Compulsory licensing and NPP

Why the regulatory framing matters

Cross-border access to specialty medicines sits on top of a lattice of regulatory regimes: the US side (FDA approval, DSCSA chain-of-custody, state pharmacy licensing, and export rules); the destination-country side (registration status, personal-import or Named Patient Program rules, customs and tariff posture); and, where relevant, data-protection rules (HIPAA in the US, GDPR for EU-connected patients, and national frameworks elsewhere). A pathway that ignores any of these does not scale and eventually breaks.

What is lawful and what is not

A Named Patient Program or personal-import import is lawful in the destination country when: a licensed local physician has prescribed a specific quantity of a specific drug for a specific named patient; the drug is imported for that patient’s personal clinical use, not for resale or stocking; the import is declared to customs with accurate documentation; and any country-specific ethics, pharmacovigilance, or distributor-notification requirements are met. It is not a gray-market channel, a parallel-import trade, or a compulsory-license workaround.

DSCSA on the US side

The Drug Supply Chain Security Act (DSCSA) is a US law that requires pharmaceutical supply-chain participants to track and verify the serialized chain-of-custody of prescription drugs. For a cross-border NPP shipment, DSCSA provenance is the evidence that the product is authentic, that it moved only through licensed trading partners, and that every unit can be traced back to the manufacturer. A cross-border operator that cannot produce DSCSA transaction documentation is, functionally, selling product without a provenance guarantee.

Patient data on the destination side

Patient data that crosses borders to support a sourcing request — the prescription, clinical justification, consent, and identity verification — should be handled under both the source-country and destination-country privacy regimes. In practice this means encrypted transmission, limited data minimization, a documented retention policy, and a defined subject-access-request workflow. Reserve Meds operates under HIPAA in the US, under GDPR where applicable, and under the destination-country framework; our posture is documented on the privacy page.

When outside counsel is warranted

Most cross-border NPP shipments do not require bespoke legal work — they follow a recognized pathway with documented precedent. Outside counsel in the destination country is warranted when the case is first-of-kind (a new gene therapy, a first shipment under a newly issued regulation), when the case intersects with a separate regulatory regime (pediatric ethics, investigational status, reimbursement dispute), or when the patient or physician wants a formal legal opinion rather than an operational feasibility note.

Further reading

See our DSCSA explainer and our legal-basis explainer for the framework-level treatment, and our country pages for jurisdiction-specific posture.

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