Named-patient program consent template.
A jurisdiction-generic consent template. Adapt to local law and institutional policy before signing.
A patient consent form is the document in which a patient, or a legally authorized representative, acknowledges that they understand the cross-border named-patient pathway they are entering, the logistics and pharmacovigilance obligations that attach, and the specific ways in which this pathway differs from the local treatment environment they are more familiar with. The template below is jurisdiction-generic. Every jurisdiction we operate into has its own consent framework, and the prescriber or the institution's medical-legal adviser should adapt this document to local law before a patient signs.
What the consent should cover
Five things, in order. First, that the patient understands the therapy, the indication for which it is being prescribed, and the main risks and benefits as the treating prescriber has explained them. Second, that the patient understands the therapy is being accessed under a named-patient pathway, that the therapy is being sourced through DSCSA-compliant US specialty supply — direct from manufacturers or via US-licensed specialty wholesalers, and that the logistics will include cold-chain shipping and customs clearance in the destination country. Third, that the patient understands the pharmacovigilance obligations and has agreed to report adverse events through the treating prescriber. Fourth, that the patient understands the data-handling framework that applies to their health information and has been given access to the relevant privacy notices. Fifth, that the patient understands the commercial terms, has reviewed the written quote, and is proceeding on a cash-pay basis.
Template text
Named-patient program: patient consent
Patient: [Full name, date of birth, identifier]
Therapy: [Drug name, strength, dose, schedule, duration]
Indication: [Diagnosis]
Treating prescriber: [Name, institution, license]
Receiving institution: [Name and address]
Date: [Date]
I, the undersigned patient, or legally authorized representative, acknowledge and consent to the following:
1. The therapy. My treating prescriber has explained to me the therapy named above, the indication for which it is being prescribed, the main benefits as understood from the evidence, and the main risks and potential adverse effects. I have had the opportunity to ask questions, and my questions have been answered to my satisfaction.
2. The pathway. I understand that this therapy is being accessed under a named-patient pathway that applies in my country of residence, because the therapy is not otherwise available to me locally in a form that meets the prescriber's clinical plan. I understand that the therapy is being sourced through a US-licensed specialty wholesale channel under the Drug Supply Chain Security Act, and that the unit I receive will be traceable from manufacturer to me under a documented chain of custody.
3. Logistics. I understand that the therapy will be shipped under cold-chain conditions appropriate to the product, will be cleared through customs by a licensed broker in my country, and will be delivered to the receiving institution named above for dispensing and administration by my treating prescriber or their team. I understand that the coordinating pharmacy will monitor the shipment and will replace any unit that does not meet the temperature and chain-of-custody standards it has committed to.
4. Pharmacovigilance. I agree to report any adverse effect or unexpected observation following administration to my treating prescriber as soon as practical, and I consent to my treating prescriber routing the report through the coordinating pharmacy's pharmacovigilance channel. I understand that serious adverse events may be reported to the US Food and Drug Administration, to the manufacturer, and to the health authority in my country, in each case under applicable law and privacy frameworks.
5. Data handling. I understand that my health information will be handled under the privacy frameworks disclosed in the coordinating pharmacy's privacy notice, including the US Health Insurance Portability and Accountability Act where applicable, the European Union General Data Protection Regulation where I have an EU nexus, and the applicable privacy law of my country of residence. I have been given access to the relevant privacy notices.
6. Commercial terms. I have reviewed the written quote prepared by the coordinating pharmacy, including the coordination fee, the drug cost, the import duty and freight, and the cold-chain line items as applicable. I understand that this is a cash-pay service, that no insurance is being billed, and that the fees disclosed in the quote are the fees I will pay.
7. Withdrawal. I understand that I may withdraw from this pathway at any time before administration, and that withdrawal will not affect my right to seek treatment through any other route. I understand that any portion of my prepayment that has not been committed to third parties will be returned to me.
Signatures.
Patient or authorized representative: [Signature, printed name, date]
Treating prescriber: [Signature, printed name, date]
Witness (where required): [Signature, printed name, date]
Adapting the template to local law
The template above is a starting framework. Local privacy law, local health consent frameworks, local institutional consent policies, and destination-specific named-patient program regulations may each require language this template does not contain. In several of the countries we operate into, the consent must be bilingual, must be witnessed by a specific category of individual, or must be registered with the receiving institution's medical records department. The treating prescriber or the institution's medical-legal adviser should adapt the document to local requirements before the patient signs.
Disclaimer
This template is a drafting aid. It does not constitute legal or medical advice, and it does not substitute for review by local counsel or by the treating institution's compliance function. Reserve Meds and Altima Care do not represent that this template meets the consent requirements of any specific jurisdiction or institution.
Reviewed 2026-04-22 by Reserve Meds’s AI clinical and regulatory review agents. Human pharmacist-in-charge: Altima Care. Next scheduled review: 2026-10-22.