Amgen Korea Pty Ltd (“Amgen Korea,” “we” or “us”), a wholly-owned subsidiary of Amgen Inc., is a leading biopharmaceutical company involved in the research, development and marketing of biopharmaceuticals in South Korea. This Privacy Policy (which may otherwise be referred to in Amgen Korea materials and communications as the ‘Privacy Policy’) explains what personal information Amgen Korea collects, uses and discloses about individuals and our commitment to protect that information in accordance with the South Korean privacy principles contained in the Personal Information Protection Act (“PIPA”). It also explains how an individual may access, update and correct their personal information or make a complaint around the handling of such information.
For the purposes of this Privacy Statement, the term “Amgen” shall refer to Amgen Inc. and its subsidiaries and affiliates, including Amgen Korea.
We may change the terms of this Privacy Policy at any time by posting revisions to our website. We will let you know of any changes to this Statement by posting a notification on our website.
1 . Information About Participants in Clinical Trials
You may choose to participate in clinical trials of biopharmaceutical products as part of Amgen’s medical research and development programs. If you participate in one of these clinical trials, Amgen may use your personal information (including sensitive information, such as your health information) for the purposes of monitoring the accuracy and completeness of the research data, performing clinical and scientific research, and medical product development. You will be asked to provide express written consent to the manner in which your personal information will be collected, used, transferred, accessed and/or disclosed in connection with the research related to the trial.
The study site that conducts the clinical trial may collect personal information (including sensitive information, such as your health information) from you as described in the study specific protocal that you are participating.
Generally, Amgen only receives pseudonymized information relating to participants in clinical trials from physicians and investigators conducting the trial. Pseudonymization means that directly identifiable information such as your name and residential address are replaced with a unique reference number (a pseudonym), referred to as a subject identification number.
Personal identifiers, such as your name, are not collected by Amgen unless required by law or regulatory authorities. Amgen Korea employees or its authorized contractors may view personal information at a clinical trial site to audit and/or monitor the trial and to comply with regulatory requirements.
Your personal information may be disclosed to and reviewed by members of the ethics committee responsible for the trial or other institutional review boards located in other countries; your personal medical practitioner; regulatory agencies and health authorities for review and inspection and in support of regulatory filings in South Korea and in other countries; a central vendor for analysis, interpretation, and reporting results back to us and/or the study doctor; and others where required or authorized by law. These third parties may be located in countries outside of South Korea including the United States of America (“U.S.”), Canada and countries in Europe, Latin America and Asia-Pacific.
2 . Information About Patients
If you contact Amgen regarding your experience in using one of our products, including to report an adverse event (‘side effect’) or a defect or quality issue with the Amgen product you received, we may ask and collect your specific facts, including patient name, age, and gender, contact information, other prescribed drugs information, medical history, pregnancy information, prescribing physician and the consent to follow up with that physician. We may use the information you provide in submitting reports to regulatory agencies as required by law. We also may use the information to contact the prescribing physician to follow up regarding an adverse event (‘side effect’) involving the use of our product according to Pharmaceutical Affairs Law.
You should know that we may disclose your personal information to third parties performing work on our behalf, such as our call center operators and other entities that assist us in responding to and processing your inquiries and product experience reports. These third parties may be located outside of South Korea. We may also disclose your personal information to our related affiliates in the United States of America, Canada, and countries in Europe, Latin America and Asia-Pacific, who assist us in responding to your enquiries.
3 . Information About Healthcare Professionals and their Staff
If you are a healthcare professional we may collect personal information about you in order to:
This personal information includes, but not limited to, your name, personal contact details, specialty and qualifications, professional association membership number, details of your hospital or medical and consulting room, whether you are a member of an Amgen advisory board or an advisory board of a similar organization, and your bank account details (if you provide services to us), curriculum vitae, business contact details. When you contract a fee for service agreement, such as lecture fee/advisory fee payment, (when recording lectures) voice and image may be collected. If you attend one of our events and/or third- party educational events sponsored by us and we arrange your travel, we may also collect your passport details (including passport ID) and airline frequent flyer numbers.
We may collect this personal information from you (such as when you register for one of the events) or your representatives, as well as customer relationship management companies and marketing agencies with your consent.
