Source: https://www.jenapharm.de/datenschutzauskunft/
Timestamp: 2019-05-21 16:41:02
Document Index: 159655161

Matched Legal Cases: ['§ 22', 'Art. 6', '§ 22', 'Art. 6', 'Art. 6', 'Art. 6', 'Art. 9']

Datenschutzinformationen für Kundenservice & medizinische Abteilung
Die Jenapharm GmbH & Co. KG (im Folgenden auch „Jenapharm“, „uns“, „unser“ und „wir“) möchte Sie hiermit informieren, wie wir als verantwortliche Stelle Ihre personenbezogenen Daten verarbeiten, wenn Sie medizinische Anfragen an uns richten.
Sie können uns für unterschiedliche Zwecke kontaktieren, z.B. für medizinische Anfragen. Wenn Sie uns dabei personenbezogene Daten mitteilen, verarbeiten wir diese Daten, einschließlich Ihrer Angaben über Ihre Gesundheit, um Ihre Anfrage zu bearbeiten. Die Rechtsgrundlage für die Verarbeitung Ihrer personenbezogenen Daten ist dabei vom Anlass Ihrer Kontaktaufnahme abhängig.
Wenn Sie uns Nebenwirkungen melden oder über andere arzneimittelsicherheitsrelevante Ereignisse berichten, ist die Verarbeitung dieser Daten zur Gewährleistung eines hohen Sicherheitsstandards bei Arzneimitteln nach § 22(1)(c) Bundesdatenschutzgesetz gesetzlich erlaubt. Zudem sind wir gesetzlich verpflichtet, arzneimittelsicherheitsrelevante Ereignisse jedenfalls in anonymer Form den zuständigen Behörden zu melden.
Wenn Sie allgemeine Anfragen haben (z.B. Zusendung von Informationsmaterial, Fragen zu Lieferzeiten, Serviceleistungen oder Veranstaltungen), folgt die Rechtsgrundlage für die Verarbeitung personenbezogener Daten aus Art. 6(1)(b) Datenschutz-Grundverordnung.
2.2 Weitergabe innerhalb der Jenapharm und Übermittlung an Dritte
Anfragen, für die der Kundenservice oder die medizinische Abteilung nicht zuständig ist, werden an die bei uns fachlich zuständigen Stellen weitergeleitet. Meldungen zu Nebenwirkungen oder andere Informationen zu arzneimittelsicherheitsrelevanten Ereignissen werden an die Abteilung Pharmakovigilanz weitergegeben. Im Rahmen der gesetzlichen Vorgaben können diese Daten den zuständigen Behörden gemeldet und an andere Bayer-Gesellschaften übermittelt werden. Sofern Ihre Daten dabei in ein Land außerhalb der Europäischen Union oder des Europäischen Wirtschaftsraums übermittelt werden, für das die Europäische Union kein ausreichendes Datenschutzniveau festgestellt hat, sorgen wir für einen ausreichenden Schutz Ihrer personenbezogenen Daten, insbesondere durch den Abschluss spezieller Vereinbarungen mit anderen Bayer-Gesellschaften.
Ihre personenbezogenen Daten werden für einen Zeitraum von 6 Monaten gespeichert. Wenn Ihre personenbezogenen Daten an die Abteilung Pharmakovigilanz weitergegeben werden, erfolgt dort eine darüber hinaus gehende Speicherung in Übereinstimmung mit den gesetzlichen Bestimmungen zur Speicherung und Meldung von Informationen zur Pharmakovigilanz. Wir sind gesetzlich verpflichtet, Pharmakovigilanz-Informationen mindestens für die Dauer des Produktlebenszyklus und für weitere zehn Jahre nachdem das betroffene Arzneimittel oder Medizinprodukt vom Markt genommen wurde zu archivieren.
