Data Protection

Data Protection Statement for Vigilance

Data protection information on processing personal information related to adverse reactions or events associated with the use of medicinal products and safety of medical devices (vigilance)

Last updated October 2022, previous version

In our capacity as a manufacturer of pharmaceuticals and medical devices, Fresenius Kabi South Africa (Pty) Ltd (“we”) will collect, use and report personal information of patient using our products and reporters of adverse reactions or events.

This data protection statement informs you about the processing of personal information when making an adverse event report.

Please be aware that we also may process your personal information in other contexts, e.g. when you visit our website, when you are a business contact for products or services, when you interact with us in your capacity as a healthcare professional, or if you submit a data subject request. Please see the specific information on the processing of your personal information in such situations.

We may collect and use your personal information in the following situation:

Information you provide to us

We collect and use the information you provide directly to us (e.g. via phone, letter or webform), as patients using our products or as reporter of adverse reactions or events.

The exact amount and kind of information depends on the information submitted to us or the information that is published, posted or shared. Such information includes:

Information identifying the patient (potentially including first and last name, date of birth, gender)
- Medical history and other characteristics including laboratory data, pregnancy, weight and height, age
- Measures and treatment of adverse reaction(s)
Information identifying the reporter
- First and last name
- Qualification
- Contact and address information (including address, e-mail address, social media account name, phone number)
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Medicine/active substance related data including batch, dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event, congentital abnormality
- Outcome of reaction(s)

Information we collect from publicly available sources

We collect and use the information as reported and published on publicly available sources such as social media and internet forums, literature or other reports we became aware of.

The exact amount and kind of information depends on the information submitted to us or the information that is published, posted or shared. Such information includes:

Information identifying the patient (potentially including first and last name, date of birth, gender)
- Medical history and other characteristics including laboratory data, pregnancy, weight and height, age
- Measures and treatment of adverse reaction(s)
Information identifying the reporter
- First and last name
- Qualification
- Contact and address information (including address, e-mail address, social media account name, phone number)
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Medicine/active substance related data including batch, dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event, congentital abnormality
- Outcome of reaction(s)

Information we collect from other organizations

We collect and use the information as provided to us by healthcare organizations or organizations otherwise involved in the provision of care such as hospitals, our distributors and resellers or universities.

The exact amount and kind of data depends on the information submitted to us such data includes:

Information identifying the patient (potentially including first and last name, date of birth, gender)
- Medical history and other characteristics including laboratory data, pregnancy, weight and height, age
- Measures and treatment of adverse reaction(s)
Information identifying the reporter
- First and last name
- Qualification
- Contact and address information (including address, e-mail address, social media account name, phone number)
Information on the adverse event or other information on the safety of our products
- Description of the adverse reactions related data including start, stop, duration
- Medicine/active substance related data including batch, dosage, application, suspected causality indication and duration of treatment
- Medical device related data including application and malfunctioning
- Seriousness criteria of reaction such as death, life threatening, hospitalization or prolonged hospitalization, permanent injury or disability, important medical event, congentital abnormality
- Outcome of reaction(s)

We collaborate with other organizations to fulfill or legal obligations. Therefore, we may send your personal information in parts or as a whole to other organizations. Such recipients are:

Other Fresenius Group companies if such a transfer of personal information is required for the specific purpose (Please refer to the overview of the locations in which Fresenius Kabi Group companies are active)
Service providers who process personal information on our behalf (e.g. for hosting or maintenance services) that have to follow our instructions on such processing; these service providers will not be allowed to use your personal information for other than our purposes
Health authorities, other pharmaceutical companies, other courts, parties in a litigation in case we are required to do so to meet any applicable laws, regulations, legal processes or enforceable governmental requests
Professional advisors or auditors, such as tax advisors, financial auditors, lawyers, insurers, banks and other external professional advisors in the countries in which we operate

International Data Transfers

We may send your personal information in parts or as a whole to Fresenius Group recipients, our service providers or otehr international organizations in countries, which are not member states of the European Union, for the purposes listed above. Please refer to the overview of the locations in which Fresenius Kabi Group companies are active.

We may send information to the following countries for which the European Commission has determined an adequate level of data protection to be in place that matches the level of data protection within the European Union in which Fresenius entities have been established: Argentina, Canada, Japan, New Zealand, Switzerland or Uruguay.

With regards to such international information transfers to third countries, for which the European Commission has not decided that an adequate level of data protection exists, we have provided appropriate safeguards in order to secure your personal information to a degree that equals the level of data protection in the European Union.

Safeguards used are:

For the exchange of data within our company: our Binding Corporate Rules for Controllers
For the exchange of data with our service providers and other international organizations: Standard Contractual Clauses that have been issued by the European Commission

You can obtain a copy of these standard contractual clauses and our Binding Corporate Rules online, or upon request.