The Danger of False Profits: The Threat of Counterfeits to Public Health

1. The Danger of False Profits: The Threat of Counterfeits to Public Health February 28, 2013, Washington D.C. Presented by: Jeffrey Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce Presentation - Global Activities to Combat Counterfeit Medicines

2. Presentation Outline • Introductory Comments • The Global Counterfeit Medicines Problem • Summary of Major Global Activities • May 2013 APEC Korea Medical Products Safety Workshop • Summary and Conclusions

3. Introductory Comments • The U.S. Department of Commerce (DOC) is the advocate for business in the U.S. government and DOC’s international trade role is to promote U.S. trade by strengthening industry competitiveness and reducing trade barriers • I direct DOC’s Office of Health and Consumer Goods and my office focuses on medical devices, pharmaceuticals, biotechnology, and a wide array of consumer goods products • During the past decade DOC has been very active in the global battle to stop the spread of counterfeit medicines and we work very closely with U.S. FDA and industry in organizing global activities. I will provide an outline of major global activities during my remarks • Although we do not have reliable data, experts agree that the amount of counterfeit and substandard medicines on the global market is increasing each year

4. The Global Counterfeit Medicines Problem • Factors leading to this increase in falsified/counterfeit medicines include: • Increase in criminal activity and level of sophistication • High profit level (even higher than for narcotics) • Internet provides a marketing vehicle for criminals to distribute counterfeit medicines • Lack of penalties, enforcement, and coordination in prosecution in many overseas markets have created conditions for counterfeiting to grow

5. The Global Counterfeit Medicines Problem (Cont’d) • Globalization of the pharmaceutical industry has contributed to the ready supply of APIs (active pharmaceutical ingredients) for counterfeiters, as manufacturing of APIs and finished dosage form medicines shifted from developed to lesser developed countries Increase in criminal activity and level of sophistication • Counterfeiting impacts all aspects of the aspects of the pharmaceutical industry – patented, generic and OTC medicines • Globalization of the pharmaceutical industry has also contributed a related but different problem - the growth of substandard medicines

6. The Global Counterfeit Medicines Problem (Cont’d) • Twenty years ago most counterfeit medicines did not contain medicinal ingredients, currently a large percent of counterfeit medicines contain real APIs and excepients • What is scary is that counterfeiters use real pharmaceutical ingredients since they are seeking repeat business • Of course, all counterfeit medicines are unsafe and may or may not have the correct ingredients • In developed markets, such as the U.S. and Europe, the majority of counterfeit medicines are distributed through the Internet. Several studies have documented that the vast majority of medicines distributed through the Internet are illegal, counterfeit or substandard

7. Counterfeit Medicines Definitional Issues • - Old WHO: In the case of medicines, includes the deliberate and fraudulent mislabeling of medicines with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging. • - IMPACT Initiative Derailed in 2011 • - Current WHO Definition – SSFFC – “Substandard/Spurious/Falsely-Labeled/Falsified/Counterfeit Medical Products”

8. Counterfeit/Falsified Medicines Other Ongoing Initiatives and Mitigating Activities • - WHO Initiatives • - Partnership for Safe Medicines • - SafeMeds Alert System: www.safemedicines.org • - Implementation of the APEC LSIF Anti-counterfeit Medicines Action Plan • - APEC LSIF Reg. Harmonization Steering Committee - Roadmap on Global Med. Product Quality and Supply Chain Integrity • - U.S. - China Pharmaceutical and Medical Devices • JCCT Subgroup • - China Regulation of API Activities and Workshops

9. Counterfeit/Falsified Medicines Other Ongoing Initiatives and Mitigating Activities • - U.S. State Department funding of country-specific projects on outreach and education about counterfeit drugs • - INTERPOL - Patient Safety and Criminal Investigation • - India Patient Safety and Drug Detection Technology Workshop • - U.S. Patent and Trademark Office (USPTO) and U.S. Justice Department Training for Judges and Law Enforcement Personnel • - Word Bank Regulatory Harmonization Efforts - Current Focus Africa • - US Pharmacopeia US AID Funded Quality of Medicines Program • - ASEAN Combating Counterfeit Medical Products Training

10. Korea May 22 - 23 LSIF RHSC Drug Safety Public Awareness and SPOC Workshop • The prime goal of the Korea workshop is to gain adoption of public awareness and single point of contact APEC tool kits and to document best APEC and global practices • The Korea Project Planning Committee is currently working on developing these tool kits which will be reviewed by the RHSC Supply Chain Oversight Committee, before they are distributed to delegates in advance of the workshop • During the workshop participants will break into smaller groups for interactive discussion on both tool kits and following the workshop the it is envisioned that both tool kits will be reviewed by the RHSC Supply Chain Oversight Committee and endorsed as APEC LSIF documents

11. Summary and Conclusions • During my presentation I covered the following: • Introductory Comments • The Global Counterfeit Medicines Problem • Summary of Major Global Activities • May 2013 APEC Korea Medical Products Safety Workshop Counterfeit/Falsified medicines is a significant growing global problem and I am confident that the programs and cooperative activities underway will make an impact to stop the spread of unsafe medicines

12. Jeffrey L. GrenDirectorOffice of Health And Consumer GoodsInternational Trade AdministrationU.S. Department of Commercetel: 202/482-2470fax: 202/482-0975jeffrey.gren@trade.govhttp://www.ita.doc.gov/td/health