International Convention on the Prohibition of Unverified Therapeutic Agents (ICPUTA)

Title: International Convention on the Prohibition of Unverified Therapeutic Agents (ICPUTA)

[Drafted by: dgintel.ai]

Preamble:

The States Parties to this Convention, Recognizing the paramount importance of safeguarding global public health and the integrity of medical science, Concerned by the development, distribution, and administration of pharmaceutical agents marketed as vaccines without rigorous verification of causative pathogens and without adherence to double-blind, placebo-controlled clinical trial standards, Affirming the necessity to prevent potential harm arising from unverified or inadequately tested medical interventions,

Have agreed as follows: Article 1 – Definitions: 1. “Pharmaceutical Agent” means any chemical or biological substance intended for therapeutic or prophylactic use in humans, including but not limited to vaccines. 2. “Verified Pathogen Isolation” means the isolation and characterization of a virus in accordance with Koch’s postulates (or modern molecular equivalents) demonstrating causality. 3. “Double-Blind Placebo-Controlled Trial” means a clinical study in which neither subjects nor investigators know who receives the active agent or inert placebo, with the placebo containing no active ingredients. Article 2 – General Obligation: Each State Party shall prohibit the development, manufacture, distribution, and administration of any Pharmaceutical Agent intended as a vaccine unless it meets the requirements of Article 3. Article 3 – Mandatory Verification and Testing: 1. No Pharmaceutical Agent shall be approved or administered as a vaccine unless: a. The causative virus or pathogen has been isolated and its role in disease causation demonstrated per Article 1.2; and b. Safety and efficacy have been established through at least one double-blind, placebo-controlled clinical trial as defined in Article 1.3. 2. Any deviation from these requirements must be justified by unanimous scientific consensus and approved by the WHO Oversight Committee established under this Convention. Article 4 – Prohibition: Any Pharmaceutical Agent failing to satisfy the criteria of Article 3 is hereby declared illegal and shall be subject to: a. Immediate withdrawal from all markets; b. Criminal sanctions against individuals or entities responsible for its production or distribution; c. Civil liability for any harm caused. Article 5 – International Oversight:

1. A WHO Oversight Committee (the “Committee”) shall be established to: a. Review and verify pathogen isolation reports; b. Audit clinical trial protocols and results; c. Maintain a public registry of approved vaccines.

2. States Parties shall provide the Committee with all relevant data, including raw trial data and isolation protocols. Article 6 – Dispute Settlement: Disputes arising under this Convention shall be submitted to the International Court of Justice. Interim measures may be requested to prevent distribution of non-compliant agents. Article 7 – Amendments and Entry into Force:

1. Amendments to this Convention may be adopted by a two-thirds majority of the States Parties.

2. This Convention shall enter into force ninety (90) days after the fifteenth instrument of ratification has been deposited. Article 8 – Reservations: No reservations are permitted to Articles 2, 3, or 4.