Privacy Notice Safety Information

NOTICE OF PERSONAL DATA PROCESSING RELATED TO SAFETY INFORMATION

This Privacy Notice was last updated on December 27, 2022

Pharmacosmos A/S is required by law to collect complaints, adverse events and other experiences concerning our products and whilst doing so to also protect your Personal Data. This Privacy Notice describes how and why we process (e.g. collect, use, store, and share) Personal Data to ensure public health and to stay compliant with legislation on the surveillance of the safety of our products i.e. Pharmacovigilance.

We will process your Personal Data in accordance with this Privacy Notice and applicable legislation.

DEFINITIONS USED IN THIS NOTICE

Pharmacovigilance: 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: Events describing the circumstances around the use of a drug which could potentially cause drug related problems or which could potentially give new knowledge of a drug e.g. exposure during pregnancy or medication errors.

Personal Data: Any data that relates to an identifiable individual e.g. name, date of birth, email address, medical history or occupation.

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, religious beliefs, physical or mental health.

IDENTITY OF THE DATA CONTROLLER

The data controller is Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.

HOW DO WE COLLECT PERSONAL DATA ABOUT YOU?

Information on adverse events and other experiences containing Personal Data are reported to usfrom the following sources:

From you (patients) directly
From Health Care Professionals such as your nurse, a pharmacist or doctor

From publicly available publications, websites, or social media

WE ARE LEGALLY OBLIGED TO RECORD ADVERSE EVENTS AND OTHER EXPERIENCES

As any other pharmaceutical company, Pharmacosmos A/S 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 third party provide Pharmacosmos A/S with information on an adverse event, 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 Authorization Holders and Health 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 following data:

Information on the adverse event(s) 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 allows the relevant affiliate or partner of Pharmacosmos A/S 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)

WHAT PERSONAL DATA DO WE PROCESS ABOUT YOU?

Depending on your role (category of data subject), we process your data for different purposes and therefore with different legal bases.

Patient subject to adverse events or other experiences:
When processing personal data of a patient, we process the following types of data: name or initials, gender, age, medical history, type of medicine (i.e. our pharmaceutical product), medical history, and other relevant medical data that may be contained in the reporting. The purpose of this processing is the fulfillment of our legal obligation to file a report on adverse events/adverse drug reactions in accordance with the General Data Protection Regulation (“GDPR”) article 6(1)(c) and article 9(2)(i).

Reporter of adverse events and other experienced:
If you are the reporter of adverse events/other experienced, we may process your full name, professional information, contact data (i.e. phone number, address and/or email). The purpose of this processing is the fulfillment of our legal obligation to file a reporting on adverse events/adverse drug reaction, hereunder our legitimate interest in identifying and/or contacting you as the reporter of the adverse events/other experienced, in accordance with the GDPR article 6(1)(f).

Patient and reporter name and contact details will never be shared.

LEGAL BASIS FOR PROCESSING YOUR PERSONAL 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.

Pharmacosmos A/S process PV relevant Personal Data, including special categories of personal data, in accordance with the European General Data Protection Regulation (GDPR) Regulation (EU) 679/2016:

to comply with legal obligations under applicable Pharmacovigilance laws and regulations (Article 6.1(c)); considering that
Pharmacovigilance EU or member state law has been issued for reasons of substantial public interest in the area of public health and safety of medicinal products or medical devices (Article 9.2 (i))

WHEN AND HOW DO WE TRANSFER YOUR PERSONAL DATA?

We may share your Personal Data with:

Health Authorities
Other Pharmacosmos entities (e.g., Pharmacosmos affiliates in other countries)

Partner companies that assist our company (e.g. partners, consultants, IT service providers)

WILL YOU NEED TO GIVE YOUR CONSENT?

Pharmacosmos A/S 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 in public health, it is not subject to the same constant requirements as other sectors. Therefore, consent is not required.

TRANSFER OF YOUR PERSONAL DATA OUTSIDE THE EU/EEA

If your Personal Data is transferred to one of our affiliated companies or a third party located in a country outside the EU/EEA, Pharmacosmos A/S will ensure that such transfer(s) will be carried out in accordance with the applicable data protection legislation, including the GDPR.

If your Personal Data is transferred to our affiliated companies outside the EU/EEA, not ensuring an adequate level of data protection, the transfer will be based on Intra-Group Agreements including the EU Commission’s Standard Contractual Clauses.

Transfers to third parties outside the EU/EEA, not ensuring an adequate level of data protection, will be safeguarded by ensuring that the third party enters into the EU Commission’s Standard Contractual Clauses.

You may request a copy of the relevant Standard Contractual by contacting Pharmacosmos A/S on dataprotection@pharmacosmos.com

RETENTION PERIOD OF YOUR PERSONAL DATA?

We will keep your Personal Data for the following period of time:

12 years for data relating to technical complaints
Permanently for data relating to adverse events and other experiences

Up to 5 years for all other enquiries

YOUR RIGHTS REGARDING YOUR PERSONAL DATA

You have the following rights in relation to your Personal Data:

Right to access your Personal Data held by Pharmacosmos A/S
Right to have your Personal Data updated and corrected, for example, if it is incomplete or incorrect
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 receive a copy of your Personal Data, in a structured, commonly used and machine-readable format (known as “data portability”), except if this cannot be permitted for reasons of public interest or applicable law.
Where you have provided personal data voluntarily, or otherwise consented to its use, the right to withdraw your consent. Withdrawing your consent will not affect the lawfulness of any processing we conducted prior to your withdrawal, nor will it affect processing of your personal information conducted in reliance on lawful processing grounds other than consent.
The right to complain to a data protection authority (see section “Complaints”)

To exercise any of these rights, please contact our Data Protection Manager at: dataprotection@pharmacosmos.com

COMPLAINTS

If you are concerned about an alleged breach of privacy law or any other regulation by Pharmacosmos A/S, you can contact us (see contact details below). The complaint will be handled in accordance with applicable law.

If you are not satisfied with the way in which Pharmacosmos A/S has resolved your complaint, you have the right to complain to the data protection authority in your country (for Denmark: the Danish Data Protection Agency at: dt@datatilsynet.dk).

CONTACT INFORMATION

If you have questions or you do not feel that your concerns have been addressed in this Privacy Notice, please contact us either by mail, Attention: “Data Protection Manager” to the address: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark or by email to: dataprotection@pharmacosmos.com

UPDATES TO THIS PRIVACY NOTICE

From time to time, we may revise this Privacy Notice. Any such changes to this Privacy Notice will be reflected on this page. Pharmacosmos A/S recommends that you review this Privacy Notice regularly for any updates. The date on which this Privacy Notice was last revised is located at the top of this Privacy Notice.

Privacy Notice of personal data processing related to safety information version 3: 2022-12-27

Privacy Notice Safety Information