Cómo Enfrentar un Caso de Ilícitos Adrián Román Director Ejecutivo - Seguridad Novartis y Miembro PSI Rafael Cortes Coordinador Investigaciones – Reg. Andina

Agenda Instituto de Seguridad Farmacéutica (PSI) Como enfrentar un caso de Ilícitos Ejemplos de dos programas Conclusiones

PSI El Pharmaceutical Security Institute (PSI) es una organización sin fines de lucro, ubicada en el área metropolitana de Washington DC, USA. Tiene como objetivo proteger la salud pública a través de la difusión de información sobre falsificación de medicamentos y la promoción de la lucha contra la falsificación a través de las autoridades locales. El instituto es apoyado por sus miembros que incluyen las 20 principales compañías farmacéuticas de investigación basadas en los Estados Unidos y la Unión Europea. Las actividades específicas de PSI incluyen recolectar, evaluar y diseminar información relacionada a la producción y comercialización de medicamentos ilegales.

Incidencia del crimen farmacéutico Incidentes 2003-2005   2003 2004 2005 (a Sep.) Falsificación 370 390 352 Contrabando 77 113 120 Robo 30 50 56 Total 477 553 528 -An increase from 477 incidents to 553 incidents has been documented from 2003 to 2004 -Counterfeiting continues to be the most common type of incident Note that the 477 total for 2003 is an updated incident number based on continued reporting during 2004. Totally, 150 new incidents were added to CIS in 2004, which occurred in 2003. PSI expects the 2004 total of 553 incidents to increase also through continued reporting in 2005.

Países reportando casos de Medicamentos Ilícitos Falsificación Contrabando Robo Total Estados Unidos 32 30 14 76 Republica Dominicana 21  47  4 72 Colombia 43 15 62 China 56 3 59 Rusia 40 8 2 50 India 36 39 Perú 21 25 Ucrania 23 1 24 Brasil 12 19 México 6 5 17 Reino Unido Israel 18 -The 555 incidents in 2004 occurred in 86 countries -The European Union, as a single entity, was involved in 46 CIS incidents in 2004 -The top countries experiencing counterfeiting incidents are China, Colombia, and Russia Note: CIS incidents are not exclusive to one country. Multiple countries can be linked to any one incident. 1. A country is included when it can be identified as the origin, point of seizure, point of transit or intended destination of illegal pharmaceuticals.

Incidentes por Región 447 newly identified suspects operating in 41 different countries A suspect is a person believed responsible or suspected of being responsible for a counterfeiting, diversion or theft incident. The suspect list includes those persons actually charged with a crime or arrested for a crime.

Análisis Regional, Latinoamérica

México y Brasil no han reportado acciones significantes Latinoamérica en 2005 Las autoridades colombianas continúan sus esfuerzos contra la falsificación y contrabando con un número sostenido de operativos Perú ha elevado el perfil de sus operaciones contra las medicinas ilegales creando un grupo de trabajo conjunto entre la industria y las autoridades En Guatemala se han llevado a cabo acciones de gran magnitud en contra de laboratorios clandestinos. México y Brasil no han reportado acciones significantes Ecuador & Bolivia – No hay esfuerzo coordinado para combatir estos delitos -A Latin American country was involved in 171 of the 553 incidents occurring in 2004. This was the highest portion recorded of all regions. -Illegal flow of pharmaceuticals is a worrisome development. Customs enforcement agencies report that their seizures are characterized by products originating from diverse countries within the region. Counterfeiter operating in one country have shipped pharmaceuticals to a second country where the drugs are repackaged and returned to the first country. Movement of stolen and diverted drugs is also common.

Cómo Enfrentar un Caso de Ilícitos Factores que contribuyen al incremento de este tipo de ilícito: Negocio muy lucrativo y con poco riesgo Falta de legislación adecuada Inacción o ausencia de programa pro-activo de investigación por las autoridades de salud/policiales e industria Escasa colaboración y coordinación entre los laboratorios y autoridades -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Cómo Enfrentar un Caso de Ilícitos Prioridades de la Industria La salud del paciente es primordial Operar de acuerdo a las normas vigentes en el país Garantizar la calidad de sus productos Asegurar el retorno de su inversión -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Cómo Enfrentar un Caso de Ilícitos Consideraciones Autoridades de salud ordenen retiro del producto como primer paso sin llevar a cabo una investigación exhaustiva Pérdida de confianza de parte de los pacientes, médicos y público en general Publicidad negativa que afecte el buen nombre y reputación de la empresa Demandas legales -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Cómo Enfrentar un Caso de Ilícitos La industria es una de las mejores fuentes de información sobre incidentes de Ilícitos: Representantes de ventas Pacientes, publico (#800 de atención al consumidor) Distribuidores, farmacias Departamento de Seguridad Departamento de Aseguramiento de Calidad Informantes -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Cómo Enfrentar un Caso de Ilícitos Las investigaciones sobre ilícitos deben manejarse con la mas estricta confidencialidad. Las compañías utilizan diferentes canales para llevar a cabo investigaciones internas: Depto. de seguridad de la empresa Departamento legal Investigador de la asociación de la industria Investigador privado Referido a autoridades de salud o policiales -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Cómo Enfrentar un Caso de Ilícitos Estudios de Mercados (muestreo) Compras encubiertas Vigilancias Seguimientos Preparación de informe detallado con fotos y evidencia para presentación de denuncia ante el fiscal/autoridades de salud Laboratorio o asociación se convierte en parte legal del caso Seguimiento del proceso legal Demanda civil (si procede) -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Control de calidad realiza peritaje Programa Novartis Al detectarse un ilícito Seg. Corporativa y Control de Calidad son notificados Control de calidad realiza peritaje Notificación a autoridades de salud Investigación – Coordinada por Dept. Seguridad Evidencia y denuncia con autoridades Seguimiento del caso y apoyo a autoridades Novartis de hace parte legal de la causa -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

Programa Republica Dominicana: Investigador trabaja directamente bajo supervisión de ARAPF Industria canaliza información a ARAPF Investigador trabaja en conjunto con autoridades de salud, policiales y aduanales (dependiendo del tipo de ilícito) Ventajas de ambos programas Bajo costo de operación Control de información y excelente coordinación Los mejores resultados en la industria -60 incident total places Colombia second worldwide in the number of CIS incidents in 2004. -Although 68% of the incidents involved counterfeiting, this year diversion incidents increased to fifteen (25%). -Enforcement actions are more frequent in Bogota. -The high level of theft in Venezuela seems to have impacted with the appearance of stolen product in Colombia. -Colombian sourced products have shown up in Argentina, Ecuador and Peru. -43% of arrests occurred at the point of sale and 38% at manufacturing facilities.

RESULTADOS (continuación) VALOR DE LOS MEDICAMENTOS INCAUTADOS ( RD $ ): TIPO DE OPERATIVO AÑO 2003 AÑO 2004 CONTRABANDO / FALSIFICACIONES: 6,051,910.00 9,136,898.00 ROBO 10,165.838.00 316,731.00 TOTAL / AÑO: 16,217,748.00 9,453,629.00 AÑO 2005 ENE-OCT 29,818,174.00 453,962.00 30,272,136.00

No existe conflicto de interés entre las autoridades regulatorias y la industria en el tema de los ilícitos de medicamentos Se necesita establecer un plan de trabajo entre autoridades y la industria con objetivos definidos La industria esta comprometida a apoyar a las autoridades en las áreas de información, apoyo técnico y entrenamiento