Sollten Sie Fragen in Zusammenhang mit dem Datenschutz oder Ihrer Einwilligung haben oder von Ihren Rechten Gebrauch machen wollen, wenden Sie sich bitte an: Jenapharm GmbH & Co. KG, Datenschutz, Otto-Schott-Straße 15, 07745 Jena oder senden eine E-Mail an Datenschutz@jenapharm.de
Data Protection Information for Customer Service and Medical Division
Jenapharm GmbH & Co. KG (also referred to below as “Jenapharm”, “we”, “us” and “our”) would like to take this opportunity to inform you how we, as the data controller, process your personal information when you send us medical questions or inquiries.
1. What information is processed, why and on what legal basis?
You can contact us for a variety of reasons, such as with medical questions, for example. If you disclose personal information to us, we process this information, including information about you and your health, so that we can respond to your question. The legal basis for the processing of your personal information depends on the reason you contacted us.
If you report side effects or other events relevant to drug safety to us, the processing of this information is permitted by law to guarantee a high standard of drug safety in accordance with § 22(1)(c) Bundesdatenschutzgesetz [German Federal Data Protection Act]. We are also required by law to report events related to drug safety in anonymized form to the responsible authorities.
If you have questions about taking and using drugs or problems handling them and we require health-related information about you to respond to your question, we also need your consent as the legal basis for processing the information. In this context, health-related information can be processed only if you have given us your consent, e.g. expressly over the telephone or by submitting your question in writing.
If you have general questions (e.g. requests for informational material, questions about delivery dates, services or special events), the legal basis for the processing of personal data is Art. 6(1)(b) of the General Data Protection Regulation.
2. Forwarding of personal information
We sometimes commission specialized service providers to process your personal information on our behalf. We carefully select and regularly monitor all our service providers. They process personal information only at our request and in accordance with our instructions on the basis of corresponding contracts governing commissioned processing.
2.2 Forwarding within Jenapharm and transmission to third parties
Inquiries on matters for which Customer Service or the Medical Department are not responsible are forwarded to specialized departments within our company. Reports of side effects or other information on events related to drug safety are forwarded to the Pharmacovigilance Department. As required by law, this information may be reported to the responsible authorities and transmitted to other Bayer companies. If your information is transmitted to a country outside the European Union or the European Economic Area for which the European Union has not certified an adequate level of data protection, we provide adequate protection of your personal information, in particular by entering into special agreements with other Bayer companies.
3. Retention periods for personal information
Your personal information will be retained for a period of 6 months. If your personal information is forwarded to the Pharmacovigilance Department, it may be retained in other locations in compliance with the statutory requirements on the retention and reporting of information for pharmacovigilance purposes. We are required by law to archive pharmacovigilance information at least for the duration of the product life cycle and for an additional ten years after the drug or medical product in question has been withdrawn from the market.
You have the following rights regarding your personal information: The right to disclosure of and access to your personal information, the right to demand the correction or deletion of your information, the right to demand restricted processing of your information or to dispute processing under Art. 6(1) (f) of the General Data Protection Regulations (justified interest) for reasons that are based on your particular situation. Additional rights include the right to have your data transferred and the right to file a complaint with the data protection regulatory authorities. You may at any time retract your consent, although such retraction does not affect the legality of processing before retraction.
If you have any questions in connection with data protection or your consent or would like to exercise your rights, please contact: Jenapharm GmbH & Co. KG, Datenschutz, Otto-Schott-Straße 15, 07745 Jena or send an e-mail to Datenschutz@jenapharm.de
Datenschutzerklärung für Pharmakovigilanz
Die Jenapharm GmbH & Co. KG, als Teil der Bayer AG, nimmt die Produktsicherheit und den Datenschutz ernst.
Sollten Sie Fragen zu dieser Erklärung oder zu der Verarbeitung Ihrer personenbezogenen Daten haben, setzen Sie sich bitte über unsere Kontaktangabe am Ende dieser Erklärung (siehe 8. Kontakt) mit uns in Verbindung.