For the purposes referred above, we may disclose your personal information to customer relationship management companies, third party event organizers, third party suppliers who assist us in providing our products and services (such as booking your travel and analyzing personal information to improve sales targeting and recommendations), market research agencies, and others where required or authorized by law. If you are attending an international event, these services providers may be located in the country where the event is located.
We also collect personal information (name, name and address of the institution, the title, business telephone and fax number, personal mobile phone number and, business email address, etc.) regarding investigators and their staff involved in clinical trials. This information will be retained by Amgen Korea in a database. The database is held by Amgen Korea’s parent company (Amgen Inc. in Thousand Oaks, California, U.S.) and accessible worldwide by Amgen. Amgen may use the database for purposes including but not limited to matching investigators to suitable trials, monitoring trial progress, and assessing administration and conduct of trial sites. Amgen may also share with clinical research organizations world-wide data held in the database regarding investigators where Amgen engages such organizations to assist in the conduct and management of a trial. Further we may use this information to comply with our legal and regulatory obligations, including where required, disclosure to regulatory agencies.
We may also disclose your personal information to vendors outside of South Korea who provide us technical support and assist us in enhancing our systems. In such cases Amgen Korea will comply with applicable laws to which Amgen Korea is subject to ensure that your information is protected.
4 . Information Relating to Users of Our Website
We may use the IP address of your computer to maintain communications with you as you move about our website and personalize website content.
We collect information about your use of our website through cookies. We will only be able to link this information to you personally if you have provided us personally identifying information while using our website. We may use the data we obtain through the use of cookies:
Individuals that register to use our online information and services for website or application that requires user’s registration:
If you choose to register to use our online information and services, we may also collect and use the personal information you give us (such as your name and contact details) to send you an e-mail confirming your registration and to respond to your questions. Upon your request, we may also send you e-mails with information about our product and services.
Individuals that participate in our online interactive services
If you choose to participate in our online interactive services (including health questionnaires and care management tools), we will collect the personal information you choose to disclose (which may include health information) and analyze it to discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. Although the information you provide through these interactive services may not identify you, we may link it with other information you provide us elsewhere on our website which does identify you. We may combine this information with that from other website users to create summary data that we will use for our business purposes, including research and analysis to improve our products and help us better market our products.
To disable cookies: If you prefer Amgen not to use cookies, and you are using Internet Explorer, select Menu Bar and Tools > Internet Options>Privacy Tab to block all cookies, and you are using Chrome, Select settings > Cookies and other site data under the Privacy and security > changes the options under General settings. Certain features of the Amgen website may not be available if all cookies are disabled.
5 . Information About Job Applicants
You may browse jobs on our website and choose to apply for vacant positions. For further information with respect to personal information that may be collected as part of a job application, please visit the Amgen Careers Online Privacy Statement at: https://wwwext.amgen.com/privacy-statement.
6 . Information About Other Individuals
If you communicate with or request information from Amgen personnel, they will have your e-mail address as well as any personal facts you choose to include in your communication.
7 . Additional Use and Provision of Personal Information
Amgen may use or provide personal information within the scope reasonably related to the purpose of initial collection after considering factors such as whether there may be detrimental effect to the data subject and whether necessary measures have been taken to ensure safety such as encryption, etc. Amgen will determine with due care whether to use or provide personal information in consideration of general circumstances including (i) relevant laws and regulations such as the PIPA, (ii) purpose of use or provision of personal information, (iii) how personal information will be used or provided, items of personal information to be used or provided, (iv) matters to which data subjects provided consent or which were notified/disclosed to data subjects, (v) impact on data subjects upon the use or provision, and (vi) measures taken to protect subject information. Specific considerations are as follows:
• Whether it is related to the purpose of initial collection;
• Whether the additional use and provision was foreseeable in light of the circumstances under which personal information was collected and the customary practices regarding personal information processing;
• Whether it unfairly infringe on the interests of the data subject; and
• Whether the necessary security measures such as pseudonymization or encryption were taken
II . Period of personal information retention and use
Unless Amgen Korea is obliged to preserve any personal information in accordance with the provisions of relevant laws and regulations, Amgen will retain and uses personal information until the purposes of collection and use are attained.
