Shaping the future of animal health
Virbac group
Responsibility contact
For more information about our actions in this field, please e-mail us: developpement. durable@virbac.com
 

Product responsibility

RESPONSIBLE INNOVATION

In terms of responsible innovation, Virbac today works with two main themes: alternative methods to animal testing and the reduction of antibiotics in animal production.

The development of prevention, particularly by vaccination, is one of the ways to reduce the use of antibiotics in animal production. Recent investments by Virbac in centers for research and vaccination production for livestock in Uruguay, Chile and Taiwan reflect this willingness on the part of the company to strengthen its development in the field of vaccines. Virbac is also involved in several partnership programs with public research institutes and private companies for the purposes of developing alternatives to antibiotics that will not lead to resistance in treated bacteria. These partnerships are part of long-term rationale and, like the vaccine strategy, will reduce the use of antibiotics.

Virbac develops pharmaceutical and biological products for which regulatory requirements, as well as some quality controls imposed by medication agencies, must involve testing on animals. Virbac commits itself to the 3Rs rule (reduce, refine, replace) and is proactive in replacing studies and trials on animals with alternative methods and techniques, in addition to negotiating with the various agencies worldwide to persuade them to accept these alternative methods.

In 2017, 18% of the animals were used for R&D studies, 82% for biology production quality control (regulatory trials for release of vaccines).

R&D Studies

Dedicated to animal health, Virbac does not use primates for its R&D studies, but focuses on the species for which its health products are intended (efficacy and safety studies). Rodents and rabbits are used in the validation phases for new vaccines.

R&D studies - breakdown by species (%)

 

etudes_RetD_par_espece_EN.png

Out of the 7,466 rodents and rabbits used in studies, 1,745, or 23%, were used for validation and development of alternative methods. This temporary phase makes it possible to prove the reliability of alternative methods, particularly for the quality control of vaccines, and to foresee a significant medium-term reduction in the use of rodents.

Quality Control

34,591 animals were used as part of Quality Control activities in 2017.

Quality control - breakdown by species (%)

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0.15% of domestic carnivores are used for the Target Animal Batch Safety Test (TABST) still required by several countries outside of Europe in order to release vaccines.

Over the past few years, Virbac has made a major effort to reduce the number of domestic carnivores.

Domestic carnivores used in quality control between 2013 and 2017

 

2013 2014 2015 2016 2017
Dogs 170 146 52 38 50
Cats 12 10 10 8 6
Total 182 156 62 46 56


This reduction in the number of animals (69%) between 2013 and 2017 was achieved thanks to a 78% reduction in the number of trials carried out on domestic carnivores (the increase between 2016 and 2017 reflects a greater number of vaccines to be tested for countries outside of Europe).

Various initiatives made it possible to achieve this result:

  • negotiation with national regulatory agencies (outside of Europe) to remove routine testing;
  • selective production of tested or untested batches based on the destination country;
  • regulatory removal of tests in Europe.

Focus on France: an adoption program that has been in place for 5 years 

Since 2013, the year in which adoption was authorized in France by the new “Animal Welfare” regulation, Virbac has collaborated with the primary French association dedicated to this activity. The goal of ensuring a host family for 100% of adoptable dogs and cats was reached.

Domestic carnivores adopted between 2013 and 2017
  2013 2014 2015 2016 2017 Total
Dogs 135 183 56 68 50 492
Cats 62 45 1 19 7 134
Total 197 228 57 87 57 626



 

 

The drop in animals adopted since 2014 is due to a reduction in the number of quality controls (removal of tests) and by the nature of the R&D studies (vaccine development).

CONSUMER HEALTH AND SAFETY

Virbac is committed to developing, producing and distributing products and services aimed at improving the quality of life for animals and guaranteeing their health, while ensuring comfort and safety for those who administer these products: veterinarians, farmers, animal owners, etc.

