Introducing 'Health Vulnerability'. Towards a Human Right Claim for Innovative Orphan Drugs?

Although several European law instruments specifically promote the development of orphan medicines, rare disease patients still suffer from an excessive lack of access to orphan drugs. In order to base a claim for equity of access to research benefits, health vulnerability is introduced as a human rights-based public health concept. It represents a potentially valuable and powerful means in European law for rare disease patients to claim for an improved public action to develop innovative orphan drugs, including through the use of novel data-driven technologies such as computer modelling and simulation, as they have the potential to palliate some of the obstacles in the current development process of orphan medicines. The human rights-based approach would be all the more valuable, as it would simultaneously draw attention on privacy aspects of vulnerability for orphan disease patients, especially regarding increased risks stemming from the processing of highly sensitive health data.

An update on the "empirical turn" in bioethics: analysis of empirical research in nine bioethics journals.

BACKGROUND: A review of literature published a decade ago noted a significant increase in empirical papers across nine bioethics journals. This study provides an update on the presence of empirical papers in the same nine journals. It first evaluates whether the empirical trend is continuing as noted in the previous study, and second, how it is changing, that is, what are the characteristics of the empirical works published in these nine bioethics journals. METHOD: A review of the same nine journals (Bioethics; Journal of Medical Ethics; Journal of Clinical Ethics; Nursing Ethics; Cambridge Quarterly of Healthcare Ethics; Hastings Center Report; Theoretical Medicine and Bioethics; Christian Bioethics; and Kennedy Institute of Ethics Journal) was conducted for a 12-year period from 2004 to 2015. Data obtained was analysed descriptively and using a non-parametric Chi-square test. RESULTS: Of the total number of original papers (N = 5567) published in the nine bioethics journals, 18.1% (n = 1007) collected and analysed empirical data. Journal of Medical Ethics and Nursing Ethics led the empirical publications, accounting for 89.4% of all empirical papers. The former published significantly more quantitative papers than qualitative, whereas the latter published more qualitative papers. Our analysis reveals no significant difference (χ2 = 2.857; p = 0.091) between the proportion of empirical papers published in 2004-2009 and 2010-2015. However, the increasing empirical trend has continued in these journals with the proportion of empirical papers increasing from 14.9% in 2004 to 17.8% in 2015. CONCLUSIONS: This study presents the current state of affairs regarding empirical research published nine bioethics journals. In the quarter century of data that is available about the nine bioethics journals studied in two reviews, the proportion of empirical publications continues to increase, signifying a trend towards empirical research in bioethics. The growing volume is mainly attributable to two journals: Journal of Medical Ethics and Nursing Ethics. This descriptive study further maps the still developing field of empirical research in bioethics. Additional studies are needed to completely map the nature and extent of empirical research in bioethics to inform the ongoing debate about the value of empirical research for bioethics.

The Council of Europe's Underrated Role in Fostering Equitable Access to Quality Health Care in Times of Pandemic.

Different Council of Europe organs have been attentive and reactive to specific human rights issues in the COVID-19 context, quickly alerting on the risks of inequitable access to quality health care, vaccines, or medicines for vulnerable groups. Yet these reactions have mainly taken the form of nonbinding instruments such as declarations, statements, and recommendations. Although these reactions derive from the interpretation of binding Council of Europe conventions, the observance or implementation of these conventions is not always monitored. Strasbourg judges have on several occasions confirmed that European Convention on Human Rights case law must consider other international instruments, especially those of other Council of Europe organs, in order to interpret the guarantees of the convention. As a consequence, soft law rules can sometimes indirectly acquire binding force when used as an interpretation and implementation tool for binding treaties. In this paper, I examine how Council of Europe organs interpret the principle of equitable access to health care of appropriate quality in the context of a pandemic and whether and how this interpretation is being implemented within the Council of Europe's interpretation of binding treaties such as the Medicrime Convention, the European Social Charter, and the European Convention on Human Rights.

[Chapter 7. Vulnerable elderly people in biomedical research: what are the responses in European law]. / Chapitre 7. Les personnes âgées vulnérables dans les recherches biomédicales?: quelles réponses du droit européen?

As the main medications consumers, elderly persons are estimated to represent up to 30% of the European population in 2050. Paradoxically there is a considerable lack of information about drug prescription in older persons, which is compromising the quality of treatments, and leaving to physicians the considerable responsibility of improvised prescriptions, which are potentially either dangerous or ineffective. In fact, the geriatric population is either excluded from clinical trials or represented by relatively healthy elderly persons who do not accurately represent real world patients. Despite repeated demonstrations of the need to include frail elderly persons in clinical trials in the medical literature, European law only offers disappointing responses to the problem. The frequent decline in older persons' cognitive capacities makes the task even more difficult (cognitive frailty, early dementia like Alzheimer's disease or psychiatric disorders). Many older persons have reduced decision making capacity without benefiting from legal protection yet. Surprisingly, ethics guidelines as well as European law are not very sensitive to the phases before legal incompetence, and do not consider alternative ways to obtain informed consent as suggested in medical and ethical literature. Although these questions fall under national competencies, the issue is common to Europe and solutions will necessarily have to go beyond state borders. Involving the European legislator is essential in order to at least act as an incentive for a better inclusion of frail elderly persons in biomedical research, and for a better promotion of their autonomy.

Integrating Advance Research Directives into the European Legal Framework.

The possibility of using advance directives to prospectively consent to research participation in the event of dementia remains largely unexplored in Europe. Moreover, the legal status of advance directives for research is unclear in the European regulations governing biomedical research. The article explores the place that advance research directives have in the current European legal framework, and considers the possibility of integrating them more explicitly into the existing regulations. Special focus is placed on issues regarding informed consent, the role of proxies, and the level of acceptable risks and burdens.

Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

Vulnerable research participants deserve special protection because of their increased risks of being wronged. Yet, paradoxically, the conduct of trials involving vulnerable groups is sometimes inescapable to develop safe and efficient therapies suitable to these groups. The key question is therefore how to protect vulnerable research participants from harm and exploitation without excluding the populations they belong to from the benefits of research. The European Union faced this challenge in April 2014 when adopting the new Regulation on clinical trials, which will replace the currently applicable 2001 Clinical Trials Directive in 2016. In order to assess the protection of vulnerable persons in the new Regulation, this paper makes four suggestions: first, the need to adopt a risk-based approach to vulnerability in biomedical research; second, to better distinguish between decisional vulnerabilities and health-related vulnerabilities; third, to emphasise the need to preserve the freedom of consent of subjects with decisional vulnerability, who are more susceptible to undue influence; and finally to assert the need of actively promoting specific clinical trials involving people with physical or psychological vulnerabilities. In conclusion, this paper claims that the protection of vulnerable subjects still needs to be improved in the new EU Regulation.