brazilian industrial and innovation complex in health ...all ltas and look for better alignment and...

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MINISTRY OF HEALTH OF BRAZIL SECRETARIAT OF SCIENCE, TECHNOLOGY AND STRATEGIC INPUTS DEPARTMENT OF INDUSTRIAL COMPLEX AND INNOVATION IN HEALTH GENERAL COORDINATION OF MEDICAL DEVICES Brazilian Industrial and Innovation Complex in Health: PAHO/WHO Brazil Technical Cooperation with the Ministry of Health in The Context of WHA 60.29 Resolution ACKNOWLEDGEMENTS The Pan-American Health Organization (PAHO/WHO), through the Unit of Medicines, Technologies and Research & Development (UMT & RD) of the Representation in Brazil (PWR/BRA), developed in 2004-2008 with the Ministry of Health a program of cooperation including three Long Term Agreements (LTAs) for a total budget of USD 23.7 million. In 2007, the WHA 60.29 Resolution (http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf) requested the Director General to provide technical support to Member States in implementingpolicies on health technologies especially for priority diseases. In 2008, R&D and the Industrial Health Complex became one of the seven priorities of the National Health Plan. To increase access to health technologies for the population through the Public Health System (SUS), the government articulated market regulation with health research (in accordance with the official National Agenda of Priorities), industrial development and innovation. This strategy counted on the purchasing power of the State as a guarantee for technology transfer and to ensure provision, supply and therefore access to health technologies. Poppe F.; C. Rerat: PAHO/WHO - Unit of Medicines, Technologies and Research & Development Antonino P. H. D.; Oliveira E. J. V.; Gadelha C. A. G.: Ministry of Health of Brazil - Secretariat of Science, Technology and Strategic Inputs Figure 1 - Model of Innovation in R&D and Health Production, Brazil – prepared by Flavia Poppe Whereas the issue of health technologies requires a systemic approach to understand the functioning of the whole supply chain, the traditional technical cooperation mechanisms needed to be assessed and adjusted to respond to the new strategies and scope of WHA resolutions. J.05 e-mail: [email protected]; [email protected] R&D and access to technologies Government Procurement Mechanism Health System PDP A C C E S S SUMMARY OF INDUSTRIAL HEALTH COMPLEX POLICY SUMMARY OF INDUSTRIAL HEALTH COMPLEX POLICY PDP PDP Health System Health System Government Procurement Mechanism Government Procurement Mechanism R&D and access to technologies R&D and access to technologies Science, Technology and Health Innova olicy Science, Technology and Health Innova olicy Na Policies & Pr ograms Na Policies & Pr ograms Blood and Blood Products Policy Blood and Blood Products Policy al Care Policy al Care Policy Pa t Safety Program Pa t Safety Program LTA for Regula LTA for Regula LTA for Industrial Complex LTA for Industrial Complex LTA for al Assistance LTA for al Assistance LTA for Research LTA for Research LTA for Bioethics & HTA LTA for Bioethics & HTA LTA for Blood LTA for Blood RERs 10.3 11.4 12.1 12.2 12.3 4 4 4 5 3 5 Figure 2 - Interrelation between PAHO Programmatic Areas and Long Term Agreements implemented to reach RER within the Brazilian Health System UMT&RD of PAHO/BRA compared scope, strategic objectives and indicators of all LTAs and look for better alignment and interaction between LTA. As a result, the technical cooperation mechanisms reflected the WHA Resolutions, PAHO Regional Strategic Plan and the National Health Plan and, consequently, integration and efficiency. Eight out of ten outcome indicators were mutually associated to two or more LTAs. The UMT&RD program reached USD 70 million for the quinquennium 2009 - 2013 and the number of LTAs increased significantly. The technical cooperation between PAHO/WHO and the MoH improved substantially and most of actions began to be executed following a horizontal approach, benefitting from synergies and integration between programs. PAHO/WHO – Strategic Plan 2008 - 2012 Region-wide Expected Results related LTAs RER Indicator related LTAs RER 10.3 – Member States supported through technical coopera o strengthen programs for the improvement of quality of care and pa t safety. 5 10.3.1 – Number of countries that show progress in programs for the improvement of quality of care, including pa t safety; 5 RER 11.4 – Member States supported through technical coopera or facilita enera ansfer of knowledge in priority ar eas, including public health and health systems research, and ensuring that the products meet WHO ethical standards. 3 11.4.1 – Number of countries that have a na esearch system with the characteris ators) deĮŶĞĚ ďLJ PAHO; 1 11.4.2 – Number of countries with na ommissions aimed at monitoring compliance with ethical standards in scien esearch 1 RER 12.1 - Member States supported through technical coopera o promote and assure an equitable access to medical products and health technologies and the corresponding technological innova 5 12.1.1 - Number of countries that have implemented policies pr o, or technological innova or medical products 4 12.1.2 - Number of countries that have established or strengthened their na ystems of procurement, pr or dis al products 3 12.1.3 - Number of countries with 100% voluntary nonremunerated blood dona 2 12.1.4 - Number of countries that have tools to evaluate access to health Technologies 1 RER 12.2 - Member States supported through technical coopera o promote and assure the quality, safety and ecacy of medical products and health technologies. 6 12.2.1 - Number of countries evaluated in their regulatory or medical products 2 12.2.2 - Number of countries that have implemented interna rules, norms, standards or guidelines on quality, safety and eĸĐacy of health technologies 2 RER 12.3 – Member States supported through technical coopera o promote and assure the ra cacious use of costee medical products and health technologies based on the best evidence available. 6 12.3.1 – Number of countries that have norms to deĮŶĞ ƚŚĞ incorpora echnologies 1 12.3.2 – Number of countries that use a list of essen updated within the lasƚ Įǀe years as the basis for public procurement 3 Table 1 - Number of Long Term Agreements associated to the Region-wide Expected Results and Indicators

