Personalised medicine, digital innovations, and neuro-technologies all offer significant potential benefit for human health and welfare, but also raise complex governance challenges. A variety of approaches have been adopted in the governance of innovative medicines and health technologies, including risk assessment, ethics and self-governance. Recently anticipatory or ‘upstream’ modes of governance have garnered favour. Anticipatory regulation demands a closer relationship between regulators and innovators, to shape the trajectories of the technology. In the EU context, responsible research and innovation has emerged as a key mechanism of governance. This is linked but distinct from a human rights governance which has the advantage of exerting both legal and moral force. What is needed in the healthcare context are governance models which ensure human rights considerations are taken into account from the earliest stages of innovation, to maximise the likelihood that developments are from the outset beneficial and oriented towards protecting ethical values.
The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic and accelerate innovation to protect global health. In order to be prepared and to be able to respond immediately to serious epidemic and pandemic diseases, the EU has already adopted the Decision No (EU) 1082/2013 on serious cross-border threats to health. The World Health Organization (WHO) has established a global system to collect genetic material and information to protect a global influenza pandemic outbreak. The article describes the current legal landscape under EU and international law.
There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.
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.