This briefing notes explain the importance of dogs as experimental animal models, why and how this species is used in research and the role of animal breeders in drug development.
- Green Hill is a dog breeding facility located in Montichiari (Emilia-Romana region, Italy) that was established in 1989. They were purchased by Marshall Bioresources in 2001.
- Most of the beagles bred at Green Hill are used in mandatory safety testing of new drugs.
- Green Hill is a licensed establishment as required by the European Directive 2010/63. This license ensures that the activities performed at the establishment ensure the highest animal welfare standards according to the 3Rs principles of replacement, reduction and refinement.
- Green Hill, like all licensed establishments, undergoes regular inspections by the appropriate regulatory body, which in this case is the Azienda Sanitaria Locale (local public health agency reporting to the Italian National Health Service (Servizio Sanitario Nationale)).
- Inspection frequency before 2010 was limited to one to two inspections per year with repeated positive evaluations.
- In the summer of 2010, Green Hill applied for permission to expand their facilities. The application attracted public and political attention and local animal rights groups began to organise against Green Hill.
- After 2010, the number of inspections at Green Hill increased to more than 15 per year.
- A petition was launched to boycott Marshall Pet Products. The petition failed to achieve the support expected (1).
- An important factor in the campaign against Green Hill is the involvement of Michela Vittoria Brambilla, People of Freedom Party (Il Popolo della Libertà, PdL) representative for the Emilia-Romana region and previously Minister of Tourism in the fourth Berlusconi administration.
- Before entering politics, Brambilla was a television journalist for Berlusconi’s Mediaset group and consequently has a strong media influence.
- Despite being the founder and owner of two seafood companies (Sal Seafood Group and Sotra Coast International) (2), Brambilla is a strong advocate for animal rights and is the President of the Italian League for the Defence of Animals and the Environment (Lega Italiana per la difensa degli Animali e dell’Ambiente).
- Brambilla is the author of the Manifesto Animalista where she refers to Green Hill as the ‘Hill of Shame’ (La Collina della Vergogna) (3).
- In September 2011 the International Organization for Animal Protection (OIPA) filed complaints and opened an investigation of Green Hill. After a six months investigation, the Institute Zooprofilattico Sperimentale of Lombardy and Emilia Romagna (IZSLER) declared Green Hill clear of any charges in March 2012 and the case was closed.
- On 18 July 2012, following allegations from animal rights groups of maltreatment of dogs, a court order temporarily closed the facilities of Green Hill. All dogs were rehomed (given away for adoption) or placed in public kennels.
- On 30 May 2013, the Court of Brescia declared Green Hill innocent of all charges. The company was free to restart production. However, the court refused to order the return or compensation for the dogs that were taken by animal rights groups.
- On 7 June 2013 the public prosecutor in Brescia reissued the same charges against four managers of Green Hill. The court hearing is scheduled to begin in November 2014.
- On 31 July 2013, the Italian Parliament approved a bill mandating significant restrictions to the European Directive 2010/63/EU on the protection of animals used for scientific purposes, introducing a ban on the breeding of non-rodent species (including dogs, cats and non-human primates (NHPs)).
- The law approved by the Italian Parliament does not comply with the European Directive 2010/63 and Italy has been notified by the European Commission.
- Breeding activities for scientific purposes, including those of Green Hill, are temporarily stopped until observations of the European Union on breaches on Directive 2010/63 are addressed.
- Marshall BioResources provides purpose-bred research animals and related services for biomedical research. They have regulated and inspected facilities in the USA, China and Europe.
- In US, Marshall BioResources maintain breeding colonies of beagles, mongrel dogs, ferrets, and Gottingen Minipigs.
- Marshall BioResources are Class A breeders licensed by the U.S. Department of Agriculture (USDA) to sell animals bred specifically for research. In July 2004, there were 4,117 Class A licensed dealers in the United States.
- Marshall BioResources’ facilities are AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accredited. AAALAC International is a private, non-profit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. More than 900 companies, universities, hospitals, government agencies and other research institutions in 39 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use.
- Marshall BioResources are members of the American Association for Laboratory Animal Science (AALAS), which is a non-profit association established in 1950 as a forum for the exchange of information and expertise in the care and use of laboratory animals (4).
- Animals are required in medical, veterinary, environmental and scientific research to develop treatments for humans and animals.
- There are many comparable physiological processes in humans and animals. In some cases, a gene present in an animal is also present in the human genome, suggesting that the function of that gene can be conserved between species.
- Before testing a treatment in vivo in an animal, candidate drugs are first evaluated using in vitro assays in cell cultures, ex-vivo tissues and computational modelling.
- Both in vivo and in vitro experiments help scientists to understand the biological processes associated with health and disease.
- New therapies are tested in animals to determine whether they trigger unwanted side effects before proceeding to human clinical trials.
- Animals for medical and scientific purposes can only be used if there is no viable alternative method.
- Animals are used in toxicology studies to determine the therapeutic index of a candidate drug, which indicates its safety.
- Animal research is performed according to the European Directive 2010/63/EU on the protection of animals used for scientific purposes. This Directive is a very progressive and stringent framework that ensures high animal welfare standards while encouraging the development of non-animal alternatives.
- Directive 2010/63/EU is firmly based on the principles of the 3Rs to 1) replace animals with animal-free alternatives, 2) reduce the number of experimental animals used and 3) refine the procedures to avoid causing pain to the animals.
DOGS IN RESEARCH
- Carnivores (which include dogs and cats) represent 0.25% of the total number of animals used for scientific purposes in 2011 in the EU, while mice (60.9%) and rats (13.9%) are by far the most commonly used species (5).
- Studies in dogs form a small but vital part of the research and development process required to find new treatments. For a new drug to reach clinical trials in humans, the U.S. Food and Drug Agency (FDA) and the European Medicines Agency (EMA) usually require toxicity tests in both a rodent and a non-rodent mammal. The rodent will often be a rat; the other mammal will usually be a dog.
- Dogs are used because they are physiologically similar to humans; they have the same organs, regulatory systems and suffer from similar pathologies.
- Dogs can be used to determine the ‘maximum tolerated dose’, which is used to select the administration dose for human clinical trials.
- Dogs are especially suitable for cardiovascular studies due to the resemblance in heart connectivity and size to the human heart.
- The number of animals used for toxicological and other safety evaluation accounts for less than ten percent of the total (5).
- Experiments on dogs led to the discovery of insulin to treat diabetic patients, the development of blood transfusion procedures and the creation of the electrical defibrillator to restore normal heart rhythm (6).
BREEDING DOGS FOR SCIENTIFIC PURPOSES
- Dogs for research are purpose-bred and come from licensed breeding establishments.
- At the breeding establishment, dogs are housed in small groups and have enough space for regular exercise.
- Breeding establishments are legally bound by the same guidelines as research centres and scientist, as laid out in European Directive 2010/63 which ensures high animal welfare standards while encouraging the development of non-animal alternatives.
- A wealth of background data on dogs is widely available within research centres and institutions. This background data is used for comparison, minimising the number of animals used and increasing the likelihood that the studies will produce satisfactory scientific results.
- The pharmaceutical industry possess state-of-the-art technical knowledge and experience on the wide range of procedures performed in toxicology studies allowing the most refined methods to be used.
For further information please contact Bob Tolliday, EARA Communications Manager.
- Seventh Report from the Commission to the Council and the European Parliament on the Statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union: http://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm