing (EPAA) – a joint effort by policymakers and industry – devoted its annual conference in Brussels to ITS.

The beauty of so-called Integrated Testing Strategies (ITS) is that it can mean using fewer animals which also generally means lower costs. As Dr Thomas Foerster of Henkel put it, this appeals “not just for ethical reasons but also for budget reasons”.

Ready for total replacement?

So why are some of the non-animal methods which are part of ITS not used universally instead of animals? Why can’t we replace animals altogether? Well, right now, even the best available non-animal methods are imperfect.

In some cases, testing how a group of cells in a dish respond to a new drug can be very useful but scientists also need to know how whole organs interact in the presence of the new substance.

Translation: dropping a new medicine on a few brain cells tells you lots of things about how the brain will respond. Testing this drug on some liver cells also tells you something about how the body will deal with this drug. But it’s not quite the same as seeing how the whole brain, liver, kidneys, heart and so on will respond as a whole.

For now then, it seems ITS can be used to reduce the reliance on animal models, but some animals will still be required.

Show me the data!

More research is certainly needed. The other big hurdle to clear is convincing regulators to accept these new kinds of experiment instead of traditional animal-based testing. According to several speakers at the EPAA event, the industry is reluctant to invest heavily in developing these kinds of non-animal methods unless regulators can guarantee that they will accept them.

For their part, regulators have been slow to make such a commitment until they’ve seen data proving that the new non-animal methods are as good as existing tests.  It’s a classical catch-22. Perhaps the only option is to jump together.

Human nature is also a drag on progress. Scientists working in industry and toxicologists in regulatory bodies are used to current animal-based methods. They understand the techniques; they trust the results.

If ITS are to be embraced, experts who are familiar with them will need to be trained or recruited – which is no easy feat. There is also the global aspect. If new ITS were acceptable in Europe but regulators in the US, China and elsewhere would only accept traditional animal-based testing then new medicines would have to be tested twice – which would increase costs rather than reducing them.

Europe can take the lead in this innovative area but there’s no point running too far ahead of the pack.

The take-home from this year’s EPAA annual event was that ITS offer real promise for reducing the use of animals but making this kind of quantum leap is never easy. It looks like we’re at the beginning of a long but exciting story.

The public is uneasy about animal testing yet research advocates shun the spotlight

Animal research has been back in the news again as controversy rages over major European laws which have been recently revamped by Brussels.

New EU rules on the use of animals in medical research are also due to be introduced across Europe in 2013 but anti-vivisectionist campaigners say the revised law was watered down by MEPs who were lobbied by pharma companies. For example, a clause that would have completely banned the use of primates was amended after industry and research organisations argued that this could jeopardise essential research into Alzeimer’s and Parkinson’s diseases

Critics claim that EU research agenda is driven by commercial interests and point to the composition of the European Partnership for Alternative Approaches to Animal Testing (EPAA) as a prime example. However in fairness the EPAA was set up to be a public-private partnership between the European Commission and industry to work together to find alternatives.

‘Tell me if this hurts’

The updated EU legislation on medical research classifies pain as “mild”, “moderate” and “severe” – a deeply subjective judgement made without the facility of asking the subject. How can anyone truly know the pain of another?

This definition matters. The decision to reuse an animal which has already been subjected to tests depends on whether scientists perceive that the animal in question has already endured “moderate to severe” distress.

The leeway given to researchers is, according to the European Coalition to End Animal Experiments (ECEAA), a compromise won by vested interests. The group says that even some of the tougher aspects of EU laws will count for little unless enforcement is improved at national level.

On top of that, they say academic and industry researchers have shared very little information with the public about how and why animals are used in research. Ironically, those claiming to stand for science are accused of stifling scientific debate.

The ‘3 Rs’

There was a time when animal research was barely questioned. There were no ethics committees, no legislation and no animal rights activists. But those days are long gone.

Today, several stakeholders subscribe to the notion that the use of animals should be reduced; that animal-based research should be replaced with alternative methods where possible; and that experiments should be refined to minimise harm.

These “3 Rs” have been a guiding principle for half a century, yet there are now more animals used in research than there were then.

The trouble is the degree to which stakeholders think each principle should apply: anti-vivisectionists would like animal testing “replaced”, while researchers have found it easier to “refine” their experiments that to phase out animal testing altogether.

In addition to research designed to understand the body or to develop new medicines, animals are used as a routine part of vaccination production to test the consistency of one batch of vaccine to the next.

The Eurogroup for Animals says around 12 million animals are used for research and testing every year in Europe. It believes there is enormous scope for “replacing or refining” many of these practices and, in some cases, discontinuing them altogether.

Public perceptions

Whatever about industry groups and activists, what does the rest of the public think?

