Patient Support Program Consent Form for Rebif®

Thank you for choosing to join the support program on behalf of Merck Serono Ltd. (the “Company”), which provides guidance, support and information services to patients prescribed Rebif® (the “Product” and the “Program”, respectively).

The Program services will be made available to you, free of charge, through representatives of the Company’s medical department.

The Program data will be maintained in a database through ExtraCare Ltd.

The Program includes:

Guidance by a registered nurse for the patient regarding the method of injecting the Product and its use in accordance with the instructions specified in the patient leaflet for use in treatment, provision of information, professional support and additional tools to improve adherence to the medicinal treatment with the Product.

In order to complete your enrollment in the Program, you are requested to fill in the required details and confirm, by your signature, the terms of the Program.

Personal Details:

General

1. I, the undersigned, hereby confirm my participation in the Program.
2. I have been informed that within the framework of the Program I may receive guidance and information regarding multiple sclerosis and the use of the Product; and that the Program includes, inter alia, telephone calls, video calls and in-person nurse guidance, as needed, at times to be coordinated with me, and in addition, the nursing team will be available to answer questions, within their authority and responsibility, on Sunday–Thursday between the hours of 08:00–17:00.
3. I understand that participation in the Program is voluntary, and I have been informed that I am under no obligation to participate in the Program. All Program services will be made available to me free of charge. In addition, it is possible to join the service components included in the Program according to my choice, and it is possible to discontinue receiving the service at any time and without any condition.
4. I understand that the Program does not constitute a substitute for medical advice and that the services do not replace the information and instructions as provided to me by my medical team. For any question or medical matter, or if information provided to me within the framework of the Program is not clear, I must contact my attending physician and follow his/her instructions. The patient leaflet of the Product must be reviewed prior to use.
5. I understand that the support service included in the Program does not constitute a substitute for treatment and medical follow-up, as explained to me by my attending physician. I understand that it is my responsibility to check independently verify, with the attending physician, the dates for having tests, follow-ups and prescription renewals, and that I shall not rely exclusively on the guidance that I will be getting as part of the Program.
6. I confirm that I am an adult (over the age of 18), legally competent and I am taking or am expected to take the Product according to a prescription.

Duration of the Program and its Termination

7. I understand that I am under no obligation to participate in the Program and that I am entitled to discontinue my participation in the Program at any time and without any condition.

8. In the event that I choose to discontinue my participation in the Program, I will inform the nurse accordingly.

9. The Company may modify the terms of the Program, the types of services and the hours of operation at any time. I understand that the Company may terminate, at any time, my participation in the Program in the event of non-compliance with the Program terms or terminate the Program in its entirety.

Personal / Medical Information

I understand that as part of the Program and for the purpose of providing the services according to the Program, personal and medical information about me (the “Personal Information”) will be collected by the Company, and I hereby consent as follows:

1. To collect, hold, process and store the Information in a registered database, number: 700025462, which is maintained and managed by the Company in accordance with the Protection of Privacy Law. The Information is collected for the purpose of managing and operating the Program, managing communication with me, reporting adverse events, performing statistical analyses in connection with the Program and/or for internal analytical purposes, and for the purpose of improving the quality of the service. I further understand that the database will be maintained by ExtraCare Ltd. on behalf of Merck Serono Ltd., for the purposes detailed in this Consent Form.
2. I authorize the medical team treating me and the caregivers on behalf of the Company within the program to share between them details relating to changes in my medical condition, side effects, information regarding my treatment protocol, my coping with the treatment and the like, to the extent deemed relevant.
3. I consent to representatives of the Company contacting me by telephone from time to time for the purpose of providing Program services
4. I authorize the Marketing Authorization Holder – Merck Serono Ltd. and/or ExtraCare Ltd. and/or anyone on their behalf to contact me in the future regarding services that may be tailored to my needs, and I shall have no claim or demand of any kind in connection with receiving such information.
5. I permit the Marketing Authorization Holder – Merck Serono Ltd. and ExtraCare Ltd. to provide (to one another) statistical information in connection with the Program, without identifying my personal details, all subject to the requirements of law.
6. I agree that any report on my part regarding an adverse event and/or quality complaint will be transferred to the Company and documented in the Company’s databases for the purpose of management, monitoring and reporting. The Company shall be entitled to report such information to authorities in an anonymous manner (without identifying details). I further consent to the Company transferring such information to other companies within the Merck group under Merck KGaA and to their service providers, in Israel and outside Israel, for the purpose of management, monitoring and reporting. I agree that the Company will retain the personal information I have provided in accordance with the provisions of law and will not transfer personal information provided by me to any third party other than those specified in this document and subject to law.
7. It is possible that the Marketing Authorization Holder or anyone on its behalf will contact me following a report of an adverse event and/or quality issue in order to receive additional information.
8. I understand that I may request deletion of my information from the Company’s database following the termination of my participation in the Program, subject to the provisions of law.
9. In any case of transfer of the registration, I permit the Company to transfer all information about me held by it to any other company on behalf of the Marketing Authorization Holder that will assist in operating the Program. I have been informed that appropriate notice will be given to me 30 days in advance. In such case, all my consents under this Consent Form shall remain valid and applicable also to the new Marketing Authorization Holder and any other company involved in operating the Program on its behalf.

Selection of Service Components in the Rebif® Patient Support Program

Please mark with “✔” the service components in which you are interested and confirm by your signature below:

Registration for additional services:

It has been clarified to me that declining to consent to one of the clauses above will not prevent my participation in the Program.