Patient Consent Form:*
Patient consent aims to protect YOU. It is a permission granted by YOU which is accompanied by full notice about the care, treatment, or service that is the subject of the consent. This consent is a process of communication that respects YOUR autonomy, whereby YOU are enabled to make a voluntary decision about accepting or declining to participate in the Programs after careful review of the consent and the Patient Information Pack (received along with this consent).
General Clauses:
The clauses below provide YOU an introduction about the Program(s) to ensure that (i) you fully understand the terms and conditions (ii) have the capacity to consent or not. It introduces YOU to YOUR rights & responsibilities, assures YOUR confidentiality, data safety, management, and privacy, validity of consent, and guarantees YOUR volunteerism and free will in decision-making.
By signing this form, I hereby acknowledge and confirm that
I understand that the Program is a patient support program implemented by Axios for Medical Education Services, (“Axios”) and its affiliates, and sponsored by Novartis Saudi (“Novartis”) which aims to enable the patients in the Kingdom of Saudi Arabia, with unmet needs such as educational, follow up and/or financial needs related to the prescribed treatment mentioned above or who have been diagnosed with above mentioned disease and are eligible to benefit from the Program detailed in the Patient Information Pack, to address their needs and facilitate their access to the prescribed treatment.
I understand that Axios is a third-party service provider, which administers the Program. Its employees and/or agents handle my Personal Information, which is for avoidance of doubt processed in accordance with applicable laws and regulations (including privacy laws) and Novartis privacy/data protection standards. I will accordingly be notified beforehand if the third party administering the Program has been changed, and I have the right to continue in the Program or not, based on my own discretion (which shall be always confirmed in writing, or via other digital means such as SMS or Email etc...), including in the case of administration by a Novartis department; and my personal information will continue to be protected with equivalent safeguards. In case of a change in the third party administering the Program, my personal information shall be transferred to the new third party administrator by Axios with all necessary adequate safety standards and my personal information will be continued to be processed only for the purposes of this Program.
I understand that this consent does not guarantee my eligibility to the Program. My participation in the Program is voluntary. If I choose not to participate, neither my medical treatment nor my insurance coverage eligibility will be impacted. However, if I do not participate, I cannot receive assistance or services from the Program. The Program is not intended to provide medical advice or medical judgment. I should always seek advice from my treating physician or other qualified health care professional if I have health concerns, and not to disregard professional medical advice based on information obtained from the Program. Novartis reserves the right to modify or terminate the Program at any time without prior notice based on local laws and regulations. Upon termination of the Program, I understand that I have the right to request for my data (including my personal information) to be destructed unless a conflict exists with any applicable laws and regulations, where Axios will maintain my personal information as long as it is necessary by any applicable laws and regulations and will comply with any retention schedule presented by Novartis. In case of a change in the third party administering the Program, Axios shall still keep my personal information as required to fulfill the purposes of Program or as required by the local applicable legislation and I shall only exercise my data subject rights to the new administrator of the Program.
I hereby authorize the disclosure (whether by my treating physician or Axios) of my personal information to healthcare professionals, insurance providers, its affiliates or strategic partners such as charity, pharmacy, concerned health authority and Novartis, as needed for the Program’s administration, services and/or audit purposes, subject always to applicable laws and regulations. I understand that my personal information will be handled lawfully, fairly, transparently, and used to apply and qualify for the Program and track supported medications. Axios will ensure appropriate security of my personal information including protection against unauthorized or unlawful processing and against accidental loss, destruction, or damage.
I may be contacted via my contacted details provided above (email, phone or in person) by Axios whenever appropriate and during my participation in the Program. Only relevant personnel from Axios will have access to my personal information as long as Axios is the administrator of the Program. I understand that any communication about the Program can only be addressed to Axios or their strategic partners as referred above and/or to my treating physician. I should not contact Novartis at any point.
My consent herein stated shall last for the duration of my full treatment plan under the Program or for a period of 5 (five) years from the date of signature of this form, subject to the applicable laws and regulations.
I hereby consent to Axios personnel to follow up with my treating physician, health insurance provider, caregiver, charities, other involved stakeholders in the administration of the Program and/or any regulatory authority in relation to my participation in the Program. For the purposes of reporting adverse events (“AEs”), Axios will share my reported AEs with (i) Novartis Pharmacovigilance Department – provided that an AE is identified and my personal information is maintained anonymous at all times; (ii) any other entity or person whether required by law or authority. In case of AE processing and reporting to regulatory authorities, if monitoring or auditing is performed, or if required and/or permitted by law, it may be that Novartis employees or agents will have access to my personal information or contact my treating physician.
I understand that Axios may transfer my personal information in an identified format for the same purposes under the Program to charity partners, health authorities, insurance companies, pharmacies, and properly authorized Program partners (subject to applicable laws and regulations, excluding Novartis) and to the new third-party administrator of the Program, if consented by myself. Axios will independently perform or have an appointed third party process any data in accordance with the applicable data protection laws.
Throughout my participation in the Program, Axios may collect my feedback and/or satisfaction with the Program for the purpose of continuous improvement and development. I understand that I may revoke my consent, request correction or updates to my data provided at any time by contacting [Connect.KSA@axiosint.com]. Withdrawing my consent will result in the termination of my participation in the Program and its services. No new personal information will be collected rather than the reasons for withdrawal.
I hereby confirm that I have the full capacity to consent and I am legally competent to execute this consent pursuant to any applicable laws and regulations. In case I am the legal guardian providing the below patient information on behalf of the patient, signing the below consent means that I already have the patient’s consent to provide such information.
Patients’ Rights & Responsibilities: I hereby confirm that I have received and read the Patient Information Pack referred herein and I agree with its terms and conditions, and all sections within this consent.
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