1. I have informed the patient/caregiver of Keytruda Patient Access Program and provided all requisite information, and the patient/caregiver has had the opportunity to ask questions and seek clarifications.
2. I confirm and assure that the patient has agreed to this treatment by his/her own free will and that the patient is free to discontinue treatment at any point.
3. In the course of administering Keytruda Patient Access Program, I may be contacted by MSD and/or one or more of its authorized service providers i.e. Medybiz Pharma Private Limited, Ramtirth Leasing and Finance Company Private Limited operating under the brand name of Arogya Finance, Healthlane Technologies Private Limited, IMS & its affiliates, Parekh Integrated Services Private Limited (“Authorized Service Providers”).
4. All information disclosed to me by the patient, MSD and its Authorized Service Providers within the context of Keytruda Patient Access Program shall be treated as confidential by me.
5. I have read and understood the KEYTRUDA® local prescribing information/product circular which contains all required information on the product.
6. I understand each order can be processed no earlier than 14 days after the most recent treatment of this patient.
7. I ensure that all unused or partially used KEYTRUDA® vials, will be destroyed immediately post infusion of the vial to the respective patient and a written confirmation of destruction shall be provided to Medybiz Pharma Private Limited.I further ensure that all expired KEYTRUDA® vials will be destroyed immediately and a written confirmation of destruction shall be provided to Medybiz.
8. I hereby give my consent to MSD and its Authorized Service Providers for (i) for collection, storage, and processing of my personal information (“PI”) provided in this form, for providing services under Keytruda Patient Access Program, regulatory, legal, pharmacovigilance requirements and for disclosing my personal information to third parties for carrying out audit or inspection. If an audit or inspection is carried out by a third party, then such party shall treat the confidentiality of personal information in accordance with the terms of this consent and applicable data privacy laws; (ii) for transferring and disclosing my personal information to any other party as may be required for the purposes set out above and such third party can contact me for the same. I understand that the third party will also be bound by the same terms and conditions as set out in this consent and will comply with the applicable data privacy laws.
9. I understand that the PI shall be treated with utmost confidentiality and in accordance with the applicable data privacy laws and MSD and its Authorized Service Provider’s Privacy & Data protection policy. For more information please refer to MSD’s data privacy policy at https://www.msdprivacy.com/in/en/.
10. I understand that the above mentioned PI is collected in this application and If I choose not to provide my personal data, MSD, MSD its Authorized Service Providers may not be able to fulfill the purposes listed on this form.
11. I consent to the purposes of collection, processing, and retention of the PI: • To complete patient enrollment and provide services related to Keytruda Patient Access Program to the patient that I will recommend the program to. To contact (Virtually/Face to Face/electronic message) me or Keytruda Patient Access Program related communication, to deliver free vial and patient verification for free vial delivery by MSD authorized Service Providers. • Anti-Bribery due diligence. • Adverse event reporting • Internal or external audit. • Legal obligation (if any)
12. Disclosures of personal information: I understand that my PI may be disclosed to MSD, its affiliates and its Authorized Service Providers., technical team, auditors, and consultants only for legitimate or regulatory purpose. MSD and its Authorized Service Providers may also disclose my PI to meet any legal obligations.
13. Data retention: I understand that my PI will be retained for as long as reasonably necessary to fulfil the purposes of collection including for the purposes of satisfying any legal, regulatory, tax, accounting or reporting requirements. The information will be retained for a duration of 10 years after program completion. My PI may be retained for a longer period in the event of a complaint or if there is any prospect of litigation.
14. International Transfers: I understand that MSD and its Authorized Service Providers may transfer my PI to MSD’s affiliates in other countries or its Authorized Service Providers in other jurisdictions, respectively, strictly for legitimate purposes. Merck & Co., Inc., Rahway, NJ, USA, which has a tradename of MSD outside of the U.S. and Canada’s holds certifications and commitments that facilitate the cross-border transfer of personal data. To learn more please visit our privacy statement here https://www.msdprivacy.com/in/en/)
15. My Legal Rights: I understand that I have the following rights under applicable data protection laws of India in relation to my PI: • Right to access and obtain a copy of my PI. • Right to rectify any inaccurate or incomplete PI. • Right to erasure of my PI in certain circumstances. • Right to restrict processing of my PI in certain circumstances. • Right to object to processing of my PI. • Right to data portability, where applicable. • Right to withdraw my consent at any time.
16. I understand that If I wish to exercise any of the rights set out above or if I have any questions regarding this privacy notice, I will contact Medybiz at KeyPAP@medybizpharma.com or I can register Data Subject Right requests using this form https://dsr.msd.com/DSR/India/English/. Upon the withdrawal of consent, MSD and its authorized service providers will stop using and sharing my PI (does not apply to personal information already used or shared) for the purposes mentioned in this consent except for legal, regulatory, pharmacovigilance requirements and audit or inspection.
17. Know more about MSD Data security: MSD privacy program is built on a platform of organizational accountability for privacy, stewardship of the data we use to operate our business, consistent global privacy practices and standards that carry on our tradition of upholding high ethical standards across our business practices, and ongoing oversight to ensure that we continue to respond to changes in privacy expectations as technology and our business continue to evolve.For more information about MSD Privacy program, please see https://www.msdprivacy.com/in/en/ .
18. I confirm that should I become aware of: - An adverse event and Product Quality complaint which is attributed to an MSD product - A case of lack of effect, misuse, product confusion, abuse, overdose, underdose, inadvertent or accidental exposure without an associated AE, occupational exposure without an associated AE, drug interaction, an unexpected therapeutic or clinical benefit from the use of the product(s). - Or, of a patient who becomes pregnant or are lactating whilst taking an MSD product This must be reported to MSD India by Contact No. - +91-124-4647300/ 022 67898888; Toll-Free no. – 18001032642; Email ID -dpoc_india@merck.com or Fax No. - +91-124-4647339) in below timeframe. - Serious adverse events within 24hrs - Non-serious adverse events within 3 calendar days I have noted that AE can be any unfavourable or unintended change in the body (e.g., sign, symptom, or abnormal laboratory finding) that occurs when using or following the use of a Company product whether or not considered related to the use of the product. A product quality complaint is any communication that describes a potential defect related to the identity, strength, quality, purity or performance of a Company product identified by an external customer.
19. I agree that the supply of KEYTRUDA® can be stopped at any time (i) with 30 days’ notice to me; (ii) if I do not comply with the terms of the Physician Consent/Declaration Form; or (iii) MSD is no longer able to supply KEYTRUDA® due to circumstances beyond its control.
20. I will promptly notify MSD and cooperate with MSD in the event of a regulatory audit or inspection that relates to the administration of KEYTRUDA® to the patient under Keytruda Patient Access Program. This includes but is not limited to the sharing of documentation, inspection reports and consultation with MSD in responses.
21. To ensure patient confidentiality is maintained, all correspondence must refer to the Unique Patient Code only for the purposes of administrating this request.
22. I acknowledge that MSD reserves the right to change the terms and conditions of this program at any time.

By sharing the above-mentioned information, you agree to comply with all the terms of this program and giving consent to the processing of your personal information by MSD’s Authorized Service Provider as mentioned in the Privacy disclaimer.