This Privacy Notice was last updated on December 18, 2023. 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.
NOTICE OF PERSONAL DATA PROCESSING RELATED TO SAFETY INFORMATION
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.
The data controller is Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark
Information on adverse events and other experiences containing Personal Data are reported to us from 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
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)
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.
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))
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)
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.
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 in countries 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 in countries 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
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
When we process personal data about you, you have a number of rights under the GDPR. These rights are stated below, but please note that certain limitations, restrictions, and conditions may apply to your ability to exercise these rights. Subject to those limitations, restrictions, and conditions, your rights are:
Right of access
You have the right to access the personal data that we process about you and obtain certain other information relating thereto.
Right to rectification and erasure
You have the right to have inaccurate or incomplete personal data about you corrected or completed and to have your personal data erased by us.
Right to restriction of processing
You have the right to obtain restriction of our processing of your personal data in specific situations.
Right to data portability
Where our processing of your personal data is based on your consent or is necessary for the performance of a contract with you and the processing is carried out by automated means, you have the right to receive the personal data about you in a structured, commonly used and machine-readable format (data portability). You may request that we transmit your personal data directly to another data controller where technically feasible.
Right to object to our processing
Where our processing of your personal data is based on our performance of a task carried out in the public interest, cf. the GDPR article 6 (1) e., or our legitimate interests, cf. the GDPR article 6 (1) f., you have the right to object, on ground relating to your particular situation, to our processing of your personal data.
Automated individual decision-making
You have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning you or similarly significantly affects you.
Right to complain to a supervisory authority
You have the right to lodge a complaint with a supervisory authority such as the Danish Data Protection Agency (Datatilsynet).
If you want to exercise any of the above rights, please contact our Data Protection Manager at dataprotection@pharmacosmos.com. Please note that we may require proof of your identity and full details of your request before processing it. The data will only be used to verify your identity and will not be stored for longer than needed for this purpose.
If you wish to lodge a complaint with the Danish Data Protection Agency, you may also contact it directly at dt@datatilsynet.dk.
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
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 4: 2023-12-18