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  • MINISTRY OF HEALTH OF BRAZIL SECRETARIAT OF SCIENCE, TECHNOLOGY AND STRATEGIC INPUTS

    DEPARTMENT OF INDUSTRIAL COMPLEX AND INNOVATION IN HEALTH GENERAL COORDINATION OF MEDICAL DEVICES 


    Brazilian Industrial and Innovation Complex in Health: PAHO/WHO Brazil 
Technical Cooperation with the Ministry of Health in The Context of WHA 60.29 Resolution

    ACKNOWLEDGEMENTS

    The Pan-American Health Organization (PAHO/WHO), through the Unit of Medicines, Technologies and Research & Development (UMT & RD) of the Representation in Brazil (PWR/BRA), developed in 2004-2008 with the Ministry of Health a program of cooperation including three Long Term Agreements (LTAs) for a total budget of USD 23.7 million. In 2007, the WHA 60.29 Resolution (http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf ) requested the Director General to provide technical support to Member States in implementingpolicies on health technologies especially for priority diseases. In 2008, R&D and the Industrial Health Complex became one of the seven priorities of the National Health Plan. To increase access to health technologies for the population through the Public Health System (SUS), the government articulated market regulation with health research (in accordance with the official National Agenda of Priorities), industrial development and innovation. This strategy counted on the purchasing power of the State as a guarantee for technology transfer and to ensure provision, supply and therefore access to health technologies.

    Poppe F.; C. Rerat: PAHO/WHO - Unit of Medicines, Technologies and Research & Development Antonino P. H. D.; Oliveira E. J. V.; Gadelha C. A. G.: Ministry of Health of Brazil - Secretariat of Science, Technology and Strategic Inputs

    Figure 1 - Model of Innovation in R&D and Health Production, Brazil – prepared by Flavia Poppe

    Whereas the issue of health technologies requires a systemic approach to understand the functioning of the whole supply chain, the traditional technical cooperation mechanisms needed to be assessed and adjusted to respond to the new strategies and scope of WHA resolutions.

