Counterfeiting and Intellectual property theft in Medicines World Bank Symposium March 10, 2005 Washington DC Frederick Razzaghi Director of Technical Affairs Consumer Healthcare Products Association member of World Self Medication Industry 5/9/2019

Overview Who is WSMI? Scale of the problem US efforts Underlying conditions Potential Solutions Conclusions Questions 5/9/2019

WSMI The World Self-Medication Industry is a federation of over 50 member associations representing manufacturers and distributors of nonprescription medicines on all continents. As a Non-Governmental Organization (NGO), WSMI supports the World Health Organization (WHO), ICH, WIPO, Codex Alimentarius, the World Medical Association, the International Pharmaceutical Federation and the International Council of Nurses. 5/9/2019

Mission To create and maintain an international environment, intended to enhance opportunities for people to manage their own health through the responsible use of safe and effective self-medication products. 5/9/2019

WSMI mission achieved by: Communicating the value of responsible self-medication to health professionals, health authorities, consumers and others; Encouraging high standards of quality, safety and efficacy of self-medication products. 5/9/2019

What is the scale of global counterfeiting/piracy? 5/9/2019

Counterfeiting/Piracy The global trade in illegitimate goods increased last year to more than $600 billion (Source: World Customs Organization and Interpol). U.S. companies lose an estimated $250 billion per year, costing 750,000 American jobs (source: USCC). Pharmaceuticals, No reliable estimate 5/9/2019

Active US organizations : US Congress (H.R. 32, “Stop Counterfeiting in Manufactured Goods Act of 2005” has 47 sponsors and is pending. US Trade Representative (through WTO) US Department of Justice (Nationally and through the G8) US department of Homeland Security (Through the customs service and boarder protection) Industry (by partnering with federal authorities of the countries where counterfeiting originates) 5/9/2019

US Government’s newest initiative 10/04/04 U.S. Trade Representative, Departments of Commerce, Justice, and Homeland Security announced a major new government-wide initiative, the Strategy Targeting Organized Piracy (STOP!) To fight billions of dollars in global trade in pirated and counterfeit goods that adversely affect American innovators, manufacturers and the U.S. economy and endanger consumers worldwide. 5/9/2019

7 Underlying conditions Continuous deterioration of economic conditions in most Latin American countries Lack of enforcement, compliance and adequate regulations in developing and underdeveloped countries Disparity in prices as an incentive along with low criminal threshold. Inducements created by free trade zones or cross border trade 5/9/2019

Underlying conditions (conti.) Access to medicines through the Internet enhances cross border trade Absence of a well understood and established harmonized program among the judicial and health authorities within each country and within each trading region Inability to control the supply chain beyond the manufacturers and verification of product authenticity 5/9/2019

What is the Solution? Globally developed and harmonized approach. Coordinated execution of an effective program in cooperation with health, justice, enforcement, customs, industry, NGO’s, IMF/WB, WHO Adoption of effective regional/national legislation and regulation specific to counterfeit medicines Effective global cooperation in surveillance and enforcement 5/9/2019

(A sample risk management process) What is the Solution? Establishment of an integrated risk management protocol (assessment, control, communication) (A sample risk management process) 5/9/2019

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Conclusions The economic viability of the developed, industrial countries and the safety of all medicines are at stake during this transition Support for global development is undermined 5/9/2019

Questions Does the World Bank have a role to play? Leveraging resources (global network ,etc)! Incorporating anti-counterfeiting provisions into current agreements with governments! 5/9/2019

Thank you 5/9/2019