Wenn Ihre personenbezogenen Daten für PV-Zwecke an einen externen Geschäftspartner mit Sitz in einem Drittland übermittelt werden müssen, verwenden wir als geeignete Garantie für ein angemessenes Datenschutzniveau die von der Europäischen Kommission verabschiedeten datenschutzrechtlichen Standard-Vertragsklauseln. Sie können eine Kopie dieser Standard-Vertragsklauseln erhalten, indem Sie über unsere Kontaktangabe am Ende dieser Erklärung (siehe 8. Kontakt) unseren Konzerndatenschutzbeauftragten kontaktieren.
Pharmacovigilance data protection policy
Jenapharm GmbH & Co. KG, as part of Bayer AG, takes product safety and data protection very seriously.
Bayer AG, 51368 Leverkusen, Germany (also referred to below as “Bayer”, “us”, “our” or “we”) develops and distributes prescription-only and over-the-counter drugs, medical products and cosmetics for use in humans and animals (“Bayer Health Products”).
As a pharmaceutical company, Bayer has a legal responsibility and obligation to conduct worldwide monitoring of the safety of all Bayer Health Products that we develop or market.
Humans and animals vary in their biological reactions to drugs or medical products and not all adverse reactions or events (side effects) associated with the use of drugs and medical products can be detected during clinical development, not even by the most comprehensive clinical trials. The collection of information on adverse events from sources worldwide, as rare as they may be in absolute terms, is of paramount importance in both the development and distribution phases.
Such monitoring of adverse events is called pharmacovigilance (“PV”). PV requirements enable us and the competent regulatory authorities (such as the European Medicines Agency and other authorities) to manage adverse events and thus protect public health and ensure high standards of quality and the safety of Bayer Health Products.
Our pharmacovigilance obligations require that we process certain information that would directly or indirectly make it possible to identify an individual (“personal information”) and that has been provided to us by a patient and/or the person submitting the report of an adverse event so that we can comply with strict requirements relating to the ongoing conduct of risk-benefit analyses of Bayer Health Products and report suspected adverse reactions or events to the appropriate regulatory authorities.
This Pharmacovigilance Data Protection Policy (“Policy”) contains important information regarding the processing of your personal data for PV purposes in accordance with our obligations under the applicable data protection laws and regulations, in particular the General Data Protection Regulations ((UE) 2016/679) (“GDPR”).
All personal information is processed exclusively for PV Purposes and only when it is relevant and appropriate for the proper documentation, assessment and reporting of your adverse event in accordance with our pharmacovigilance obligations.
If you have questions about his policy or about the processing of your personal information, please contact us at the address indicated at the end of this policy statement (see 8. Contact Information).
In some cases we are required to process (which includes the collection, retention and continued use of) the following personal information:
I. About the patient:
Patient’s name and/or initials,
Date of birth/age group, gender, weight, height
Information about the patient’s health, racial or ethnic origin, sexual activity
History of illness and status of the patient’s health, e.g.:
Details about the Bayer Health Product that is suspected of having caused the adverse event, including the dose you took or that was prescribed, the reason for taking or prescribing the Bayer Health Product and all subsequent changes in your customary therapy,
Details about other drugs or medications you take or were taking at the time of the adverse event, including the dose you took or that was prescribed, the length of time you took the drug, the reason for taking the drug and all subsequent changes in your therapy,
Details about the adverse event you experienced, the treatment you received on account of this event, and potential long-term effects on your health as a result of the adverse event, and
other information about your medical history that the individual reporting the event considers relevant, including documents such as lab reports, a list of other medications you may be taking and the patient’s account of his or her medical history.
II. About the party reporting the adverse event:
Contact information (e.g. your address, e-mail address, telephone or fax number),
Profession or occupation (this information can have an influence on the questions you are asked about the adverse event, depending on your assumed level of medical knowledge), and
Your relationship to the person who is the subject of the report.
2. Purposes of processing (“PV purposes”)
In the context of complying with our pharmacovigilance obligations we can process your personal information to:
investigate the adverse event,
contact you for further information about the adverse event you reported,
compare the information about the adverse event with information about other adverse events received by Bayer to analyze the safety of a production batch, Bayer Health Product or active ingredient in general, and
submit the required reports to the competent national and/or regional regulatory authorities so that they can analyze the safety of a production batch, Bayer product, generic or active ingredient in general together with reports from other sources.
