The European Medicines Agency (EMA) has published last weekend their long-waited technical position on the vulture-killing drug diclofenac, following a request from the European Commission (see documents below) – they confirm that veterinary diclofenac does represent a real risk to European vultures, and therefore recommends that a number of risk management measures should be taken to avoid the poisoning of vultures, including more regulation, veterinary controls, better labeling and information and/or a ban of the drug.

 

This position acknowledges and supports the Vulture Conservation Foundation (VCF) arguments about the danger that veterinary diclofenac represents to European vultures.

 

The EMA´s position falls short of recommending one or more of the possible solutions listed as they did not have enough elements and/or remit to evaluate their effectiveness, although they recognize that only a ban would reduce the risks to zero. It is now up to the EU Commission to decide if they will start a formal referral process reviewing the marketing authorization of veterinary diclofenac (approved for sale in 5 EU countries, including Italy and crucially Spain, which holds 90% of all European vultures).

The VCF believes that the safest, simplest, and most cost-effective solution is indeed the ban on the veterinary use of diclofenac in Europe. The VCF believes the EU Commission should apply the much-taunted but often ignored precautionary principle, also because an alternative drug that is no toxic to vultures exists, and is equally cheap and available in the markets – why then risk impact on vultures by bringing expensive regulatory processes when one can decide for an outright ban of a drug that should have never appeared in the market in the first place?

 

Vet diclofenac is marketed by the Italian company FATRO, which used loopholes in the EU risk assessment guidelines for veterinary drugs to get it approved in Italy and Spain, in spite of a solid and massive body of evidence about its impacts on vultures and other wildlife. Veterinary diclofenac has caused a massive decline in vultures in the Indian subcontinent (95% declines of several species, driving to extinction some of the most abundant vulture species in the world in the last 20 years), and was finally banned there. Vultures provide key ecosystem services, removing tons of livestock carcasses from the countryside, and helping to control disease.

 

The VCF has led, in collaboration with many other environmental groups, an international advocacy and communications campaign aiming to ban veterinary diclofenac in Europe.  We will continue to work with our partners to achieve our aim – prevent any risk to Europe´s vultures by eliminating this drug from the food chain. We are now lobbying the EU Commission, and the European Parliament, to address the issue, and take the only sensible and risk-free decision – #banvetdiclofenac!

 

What can you do?

 

Here are five things you can do to help us (For Vultures!) this holiday season

 

1.      Sign the change.org petition on veterinary diclofenac – see https://www.change.org/p/janez-poto%C4%8Dnik-european-union-diclofenac-the-vulture-killing-drug-is-now-available-on-eu-market-ban-it-now

 

2.      Write to your MEP about the issue. Please use, adapt and/or translate template letter below. The contacts of your MEP are here - http://www.europarl.europa.eu/meps/en/map.html

 

3.      Write to Commissioner for Health and Food Safety Mr Vytenis Andriukaitis (cab-andriukaitis-webpage@ec.europa.eu) and put in copy Commissioner for Environment, Maritime Affairs and Fisheries Mr Karmenu Vella (cab-vella-external-petitions@ec.europa.eu). You can use the template email below.

 

4.      Send twitter on the matter to Commissioners Andriukaitis and Vella (@V_Andriukaitis & @KarmenuVella)

 

5.      Send an email to FATRO (comunicazione@fatro.it) asking them to stop commercializing veterinary diclofenac. You can copy-paste the text below.

 

Many thanks!

A few days before the European Medicines Agency (EMA) is due to take a final decision regarding the banning of diclofenac – a veterinary drug that causes kidney failure and death of vultures, and that decimated vulture populations in Pakistan, India, and Nepal during the 1990s, and is now available in Spain and Italy-, a large section of the European scientific community (including researchers in the advisory board of the VCF) published a paper this week in Science advocating the need to keep harmful veterinary medicines out of the environment.

Margalida et al suggest that researchers and policymakers need to establish programs similar to those proposed for human drugs to prevent the approval and use of veterinary drugs out there that can have impacts on scavengers. The authors call for the adoption of a more holistic system of screening veterinary drugs that promotes environmental responsibility, involves all sectors of society and considers environmental effects during the production, use, and disposal of veterinary medicines.

With the EMA about to publish their scientific advice on the possible negative effects of diclofenac on Europe´s vultures - Spain harbours about 95% of the European Union’s vultures, as well as the continent’s entire population of threatened Spanish Imperial Eagles and populations of Red Kites, we hope this latest call from the scientific community will help the EU Commission take the right decisions:

1.    Ban vet diclofenac

2.       Change the EU guidelines on risk assessment of new veterinary drugs to consider eco-toxicity factors

3.       Help develop a comprehensive programme of testing of toxicity levels of veterinary drugs to scavenging species

As the deadline for a final decision by the EU Commission on banning veterinary diclofenac approaches, vultures really need you.

