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1.
Rev. bioét. derecho ; (47): 5-15, nov. 2019. ilus
Artigo em Inglês | IBECS | ID: ibc-184862

RESUMO

DNA read and write technologies have accelerated biotechnology at an unprecedented pace. This enhanced capacity to engineer living beings has accelerated not only scientific research, but also the translation into novel therapies. New approved medicinal products include the correction of the diseased genome and synthetic enhancement to fight diseases. These practices are widely supported socially and scientifically. Applications beyond therapy have also be attempted. In 2018, researcher He Jiankui reported on the edition of human germline during the Second International Summit on Human Genome Editing. On the other hand, during the last years, there have also been attempts at somatic genetic enhancement without the provision of detailed outcomes. Reading and writing DNA empowers us to change our world, even ourselves. The social benefits may be enormous. We need to accelerate the debate, including the stakeholders, to foster a responsible use of these technologies and maximize the positive impact on society


Las tecnologías de lectura y escritura de ADN han acelerado la biotecnología a un ritmo sin precedentes. Esta capacidad mejora para diseñar seres vivos no solo ha acelerado la investigación científica, sino también la translación a terapias novedosas. Nuevos medicamentos aprobados incluyen la corrección del genoma enfermo y la mejora sintética para combatir las enfermedades. Estas prácticas son ampliamente apoyadas social y científicamente. También se han intentado aplicaciones más allá de la terapia. En 2018, el investigador He Jiankui informó sobre la edición de la línea germinal humana durante la Segunda Cumbre Internacional sobre la Edición del Genoma Humano. Por otro lado, en los últimos años también se han producido intentos de mejora genética somática. Leer y escribir ADN nos permite cambiar nuestro planeta, incluso cambiarnos a nosotros mismos. Los beneficios sociales


Les tecnologies de lectura i escriptura d'ADN han accelerat la biotecnologia a un ritme sense precedents. Aquesta capacitat millorada per dissenyar éssers vius no només ha accelerat la recerca científica, sinó també la translació a teràpies noves. Nous medicaments aprovats inclouen la correcció del genoma malalt i la millora sintètica per a combatre les malalties. Aquestes pràctiques són àmpliament recolzades social i científicament. També s'han intentat aplicacions més enllà de la teràpia. El 2018, l'investigador He Jiankui va informar sobre l'edició de la línia germinal humana durant la Segona Cimera Internacional sobre l'Edició del Genoma Humà. D'altra banda, en els últims anys també s'han produït intents de millora genètica somàtica. Llegir i escriure ADN ens permet canviar el nostre planeta, fins i tot canviar-nos a nosaltres mateixos. Els beneficis socials poden ser enormes. Necessitem accelerar el debat, incloent-hi les parts interessades a fi de fomentar un ús responsable d'aquestes tecnologies i maximitzar-ne l'impacte positiu en la societat


Assuntos
Humanos , Edição de Genes , Pesquisa Médica Translacional , Biologia Sintética/ética , Biotecnologia/ética , Biotecnologia/instrumentação , Biotecnologia/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
2.
Value Health ; 22(4): 399-407, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30975390

RESUMO

BACKGROUND: Conditional financing (CF) of hospital drugs was implemented in the Netherlands as a form of managed entry agreements between 2006 and 2012. CF was a 4-year process comprising 3 stages: initial health technology assessment of the drug (T = 0), conduct of outcomes research studies, and reassessment of the drug (T = 4). OBJECTIVES: To analyze stakeholder experiences in implementing CF in practice. METHODS: Public and private stakeholders were approached for participation in stakeholder interviews through standardized email invitations. An interview guide was developed to guide discussions that covered the following topics: perceived aims of CF, functioning of CF, impact of CF, and conclusions and future perspectives. Extensive summaries were generated for each interview and subsequently used for directed content analysis. RESULTS: Thirty stakeholders were interviewed. Differences emerged among the stakeholders on the perceived aims of CF. Conversely, there was some agreement among stakeholders on the shortcomings in the functioning of CF, the positive impact of CF on the Dutch healthcare setting, and improvement points for CF. CONCLUSIONS: Despite stakeholders' belief that CF either did not meet its aims or only partially did so, there was agreement on the need for new policy to address the same aims of CF in the future. Nevertheless, stakeholders diverged on whether CF should be improved on the basis of learnings identified and reintroduced into practice or replaced with new policy schemes.


