– 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

It was only when animal rights groups began to put pressure on airlines and ferry companies to stop transporting laboratory animals that this came to our attention.

Researchers are concerned that research on non-human mammals, as well as studies involving frogs, insects and fish, could be hampered if companies refuse to transport animals which will be used in labs. This, according to scientists, could even disrupt the fruit fly research used to study genetics.

Interestingly, scientists and policymakers in India managed to convince Air India to reverse an earlier decision to stop transporting animals.

From a European perspective, one wonders whether researchers and politicians in India are more willing to publicly support medical research by working with transport companies and animal welfare groups to find solutions.

What do you think?

Now that the issue is on the agenda, it prompts a number of thorny questions. If animals could not be transported to labs, resulting in a decline in medical research, would this be a price we’re willing to pay?

Should animal welfare campaigners focus on the conditions under which animals are transported – and the length of the journeys they take – rather than on banning transport altogether?

Let us know…

We want to hear from you.
Please use the comment box below to submit your views.

Editorial team of Animal Testing Perspectives

The reasons for this are many and varied. For one thing, the low-hanging fruit was picked a couple of decades ago so the diseases for which we now need new therapies are the most difficult to treat. This requires a huge investment of time, effort and resources and call for a more collaborative approach to innovation.

For another thing, the cost of conducting research has risen at a time when the rewards are on the wane. A recipe for new drugs it is not.

Yet the world is facing fresh public health challenges due to shifts in demography and lifestyle. Our ageing population means conditions such as Alzheimer’s will become a much greater burden. At the same time diabetes rates are through the roof in develop – and in developing – countries across the world.

What’s this got to do with animal research?

Glad you asked. This slow-motion crisis is paving the way for new approaches to drug development.

One area which shows considerable promise is personalised medicines. The primary goal of research in this field is to develop medicines which are best suited to individual patients or to particular categories of patients. This would mean, for example, that if you had a certain gene, your doctor would choose the medicine most likely to work for people like you.

The push towards deepening our scientific knowledge in this area is changing how research is conducted. In search of more precise and predictive methods of treating people, scientists are developing new models for testing drugs.

Innovation through collaboration

The need for more open collaborative approaches is spawning exciting public private partnerships like the Innovative Medicines Initiative (IMI). NEWMEDS – Novel Methods leading to New Medications in Depression and Schizophrenia – a five-year IMI project funded by the EU and pharmaceutical industry is committed to finding new treatments for psychiatric illnesses.

One of the key elements of the NEWMEDS project will be the search for better animal models. ‘Better’ means more accurate and predictive but using fewer animals.

The investment in better animal models which can more accurately represent human diseases should give scope for using fewer animals in the years ahead. Good news for delivering on scientists’ commitment to pursue the 3Rs of animal research – reduction, refinement and replacement.

Diabetes is a case in point. Around 350 million people worldwide are affected by diabetes and this number is rising steadily. Research using animal models has been central to pretty much all the therapies currently available for managing diabetes but the revolution in personalised medicine might help deliver better medicines using fewer animals. This is addressed by another IMI project, IMIDIA.

So, perhaps the headlines of recent years might be caused for concern given the essential role of the medicines sector in improving public health and generating wealth, but the concerted response for public and private players is cause for hope.

Crises can be catalysts for change. In the future, we could have better medicines developed using fewer animals.

Well, yes. International cooperation is climbing steadily up the agenda as scientists and policymakers from Europe, the US, China, Brazil and elsewhere share their views on how to support medical progress while making meaningful strides forward towards the 3Rs – reduction, refinement and replacement.

It makes perfect sense, regardless of your view of animal research. Collaboration is at the core of science; it’s where some of the best ideas come from. So if we are serious about finding therapies for diseases like cancer and Alzheimer’s disease we should encourage international cooperation.

And if we want to see the highest standards of animal welfare and the sharing of best practices – not to mention the adoption of viable non-animal testing methods by regulators – then a global approach is needed.

