Data Protection Privacy Notice relating to the reporting of adverse events for PV monitoring and reporting
Personal Data - Introduction
This Notice describes our policies and practices with regard to the Personal Data collected about you in connection with our obligations to monitor and (in certain circumstances) report on "adverse events" , or any issues that arise following exposure to any of our products, for Veterinary Pharmacovigilance ("PV") purposes. In particular, it explains what types of information we collect and how that information is used.
We are committed to taking all reasonable steps to ensure that all Personal Data held by us is kept secure, processed in a fair and lawful manner and managed in accordance with all applicable data privacy laws. Please review this Notice carefully.
For the purpose of this Notice, “Personal Data” refers to information or pieces of information that could identify you, and could include, for example, your name, date of birth, email and/or mailing address, or those types of information described in more detail below; and “we” or “us” includes Dechra Pharmaceuticals PLC, and any other subsidiary companies of Dechra Pharmaceuticals PLC (the “Dechra Group”).
For the purposes of applicable data protection laws, the data controller will be the entity within the Dechra Group that holds the marketing authorisation for the product to which the relevant PV monitoring and reporting relates. For confirmation of the identity of the data controller, please contact us by email at DataProtection@dechra.com. In this Notice, references to “Dechra” will mean the data controller for your Personal Data.
What Personal Data will be collected in relation to our PV monitoring and reporting activities?
In order to comply with the legal and regulatory obligations to which we are subject when we undertake PV monitoring and reporting, we will collect the following personal information about you:
- your name, address, telephone number, and other basic contact information
- where you are reporting the adverse event to us in the course of your profession or employment, the name, address, telephone number, and other basic contact information of the person who has (or whose animal has) experienced the adverse event), your professional status, employment details and specialty;
- details of the relevant persons(s) and animal(s) affected by the adverse event, such as sex, age, weight and (in the case of animals) species and breed;
- details of the adverse event, including details of the relevant products which are suspected to have caused the event, when the affected person(s) or animals first came into contact with the product, the signs or symptoms displayed by the relevant person(s) and/or animal(s), their nature and duration; and
- other relevant medical information relating to the person(s) or animal(s) experiencing the adverse event (which may include blood and other laboratory testing results, mental and physical conditions and details of any medications prescribed or treatment administered in relation to those conditions).
Certain of the information we collect from you as part of our PV monitoring and reporting may be "special category" or "sensitive" Personal Data for the purposes of applicable data privacy laws. For example, any information we collect about you which reveals details of your physical or mental health will be special category Personal Data. As described in more detail below, we will only collect and share that Personal Data where we have a specific legal basis to do so.
We will only collect, use and share your Personal Data where we are satisfied that we have an appropriate legal basis to do this. This may be because:
- our use of your Personal Data is necessary to comply with a relevant legal or regulatory obligation that we have, for example in relation to our interaction with relevant regulatory authorities; or
- in respect of our use of your special category Personal Data (as identified above), we will only use that Personal Data for the purposes required to enable us to fulfil our monitoring and reporting obligations under applicable laws to which we are subject in respect of pharmacovigilance of medicinal products for veterinary use. This processing is necessary for reasons of public interest in the area of public health, specifically ensuring high standards of quality and safety of health care and of medicinal products or medical devices.
What will your Personal Data be used for?
We will use only your Personal Data to properly carry out our PV monitoring and reporting obligations which will include:
- obtaining follow up information and status updates in relation to reported adverse events;
- maintaining full and accurate records of all adverse events reported to us in respect of our products (including those products which we sell but which have been manufactured by third parties);
- in certain circumstances, providing details of adverse events to the third party that is the marketing authorisation holder for the relevant product (if this is not us); and
- in certain circumstances, providing details of adverse events to relevant regulatory authorities.
We will ask only for data that is adequate, relevant and not excessive for those purposes.
While we are required by law to collect the special category Personal Data described above in order to comply with our PV monitoring and reporting obligations, if you are based in the UK or the European Economic Area, the information we submit to the marketing authorisation holder or the relevant regulatory authorities (as applicable), in respect of any adverse events will always be in an anonymised form.
For detailed information on how we use Personal Data generally, please see our general Privacy Notice on our website: www.dechra.com/privacy-notice. Our general notice set outs further information about how Dechra:
- ensures your Personal Data is kept secure
- may transfer your Personal Data to any third parties;
- may transfer your Personal Data abroad;
- determines how long it will retain your Personal Data for; and
- can assist with the exercise of your rights in relation to your Personal Data.
If you have questions about data protection issues in relation to our reporting obligations described in this Notice, please contact us by email at DataProtection@dechra.com.