Jeffrey Gren, Executive Office of Wellbeing and Buyer Products U.S. Division of Business January 15 - 19, 2007.


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U.S. – Asian Business Chamber Against Duplicating Medication Gathering Week of January 15 – 19, 2007 Indonesia, Philippines and Thailand Subject: Worldwide Exchange Issues Identified with Fake Meds and the Requirement for Worldwide Participation Jeffrey Gren, Chief
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U.S. – Asian Business Council Anti-Counterfeiting Medicine Conference Week of January 15 – 19, 2007 Indonesia, Philippines and Thailand Topic: International Trade Issues Related to Counterfeit Medicines and the Need for Global Cooperation Jeffrey Gren, Director Office of Health and Consumer Goods U.S. Division of Commerce January 15 - 19, 2007

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Outline Definitions of Counterfeit Medicines Why an International Trade Problem Industry Trends Impacting the Counterfeit Medicine Problem Solutions Summary and Conclusions

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Definitions: The World Health Organization (WHO) characterizes fake medication as “a medication that is intentionally and deceitfully mislabeled regarding personality and/or source”

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Definitions (proceeded with) Counterfeit medications may incorporate items with the right fixings, or with the wrong fixings, without dynamic fixings, with deficient dynamic fixings, or with fake packaging” Counterfeit medications apply to both protected and bland medications

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Definitions (proceeded with) What separates a fake medication from a substandard medication is that the fake medication is purposely and falsely mislabeled as for personality and source Some nations, for example, China, utilize the term “fake” medications, inferring that the issue is constrained to fake medications that don\'t work

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Definitions (proceeded with) However, our perspective at DOC is that all medications intentionally and falsely mislabeled with deference of character and source are fake and perilous Even if a fake medication has the right mix of dynamic pharmaceutical fixings (APIs) and excipients, it is still risky, since it may contain controls, for example, overwhelming metals, pesticides, and so on., because of absence of cGMP assembling

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Definitions (proceeded with) Substandard medications are likewise a huge worldwide issue; then again, the center of this presentation ceasing the worldwide spread of fake medications The reasons and answers for substandard medication issues are totally not the same as the reasons and answers for the fake drug issue

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Why a universal exchange issue? Disregards Intellectual Property Rights (IPR) Manufacturers lose income. The Center for Medicines in the Public Interest in the United States predicts that fake medication deals will reach $75 billion all around in 2010. The WHO takes note of that this is an increment of more than 90 for each penny from 2005. Damages WTO Accession Agreements and Free Trade Agreements

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Why a worldwide exchange issue? (cont’d) The utilization of fake meds has turned into a huge worldwide issue bringing on noteworthy passing and harm Counterfeit meds likewise add to the advancement of medication resistance; if a pathogen is more than once presented to a lower measure of the dynamic pharmaceutical fixing the parasite/microbes/infection can adjust and get to be impervious to treatment Counterfeit solutions can likewise bring about a loss of trust in the general wellbeing framework by patients and a loss of trust in brand names

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Why a global exchange issue? (cont’d) Combating Counterfeit Drugs , “Drug forgers not just swindle clients, they likewise deny sick patients the treatments that can allay enduring and spare lives” According to the U.S. Nourishment and Drug Administration February 2004 report, there are various archived, heart tweaking stories of human enduring and demise because of fake medications

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Why an International Trade Problem (cont’d) There are no dependable insights to gauge the full worldwide effect on the worldwide fake meds issue 10-20 years prior most fake medications did not have any dynamic pharmaceutical fixings (APIs) Now more medications have genuine APIs Although there are fake APIs, numerous fakes medications are made with genuine APIs In creating markets and rising nations in Africa, Asia, Eastern Europe, Russia, and Latin America residents routinely experience fake medications

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Why a universal exchange issue - Lack of Statistics (Cont’d) In created nations, the degree of fake medications inside of the medication inventory network is right now little, yet the danger is expanding, and web deals represent most of the fake medications available Most measurements under assessed the issue and the effect According to a late PhRMA study, the five nations of most elevated fake prescriptions effect are China, India, Mexico, Russia, and Brazil

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Why a global exchange issue (Cont’d) Definitions: Illegal Diversion – When a honest to goodness pharmaceutical item is affirmed and planned available to be purchased in one nation, yet is then wrongfully caught and sold in another nation. This is regularly finished with false explanations or revelations. Now and again the medications sold in the other nation is not sanction by the administrative powers .

