Development and initiatives of medical devices in the Americas Alexandre Lemgruber Third WHO Global Forum on Medical Devices Geneva, 10-12 May 2017
Regional Strategy on Universal Access to Health & Universal Health Coverage (Sept 2014) Resolution CSP28.R9 on HTA and Decision Making (Sept 2012) Four Strategic Lines of Action: 1. Progressively expanding access to quality, integrated and comprehensive health services 2. Strengthening governance and stewardship 3. Increased and more efficient public financing in health 4. Addressing the social determinants of health Key elements of the integrated approach: 1. Integration of HTA into public policies on health technologies 2. Establishment of an institutional framework for HTA-based decision making 3. Human Resources Development 4. Dissemination of information 5. Rational use of health technologies 6. Promotion of Network Collaboration 1
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Regulation Regional Working Group established in 2012, currently with 16 countries Regional mapping with basic indicators showed important progresses but also gaps: half of the countries with at least one critical indicator not achieved; 21% with no legislation to support technovigilance programs Assessment tool with advanced indicators to measure the level of implementation: pilot with 5 countries PAHO as an IMDRF affiliate organization: mirror groups on NCAR and Software as a Medical Device REDMA Program: Exchange of reports on adverse events; secure platform; pilot with 10 countries being implemented Report on Reuse and reprocessing: situation in 14 countries E-learning courses on medical device regulation developed by CECMED and INVIMA: 53 representatives from 10 countries were benefited Important role of the WHO CC (CECMED) 3
Assessment HTA Network of the Americas (RedETSA) established in 2011, currently with 31 institutions from 15 countries Regional mapping with information from 31 countries: 11 with HTA institutions, units or commissions; 86 organizations that carry-out HTArelated activities; 32% with legislation establishing some kind of link between HTA and decision making; only 29% of the countries there are mechanisms in place for the implementation of the decisions Capacity building: e-learning courses (95 benefited from basic courses and 15 from Masters programs); monthly webinars (17 so far); professional exchanges (Brazil, Colombia and Canada; with 35 participants) Toolbox on best practices and recommendations on HTA implementation, with examples from the Region: building HTA function; HTA products; implementing decisions RedETSA Database to be launched in 2017, initially with 600 HTA reports MoUs with INAHTA and EuroScan Manual on Disinvestment 4
Recent Milestones for HTA in the Americas June 2011: Launch of RedETSA: Meeting in Rio de Janeiro Dec 2012: Creation on National Commission on HTA (ETESA), Chile June 2012: Creation of National HTA Commission, Costa Rica May 2014: Resolution WHA 67.23 on Health intervention and technology assessment in support of UHC February 2015: Creation of HTA Institute (IETSI), Peru May 2016: Proposal for the creation of an HTA Agency, Argentina. 2011 2012 Dec 2011: Creation of National Commission on Technology Incorporation (CONITEC), Brazil Sept 2012: Creation of HTA Institute (IETS), Colombia 2013 2012: Launch of HTA program in Ecuador Sept 2012: Resolution CSP28.R9 on HTA and Decision Making 2014 2015 2016 June 2014: V RedETSA meeting, WDC: HTA and Universal Health Sept 2013: IV RedETSA meeting, Brasilia: NRA s and HTA bodies Oct 2015: Creation of HTA unit, El Salvador. 2015: Legislation on the use of EE on decision making, Uruguay 2016: New legislation defining articulation between HTA body (CENETEC), Pricing Committee and General Health Council to improve decision making, Mexico.
Focus on capacity building Management Collaboration with University of Vermont E-learning courses: Introduction to Biomedical Technology (299 candidates, 53 participants from 29 countries); Healthcare Technology Planning and Management (486 candidates, 61 participants from 28 countries); Spanish and English versions; topics: policies, evaluation, budgeting, acquisition, training, patient safety, maintenance, implementation New edition of the HTM course to be launched in June 2017 New Webinar program on HTM to be launched in May 2017 Collaboration with the American College of Clinical Engineering (ACCE): Workshops in Brazil and Canada; next activity in September 2017, in Sao Paulo 6
Other priorities in 2017 Pilot of price database for 26 medical devices: information received from 5 countries; ~ 17,000 prices Support countries to develop list of Priority Medical Devices Project on devices for Chronic Kidney Disease in Central American Countries 7