Management of Product Responsibility
Patient safety is the guiding value in all Orion’s operations and the essence of our corporate responsibility. Responsibility and caring are an integral, uncompromised and natural part of everything we do at Orion. The responsibility of the manufacturer and the manufacturer’s principal for the safety, quality and uncompromised compliance with requirements extends through all the phases and functions included in research and development, procurement, manufacturing, marketing and communications. The legal and regulatory requirements of healthcare authorities, the primary purpose of which is to ensure patient safety, guide our activities in everything we do. In addition to this, we also follow the commonly agreed codes of harmonised practices applied by our industry internationally.
Our basic mission is to build sustained well-being by providing efficient, safe and competitive products for the diagnosis, prevention and treatment of illnesses. We promote health and quality of life with our products and by sharing guidance to consumers and healthcare professionals on the correct and proper use and storage of the products. The complementary education and training we offer to healthcare professionals, in particular to doctors and nurses as well as to pharmacy staff also fall within the scope of product responsibility, as does our support to patient organisations.
As a pharmaceutical company, we must ensure that the drugs and active pharmaceutical ingredients developed, manufactured and marketed by us are proven safe for their users, effective for the indications for which they are approved, and that they meet the quality requirements set for them as well as the needs of the customers and patients. As a manufacturer of diagnostics products, we are responsible for ensuring that the tests and test systems work as planned and produce reliable results for the patient’s condition to support appropriate treatment decisions.
It is important from the point of view of our product responsibility that the information about a medicinal product we share to doctors, pharmacies and patients is in accordance with the product characteristics confirmed for it by regulatory medicinal authorities on the basis of the results of the research and the data collected in clinical use. It is also important that we provide the necessary guidelines for taking and storing the product correctly.
The guiding principles of the quality standards of our entire supply chain are based on full compliance with the EU-regulated good operating practices in manufacturing, laboratories, and R&D, and the efficiency and fluency of processes, product safety and consistent quality and high reliability of delivery. As our products are also sold outside the EU, we make sure that our operations are compliant with the good practices applicable in those countries.
In our pharmaceutical research and development operations, we follow relevant legislation, regulatory authorities’ instructions and guidelines, and the principles determined in our Pharmaceutical R&D Ethics Policy which conforms to the Helsinki Declaration and the common codes of our industry.
As the manufacturer and the marketing authorisation holder, we are responsible for the quality and safety of our products. The Finnish Medicines Agency Fimea is the authority that inspects pharmaceutical and API plants and contract manufacturers in Finland according to the Pharmaceutical Products Act, also on behalf of the authorities of other EU member states. Moreover, healthcare authorities of many other countries continuously supervise our operations. The supervision and inspections also cover the pharmacovigilance and the operational premises, the R&D operations, as well as those products for which we act as a distributor when the marketing authorisation is held by another pharmaceutical company.
Orion Diagnostica follows the safety requirements concerning its products, such as the EU directive concerning IVD diagnostics, as well as the corresponding requirements of the US Food and Drug Administration (FDA) and other national regulators, and the ISO 9001 and ISO 13485 standards. The Finnish regulatory authority for diagnostic products is called Valvira.
Management of Product Responsibility
The basics of the management of our product responsibility are determined in the Quality Management System to ensure that each product batch released for sale is in accordance with the marketing authorisation, and based on this we continually monitor safety throughout each product’s life cycle. We systematically follow the outcomes of the quality and safety monitoring, and in events of concern we instantly carry out the necessary procedures to ensure patient safety.
Management of pharmaceutical product responsibility
The management of product responsibility concerning pharmaceuticals is arranged as follows:
- Chief Medical Officer (CMO) is an experienced senior physician carrying the primary responsibility for the company’s medical governance and medical ethics. The CMO is responsible for the safety of our study programmes, the assessment of medicinal benefit/risk balance and activities related to them. The CMO shall always prioritise the benefit for the patient. The CMO reports to the Senior Vice President, R&D, who is a member of the Orion Group’s Executive Management Board.
- The Global Medical Affairs, headed by the Vice President, CMO, Medical Affairs & Pharmacovigil, in collaboration with the global marketing and sales organisations,is responsible for our compliance with the legal requirements concerning the marketing of pharmaceuticals in all those countries where Orion is present. The Global Medical Affairs reports to the Chief Medical Officer.
