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Entyvio® Pathway Patient Consent Form

Patient to read and sign
Privacy Notice & Consent for Entyvio® Pathway

Your privacy is important to us. Takeda recognises and respects the privacy rights of individuals with regards to their personal data. This Privacy Notice and Consent form (“Form”) explains what type of personal data we may collect from you and how we use it when you enrol in Entyvio® Pathway (the “Program”). Such information is subject to applicable privacy requirements. The Program is a free service provided to you by Takeda and will be performed by View Health Pty Ltd Group (“View Health” or “Provider”) with full collaboration from participating hospitals. For more details see the How to Contact Us section below. For more detailed information on how Takeda processes personal data, please refer to Takeda’s Privacy Notice at www.Takeda.com. For more detailed information on how Provider processes personal data, please refer to Provider’s Privacy Notice at https://chemoathome.com.au/ Before enrolling in the Program, you should read this entire Form. At the end of this Form, you will be asked to consent to the processing of your personal data by signing this Form. If you do not sign this Form, it will not be possible to enrol in the Program. In this document, process means to perform any operation or set of operations on personal data or sets of personal data, whether or not by automatic means, such as collection, recording, organisation, structuring, storage, access, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, evaluation, analysis, reporting, sharing, alignment or combination, restriction, erasure or destruction.

Entyvio® Pathway

Entyvio® Pathway aims to provide support for patients who have been prescribed ENTYVIO (vedolizumab) for their condition. The program offers the provision of home nursing services, so you can receive your ENTYVIO at your home or other approved location. The program offers, but is not limited to, providing home infusion, ENTYVIO delivery and ancillaries required for administration.

What personal data will be collected?

We will only collect personal data about you that is required to perform the Program as described above. The personal data collected includes, but is not limited to, your contact information, date of birth, details of your emergency contact (or carer if relevant), your hospital or clinic, treatment, and medication and includes the meaning given to “Personal Information” under applicable privacy laws in Australia. This personal data will be collected by View Health and may include the collection of personal data relevant to your participation from your prescribing physician or other healthcare professionals, including but not limited to your nurses or pharmacists.

What happens with my personal data?

If you decide to enrol in the Program, your personal data, including health-related information, will be processed (e.g. collected, used, disclosed, stored, and disposed of) by the Provider as described based on your consent. Information about your participation in the Program and results may also be shared back to your prescribing physician, or other healthcare professionals, including but not limited to, your nurses or pharmacists. This information will be stored securely in an electronic format on a server in Australia so that your doctor is able to access it. The Provider administering the service will access the information needed to fulfil regulatory requirements for the reporting of safety information, to coordinate the services and relay information about these to your doctor and hospital. Takeda will have no access to your personal data unless required by law or where required to ensure the integrity and proper administration of the Program. To protect your privacy, any of your personal information that is shared with Takeda will be de-identified by means of a patient ID number (as opposed to your name or other identifying information) together with your year of birth for purposes of safety information reporting, monitoring of the program and measuring treatment efficacy in relation to clinical trial results. The ID number will be assigned by View Health. Only they will be able to connect this number to your name, and they will securely maintain the key that links your identification number to your name. Information about you will only be shared with Takeda in aggregated reports for the purpose of program administration, monitoring and safety reporting. If you experience adverse events during the nurse home visit and infusion or disclose safety information/details about your health to the Program nurse, the nurse will be required to report this both to Takeda and to your doctor. You will not be identified by name to Takeda, although it is a standard requirement by government that companies collect and report information such as your initials, date of birth and gender, medications that you are taking and any medical details that will assist in the evaluation of the report. Your personal data may be sent to countries around the world where Takeda has an affiliate or business partner. The data protection and privacy laws in these countries may not provide the same level of data protection as the laws in your home country or the country where you are participating in the Program. With respect to transfers to its affiliates and business partners located outside of your home country, Takeda has entered or will enter into specific agreements with these parties to provide appropriate protections for your transferred information (e.g., “EU Standard Contractual Clauses”), where required.