A Eurobarometer opinion poll shows the public is divided on the use of animals in experiments – even if researchers claim their work will lead to benefits for human health. This is particularly stark when people are asked whether scientists should be allowed to experiment on larger animals like dogs and monkeys for the improvement of human health.

Only 44% of respondents agree while 37% disagree. In some countries, such as Finland, Slovenia, Luxembourg and France more than half of those surveyed opposed such experiments, according to the ECEAE.

Worth the ‘sacrifice’

Animal rights groups argue that despite the millions of animals killed in the name of, for example, cancer research, medical progress has been too slow to justify the suffering.

Most experiments will not lead to medical breakthroughs and are conducted to test how animals respond to drugs, stress, foods or chemicals. Often this work adds little to scientific knowledge but the animals are killed – or ‘sacrificed’, to use the industry jargon – anyway.

Part of the reason for this, say activists, is that the genetic and physiological differences between humans and mice are greater than once presumed. Cures that work in animal models sometimes fail – or are unsafe – in humans, and vice versa.

‘Trust us, we’re scientists’

So between accusations that industry groups are lobbying policymakers behind closed doors and claims that scientists are shy about sharing details of their work, it’s clear the public have been left out of the discussion.

Expecting the public to support the use of animals in research simply because most scientists say it’s necessary will no longer wash. There’s a lot of explaining to do…

So, it’s easy to find information that points the finger at industry and the biomedical community at large. Silence has been the preferred response so far, but its time the research community to step forward to help us understand what they are doing, for whom and why.

It was clear when talking with Neil about his experience during the first reading that it was a challenging time for him. Each person faces their own personal dilemma about animal research and for Neil it was between his natural love of animals, as a farmer and dog owner, with the desire for legislation that allows medical advancement for humans.

Whether you agree with Neil’s view or not, I hope the video gives you a new or better insight into the thinking behind the development of the new European animal research directive 2010/63/EU.

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In this second video, Neil goes into detail on what drove his decisions that shaped the final legislation; policy regarded by some as contradictory and by others as too pro-science.

However, Neil is made of sterner stuff and I respect his final comment in the video, “I wasn’t going to be dictated by just the popular view, I was actually going to take a view that I could stand up in [sic] my conscience and live with”.

I’d be interested to hear your views on our chat with Neil, particularly his comments on the 3Rs (Replacement, Reduction, Refinement) policy. He believes the 3Rs focuses science and industry on reducing and find alternatives to using animals in research, do you?

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Understanding Directive 2010/63: the new legislation governing the use of lab animals

Finding the right balance between animal welfare & human welfare

Thanks to European legislation over the past 20 years, animal experts with specialized training are required on site to provide care and manage the welfare of animals used in research. The animal welfare team work in parallel with the scientific team, looking after the animals, while the scientists focus on research.

The animal welfare officer helps facilitate research and optimize techniques for the best results, so finding the right balance for the animals. This isn’t a passive relationship with the scientists; along with strict regulation that surrounds the use of animals in research, animal welfare officers review new scientific studies before they are sent for ethical review.

Surprisingly he went on to explain that his company is actively looking for and investing in alternatives for certain research. They need further development but hoped that within 10 years or so it would be a real possibility.

However, as I’ve heard several times already, it’s the authorities, who put human safety first, are the main audience to convince in relation to alternatives. Animal research and testing is required by-law before clinical trials can take place. He admitted that even if legislation didn’t demand it, the biomedical community would still use animals, but they’d do it differently.

So from an ethical standpoint, where does a person like this stand? Doing animal research does expose a dilemma, a personal dilemma he told me; even within industry people are reluctant to use animals. They understand that to produce good vaccines, they need to go through necessary testing on animals before being testing on humans, but still no one is happy to use animals.

He went on to explain, “If we must use animals we do, but from ethical point of view, animals aren’t a perfect model of humans, they don’t mimic humans, so there are some uncertainties. It’s not 100% perfect and is has limitations.”

Discussing the perception of animal research verses the reality, the vet explained that the problem starts with the lack of visibility of animal facilities. These centres are generally closed to the public so one’s imagination simply fills in the gaps. Moreover industry has never communicated on the improvements made over the past 20 years, so naturally our perceptions are stuck in the past and is far from today’s reality.

“While there is so much emotion and extremism around the use of animals in research, it’s decreasing the opportunity to have a dialogue and transparency.
If industry could be more open, the dialogue would be much more easy.”

So in fact, as a vet he was committed to ensuring animals were used ethically in research and that his company upheld, and often exceeded, the 3R guidelines.

Also read:
What’s in a name? Animal research vs testing vs experimentation

How did we arrive at the 3 Rs: Replacement, Reduction, Refinement?