Pharmacovigilance data privacy statement
Octapharma Ltd respect your privacy when collecting your personal data. This privacy statement aims to give you information on how Octapharma collects and processes personal data in relation to pharmacovigilance data and to inform you about your privacy rights and how the law protects you.
Purpose of the data collection
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Octapharma Ltd is obliged to fulfil legal requirements associated with the collection of drug safety information from the use of its products in the UK and Ireland .
Reported data will be sent in an anonymised form to PharSafer Associates Ltd, where it will be documented in a standardised format and transferred to Octapharma’s global pharmacovigilance database (located at Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Strasse 235, 1100 Vienna, Austria), for onward processing and sharing with relevant health authorities worldwide. The case report shared with authorities will contain personal data of the patient and of the person reporting the drug safety information but will never contain the patient’s name. Contact information is required to allow follow-up with the reporter to gain high quality and complete information. Where data is shared, we will ensure adequate protection of personal data by contractual means.
Octapharma is obliged to report pharmacovigilance relevant information to health authorities worldwide (including to countries that may have another level of data protection compared to the EU). The reports might contain details about the incident but only a limited amount of personal data:
For patients, the report may contain initials, birth date and gender, reaction reported including outcome, relevant lab data, information about suspected drug (dose, route of administration, indications for use), information about therapy (duration), information about concomitant medication and relevant medical history. These data will never contain the patient´s name.
For the individuals reporting, the report will include the initials, qualification (e.g. physician, pharmacist, etc.), or address and phone number as provided. The contact information is required to allow follow-up with the reporter to gain high quality and as complete as possible information on adverse events.
If the reporter does not wish to provide their contact details to Octapharma or authorities, the word “Privacy” can be entered instead of the reporter’s contact details and the report will be processed in an anonymised format and follow-up will not be undertaken.
Octapharma may also share your reported data to fulfil legal requirements and obligations with Octapharma Affiliates, business partners or third companies authorized for this purpose by Octapharma within and outside of the EU. Where data is shared, we will ensure an adequate protection of personal data by contractual means.
As reports about adverse events are important for public health reasons, reports are kept in accordance with the applicable law, which foresees currently a minimum duration of 10 years after withdrawal of the marketing authorization of the product in the last country where the product is registered.
Information requests about the handling of all personal data
Upon your request, we will inform you which data we store about you for which purposes. You may also request the deletion, correction or limitation of the processing of your personal data. However, your rights might be limited due to the legitimate interests of Octapharma or due to obligations imposed on Octapharma by law.
You may also object to the processing of your personal data for the transfer to authorities outside the EU described above unless the legitimate interest of Octapharma prevails or unless Octapharma is obliged to do so by law.
For questions or requests concerning your personal data, please send an e-mail to: firstname.lastname@example.org.