Patient safety reporting privacy statement
Updated: March 23rd, 2018
At Orion Corporation (“Orion”), we know you care about your personal privacy and about the terms and conditions that govern how we collect, use, disclose, transfer, and store your information. Because we are dedicated to serving your needs and respecting your preferences, we have adopted the policies and practices described in this Orion Corporation Patient Safety Reporting Privacy Statement.
The purpose for processing the personal data you provide through the Orion Patient Safety reporting channels is to analyse the safety and effectiveness of Orion’s products, as well as to enable Orion Global Drug Safety to maintain its pharmacovigilance system as required by applicable pharmacovigilance legislation (e.g. by EU and FDA). Pharmacovigilance means the science and activities relating to the detection,assessment, understanding and prevention of adverse reactions and other medicine-related problems. A pharmacovigilance system including safety databases is used to fulfil Orion’s legally binding obligations in relation to pharmacovigilance and to monitor the safety of medicinal products and detect any change in their risk-benefit balance. Similar safety surveillance principles and procedures are applied for non-medicinal products as required by applicable legislation. Moreover, Orion must also process your personal data due to its responsibilities in the field of product quality, complaint handling and risk management based on applicable product quality legislation (e.g. by EU and FDA) for the purpose of investigating the quality defects and complaints and putting in place appropriate preventative actions.
We share your information with Orion’s affiliates and third parties, including licensing partners and those who assist us by performing technical operations such as data storage and hosting, if this is required for the purposes of analysing and reporting safety and quality information. We also use services of third party service providers for purposes of data collection and entry of adverse event reports for which purposes personal data is disclosed to a service provider. All these companies agree to process your personal data in accordance with this Privacy Statement. We are also obligated to submit the data to the national competent authorities as well as European Medicines Agency’s and other competent authorities’ databases for managing and analysing information on suspected adverse reactions.
If ownership or control of Orion Corporation or all or any part of our products, services or assets changes, we may transfer your personal data to any new owner, successor or assignee, in which case we would require the new owner, succerssor or assignee to treat your personal data in accordance with this Privacy Statement. Also, personal data may be disclosed to a third party such as a health authority if we are required to do so because of an applicable law, court order or governmental regulation, or if such disclosure is otherwise necessary in support of any criminal or other legal investigation or proceeding here or abroad.
Orion will not disclose the collected data for commercial purposes.
The legal basis of processing of the personal data is compliance with the Orion’s legal obligations based on binding law (EU General Data Protection Regulation Article 6.1.c).
Orion collects personal data for the above-mentioned purposes. As regards clinical trials, Orion collects patient number, patient’s sex, date of birth, certain physical traits and habits, relevant medical history, investigator’s observations, pharmacodynamics, and information on the results of tests measuring efficacy and safety of a product as described in the clinical trial information leaflet. As regards authorised medicinal products, cosmetic products, food supplements and medical devices, Orion collects all necessary information which is provided to Orion by regulatory authorities, healthcare professionals, distributors, pharmacies, customers, patients or animal owners to ensure patient safety and pharmacovigilance related legal obligations. For product quality, complaint handling and risk management purposes Orion collects names, addresses, e-mail addresses and telephone numbers of the complainant or the reporter of the complaint. As regards product enquiries, Orion collects all relevant information to ensure the fulfilling of legal obligations for collecting and processing pharmacovigilance and product quality related data.
As part of pharmacovigilance operations Orion may implement risk minimisation measures with aim to optimise the safe and effective use of a medicinal product throughout its life cycle. Risk minimisation measures may include e.g. direct health care professional communication (DHPC), educational programmes and materials, controlled access programmes or other risk minimisation measures. Additional risk minimisation measures can consist of one or more interventions that are implemented in a defined target group. Such distribution systems should be auditable and therefore various type of quantitative and qualitative data is collected concerning these actions. E.g. information on training dates and participants, measures of distribution of DHPC or other materials, information on receipt of such information are collected as basic information on implementation. Orion shall record and retain this information in line with the the legal requirements.
Orion as a marketing authorization holder maintains pharmacovigilance system which needs to be documented in Pharmacovigilance System Master File (PSMF). PSMF include e.g. information on organizational structures, personnel, list of the site(s) where the pharmacovigilance activities are undertaken (including both headquarters and affiliates) and information on services subcontracted. Therefore Orion maintains also contact lists for service providers, consultants, affiliates, licensing partners and other third parties which are used as part of the pharmacovigilance system. Contact lists contain company names and addresses, names of responsible persons within those companies and their contact details (phone numbers and e-mail addresses).
In the context of clinical trials sponsored by Orion and partners, which are performed according to a study protocol, patient data is collected from healthcare service systems based on a data subject’s freely given informed consent, and it is derived directly from the data subject or the investigator, or from the results of testing or examinations of said clinical studies.
As regards authorised medicinal products, cosmetic products, food supplements and medical devices, Orion receives notifications of suspected adverse events and feedback on quality and complaints directly through its reporting channels, as well as through its subsidiaries or licensing partners, who have received reports from regulatory authorities, healthcare professionals or patients and/or consumers.
The personal data collected may be processed in your country of residence or transferred to another country where Orion, its affiliates, subcontractors or other recipients of personal data are located, both inside and outside the European Economic Area (EEA). Please find further information on the destinations of data and the global drug safety system on our webpage.This means that your personal data may be processed or stored in a country that has less stringent data protection standards than those of the EEA. If Orion transfers the personal data to its partners, it will pseudonymize the personal data, which means that direct identifying of the individual is no longer possible. We will ensure that your personal data will be processed in accordance with this Privacy Statement at all times even if it is being transferred outside the EEA. The personal data transferred outside the EEA is based on legal requirements and protected based on the adequacy decision made by the European Commission, or by appropriate contractual arrangements (either by the signing of the Standard Contractual Clauses by the controller and the recipient(s) or by the recipient’s self-certification under the EU – US Privacy Shield). For further information, please contact Orion.