3. Forwarding of personal information
To comply with our pharmacovigilance obligations we may forward and/or disclose personal information as follows:
within the Bayer Group, to analyze and process a reported adverse event.
to the responsible regulatory authorities with regard to a suspected adverse event.
to third-party service providers working for the Bayer Group. These third party service providers may include safety database providers, call center operators, and in the event that you disclose details of your suspected adverse reaction to our market researchers, that particular market research provider. Appropriate data privacy security precautions have been implemented with our service providers to which the Bayer Group forwards personal information and that perform services at our request.
to other pharmaceutical companies that are co-marketers, co-distributors or license partners of the Bayer Group, if the pharmacovigilance requirements for a Bayer Health Product require such an exchange of safety information. Appropriate data privacy security precautions have been implemented with business partners with which the Bayer Group shares personal information and that perform services at our request.
to any legal successor to the business in the event of a sale, assignment, transfer or takeover of the company or of a special Bayer product or therapeutic area, in which case we will demand that the buyer, assignee or transferee process personal information only in compliance with the applicable data protection laws and regulations.
if information on adverse events is to be published (e.g. in the form of case studies and summaries); in these cases all identifying information will be removed from publications to keep your identity secret.
I. Third countries
Our pharmacovigilance databases are hosted in Germany by Bayer.
However, we may be required to transmit your personal information to other companies of the Bayer Group or to outside business partners and regulatory authorities. These companies and authorities may have their registered offices outside the European Economic Area (“EEA”) in a country where the European Commission has not determined the existence of an adequate level of data protection (“Third Country”).
If your personal information must be transmitted for PV purposes to an outside business partner that has its registered office in a Third Country, we shall apply standard contractual data protection clauses approved by the European Commission as an appropriate guarantee of an adequate level of data protection. You can receive a copy of these standard contract clauses by contacting our Group Data Protection Officer at the address indicated at the end of this Policy (See 8. Contact Information).
We have implemented appropriate state of the art technical and organizational measures to safeguard personal information processed for PV Purposes, including safeguards and procedures designed to restrict access to personal information to those employees who need it to perform their jobs.
We maintain physical, electronic and procedural measures to protect personal information from accidental loss, destruction or damage and unauthorized access, use and disclosure.
Wherever appropriate or possible, we process personal information in encrypted/pseudonymized form.
We will use and retain your personal information in compliance with the applicable statutory requirements on the retention and reporting of information for pharmacovigilance purposes. We are required to archive PV information which may include personal information at least for the duration of the product life cycle and for a further ten years after the respective drug or medical product has been withdrawn from the market.
Bayer processes this PV-relevant personal information, including special categories of personal information, in accordance with the GDPR
to comply with the applicable laws and regulations on pharmacovigilance and its justified interest in the pursuit of PV purposes (Art. 6 GDPR),
under the laws of the EU or its member states, PV has been deemed of substantial public interest in the field of health care and the safety or drugs or medical products (Art. 9 GDPR).
to request information about your personal information processed by Bayer,
to demand the correction of your personal information if it is incorrect or incomplete. During the examination of your request, you have the right to demand the restriction of processing of the information,
to have your personal information transmitted to you or to another person in a conventional format,
to file a complaint with the data protection authorities,
to object to the processing of your personal information if the processing is based exclusively on Bayer’s justified interest,
to demand the deletion of your personal information if the processing is no longer necessary for the basic purpose or if there is no legal basis for further processing.
However, please note that these rights may be restricted so that we can comply with our pharmacovigilance obligations. Your rights are not enforceable without restrictions if there is a legal basis for processing your personal information. For example, we cannot delete information that was collected in the context of the reporting of an adverse event unless it is incorrect. We can also require appropriate verification of your identity before we respond to a request to provide access to or correct your personal information.
For your concerns about data protection in connection with pharmacovigilance or data protection in general, please use the contact form provided or contact our Group Data Protection Officer at the following address: