Research & Development Ethics Policy

Developing and providing safe and efficacious medicinal products and devices is based on high quality science in the discovery and research for new innovations, as well as in the further development of treatments already in clinical use. Commitment to the practices and high ethical standards concerning our industry means that Orion follows the relevant laws, regulations, guidelines and codes concerning pharmaceutical industry R&D.

In our R&D activities our commitment to build well-being means that we develop efficacious and safe treatments for unmet medical needs, representing innovation and the highest quality standards. Our purpose is to deliver the best for the patient and the care-giving professionals. 

Patients taking and doctors prescribing Orion’s products can rely on the fact that our products are manufactured using authorized methods and that their materials and components are sourced from trusted and monitored suppliers. Importantly, they can trust that our products become available to the patients through multiphase quality assurance, only via legal and controlled distribution channels, in genuine packages originating from Orion and that they contain all the relevant and required product information for the patient.
 
The working society engaged in the years long process of developing a completely treatment into a commercial product is characterized by highly academic scientific curiosity, discipline, patience and target-orientation, joy of new findings and achievements, and continuous learning. Work in our R&D is intensive search for, collection and verification, analyzing, reporting on and filing information of the compounds and concepts studied. The primary purpose is to show sufficient evidence of the treatment’s approvability for clinical use, i.e., for use in patients suffering from the target disease to relief symptoms or to change the course of the disease. 
 
An equally important purpose of our investment in R&D is to discover products upon which Orion can build its future existence. The business-related economic risks and possible disappointments are also present in the work: if a research or development project at some point indicates that this goal is all too difficult to reach, we choose another compound and route to study. 

Before we start a project, we explore a lot of available information to evaluate whether it is worth investing. The following criteria are among the key ones for the basis of decision-making:

• The confidence that the target idea or treatment concept would have significant impact on the disease
• There is a real need for new and better approaches to treat the disease
• Clear health economic benefit can be expected for patients and society
• The disease sufficiently relates to our core therapy areas and thus we have sufficient competence and knowledge
• The idea is scientifically feasible to study using the latest knowledge, methods and findings
• The risks and benefits of the idea have been assessed and the balance is feasible
• There is commercial potential for the new treatment approach, and we can arrange the necessary resources

Health being among the most important values for people, pharmaceuticals and their R&D have a most intimate human touch. Unfortunate events in the early history of the modern pharmaceutical industry have led to strict and comprehensive regulation and control of the entire life cycle of a medicine, as well as to extremely high transparency requirements. Pharmaceutical companies like Orion operate globally, and accordingly, also the required standards are valid globally. Healthcare authorities are not the only source of compelling requirements and good practices ─ also pharmaceutical industry associations have agreed and issued many self-regulatory and obligatory codes, compliance with which are efficiently monitored. The key standards concerning R&D are determined in the Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines. The specific regulatory guidance and codes for veterinary product development and device development are similarly followed.

 
Orion appreciates and follows the requirements, standards and ethical codes, understanding that by compromising them we would also compromise our good reputation and our purpose to show excellent operational R&D. 
The leadership responsibilities follow our operational management and reporting structure, according to which the Senior Vice President heading our R&D and the R&D leadership team carry the operational responsibility for our commitment to both regulatory and ethical conduct in our research and development. 

Orion’s Chief Medical Officer, Taru Blom puts our intention into the following words: 
“Patient safety is Orion’s absolute priority. We are committed to collecting information on safety throughout the research and development phase, to enable the regulatory approvals for the use of the product by patients. We continue the monitoring of the collected data throughout the manufacture and distribution chain, and for as long as the product is available and in use anywhere in the world. We continuously evaluate the benefits and risks of our products and act promptly if the gained information that required” 

In the following chapters we highlight our practices and approaches applied in the sequence of phases through which a research and development project is advanced. The scheme presented in the R&D section of our corporate website gives an overall view of the road of an innovative medicine which usually takes at least ten years to go.