Veterinary diclofenac is extremely toxic to vultures, and has been banned from the Indian subcontinent after causing a 95-99% decline of several vulture species there. Incredibly, it has been approved for use on livestock in Italy and Spain. The Vulture Conservation Foundation (VCF) has been leading a campaign, together with other organisations, to ban this drug in Europe too: given the existence of a non-toxic alternative (Meloxicam), common sense suggests a precautionary approach should be taken. We had therefore asked the EU Commission to start a procedure for the withdrawal of an authorized veterinary medicinal drug which affects Community interests, Under Article 35 of Veterinary Medicines Directive (2001/82/EC).  You can see more details about veterinary diclofenac, its impacts, and the whole campaign, here

The EU has been considering the issue for several months, and asked last summer the European Medicines Agency (EMA) for a technical opinion, originally due in the end of this month. Following a public consultation (see VCF´s contribution here), the EMA has now recently announced that they will take a position by mid-December, following which the EU Commission should take the final decision.

It is therefore crucial to lobby now the European decision makers towards the only sensible solution – a ban on veterinary diclofenac in the EU, as evidence of its impacts on vultures is irrefutable, while a safe alternative exists.

The VCF and other organisations have written another letter to Commissioner Andriukaitis (see below) to keep up the pressure. Now we are asking you to help - please write to your MEP and ask him to put a word for vultures through a Parliamentary Question directed at the EU Commission. You can find who your MEPs are here - http://www.europarl.europa.eu/meps/en/map.html 

Earlier this month the Convention on Migratory Species (CMS), to which both the EU and all EU members states are signatory, has recommended a ban on veterinary diclofenac (see here). We need to make sure that MEPs and the EU Commission know that we all expect them to take immediate action to implement these recommendations. You can use or adapt the draft letter below – please write it in your own language. It may take 30 minutes to do so – yet, the long term future of European vultures may depend on it. Please help!

The last few weeks saw vulture conservation score a few points against the biggest threats impacting on these scavengers worldwide – poison & veterinary drugs such as diclofenac.

First and foremost, a landmark political decision by the conference of the parties of the Convention on Migratory Species (CMS), held earlier this month in Quito (Equador), adopted a resolution on poisoning, including approval of a set of guidelines to tackle its causes. This resolution includes a ban on veterinary diclofenac, the phasing out of all lead ammunition, and action on rodenticides, insecticides and poison baits.  

On veterinary diclofenac, the guidelines now approved by the CMS recommend  to “Prohibit the use of veterinary diclofenac for the treatment of livestock and substitute with readily available safe alternatives, such as meloxicam, with mandatory safety-testing of all new veterinary pharmaceuticals for risks to scavenging birds before market authorization is granted”. However, this resolution is not legally binding, and countries can now decide on what to do: “it is for each Party to determine whether or how to implement the recommended actions, considering the extent and type of poisoning risk, whilst having regard to their international obligations and commitments, including those under the Convention".

You can see read the whole text of the resolution, as well as the guidelines, in the links below

Resolution adopted: 

http://www.cms.int/sites/default/files/document/cop11_crp31_dr_preventing_poisoning_migratory_birds.pdf
Guidelines adopted: 

http://www.cms.int/sites/default/files/document/COP11_Doc_23_1_2_Bird_Poisoning_Review_%26_Guidelines_E_0.pdf

This landmark political decision, achieved after months of lobbying by the VCF, BirdLife International, WCS, IUCN and many other organisations, now puts even more pressure on the EU – a signatory to the CMS – to take a final decision regarding veterinary diclofenac in Europe. A technical review of the situation by the European Medicines Agency (EMA) is expected in the next weeks, before the EU Commission takes a final decision.

This milestone comes a few weeks after the VCF and other conservation organisations submitted their reasoned opinions on veterinary diclofenac, following a public consultation by EMA. You can see the VCF contribution at http://www.4vultures.org/our-work/campaigning-to-ban-diclofenac-in-europe/

Also, in the end of September IUCN launched its own official position in relation to the increasing incidence and scale of the use of poison causing catastrophic declines in wildlife populations (including vultures) across Africa. You can download the document below.

 

The threat posed by diclofenac and other veterinary agents to avian scavengers has also been highlighted in a great short overview just published – you can also download it below.

All in all, politicians, government representatives, chemists, vulture researchers and conservation practitioners increasingly converge: veterinary diclofenac should be banned in the EU, as evidence of its impacts on vultures is irrefutable, while a safe alternative exists. The VCF now expects the EU Commission to take immediate action to implement these recommendations.

http://www.nature.com/news/toxic-influence-1.16190?WT.mc_id=TWT_NatureNews

 

Thank you NATURE! EU, please ban vet diclofenac!

