1. VI Pan American Conference on Drug Regulatory Harmonization (CPANDRH) Conference Summary Brasilia, Brazil July 06-08 2011 Strengthening of National Regulatory Authorities in the Context of Health Systems

2. AGENDA Seven roundtables Seven major presentations Multiple innovative activities carried out by the regulatory authorities of the Americas, presented orally or through posters The work plans, activities, results, and recommendations of seven working groups presented in the plenary session. In addition, work sessions for each of these groups

3. ROUNDTABLES 1.Strengthening National Regulatory Authorities for Medicines and Biologicals. Resolution CD50.R9 2.Implementation of PANDRH Guidelines in the Subregions 3.International Cooperation 4.Information and Communication Systems 5.Transparency 6.Future Challenges for the PANDRH Network 7.Pharmaceutical Policy - Generics Strategy

4. MAJOR PRESENTATIONS 1.Neglected diseases 2.Antimicrobial resistance 3.Internet sales of medicine 4.Results of the World Health Assembly 5.Advances in nanotechnology 6.Sale of medicines directly to the home 7.Economic regulation

5. Innovative activities carried out by the Regulatory Authorities of the Americas Oral presentations: Validation of an algorithm for analysis of therapy decisions Colombia Monitoring of medicines in Cuba The Educanvisa education project Application of information technologies to sanitary surveillance of imported pharmaceutical products Combating counterfeit medicines Evidence-based pharmaceutical development in the Caribbean

6. ROUNDTABLES: MAIN CONCLUSIONS AND RECOMMENDATIONS

7. CONCLUSIONS Strengthening National Regulatory Authorities Resolution CD50.R9 The strengthening of national regulatory authorities (NRAs) is a high-impact national and regional initiative that promotes agreements among countries. PAHO reiterates its commitment to continue strengthening drug regulatory authorities and fostering horizontal technical cooperation. The State, through its health authorities, should exercise its regulatory and health surveillance functions as an unrelinquishable and nondelegable service to the community. A strengthened regulatory authority requires a political decision, a regulated sector convinced that there is an NRA, and the identification of skilled human resources. The evaluation guide is a valid and essential tool for strengthening NRAs, consolidating policies, and upgrading technical procedures in regulation, supervision, and control. Two challenges for the NRAs are promoting transparency and modernizing management. Certified authorities make the commitment to work with PAHO in strengthening other authorities and promoting discussion of a reference authority model in the context of the WHO prequalification of medicines. Each country must meet the challenge of guaranteeing the quality of the technologies procured for the populations of our countries and improving access to medicines.

8. RECOMMENDATIONS Strengthening National Regulatory Authorities Resolution CD50.R9 Adopt models that are sustainable over time and improve supervision, control, and surveillance of products and processes. Identify mechanisms that facilitate real support by certified authorities to as-yet- uncertified NRAs during the necessary preparations for achieving their certification. Define and exercise good regulatory practices. Recognize the decisions of reference NRAs because of PAHO’s trust in them and its endorsement of their qualifications. Promote strategic partnerships among NRAs for capacity building and improvement. Promote harmonization and mutual recognition among NRAs. Establish mechanisms for information exchange that guarantee implementation and adoption of the documents approved to make the standardization of processes a viable undertaking.

9. CONCLUSIONS Implementation of PANDRH Guidelines in the Subregions PANDRH is a mechanism with high strategic value that enables NRAs to join together to improve and harmonize their regulations, technical documents, and guides, providing them with tools for better exercise of their functions in protecting the health of the population. PANDRH has provided the countries with training, technical assistance, and specific training in various matters of interest to the NRAs, in addition to strategies and policies for improving public health. PANDRA guidelines per se have not always been adopted, but many of the principles, practices, and requirements for consistency with country regulations have.

10. RECOMMENDATIONS Implementation of PANDRH Guidelines in the Subregion Foster greater joint efforts among NRAs (agreements, conventions, etc.) to make more efficient use of the available resources. Develop strategies to improve communication among the representatives in the working groups and increase their participation. Determine the obstacles or problems that the countries face in adapting or implementing PANDRH documents and guidelines. Assess the impact of the PANDRH guidelines, as well as their degree of implementation in the countries of the Hemisphere.

11. CONCLUSIONS International Cooperation International cooperation is an opportunity to foster collaborative capacity building among NRAs, strengthen them, and reduce asymmetries. The will is there to develop mechanisms that will make technical cooperation dynamic and effective, with tangible results. It helps build trust and recognition among the NRAs of the Region.

12. RECOMMENDATIONS International Cooperation NRAs should identify their needs and/or strengths in terms of receiving or providing technical cooperation, within the framework of a strategic institutional development plan. Assess the impact of international cooperation in terms of expected results and indicators. Take advantage of all technical cooperation modalities.

13. CONCLUSIONS Information and Communication Systems The NRAs of the Region of the Americas want to share information about their regulatory systems and products marketed through a mechanism that maintains equity and improves regulatory decision-making. The Regional Platform for Access and Innovation for Health is an integrating collaborative project that is under development; based on the resolutions of PAHO’s Governing Bodies, it is proposed as tool for information exchange among NRAs. Implementation of this Platform has begun with four countries currently participating; participation is open to other countries on request.

14. RECOMMENDATIONS Information and Communication Systems Urge national regulatory authorities to join the Regional Platform for Access and Innovation for Health.

15. CONCLUSIONS Transparency -Transparency is a means of obtaining effective results with NRA activities. -Good regulatory practices are the cornerstone of transparency. -Transparency is linked to all matters addressed by PANDRH, because the type of information managed is of interest to regulators, the regulated, and the general public. -In some countries in the Region of the Americas, activities related to good governance and transparency are being applied to pharmaceutical regulation.

16. RECOMMENDATIONS Transparency -Establish regulatory practices as a necessary mechanism for improving transparency, considering: The need to maintain the confidentiality of the information in specific matters; The inclusion of public participation in the development of national regulations; The application of good governance as part of the necessary assessment for determining the transparency and vulnerability of national regulatory systems; The need for computer systems that show the application of previous practices in national public health systems, including those related to access to medicines.

17. CONCLUSIONS Future challenges for PANDRH The political will to support PANDRH is there. The progress made in its 14 years of operation was recognized, and the participants urged that its achievements be maintained. Priority areas were repeatedly mention; some of them, such as good manufacturing practice and bioavailability and bioequivalence, need to be revisited. NRA participation through multidirectional coordination is essential.

18. RECOMMENDATIONS Future challenges for PANDRH Request the PANDRH Steering Committee to: –Develop a strategic plan that includes the Directing Council mandate contained in CD50.R9 (2010) for all regulatory authorities in the Americas, regardless of their degree of development. –Analyze the structure of the Network and submit a proposal at the next conference. –Create an ad hoc group and facilitate preparation and implementation of the strategic plan for strengthening technical capacity. –Reactivate the technical working groups on GMP and bioavailability and bioequivalence. –Coordinate PANDRH’s work with other regional initiatives for efficient resource management. –Implement strategies and actions for strengthening regulatory capacities to promote the health of peoples.

19. RECOMMENDATIONS Future challenges for PANDRH Request that NRAs be proactive in the application and implementation of the documents produced at the different meetings of PANDRH. The regulated sector should be committed to implementing the technical documents produced by PANDRH. Engage in planning and work strategically to meet the training needs identified. Promote interaction among the authorities to make knowledge transfer a mechanism for strengthening the national regulatory authorities. Adopt measures for recognizing existing regulatory capacity, rather than the duplication of efforts, complying with the health-related Millennium Development Goals and mandates.

20. CONCLUSIONS Pharmaceutical Policy – Generics Strategy It should be emphasized that health policy should be the guide for priorities in the development of an industry policy that promotes access to drugs. Progress has been made in harmonizing the definitions used for generic and multisource medicines. Network members are invited to consider the development of a collaborative model by the NRAs for evaluating requests for sanitary registration of multisource medicines. Political will is a sine qua non for implementing generic drug strategies within the framework of a health policy that promotes access to drugs, as seen in the experiences of Brazil, Panama, and Peru. The document “Framework for Implementation of Equivalence Requirements for Pharmaceutical Products,” approved at the V PANDRH Conference, has contributed significantly to the definition of the criteria that NRAs should apply when evaluating equivalence studies. However, it is important that this document be distributed widely and appropriated by all members of the Network to eliminate the confusion that still persists.

21. RECOMMENDATIONS Pharmaceutical Policy - Generics Strategy Progress toward the implementation of generics strategies requires objective, evidence-based information on sensitive issues that may pose a barrier to such progress. In the meantime, it is recommended that the Network support studies that address such issues, among them generic drug prices versus patent drug prices and therapeutic failure attributable to quality issues.

22. WORKING GROUPS

23. The 2011-2013 work plans of the technical working groups that participated of the Conference were presented. These plans will be reviewed and prioritized by the PANDRH Steering Committee as established in the Network’s statutes. Documents approved by the Conference: Biotechnological Products –Recomendaciones para la evaluación de productos bioterapéuticos (PBS) [Recommendations for the evaluation of similar biotherapeutic products (SBP)] Combating Counterfeit Medicines –Actualización del documento de referencia de las Jornadas de Discusión de Herramientas y Generación de Propuestas [Update of the reference on Conducting Workshops for Discussion of Tools and Generation of Proposals] –Actualización del documento de referencia de la Red de Puntos Focales para la Prevención y Combate a la Falsificación de Medicamentos y Productos Médicos [Update of the reference for the Focal Points Network for the Prevention and Combating of Counterfeit Drugs and Medical Products] –Pautas a ser Consideradads por las Autoridades de Salud ante una sospecha de Falsificación de Medicamentos y Productos Médicos [Guidelines to be Considered by the Health Authorities when Counterfeiting of Drugs and Medical Products is Suspected]

24. WORKING GROUPS Medicines Registration –Guidelines for the Registration of Medicines in the Americas Module 1: Characteristics of the Medicine Module 2: Information on the quality of IFA Module 3: Nonclinical reports Module 4: Clinical Reports Good Clinical Practices –Investigator’s Manual from Good Clinical Practice Guidelines –Guidelines for Pediatric Clinical Trials –Considerations on Placebo Use Medicines Promotion –Ethical Criteria for Medicines Promotion, Advertising, and Publicity

25. WORK SESSIONS The coordinator of each technical working group will send the main conclusions of the work sessions held to the Secretariat, which will include them in the Conference report. Thirty days will be allotted for sharing the final Conference report with the members of the PANDRH Steering Committee, members of the working groups, and Secretariat so that it can be reviewed and edited before publication on the PANDRH website [www.paho.org/RedPANDRH]

26. NEW MEMBERS OF THE PANDRH STEERING COMMITTEE PARTICIPANTSREPRESENTATIVEALTERNATE MERCOSUR ParaguayUruguay ANDEAN COMMUNITY PeruVenezuela SICA El SalvadorGuatemala NAFTA USACanada CARICOM BarbadosSuriname ALIFAR Rubén Abete FIFARMA José Manuel Cousiño ALBA OBSERVER