Orion is obligated to store all information including the personal data regarding safety of medicinal products for at least ten years after the end of the expiration of the marketing authorisation or longer if any local legislation so requires. Orion is obligated to store the product quality and feedback related information for a period of eleven years after the receipt of the feedback.
Orion is obligated to store PSMF related data at least five years after the system as described in the PSMF has been formally terminated by the marketing authorisation holder.
The purpose of processing of the personal data in this register is to ensure quality and safety of Orion’s pharmaceutical and non-medicinal products, as defined in detail above. Orion is obligated under binding law to retain the data in the register for the above-mentioned time periods. However, the data is soon after collection pseudonymized, which means that the data in most cases no longer enables identification of the individual to whom it relates. Only certain identifiers are kept in order to ensure that duplicate reports can be detected. If your personal data has been reported and stored in this register, you may contact Orion to inquire whether the register contains your personal data. Subject to legal exceptions, after you have supplied sufficient search criteria, Orion will search for your data in Orion’s register. If data that can be identified as your personal data is found, you will be given copy of it, or you will be given a notice that the register contains no data which can be identified as your personal data.
You may also request Orion to complete or correct any inaccurate report that you have submitted through the system, or to correct or delete any data that is erroneous, unnecessary or incomplete or to request Orion to restrict the processing of personal data. You can make such a request to the person in charge at Orion through the same channel as your original report or by a personally signed or otherwise comparably verified document to the contact person of the register.
Orion Contact Information and Contact Person for the Register:
Orion Corporation (Business ID 1999212-6) (“Orion”)
Address: Orionintie 1, 02200 Espoo, Finland
Contact person: Jukka Pesonen, Director, Global Drug Safety (QPPV)
Telephone: +358 10 4264937
Contact person: Leena From, Senior QA Advisor, Quality Management
Telephone: +358 10 4262588
Contact person: Paula Rytilä, Vice President, Chief Medical Officer, Medical Affairs and Pharmacovigilance
Telephone: +358 10 4264416
Contact information of the Data Protection Officer:
Data Protection Officer: Heidi Arala
In case you wish to use your above-mentioned rights, you can make a request to this effect by a personally signed or otherwise comparably verified document in writing to Orion’s contact person named above. Please note that all requests regarding your personal data will be subject to any applicable legal and ethical reporting, document filing or retention obligations binding on Orion.
If you are not satisfied with Orion’s response to your inquiry, you may bring the matter to the attention of the Data Protection Ombudsman.
Orion shall notify any rectification of data to the recipients to whom the data have been disclosed. However, there is no duty of notification if this is impossible or unreasonably difficult.
If you have any questions about our Privacy Statement, or any concern about privacy at Orion Corporation, please contact us by e-mail at email@example.com.
We may update or revise this Orion Corporation Patient Safety Reporting Privacy Statement at any time. When we change the Statement in a material way, a notice will be posted on our website along with the updated Privacy Statement.
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 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 in Espoo Finland. Appropriately, qualified and trained experts are responsible for the assessment and activities related to the management of benefit/risk balance of the products. Our pharmacovigilance operations and Quality Management System are compliant with international regulatory requirements and guidelines.
Locally in Orion subsidiaries and sales offices the data is handled by local pharmacovigilance responsible personnel. All global safety data from all sites are collected into a single point by Global Drug Safety (Espoo Finland) for assessment, continuous monitoring and reporting. Safety data that is collected include e.g. information about suspected adverse reactions, lack of efficacy, medication errors, interactions, exposure during pregnancy and over-doses. Information is received from clinical trials and as spontaneous reports e.g. from healthcare professionals, regulatory authorities, patients, relatives and scientific literature.
Orion collects safety information globally and these are reported to the regulatory authorities worldwide in line with the local legislation (e.g. to European Medicines Agency/EudraVigilance, US FDA, National Competent Authorities in EU and other countries outside EU). Data is shared as well with licensing partners according to Safety Data Exchange Agreements concerning the products. Orion and its licensing partners as well as regulatory authorities continuously evaluate the information to detect safety signals that might affect the benefit-risk balance of the products to early identify any emerging safety issues. In addition to continuous signal detection procedures, Orion reviews the cumulative safety data periodically. 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 is thoroughly evaluated and e.g. changes to the product information or other risk minimisation actions will be proposed if necessary. PSURs are shared with licensing partners as well.
We work in continuous collaboration with authorities in the evaluation of the safety of our products and the balance between risks and benefits. When necessary, we undertake actions to ensure patient safety and the correct and safe use of our products. Such actions may include, for example, updating of the information provided in the Summary of Product Characteristics and the Package Leaflet, communicating information to or training of healthcare professionals, adding, e.g., contraindications or precautions and warnings to the medicines, or discontinuation of sales. The possible actions are always taken in a controlled manner in collaboration with healthcare authorities.
All data, documents and records related to pharmacovigilance are physically and electronically stored in designated access controlled archives and databases, and retained in accordance with the relevant legislation and requirements.
Some global or local pharmacovigilance tasks can be subcontracted. The subcontracting of Orion pharmacovigilance tasks is done in accordance with the requirements of the Orion quality management system. Orion retains responsibility for the pharmacovigilance tasks that have been subcontracted and performs regular audits of subcontractors.