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HHS - The Minister of the Interior of the French Republic

En Français

LETTER OF INTENT

BETWEEN

THE SECRETARY OF HEALTH AND HUMAN SERVICES
OF THE UNITED STATES OF AMERICA

AND

THE MINISTER OF THE INTERIOR
OF THE FRENCH REPUBLIC

ON REINFORCING
LAW ENFORCEMENT COOPERATION
WITH REGARD TO THE FIGHT AGAINST
OFFENSES AGAINST PUBLIC HEALTH

The Secretary of Health and Human Services of the United States of America
and
The Minister of the Interior of the French Republic,
hereinafter referred to jointly as “the Participants”;

CONCERNED by the global development of organized crime and prompted in particular by the increasing investment of transnational criminal organizations in illegal trafficking, counterfeiting and large-scale fraud affecting public health;

CONVINCED of the need for coordinated international action as a continuation of the first international instruments addressing these forms of criminal activity;

DESIRING to contribute jointly to enhance law enforcement cooperation on preventing and fighting against crimes affecting public health, notably by drawing on the expertise of both the Office of Criminal Investigations of the United States Food and Drug Administration and the Central Office to Combat Damage to the Environment and Public Health (Office central de lutte contre les atteintes à l'environnement et à la santé publique) of the Directorate General of the French National Gendarmerie;

MINDFUL of the legal framework that governs mutual legal assistance in criminal matters between the law enforcement authorities and agencies of their two States;

declare their intention to strengthen their law enforcement cooperation in the fight against offenses against public health, guided by the following general principles:

1. Purpose of this Letter of Intent

The Participants intend to increase and intensify their technical and operational cooperation to counter crimes against public health. With this objective in mind, they also intend to assist each other accordingly.

This Letter of Intent does not create a legal commitment between the Participants. The Participants intend that cooperation carried out on the basis of this Letter of Intent be implemented without prejudice to the international commitments of the Participants' States, in accordance with each Participant’s domestic legislation, policies, and internal administrative organization, subject to the availability of funds and personnel of the Participants.

2. Areas of Cooperation

The Participants intend that their cooperation address the following issues, in particular:

  1. the manufacture, storage, sale or attempted sale (including brokerage), trafficking (including distributing, importing, exporting, passing in transit and transhipping), supply, offer to supply and unauthorized possession of medical products, active substances, excipients, parts, materials and accessories that are counterfeit or adulterated;
  2. any kind of economic activity that pertains or contributes to the illegal trafficking of medical products (excluding those natural or synthetic substances and raw materials that are classified as « psychotropic substances » according the Tables I to IV of the Convention on Psychotropic Substances of 21 February 1971);
  3. the manufacture of false documents or the falsification of documents related to a medical product, an active substance, an excipient, a part, a material or an accessory (including the packaging, labelling, instructions for use, certificate of origin or any other certificate accompanying it, or otherwise directly associated with the manufacturing and/or distribution thereof);
  4. the manufacture, storage, sale or attempted sale (including brokerage), trafficking (including distributing, importing, exporting, passing in transit and transhipping), supply, offer to supply or placing on the market of regulated medical products without the authorization of the relevant authorities of both Participants' States;
  5. the manufacture, storage, sale or attempted sale (including brokerage), trafficking (including distributing, importing, exporting, passing in transit and transhipping), supply, offer to supply or placing on the market of medical devices that do not meet the conformity requirements stipulated in the domestic legislation of both Participants' States;
  6. the misuse of medical products and active substances for unauthorized purposes (doping, misuse for cosmetic purposes, etc.);
  7. offenses against the domestic law of both Participants' States on the security and integrity of blood products and other products, organs, tissues or cells extracted from the human body;
  8. offenses against the domestic law of both Participants' States perpetrated by health professionals and companies;
  9. offenses against the domestic law of both Participants' States on the security of food products at the different stages of their production and handling chains;
  10. aiding or abetting the perpetration of one of the above-listed offenses;
  11. the attempt to commit one of the above-listed offenses; and
  12. conspiracy or criminal association with a view to the perpetration of the above-listed offenses.

3. Cooperation Instruments

The Participants intend to draw on the following forms of cooperation, in particular:

  1. exchanging their respective experience on law and regulation enforcement, on crime prevention and also on the methods, means and forensics techniques used;
  2. exchanging technical and operational information and disseminating good law-enforcement practices;
  3. carrying out training activities such as sending experts on short-term missions, hosting interns or organizing joint seminars;
  4. coordinating operations carried out in the territories of their respective States, in the framework of joint cases or operations planned on an international level;
  5. making experts available to the other Participant - as liaison officers, if need be - in order to foster contacts for operations; and
  6. periodically organizing high-level working groups.

This Letter of Intent will be primarily implemented by the Office of Criminal Investigations of the Food and Drug Administration (as part of the United States Department of Health and Human Services), and the Central Office to Combat Damage to the Environment and Public Health of the Directorate General of the French National Gendarmerie (as part of the Ministry of the Interior of the French Republic).

SIGNED in Washington on December 2, 2014, in two originals in the French and English languages.

For the Secretary of Health and Human Services of the United States of America

---/s/---

Howard R. SKLAMBERG, J.D.
Deputy Commissioner for Global Regulatory Operations and Policy
of the Food and Drug Administration

For the Minister of the Interior of the French Republic

---/s/---

COL Bruno MANIN
Head of the Central Office against Environment and Public Health Criminality of the Directorate
General of the National Gendarmerie