Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

Responsiveness and the Role of Rights in Medical Law: Lessons from Montgomery†.

Over time, medical law has moved away from paternalism in favour of an approach grounded in patients' rights. Using Montgomery v Lanarkshire Health Board (2015) as a case study, we offer a deeper analysis of this emerging approach. We argue that patients' rights should be evaluated in terms of their contribution to making medical law more socially responsive, by developing it to give effect to social needs and aspirations pertaining to health care. Although rights can play an important role in achieving social responsiveness, they also carry the risk of entrenching approaches unrepresentative of patients' actual needs and empirical realities. This is evident in Montgomery, where the law, despite being derived from General Medical Council (GMC) guidance, has effects that differ significantly from the GMC's goals. Drawing on socio-legal literature, we outline a new approach for guiding the use of rights in medical law focused on the functional consequences of rights in facilitating patients' aspirations, and the capacity of rights to respond to social and institutional contexts in which medical interaction occurs. We conclude by showing how this approach, applied to informed consent, would produce a different and arguably a superior duty, providing a sounder basis for responding to patient needs.