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Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.

In: European Journal of Health Law
Author: Éloïse Gennet

Abstract

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.

In: European Journal of Health Law

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.

In: European Journal of Health Law