Teva Privacy Notice – Drug Safety Surveillance (Pharmacovigilance, Quality and Medical)
“Teva” means Teva Pharmaceutical Industries Ltd. having its principal office at Dvorah Haneviah 124, Tel Aviv, Israel or its Affiliates (or both), also referred to in this Privacy Notice as “we”, “us” and “our”. “Affiliate(s)” shall mean any person, corporation, company, partnership, joint venture or other entity controlling, controlled by or under common control with Teva. For such purpose the term “control” means the holding of 50% or more of the common voting stock or ordinary shares in, or the right to appoint 50% or more of the directors of the said corporation, company, partnership, joint venture or entity
Teva and your privacy
Ensuring patient safety is extremely important to Teva and we take the safe use of all our products seriously. Teva needs to be able to get in touch with people who contact Teva about our products in order to follow-up and obtain further information, give answers to requests or to send requested material. This Privacy Notice describes how we collect and use Personal Data (which means information in any format that can be used, directly or indirectly, alone or in combination with any other information, to identify a person or as otherwise defined in applicable legislation).to help us fulfil our pharmacovigilance, product complaint and medical inquiry obligations/requests to monitor and ensure the safety and quality of all our products, including medicines, cosmetic products, food supplements and medical devices that we market or have in clinical development.
Although this notice is also applicable to cosmetic products, food supplements and medical devices, to facilitate the reading only reference to drug safety is made.
Scope of this Privacy Notice
This Privacy Notice applies to information we collect from or about you online (such as website, social media, chatbot or live chat), by phone, fax, e-mail or post, as part of the adverse event, quality or medical inquiry or reporting regulations applicable to Teva. We may also collect this information about you through specific forms submitted by you on a website that is owned or controlled by Teva.
An “Adverse event” means an unwanted, unintended or harmful event in relation to the use of a Teva product. With respect to medical devices, it also includes “incidents” and for cosmetics "serious undesirable effects" , but for ease of reading, only the term “adverse event” will be used in this notice.
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 third parties may include medical professionals, lawyers, relatives or other members of the public.
Information we collect, why we collect it, and how long we keep it
Pharmacovigilance: Teva is under a legal obligation under pharmacovigilance and product safety and quality legislation, including as set out in Good Pharmacovigilance Practices (“GVP”), to collect specific data for reasons of public interest in the area of public health (in the EU, GDPR Art. 6(1)(c) and 9.2(i)). .Quality and Medical Inquiry: Teva may also process your Personal Data to the extent necessary to meet quality control requirements and medical inquiry requests, either in accordance with its legal obligation (EU GDPR Art. 6(1)(c) and 9(2)(i)), or for its legitimate business interest (EU GDPR Art. 6(1)(f)), or based on your consent (EU GDPR Art. 6(1)(a) and 9(2)(a)), which would be obtained at the time of collection. In accordance with these requirements/requests, Teva must manage and respond to such information/requests.
Any Personal Data which is collected in relation to the safety of our products for any of the above purposes will be retained in pseudonymised form (when possible and only after any necessary follow up), fully secured and minimized in accordance with data protection principles, and in always in compliance with our legal obligations. This data is retained for a period 30 years following life of the product market authorisation in accordance with our obligations. Your data will not be used for any other purposes than those purposes listed herein.
Patients (subject of report)
We collect Personal Data about you when you or a third party provides us with information in relation to an adverse event, quality complaint or medical inquiry that affected you or someone else. Where you are reporting the adverse event, quality complaint or medical inquiry yourself, please also refer to the Reporters section.
Pharmacovigilance: Pharmacovigilance laws require us to take “detailed records” of every adverse event passed to us to allow the event to be evaluated and collated with other adverse events recorded about that product. The Personal Data that we may collect about you when you are the subject of an adverse event report is:
- name or initials;
- contact details for follow up purposes (when relevant);
- age (date of birth, if provided);
- weight and height;
- details of the product causing the reaction, 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 medicines or remedies you are taking or were taking at the time of the reaction, including the dosage you have been taking or were prescribed, the period of time you were taking that medicine, the reason you have been taking that medicine and any subsequent change to your regimen;
- details of the adverse reaction you suffered, the treatment you received for that reaction, and any long-term effects the reaction has caused to your health; and
- other medical history considered relevant by the reporter, including documents such as lab reports, medication histories and patient histories.
Some of this information is considered by law to be “sensitive Personal Data” about you. This includes any information that tells us about your:
- religion; and
- sexual life.
Quality: The Personal Data we may collect about you when you are the subject of a quality complaint report is:
- Name and contact details (for follow up purposes);
- Possibly health related details depending on the nature of the complaint (e.g. type of medication used)
- Details on the relevant product and events
Medical Inquiry: The Personal Data we may collect about you when you are the subject of a medical inquiry is:
- Name and contact details (for follow up purposes);
- Details of your inquiry as provided by you
All information is only processed where relevant and necessary to document your reaction properly and for the purpose of meeting our pharmacovigilance, safety, quality and any other legal requirements or to respond to a request/inquiry made by you. The legal requirements exist to allow us and competent authorities (such as the European Medicines Agency) to evaluate adverse events, quality complaints or medical inquiries and make efforts to prevent similar events from happening in the future. We also need to process this information in order to respond to any request or inquiry made by you (follow up).
We collect information about you when you provide us with information in relation to an adverse event or quality complaint you report or medical inquiry you make.
