A. Information About Participants in Clinical Trials
You may choose to participate in clinical trials of biopharmaceutical products as part of Amgen Australia's medical research and development programs. These trials are conducted by hospitals or other institutions but are funded and supported by Amgen Australia. If you participate in one of these clinical trials, 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 kinds of information provided to Amgen Australia about you for the purposes of conducting and auditing a clinical trial include health information about you relevant to the conduct and audit of the clinical trial, such as your medical history, medication use, results of tests and scans and reports of adverse events.
Generally, Amgen Australia only receives pseudonymized information relating to participants in clinical trial 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. Amgen Australia does not have the ability to tie a subject identification number to your name.
In limited circumstances, personal identifiers, such as your name and residential address, may be collected by Amgen Australia, but only with your express consent or where required by law. These circumstances include certain clinical trials where Amgen Australia 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 human research ethics committee responsible for the trial as part of their responsibility to provide oversight for the study, which includes monitoring and audit, 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 Australia 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 authorised by law.
We may also disclose your personal information to third parties that assist us in analysing the results of the study. These third parties may be located in countries outside of Australia including the United States of America ('U.S.'), Canada and countries in Europe, Latin America and Asia-Pacific. In such cases Amgen Australia will take reasonable steps to ensure that your information is protected.
If you are a participant in a clinical trial who provides information to us through our website or any mobile phone application ('Apps') operated by us, you should also read the section titled 'E. Information About Users of Our Website'.
B. 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 you for specific facts, including patient initials, age, and gender, and the identity of the prescribing physician. We may use the information you provide in submitting reports to regulatory agencies as required by law (e.g., the U.S. Federal Food and Drug Administration, the European Medicines Agency, the Australian Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority). We also may use the information to contact the prescribing physician to follow up regarding an adverse event ('side effect') involving use of our product.
You should know that we may disclose your personal information to third parties performing work on our behalf, such as our call centre operators and other entities that assist us in responding to and processing your enquiries and product experience reports. These third parties may be located outside of Australia. We may also disclose your personal information to our related affiliates in the U.S., Canada, and countries in Europe, Latin America and Asia-Pacific, who assist us in responding to your enquiries.
C. Information About Health Care Professionals and their Staff
If you are a healthcare professional, we may collect personal information about you in order to:
- conduct clinical trials;
- inform you of our events, products, new products and product recalls;
- fulfil our statutory pharmacovigilance reporting obligations;
- organise your travel for our events and third party educational events sponsored by us;
- improve our products and services and marketing activities, including by conducting market research; and
- manage our relationship with you.
This personal information includes such things as your name, 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 organisation, and your bank details (if you provide services to us). 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 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.
For the purposes referred to above, we may disclose your personal information to customer relationship management companies, third party event organisers, third party suppliers who assist us in providing our products and services (such as booking your travel and analysing personal information to improve sales targeting and recommendations), market research agencies, and others where required or authorised by law. If you are attending an international event, these services providers may be located in the country in which the event is located.
We also collect personal information regarding investigators and their staff involved in clinical trials. This information will be retained by Amgen Australia in a database. The database is held by Amgen Australia'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 organisations worldwide data held in the database regarding investigators where Amgen engages such organisations 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. (e.g., the U.S. Federal Food and Drug Administration, the European Medicines Agency, the Australian Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority).
We may also disclose your personal information to third parties outside of Australia who provide us technical support and assist us in enhancing our systems. In such cases Amgen Australia will comply with applicable laws to which Amgen Australia is subject to ensure that your information is protected.
If you are a healthcare professional who provides information to us through our website, you should also read the section below titled 'E. Information about Users of Our Website'.
D. Medicines Australia Code of Conduct Financial Transparency Requirements
Amgen is committed to compliance with the Medicines Australia Code of Conduct ('Code') in reporting Transfers of Value ('ToV') to Healthcare Professionals and Healthcare Organisations. The Code requires that Amgen publicly disclose information regarding ToVs resulting from Amgen's interactions with Healthcare Professionals.
If you are engaged in activities with Amgen that result in a payment or transfer of value to you, Amgen will collect and process personal information about you in order to comply with the Code reporting obligations. Such information will include your name and profession, your business/practice address, a description of the event and service you provided to Amgen (if relevant); and the amount of ToVs you received from Amgen. In accordance with the Code, the information will be publicly available for a period of three years after the original date of public disclosure, unless a different period is legally required.
E. Information About Users of Our Website
All users of our website
We retain a record of the IP address of your computer. We will only link a particular IP address to you personally if you have provided us personally identifying information whilst using our website.
We may use the IP address of your computer to maintain communications with you as you move about our website and personalise website content.
- to customise your website experience by anticipating the information and services that may be of interest to you;
- to improve the functioning of our website by monitoring traffic in popular areas and to modify the services and information we provide to meet customer demand; and
- for our business purposes, including operation of our website, as well as research and product analyses to help us better market our products.
We may use third-party analytics services on our website, such as Google Analytics. The analytics providers that administer these services use technologies such as cookies, web beacons and similar technologies to help us analyse your use of the website. To learn more about Google Analytics services, please visit: https://policies.google.com/technologies/partner-sites?hl=en-US
Individuals that register to use our online information and services
If you choose to register to use our online information and services, we may 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 send you e-mails with information that we think may be of interest to you, including information about our product and services. We will also be able to link the personal information you give us with the IP address you use and information we have collected by reference to that IP address (see section above titled 'E. Information about Users of Our Website').
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 analyse 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.
F. 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://recruit.smashfly.com/SmashFlyMedia/Docs/17267/17267_3949_Job-Applicant-Privacy-Statement_2019.pdf
G. Information About Other Individuals, Including Suppliers and Contractors
If you communicate with or request information from Amgen personnel, or supply goods or services to Amgen, the personnel you interact with may collect your name and e-mail address as well as any personal facts you choose to include in your communications with them.
H. Disclosure to Vendors and Suppliers.
We have relationships with different vendors and suppliers who help us design and maintain our computer systems and security, respond to e-mail and customer inquiries, analyse our data and create special promotions. We will not authorise our vendors and suppliers to use personal information we have collected or received for any purposes unrelated to our contractual relationship with them.
I. Transfers Overseas
As previously stated, please note that any personal information that Amgen Australia may collect may be processed in Australia or in other countries including the U.S., Canada and countries in Europe, Latin America and Asia-Pacific —in which Amgen, or one of the third parties with whom Amgen has a relationship, is located. Some countries may have different data protection standards than the country in which you live. Amgen Australia remains accountable for all personal information it transfers overseas and takes appropriate measures to ensure that the confidentiality of the personal information is safeguarded.