Ethical and Social Values for Paediatric Health Technology Assessment and Drug Policy.

BACKGROUND: Public policy approaches to funding paediatric medicines in advanced health systems remain understudied. In particular, the ethical and social values dimensions of health technology assessment (HTA) and drug coverage decisions for children have received almost no attention in research or policy. METHODS: To elicit and understand the social values that influence decision-making for public funding of paediatric drugs, we undertook a series of in-depth, semi-structured interviews with a stratified purposive sample (n = 22) of stakeholders involved with or affected by drug funding decisions for children at the provincial (Ontario) and national levels in Canada. Constructivist grounded theory methodology guided data collection and thematic analysis. RESULTS: Our study provides empirical evidence about the unique ethical and social values dimensions of HTA for children, and describes a novel social values typology for paediatric drug policy decision-making. Three principal categories of values emerged from stakeholder reflections on HTA and drug policy-making for children: procedural values, structural values, and sociocultural values. Key findings include the importance of attention to the procedural legitimacy of HTA for children, with emphasis on the inclusion of child health voices in processes of technology appraisal and policy uptake; a role for HTA institutions to consider the equity impacts of technologies, both in setting review priorities and in assessing the value of technologies for public coverage; and the potential benefits of a distinct national framework to guide drug policy for children. CONCLUSION: Current approaches to HTA are not well designed for the realities of child health and illness, nor the societal priorities regarding children that our study identified. This research generates new knowledge to inform decision-making on paediatric drugs by HTA institutions and government payers in Canada and other publicly-funded health systems, through insights into the relevant social values for child drug funding decisions from varied stakeholder groups.

An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries' methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.

How does HTA addresses current social expectations? An international survey.

OBJECTIVES: Integration of ethics into technology assessment in healthcare (HTA) reports is directly linked to the need of decision makers to provide rational grounds justifying their social choices. In a decision-making paradigm, facts and values are intertwined and the social role of HTA reports is to provide relevant information to decision makers. Since 2003, numerous surveys and discussions have addressed different aspects of the integration of ethics into HTA. This study aims to clarify how HTA professionals consider the integration of ethics into HTA, so an international survey was conducted in 2018 and the results are reported here. METHODS: A survey comprising twenty-two questions was designed and carried out from April 2018 to July 2018. Three hundred and twenty-eight HTA agencies from seventy-five countries were invited to participate in this survey. RESULTS: Eighty-nine participants completed the survey, representing a participation rate of twenty-seven percent. As to how HTA reports should fulfill their social role, over 84 percent of respondents agreed upon the necessity to address this role for decision makers, patients, and citizens. At a lower level, the same was found regarding the necessity to make value-judgments explicit in different report sections, including ethical analysis. This contrasts with the response-variability obtained on the status of ethical analysis with the exception of the expertise required. Variability in stakeholder-participation usefulness was also observed. CONCLUSIONS: This study reveals the importance of a three-phase approach, including assessment, contextual data, and recommendations, and highlights the necessity to make explicit value-judgments and have a systematic ethical analysis in order to fulfill HTA's social role in guiding decision makers.

Does Consumer Engagement in Health Technology Assessment Enhance or Undermine Equity?

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner.

Progress bias versus status quo bias in the ethics of emerging science and technology.

How should we handle ethical issues related to emerging science and technology in a rational way? This is a crucial issue in our time. On the one hand, there is great optimism with respect to technology. On the other, there is pessimism. As both perspectives are based on scarce evidence, they may appear speculative and irrational. Against the pessimistic perspective to emerging technology, it has been forcefully argued that there is a status quo bias (SQB) fuelling irrational attitudes to emergent science and technology and greatly hampering useful development and implementation. Therefore, this article starts by analysing the SQB using human enhancement as a case study. It reveals that SQB may not be as prominent in restricting the implementation of emergent technologies as claimed in the ethics literature, because SQB (a) is fuelled by other and weaker drivers than those addressed in the literature, (b) is at best one amongst many drivers of attitudes towards emergent science and technology, and (c) may not be a particularly prominent driver of irrational decision-making. While recognizing that SQB can be one driver behind pessimism, this article investigates other and counteracting forces that may be as strong as SQB. Progress bias is suggested as a generic term for the various drivers of unwarranted science and technology optimism. Based on this analysis, a test for avoiding or reducing this progress bias is proposed. Accordingly, we should recognize and avoid a broad range of biases in the assessment of emerging and existing science and technology in order to promote an open and transparent deliberation.

Picturing ELSI+: a visual representation of ethical, legal, and social issues, and patient experiences in Health Technology Assessment in Canada.

OBJECTIVES: Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA. METHODS: We conducted a scoping review (Medline and EMBASE, 2000-2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters. RESULTS: Our final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters. CONCLUSIONS: This study suggests an alternative approach to ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.