    J.05

    e-mail: [email protected]; [email protected]

    R&D and access to

    technologies

    Government

    Procurement

    Mechanism

    Health SystemPDP

    A

    C

    C

    E

    S

    S

    SUMMARY OF INDUSTRIAL HEALTH COMPLEX POLICYSUMMARY OF INDUSTRIAL HEALTH COMPLEX POLICY

    PDPPDPHealthSystemHealthSystem

    Government ProcurementMechanism

    Government ProcurementMechanism

    R&D and access to

    technologies

    R&D and access to

    technologies

    Science, Technology a

    nd

    Health Innova olic

    yScience, Technology a

    nd

    Health Innova olic

    y

    NaPolicies & P

    r ogramsNa

    Policies & Pr ograms

    Blood and Blood

    Products PolicyB

    lood and Blood

    Products Policy

    al

    Care Policyal

    Care Policy

    Pa t Safety

    ProgramPa t Saf

    ety

    Program

    LTA for

    RegulaLTA for

    Regula

    LTA for Industrial ComplexLTA for

    Industrial Complex LTA for al

    AssistanceLTA for al

    Assistance

    LTA for

    ResearchLTA for

    Research

    LTA for

    Bioethics & HTA

    LTA for

    Bioethics & HTA

    LTA for

    BloodLTA for

    Blood

    RERs10.311.412.112.212.3

    44

    4 5

    3

    5

    Figure 2 - Interrelation between PAHO Programmatic Areas and Long Term Agreements implemented to reach RER within the Brazilian Health System

    UMT&RD of PAHO/BRA compared scope, strategic objectives and indicators of all LTAs and look for better alignment and interaction between LTA. As a result, the technical cooperation mechanisms reflected the WHA Resolutions, PAHO Regional Strategic Plan and the National Health Plan and, consequently, integration and efficiency. Eight out of ten outcome indicators were mutually associated to two or more LTAs.

    The UMT&RD program reached USD 70 million for the quinquennium 2009 - 2013 and the number of LTAs increased significantly. The technical cooperation between PAHO/WHO and the MoH improved substantially and most of actions began to be executed following a horizontal approach, benefitting from synergies and integration between programs.

    PAHO/WHO – Strategic Plan 2008 - 2012Region-wide Expected Results related LTAs RER Indicator related LTAs

    RER 10.3 – Member States supported through technical coopera o strengthen programs for the improvement of quality of care and pa t safety.

    5 10.3.1 – Number of countries that show progress in programs for the improvement of quality of care, including pa t safety;

    5

    RER 11.4 – Member States supported through technical coopera or facilita enera ansfer of knowledge in priority ar eas, including public health and health systems research, and ensuring that the products meet WHO ethical standards.

    3 11.4.1 – Number of countries that have a na esearch system with the characteris ators) de PAHO;

    1

    11.4.2 – Number of countries with na ommissions aimed at monitoring compliance with ethical standards in scien esearch

    1

    RER 12.1 - Member States supported through technical coopera o promote and assure an equitable access to medical products and health technologies and the corresponding technological innova

    5 12.1.1 - Number of countries that have implemented policies pr o, or technological innova or medical products

    4

    12.1.2 - Number of countries that have established or strengthened their na ystems of procurement, pror dis al products

    3

    12.1.3 - Number of countries with 100% voluntary nonremunerated blood dona

    2

    12.1.4 - Number of countries that have tools to evaluate access to health Technologies

    1

    RER 12.2 - Member States supported through technical coopera o promote and assure the quality, safety and efficacy of medical productsand health technologies.

    6 12.2.1 - Number of countries evaluated in their regulatory or medical products

    2

    12.2.2 - Number of countries that have implemented internarules, norms, standards or guidelines on quality, safety and e acy of health technologies

    2

    RER 12.3 – Member States supported through technical coopera o promote and assure the ra fficacious use of costeff emedical products and health technologiesbased on the best evidence available.

    6 12.3.1 – Number of countries that have norms to deincorpora echnologies

    1

    12.3.2 – Number of countries that use a list of essenupdated within the las e years as the basis for public procurement

    3

    Table 1 - Number of Long Term Agreements associated to the Region-wide Expected Results and Indicators