A. Information on clinical trial participants: 25 years from the approval of the last marketing licensee in the ICH region, or from discontinuation or rejection of clinical development of the clinical trial
B. Patient information: 25 years from the time of collection
C. Information on medical institutions and their employees: 5 years from the time of collection
D. Information on job applicants: 2 years from the time of hiring decision
E. Other personal information: 5 years from the completion of the request
III . Provision of personal information to Third Parties
Amgen Korea does not provide personal information collected and retained by it to a third party without each user’s consent, except in the cases that is required or permitted to be provided by laws and regulations.
Amgen Korea provides personal information to Third Parties as follows.
|
Information of recipients |
Purpose of use |
Items to be provided |
Period of retention and use |
|
Amgen Inc. and its subsidiaries and affiliates, except Amgen Korea |
Sharing information among affiliates (all purposes stated in Section I.), product quality management and analysis at the headquarters level, comply company regulations and national laws and regulations, and conduct of audits and inspections (internal investigation, including various dispute manage and monitoring) |
All general personal and sensitive information collected pursuant to Section I. |
Until the period stated in Section II. |
|
Ministry of Health and Welfare of South Korea |
Submission of expenditure reports on details of providing economic benefits under the Pharmaceutical Affairs Law |
Health care professional's name, institution, and benefitted amount |
Until the retention period according to the regulations of the Ministry of Health and Welfare |
|
Korea Research-Based Pharma Industry Association (KRPIA) |
Complying the quarterly reporting obligations and checking the maximum cap of lecture/advisory fees in accordance with the KRPIA Fair Competition Code |
Lecture: date, location, event name, name and institution of lecturer, the lecture fee, subject Consultation: The date or period of consultation, purpose, the name of the event, the name and affiliation of the consultant, the consultation fee, subject. |
Until five years from January 1st of the following year to the time when the lecture or consultation date belongs |
|
Ministry of Food and Drug Safety of South Korea and the health care authorities in the country where the headquarters and affiliates are located |
Report on adverse events in accordance with relevant laws and regulations |
All general personal and sensitive information collected pursuant to I.A and I.B |
Until the retention period according to the regulations of the authorities |
|
Ethics Committee/Clinical Trial Review Committee in each institution. |
Comply various reporting obligations, such as application for deliberation of a clinical trial plan (including change of plan), clinical trial status report, adverse drug events report, clinical trial result report |
All general personal and sensitive information collected pursuant to I.A and I.B |
Until the date when the purpose of the use is achieved |
IV . Transfers Overseas
Amgen is a multi-national company headquartered in the United States. Amgen maintains data centers around the world, including in the European Union and the United States. Amgen may process the personal information detailed above (I. Purposes for processing personal information) in global databases that can be accessed by authorized Amgen personnel worldwide. Please see the list of Amgen’s affiliates at https://wwwext.amgen.com/amgen-worldwide. Transfers outside of South Korea are made in accordance with applicable privacy laws. Regardless of personal information is collected or processed; Amgen maintains appropriate administrative, technical and physical safeguards to protect information.
V . Entrustment of Processing of Personal Information
Amgen Korea complies with the PIPA when we entrust a third party with the processing of personal information. Amgen may disclose Personal Information to information technology providers or other service providers around the world that act under Amgen’s instructions regarding the processing of such data. Providers will be subject to contractual obligations to implement appropriate technical and organizational security measures to safeguard the Personal Information, and to process Personal Information only as instructed.
You may consult the list of consignees here. (in Korean only).
VI . How We Hold and Protect Personal Information
We hold your personal information in a combination of hard copy and electronic files. Electronic files are stored in servers that are operated and maintained by Amgen and third parties under contract with Amgen.
We want your personal information to remain as secure as reasonably possible. To help ensure the integrity and confidentiality of the personal information (including health information) you provide to us, we may use encryption practices. As an added security precaution, all personal information (including health information) is kept physically behind firewalls and other network security devices to prevent intruders from gaining access.