Mapping the rise of digital mental health technologies: Emerging issues for law and society.

The use of digital technologies in mental health initiatives is expanding, leading to calls for clearer legal and regulatory frameworks. However, gaps in knowledge about the scale and nature of change impede efforts to develop responsible public governance in the early stages of what may be the mass uptake of 'digital mental health technologies'. This article maps established and emerging technologies in the mental health context with an eye to locating major socio-legal issues. The paper discusses various types of technology, including those designed for information sharing, communication, clinical decision support, 'digital therapies', patient and/or population monitoring and control, bio-informatics and personalised medicine, and service user health informatics. The discussion is organised around domains of use based on the actors who use the technologies, and those on whom they are used. These actors go beyond mental health service users and practitioners/service providers, and include health and social system or resource managers, data management services, private companies that collect personal data (such as major technology corporations and data brokers), and multiple government agencies and private sector actors across diverse fields of criminal justice, education, and so on. The mapping exercise offers a starting point to better identify cross-cutting legal, ethical and social issues at the convergence of digital technology and contemporary mental health practice.

What Are Criteria for Considering Technologies' Uses and Influences in LMICs' Health Care Infrastructures?

A lack of health technology is an obstacle to health system growth in low- and middle-income countries (LMICs). US-based clinicians participating in global health efforts might sometimes wonder about clinical and ethical standards by which they should judge short- and long-term risks and benefits of bringing technological assistance with them to care for patients in LMICs. These countries are heterogeneous and changing, so establishing an evidence base for clinical and ethical decision making about technology use could be an important priority. This article suggests clinically and ethically relevant criteria according to which health technologies' use and influence can be evaluated.

An Ethical Analysis of Coverage With Evidence Development.

Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost-effectiveness that is prominent and fairly clearly defined.

Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment.

OBJECTIVES: Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®. METHODS: The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis. RESULTS: The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process. CONCLUSIONS: The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

Health Technology Assessment of Public Health Interventions Published 2012 to 2016: An Analysis of Characteristics and Comparison of Methods.

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

Ethical Challenges Related to Patient Involvement in Health Technology Assessment.

Including information and values from patients in HTA has the potential to improve both the process and outcomes of health technology policy decisions. Accordingly, funding and structural incentives to include patients in HTA activities have increased over the past several years. Unfortunately, these incentives have not yet been accompanied by a corresponding increase in resources, time, or commitment to responsiveness. In this Perspectives piece, we reflect on our collective experiences participating in, conducting, and overseeing patient engagement activities within HTA to highlight the ethical challenges associated with this area of activity. While we remain committed to the idea that patient engagement activities strengthen the findings, relevance, and legitimacy of health technology policy, we are deeply concerned about the potential for these activities to do ethical harm. We use this analysis to call for action to introduce strong protections against ethical violations that may harm patients participating in HTA engagement activities.

Mobile health ethics and the expanding role of autonomy.

Mhealth technology is mushrooming world-wide and, in a variety of forms, reaches increasing numbers of users in ever-widening contexts and virtually independent from standard medical evidence assessment. Yet, debate on the broader societal impact including in particular mapping and classification of ethical issues raised has been limited. This article, as part of an ongoing empirically informed ethical research project, provides an overview of ethical issues of mhealth applications with a specific focus on implications on autonomy as a key notion in the debate. A multi-stage model of references to the potential of mhealth use for strengthening some or other form of self-determination will be proposed as a descriptive tool. It illustrates an assumed continuum of enhanced autonomy via mhealth broadly conceived: from patient to user autonomy, to improved health literacy, and finally to the vision of supra-individual empowerment and democratised, participatory health and medicine as a whole. On closer examination, however, these references are frequently ambivalent or vague, perpetuating the at times uncritical use of established autonomy concepts in medical ethics. The article suggests zooming in on the range of autonomy-related aspects against the backdrop of digital innovation and datafied health more generally, and on this basis add to existing frameworks for the ethical evaluation of mhealth more specifically.