To do this, Virbac meets the highest applicable quality-safety-efficacy standards. At the development stage, Good Laboratory Practices (GLP) are followed systematically, for example through data traceability. Current Good Manufacturing Practices (cGMP) are applied during the production stage, particularly through the certification of all Virbac factories. Finally, for the supply of drugs, Virbac uses Good Distribution Practices (GDP), such as compliance with the cold chain, when required by the nature of the products.

Assessment of product safety during its use is carried out whenever necessary, particularly through the development or selection of specific packaging. In product labeling, Virbac intends to clearly explain all the information useful to the proper administration of the product and to the understanding of its properties and contra-indications. The Group also has a leading role in the development of diagrams and pictograms that provide a clear understanding of information fundamental to consumer health and safety.

For species intended for consumption, Virbac ensures that during product development, its products comply with pharmaceutical standards relating to residual traces of medicines in foodstuffs: meat, milk, eggs... In addition, the guidelines for use are systematically brought to the attention of the consumer through product packaging and various associated communication media.

Throughout the life cycle of the products, including during development, Virbac assesses the expectations of customers and their satisfaction, in order to continuously adjust product features. In terms of marketing, all Virbac promotional communications are consistent with the scientific and technical claims demonstrated during the development stage of the product.

Lastly, the Virbac quality system enables the company to efficiently detect, trace and treat all quality incidents inherent to the pharmaceutical business.

Pharmacovigilance

Like all pharmaceutical companies, the Virbac Group is legally obliged to monitor the veterinary medicines it places on the market, in terms of their safety and efficacy. This obligation is known as pharmacovigilance. Its purpose is to create an organization that keeps track of adverse reactions (whether serious or not) reported by veterinarians or other health professionals, or even by users of such medicines (owners of companion animals, for example). This organization, placed under the responsibility of a person qualified in (veterinary) pharmacovigilance and a qualified interim person, must compile all of the cases originating from all countries in the world, analyze them, decide whether the side effects are attributable or not to the use of the drug in question and, finally, officially report these cases to the supervisory authorities. Periodically, all cases declared during a given period for a given medicine are compiled in a report, which is then sent to the same authorities. Compiling all the side effects attributable to a drug eventually allows precautions for use to be added to the packaging leaflets and make their use safer. Due to the increasing globalization of its medicines, the Virbac Group goes about compiling cases of side effects on a global scale, by implementing a reporting system in all subsidiaries. The Virbac Group's ambition is perfect pharmacovigilance; that is to say, allowing them to compile all cases of side effects attributable to medicines that it places on the market, to fulfill all its obligations within the time frames prescribed by the administration, and to use the pharmacovigilance tool to develop knowledge of its products.

PRODUCT AND SERVICE LABELING

In terms of the safety of products and their components, Virbac's policy is as follows:

  • provision of safety data sheets for "raw materials" and "finished products" to Virbac staff and carriers;
  • organization of transportation in accordance with European regulations governing the shipping of high-risk products:
    • availability of safety data sheets for finished products in French and in English,
    • packaging of hazardous products in packaging that meets current standards;
  • from the client's perspective, Virbac complies with the European directives and regulations on indications and precautions for use that must appear on packaging, both for products requiring marketing authorization and those referred to as nutritional.

Each claim is supported by appropriate clinical studies.

MARKETING COMMUNICATIONS

GoatDue to the nature of its pharmaceutical industrial activity, the Virbac Group is subject to the requirements defined by national or supranational veterinary pharmaceutical agencies. Any product claims must be scientifically proven and made available to the regulatory agencies. The pharmaceutical manager at each Virbac subsidiary vouches for the compliance of products sold in his country with the regulations.

These principles apply both to medicines with marketing authorizations and also to foods, complementary and dietetic food for which Virbac complies with local regulations (e.g. for nutritional supplements and food: European Regulation 767/2009, US NASC accreditation). In addition, Virbac does not directly promote products that require a prescription (and which may not be subject to exception) among owners or farmers, but refers them to veterinary consultation in order to promote preventive medicine.

All the social indicators in the 2017 sustainable development report (page 54)

 
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