Privacy Notice for Pharmacovigilance, Medical Information enquiries and Product Complaints

The type of information that we collect will depend on the type of activity and whether you act as a reporter or are the subject of adverse events, safety information, medical information enquiries, and/or product complaints.

• Pharmacovigilance: We may collect the name, contact details, social media handle, profession and professional qualifications of the reporting individual. We may collect some additional personal information related to the individual experiencing an adverse event such as date of birth or age, gender, ethnic origin and health and medical history if required for pharmacovigilance purposes.
• Medical Information enquiries: We may collect the name, contact details and affiliation/profession of the individual making the enquiry. If an enquiry reveals an adverse event or a complaint in relation to a Jazz Pharmaceuticals product, we are required to process additional personal information in relation to this in order to comply with our legal obligations as described in this Privacy Notice.
• Product Complaints: We may collect the name, contact details and affiliation/profession of the individual reporting the complaint. If a product complaint reveals an adverse event in relation to a Jazz Pharmaceuticals product, we are required to process additional personal information in relation to this in order to comply with our legal obligations as described in this Privacy Notice.

In most cases we will obtain information directly from you when you report adverse events, provide safety information concerning our products, request medical information and/or submit product complaints.

We may also collect your personal information from other sources when you are the subject of adverse events, safety information, medical information enquiries, and/or product complaints, including from health care professionals on behalf of a patient, your relatives or via a third party (e.g. pharmacy, regulatory agency, distributor, market research agencies, etc).

Pharmacovigilance

Pharmacovigilance regulations were put in place to protect Public Health. It requires pharmaceutical companies to collect safety information related to their products, investigate any reports of adverse events that they receive and maintain the information in a safety database. We process personal information collected for pharmacovigilance to comply with our legal obligations to monitor and report adverse events and safety information and for reasons of public interest and public health.

As part of meeting our pharmacovigilance obligations, we may process your personal information to:

• investigate the adverse event;
• collect and monitor safety information
• contact reporters for further information about the adverse event reported;
• collate the information about the adverse event with information about other adverse events received by Jazz Pharmaceuticals to support safety monitoring of the product; and
• provide mandatory reports to national and/or regional competent regulatory authorities.

Product Complaints

We process personal information collected through product complaints to comply with our legal obligations to monitor the safety and quality of our products and for reasons of public interest and public health. Personal information collected for such purposes 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.

Medical Information enquiries

Any personal information provided to us related to a medical information enquiry will be processed based on our legitimate interests to answer the enquiry, 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.

We may also use your personal information in relation to pharmacovigilance, product complaints and medical information enquiries to fulfill our contractual obligations and for the establishment, exercise or defence of legal claims or proceedings.

We may share your personal information among the Jazz Pharmaceuticals group on a worldwide basis including through the Jazz Global Safety Database for adverse events. The Jazz Global Safety Database is validated and tested periodically to ensure appropriate security and access to the system is restricted to authorised personnel only.

We are also obliged to transfer adverse event data to regulatory authorities such as the European Medicines Agency, the US Food and Drug Administration, and any other national regulatory authorities for their databases, including the European Medicine Agency’s EudraVigilance database. Any names and contact details of patients are hidden and only initials and/or an identifier number as well as information on age/age group, date of birth and gender are transferred in addition to the information concerning the adverse event and the health of the patient.

We may also disclose your personal information:

• to service providers acting on our behalf (e.g. IT system and data hosting providers, safety database providers, adverse event processing providers, call centre operators);
• to third parties marketing or distributing Jazz Pharmaceuticals’ products;
• to any third party that acquires, or is interested in acquiring, all or part of Jazz Pharmaceuticals’ assets or shares, or that succeeds Jazz Pharmaceuticals in carrying on all or a part of its business, whether by merger, acquisition, reorganization or otherwise; or
• as required or permitted by law, including to comply with a subpoena or similar legal process or government request, or when we believe in good faith that disclosure is legally required or we have a legitimate interest in making a disclosure, such as where necessary to protect our rights and property.

Adverse event information may also be published in case studies. In such situations any identifying information will be removed from the publication to ensure complete anonymity.

Given the global nature of Jazz Pharmaceuticals' activities, your personal information may be transferred to countries located outside your home country or region, including to countries that may not have data protection laws equivalent to those in your home country. In such a case, we will implement appropriate measures to protect your personal information in accordance with the applicable data protection laws.

For example, if you are located in the European Economic Area (“EEA”), the United Kingdom (“UK”) and Switzerland, we may transfer your personal information to the United States or other countries outside of the EEA, UK or Switzerland. For the transfer of personal information from the EEA, UK or Switzerland to any countries not recognized by the European Commission, UK or Swiss governmental authorities as providing an adequate level of data protection according to EEA, UK or Swiss standards, we have implemented adequate measures to protect your personal information, such as (i) by ensuring the recipient is bound by standard contractual clauses adopted by the European Commission, UK and Swiss governmental authorities; or (ii) where this is not practical (for example, because of a transfer to a governmental authority), by making the transfer on the basis that the transfer is necessary to safeguard an overriding public interest in the context of public health.

All Jazz Pharmaceuticals’ entities have entered into an Interaffiliate Data Processing and Transfer Agreement including Standard Contractual Clauses to govern the transfer of personal information within Jazz Pharmaceuticals from the EEA, the UK and Switzerland to other countries including the United States.

Adverse event and safety information for Jazz Pharmaceuticals’ products, which may include personal information and related correspondences, are retained at least for the duration of the product life-cycle and for an additional twenty-five years after the product has been removed from the market in accordance with our Information Governance Policy.

Personal information retained as part of a medical information enquiry are kept for thirty years from the date of the enquiry in accordance with our Information Governance Policy and may be kept longer if the enquiry is associated with an adverse event .

Personal information related to product complaints are kept for 15 years from the date of the complaint in accordance with our Information Governance Policy and may be kept longer if the product complaint is associated with an adverse event.

You may have certain rights under local applicable data protection laws 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 information; (ii) obtain restriction of processing or to object to processing of their personal information; and (iii) the right to data portability.

If you wish to exercise one of the above-mentioned rights, please send us your request by using any of the methods listed in the “How to contact us” section below.

When you submit a request regarding your personal information, we reserve the right to verify your identity to help ensure that we provide the information we maintain to the individual to whom it pertains and allow only those individuals or their authorized representatives to exercise rights with respect to that information.

Additionally, a person authorized to act on your behalf may make a verifiable request related to your personal information. If you designate an authorized person to submit requests to exercise certain privacy rights on your behalf, we will require verification that you provided the authorized person permission to make a request on your behalf.

If you feel your rights have been infringed as a result of the processing of your personal information in non-compliance with applicable data protection laws, you also have the right to lodge a complaint with your local data protection authority.

If you have any questions, comments or suggestions about this Privacy Notice or our privacy practices, please contact the Jazz Pharmaceuticals Privacy Office at:

Address: 3170 Porter Drive, Palo Alto, CA 94303, U.S.         
Tel.: 650 496-3777         
Email: privacy@jazzpharma.com

For UK, Swiss and European purposes, our Data Protection Officer can be reached at dpo@jazzpharma.com 

If you are a resident of California, Washington or Nevada please use our online Privacy Request Form.

We may update this Privacy Notice from time to time and will provide notice of such changes by updating the “Last Updated” date listed on this Privacy Notice. If changes are significant, we will provide a more prominent notice to let you know what the changes are.