- Qualified Person responsible for pharmacovigilance (QPPV) is responsible for the establishment and the maintenance of the pharmacovigilance system of the marketing authorisation holder, as provided in EU directives 2001/83/EU and 2001/82/EU and, accordingly, in Section 30 of the Finnish Medicines Act. The QPPV shall act as a contact point for the regulatory authorities on a 24-hour basis for safety related issues. The QPPV in Orion is Director, Global Drug Safety, who reports to the Chief Medical Officer. The duties of the QPPV include the responsibility of our operational compliance with the international regulatory requirements concerning the monitoring the safety of medicines, regulatory reporting and actions related to the management of patient safety risks.
- The Accountable Director is, as provided in Section 9 of the Medicines Act, primarily responsible for ensuring that our medicinal products are manufactured in the correct way and that the quality requirements are met. In the Orion Group, the Vice President, Quality Management, who reports to the President and CEO, holds the position of the Accountable Director. The VP, Quality Management, is responsible for the compliance of our Quality Management System with the requirements of international regulatory authorities as well for the quality assurance and control of our products. In compliance with the Medicines Act, Fermion also has an accountable director who reports to the President of Fermion.
- The produced batches of medicines are released for sale by the so-called Qualified Person in our Quality Assurance organisation, whose professional qualifications are determined in EU directive 2001/83/EU and in the Finnish Medicines Act. Active pharmaceutical ingredient (API) batches are released for sale by independent Quality Assurance departments at each production site of Fermion. Correspondingly, the release of diagnostic products is also subject to an independent Quality Assurance organisation.
Tasks related to product responsibility are performed in cross-organisational working groups consisting of persons with a broad range of skills and competences necessary both in the product development phases and in commercial manufacturing.
The basis for the quality of a medicinal product and an API is built into the course of the research and development phases. The manufacturing methods and equipment are determined during these phases, as are the requirements for the raw materials and the product. Industrialisation is included as an elementary part in the product development phase, the purpose of which is to make sure that the manufacturing methods are applicable on an industrial production scale and that each production batch corresponds to the product described in the marketing application.
We purchase our materials from suppliers whose qualifications we have confirmed. Audits of their manufacturing sites are important steps in the process of selecting and monitoring our raw material suppliers as well as in ensuring the continued availability and consistent quality of the raw materials and the traceability of the documentation. In the qualification process for API suppliers, we also audit the manufacturers of the intermediate materials used in the manufacturing process of the API.
Before approving the raw materials for production, we always take and analyse samples of them. Packaging materials and the printed packaging information are also checked accordingly. To ensure the quality not only of our pharmaceutical preparations but also of other products, we carry out controls during the manufacturing phase. Samples are taken and analysed of each manufactured batch, and the documentation of the batch is checked before it is approved for sale. In the approval process we check that the batch has been manufactured in accordance with the marketing authorisations granted for the product by the authorities in different countries and that all the results of the analysis meet the requirements confirmed in the authorisations. When releasing products for sale, we use even stricter internal quality criteria in order to ensure the required quality throughout the entire shelf-life of the product. With the help of the batch documentation, all the materials and the phases of manufacturing, quality control, transportation and distribution can be traced without gaps.
The quality management procedures for APIs are described in the control strategy. The quality control methods are established at an early stage when the multi-staged manufacturing process is being developed, whereby the purity profile and the corresponding quality requirements for the ingredient are determined. The quality of the active ingredient is monitored throughout the manufacturing process, and all batches are analysed before they are released for sale.
Like the medicines and APIs, diagnostic products are also furnished with a batch code which we can use to make sure of the properness of the manufacturing phases, from the raw materials to the finished product. This traceability is extremely important when there is reason to find out if a manufacturing error has occurred.
Patient safety is a fundamental priority and a core value at Orion. We work to ensure the safety and optimal benefit/risk balance of our products throughout their lifecycles. We maintain a pharmacovigilance system required by legislation and regulatory requirements to monitor the safety of our medicines and to implement timely and effective risk mitigation actions when appropriate to ensure the safe use of our products and patient safety.
All customer complaints concerning our products are assessed, and the root causes are investigated. Centralised handling of the complaints enables us to form an overall picture based on the complaints concerning a single product over its entire life cycle, covering all phases from R&D until the end of its sales. This procedure also facilitates the assessment and follow-up of the impacts of corrective and preventive actions.
