Pharmaceutical R&D Ethics Policy

Like in all other operations, our aim is to work in accordance with the requirements, standards and ethical codes of our industry in our pharmaceutical research and development activities too. Our R&D Policy highlights how we make sure that our practices are on an ethically sustainable basis. 

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

In our R&D activities our commitment to building well-being means that we develop efficacious and safe medicinal 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. We take every step of our research and development process in compliance with the internationally adopted regulatory standards and criteria concerning pharmaceutical R&D.

Our mission to build well-being also means that patients taking and doctors prescribing Orion’s products can rely on that our products are manufactured using authorised 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 screens of multiphase quality assurance, via legal and controlled distribution channels only, in genuine packages originating from Orion and containing all the relevant and required product information for the patient.

The working society engaged in the years long process of developing a completely new medicine into a commercial product is characterised by highly academic scientific curiosity, discipline, patience and target-orientation, joy of new findings, achievement and never ending learning. Work in our R&D is intensive search for, collection and verification, reporting on and filing information of the compounds studied, the primary purpose being to show sufficient evidence of the investigational drug’s approvability for clinical use, i.e. for use in real patients suffering from the target disease and needing efficient and safe relief of symptoms or treatment slowing down the progress 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 facts of business as well as economic risks and possible disappointments are also present in the work: if a research 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 research program, we explore a lot of available facts for the basis of decision-making. The following criteria are among the key ones:

  • The idea and the target disease relates to our core therapy areas
  • 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 idea is scientifically feasible to study using the latest knowledge and findings
  • The risks and benefits of the idea have been assessed
  • We have sufficient competence, knowledge and the necessary resources
  • There is commercial potential for a new treatment approach

Health being among the most important values for most people, pharmaceuticals and their R&D have a most intimate human touch. Unfortunate events in the early history of 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 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 a number of self-regulatory and obligatory codes, compliance with which is 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.

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 the best operational R&D.

The managerial responsibilities follow our operational management and reporting structure, according to which the Senior Vice President heading our pharmaceutical R&D and the Vice Presidents heading our nonclinical and clinical research carry the operational responsibility for our commitment to both regulatory and ethical conduct in our pharmaceutical research.

Orion’s Chief Medical Officer, Paula Rytilä puts our intention into the following words:

“Patient safety is Orion’s core value and our absolute first priority. We are committed to collecting information on safety before our molecules enter human clinical trials, during the clinical development phase, to the product’s approval by regulators for use by patients, through its manufacture and distribution chain, and for as long as it is available and in use anywhere in the world.”

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

 

The next pages of the Policy:

Bioethics and Animal Welfare >>

Using Human Tissues, GMO and Stem Cells >>

Ethics in Clinical Research Phases >>

Ethics in the Marketing Phase >>