In an evolving environment, the Virbac group must provide an innovative, safe range of products and services, developed and produced in keeping with animal well-being. Customers, veterinarians, farmers and animal owners are becoming increasingly mindful of their impact on the environment and human health.
As a result, we are naturally driven to shape our activities accordingly. We are committed to steer our research on a long-term horizon and to develop innovative solutions that address a variety of pathologies and production needs, according to the particularities of each geographical area where they occur. We strive every day to find the best way to achieve this while remaining true to health quality requirements.
The veterinary pharmaceutical industry is highly competitive. Each year, to respond to market developments and needs, maintain our market share and ensure our development, we devote significant resources to research and development. We attach particular importance to the search for continuous improvement in the innovative solutions proposed and in the way they are developed
OUR KEY OBJECTIVES
The organization in charge of Group innovation is structured as research centers, divided by type and global regions. This close proximity to our customers and their needs in the various global markets enables us to offer a range of relevant and adapted products and services.
OUR POLICIES AND ACTION PLANS
Developing alternatives to antibiotics
The development of prevention, in particular through vaccination, is one way of reducing the use of antibiotics in animal production. Virbac's recent investments in research and production centers dedicated to vaccines for food producing animals in France, Australia, Chile, Uruguay and Taiwan reflect this desire to strengthen the Group's development in this area. We have also initiated several partnership programs with public research institutes and private companies to advance together in the development of innovative products (immunostimulants, micronutrition, biocides), some of which may replace antibiotics or help reduce their use.
Developing modern alternatives to traditional treatments
Mindful of the balance of ecosystems and environmental protection, we aim to develop alternatives to certain traditional therapies. As part of our responsible innovation process, we have taken a further step forward with the discovery of a new treatment which offers a real alternative to surgical castration in dogs, thanks to hormonal regulation that neutralizes the animal’s reproductive capacity for six months or a year. The animal’s well-being is preserved and, in the interest of the animal and its owner, any irreversible surgical procedure becomes unnecessary.
|% of RDL biology/total expenditures||40.6%||33.0%|
|% of RDL expenditures/Group revenue||8.4%||8.1%|
* Vaccines, immunological products and biopharmaceutical products
Virbac’s stakeholders (customers, veterinarians, farmers, employees, etc.) are increasingly concerned about the impact of our products on the entire value chain. This is why we conduct our innovation process and our operations within a strong ethical framework, by promoting in vitro testing as much as possible and by involving our various partners and stakeholders: suppliers, regulatory authorities, professional associations, etc.
As an animal health player, Virbac must rely on animal studies, in accordance with applicable pharmaceutical regulations. However, we are committed to limiting them to the necessary minimum, in specific cases where they are required by regulations, and no known alternative or suitable method is possible.
These animal studies include:
animal protection: verification of the product’s safety (non-toxicity, no impact on reproduction, non-carcinogenic, etc.) and of its effectiveness in healing or protecting the target animal;
human protection: verification of safety for the product user and the absence of residues in species intended for consumption (meat, milk, eggs);
protection of the environment: verification of the absence of toxicity for organisms other than the target species that may come in contact with the product.
Preclinical and clinical studies
pre-clinical studies (studies carried out in animal units, under standardized and controlled conditions) are governed by regulations covering all aspects of animal studies: approval of the establishments where the studies are carried out, staff training and qualification, the origin of the animals and their traceability, prior ethical evaluation of the studies and their follow-up, controls by the authorities, ethics committees and audits carried out by Virbac teams. These studies allow the effectiveness and safety of the products to be verified under strict conditions.
then the clinical studies (carried out on companion or food producing animals) aim to confirm the effectiveness and safety of the products under field conditions and are subject to regulatory submission or prior trial authorization (depending on the country) and are conducted under the responsibility of veterinarians.
In the Group’s animal units, the different categories of animals were distributed as follows in 2019: rodents 96.3%, rabbits 2.5%, food producing animals 0.6%, domestic carnivores 0.6%.
OUR KEY OBJECTIVES
Our key objective is to reduce the number of animals used in R&D studies and quality control by eliminating studies or replacing them with alternative methods. Specifically, Virbac is committed to reducing the number of animals used for quality control by 14,000 (i.e. a reduction of 50%) by 2025.
The Innovation department defines the strategic resource areas for the performance of animal studies and the development of alternative methods. These areas are implemented by the corporate animal ethics department in the form of policies, action plans and control processes. This department is also in charge of promoting and ensuring respect for ethics and animal welfare within the Group and among its partners.
OUR POLICIES AND ACTION PLANS
An ethical charter and policies to manage animal studies
The Group has drawn up an ethical charter relating to animal studies, which consists of ten points and applies to all employees of the Group and its subcontractors. This charter is based on the international principles of the 3Rs: Reduce, Replace, Refine animal studies.
Furthermore, there are two Group policies governing animal studies: Animal ethics committee and Animal welfare.
the Animal ethics committee policy defines the field of action, the roles and responsibilities, the organization, the ethical rules and the functioning of Virbac’s ethics committees.
the Animal welfare policy, defines the roles and responsibilities of personnel in terms of animal welfare. Based on the principles of the 3Rs and the Virbac code of animal care, it describes the standards to be applied to animals, studies and animal units within the Group. These standards are also required of the Group’s partners when conducting animal studies.
ethics committees are established in all areas where animal studies may be conducted. They are all governed by the same ethical principles (independence, impartiality, absence of conflict of interest) and operating principles (imposed membership categories, ethical evaluation of studies, deliberation, voting, etc.). They review 100% of the studies, which can only be conducted after obtaining their approval.
with regard to outsourced studies, the Group imposes the same level of requirements on its partners: CRO (Contract research organizations), universities, etc. These requirements include the setting up of ethics committees within their own bodies, as well as the deployment of strict procedures for monitoring their studies and compliance with animal welfare and regulations.
in France, the structure in charge of animal welfare (SBEA) is responsible for advising on welfare and the application of the 3Rs, and for verifying the application of measures and the conduct of studies in accordance with the authorizations issued.
Main actions implemented
the 3Rs rule is our guiding principle to substitute animal studies and controls as much as possible in our laboratories, but also to promote alternative methods to regulatory agencies around the world. In particular, where possible, in vitro tests should be carried out instead of in vivo tests or by capitalizing on reproducible tests, bibliographical research or computer modeling. For example, the leptospirosis vaccine release quality control hamster test was replaced in 2019 by a fully in vitro test (Elisa test) for countries accepting this test.
furthermore, studies are carried out on the species for which the health products are intended (effectiveness and safety studies). As a result, no tests are carried out on primates. Rodents and rabbits are mainly used in the validation phases for new vaccines and regulatory quality controls.
various initiatives (including negotiations with regulatory agencies to eliminate routine testing, production of batches dedicated to countries that do not require animal testing, etc.) have led to an 86% reduction in domestic carnivores used for quality control testing (regulatory requirements for vaccine batch release).
In addition, since 2013, we have set up a post-study animal adoption program in collaboration with the leading French association dedicated to the adoption of laboratory animals.
Our objective through this approach, which was to guarantee a foster family for 100% of adoptable dogs and cats, has been achieved.
|Number of animals used for R&D studies||5,773||6,664|
|Number of animals used for quality controls||36,361||27,917|