Assuntos
Aprovação de Drogas/economia , Custos de Medicamentos , Administração Financeira de Hospitais/economia , Gastos em Saúde , Custos Hospitalares , Participação dos Interessados , Avaliação da Tecnologia Biomédica/economia , Orçamentos , Aprovação de Drogas/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Administração Financeira de Hospitais/legislação & jurisprudência , Gastos em Saúde/legislação & jurisprudência , Política de Saúde/economia , Custos Hospitalares/legislação & jurisprudência , Humanos , Entrevistas como Assunto , Países Baixos , Formulação de Políticas , Avaliação de Programas e Projetos de Saúde , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
3.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 733-742, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30900482

RESUMO

Objectives: The current study aims to analyze, from a historical perspective, the regulatory framework of prices and reimbursement in Bulgaria with emphasis on the introduction of economic evaluation.Methods: The study explores all regulatory changes during the period 1995-2016 combining the macroeconomic and regulatory analysis on medicines pricing and reimbursement. A roadmap summarizing the current regulatory requirements for the medicinal product entrance on national market and access to public funding was elaborated.Results: Demographic processes in the country have been negative for the past decade. On the other hand, health care and pharmaceutical expenditures experienced a growth up to 8.6% and 3% of total GDP, respectively. The total pharmaceutical market permanently grew from 309 to 1409 million of Euro. During the last 20 years, the pricing and reimbursement legislation of medicines in Bulgaria was changed extensively.Conclusion: Pricing policy remains oriented toward the lowest European prices and reimbursement policy impose cost containment measures. Appraisal of the obligatory Health Technology Assessment Dossiers and pharmacoeconomic analysis is in accordance with world recommendations. Main regulatory issues that still remain to be tackled are the slower entrance of medicines on the national market and lower national prices that often lead to parallel import.


Assuntos
Custos e Análise de Custo/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Farmacoeconomia , Mecanismo de Reembolso/legislação & jurisprudência , Bulgária , Controle de Custos/métodos , Custos e Análise de Custo/tendências , Custos de Medicamentos/tendências , Gastos em Saúde/legislação & jurisprudência , Humanos , Mecanismo de Reembolso/tendências , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
5.
Expert Rev Pharmacoecon Outcomes Res ; 19(3): 251-261, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30696372

RESUMO

INTRODUCTION: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.


Assuntos
Política de Saúde , Formulação de Políticas , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Pessoal Administrativo , Comportamento Cooperativo , Tomada de Decisões , União Europeia , Humanos
6.
Clin Pharmacol Ther ; 105(4): 899-911, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30653670

RESUMO

Model-informed drug development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision-making process. MIDD was formally recognized in Prescription Drug User Fee Act (PDUFA) VI. There have been many regulatory applications of MIDD to address a variety of drug development and regulatory questions. These applications can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, and informing policy. Case studies, literature papers, and published regulatory documents are reviewed in this article to highlight some common features of these applications in each category. In addition to the further development and investment in these established domains of application, new technology, and areas, such as more mechanistic models, neural network models, and real-world data/evidence, are gaining attention, and more submissions and experiences are being accumulated to expand the application of model-based analysis to a wider scope.


Assuntos
Desenvolvimento de Medicamentos/legislação & jurisprudência , Tomada de Decisões , Medicina Baseada em Evidências/legislação & jurisprudência , Humanos , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
7.
Clin Pharmacol Ther ; 105(4): 935-942, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30472729

RESUMO

There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide a value-based approach to meeting society's most important healthcare needs. The Centre for Innovation in Regulatory Science (CIRS) identified key issues regarding the confluence of regulatory and health technology assessment processes from discussions and presentations given by international regulators, health technology assessment bodies, payers, patient representatives, and multinational pharmaceutical company representatives on this topic at CIRS workshops held in 2014 and 2017 that focused on the commonalties and differences across these pathways. Recent publications have also been highlighted. The barriers to and opportunities for aligning stakeholder expectations and needs were investigated and recommendations provided. Early dialogue among the stakeholders is the process that will likely provide the greatest return on investment of time and effort to identify, develop, review, and recommend important new medicines, especially those that address an unmet medical need.


Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Assistência à Saúde/legislação & jurisprudência , Regulamentação Governamental , Humanos
8.
Clin Pharmacol Ther ; 105(4): 912-922, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30178490

RESUMO

Judicious use of real-world data (RWD) is expected to make all steps in the development and use of pharmaceuticals more effective and efficient, including research and development, regulatory decision making, health technology assessment, pricing, and reimbursement decisions and treatment. A "learning healthcare system" based on electronic health records and other routinely collected data will be required to harness the full potential of RWD to complement evidence based on randomized controlled trials. We describe and illustrate with examples the growing demand for a learning healthcare system; we contrast the exigencies of an efficient pharmaceutical ecosystem in the future with current deficiencies highlighted in recently published Organisation for Economic Co-operation and Development (OECD) reports; and we reflect on the steps necessary to enable the transition from healthcare data to actionable information. A coordinated effort from all stakeholders and international cooperation will be required to increase the speed of implementation of the learning healthcare system, to everybody's benefit.


Assuntos
Assistência à Saúde/legislação & jurisprudência , Desenvolvimento de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , /legislação & jurisprudência , Tomada de Decisões , Humanos , Cooperação Internacional/legislação & jurisprudência , Ensaios Clínicos Controlados Aleatórios como Assunto/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
10.
JACC Cardiovasc Interv ; 11(21): 2220-2225, 2018 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-30409280

RESUMO

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.


Assuntos
Doenças Cardiovasculares/terapia , Aprovação de Equipamentos/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/fisiopatologia , Difusão de Inovações , Estudos de Viabilidade , Regulamentação Governamental , Humanos , Segurança do Paciente/legislação & jurisprudência , Formulação de Políticas , Fatores de Tempo , Estados Unidos , Fluxo de Trabalho
11.
Value Health Reg Issues ; 16: 66-73, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30195093

RESUMO

OBJECTIVES: To provide a detailed overview of the recent reforms in pharmaceutical pricing and reimbursement processes as well as in other important areas of the pharmaceutical policy in Greece. METHODS: Information was collected via a structured questionnaire. The study used publicly available resources, such as publications, relevant legislation, and statistical data, while health experts were also consulted. RESULTS: Recent pharmaceutical reforms included significant price cuts, increased co-payments and some provisions for vulnerable groups, rebates/clawbacks, mandatory electronic prescribing and prescription by international nonproprietary name, generics substitution, prescription limits and detailed auditing, centralized procurement, as well as changes in the pricing and reimbursement processes, with the introduction of positive and negative lists and an internal price referencing system. Price lists are compiled by the National Organization for Medicines and are issued by the Ministry of Health (MoH). An advisory pricing committee comprising representatives of stakeholder groups was abolished in early 2018. Nevertheless, under the new provisions, a health technology assessment body for the economic evaluation of reimbursed drugs is to be established for the first time in Greece. The committee is to be staffed by experts appointed by a ministerial decision of the MoH. The specific features of the process are yet to be determined. CONCLUSIONS: The pricing and reimbursement decision-making processes are centralized under the competence of the MoH. Despite the good intentions of the reformers, there are still some aspects of transparency, equity, and long-term sustainability that remain under question in Greece.


Assuntos
Custos e Análise de Custo , Controle de Medicamentos e Entorpecentes/tendências , Órgãos Governamentais , Medicamentos sob Prescrição/economia , Mecanismo de Reembolso/economia , Assistência à Saúde/organização & administração , Grécia , Política de Saúde , Humanos , Programas Nacionais de Saúde/economia , Medicamentos sob Prescrição/provisão & distribução , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
12.
Z Evid Fortbild Qual Gesundhwes ; 131-132: 8-16, 2018 04.
Artigo em Alemão | MEDLINE | ID: mdl-29331280

