The Genetic Discrimination Observatory: confronting novel issues in genetic discrimination.

Genetic discrimination (GD) is the differential or unfair profiling of an individual on the basis of genetic data. This article summarizes the actions of the Genetic Discrimination Observatory (GDO) in addressing GD and recent developments in GD since late 2020. It shows how GD can take many forms in today's rapidly evolving society.

Balancing Innovation, 'Ordre Public' and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law.

This article analyses the role that 'ordre public' and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to recent patent disputes and, second, examine 'ordre public' and morality exceptions under patent law in international, national and regional law, and the implications for innovation and access to novel treatments. The article argues that patent exceptions should not be used as a blunt policy instrument, nor interpreted in a way that is contrary to the patent system's overall objectives. The 'ordre public' and morality based exceptions in the context of human germline editing should not be interpreted and applied in a way which results in outcomes counterproductive to the goal of balancing innovation with the protection of societal higher normative values. Instead, the application of the exception should be based on a sound understanding of both the underlying science as well as the broader ethical, social, and legal implications, thus enabling case-by-case decisions that provide the basis for patent claim amendments and nuanced purpose-bound protection. Further analysis and debate as to the role that such flexibilities can play in the context of genome editing technologies is therefore both necessary and desirable, and can be facilitated in the ways set out in this article.

3D Printing, Intellectual Property Rights and Medical Emergencies: In Search of New Flexibilities.

The COVID-19 pandemic has exponentially accelerated the use of 3D printing (3DP) technologies in healthcare. Surprisingly, though, we have seen hardly any public intellectual property right (IPR) disputes concerning the 3D-printed medical equipment produced to cope with this crisis. Yet it can be assumed that a great variety of IPRs could potentially have been enforced against the use of various items of equipment printed out without express consent from IP holders. Many reasons might have motivated IP owners not to enforce their rights during the pandemic, such as the fear of acquiring a bad reputation during a declared situation of national emergency. There is no internationally recognised general exception to IPR enforcement for health emergencies, while several - sometimes ineffective - tools, like compulsory licensing, voluntary licensing arrangements and potential TRIPS waivers, have been considered or used to facilitate access to and the distribution of innovations in critical situations. During the COVID-19 emergency, this has meant that the 3DP community has been operating in a state of relative uncertainty including with regard to the risks of IP infringement. This study contextualises these issues for pandemic-relevant 3DP. Building upon experience gathered during the COVID-19 pandemic, we look to the future to see what novel mechanisms within the IPR system could provide the additional flexibility required for dealing more smoothly, with the help and support of digital technologies, with situations such as global health emergencies.

Regulating germline editing in assisted reproductive technology: An EU cross-disciplinary perspective.

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global-scale responsibility and governance should be fostered by promoting cross-disciplinary thinking and multi-level stakeholder involvement in legal and regulatory processes.

When Does Stand-Alone Software Qualify as a Medical Device in the European Union?-The Cjeu's Decision in Snitem and What it Implies for the Next Generation of Medical Devices.

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data.

What lurks in the shadows of the openness hyperbole for biopharmaceuticals?

Recent advances in transparency initiative signify laudable developments. Yet, a closer look on the legal developments indicates that commercially confidential information and personal data will continue to pose persisting challenges for clinical trial transparency and drug development. This article depicts these developments with a particular focus on European Medicines Agency (EMA) and Biologics. We argue that in order to promote the development of innovative biologics and biosimilars, the EMA will need to carefully consider and address such challenges.

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models.

This Viewpoint discusses how regulators across the world should approach the legal and ethical challenges, including privacy, device regulation, competition, intellectual property rights, cybersecurity, and liability, raised by the medical use of large language models.

The new EU-US data protection framework's implications for healthcare.

In July 2023, the United States and the European Union introduced the Data Privacy Framework (DPF), introducing the third generation of cross-border data transfer agreements constituting adequacy with respect to personal data transfers under the General Data Protection Regulation (GDPR) between the European Union (EU) and the US. This framework may be used in cross-border healthcare and research relationships, which are highly desirable and increasingly essential to innovative health technology development and health services deployment. A reliable model meeting EU adequacy requirements could enhance the transfer of patient and research participant data. While the DPF might present a familiar terrain for US organizations, it also brings unique challenges. A notable concern is the ability of individual EU Member States to establish individual and additional requirements for health data that are more restrictive than GDPR requirements, which are not anticipated by the DPF. This article highlights the DPF's potential impact on the healthcare and research sectors, finding that the DPF may not provide the degree of lawful health data transfer desirable for healthcare entities. We examine the DPF against a background of existing Health Insurance Portability and Accountability Act obligations and other GDPR transfer tools to offer alternatives that can improve the likelihood of reliable, lawful health data transfer between the US and EU.