Pharmacovigilance is a science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions or any other drug-related problems. Our duty is to monitor the safety of our medicinal products throughout their life-cycles ever since the early R&D phases until the product is no more available on the market. Several functions of the company are involved in the pharmacovigilance processes coordinated by the Global Drug Safety organisation, which is a headquarter function. Appropriately qualified and trained experts are responsible for assessing and the activities related to managing the benefit/risk balance of the products. Our pharmacovigilance operations and Quality Management System are compliant with international regulatory requirements and guidelines. All data concerning the safety of our products is collected into a single point for assessment, continuous monitoring and reporting. In addition to data collected from clinical trials, the information which is monitored includes spontaneous reports and feedback from healthcare professionals, literature, regulatory authorities and patients about adverse effects, medication errors, interactions and overdoses, for example.
The core activities in the pharmacovigilance operations also include risk management plans, safety reporting to healthcare authorities, various periodic safety reviews and internal audits of pharmacovigilance activities. Orion prepares a Risk Management Plan (RMP) for all new medicines, which describes what is known and not known about the medicine’s safety and states what measures will be taken to prevent or minimise its risks. The authorities approve the RMP and the measures agreed in the RMP are implemented when the product is placed on the market. The measures are product-specific and can include e.g. additional materials or educational programmes for health care professionals to ensure the safe and correct use of the product or e.g. Post Authorisation Safety Studies (PASS) to obtain further information on a medicine's safety, or to measure the effectiveness of risk management measures. RMP is continuously maintained throughout the life cycle of the product.
Orion collects safety information on e.g. adverse effects worldwide and reports it to the relevant regulatory authorities. Both Orion and the regulatory authorities continuously evaluate the information to detect safety signals that might affect the benefit-risk balance of the products to identify any emerging safety issues at an early stage. In addition to continuous signal detection procedures, Orion periodically reviews the cumulative data. Periodic Safety Update Reports (PSURs) are prepared and submitted to the regulatory authorities. In the PSUR, all available safety information and the benefit-risk profile of the product are thoroughly evaluated and e.g. changes to the measures described in the RMPs or other risk minimisation measures will be proposed if necessary.
We work in continuous collaboration with authorities in evaluating the safety of our products and on the balance between risks and benefits. When necessary, we undertake actions to ensure patient safety and to ensure that our medicines are used correctly and safely. Such actions may include, for example, updating the information provided in the Summary of Product Characteristics and the Package Leaflet, communicating information to healthcare professionals or providing training, adding, e.g., contraindications or precautions and warnings to the medicines, or discontinuing sales. The possible actions are always taken in a controlled manner in collaboration with healthcare authorities.
Audits help to ensure operational quality
Manufacturing and sales of medicines and APIs are subject to certain regulatory permissions. During the authorisation procedure, the regulatory authorities have ensured that Orion has the appropriate qualities for the operations and that each drug released by Orion meets the specified requirements. The regulatory authorities for pharmaceuticals (Fimea in Finland) and those for healthcare equipment and supplies (Valvira in Finland) monitor and assess our research, supply chain and pharmacovigilance operations by means of regular inspections. In these inspections they also assess the effectiveness of the procedures we have in place for the follow-up and processing of adverse effects and complaints, and our readiness to withdraw a product from the market.
The inspections are conducted in the name of the medicinal authorities of the EU and other countries in the so-called PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme) collaboration, which covers 49 countries. In addition, our operations are regularly monitored and inspected by authorities representing non-PIC/S countries, such as for example the US Food and Drug Administration, FDA.
First, however, we take our own initiative to proactively ensure and monitor the adequacy and compliance of our operations and facilities by means of internal control. We carry out systematic audits and management reviews of our own operations, and we continuously develop our internal procedures.
In addition to the authorities, our customers, partners and contract manufacturing principals also assess our ability to operate in compliance with the regulations and the commitments agreed in the contracts. In their inspections and audits they check the adequacy and regulatory compliance of our operations and facilities for our supply chain and R&D of pharmaceuticals, APIs and diagnostic products.
