Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in International Cooperation

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Panel 4 - Linda Marks Senior Counsel: Overview of New Developments in International Cooperation

  1. 1. New Developments in International Cooperation Partnership for Safe Medicines Interchange 2013 October 24, 2013 Washington, D.C. Moderator: Linda I. Marks Senior Litigation Counsel Consumer Protection Branch U.S. Department of Justice linda.marks@usdoj.gov ■ Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.
  2. 2. Panelists ■ J. Scott Ballman, Jr.: Technical Expert for IP Program - North America, World Customs Organization ■ Dr. Patrick Lukulay: Vice President, Global Health Impact Programs, USP, and Program Director, Promoting the Quality of Medicines Program ■ John Roth: Director, Office of Criminal Investigations, U.S. Food and Drug Administration
  3. 3. THE PROBLEM ■ ■ ■ Large quantities of prescription drugs coming from “Canada” and other countries create challenges for Customs and Border Protection & FDA. “Prescription drug abuse is the Nation’s fastestgrowing drug problem.” (United States Office of National Drug Control Policy, 2011) Trade/B2B sites: anyone with a computer can now become a drug wholesaler.
  4. 4. THE PROBLEM ■ Physicians are ordering directly from unlicensed brokers/wholesalers ■ Receiving drugs not approved for U.S. market ■ Receiving drugs not properly stored and shipped ■ Receiving counterfeits
  5. 5. Unapproved/Counterfeit Drugs ■ Drugs can be counterfeit, unapproved, misbranded: ■ Contains API – too much/too little ■ Different API (sildenafil vs. tadalafil) ■ No API ■ Harmful/toxic ingredients
  6. 6. Direct Customer Orders
  7. 7. Direct Customer Orders
  8. 8. Physicians looking for cheaper suppliers UNAPPROVED & COUNTERFEIT
  9. 9. Global Challenges Tracing money ■ ■ Phony or shell names ■ Intermediaries ■ Bank and wire transfer details
  10. 10. Global Challenges Tracing packages ■ ■ Phony names/addresses ■ False customs declarations ■ Drop shippers/re-packagers ■ Multi-jurisdictional businesses
  11. 11. Global Challenges ■ Identification of key players ■ VOIP telephones ■ New websites
  12. 12. Global Challenges FORMAL REQUESTS ■ Mutual Legal Assistance Treaties/Letters Rogatory ■ ■ Requests made for bank records, corporate records, e-mail/server records, phone records, identifications, interviews ■ Can take many months, or years
  13. 13. Global Challenges ■ Will foreign country notify account holder? ■ Will foreign country open own investigation? ■ Once received, will we need to translate?
  14. 14. Global Challenges OTHER MEANS TO GATHER EVIDENCE: ■ ■ Tracker warrants – ok with foreign country? Assistance with surveillance? ■ Are there informal ways to receive information? ■ Industry assistance: purchasing product, testing product, identifying subjects, introducing agents to subjects; international resources
  15. 15. Charging Decisions ■ Can we extradite from defendant’s country? ■ From another country where defendant is found? ■ ■ ■ Do we have extradition treaty? Does foreign country have similar laws? Can we seize assets?
  16. 16. Global Initiatives: International cooperative enforcement operations ■ Operation Mercury I & II (2009 - 2010) ■ Looked for drugs shipped via international mail facilities, express consignment hubs ■ 2010: included a system to exchange data between Customs administrations
  17. 17. Global Initiatives: International cooperative enforcement operations ■ Operation Pangea (2008 - 2013) ■ Initiated by PFIPC, INTERPOL, WHO/IMPACT ■ Targets the illegal advertising, sale and supply of medicines over the Internet ■ In 2013, 99 participating countries, 10.1 million illicit and counterfeit pills confiscated, more than 13,700 websites shut down
  18. 18. Global Initiatives: Support to Developing Countries ■ USP’s Promoting the Quality of Medicines in Developing Countries (PQM) program Funded by USAID ■ Strengthens QA and QC systems ■ Increases the supply of quality-assured medicines ■ Combats the availability of substandard and counterfeit medicines ■ Provides technical leadership and global advocacy ■
  19. 19. Panelists ■ J. Scott Ballman, Jr.: Technical Expert for IP Program - North America, World Customs Organization ■ Dr. Patrick Lukulay: Vice President, Global Health Impact Programs, USP, and Program Director, Promoting the Quality of Medicines Program ■ John Roth: Director, Office of Criminal Investigations, U.S. Food and Drug Administration

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