 

http://www.nature.com/news/poisoned-vulture-could-herald-european-bird-crisis-1.16161

 

The recently published evidence about the death of a griffon vulture in Spain poisoned with fluxinin, an anti-inflammatory drug like diclofenac, has been hitting the headlines -  a timely reminder that in countries like Spain vultures do indeed eat carrion from medicated animals. This indeed suggests that we need to ban diclofenac as a precautionary measure to prevent an India-like crash in vulture populations in Europe.

 

On the same day that a EU public consultation on the use of veterinary diclofenac (a non-steroid non-inflammatory drug NSAID) in Europe and its potential impact on vultures closed (see http://www.4vultures.org/our-work/campaigning-to-ban-diclofenac-in-europe/  for VCF´s contribution), a new paper was published online on Conservation Biology with evidence that a Griffon vulture in Spain had died due to high levels of flunixin (another NSAID licensed for veterinary use in the EU). The authors suggested that this vulture died after scavenging on a dead agricultural animal that had been treated with flunixin prior to its death.

 

This is the first reported case of a wild vulture being exposed to and killed by any NSAID outside Asia - it is also the first instance of wild mortality resulting from any NSAID other than diclofenac globally. This case also provides clear and indisputable evidence that medicated carcasses are currently available to and being consumed by scavenging birds in Europe, and reinforces the VCF calls for a ban on veterinary diclofenac use within Europe. You can download the paper below.

The Vulture Conservation Foundation (VCF) has been leading a campaign together with other organisations, to ban veterinary diclofenac - given the risk to vultures, and the existence of an alternative, common sense suggest a precautionary approach should be taken. We had therefore asked the EU Commission tostart a procedure for the withdrawal of an authorized veterinary medicinal drug which affects Community interests,Under Article 35 of Veterinary Medicines Directive (2001/82/EC).

 

Recently, after months of wrestling, the Commission has mandated the European Medicines Agency (EMA) to come up with a technical opinion on the matter – a de factoacknowledgment that the facts raised by the VCF are relevant.One of EMA´s first steps has been to start a public consultation on the matter, directed at all professional bodies with information about scavenging birds, veterinary practices and the disposal of animal by-products.

 

The VCF has now submitted its paper on the matter, and tried to answer all the questions asked by the EMA. You can find the VCF´s paper below.

 

The paper concludes that

 

• Veterinary diclofenac is extremely toxic to vultures - half of the Griffon vultures will die after ingesting less than 1 mg

• In India, it caused a 99% decline of vultures – the decline observed could be explained if only 1 in 1000 carcasses available to vultures contained a lethal concentration of diclofenac

• Between 9,460 and 27,700 animals were treated with diclofenac in Spain during the first year of marketing of this drug alone

• Tens of thousands, probably hundreds of thousands, of carcasses of cattle, pork and horses are eaten by vultures alone in Spain

• Many of those come from intensive explorations where veterinary control is not individualised

• Animal carcasses treated with diclofenac can still kill vultures seven days after treatment (thus even more difficult to control)

• Vultures are gregarious eaters, with tens, often hundreds of animals eating from a single carcass. One animal carcass treated with diclofenac would be enough to kill dozens of vultures

• Day to day decision on what to send to vulture feeding stations remains in the hand of farm managers, not veterinarians

• There is risk that treated cattle in extensive systems can die in the fields and are then almost all eaten by vultures within 1 hour of death

• The practical measures suggested to minimise risk to diclofenac would be extremely expensive to set up, and would not be 100% safe 100% of the time, due to lack of enforcement, awareness, and veterinary oversight

• According to the Spanish government own estimate, between 0,11 and 0,22% of all carcasses available to vultures could include diclofenac in 5 years – close to the 0,13%-0,75% that caused the 99% decline in India!

• Legal availability of diclofenac in Europe causes a precedent and a conduit for a global boom in veterinary diclofenac worldwide

• THERE IS AN ALTERATIVE DRUG WITH THE SAME THERAPEUTIC PROPERTIES AND PRICE (Meloxicam)

 

 

 

The VCF thus concludes that the risk to European vultures is unacceptable, and thus veterinary diclofenac should be banned in Europe

 

Diclofenac is a veterinary anti-inflammatory drug that kills vultures and eagles – in India it caused a 99% decline of a number of vulture species there, before eventually being banned in 4 countries in the region. There is a patent-free, non-toxic alternative with the same veterinary effects available (Meloxicam).

Quite incredibly, veterinary diclofenac has now been allowed to be used on farm animals in Europe – in Estonia, Italy and Spain for cattle, pigs and horses, and in the Czech Republic and Latvia for horses only. The drug has been marked by an Italian company named FATRO, and was allowed using loopholes in the EU guidelines to assess risk of non-steroid anti-inflammatory drugs.