Pharmacovigilance and product safety laws require us to ensure that adverse events and quality complaints are traceable and available for follow-up. As a result, we must keep sufficient information about reporters to allow us to contact you once we have received the report. We may also collect information about reporters in order to manage and respond to any requests concerning the quality of our products or medical information. The Personal Data that we may collect about you when you report an adverse event, quality complaint or medical inquiry is your:
- Name and contact details ;
- profession (this information may determine the questions you are asked about an adverse event, quality complaint or medical inquiry, depending on your assumed level of medical knowledge); and
- relationship with the subject of the report.
Where you are also the subject of a report, this information may be combined with the information you provide in relation to your reaction.
How we use and share Personal Data
As part of meeting our pharmacovigilance and other legal and regulatory obligations, we may use and share Personal Data to:
- investigate the adverse event, quality complaint or medical inquiries;
- contact you for further information about the adverse event, quality complaint or medical inquiries you reported;
- collate the information about the adverse event, quality complaint or medical inquiry t with information about other adverse events, quality complaint or medical inquiries received by Teva to analyse the safety of a batch, Teva product or active ingredient as a whole (only in pseudonymised form); and
- provide mandatory reports to national and/or regional authorities so that they can analyse the safety of a batch, Teva product, active ingredient as a whole alongside reports from other sources (in pseudonymised form).
Personal Data collected from you in accordance with this Privacy Notice may also be transferred to a third party in the event of a sale, assignment, transfer, or acquisition of the company or a specific product or therapeutic area, in which case we would require the buyer, assignee or transferee to treat that Personal Data in accordance with applicable data protection laws.
We may also share Personal Data with other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where pharmacovigilance obligations for a product require such exchange of safety information.
We share information with national and/or regional authorities, such as the European Medicines Agency in accordance with pharmacovigilance laws. We are unable to control their use of any information we share, however note that in these circumstances, we do not share any information that directly identifies any individual (such as names or contact information), but we only share pseudonymised information.
We may publish information about adverse events (such as case studies and summaries); in this case, we will remove identifiers from any publications so that no individual can easily be recognized.
Our pharmacovigilance and quality obligations require us to review patterns across reports received from every country where we market our products. To meet these requirements, information provided as part of an adverse event or quality report is shared within Teva on a worldwide basis through Teva’s Global Database. This database is also the platform through which Teva uploads adverse event reports to various oversight authorities, including the Eudravigilance database (European Medicines Agency corporate system for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area) and other similar databases as required by law. We also maintain a global medical inquiry database in order to answer your inquiries and internally manage these answers. However, your Personal Data is pseundonymised and de-identified when possible in order to protect your privacy.
Because patient and product safety is so important, we retain all the information we gather about you as a result of an adverse event, quality complaint or medical inquiry report to ensure that we can properly assess the safety and suitability of our products over time.
For Europe: You may be entitled under applicable law to ask Teva for a copy of your information, to correct it, erase or restrict its processing, or to ask us to transfer some of this information to other organisations. You may also have rights to object to some processing. These rights may be limited in some situations – for example, where we can demonstrate we have a legal requirement to process or keep your Personal Data. You may exercise these rights by contacting Teva’s EU Data Protection Officer. (EUPrivacy@tevaeu.com)
Please note that for legal reasons, we cannot delete information that has been collected as part of an adverse event report. Also, we may require you to provide proper identification before we comply with any request to access or correct Personal Data.
We hope that we can satisfy any queries you may have about the way in which we process your Personal Data. If you have any concerns about how we process your Personal Data, you can get in touch with Teva’s Data Protection Office (see below for contact information).
Teva takes measures to secure Personal Data from accidental loss and from unauthorised access, use, alteration or disclosure. Additionally, we take further information security measures including access controls, stringent physical security and robust information collection, storage & processing practices.
Pharmacovigilance databases, including the Global Database, are hosted in Israel by Teva. These are administered and supported around the clock by Teva’s dedicated pharmacovigilance IT teams in Israel, Romania, Germany, India and the United States. Teva also engages a data processing company in India (Accenture) for data entry, administration and data cleansing of a limited part of the pharmacovigilance database.
Our medical inquiries database is hosted in Europe and our quality complaints database is hosted within Teva in the USA. Because Teva is a global company, access to these databases may be provided to our global quality and medical teams, however in all cases, only strictly to what is required in order for our teams to complete their responsibilities and where possible, only in pseudonymised form.
For Europe: Transfers to Israel are based on the European Commission’s adequacy decision for the State of Israel. Transfers to India and to the USA are based on European Commission Model Clauses or equivalent based on applicable data protection laws.
For all: Information on the relevant mechanism can be provided upon request to Teva Privacy Office (IL_Privacy.Tevail@teva.co.il).
Changes to this Privacy Notice
If we decide to change the substance of this Privacy Notice materially, we will post those changes through a prominent notice.
If you have any concerns about how we process your Personal Data or wish to exercise any of your rights or wish to obtain other information, such as a copy of a legitimate interests balancing test, you can get in touch with Teva Data Protection Office by contacting us:
For Europe, you can contact us at EUPrivacy@tevaeu.com.
For the United States or Canada, you can contact us at USPrivacy@tevapharm.com.
For other regions, please contact us at IL_Privacy.Tevail@teva.co.il.
We hope that we can satisfy any queries you may have about the way in which we process your Personal Data. However, if you have unresolved concerns you also have the right to complain to the data protection authority in the location in which you live, work or believe a data protection breach has occurred.
Teva Pharmaceutical Industries Ltd., an Israeli limited liability company whose principal place of business is at Dvorah Haneviah 124 Tel Aviv, Israel.
Effective: October 2021