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Panel 111 – HtA CAPACItY bUILDInG – EXPLORAtIOn Of DIffEREnt MODELS Of nAtIOnAL GUIDELInES DeVeLoPmeNt AND ImPLemeNtAtIoN

Paulo D. Picon, Advisor of Brazilian Ministry of Health; Itajaí Oliveira Albuquerque, Secretariat of Health Care Attention, Ministry of Health, Brazil; Sivalal Sadasivan, Malaysia Ministry of Health; Cindy Farquhar, University of Auckland, New Zealand; Victoria Wurcel, Argentinian Ministry of Health

As part of HTA process of introduction of Evidence-Based Medicine into Practice, the creation and implementation of National Guidelines for Rational Use of Medicines is becoming increasingly important in health-care systems especially in countries where resources are scarce. Doctor tends not to follow new recommendation and it is important to explore different ways to build local capacity for implementation and dissemination of evidence-based recommendation.

This panel session will explore different models to achieve those goals. The main objectives are: to explore different models adopted by different countries (and their relative advantages/disadvantages) for:

• Strategies of creation of national guidelines for rational use of medicines;

• Strategies of implementation;

• Strategies of dissemination;

• Multiple level of involvement (different stakeholders);

Each presenter will highlight a specific strategy and giving examples will elucidate the local experience (pros and cons).

Panel 112 – VARIOUS APPROACHES fOR tHE DEVELOPMEnt Of AMbULAtORY IntERVEntIOnAL AnD SURGICAL PROCEDURES

Gerard Parmentier, UNHPC; Constantino Gallo, Padova’s Hospital; Guy Maddern, Queen Elizabeth Hospital; Jean Michel Dubernard, HAS; Michele Morin-Surroca, HAS

Medical innovation and progress, as well as rising health costs, have led to the transfer of interventional and surgical practices from hospitals to ambulatory settings. This move has required the health care system to rethink/re-evaluate the organization of these activities and consequently, to define the most appropriate settings for performing those procedures. This reorganization is based on the development of ambulatory health care settings that is the creation of e.g. free standing units and the transfer of part of those activities from traditional hospitals to these new health care settings. This implies an evolution from an organization that is hospital centered towards one that is patient centered and also contributes to the sustainability of healthcare.

OBJECTIVE: To illustrate how different heath care systems define appropriate technical environment to safely perform interventional and surgical procedures when developing ambulatory health care settings and to address the issue of the required systems of control and regulation Including: nature of evolution, rationale for the evolution, difficulties of implementation and key factors of success and whenever data are available the quality of care and economic impact.

This session will be of interest to conference attendees from countries which:

• Have already implemented and assessed the reorganization of interventional and surgical activities – but need to refine it further;

• Are in the process of implementing such a reorganization or aspire to do so in the future.

The session will present the experiences of four countries that have established or are in the process of implementing such reorganization.

Experiences to be presented

• Australia: University of Adelaide, South Australia – Pr Guy Maddern, Australia

• France: Haute Autorite Sante – HAS- Mr. Gérard Parmentier, France

• Italy: Padova’s Hospital – Dr Constantino Gallo, Italy

• Professor Dubernard (HAS) is the moderator

The speakers will explore the following:

• The current, ongoing or already implemented reorganization process in their respective countries;

• Any lessons learned that could benefit countries that are in the initial stages of this type of reorganization;

• The potential for benchmarking (e.g. to avoid shortcomings or to optimize the use of resources).

This Parallel Session proposal arises from the recent completion of a health technology assessment aimed at defining the most appropriate environment for ambulatory interventional and surgical procedures in France, as well as the criteria to guide the choice of the most appropriate setting to perform a specific intervention.

Panel 113 – MEDICInES fOR DISEASES tHAt AffECt tHE WORLD’S POOR – RESEARCH AnD DEVELOPMEnt In tHE PERSPECtIVE Of SUStAInAbILItY Of HEALtH SYStEMS AnD HUMAn RIGHtS

Panel Session Organizers: Claudia Garcia Serpa Osorio de Castro, Vera Lúcia Luiza, Ângela Esher

Center for Pharmaceutical Policies, Núcleo de Assistência Farmacêutica – NAF, Sérgio Arouca National School of Public Health – ENSP, Oswaldo Cruz Foundation – Fiocruz

The panel intends to bring together key actors in the field of neglected diseases to discuss the need for sustainable strategies for innovation and access and the role played by Health Technology Assessment in the perspective of guaranteeing human rights.