The Vulture Conservation Foundation (VCF) has been leading a campaign together with other organisations, to ban veterinary diclofenac - given the risk to vultures, and the existence of an alternative, common sense suggest a precautionary approach should be taken. We have therefore asked the EU Commission to start a procedure for the withdrawal of an authorized veterinary medicinal drug which affects Community interests, Under Article 35 of Veterinary Medicines Directive (2001/82/EC).

Recently, after months of wrestling, the Commission has mandated the European Medicines Agency (EMA) to come up with a technical opinion on the matter – a de facto acknowledgment that the facts raised by the VCF are relevant. One of EMA´s first steps has been to start a public consultation on the matter, directed at all professional bodies with information about scavenging birds, veterinary practices and the disposal of animal by-products.

Now the time has come for relevant stakeholders to explain to the EMA the reality on the ground in countries like Italy and Spain, where it is virtually impossible to guarantee that vet diclofenac will not enter the vulture food chain. Even if there was a strict veterinary prescription system – this is not the case! –, the veterinaries administering the drugs can not and do not oversee the disposal of all the dead animals. In Spain pigs, lambs and goats are allowed to be left out for vultures when they die in the extensive explorations, and the reality is that animals are often consumed by vultures before farmers are aware of it. Further, whole pigs and lambs, and even pig viscera, are deposited in vulture feeding stations. Testing all the carcasses at feeding stations is simply not an option, as this is prohibitively expensive – besides, routine testing for diclofenac is not yet available in Spain and Italy! Also, in certain parts of Europe, illegal dumping of carcasses is still a real problem.

It is virtually impossible to control for the presence of veterinary diclofenac in the hundreds of kilos of carcasses, animal parts and viscera, often from industrial explorations, that are eaten every day by vultures in Italy and specially Spain, both in a natural pattern across the landscape, or in feeding stations. Scientists estimate that the carcass of a dead cow treated with diclofenac, if available to griffon vultures one week after treatment, is more than enough to kill a dozen vultures.

You can read EMA´s public consultation call here. Documents should be submitted using the template provided to vet.guidelines@ema.europa.eu by 10 October 2014.

The VCF is preparing a response, but we urge all organisations with relevant information to do the same. Please get in touch with us (info@4vultures.org) if you need some more information or a filled in template to adapt. Now it is the time for all of us to say #banvetdiclofenac!

 

 

Veterinary diclofenac has caused a 99% decline in the once formidable vulture population in India, leading several species there to the brink of extinction – the drug causes renal failure in vultures (and eagles). It was finally banned in the Indian subcontinent in 2006, only to surface in… Europe!

The VCF has been leading a campaign to ban it – it really does not make any sense that a veterinary drug linked to such a catastrophic biodiversity crisis is allowed to be marketed in Europe, when alternatives exist.

Using loopholes in the risk assessment procedures, FATRO, an Italian company, has managed to get the drug legally approved in Italy and Spain - the latter the most important country in Europe for vultures. The VCF and others have approached FATRO and asked for a voluntary withdrawal, promptly refused by the greedy Italian company.

The whole world is watching what European decision makers now do – the VCF has asked several governments and the EU to correct the wrongdoing and start a formal re-evaluation process to revert the legal authorizations (in a process called referral in Eurolanguage). So far no final decision has been taken, and the EU has asked one of its agencies (the European Medicines Agency).

This week the powerful IUCN has added its voice to the campaign. In a letter sent to EU Commissioners, Julia Marton-Lefèvre, its director-general, urges them “to put your weight behind an EU and global ban on the drug for veterinary uses”. The IUC repeated the argument that the VCF has been maintaining since the beginning – even though condition in Europe are different than in India, risk is not zero; “Although IUCN is conscious that veterinary regulations are relatively strict in Europe, these are not always failsafe”. So the IUCN asks for a ban of the drug, not only in Europe, but worldwide: “we urge the European Commission to call for a worldwide ban on the veterinary uses of diclofenac under guidance provided by the World Organisation for Animal Health (OIE)”, says the letter.

This call is relevant because IUCN is also composed of many EU government agencies. Will EU politicians listen to a call from their own brethren?

You can read the full letter below

 

 

 

Banning the drug –advocacy & the regulatory process

 

• Even though we have asked 16 EU governments (Bulgaria, Croatia, Cyprus, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Netherlands, Portugal, Slovakia, Slovenia, Spain and the UK) and the EU to start a referral procedure (under Article 35of the Veterinary Medicines Directive) to ban the drug in Europe, we have had NO CONCRETE MOVES in that direction. There seems to be no appetite in DG SANCO or in national governments to start the referral– seems that the regulatory hurdles are high to get drugs off the market once they have been authorized, and this has been used very few times. The indication so far is that DG Sanco and national governments would favour a change in the labeling of the product, to stop prescription of the drug to animals in the special zones for vultures where carcasses can remain on the field, and the disposal of animals in vulture feeding stations.This labeling ‘solution’ will only work in theory but clearly not in practice. We have plenty of evidence that it is impossible, both in Spain and Italy, to eliminate risk.