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Why a global exchange issue - (Cont’d) Definitions (cont’d): Pharmaceutical Theft – Theft of completed dose structure meds anyplace in the circulation chain, for example, at the site of generation, cargo forward dispersion focus, stockrooms, drug stores, or clinics Incident – An attentive occasion activated by revelation of fake, illicitly redirected or stolen pharmaceutical

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Why a universal exchange issue – The Counterfeit Medicines Problem is Growing

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Top 10 nations by Reported Incidence 2005 (Cont’d)

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Incidence of Fake Antimalarial Drugs in Five Southeast Asian Countries: 2002-2003 Source: A.M. Dondorp, Tropical Medicine and International Health , Dec. 2004.

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Why a worldwide exchange issue - Who are the medication forgers? Assembling fake medications has turned out to be amazingly beneficial therefore, sorted out wrongdoing has moved from opiates into forging obviously, a few makers of fake medications are not from composed wrongdoing, but rather they are still crooks The punishment for delivering fake medications is far not exactly the punishments for illicit opiates

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Industry Trends Impacting the Problem: Active Pharmaceutical Ingredients Global Overview 2003 2008 Source: SRI Consulting “Active Pharmaceutical Ingredients” 2004

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Industry Trends Impacting the Problem: Global API Manufacturing - 2004 Total Global Number of API Manufacturers Sites about 2,000 *Source: Newport Horizon Sourcing, October 2004

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Industry Trends Impacting the Problem: APIs European API makers basically serve the licensed pharmaceutical market The quickest developing nations for API creation is China and India Many specialists anticipate that in 20 years 80% of all APIs will originate from India and China

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Industry Trends Impacting the Problem: APIs (Cont’d) According to IMS for the following 20 years India will be prevailing for API generation, and throughout the following 50 years China will turn out to be more overwhelming for API creation Currently most API assembling in India and China is for the nonexclusive medication market, yet this will change after some time because of: lower formative expenses complex amalgamation capacities moving pharmaceutical medication generation administrative consistence and adherence to GMP and GCP

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Industry Trends Impacting the Problem: The Generic Trend Generic creation is developing at a quicker rate than imaginative medications We are likewise seeing a movement in the worldwide generation of bland medications – nations/areas with huge development of non specific creation incorporate India, China, Southeast Asia, Brazil, Middle East, Russia

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Industry Trends Impacting the Problem: The Generic Trend (cont’d) The movement in non specific creation far from the created markets U.S., Europe and Japan adds to the issue of fake medications, since the administrative administrations and guidelines built up by pharmacopeias, are much weaker far from the U.S., Europe, and Japan

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Industry Trends Impacting the Problem: Growth in Pharmaceutical Segments Source: IMS Health MIDAS - 2005

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Industry Trends Impacting the Problem: Global Pharmaceutical Manufacturing

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Solutions Protecting the supply\'s respectability chain Need for worldwide participation to stop fake meds and catch the fakes Cooperation wellbeing authorities, traditions, law authorization and industry

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Solutions: Protecting the drug\'s honesty store network Part of the arrangement is to verify that a country’s medication production network is satisfactory to forestall dispersion of fake prescriptions The fake pharmaceutical issue shifts enormously among nations Countries with feeble administrative administrations, and absence of pharmaceutical principles requirement are affected most seriously

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Solutions: Protecting the drug\'s trustworthiness inventory network (cont’d) Some nations, fundamentally creating nations, have a to a great degree high rate of fake meds that are regularly found inside of the drug inventory network Other nations, principally created economies, have a fake medication issue that is not as extreme and for the most part no huge vicinity of fake meds in the solution production network

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Solutions: Protecting the drug\'s uprightness production network (cont’d) According to the FDA 2004 report, “in a few nations the falsifying of medications is endemic – with a few patients having a superior shot of getting a fake solution than a genuine one” According to the WTO 2004 Report on Safety of Medicines, “in wealthier nations, new costly meds are as often as possible duplicated, for example, hormones, corticosteroid, tumor drugs, and antiretroviral” In creatin

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