Fostering cooperation

That’s why it was encouraging to see experts and regulators from the US and China joining their EU counterparts for a conference in Brussels this month. The 8^th annual EPAA conference in Brussels took international cooperation as its theme and looked beyond Europe rather than focusing within. 

The Platform signed a memorandum of understanding with the US-based Institute for In Vitro Sciences dedicated to international dissemination of alternative techniques for safety evaluation, and the EPAA will provide up to €100,000 in sponsorship over two years to the IIVS to support training in several regions including China and Brazil.

Why should Europe care?

In this age of austerity, you might ask why Europe would want to help an American company to train scientists and regulators in China. Fair question! The answer is partly that better global standards will be good for medical research, good for animal welfare and good for us.

But the full answer is also that Europe should encourage standards in medical research to rise in tandem across the globe. Not only does this help to discourage migration of research to areas with weak regulation, it also incentivises European industry to invest in non-animal methods – if companies are confident that these models will be acceptable to authorities around the world they are more likely to take the risk of developing them.  

Here at Animal Testing Perspectives we have been asking you about the future of research in Europe, pointing to some of the discouraging signs which suggest medical research was unwelcome here.

But at the EPAA conference it was tempting, at least for a moment, to imagine a future where Europe not only sets the standard for animal and non-animal testing but also brings others with it in a way that preserves its global competitiveness.

Are we being too optimistic? Let us know…

Orphan diseases, affect not more than 5 in 10000 people, With some 29 million sufferers in the EU;

The EU offers the pharmaceutical industry some incentives to investigate rare illnesses. According to the General Director of LEEM, Philippe Lamoureux, European-backed research into drugs for the treatment of orphan diseases has led to 68 new medicines approved between 2000 and 2011. But there are between 6,000 and 7000 different rare diseases, so these drugs help just a fraction of sufferers.

Where does animal testing fit into the orphan drug equation? It is present in preclinical trials – as is the case with all drugs – but would it be right to ban the use of animals in research when patients have so few treatments to choose from in the first place? The Journal of Animal Ethics proposes that doctors tell patients, or their carers, the role that animals played in the development of their medicines. If sufferers of rare illnesses had access to this information, would they refuse treatment?

Stopping experimentation on animals in the EU probably wouldn’t stop European patients using drugs that have been tested on animals. The problem would simply be relocated, with testing taking place further away, in countries with less stringent regulations. Banning animal testing could also lead to a slowdown in research, as scientists consider alternative means of testing. The question remains: would sufferers of rare diseases be able to wait?

Some believe that not enough is being done to develop orphan drugs. According to work published by three Italian pharmaceutical researchers, a lack of testing on recommended animal species may have affected the investigations of 24 molecules, candidates for treatment of rare diseases. So when it comes to orphan drugs, should there be more, rather than less, research?

Sufferers of orphan diseases already face limited treatment options. Take animal experimentation out of the equation, and drug development options shrink even further.

The EU research budget – a major source of support for medical science – is under serious threat and could be about to fall victim to a much wider political spat over public spending.

It’s an almighty row. The European Commission and the European Parliament would like the EU’s main research funding programme (to be known as ‘Horizon 2020’) to have a budget or around €80 billion over six years. National governments want to slash this in half to just €40 billion. The European Research Council (ERC) is also targeted by some EU leaders.

All of this takes place at a time when widespread austerity means national research budgets are shrinking too. For medical researchers, EU funds are often their best hope of securing funding for ambitious projects designed to push the boundaries of medical knowledge.

But scientists are not about to take this lying down. A group of Nobel prize winners have written an open letter calling for the research budget to be protected and a new petition – ‘No Research Cuts’ – has been launched by the Initiative for Science in Europe.

We’ve been discussing the future of medical research in Europe and whether the EU wants to be a research hub. The outcome of this debate – which is due to come to a head at a crunch November EU Summit – could provide the answer!

As part of our ‘Shall it stay or shall it go?’ campaign we’ve been asking you about the future of animal research in Europe.