• We are now continuing our pressure on the Commissioners, and national governments

• Our contacts with the Italian manufacturers of the drug are going nowhere. We believe that they also have a big role to play in this entire story, so we are now going to target them directly, both in the press, and legally. Please voice your discontent at FATRO by writing to comunicazione@fatro.it

• We are also working to gain the support of the veterinaries. It was encouraging to see that the UK veterinary agency put out a very strong statement on diclofenac, and also good to see that several veterinary agencies are starting to get mobilized against veterinary diclofenac (see letters below in the Veterinary Record). We are now writing to dozens of veterinary agencies in Spain and Italy to ask for their support, and more information.

 

 

 

Communications

 

The short video clip addressing the Commissioner for Health, Tonio Borg, asking him to ban diclofenac, has been well seen – 1750 hits alone in the VCF website, plus lots more on the other sites where it is hosted (BirdLife International, etc). This video has been published on VCF´s Vimeo and Youtube (see http://vimeo.com/93067364& http://youtu.be/59OIdukZQZY).

 

Articles continue to be published on the European press. The latest ones were

 

Frankfurter Allgemeine Zeitung

 

 

The Observer

 

http://www.theguardian.com/environment/2014/jun/07/european-vultures-threat-diclofenac-vets-spain-italy

 

 

 

Statements from other conservation organizations

 

 

The World Conservation Society has written to the EU about this – see letter below. Similarly, the Society for Conservation Biology has released a statement. See

 

http://www.conbio.org/policy/scb-europe-warns-that-diclofenac-approval-threatens-european-vultures-and-e

 

Also, a coalition of Portuguese NGOs has written to the Portuguese government about it. See below.

 

BirdLife Luxembourg has also published an article on the matter on their magazine - see below.

 

Finally, the SAVE programme in India has also written a letter to FATRO.

 

 

Statement from the Society for Conservation Biology

 

http://www.conbio.org/policy

 

27 May - STOP PRESS - New evidence published today shows that veterinary diclofenac kills eagles too

 

This drug is now ‘a global problem’ threatening many vulnerable birds of prey. The Spanish Imperial Eagle, a threatened and endemic Iberian species, is now at risk too!

 

 It is well known that veterinary diclofenac caused an unprecedented decline in South Asia’s Gyps vulture populations, with some species declining by more than 97% between 1992 and 2007. Veterinary diclofenac causes renal failure in vultures, and killed tens of millions of such birds in the Indian sub-continent. The drug was finally banned there for veterinary purposes in 2006.

 

 It was then surprising and frustrating to find, late last year, that diclofenac had been licensed for veterinary use in Italy and Spain, thus creating a real and immense risk for European vulture populations. For the last few months the Vulture Conservation Foundation has led, together with BirdLife International, the Royal Society for the Protection of Birds (UK), SEO/BirdLife (Spain) and LIPU (Italy), a campaign aiming to ban this veterinary drug from Europe. EU decision makers can and should indeed revaluate the risk this drug poses to vultures, and cancel the legal marketing permits.

 

 Now, a new scientific study, published today (Tuesday 27^th May) in the journal Bird Conservation International, confirms that eagles are also susceptible to veterinary diclofenac, effectively increasing the potential threat level, and the risks for European biodiversity. Tests carried out on two steppe eagles (Aquila nipalensis) found dead at a cattle carcass dump in Rajasthan, India, showing the same clinical signs of kidney failure as seen in vultures, indicated they had diclofenac residue in their tissues. The authors suggest that all the 14 eagle species in the genus Aquila are also probably susceptible to diclofenac.

 

 Steppe eagles are closely related with golden eagles (Aquila chrysaetus), imperial eagles (Aquila heliaca) and Spanish imperial eagles (Aquila adalberti), and all these species scavenge opportunistically on carcasses throughout their range. The Spanish imperial eagle, considered Vulnerable at global level, is now particularly at risk, due to the availability of diclofenac in Spain.

 

 These findings strengthen the case for banning veterinary diclofenac across. Tens of thousands of people, many leading conservation organisations, distinct veterinary bodies and several Members of the European Parliament have already questioned the EU Commission, the Spanish and the Italian governments, and the Italian company FATRO (the distributor of the drug in Europe) on the risks of this drug to European Vultures. Now, with unequivocal evidence that this veterinary drug can cause a much wider impact on Europe´s biodiversity, it is time for action – please ban veterinary diclofenac now!

 

 Dr Toby Galligan, a RSPB conservation scientist and one of the authors of the paper, said: “We have known for some time that diclofenac is toxic to Gyps vultures, including the Eurasian griffon vulture, but we now know it is toxic to an Aquila eagle too. This suggests that the drug is fatal to a greater number of birds of prey in Asia, Europe and around the world. We had suspected as much from observed declines in non-Gyps vultures in Asia, but this study confirms our worst fears.”

 

 Dr. José Tavares, the director of the Vulture Conservation Foundation, said: “The European Commission, and the Italian and the Spanish governments need to recognise this problem and impose a continent-wide ban on veterinary diclofenac before it is too late. This new paper raises the stakes - now it is vultures AND Eagles”.

 

For more information on the campaign to ban veterinary diclofenac in Europe, please check below

For a video on the issue of diclofenac and vultures, please see http://vimeo.com/93067364

 

 

Banning the drug –advocacy & the regulatory process

• 16 EU governments (Bulgaria, Croatia, Cyprus, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Netherlands, Portugal, Slovakia, Slovenia, Spain and the UK) and the EU Commission have received a formal request to start a referral procedure (under Article 35 of the Veterinary Medicines Directive) to ban the drug in Europe. None of the EU governments have acted yet - actually started the referral process.German government has recently wrote back saying that they are very worried about this situation and that they will decide by mid-June. Ligue pour la Protection des Oiseaux (LPO) will also be meeting the French relevant agencies in the end of May.

   

• Message we have been getting is that there is no appetite in DG SANCO or in most governments to start the referal – seems that this regulatory route is very challenging. The system is such that the regulatory hurdles are high to get drugs off the market once they have been authorised, and this has been used very few times – we have not been able to find any example of veterinary medication that was withdrawn from the market for environmental reasons, instead a second examination of risks by the European Medicines Agency in London almost always results in a change of labelling. Further, now the burden of proof is no longer on the company but with the complainant. It does not make much sense that a critical failure at the risk assessment  phase by the Spanish and Italian authorities can now be permanently locked in EU regulations!

   

• DG Sanco´s position is that this is currently under discussion at their Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary CMDv, which has no public agendas nor minutes and has no deadlines for reaching a decision. The indication so far is that this group, and thus DG Sanco, would favour a change in the labelling of the product, to stop prescription of the drug to animals in the special zones for vultures where carcasses can remain on the field, and the disposal of animals in vulture feeding stations.

   

• This labelling ‘solution’ will only work in theory but clearly not in practice. We have plenty of evidence that it is impossible, both in Spain and Italy, to eliminate risk. First of all, the veterinarian administering the drug will not oversee the eventual disposal of the animals, so even if everything is done correctly it is up to the farmer to remember that an animal must not be made available to vultures. Second the farm where the domestic animals originate and the vulture feeding station might be far apart, but it is unlikely that farmers or veterinarians would follow the labelling on farms where vultures do not occur in the vicinity. Testing the carcasses at the feeding station is also not an option, as this is prohibitively expensive, and specific testing for diclofenac does not exist in Spain or Italy. Livestock that die in the open can be reached by vultures before farmers are aware of it. Vulture feeding stations do work with animals which are not fit for human consumption, including animals that died of diseases and that are likely to contain medication – ofte these feeding stations receive tonnes of viscera. We also still face considerable illegal dumping of dead animals. So it is evident that it is virtually impossible to eliminate and even decrease significantly the risk, and therefore only a ban of vet diclofenac will work

   

• We are now stepping up our pressure on the Commissioners, and also working to gain the support of the veterinaries

   

• We have been asking our supporters to engage with their MEPs, and encourage them to ask Parliamentary Questions on this issue. It was then very good to get the news that not one , but FIVE PQs have already been tabled! Great to know that that vultures have so many engaged supporters!

   

  Some questions are spot on, and more interesting some refer to the Birds Directive and to fact that Diclofenac is a priority substance under the Water Framework Directive.

   

  This has certainly sent a clear message to DG SANCO that we can get MEPs to take action and that we can put pressure on them

   

  Here are the PQs, with a link to the actual questions

   

Risk of diclofenac to Spanish vultures

Question for written answer to the Commission Rule 117
Glenis Willmott (S&D)

Date :10-04-2014Reference :E-004508/2014 Documents

Veterinary drug Diclofenac and EU legislation

Question for written answer to the Commission Rule 117
Sirpa Pietikäinen (PPE)

Date :04-04-2014Reference :E-004212/2014 Documents :

Use of veterinary diclofenac for livestock farming in Spain and Italy

Question for written answer to the Commission Rule 117
Fiona Hall (ALDE)

Date :03-04-2014Reference :E-004151/2014 Documents :

Effect of Diclofenac on vultures

Question for written answer to the Commission Rule 117
Bill Newton Dunn (ALDE)

Date :02-04-2014Reference :E-004080/2014 Documents :

Danger posed to vultures by pharmaceutical product

Question for written answer to the Commission Rule 117
Nuno Melo (PPE)

Date :20-03-2014

The reply from FATRO

FATRO, the Italian company marketing the drug in Europe, has replied to the letter VCF and BirdLife International had sent them, asking for a voluntary ban on the drug. The reply was very poor – FATRO suggests that that labeling is enough, and hint that a ban would not result because veterinarians can always use human formulations of diclofenac to treat animals. An inherent contradiction, because labeling assumes best practice on the part of the veterinarians while they hint themselves that vets can always go around the legislation!

