If you are a patient we may also be provided with information about you by a third party reporting an adverse event that affected you, such as e.g. healthcare professionals or relatives to you.
Information we collect and why we collect it
The purpose for processing the personal data about you provided through the Sobi Patient Safety reporting channels is to enable Sobi Drug Safety to maintain its pharmacovigilance system as required by applicable pharmacovigilance legislation (e.g. by the European Medicines Agency [EMA]and the US. Food and Drug Administration [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 Sobi’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.
Information we collect about patients (subject of the report)
We collect personal data about you when you, or a third party, provide us with information about you in relation to an adverse event that affected you. Where you are reporting the adverse event yourself, please also refer to the Reporters section below.
The personal data that we may collect about you when you are the subject of an adverse event report is:
- name or initials;
- age and date of birth;
- weight and height;
- details of the product causing the reaction, including the dosage you have been taking or were prescribed, the reason you have been taking or were prescribed the product and any subsequent change to your usual regimen;
- details of other medicines or remedies you are taking or were taking at the time of the reaction, including the dosage you have been taking or were prescribed, the period of time you were taking that medicine, the reason you have been taking that medicine and any subsequent change to your regimen;
- details of the adverse event you suffered, the treatment you received for that event, and any long‐term effects the event has caused to your health; and
- other medical history considered relevant by the reporter, including documents such as lab reports, medication history and patient history.
Some of this information may be considered by law to be “sensitive personal data” about you. This includes any information that tells us about your:
- religion; and
- sexual life
This information is only processed where relevant and necessary to document your adverse event properly and for the purpose of meeting our pharmacovigilance requirements. These requirements exist to allow us and competent pharmacovigilance authorities to diagnose, manage and prevent such adverse events from occurring in the future.
Information we collect about reporters
- Sobi is legally required to ensure that adverse events are traceable and available for follow-up. As a result, we must keep information about reporters to allow us to contact you once we have received the report. The personal data that we may collect about you when you report an adverse event is your:
- contact details (which may include your address, e‐mail address, phone number or fax number);
- profession (this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and
- relationship with the subject of the report.
Legal basis for processing
The legal basis for processing of the personal data is compliance with Sobi’s legal obligations based on binding law (EU General Data Protection Regulation Article 6.1.c).
How we share your Personal Data
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.
Sobi will not disclose the collected data for commercial purposes.
Transfers of Personal Data outside the EEA
Retention of Personal Data
Sobi is required 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 required by local legislation.
Information regarding your rights
You have the right to view the personal information that we hold about you. You may contact Sobi to inquire whether our register contains your personal data. Subject to legal exceptions, after you have supplied sufficient search criteria, Sobi will search for your data in Sobi’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 Sobi to complete or correct any inaccurate personal data held about you, or to correct or delete any data that is erroneous, unnecessary or incomplete or to request Sobi to restrict the processing of personal data. You can make such a request by contacting us at firstname.lastname@example.org or via the contact information provided below.
If you have any comments or complaints regarding the way your personal data is being handled, you have the right to contact the supervisory authority in Sweden (Swedish: Datainspektionen, see this link) or in the country where you live, to lodge a complaint.
Sobi takes precautions to ensure that personal data collected for pharmacovigilance purposes is protected and that the processing is in accordance with applicable data protection rules including encrypted transfer of personal data when feasible.
The database used for processing safety data is validated, or tested as appropriate, to ensure that any changes to data can be identified and access to these systems is restricted to named individuals.
Any hard copies of documents is stored in a secure and robust area such as fire proof cupboards or archives to which access is limited.
Swedish Orphan Biovitrum AB
SE-112 76 Stockholm
Data Protection Officer:
Swedish Orphan Biovitrum AB
Data Protection Officer: Max Tullberg
112 76 Stockholm