Pharmacovigilance data privacy statement

Purpose of the data collection

We, Octapharma USA will use and share any reported data solely for pharmacovigilance purposes. Pharmacovigilance is the pharmacological science of collection, detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Reported data will be captured in pseudonymized form in a report which will be transferred to the global Octapharma pharmacoviligance database located at Octapharma Pharmazeutika Produktions.ges.m.b.H., Oberlaaer Strasse 235, 1100 Vienna, Austria, which is a database used to administer and record reported data.

Handling of the report (sharing with the relevant companies within the Octapharma Group and authorities)

Octapharma USA will share the report with Octapharma Pharmazeutika Produktions.ges.m.b. H., Oberlaaer Strasse 235, 1100 Vienna, Austria which is responsible for the global pharmacovigilance database.

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 his contact details to Octapharma or authorities, the word “Privacy” can be entered in reporter's names field, instead of the name of the reporter.

Octapharma might 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.

Retention period

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 your 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/regulation.

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/regulation.

For questions or requests concerning your personal data, please send an e-mail to: dataprivacy@octapharma.com.

In addition and in case of concerns, you can also contact the competent data protection authority: Eidgenössischer Datenschutz- und Öffentlichkeitsbeauftragter (EDÖB)