La actualización del método clínico / Updating on the clinical method

En la actualidad existe desarrollo de la tecnociencia aplicada a la medicina con tendencia a relegar a un segundo plano el método clínico. Las diferentes escuelas de medicina del mundo, incluyendo la cubana, han comenzado una modernización del método clínico, el cual está basado en un método científico, por lo que es importante centrar su enseñanza en aspectos eminentemente prácticos, además de usar adecuadamente los exámenes complementarios para ratificar el diagnóstico, pronóstico y tratamiento del enfermo. El objetivo de esta investigación es aunar criterios sobre la enseñanza y aplicación del método clínico, para ello se hacen algunas reflexiones sobre su utilidad práctica, los programas actuales de su enseñanza y los textos en los que se basa. La conceptualización del método clínico es fruto de la Escuela Cubana de Clínica, donde los internistas han tenido una función importante en los últimos 50 años. Los especialistas de esta área del conocimiento, junto a todos los médicos asistenciales que están en la necesidad de utilizar este método para el manejo de sus enfermos, están llamados a continuar con la tarea de mantener y transmitir la esencia misma de la clínica, en medio de un ambiente inestable y cambiante(AU)

At present, due to the development of techno science applied to medicine, there is a tendency to overshadow the clinical method. Different medical schools in the world, including the Cuban school, have begun the modernization of the clinical method, which is based on the scientific method. Therefore, it is important to focus teaching on the eminently practical aspects, in addition to properly using complementary tests to confirm the patient´s diagnosis, prognosis and treatment. The objective of this research is to combine criteria on the teaching and use of the clinical method. Some reflections arise from its practical convenience, current syllabus and the texts on which it is based. The conceptualization of the clinical method is the result of the Cuban School of Clinic, where internists have played important role in the last 50 years. The specialists of this area of knowledge, together with all the medical assistants who need to use this method for treating their patients, are called to continue with the task of maintaining and transmitting the very essence of the clinic, in the midst of unstable and changing circumstances(AU)

[Ethics in health technology assessment. Review]. / Ética y evaluación de tecnologías sanitarias. Revisión.

INTRODUCTION: Bioethics and the health technologies assessment emerged to help make decisions. The objective of the work was to know, with respect to the health technologies assessment, the scientific production on its ethical issues, the degree of incorporation of these in practice, the inclusion of the values in the deliberative processes and the most relevant approaches to ethical analysis. METHODOLOGY: A narrative review was made, based on a systematic search of literature in both natural and hierarchical language, using the terms technology assessment biomedical, ethics and deliberation (and its related terms). All types of papers published between May 2007 and April 2017 in Spanish, French, English or Italian that included both ethical aspects and health technology assessment were included. The PUBMED, OVID-Medline, Scopus databases and secondary searches were explored from the identified works. The information was extracted by a single researcher and managed with Mendeley and EPIINFO 7.2. RESULTS: A total of 141 papers were identified, including 85 after revision by title and summary, with the following characteristics: 29 reviews (5 systematic), 16 frameworks, 18 methodological works and 29 with description of experiences. Multiple frameworks, approaches and methods in ethical analysis were identified. CONCLUSION: The health technologies assessment has an approach excessively mechanistic, and can be improved by incorporating the values of the stakeholder, through deliberative processes. The methods of ethical analysis that seem most suitable are the axiological ones and those developed specifically for the health technologies assessment.

Maqasid al-Shariah Based Islamic Bioethics: A Comprehensive Approach.

Maqasid al-Shariah based Islamic bioethics is an Islamic bioethics concept which uses the objectives of the Shariah (maqasid al-Shariah) as its approach in analysing and assessing bioethical issues. Analysis based on maqasid al-Shariah based Islamic bioethics will examine any bioethical issues from three main aspects namely intention, method, and output or final goal of the studied issues. Then, the evaluation will be analysed from human interest hierarchy, inclusivity, and degree of certainty. The Islamic bioethics concept is a manifestation of dynamic Islamic jurisprudence which can overcome new complex and complicated bioethical issues such as tri-parent baby technology issues. Therefore, this article will introduce and explain the concept of maqasid al-Shariah based Islamic bioethics and outline a general guidance of maqasid al-Shariah based Islamic bioethics to determine a maqsad (objective) based on standards of human good or well-being (maslahah) and harm (mafsadah).

ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: A SYSTEMATIC REVIEW.

OBJECTIVES: Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA. METHODS: Search criteria included "ethic," "technology assessment," and "HTA". The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method. RESULTS: A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation. CONCLUSIONS: Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

Evaluating and Valuing Drugs for Rare Conditions: No Easy Answers.

We find ourselves in an era of unprecedented growth in the development and use of so-called "orphan" drugs to treat rare diseases, which are poised to represent more than one-fifth of pharmaceutical expenditures by 2022. This widespread use has been facilitated by legislative and regulatory incentives in both the United States and abroad, yet US payers and health systems have not yet made a concerted effort to understand whether and how rare diseases require special considerations on their part and how to adapt traditional methods of health technology assessment and economic evaluation to accommodate these situations. In this article, we explore the general ethical dilemmas that rare diseases present, steps taken by health technology assessment bodies worldwide to define the level of rarity that would necessitate special measures and the modifications to their assessment and valuation processes needed, and the contextual components for rare-disease evaluation that lie outside of the assessment framework as a guide to US decision makers on constructing a formal and relevant process stateside.