Correspondingly, we in turn monitor the adequacy and regulatory compliance of our sub-contractors, suppliers and other collaboration partners. In addition to assessments based on written enquiries, we carry out on-site audits of their facilities to make sure that the external parties involved in our supply chain, R&D and distribution meet the regulatory requirements and obligations mutually agreed upon in the collaboration contracts. We also follow up and monitor the fulfilment of the corrective actions of the shortcomings identified in the audits.
We withdraw the product in the event of defects
Medicinal products and APIs which do not comply with their specifications and which may cause harm to their users will immediately be withdrawn from sale and distribution, and from consumption if necessary. Depending on the seriousness of the case, the product is either withdrawn just from the wholesalers and retailers or also from patients as well. Similar measures are taken if there are deficiencies in the integrity of the data in the manufacturing documentation. We instantly report the events to the relevant regulatory authorities in all countries where the product is sold.
We have internal processes in place to support the prompt and proper initiation of recalls, prompt and accurate communication and efficient processing in such cases. The recall can be initiated at any time of the day if necessary. We also regularly test the efficiency and functionality of our recall procedures.
The criteria for recalls of diagnostic products are specified in the Quality Manual of Orion Diagnostica and the procedures are laid down in the internal guidelines on customer complaints and situations which are hazardous to customers. The key guidelines concern the handling of customer complaints, sales restrictions and recalling batches from the market. They also address country-specific guidelines, such as Vigilance Reporting in the United States.
All employees of the Orion Group are obliged to inform the local person responsible for pharmacovigilance about any adverse effect events they have become aware of. In addition, our phone operators have been trained to forward any queries requiring urgent action to the attention of our experts even outside office hours.
Information about a medicine can only be shared based on the product’s marketing authorisation
Pharmaceutical products may only be sold and used under a product-specific marketing authorisation granted by a pharmaceutical regulatory authority, and using the facts provided in the Summary of Product Characteristics (SPC) are confirmed for the product as part of the marketing authorisation. A marketing authorisation is granted and maintained valid for products which are safe to use for their indicated purpose, are proven to be therapeutically effective, appropriate for use as drugs, meet quality requirements and are appropriately manufactured and labelled. The authorisation also defines the product’s indication, i.e. the purposes for which the medicine can be used.
The product-specific Package Leaflet (PL) must be found in every single retail package. Pharmaceutical legislation and regulatory authorities require that for products classified as drugs the pharmaceutical company may only provide information which is contained in the SPC. The product information leaflet in the package contains the main facts about the drug and its use as approved by authorities. The drug and health authorities maintain national and international drug databases, which contain up-to-date information for every product with a valid marketing authorisation. The information and arguments presented by the manufacturer and/or the marketer in any communication about the product must always conform in full with the information confirmed in the registered Product Information confirmed for the valid marketing authorisation.
In the EU, pharmaceutical companies are not allowed to communicate information about prescription drugs directly to consumers. Instead, this is the responsibility of healthcare professionals such as doctors and pharmacies as well as healthcare authorities. Marketing self-medication products directly to consumers is allowed under strictly regulated conditions.
We also aim to look after patient safety by sharing accurate and up-to-date information about the use, storage and safety of our products via our own marketing and corporate communications channels to the extent permitted by law and the commonly adopted industry codes.
For the sale of an API, Fermion shall provide its customers with registration materials (DMF, CEP) approved by regulatory authorities which form part of the marketing authorisation documentation concerning the medicine in which the API acts. For each batch, the customer shall receive the related supply documents, an analysis certificate and a safety data sheet concerning the substance. All packages are labelled with warning signs and information allowing it to be traced.
Regulations concerning diagnostic products require the product packages to contain all essential information about the product, the manufacturer, the purpose of the product as well as the storage and validity. The packaging contains appropriate warnings. The end user will always receive detailed user instructions with the package. Where required, an analysis certificate, information on tracing the product calibration and a safety data sheet is provided for each batch.
Our marketing and marketing communications practices are in line with EFPIA codes
In Europe, the practices applicable in the marketing of pharmaceuticals are recorded in the EFPIA Code on the Promotion of prescription-only medicines to, and interactions with, Healthcare Professionals – EFPIA HCP Code, adopted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The HCP Code determines the practices and obligations which are required to be followed by the EFPIA member companies in the marketing of prescription medicines and in other relationships with healthcare professionals.
