Privacy Statement for Pharmacovigilance Data

Bayer Israel and its affiliates (hereinafter “Bayer”, “us”, “our” and “we”) develop and market prescription and over the counter medicines as well as medical devices and cosmetics, for human use (“Bayer Health Products”). The safety of all Bayer Health Products worldwide that are in development or are marketed in any country has to be monitored. 

Humans vary in their biological reactions to medicinal products or medical devices and not all adverse reactions or events (side effects) associated with the use of medicinal products and medical devices can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing adverse events, however rare they may be in absolute terms, in the development and marketing phase from worldwide sources is of paramount importance. 

Such monitoring of adverse events is called Pharmacovigilance (“PV”). PV requirements exist to allow us and competent regulatory authorities to manage adverse events and to protect public health and ensure high standards of quality and the safety of Bayer Health Products. 

Our Pharmacovigilance obligations and our Ministry of Health procedures and its regulations require us to process certain information, which may allow to directly or indirectly identify a person, (“Personal Data”) of a patient and/or the reporter of an adverse event that we receive in order to comply with strict obligations to perform benefit-/risk assessments of Bayer Health Products continuously and report suspected adverse reactions or events to relevant regulatory authorities. 

This Pharmacovigilance Privacy Statement (“Statement”) provides important information to you about how we process Personal Data for PV purposes, in line with our obligations under applicable data privacy laws, including the Israeli Privacy Protection law, 5741-1981 and the regulations thereunder. 

All Personal Data is processed exclusively for PV purposes and only where relevant and appropriate to document, assess and report patients' adverse event properly in accordance with our Pharmacovigilance obligations and our Ministry of Health procedures and its regulations. 

If you have any questions about this Statement or about how we use your Personal Data, please contact us via our contact details at the end of this Statement.

Should you send us adverse event report that includes details of a patient, we may need to process (includes collecting, storing or otherwise using) the following Personal Data:

1.1    About the Patient 

• patient name and / or initials; 
• date of birth / age group, sex, weight, height; 
• information about health, racial or ethnic origin and sexual life (sometimes those details may be relevant for examining physical reactions/effects.
• medical history and status, which may for example include: 
  • details of the Bayer Health Product suspected to cause the adverse event, including the dosage you have been taking or were prescribed, the reason you have been taking or were prescribed the Bayer Health 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 adverse event, 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 event you suffered, the treatment you received for that event, and any potential long-term effects the adverse event 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. 

1.2    About the Reporter: 

• name; 
• contact details (which may include your address, e-mail address, phone number or fax number); 
• profession (this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and
• relationship with the subject of the report. 
   

As part of meeting our Pharmacovigilance obligations and our Ministry of Health procedures and its regulations, we may process Personal Data to: 

• investigate the adverse event; 
• contact you for further information about the adverse event you reported; 
• collate the information about the adverse event with information about other adverse events received by Bayer to analyze the safety of a production batch, Bayer Health Product or active ingredient as a whole; and 
• provide mandatory reports to national and/or regional competent regulatory authorities so that they can analyze the safety of a production batch, Bayer Health Product, generic or active ingredient as a whole. 

As part of meeting our Pharmacovigilance obligations and our Ministry of Health procedures and its regulations, we may share and/or disclose Personal Data: 

• within the Bayer Group in order to analyze and process a reported adverse event; 
• with competent regulatory authorities, in respect of a suspected adverse event; 
• with third party service providers of the Bayer Group; these service providers may include safety database providers, call center operators, and in the event that you disclose details of your suspected adverse reaction to our market researchers, that particular market research provider. Please note that we have appropriate data protection safeguards in place with our service providers with whom the Bayer Group shares Personal Data and who are providing services or functions on our behalf; 
• with other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners of the Bayer Group, where pharmacovigilance obligations for a Bayer Health Product require such exchange of safety information. Please note that we have appropriate data protection safeguards in place with such business partners with whom the Bayer Group shares Personal Data and who are providing services or functions on our behalf; 
• with a third party successor in business in the event of a sale, assignment or transfer of a specific Bayer Health Product, related project 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; 
• when publishing information about adverse events (such as case studies and summaries); in such cases, we will remove identifiers from any publication to keep your identity private.

3.1    Third countries 

Our Pharmacovigilance databases are hosted in Germany by Bayer. However, we may need to transfer your Personal Data to other members of the Bayer Group or to third party business partners and regulatory bodies. These may be based outside of Israel and the European Economic Area (“EEA”) in a country for which the European Commission has not decided that it ensures an adequate level of data protection (“Third Country”). Whenever we need to transfer your Personal Data for the PV Purposes to a third party business partner located in a Third Country, we apply the measures required and take the necessary steps to protect it, as ordered by the applicable law to your data. You can get more information about our data transfers by contacting our Data Privacy Officer using the contact details set out below. 

We have implemented appropriate state of the art technical and organisational measures to safeguard Personal Data processed for the PV Purposes, including safeguards and procedures designed to restrict access to Personal Data to those employees who need it to perform their job responsibilities. 

We maintain physical, electronic and procedural measures to safeguard Personal Data from accidental loss, destruction or damage and unauthorized access, use and disclosure. 

Where reasonably possibly, we process Personal Data in key coded/pseudonymized form.

We will use and store your Personal Data in accordance with mandatory legal requirements governing storage and reporting of Pharmacovigilance related information. Such mandatory requirements oblige us to archive PV information which may include Personal Data at least for the duration of the product life-cycle and for an additional ten years after the respective medicinal product and medical devices has been taken from the market. 

Bayer processes PV relevant Personal Data to comply with legal obligations under applicable Pharmacovigilance laws and regulations, and to ensure the PV Purposes, stated above. We will not transfer PV relevant Personal Data to any other party for other purposes.

Subject to the applicable laws, you have the right to request access to your Personal Data processed or obtained by Bayer, and if you believe this data is incorrect or not update, you may ask us to correct or delete it. The decision on your request to delete the Personal Data will be at our discretion. 

Please note that we may require you to provide proper identification before we comply with any request to access, correct or delete your Personal Data. 

More generally, we encourage you to contact us via the contact info below with any questions regarding your Personal Data or privacy. 

For any questions you may have with respect to data privacy for pharmacovigilance data or data privacy in general, please use the provided contact our company data protection officer at the following address: privacy.il@bayer.com

Further and general information about data privacy at Bayer you will find in the Privacy Statement