Documentation Proposed framework

The delivery standard

This is not a request for exclusivity: it is the definition of a requirement, which today only a person placed under the pharmacy's authority can satisfy.

• 1 · Custody and responsibility. Uninterrupted responsibility of the pharmacist up to handover, custodian mandated and controlled by the pharmacy, auditable time-stamped chain. The code of ethics already provides for it: the pharmacist answers for acts performed under their authority (art. 32) and instructs their staff in professional secrecy (art. 13).
• 2 · The act at a distance. Identity verification at handover; effective pharmaceutical advice, provided by the dispensing pharmacy; refusal and return protocol; no change of quantity, substitution or timing introduced by logistics.
• 3 · Product integrity. European serialisation respected (regulation 2016/161, art. 13 and 25); tamper-proof seal per patient; maximum time between dispensing and handover; cold chain validated before temperature-sensitive products are included; narcotics excluded from a first phase.
• 4 · Health data. Minimal exposure for the hand-over staff; pharmacy as data controller, platform as processor with no rights of its own; express prohibition of commercial exploitation; no cross-use with services outside the authorisation.
• 5 · Independence and free choice. Free choice of pharmacy preserved: no paid placement, no default, no incentive; prohibition of payments tied to steering a patient; no delivery-time promise enforceable against the pharmaceutical act.

The principle that carries the whole: delivery is the extension of the act of dispensing. The standard must disadvantage any operator unable to keep the medicine under professional supervision: whoever they are.