Anti-Drug Falsification Work Group GT/CFM 6th Conference of the PARF Network Brasilia, 07 July 2011

Members of the GT/CFM MERCOSUR: Tiago Lanius Rauber, Brazil (Coordinator). ANDEAN COMMUNITY: Marisa Papen, Peru. SICA: Eric Conte, Panama. NAFTA: Michelle Limoli, USA ALIFAR: Miguel A. Maito, Argentina. CARICOM: Princess Osbourne, Jamaica FIFARMA: Néstor Garrido Aranda, Peru.  Appointed by the OPS: María José Sánchez, Argentina.     Secretary (OPS/OMS): José Luis Castro, Washington, DC. Alternate Members MERCOSUR: María José Sánchez, Argentina. COMUNIDAD ANDINA: Delia Villaroel, Bolivia. SICA: Reynaldo Hevia Pumariega, Cuba. CARICOM: David Crawford. ALIFAR: Carmen E. Perez. Colaboradores Leandro Teixeira de Morais, Brasil. Maristela de Almeida, Brasil. Maximiliano Derecho, Argentina.

Background 1999 2nd PARF Conference Creation of the GT/CFM 2001 1st GT meeting Prepared the diagnostic survey 2002 3rd PARF Conference Presented the diagnostic and approved the work plan 2003 2nd GT meeting Developed the mission and objectives of the GT 2004 3rd GT meeting Proposed training for health authorities 2005 4th PARF Conference Approval of documents: Critical Path; Executive Unit; Indicators and Education Program 2006 4th GT meeting Update of the Education Program 2008 Discussion Meeting on Tools and Generation of Proposals for the Prevention and Combating of Falsified Drugs – holding of pilot in Panama 5th PARF Conference Approval of documents: Network Focal Points and Discussion Meetings and work plan

Activities Performed Holding the Meetings in Bolivia (2009), Jamaica / CARICON and English Caribbean (2009) and Costa Rica (2011) Update of the introduction and reference document for the Tools Discussion Meetings and Generation of Proposals to Prevent and Combat the Falsification of Drugs (2010 – 2011) Update of the reference document on the Focal Points for the Prevention and Combating of the Falsification of Drugs and Medical Products (2010 – 2011) Preparation of the outline of the Guidelines to be Considered by the Health Authorities Faced with Suspicion of Falsification of Drugs and Medical Products (2011)

Documents Presented for Approval 1. Update of the reference document for the Tools Discussion and Generation of Proposals Meeting Improvements identified based on the experiences in Panama, Bolivia and Jamaica Establish a strategy to strengthen the health authorities confronting the problem Structure an inter-institutional committee to face the problem nationally Establish mechanisms for preparing the meeting so as to expand the working liaisons between the GT/CFM and the health authority in the country Review the planned program Establish a methodology to monitor and follow up Preparation of the Introduction and Awareness Document

Panama Progress from the Meetings held in 2008 Cooperation Agreement between the Ministry of Health, the Public Ministry, the General Customs Authority, National Police and University of Panama, to form an inter-institutional executive committee to prevent and detect falsified pharmaceutical products – 05 March 2009 Among the objectives of the agreement are: To prepare, develop, present, and update an interoperability protocol and procedures manuals. Performing 10 joint operations by the Public Ministry, the Ministry of Health and the National Police, with cooperation from the industry Investigation of administrative and criminal cases

Panama Progress from the Meetings held in 2008 Other products of the Cooperation Agreement 14 meetings of the inter-institutional committee 8 meetings of the support committee 6 national seminars More than 700 people trained Dissemination to the media or the public Committee forecasts Forming of the National Border Service, Naval Air Service, Judiciary and Legislative Assembly National dissemination campaign International cooperation Create an inquiry and information website

Documents Presented for Approval 2. Updating the Reference Document on the Network Focal Points for the Prevention and Combating of Drug and Medical Product Falsification Objective To strengthen communication and effective cooperation between the Party States through the health authorities, in order to protect the population against the falsification of drugs and medical products. Subjects proposed for discussion Structure and functioning of the Network Responsibilities of the National and Subregional Focal Point Implementation and maintenance of the PFCF Network Public Hearing from April 19 to June 10, 2011

Documents Presented for Approval Proposed Structure – PFCF Network GT/CFM/OPS PFCF CAN CARICOM SICA Mercosur NAFTA NATIONAL PFCF’s

Documents Presented for Approval 3. Guidelines to be Considered by the Health Authorities Faced with a Suspicion of Falsified Drugs and Medical Products The purpose of this document is to provide common action guidelines, based on the experiences seen in the countries in the region, to be considered by the health authorities for the effects of defining and taking action in view of a suspicion of falsified medical products in the market. Public hearing from May 11 through June 12, 2011

Documents Presented for Approval Guidelines to be Considered by the Health Authorities Faced with a Suspicion of Falsified Drugs and Medical Products Objectives of the actions of the health authority faced with suspicions Confirm and define the falsification; Limit and interrupt the harmful effects of the falsification; Communicate and disseminate the case; Identify the perpetrators of the fabrication and distribution of the falsified product. Planning and Conducting of Inspections

Work Plan 2011 - 2014 ACTIVITY DATE February/2012 1. Effectively implement the Focal Point Network according to the document to be approved in the 6th Conference. February/2012 2. Promote Discussion and Proposal Generation Meetings in the countries in the region (maximum 2 events per year). Ongoing Activity 3. Follow-up and support of the countries where the Meetings were held. 4. Participate on the task force for preparing the distribution good practices guidelines, [if?] approved by the Conference. March/2013 5. Review the critical path and operating unit documents. October/2013 6. Prepare a guideline on the legislative aspects related to combating the falsification of drugs and medical products. November/2013 7. Evaluate and analyze the technologies and experiences existing in the region for the traceability of drugs and medical products March / 2012

Work Plan 2011 - 2014 ACTIVITY DATE November/2013 8. Evaluate and analyze the existing technologies and experiences in the region to control the improper sale of drugs and medical products over the Internet. November/2013