The use of machine learning (ML) in medicine is becoming increasingly fundamental to analyse complex problems by discovering associations among different types of information and to generate knowledge for medical decision support. Many regulatory and ethical issues should be considered. Some relevant EU provisions, such as the General Data Protection Regulation, are applicable. However, the regulatory framework for developing and marketing a new health technology implementing ML may be quite complex. Other issues include the legal liability and the attribution of negligence in case of errors. Some of the above-mentioned concerns could be, at least partially, resolved in case the ML software is classified as a ‘medical device’, a category covered by EU/national provisions. Concluding, the challenge is to understand how sustainable is the regulatory system in relation to the ML innovation and how legal procedures should be revised in order to adapt them to the current regulatory framework.
The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.
Healthcare systems face challenges due to budget constraints, complex therapies, and new treatments for rare diseases. One of the most successful patient advocacy campaigns of all times was initiated by people living with HIV and AIDS in African countries. Facing industry giants, they won court cases allowing governments to ignore intellectual property rights when the price of a medicine was abnormally high. This led to the approval of the international ‘Agreement on Trade Related aspects of Intellectual Property Rights’, which contributed to improving the availability of AIDS treatments for millions of people. Beyond this successful patient advocacy campaign, patient organisations have an important role to play in national discussions on prices of treatments and pharmaceuticals, especially for rare diseases. This article first discusses the specificity of the pricing of orphan medicinal products, and then provides an overview of some of the important actions that can be carried out by patients’ organisations.
This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.
‘Do not resuscitate’ (DNR) imprints on the human body have recently appeared in medical practice. These non-standard DNR orders (e.g., tattoos, stamps, patches) convey the patient’s refusal of resuscitation efforts should he be incapable of doing so. The article focuses on such innovative tools to express one’s end-of-life wishes. Switzerland provides a unique example, as ‘No Cardio-Pulmonary Resuscitation’ stamps and patches have been commercialised. The article discusses the challenging legal questions as to the validity of non-standard DNR orders imprinted on the human body. It analyses the obligation of healthcare providers to honour such orders, either as an advance directive or an expression of an individual’s presumed wishes, and withhold treatment. Finally, the article addresses the balancing of interests between the presumed wishes of an unconscious patient and his best interests of being resuscitated and potentially staying alive, a dilemma facing healthcare providers in a medical emergency.
New treatment options for various cancer therapies appear to be extremely expensive and prices may increase further. The affordability and availability of life-saving medicines is therefore a key issue in the national health policies of all countries. International and European law grant several price-reducing options, including compulsory licensing. Still, countries are reluctant to apply for compulsory licensing and/or other regulatory options to curtail pharmaceutical prices. Why is that? Evaluating the options will support health policy decision-making on safeguarding access to affordable innovative medicines.
This contribution examines deprivation of liberty in Belgian healthcare within the frameworks of the ECHR and CRPD. We develop and apply an ECHR-based framework to demonstrate that it is not the admissions to care facilities based on Belgium’s involuntary commitment law that give rise to the unjustified deprivation of liberty, but those based on representation regimes. This can be remedied by broadening Belgium’s involuntary commitment law. However, doing so would go against a CRPD-based framework, which is incompatible with the ECHR; the former opposes disability-based laws. Building on the right to legal capacity and to liberty, the scope of the CRPD’s approach is uncovered. It is suggested that to reconcile the two frameworks, Belgium’s involuntary commitment law should be abolished, and representation regimes should be changed to avoid (rather than to justify) deprivation of liberty. Although its desirability is open for discussion, this could solve a problem that occurs worldwide.