Data Privacy Notice for pharmacovigilance data, medical information and product quality complaints
At Idorsia Pharmaceuticals (hereafter “Idorsia”, “we”, us”), we take data privacy seriously and treat all personal data we manage in accordance with Idorsia’s Data Protection Policy and applicable privacy and data protection laws, including the Swiss Federal Data Protection Act, the European Union General Data Protection Regulation (GDPR), and other applicable local laws that regulate the storage, processing, access and transfer of personal data.
Any personal data provided to Idorsia related to adverse events or other activities related to pharmacovigilance/safety will be used exclusively to:
- Document the adverse event or other pharmacovigilance/safety information;
- Contact the reporter for further information about the adverse event;
- Assess and investigate the information about the adverse event and compare it with information about other reported adverse events;
- Provide mandatory reports to national and/or regional regulatory authorities.
Any personal data provided to Idorsia related to medical information will be used to follow-up and answer a medical inquiry, only. For reference we may record such medical information in a medical information database.
Any personal data provided to Idorsia related to a product quality complaint will be used for the assessment and severity classification of the complaint and for the maintenance of the data in a product quality complaints database.
Legal basis for processing
To the extent the personal data processing is subject to GDPR, the legal basis for the processing of
- pharmacovigilance data is 6(1), (c) and Art. 9 (2), (a) GDPR – i.e. legal obligation
- medical information is Art. 6 (f) GDPR– i.e. legitimate interest
- product quality complaints is Art. 6(1), (c) and Art. 9 (2), (a) GDPR – i.e. legal obligation
Categories of personal data
We may need to process (this includes collecting, storing or otherwise using) the following personal data:
- Patient name/initials;
- Date of birth/age group, sex, weight, height;
- Information about health, medical history, amongst others:
- Details of the Idorsia product suspected to cause the adverse effect, including dosage, the medical indication and the period of time such Idorsia product was taken;
- Details of other medicines or remedies that were taken at the time of the adverse event, including dosage and the medical indication of prescription and the period of time such medicine was taken;
- Details of the adverse event or effect as well as any other pharmacovigilance information.
About the reporter:
- Name and contact details;
- Relationship with the subject of the report.
For medical information:
Idorsia may collect the requestor
- Name and contact details;
For product quality complaints:
- Name and contact details of the reporter;
- Profession of the reporter;
- Details of the complaint.
- Information about patient health and medical history, if relevant to evaluate, classify and assess the complaint;
- Details of the Idorsia product subject of the quality compliant, such as batch number, dosage, the medical indication and the period of time such Idorsia product was taken.
Recipients of personal data
To meet our obligations as a pharmaceutical company Idorsia may share and disclose personal data to:
- Idorsia group companies;
- Competent regulatory authorities worldwide;
- Third party service providers and business partners, where required to operate Idorsia product quality compliant database and the medical information database;
- Other pharmaceutical companies who are co-marketing, co-distributing or a license partner, where pharmacovigilance or product quality obligations require such exchange of data;
- A third party successor in business in the event of a sale, assignment or transfer of a specific Idorsia business or product;
Idorsia will only retain the personal data, in relation to this privacy notice, for as long as we reasonably need to achieve the purposes described above and as required under applicable laws.
Pharmacovigilance: pharmacovigilance are kept at least for the duration of the product life-cycle and for an additional ten (10) years after the product has been taken from the market in the last country where the product is marketed
Medical information: Personal data retained as part of a medical information inquiry are kept for a minimum of 10 years after closure of the enquiry.
Product quality complaints: As information related to product complaints and drug safety are important for public health reasons, complaint records, including personal data contained, are kept for a minimum of 5 years.
The above retention periods may be extended if required by law or for other compelling legitimate grounds of Idorsia, which override the interests, rights and freedoms of the data subjects concerned, or for the establishment, exercise or defence of legal claims.
Information regarding your rights
You have the following rights:
- the right to request from Idorsia information on personal data we store and the purpose for which we process them;
- The right to request access to and correction of your personal data;
- The right to request transfer of personal data;
- The right to request erasure or restriction of processing personal data.
Please note however, that these rights may be limited in order to fulfill product safety and pharmacovigilance obligations. Your rights are limited where there is a legal reason for processing personal data (e.g. pharmacovigilance adverse event reporting, unless such report is inaccurate).