Pharmacovigilance notice of personal data processing
Patient safety is a high priority for LEO. We take on the responsibility of keeping patients safe by pre-empting and preventing unexpected and unintended events related to our products and services. We are committed to and focused on providing safety and comfort to the millions of patients receiving our products and services every day.
Scope of this statement
This statement applies to any kind of data collection involving patients and health care professionals. The information may be receive online, by phone, fax, e‐mail or post It may be intentionally reported or incidentally reported to any LEO representative. It may also be actively collected in connection with any study or customer care or patient support programme.
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.
Definitions used in this statement
Pharmacovigilance: Means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
Adverse Event: Any untoward medicinal occurrence in a patient using a medicinal product.
Other Experiences: Other Experiences (OE) are events which describe the circumstances around the use of a drug which potentially could cause drug related problems or which could potentially give new knowledge of a drug. e.g. pregnancy exposure or medication errors.
Personal Data: Any data that relates to an identifiable individual e.g. medical history or occupation. Some Personal Data can be enough to identify someone on its own e.g. full name, e-mail address, telephone number, postal address, date of birth, photographs, patient reference number. Other personal data would only identify someone in the context of other data being available.
Sensitive Data: Concerns special categories of Personal Data that by their nature are sensitive, such as those relating to health e.g. medical records, medical history, test results, medical/clinical treatments, physiological or biomedical state.
We are legally obliged to record Adverse Events and Other Experiences
As any other pharmaceutical company LEO Pharma is under legal obligations to collect Adverse Events and Other Experiences, which may add information about the safety of our products. When you, your doctor or a third party provide LEO Pharma with information on an Adverse Events, experienced with the use of our products, we record and process the information in order to meet our Pharmacovigilance obligations. If needed, we will revert to the reporter and request additional information about the experience. These obligations exist to allow Marketing Authorisation Holders and Regulatory Authorities to learn from the experiences of patients in order to minimize the risks for patients.
In order to maintain a license for our products worldwide we must record the below data:
- Information on the Adverse Even or Other experience(s)
- Results of tests and procedures relevant to the investigation of the patient
- If applicable, date and reported cause of death
- Information on the primary source(s) which allow the relevant affiliate or partner of LEO Pharma to request additional information as needed
- Information identifying the patient
- Relevant medical history and concurrent conditions
- The name of the medicinal product(s) and the active substance(s)
- Concomitant medicinal products, and past-medical drug therapy for the patient
- Why are we allowed to process Pharmacovigilance data?
- The European General Data Protection Regulation (GDPR) Regulation (EU) 679/2016 allows processing of Personal Data when it is in the interest of public health and required by other legislation.
When and how do we transfer your Personal Data?
Regulatory Authorities in countries where LEO Pharma’s products are sold may require information about Adverse Events and Other Experiences observed in their own country as well as in other countries. When that is required, LEO Pharma or a local partner will provide the required information. However, patient and reporter name and contact details will never be shared.
At LEO Pharma we limit the number of patient and reporter identifiers shared in every case handling step. i.e. your full name will not be transferred from the affiliate of your country to the global safety database, to partners or to Regulatory Authorities.
Will you need to give your consent?
LEO Pharma is committed to ensure that appropriate consent is obtained before collecting or processing Personal or Sensitive Data. However, as data collected to fulfill Pharmacovigilance obligations is collected and processed for reasons of public interest and public health, it is not subject to the same consent requirements as other sectors. Therefore, consent is not required.
Retention of your Personal Data
Only Personal Data required for LEO to be compliant with current legislation will be entered in the LEO global safety database and will be kept permanently or for as long as required by current legislation. All data will be treated confidentially.
Your rights as a data subject are the following:
- Right to access: You have the right to request a copy of the information we hold about you
- Right to rectification: You have the right to request a correction of the information we hold about you
- Right to erasure and restriction of processing: For legal reasons, we cannot delete information that has been collected and processed as part of an Adverse Event or Other Experience.However, you may request that your contact details including your name are deleted
- If your name and contact details are deleted we can no longer provide a copy of the data we hold on you to you. However, the remaining information about the Adverse Event or Other Experience will still be shared with Regulatory Authorities and partners as legally required
- Right to data portability: You have the right to request that we transfer the Personal Data we hold about you to another party, except if this cannot be permitted for reasons of public interest or legislation
- Right to object: You can submit a complaint about how we process your Personal Data. You may either
- Contact a local affiliate of LEO Pharma
- Contact the LEO Pharma Data Protection Officer, see contact details below
- Complain to the Supervisory Authority. Where applicable laws provide you with such right, you are entitled to file a complaint with the Supervisory Authority in the country of your habitual residence, place of work or place of the alleged infringement, if you believe that the processing of your Personal Data infringes your right to data protection
Contact information on the Data Protection Officer
If you have any questions about the processing of your Personal Data, you are always welcome to contact our Data Protection Officer in the following ways:
By e-mail: email@example.com
By phone: +45 4494 5888
By letter: LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark, c/o Data Protection Officer