RESUMO

BACKGROUND: In Germany reimbursement for new medical technologies is often enforced before a social court. It is likely that these judicial decisions also affect the sickness funds' decisions on requests for reimbursement and thus patient access to new technologies in general. OBJECTIVES: The aim of this study was to identify the technologies that have repeatedly generated court actions and whether these actions have been successful. The focus was on differences between sectors, technology groups and indications. Based on this, we analysed in a case study whether judicial decisions on the reimbursement of the same technologies vary across the years. MATERIAL AND METHODS: Based on a systematic review, we identified judicial decisions of German social courts on new technologies for the years 2011 to 2016. The analysis included social court decisions on reimbursements for technologies used in the treatment of individual patients. RESULTS: 284 judicial decisions on new technologies were considered in the analysis. In one third of the cases, the sickness funds were required to reimburse the costs, with a higher percentage in inpatient than in outpatient care. Technologies used in treatment of diseases of the eyes and the ears were granted most frequently. In cases involving similar circumstances the social courts sometimes came to conflicting decisions; these decisions are, in part, contradictory to subsequent assessments by the Joint Federal Committee (G-BA). CONCLUSIONS: Decisions as to whether reimbursement for new technologies is granted or not do not appear to follow a systematic approach. In the context of the seemingly innovation-friendly policy in inpatient care, there is uncertainty with regard to the "generally accepted state of medical knowledge." It is problematic for both patients and their treating physicians that over a number of years legal proceedings are being initiated for technologies that have not been subjected to a systematic assessment of their benefit.


Assuntos
Reembolso de Seguro de Saúde , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Custos e Análise de Custo , Alemanha , Humanos , Seguro Saúde , Reembolso de Seguro de Saúde/legislação & jurisprudência , Saúde Pública
13.
Health Res Policy Syst ; 15(1): 89, 2017 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-29041939

RESUMO

This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic 'methods' in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears to be much more regulated than the inpatient sector (based on a strict separation of the two care settings), developments in Germany have led to a more tightened assessment framework, making the use of evidence a firm component in the decision-making process. Nevertheless, a comprehensive approach for a systematic assessment of diagnostic and therapeutic 'methods' still does not exist. Readjustments of current regulations in Germany, such as the existing 'Verbotsvorbehalt' (i.e. provision of a diagnostic and therapeutic 'method' possible unless actively delisted) in the inpatient care setting, as well as further developments at the European level are needed in order to create a system that ensures early access to innovation under controlled study conditions.


Assuntos
Tomada de Decisões , Técnicas e Procedimentos Diagnósticos/normas , Avaliação da Tecnologia Biomédica/organização & administração , Análise Custo-Benefício , Técnicas e Procedimentos Diagnósticos/economia , Medicina Baseada em Evidências , Alemanha , Humanos , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/normas
14.
Int J Technol Assess Health Care ; 33(3): 396-401, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28756795

RESUMO

OBJECTIVES: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. METHODS: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. RESULTS: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. CONCLUSIONS: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.


Assuntos
Medicamentos sob Prescrição/economia , Medicina Estatal/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração , Controle de Custos , Custos e Análise de Custo , Grécia , Política de Saúde , Humanos , Reembolso de Seguro de Saúde/legislação & jurisprudência , Uso Off-Label/legislação & jurisprudência , Medicina Estatal/economia , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
15.
Int J Technol Assess Health Care ; 33(3): 365-370, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28831942

RESUMO

OBJECTIVES: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. METHODS: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. RESULTS: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. CONCLUSIONS: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.


Assuntos
Custos e Análise de Custo/métodos , Controle de Medicamentos e Entorpecentes/organização & administração , Reembolso de Seguro de Saúde/normas , Avaliação da Tecnologia Biomédica/organização & administração , Bulgária , Custos e Análise de Custo/normas , Assistência à Saúde/organização & administração , Controle de Medicamentos e Entorpecentes/economia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Humanos , Medicamentos sob Prescrição/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
16.
Health Policy ; 121(11): 1139-1146, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28807332

RESUMO

Synthetic biology is an emerging technology with potential benefits to various fields, yet also contains potential risks to human and environmental health. The field remains in an emerging state with limited quantitative guidance and a small but growing population of international researchers that conduct work within this field. Given the uncertain nature of this technology, an adaptive and anticipatory governance framework may be necessary to balance the potential benefits that may accrue from the technology's continued research alongside a desire to reduce or eliminate potential risks that may arise. However, such developments must account for the unique political and institutional factors that form a government's risk culture - something that can facilitate or impede the development of adaptive synthetic biology governance moving forward. The TAPIC framework helps illustrate those factors that are essential to develop good governance for emerging technologies like synthetic biology. Specifically, an application of TAPIC to synthetic biology governance indicates that the factors of accountability, participation, and integrity must be bolstered to improve technology governance in governments like with the United States, European Union, and Singapore.