The VCF maintains that labeling does not guarantee a zero risk. Scientific evidence so far suggests that half of all Griffon vultures (8 kg) exposed to 200 microgrammes of diclofenac will die (Swan et al 2005). In real terms, this means that a 1,5 kg liver from a pig could easily kill two-three vultures if they eat it after a week after treatment with diclofenac (a normal dose will result in 600 microgrammes diclofenac / kg liver after a week). Cows are even more dangerous - a cow’s 6 kg liver could easily kill fifteen vultures if they eat the cow a week after treatment with diclofenac (1000 microgrammes diclofenac / kg liver).

We are now asking our supporters to voice their discontent at FATRO. Please write to FATRO, comunicazione@fatro.it, if you feel that FATRO has not been responsive in this issue – we certainly do!

Communications

We have launched a short video clip addressing the Commissioner for Health, Tonio Borg, asking him to do so. This video has been published on VCF´s Vimeo and Youtube (see http://vimeo.com/93067364 & http://youtu.be/59OIdukZQZY). So far they have had 1,300 hits. BirdLife International, SEO and others have already put the clip on their website, so thousands of Europeans have seen t is clip

Articles continue to be published on the European press. The latest ones were

NZZ – Switzerland

http://klima.blog.nzz.ch/2014/04/01/schmerzmittel-bedroht-europas-geier/

and see below

Charlie Hebdomadaire (France) - see below

http://focusingonwildlife.com/news/europe-approves-vet-drug-that-killed-off-almost-all-of-asias-vultures/

http://afundacionesnaturaleza.org/2014/05/adios-vacas-locas-hola-diclofenaco/

The VCF also gave an interview on the issue to radio New Zealand . listen to the podcast below

More than 25,000 people have already signed the on-line petition at https://www.change.org/petitions/janez-potočnik-european-union-diclofenac-the-vulture-killing-drug-is-now-available-on-eu-market

Statements from other conservation organizations

The European Association of Zoos and Aquaria (EAZA), and the Raptor Research Foundation (RRF)  added their voices to the many other organisations that have already asked for a ban on vet diclofenac. See the EAZA letter to Commissioner Borg below. You can also download the RRF statement here http://www.raptorresearchfoundation.org/conservation/position-statements   (click on 2014 tab)

 

 

The VCF and BirdLife International ask Commissioner Borg to take urgent action to protect Europe’s vultures from poisoning by diclofenac by introducing an EU ban on its production, marketing and use for veterinary purposes.

The VCF and BirdLife International had already asked the Commission to start a referral procedure, under Article 35 of Veterinary Medicines Directive (2001/82/EC), for the withdrawal of an authorized veterinary medicinal drug which affects Community interests. Wild animal species are of Community interest, as stated in the preamble of Habitats Directive (92/43/EEC), and thus fall within the scope of this provision.

The effect of diclofenac on vultures has not been examined at all in the risk assessment, and labelling and other potential management measures are not an adequate safeguard to prevent vultures being poisoned by diclofenac in Europe – only its full withdrawal from the market will keep the vultures safe!

The decision should be easy – there is a safe alternative to diclofenac readily available, solid scientific evidence on the impacts of the drug, and even a ban in place in some other regions of the globe (Indian subcontinent, where veterinary diclofenac caused a 99% decline in some vulture species).

Tens of thousands of European citizens, dozens of conservation and environmental organisations, many scientists, and even members of the European parliament have already asked the Commission to act. Commissioner Borg, please ban veterinary diclofenac.

It is essential that EU decision makers hear from Europe’s voters about the mistake that has been made with this deadly drug. There are three things you can do:

 

1. Please sign the online petition here https://www.change.org/es/peticiones/janez-poto%C4%8Dnik-european-union-diclofenac-the-vulture-killing-drug-is-now-available-on-eu-market

2. Please write to your Member of the European Parliament to ask if they can write a letter to both the European Commissioners for Health and the European Commissioner for the Environment to ask for action.

3. Please use Twitter to contact the European Commissioner for the Environment, Janez Potocnik asking for action from the European Commission on this issue. It is good to be passionate but polite as Commissioner Potocnik is a force for good when it comes to environmental protection. His Twitter feed is https://twitter.com/JanezPotocnikEU

4. Lodge a formal Petition in the European Parliament on the issue. The procedure for this can be found here:

   http://www.europarl.europa.eu/aboutparliament/en/00533cec74/Petitions.html

   Make sure you follow the guidelines.