Well it seems that some of the scientists who work in this area have given their verdict: they want it to stay and are more than a little worried about what they see as myths around animal studies.

The folks who run the Understanding Animal Research website have brought together concerned researchers from the UK to create the Science Action Network.

The group wants scientists to enter the debate which it says has been characterised by inaccuracies and confusion, partly because scientists have been reluctant to speak up.

They are asking scientists to give five minutes per week to reply to misinformation on the internet and social media channels. There’s even a dedicated Twitter hashtag – #ARnonsense – which they want scientists to use when debunking myths, and a Facebook page where researchers are encouraged to weigh in on videos and articles about animal science.
 

So, dear reader, the question is: will it work?

Are scientists the right people to discuss the ethics of animal research? Does the campaign target the right people through the right channels? What about the tone? Do you find it abrasive, irreverent – or both?

The EU also celebrated last week when Professor Serge Haroche, the recipient of a European Research Council (ERC) grant, picked up the Nobel Prize for Physics. Europe plans to increase ERC funding from €7.5 billion to €13 billion from 2012 to help “the very best researchers to conduct pioneering research across Europe”.

But what about health research? Well, the Nobel Prize for Physiology or Medicine went to researchers from Britain and Japan for their work on reprogramming mature cells into stem cells.

They basically found ways to trick cells into reverting back to their immature days when they had the potential to become other kinds of cells. It’s like they turned ‘adult’ cells which were set in their ways into teenagers that can become anything they want if they are given the right environment.

The point is that this work was done using frogs and mice.

In fact, over the past 40 years, every single Nobel Prize in Physiology or Medicine – with one exception in 1983 when a plant geneticist collected the award – has depended on animal studies.

As if that wasn’t enough, this year’s Nobel Prize for Chemistry went to US scientists whose work in genetically-altered mice could lead to new and better medicines.

We’ve been asking you what the future of animal research is in the EU. The question now is whether waving goodbye to animal research would mean farewell to Nobel Prizes in Medicine

Is Europe content to be a beacon for peace and a dab hand at physics while leaving excellence in medicine to scientists in the US and Asia?

Or could future Nobel Prizes go to breakthroughs in non-animal models for medical research? Would that be the kind of game-changing incentive needed to make a giant leap towards the 3Rs?

Share your thoughts!

After an intense campaign by policymakers and animal rights groups, the Green Hill animal breeding firm closed its doors, having handed more than 2,500 dogs over to animal rights campaigners in line with the court ruling.

Activists – and plenty of ordinary tweeters who just love dogs – celebrated. If you almost never give much thought to animal research, a headline about dogs in Italy being saved rather than sacrificed looks like good news.

But could the Green Hill story prove to be a pyrrhic victory for animal rights campaigners?

A bit of background

The first thing to consider is how many dogs are used in animal research and why scientists have to use dogs at all.

Using dogs for cosmetics is illegal in Europe but limited use for medical purposes is permitted, under strict conditions.

Around 21,000 dogs were used in European research, according to figures from 2008. While rats and mice are the most commonly used animals in laboratories, larger mammals such as dogs are needed for certain kinds of tests. Many of these are required by EU regulations  to ensure that medicines are safe and effective.

In the event that all research on dogs were to end, much of the current work scientists do in search for new cures of heart disease, cancer and dementia would reach a cul-de-sac.

That might be bad news for human and animal health research but what about laboratory animals themselves?

NIMBY

Europe has the strictest animal welfare standards in the world. If European countries were to become openly hostile to this kind of medical research, would it simply move elsewhere?

Is it unfair to suggest that the campaign against Green Hill is a case of ‘Not In My Back Yard’ – or NIMBY as we like to say.

And are European protests simply going to shift research to jurisdictions where standards are less rigorous?

For pragmatic animal welfare advocates – and dog lovers across Europe – the threat to animal research in Europe presents a dilemma: would pushing dog breeding out of Europe do more harm than good?