Last updated on August 19, 2020

Ensuring patient safety is of paramount importance to Helsinn and we take the safe use of our products (meaning and including medicinal products, medical devices and nutritional supplements) seriously.

This Pharmacovigilance Data Privacy Policy applies to the pharmacovigilance process as described below of Helsinn Healthcare S.A. and Helsinn Birex Pharmaceuticals Ltd (“Helsinn” “we”, “us”, “our”), in charge of managing and maintaining the Helsinn Group Pharmacovigilance System, in order to fulfill legal tasks and obligations in relation to pharmacovigilance also for, and on behalf of, Helsinn Therapeutics (U.S.), Inc. and Helsinn Pharmaceuticals (Beijing) CO. Ltd.. Please read this Pharmacovigilance Data Privacy Policy carefully and contact us if you have any questions. For general information about data processing at Helsinn, please visit the Privacy and Cookies Policy.

This Pharmacovigilance Data Privacy Policy explains what personal information may be collected and processed about you in order for Helsinn to fulfill the legal requirements to monitor the safety of all products we market, directly or indirectly.


This Pharmacovigilance Data Privacy Policy applies to information we collect from the person (“you”, “your”) reporting the adverse event, as described below, online, by phone, fax, e-mail or post, as well as through any media or communication channel and voice recordings, if any, or as part of the adverse event reporting processes applicable to Helsinn.

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 but not limited to, e.g. our commercial and licensing partners, service providers, healthcare professionals or relatives to you.


Information on adverse events is very important for public health and will be used for the detection, assessment, understanding and prevention of adverse effects or any other product-related problem.

A pharmacovigilance system, including safety databases, is used to fulfill Helsinn’s legally binding obligations in relation to pharmacovigilance and to monitor the safety of products (meaning and including medicinal products, medical devices and nutritional supplements) and detect any change in their risk-benefit balance.

The purpose for processing the personal data about you, provided to document information on adverse events through the Helsinn patient safety reporting channels, is to enable Helsinn 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]).


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 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/or date of birth and/or age group; gender; weight and height; details of the product causing the event, 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 products or remedies you are taking or were taking at the time of the event, including, as necessary and/or known, the dosage you have been taking or were prescribed, the period of time you were taking that product; details of the adverse event you suffered, the treatment you received or any measure taken for that event, any long‐term effects the event has caused to your health; and other medical history considered relevant to document the, such as lab reports, medication history and patient history.

Some of this information may be considered by law to be “special categories of personal data” (formerly known as sensitive personal data) about you. This includes any information that tells us about your health and may be ethnicity, religion, and sexual life, when strictly necessary.

This information is only processed where relevant and adequate to document your adverse event properly and for the purpose of meeting our pharmacovigilance requirements. These pharmacovigilance requirements exist to allow us and Health Authorities to diagnose, manage and prevent such adverse events from occurring in the future.


Helsinn is legally required to ensure that adverse events are traceable and available for follow-up. As a result, we must keep information about the reporter (i.e. the person reporting the occurred adverse event) to allow us to contact him/her once we have received the report. The personal data that we may collect when you report an adverse event is your: name; contact details (which may include your address, e‐mail address, phone number or fax number); profession, and in case of healthcare professionals it may be asked also the clinic/institution name and address.

All this information may determine any other further questions you could be asked about when you report an adverse event. It must be eventually defined the relationship between you and the subject of the adverse event.


The legal basis for processing of the personal data is observance of Helsinn legal obligations in order to comply with specific pharmacovigilance legislation, in conjunction with the EU General Data Protection Regulation 2016/679 (“GDPR”) as well as any legislation enacted either by the European Commission or any European country for the purpose of implementation or adaptation of the GDPR; the Swiss Federal Act on Data Protection of 19 June 1992 and/or other country regulations in that are similar, equivalent to or that are intended to or implement and/or modify the laws that are identified in above.


We share your information with Helsinn affiliates, entities and third parties, including commercial and licensing partners and service providers who may assist Helsinn in pharmacovigilance processes, such as receipt and follow-up of reported adverse events, reporting to Health Authorities as set forth by the applicable law and signal evaluation. All these companies agree to process your personal data in accordance with this Pharmacovigilance Data Privacy Policy. We are also obligated to submit the data to worldwide Health Authorities, as applicable by law, for their databases, to manage and analyse information on adverse events.

If ownership or control of the Helsinn Group 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, successor or assignee to treat your personal data in accordance with this Pharmacovigilance Data Privacy Policy.
Also, personal data may be disclosed to a third party such as a Health Authority, in case 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. Helsinn will never disclose the collected data for commercial purposes.


Some recipients of Personal Data, as stated above, may reside outside Switzerland and/or the European Economic Area (EEA).

The level of legal protection for personal data is not the same in all countries and may not provide the same level of protection as the data protection laws in the EEA or of the country in which you live, in such case Helsinn will take reasonable efforts and security measures to keep your information secure and to ensure that the transfer takes place in accordance with this Pharmacovigilance Data Privacy Policy and applicable laws.

You may contact us at [email protected] if you have any questions about the methods we use to safeguard any personal information transferred outside Switzerland and the EEA.


Helsinn is required to store all information including personal data regarding the safety of products for at least ten years after the end of the expiration of the marketing authorization or longer if required by local legislation.


Individuals in the EEA have certain data subject rights which may be subject to limitations and/or restrictions. These rights may include the right to: (i) request access to and rectification or erasure of their personal data; (ii) obtain restriction of processing or to object to processing of their personal data; and (iii) the right to data portability.

If you wish to exercise one of the above-mentioned rights, please send us your request via email to: [email protected]. Individuals may also lodge a complaint about the processing of their personal data with their local data protection authority, according to the applicable law.


Helsinn 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, consistent with generally accepted industry standards, including technical, administrative and physical safeguards to protect the personal data submitted to us from loss, misuse and unauthorised access, disclosure, alteration and destruction.

The database used for processing safety data is validated, or tested as appropriate, to ensure that access to these systems is restricted to named individuals and any changes to data can be identified.

Any hard copies of documents are stored in a secure and robust area such as fireproof cupboards or archives to which access is limited.


We may update this Pharmacovigilance Data Privacy Policy from time to time. In case of material changes (meaning any changes that materially affect your rights), a temporary notice will be published on the website.


Should you have any further question on this Pharmacovigilance Data Privacy Policy you may send an email to the following addresses: [email protected] or [email protected]

For any adverse event related information, please send an email to the following link: Report Adverse Event.