If you’re unsure how to contact your Members of the European Parliament you can look them up here: http://www.europarl.europa.eu/meps/en/map.html

 

 

Let us know if you hear anything back from any of your decision makers.

 

You can also voice your discontent writing to FATRO. Please write to FATRO, comunicazione@fatro.it, if you feel that FATRO has not been responsive and/or proactive and accommodating  in this issue – we certainly do!

The Vulture Conservation Foundation has been at the forefront of the campaign to ban diclofenac in Europe. Ever since we were alerted for the legal marketing of this drug in Italy and Spain in late 2013, the VCF has researched the situation, established the current state of play, and promoted the building of a coalition of like-minded organisations to fight together this threat (Birdlife International, SEO/BirdLife, RSPB and the IUCN Vulture Specialist Group).

 

Diclofenac is extremely lethal to vultures, and has caused a 99% decline in several vulture species in the Indian subcontinent. This veterinary drug has been now banned from 4 countries in South Asia, only to reappear legally in Europe. This is probably the most significant threat to Europe’s vultures – whose populations have been steadily recovering following considerable investment by the EU, national governments and organisations like the VCF.

 

New evidence has also been published that also Egyptian vultures (a globally endangered species) may be affected by Diclofenac - see paper above.

 

There are alternatives readily available to vet diclofenac, so we must learn from the Indian example, and STOP this drug before it is too late for Europe’s vultures. The VCF wants to see a total ban on diclofenacin the EU.

 

This is what the VCF has already done so far:

 

-The VCF has submitted to the European Union, together with other organisations, a formal request for the EU to start areferral procedurefor a withdrawal of the marketing authorization of diclofenac, under Article 35 of Directive 2001/82/EC, based on the risks for vulture populations in Europe. The VCF has led on the production of a series of technical documents detailing the risks and potential exposure to vultures, and informing on the known-science on diclofenac (seedocumentbelowfor more details). If the referral procedure is started, the Commission will ask for a scientific opinion from the European Medicine Agency, before taking a final decision. Usually the Commission upholds the opinion of the EMA.

 

-This referral procedure can also be initiated by EU member states, and the VCF and BirdLife International have been working with national organisations in a number of countries so that they also formally ask their respective governments to push for this referral procedure – so far this request has been sent to 12 EU members governments:  Bulgaria, Croatia, Cyprus, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Slovakia and Spain.

 

-A number of national and international conservation organisations have issued their own press releases on diclofenac, following the public launch of the campaign by the VCF and Birdlife International on the 3^rd of March. You can see several examples here:

 

Hawk Conservancy Trust (here)

 

NABU (here)

 

Liga Para a Proteção da Natureza (here)

 

Rewilding Europe (here)  

 

Ligue Pour la Protection des Oiseaux (here)

 

Birdguides (here)

  

-The Convention on Migratory Species (CMS, also known as the Bonn Convention) has written to the Italian governments asking them to take some action.

 

-The issue has received some attention in the European and world press. Here are some examples of newspaper articles published in mainstream or the specialist national and international media

 

The Guardian (UK) here

 

El País (Spain) here

 

ABC (Spain) here

 

Publico (Portugal) here

 

Koelner (Germany) here

 

Vet Magazine (Germany) here

 

Dnevnik (Bulgaria) here

 

Farmer (Bulgaria) here

 

La Buvette des Alpages (France) here

 

WildLife Extra here

 

Makedonia (Greece) here

 

Avgi (Greece) here

 

Der Falke (Germany) (see above)

 

Oiseaux Passion (France) (see above)

 

The Independent (UK) here

TAZ (Germany)

 

Midi Libre (France) 

 

-In the meantime, a couple of petitions have also been initiated, one in English and one in Spanish. The English petition is addressed to the two EU Commissioners, and has already 25,000 signatures!

 

-Two scientific letters have also been published by vulture researchers and scientists to  the prestigious journals Conservation Biology & Science - see above.

 

-Quite relevant, the company marketing the drug in Spain (FATRO Ibérica) has put out – and then withdrew - an announcement with a recommendation that the vet diclofenac should not be administered to products that are susceptible to enter the vulture food chain. Considering the extensive character of many livestock explorations in Spain, and also the way that many vulture feeding stations work, this is impossible to control – but at least they recognise now the risk to vultures. This should have been adequately evaluated during the risk assessment!VCF and BirdLife International have in the meantime formally contacted the company marketing the drugs in Europe (FATRO), informed them of the issue, and have been requested to present a proposal.

 

- VCF and BirdLife have sent a formal request to FATRO for a voluntary withdrawal of veterinary diclofenac in Europe, and for a joint work programme aiming at a legal ban. Reply not yet received.