At present, there is controversy on which diseases may be called neglected and which are being prioritized by funding where research and development for innovative medicines is concerned. Notwithstanding, diseases such as malaria, tuberculosis and aids and many neglected diseases such as bacterial pneumonia, meningitis, diarrhoeal diseases, Chagas´, leishmaniasis, dengue, leprosy and trachoma are still rampant in many low and middle-income countries. While these diseases persist, costly new technologies for other ailments may be perceived as a better investment opportunity in R&D.

More profit is expected from technologies that afflict population segments that are better off and can actually buy medicines or that are attended to by healthcare systems in high-income countries. In addition to this, R&D funding has not been homogeneous among diseases or among targets – new medicines, vaccines, diagnostics, vector control products and basic research.

We propose to discuss targets and funding for R&D in relation to diseases that affect the world´s poor and burden low and middle income country-health systems, while pointing to possible strategies to enhance innovation and access that may be sustainable for health systems as a whole, including the to-be-enhanced role of Health Technology Assessment.

The topics to be presented by panel invitees are the new and challenging targets for research and development in neglected diseases, followed by a discussion on possible alternative sources and mechanisms for the funding of innovation research and health technology assessment for medicines that affect low and middle-income countries, many in which the costs of treatment are entirely fielded by the public sector. Strategies for enhancing access will also be addressed.

Since it was introduced, the Patent Pool has been referred to as an important strategy for innovation and access to medicines.

Finally, a presentation on aspects that surround R&D, innovation and HTA is intended. Discussion is to center on interests that permeate R&D for medicines for diseases that affect the world’s poor, the possibilities for sustainable innovation and the role to be played by health technology assessment in sustainability of healthcare systems, in the perspective of human rights.

Challenging targets in R&D for neglected Diseases Isabela Ribeiro PhD, Head of Chagas Clinical Program, DNDi

Exploring Alternative Mechanisms to fund Innovation for Medicines for Diseases that Affect the World’s Poor Michelle Childs – Director of Policy Advocacy, MSF Campaign for Access to Essential Medicines

the Patent Pool as a Strategy for Innovation and Access to Medicines Jorge Bermudez MD, PhD, Executive Secretary, UNITAID

What Interests Permeate R&D for Medicines for Diseases that Affect the World’s Poor? Is Sustainable Innovation Possible?

Lia Hasenclever PhD, Associate Professor, Economics Institute, Federal University of Rio de Janeiro, Brazil Carlos Médicis Morel MD PhD, Coordinator for Innovation, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil

Panel 28 – HEALtH tECHnOLOGY ASSESSMEnt AnD IntRODUCtIOn Of nEW VACCInES In nAtIOnAL IMMUnIZAtIOn PROGRAMS: WHAt ARE tHE CHALLEnGES?

Hillegonda Maria Dutilh Novaes, Associate Professor, Department of Preventive Medicine, Faculdade de Medicina/USP, Brazil; Damian G. Walker, Bill and Melinda Gates Foundation; Jon k. Andrus, Provac Initiative, Pan American Health Organization - PAHO; Cláudio Maierovitch Pessanha Henriques, Secretariat of Health Surveillance, Ministry of Health, Brazil

In the last decade many new vaccines have been marketed and considered for introduction in national immunization programs, and the demand and use of economic evaluations in decision making processes has increased. Vaccines have features that demand specific economic evaluation and impact analysis methods and decision making processes and they have been the object of important discussions in academic and health and science and technology policy environments. The panel proposes to present and discuss the major challenges in this area.

Cooordinator: Hillegonda Maria Dutilh Novaes, Associate Professor, Department of Preventive Medicine, Faculdade de Medicina

– USP, Brazil

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