Contemporary Issues in Law - Volume 13 - Issue 4
DEFECTIVE MEDICAL DEVICES: ANALYSING THE ROLE OF THE CRIMINAL LAW IN THE PIP BREAST IMPLANTS SCANDAL
Mélinée Kazarian Senior Lecturer in Law, University of Portsmouth
In the wake of recent healthcare scandals involving company directors deliberately breaching regulatory requirements at the expense of patient safety, the question has arisen whether criminal law would be useful to hold directors to account, deliver justice to patients, and ensure safety in medical devices and products. This article examines the role of the criminal law in the PIP breast implants scandal in France, which involved company directors being held criminally liable for fraudulently manufacturing and supplying faulty breast implants to thousands of patients worldwide. The article shows that convictions of PIP directors for tromperie(deception) in a first set of proceedings were successful in meeting some of the victims’ demands, but did not address the deliberate endangering of patients. The article shows that this may not be easily achieved using offences against the person (namely involuntary homicide and involuntary wounding) given the difficulties in proving causation. Instead, when company directors have deliberately put patients at risk of harm, the criminal law should offer a way to penalise deliberate endangering without having to prove that any harm resulted from the conduct. Mise en danger délibérée (deliberately putting someone in danger), which does not require proof of any harm, may therefore assist in the punishment of PIP directors and deliver justice to victims of the scandal. This article also explores the possibility of holding regulators to account for failing to uncover PIP’s fraud soon enough, while demonstrating that criminal liability would be unhelpful in that respect, and instead, reforms should be considered to ensure safety in medical devices.
HARMONISATION OF BIOBANK REGULATIONS IN AFRICA: LESSONS TO BE LEARNED FROM EUROPE
Ciara Staunton Centre for Medical Ethics and Law, Stellenbosch University, South Africa
Biobanks are crucial to the understanding of the complex interplay between genetics and environment in the development of diseases. Inherent in the success of this research is the availability of large quantities of biological samples. To meet this demand large consortia have emerged that promote collaboration and set standards. This research has largely been focused on in the Global North and until the development of the Human Hereditary and Health in Africa (H3Africa)) consortium, biobanking research in Africa was largely confined to small, localised biobanks. Africa is now in the midst of a genomic revolution with the development of capacity across the continent. However this new research faces serious governance challenges. The H3Africa project requires collaboration across borders, yet many African countries either have restrictive rules on cross-border movement of samples, or the legal regime is simply not adequate to deal with this new and emerging technology. Where there are rules and regulations in place, they are often in conflict with national legislation, regulations and ethical requirements as well as the local rules of the biobank itself all governing the use of the samples. There is also considerable cultural diversity across the continent and biological samples often have special significance not seen elsewhere. However, the success of any large consortia such as H3Africa is dependent on collaboration and this can be encouraged by the development of harmonised governance frameworks between international collaborators. However, Europe has had to deal with many of these issues that are facing Africa and this has not had a detrimental impact on the research. This article will thus examine the European experience with biobank governance and ascertain what, if any, lessons can be learned for Africa as it seeks to strengthen its governance frameworks.
PROTECTING HUMAN DIGNITY: REFRAMING THE ABORTION DEBATE TO RESPECT THE DIGNITY OF CHOICE AND LIFE
Samantha Halliday Associate Professor, University of Leeds