– Douglas Adams

It had all been going so well. The path EU legislation must navigate is notoriously complex. Consultations, proposals, amendments – input from MEPs and compromises between national governments – the road is long and winding.

But for the EU’s directive on how animals are used in medical research, this lengthy process appeared to have produced a compromise which governments agreed would raise standards of animal welfare, reduce red tape by harmonising rules across Europe, and promote the 3Rs.

Scientists, some of whom initially worried that the new rules would make research more difficult, had their say during the consultation period and broadly accepted the final outcome. Yes, there will always be some who hope for less regulation – just as others will be disappointed that the law could not go further – but EU policy is a world of compromise and this directive looked to have struck a reasonable balance after a robust debate.

So you might have expected that the final step in the journey – turning the EU directive into national law – would be the least complex. Not so!

All 27 Member States should have had laws, regulations, and administrative provisions in place by November 2012 so that these could be in force by the beginning of this year.

At last count, most governments were behind schedule and struggling to meet the deadline. Perhaps this is because not all costs could have been anticipated at adoption of the directive and only now has everyone realised some additional bureaucratic and financial burdens that stem from the way countries interpret the provisions.

While local political and economic crises might be dominating the agenda in several Member States, the directive has been coming down the tracks for some time, so its transposition ought to be a fairly routine technical matter.

Never-ending story

The painstaking process of agreeing on a final EU text has been concluded; the debate is over – or at least it should be…

Let’s look at Italy as an example. Efforts to transpose the directive into Italian law have been complicated by amendments proposed by Italian politicians. Scientists in Italy have already raised concerns about this, warning that medical research in Italy could be jeopardised if the country fails to implement European law.

Italy, which has endured its share of controversies over animal research in recent months, could even be hit with fines for non-compliance with a law its government signed up to.

Are national parliaments set to re-fight the battles that were fought before the directive was agreed?

And, in light of our Shall It Stay or Shall it Go debate, is this the latest signal that animal research is no longer welcome in Europe? If so, what would this mean for European patients and for animal welfare standards?

We want to hear from you

Some 3.8 million procedures were carried out on animals including dogs, cats, mice and monkeys last year, according to press reports.

The numbers are less important than the trend. The total figure is the highest since 1981.

[Here’s one for Europhiles: If you want a sense of how long ago that was, 1981 was the year when Roy Jenkins handed over the Presidency of the European Commission to Gaston Thorn; Greece joined the European Communities; and Bucks Fizz won the Eurovision Song Contest for the UK!]

The report was published by the UK Home Office and was met with some disappointment among animal welfare proponents. This comes after years of political commitments to reduce the number of animals used in research, refine experiments which rely on animals and, ultimately, replace animal models with viable alternatives (the 3Rs).

In light of the latest numbers from the UK, it might be tempting to claim that the ‘3Rs’ commitment is no more than a fig-leaf; an empty PR promise not reflected in the daily reality of research labs. Or maybe there are simply more research projects than before?

Digging into the data

On closer inspection of that 3.8 million headline figure, it emerges that some animals were operated on more than once so we are talking about 3.8 million procedures rather than 3.8 million animals. Large numbers nonetheless but details are important.

There’s also a matter of definition. The genetic modification of animals – which is done so that an animal carries certain genes or has particular symptoms that are to be studied – is classed as a ‘procedure’. The same is true of taking a blood sample.

In fact, the number of procedures classed as ‘significant’ was just 5% of the total.

Given the particular sensitivities about the use of primates, it’s also worth asking what animals were involved.

71% of the animals used in the UK in 2011 were mice; 15% were fish; 7% were rats and 4% were birds. 235 procedures were carried out on cats, although all of that work was aimed at improving nutrition and health in cats.

Meanwhile, there was a dramatic decrease – by 75% – in the number of new world monkeys used in research.

Inspiring progress

For all of that, the headlines generated by the report, coming as they do at a time when governments are converting the new EU directive into national law, should add extra impetus to the drive towards applying the 3Rs.

One thoughtful response to the figures came from a group of scientists who took the opportunity to suggest that European funds should be tapped to fund investment in non-animal research. In fact a lot of research of this type has been funded without much genuine progress. So rather than focusing researchers on non animal research methods, wouldn’t it be better to invest in the development of more effective research tools that would bring clear 3R benefits?

Perhaps the EU’s Horizon 2020 research and innovation funding programme has the firepower and forward-looking mandate needed to support large projects of this kind.

Maintaining momentum

So while the total number of procedures on lab animals in the UK last year was up, there might be reason to hope that the momentum generated by the report will encourage timely transposition and implementation of the EU directive – and maybe even inspire policymakers to focus on and invest further in innovative research tools which could bring us faster to non animal alternatives.

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.

Related content

Finding the right balance between animal welfare & human welfare

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

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