Amgen takes reasonable and appropriate security measures consistent with relevant laws and current industry practices to protect your personal information:
- To set up and implement the internal management plan for the safe processing of personal information;
- To control access to the personal information and restrict the authority to access hereto;
- To adopt such encryption technology as to store and transmit the personal information in safety and other measures equivalent hereto;
- To retain log-in records in order to respond data breach incidents and to take measures to prevent the forgery and falsification hereof;
- To install and upgrade security programs to protect personal information;
- To take such physical measures as storage to keep personal information in safety or locking system.
VII . Destruction of personal information
All personal information after the specified retention period shall be destroyed without delay. Any prints of personal information shall be shredded using a shredding machine for destruction, and any electronic files of such personal information shall be destroyed using either technological or physical method making retrieval impossible
VIII . Web
1 . Links to Other Websites
Amgen Korea’s website features links to other websites that we believe you might find useful and informative. Please be aware, however, that we do not endorse or recommend these websites' content or services, and we are not responsible for the privacy practices of these other websites. We encourage you to be aware of and read the privacy statement of each website you visit. Remember, the statements in this Privacy Statement apply solely to information collected by Amgen Korea and Amgen.
2 . Co-branded Websites
We may partner with other companies to provide you with content or services on a joint or "co-branded" basis. At a co-branded website you will see both the Amgen logo and the logo of the co-branded partner displayed on your screen. To access the services available on a co-branded website you may have to complete a new on-line registration form, and this registration information may be shared with Amgen's co-branded partners. You should read the individual privacy policies of our co-branded partners, as these may differ in some respects from ours. Reading these policies will help you to make an informed decision about whether to provide your information to a given website. Remember, you may always opt-out of sharing your information with a co-branded website by choosing not to use the service or content provided by the co-branded website.
3 . Our Children's Policy
Amgen Korea's website content and services are intended for users over the age of 14. The website is not designed to attract child users. If we learn that an under-14 user has volunteered personal information (including health information) on our website, or that a provider has volunteered information about a patient who is identified as younger than 14, we will delete such information from our active databases in accordance with our deletion practices, which is described in the section titled, 'How We Hold and Protect Personal Information' except as required to fulfil our pharmacovigilance reporting obligations or where the express consent is obtained from the child user’s legal guardian.
IX . Your Privacy Choices (Including Access and Correction of Personal Information and Privacy Complaints)
- Accept Cookies. Your browser software can be set to reject all cookies. However, if you reject our cookies, certain areas of our website’s functions may not work properly. To find out more about cookies, and how you can decline to accept them, please refer to your internet browser’s instructions or help option.
- Access and Correct/Update Personal Information. You have a right to request to access or correct/update your personal information (including your health information). You may make such a request at any time, by contacting our Privacy Officer on the details set out at the end of this Privacy Statement. We will provide you with access to the information we hold about you, and/or correct/update that information, unless there is an exception that applies under South Korean law. In particular, we may not be able to amend your personal information if it was provided to us by a health care professional or a consumer regarding an adverse drug event.
- Remove Personal Information. You may request that Amgen delete/erase previously provided personal information (including health information) by contacting our Privacy Officer on the details set out at the end of this Privacy Statement. Legal requirements in some countries may prevent us from deleting certain personal information. In particular, we may not comply with a consumer's request to delete information that was provided to us by a health care professional or a consumer regarding an adverse drug event.
- Make a Privacy Complaint. If you wish to make a complaint about our handling of your personal information, please contact our Privacy Office on the details set out at the end of this Privacy Statement. You will be asked to submit your complaint in writing. We will respond to your complaint as soon as practicable. If you are a participant in a clinical trial, your complaint may be referred to the principal investigator for the clinical trial.
X . Contact Us
If you have any questions or comments about this Privacy Statement, or wish to access or correct your personal information or make a privacy complaint, please contact our Privacy Officer at:
Attn: Privacy Office
Privacy Office Email: privacyoffice@amgen.com
Alternatively, you may click on the "Privacy Request" link at the end of this paragraph. By doing so, you acknowledge that you will be redirected to a secure website hosted by OneTrust, which processes privacy requests for Amgen. To submit a request, please click Privacy Request.
This privacy statement applies from August 01, 2021.
The previous privacy statement can be found below.
Before August 01, 2021 (Click)