Medical Law International

To understand the causes of disease and improve diagnosis and treatment regimes, biomedical researchers need access to large numbers of well-characterized data and samples. Over the past decade, biobanks have been established across Europe to collect and manage access to data and samples. The challenge that we face is how to develop the tools and collaborations to enable researchers to access samples and data from a network of biobanks, rather than applying to individual biobanks. One of the perceived stumbling blocks to achieving this is represented by the different legal requirements in each country. The aim of the BioSHaRE-European Union (EU) project is to address these challenges by developing tools and methods for researchers to access and use pooled data from different cohort and biobank studies. The purpose of this article is to identify and compare the key legal requirements regarding research use of data across biobanks based in Finland, Germany, the Netherlands, Norway and the UK. Our investigation starts with the analysis of the key differences for the use of data between these countries. As a result, we identified three key areas where legal requirements differ across the five BioSHaRE-EU jurisdictions, namely, in the definition of personal data, the requirements regarding pseudonymization and processing for medical research purposes. This article provides an overview of these differences and describes them in the light of the proposed EU regulation on data protection.

The common law in the United Kingdom dictates that children facing medical treatment should be treated in accordance with their best interests. The Children Act 1989 also demands that the welfare of the child is paramount. However, in light of the creation of saviour siblings after the case of Quintavalle, it is disputed that the donor child is treated in accordance with his/her best interests when undergoing a non-therapeutic procedure for the benefit of another. The Human Tissue Authority (HTA) can, for example, validate a bone marrow harvest on a child created specifically for harvest without the consent of the High Court. The doctrine of substituted judgement was developed in the United States to substitute a previously competent adult decision, but it is proposed that parents of saviour siblings are reviving it in a modified form to install a speculative psychological benefit into the saviour child to satisfy the criteria for a harvest in common law. As a result, there is a glaring discrepancy between the objective jurisdiction of the courts and the validation of non-therapeutic harvesting procedures upon children by the HTA, opening the door to potential legal action.

In April 2014, the Law Commission published its report, Regulation of Health Care Professionals and Regulation of Social Care Professionals in England. This provides a timely reminder that medical regulation remains potentially problematic and contentious. In this article, I review the origins of the so-called state–medical profession bargain created in 1858, the history of its effectiveness, or lack of effectiveness, and the extent to which recent regulatory developments and the Law Commission proposals constitute significant renegotiation of the bargain. I conclude by considering whether the proposal may even represent the beginnings of state imposition of a new bargain, in which other health-care professions might significantly challenge the traditional dominance of doctors.

The current debate surrounding the Medical Innovation Bill purports to be aimed at improving the normative framework to the extent that innovation is more likely. A closer look at the mechanisms of the proposed legislation and a more detailed assessment of the reasons given for initiating the legislative process in this instance reveal that the Bill seem to rest on a significant misunderstanding of the current law of medical negligence. This article analyses the provisions of the Bill, puts them into the wider context of medical negligence and critically reviews the utility of the proposed legislation.