Privacy notice for pharmacovigilance, medical information and product complaints
Updated: April, 2021
This Privacy Notice (“Notice”) is intended to explain how Roche collects and processes your personal data for the purposes of pharmacovigilance related activities, medical information inquiries and product complaints. The scope of this Notice is limited to the collection and processing of your personal data for pharmacovigilance, medical information inquiries and/or product complaints. For general information about data processing at Roche, please visit the Roche Privacy Notice.
Purposes and legal basis for processing - Pharmacovigilance
Any personal data provided to Roche related to adverse events or other activities related to pharmacovigilance will be used solely for these purposes. This information is very important for public health and will be used for the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
Likewise, it is possible that we may be required by law to communicate the data to the Health Authorities. Your data will not be used for purposes other than those mentioned.
Purposes and legal basis for processing – Medical Inquiries
Any personal data provided to Roche related to a medical inquiry may be used to answer the inquiry, follow up on such requests and maintain the information in a medical information database for reference. Where required by law (such as for pharmacovigilance and drug safety), we may also be required to report the data to regulatory authorities. Your data will not be used for any other purposes.
If your medical inquiry is related to a notification of adverse events, your data may be processed to comply with Roche legal pharmacovigilance (GVP) obligations. If your medical inquiry consists of a product complaint, your data may be processed to comply with our legal obligations in the context of drug safety.
Purposes and legal basis for processing – Product Complaints
Any personal data provided to Roche related to a product complaint will be used solely for these purposes. This information is very important for public health and will be used for the evaluation, classification and assessment of the product complaint, to follow up on such requests and to maintain the information in a product complaints database for reference.
Categories of personal data processed
The type of information that we collect from you will depend on the data subject and the type of processing activity:
Pharmacovigilance: We collect the name, contact details, and affiliations/profession of the reporting individual. We may collect some additional personal data related to health and medical history of the individual experiencing an adverse event if required for processing of adverse event for pharmacovigilance purposes.
Medical Inquiries: We may collect the name, contact details and affiliation/profession of the individual making the inquiry.
Product Complaints: We may collect the name, contact details and affiliation/profession of the individual reporting the complaint. We may collect some additional personal data related to health and medical history of the individual affected by the product complaint if such information is relevant to evaluate, classify and assess the product complaint.
Recipients of your personal data
Roche may share the data you provided to us among Roche Group companies and affiliates, business partners and service providers, where required to operate Roche global pharmacovigilance database, the Roche product complaint database and fulfill obligation of pharmacovigilance legislation and/or legislation regarding drug safety.
Roche is also obliged to report certain pharmacovigilance and product relevant information to Health Authorities worldwide. The reports contain details about the incident but will only contain limited personal data:
Patients: Information as provided, including age or date/year of birth (where permitted by regulations) and gender (note that patient name will never be provided)
Reporting Individuals: Information as provided to allow the regulatory authority to follow up with the reporting individual, including name, profession, initials, address, email, phone number
All the personal data that you provide us for these purposes may be transferred or stored in a geographic region with different obligations regarding privacy, with respect to your country of origin. It is possible that in the exchange of data within the Roche Group, business partners and service providers, your personal data may be transferred to countries that do not provide the same level of protection as that provided for Central America and the Caribbean, for which, we guarantee that the transfer of data and its due protection will be carried out according to Law 8968 of Costa Rica and its due regulations.
As information related to pharmacovigilance (reports about adverse events) are important for public health reasons, reports are kept for minimum of 10 years after the withdrawal of the product in the last country where the product is marketed.
Personal data retained as part of a medical information inquiry are kept for minimum of 10 and maximum of 15 years after receipt.
As information related to product complaints and drug safety are important for public health reasons, complaint records, including personal data contained, are kept for minimum of 15 years.
Information about your rights
Your personal data is protected by Law 8968 on Protection of the Person Against the Treatment of your Personal Data, of Costa Rica; consequently, you have the right to request information about the personal data that has been stored and processed by Roche.
In addition, you may rectify, update, cancel and/or delete your personal data at any time, for which, you will have to make the request through the person responsible for the processing of your personal data from Roche.
In the event that you believe or have the impression that our data processing does not comply with Costa Rican Law 8968, you have the right to file a complaint with the responsible supervisory authority.
Identity and contact details of the data controller
F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070 Basel, Switzerland, is the data controller.
The representative for Central America and the Caribbean (CAC) of F. Hoffmann-La Roche Ltd is Roche Servicios S.A., a company located in Heredia, Costa Rica.
You can contact us as those responsible for data protection and administration via email at [email protected].