Assuntos
Medição de Risco , Biologia Sintética/legislação & jurisprudência , União Europeia , Singapura , Responsabilidade Social , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Estados Unidos
17.
Int J Technol Assess Health Care ; 33(3): 376-383, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28803589

RESUMO

OBJECTIVES: The aim of this study was to provide a brief, 7-year history of health technology assessment (HTA) implementation in Croatia through national and international activities. METHODS: We used retrospective descriptive analysis of key documents related to the legal framework, process of decision making, and HTA. Analysis of the Agency's plan for and experience with the implementation of a transparent HTA process in Croatia was performed by addressing seven key components of the HTA implementation scorecard framework. The main challenges and facilitating factors were also assessed. RESULTS: HTA is not yet fully implemented in Croatia. The main challenges are the insufficient legal framework, limited human and financial resources, and limited stakeholder involvement. Facilitating factors are active international collaboration and education through EUnetHTA and the International Society for Pharmacoeconomics and Outcomes Research and production of national and international HTA reports. CONCLUSIONS: The HTA process is not yet sustainable in Croatia and HTA reports are still not mandatory for reimbursement/investment or disinvestment decision processes. There are still barriers to overcome.


Assuntos
Assistência à Saúde/organização & administração , Medicina Estatal/organização & administração , Avaliação da Tecnologia Biomédica/normas , Croácia , Tomada de Decisões , Assistência à Saúde/economia , Alocação de Recursos para a Atenção à Saúde , Reforma dos Serviços de Saúde/organização & administração , Humanos , Cooperação Internacional , Estudos Retrospectivos , Medicina Estatal/economia , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
18.
Tech Vasc Interv Radiol ; 20(2): 109-115, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28673647

RESUMO

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients.


Assuntos
Aprovação de Equipamentos/legislação & jurisprudência , Equipamentos e Provisões , Setor de Assistência à Saúde/legislação & jurisprudência , Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência , Determinação de Necessidades de Cuidados de Saúde/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Difusão de Inovações , Desenho de Equipamento , Equipamentos e Provisões/efeitos adversos , Necessidades e Demandas de Serviços de Saúde/organização & administração , Humanos , Determinação de Necessidades de Cuidados de Saúde/organização & administração , Segurança do Paciente , Medição de Risco , Fatores de Risco , Avaliação da Tecnologia Biomédica/organização & administração , Estados Unidos
19.
Tech Vasc Interv Radiol ; 20(2): 116-120, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28673648

RESUMO

Intellectual property (IP) is a term that describes a number of distinct types of intangible assets. IP protection allows a rightsholder to exclude others from interfering with or using the property right in specified ways. The main forms of IP are patents, copyrights, trademarks, and trade secrets. Each type of IP protection is different, varying in the subject matter that can be covered, timeframe of protection, and total expense. Although some inventions may be covered by multiple types of IP protection, it is important to consider a number of business and legal factors before selecting the best protection strategy. Some technologies require strong IP protection to commercialize, but unnecessary costs can derail bringing a product to market. IP departments of organizations weigh these various considerations and perform essential IP protection functions. This primer introduces researchers to the main forms of IP and its legal aspects.


Assuntos
Setor de Assistência à Saúde , Necessidades e Demandas de Serviços de Saúde , Propriedade Intelectual , Determinação de Necessidades de Cuidados de Saúde , Avaliação da Tecnologia Biomédica , Direitos Autorais , Difusão de Inovações , Desenho de Equipamento , Setor de Assistência à Saúde/legislação & jurisprudência , Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência , Necessidades e Demandas de Serviços de Saúde/organização & administração , Humanos , Determinação de Necessidades de Cuidados de Saúde/legislação & jurisprudência , Determinação de Necessidades de Cuidados de Saúde/organização & administração , Patentes como Assunto , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/organização & administração
20.
Int J Technol Assess Health Care ; 33(3): 384-389, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28662733

RESUMO

OBJECTIVES: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA). METHODS: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies. RESULTS: Healthcare law creates conditions that allow implementation of the principle "value for money." The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal. CONCLUSIONS: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.


Assuntos
Avaliação da Tecnologia Biomédica/organização & administração , Controle de Custos/organização & administração , Custos de Medicamentos , Controle de Medicamentos e Entorpecentes/organização & administração , Política de Saúde , Humanos , Programas Nacionais de Saúde/organização & administração , Qualidade da Assistência à Saúde , Sérvia , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
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