How will your personal data be protected?

The Provider will protect your personal data in accordance with all applicable privacy requirements. We take steps to ensure that your personal data is secured against unauthorised access. Security measures reduce the risk of unauthorised individuals accessing your personal data, but such risks cannot be eliminated, and you should keep in mind that no internet transmission is ever completely secure or error-free. If your personal data were to be accessed by unauthorised individuals, information about you could be used to make decisions which may be unfavorable to you. Many, but not all, possible unfavorable uses of your re-identified or improperly disclosed information are prohibited by medical ethics, law or regulation.

How long will my personal data be retained?

Your personal data will be retained by the Providers for at least seven years, or as required by applicable law, after you have ended your participation in the Program or after the Program has ended, whichever is shortest. After this period, your personal data will be securely deidentified and archived. Takeda will retain aggregated data about the Program for the purpose of fulfilling regulatory obligations under applicable law.

Your rights regarding your personal data

You have the right to request access to your personal data, request corrections of any errors in recorded personal data, or where personal data may be missing or incomplete, ask that it be completed. You also have the right to ask that your personal data collected and used for the Program be erased or that its use be restricted. You can contact the Providers for such requests, who will in turn contact Takeda, and we will ensure that we respond to your request within the timeframes required by applicable laws and/or as soon as we reasonably can. If you make a request for access, correction, completion, erasure, or restriction and it cannot be fulfilled, you will be informed and provided with the reasons why your requests cannot be fulfilled. For complaints about privacy, we will establish in consultation with you a reasonable process, including timeframes provided by applicable laws, to seek to to resolve your complaint.

Can I withdraw from the Program?

The consent to process your personal data for this Program may be withdrawn at any time without giving any reasons and without any penalty or loss of any benefits to which you are otherwise entitled; however, to the extent that consent is necessary to provide the services under the Program, your participation in the Program may be terminated. If you want to withdraw, please contact View Health – see the How to Contact Us section below.

How to contact us?

Takeda does not receive any directly identifiable information about you; we therefore request you to contact the Provider for questions and not contact Takeda directly.

The Provider can be contacted at View Health, PO Box 378, North Perth WA 6906, 1300 466 324

or via email:entyviopathway@viewhealth.com.au

Takeda, the sponsor of this Program and Takeda’s Data Protection Officer can be contacted at Takeda Pharmaceuticals International AG, Thurgauerstrasse 130, 8152 Glattpark-Opfikon (Zurich), Switzerland, Tel.: +41 044 555 1000; fax: +41 44 555 1250; e-mail: PrivacyOffice@takeda.com.


By signing this consent form, I acknowledge that I have read and understood the information above and that I have been informed of, and consent to, the following:

• My personal data, including health information, being processed by the Provider, in accordance with applicable privacy requirements in Australia;

• My personal data only being shared with relevant parties providing this service in accordance with the Privacy Notice;

• My personal data being processed and transferred to others, like our consultants, agents, contractors and service providers, and other companies within the Takeda group, both within and outside of my home country (including the countries shown on Takeda’s website www.takeda.com/countries in which Takeda operates), as well as to authorities as needed to comply with law or regulatory requirements;

• My personal data may be transferred to countries where laws may not provide the same level of data protection as the laws in my home country;

• I understand that Takeda’s privacy policy located at https://www.takeda.com/privacy-notice provides further details about Takeda’s privacy practices;

• I understand that it is my responsibility to ensure that I have the consent of other individuals before sharing their personal data with the Provider or Takeda e.g. emergency contact/caretaker’s contact details;

• I understand that my participation is voluntary, and I can withdraw my consent at any time without providing any reason.

Printed name of patient or legal representative:
If you have any questions about Entyvio® Pathway, please contact View Health on 1800 313 019 or via email: entyviopathway@viewhealth.com.au