1. 6 TH PARF NETWORK CONFERENCE MEDICATION PROMOTION WORK GROUP Maria José Delgado Fagundes Coordinator of the PARF Network Medication Promotion GT General Manager of Monitoring and Supervision of Advertising, Promotion and Information regarding Products Subject to Health Surveillance - GGPRO/DIJCO/ANVISA July/2011

2. Mission of the GT:  Promote and Harmonize the Criteria for the Promotion of Medications as a contribution to Rational Use, within the framework of health policies in the Americas Region. VISION of the GT:  To broaden and strengthen awareness and responsibility related to the Promotion of Medications. : MISSION AND VISION OF THE MEDICATION PROMOTION WORK GROUP

3. . MEMBERS OF THE MEDICATION PROMOTION WORK GROUP MERCOSURMaria José Delgado Fagundes (Full) BRA (Coordination) Sebastian Duarte (Alternate) ARG COMUNIDAD ANDINAElvira Tincopa (Full) PER Wilma Teran (Alternate) BOL SICADigmara Barban Lores (Full) CUB Edgar Domínguez (Alternate) PAN CARICOMHeather Carter (Full) Barbados Mary Louis (Alternate) Trindad and Tobago NAFTAMargarita Contreras MEX ALIFARMaría Angélica Sánchez (Full), CHI Laura Castellanos (Alternate) REP DOM FIFARMAJosé Manuel Cousiño (Full), CHI Héctor Bolaños (Alternate), MEX Designación por OPS/OMSCarlos Fuentes, NIC

4. Background  Medication Promotion GT Meeting – Brasilia / Brazil August 2006;  5 th PARF Network Conference - Buenos Aires/Argentina - November 2008;  Virtual Meeting and Recommencement of Activities of the new GT – September 2010;  Meeting of the GT – Buenos Aires/Argentina – May 2011. à BACKGROUND OF THE MEDICATION PROMOTION WORK GROUP

5. 3 Activities related to the Virtual Work M.:  Questionnaire on national regulation, implementation, and monitoring laws related to the promotion of medications. Document prepared and contributions to its format. Entrusted to OPAS.  Work Plan on training activities needed in the region. Training Form and Terms of Reference. Rescheduled for the 2011 / 2014 Work Plan.  Definition of the Ethical Criteria for the PARF Network (based on the OMS reference): Different Contributions and Consolidations to the document that was defined in the Meeting held in Buenos Aires / Argentina in May 2011, and placed for Public Consultation on OPAS’s website, from 05/11 to 06/12/2011. Completed. ACTIVITIES PERFORMED 2010-2011

6. ETHICAL CRITERIA FOR THE PROMOTION, ADVERTISING AND PUBLICITY OF MEDICATIONS  Presentation in the 6 th Conference of the Consolidated Version witt the contributions presented in the Public Hearing made available on OPAS’s website during the period from 05/11 to 06/12/2011;  Disclosure and Adoption / Adaptation of the document Ethical Criteria for the Promotion, Advertising, and Publicity of Medications. DOCUMENT FOR DISCLOSURE

7. Summarized Objectives:  To support and foster improvement in healthcare through the rational use of medications;  To serve as a reference framework for member countries of the PARF Network for the preparation and review of health policies and the mechanisms regulating the promotion, advertising, and publicity of medications;  The primary objective of the promotion, advertising, and publicity of medications will be the benefit of users and society;  To expand and strengthen the responsibility of the sectors related to the promotion, advertising, and publicity of medications. ETHICAL CRITERIA FOR THE PROMOTION, ADVERTISING AND PUBLICITY OF MEDICATIONS

8. General Principles Summarized:  Medications are social goods, therefore they must be treaded as health assets and not as consumer products;  The information must be based on provable scientific evidence, be independent, exact, reliable and true;  Only medications sold without a prescription may be the subject of promotion, publicity and advertisement aimed at the general population;  In no case may a medication that is innocuous or safe be indicated.  The information must be disclosed equitably, describing both the benefits and the risks associated with its use;  Pharmaceutical companies must not offer incentives to professionals authorized to prescribe and dispense medications and the latter should not solicit or receive incentives of any type ETHICAL CRITERIA FOR THE PROMOTION, ADVERTISING AND PUBLICITY OF MEDICATIONS

9. General Principles Summarized:  In public and private health establishments, the representatives must respect and not interfere with the activities of the health professionals.  Printed, audiovisual, electronic/digital/virtual/Internet materials, or materials on any other medium aimed at professionals and the general public, must respect the conditions of the prior articles. Other components related to the promotion, advertising and publicity of medications summarized:  Pharmaceutical representatives must have the appropriate training and perform their work in accordance with these ethical criteria;  In case of sponsorship or receipt of economic resources for meetings, symposiums and other events on medications, the existence of a conflict of interest must be declared explicitly. ETHICAL CRITERIA FOR THE PROMOTION, ADVERTISING AND PUBLICITY OF MEDICATIONS

10. Other components related to the promotion, advertising and publicity of medications summarized:  The laboratories producing medications may only give grans aimed at professional training or participation in scientific activities, if the professionals are informed in advance of their conditions for entry and the selection procedure for candidates with equitable and transparent mechanisms for them to be given. ETHICAL CRITERIA FOR THE PROMOTION, ADVERTISING AND PUBLICITY OF MEDICATIONS

11. 4 Activities Work Plan Proposed in the Meeting held in Buenos Aires/Argentina, in May 2011:  Activity 1 – Disclosure, Adoption / Adaptation of the Ethical Criteria;  Activity 2 – Work Plan on Training Activities necessary in the Region;  Activity 3 – Internet Project – Preparation of a Proposal to monitor sites and regulate Internet advertisements;  Activity 4 – Work Network Project on the Monitoring of Advertising. Rem.: All the activities are organized in a Performance Schedule. WORK PLAN 2011-2014

12. General Office of Monitoring and Supervision of Advertising, Publicity, Promotion and Information regarding Products Subject to Health Surveillance – GGPRO/DIJCO/ANVISA SIA Office SIA, Section 5, Special Area 57 Block B – 1 st Floor – Room 02 Brasilia-DF – Postal Code: 71.205-050 0800-642-9782 ouvidoria@anvisa.gov.br