Bioethics and Animal Welfare

Animal studies continue to play a vital role in the search for new and improved medicines, and are an essential and unavoidable part of the nonclinical phase of the research process. Without animal testing, there would be no new medicines.

As a requirement, certain results from animal studies must be reported before the medicinal authority can grant a permission to forward a new investigational medicine to tests in humans, i.e., into clinical study phases. Animal studies are even required when the investigational substance is being developed for a treatment of animals.

Orion is committed to the responsible use of animals. The welfare of the research animals is our top priority. We only use animals when it is necessary and unavoidable: to help scientists bridge the gap between the theories developed in the test tube and the research results required for introducing a new treatment to the patient.

The European Federation of Pharmaceutical Industries and Associations, EFPIA, is actively devoted to promoting animal welfare issues in all of its actions. Orion is a member of EFPIA, and we support and facilitate the same goals throughout our research activities.

In all our nonclinical work we apply the 3Rs principles – Replacement, Reduction, Refinement. The purpose of these principles is to minimise the use of research animals and promote the development of alternative methods, thereby contributing to ethically better science.

Replacement means methods, strategies or approaches which do not involve the use of live animals. Tests in animals can be replaced through e.g. in vitro techniques using cells or tissues, or by using computerised models and “omics” technologies such as transcriptomics (gene expression analyses) or metabolomics (analyses on biochemical metabolites).

Reduction covers approaches with which fewer animals can be used instead of traditional methods without compromising the reliability of the results. It includes better use of the information obtained from a single animal, thus limiting the use of additional animals.

Refinement means modifications of procedures, husbandry and care practices of animals during the whole life of a single animal. Pain, suffering and distress are minimised to enhance an animal’s well-being. The overall good condition and well-being of the animals improve the quality of the data obtained from studies.

The 3Rs principle was introduced into animal testing years ago, and is now adopted in both Finnish and EU legislation. The conditions of obtaining a licence to conduct animal studies, including the required qualifications of companies carrying out animal studies and scientists involved in them, are also covered by the legislation. Every study has to be approved by the National Project Authorization Board, which acts under the Regional State Administrative Agency.

All Orion’s research using animals is carefully considered and justified. Every study shall be scientifically necessary and designed so that the minimum possible number of animals of an appropriate species can be used to achieve the scientific objectives. We pay special attention to causing minimum necessary harm and pain.
Orion has adopted practices that exceed the requirements of the EU and Finnish authorities concerning training and education of the personnel involved in animal research. Our research personnel is continuously trained to plan and execute studies using animals and to take the best possible care of the animals and their well-being.

Our animal facilities are built to give enough space to move and allowing natural behaving and inspiring activity for each animal species. The animals are sourced from specialised animal breeders, which are highly controlled, and on ethically solid ground. The EHS (environmental, health and safety) and cleanliness aspects have been implemented with very high ambition.

Part of our animal studies is carried out by specialist contract research organisations. Before the assignment we make sure that their animal welfare issues are at the same high level as in Orion. We regularly visit and audit all research partners to make sure that their operations are in compliance with regulatory requirements and our own policies and that the 3Rs are applied in animal research.

In our core therapy areas of R&D, i.e. neurodegenerative diseases and cancer, we need studies using animals to explore physiological phenomena, hormonal background and interactions of different cells and tissues, which can only provide relevant information when studied in whole animals. Only a whole, living animal can give us an answer to questions like whether an investigational new drug molecule relieves symptoms of a disease, or how a molecule is absorbed and metabolised in the body.
In vitro techniques are used for evaluating the molecular mechanism behind a drug molecule, but this has to be confirmed using suitable animal models.
The regulatory methods have to be approved by the authorities. In animal and in vitro testing, we follow Good Laboratory Practice (GLP) guidelines and our internal Standard Operating Procedures. All methods used must give the most reliable information on the investigational drug molecule.

Regular audits of animal testing practices are performed in-house by our veterinarians and also by the Animal Welfare body (AWB); they also give advice in the refinement and development. Inspectors from regulatory agencies, such as the Regional State Administrative Agency and the National Supervisory Authority for Welfare and Health, audit regularly the facilities and animal welfare and experimentation procedures.

All exceptional issues in animal experiments are reported to the AWB, which in turn decides on the actions to be taken. These issues are also reported to the National Projects Authorisation Board.

The results of nonclinical research covering both in vitro and animal research are evaluated by our experts for the basis of taking the research project into clinical phases, i.e. studies in humans or target animal species. In the evaluation, the usefulness of the results in predicting what happens in humans is carefully considered. If the signs of efficacy and safety are promising enough and predict that benefit for patients will overweight the risks, the molecule can proceed to the clinical phase.
As a rule applicable to any point of a research project, studies are discontinued as early as possible, if the molecule shows lack of safety or efficacy.


References

EFPIA website:  www.efpia.eu

Act on the Protection of Animals Used for Scientific or Educational Purposes (Laki tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta) 497/2013, in Finnish: www.finlex.fi/fi/laki/alkup/2013/20130497. Unofficial translation into English: pdf

Government Decree on the Protection of Animals Used for Scientific or Educational Purposes (Valtioneuvoston asetus tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta) 564/2013, in Finnish: www.finlex.fi/fi/laki/alkup/2013/20130564. Unofficial translation into English: pdf

 

The next pages of the Policy:

Using Human Tissues, GMO and Stem Cells >>

Ethics in Clinical Research Phases >>

Ethics in the Marketing Phase >>