Doctors and other healthcare professionals as well the organisations with whom they work are important collaboration partners for the pharmaceutical industry. They provide companies with valuable clinical expert knowledge for the development and improvement of medicinal treatments, which results in significant benefits for both individual patients and society. Healthcare professionals in turn can benefit from the forums for the further education and exchange of information offered by the pharmaceutical industry. In order to increase the transparency of the different forms of interaction and the related financial compensation, EFPIA has supplemented its set of principles with the HCP/HCO Disclosure Code, which obliges member companies to publicly disclose the details of transfers of value with healthcare professionals with the right to prescribe and deliver medicines on an individual basis for each identifiable recipient. Pursuant to the Disclosure Code, Orion started reporting the required data as of 2016, the first disclosure concerning events in 2015. The most recent disclosure report is available in the Sustainability section of our corporate website. Individual healthcare professionals however can prevent their names from being disclosed in the report based on their legal right to privacy.
As an EFPIA member company, Orion acknowledges the purpose and spirit of the EFPIA Codes, which is stated in the EFPIA Leadership Statement on Ethical Practices as follows:
As industry leaders, we are committed to working in partnership with all stakeholders to improve healthcare across Europe. In doing so, we are conscious of the importance of providing accurate, fair and objective information about our medicines to allow rational decisions to be made about their use. As such, we fully respect the role that EU legislation plays in regulating interactions between pharmaceutical companies and healthcare professionals.
Our sales and marketing organisations for pharmaceuticals primarily follow the locally valid legislation concerning medicinal products, marketing, consumers and competition, the International Code on Advertising and Marketing Communication Practice as well as the Orion Group’s Code of Conduct and internal guidelines, which correspond to the EFPIA Codes of Practice. The management responsibilities in our pharmaceutical sales and marketing operations have been arranged in accordance with the requirements provided in the relevant legislation (the Medicines Act in Finland) and the EFPIA codes.
We organise continuous training and regular testing for our sales and marketing organisation to ensure that those involved in marketing can manage and follow both the common codes and practices of our industry and our own practices and principles.
When preparing marketing communications and advertising material, we follow the procedures determined by healthcare authorities for checking and confirming the legal, regulatory and ethical compliance of the content before the material is released for use and publication.
The Global Medical Affairs is a headquarter function which coordinates and consults regarding the planning of marketing communication, and monitors the implementation of it in order to confirm its compliance with national and transnational regulations. Medical Affairs is independent from the Sales & Marketing department and reports to the Chief Medical Officer. In order to ensure that the promotional activities are in line with regulatory requirements, the specialists in the Medical Affairs organisation work closely together with the sales and brand managers and the sales organisation as well as with the non-Orion marketing partners who promote our products in their agreed territories.
Marketing of diagnostic products follows the recommendations of MedTech Europe
MedTech Europe, the European trade association representing the medical technology industries, has provided its member organisations with recommendations on how to market diagnostic products. As a member of SaiLab MedTech Finland ry, a Finnish association of manufacturers of hospital laboratory equipment, Orion Diagnostica follows both their recommendations and those of MedTech Europe. These recommendations do not include any sanctions. Our marketing communications guidelines concerning diagnostic products have been set up based on these recommendations.
Monitoring of customer satisfaction
We monitor customer satisfaction based on monthly market data and sales statistics. Changes in trends indicate changes in customer satisfaction with regard to the competitive situation. We make use of research reports published by independent market research organisations on studies and surveys of our industry. We also collect qualitative data on our key accounts by conducting customer and market segment-specific surveys, and use their results as guidance for strategic targets and operational development.
Transparent collaboration with patient organisations
As a pharmaceutical company, it is natural for us to collaborate with patient organisations. In these activities too, we follow the commonly agreed rules of our industry recorded in the EFPIA PO Code, which covers relationships between EFPIA corporate members and the patient organisations which operate in Europe.
The purpose of the Code is to ensure ethical and transparent collaboration with patient organisations. The Code emphasises the patient organisations’ integrity and independence of pharmaceutical companies. Promotion of prescription-only medicines via patient organisations is prohibited. Direct and indirect support to patient organisations must be transparently disclosed, and the support must be provided without any terms restricting competition or the supported organisation’s freedom of activity. A written agreement on the support must be made.
Group-wide annual summaries detailing our level of collaboration with patient organisations by country are presented in the Sustainability section of our corporate website.
Complementary references in the Sustainability section of our corporate website: