Communicating the Risk of Taking Medicines to (Potentially) Pregnant Women post- Montgomery: A socio-legal exploration

This thesis explores how one key group of Health Care Practitioners (HCPs) navigate competing obligations within relevant regulation governing patient choice and the disclosure and management of risk in Britain, using the case study of sodium valproate (SV), an anti-seizure medication. Since its licensing in 1973 there has been growing understanding of the risks it poses when taken during pregnancy, including congenital malformation and neurodevelopmental impact. Hence, while SV remains the most effective treatment in some cases, restrictions have been placed on prescribing, particularly among women and girls of childbearing potential.

In 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a Pregnancy Prevention Programme (PPP) which removes SV as first line treatment for this patient population and introduces mandatory contraception and an annual risk acknowledgement form (ARAF) into its licensing. Most literature concerning the PPP has focused on implementation. Little attention has been given to 1) how the social history of risk management in pregnancy has influenced the creation of a PPP and 2) how a PPP, as a restrictive form of regulation, can be reconciled with contemporary legal standards of consent and patient choice as reflected in Montgomery.

Through an interview study with 20 consultant neurologists (CNs) with SV prescribing responsibilities, this thesis offers a socio-legal analysis of the interplay between hard law and soft law and how this is, potentially, impacted by societal expectations of risk management in pregnancy. Chapters 1 and 2 situate the PPP for SV in its wider historical and legal context. They explore a context of a demand of complete risk elimination in pregnancy and question whether this can be reconciled with legal developments towards choice and autonomy, as considered in Chapter 3. Following a discussion of methodology, analytical approach and study design in Chapter 4, Chapters 5, 6 and 7 present my analysis of the interviews, to discuss 1) how CNs perceive their responsibilities in managing risk, 2) how CNs perceive their patients' responsibilities in managing risk, and 3) how CNs operate in the shadows of an inconsistent regulatory framework. Using sociological concepts such as 'reproductive citizenship' and 'democratised risk', my analysis suggests that UK jurisprudence on patient autonomy and informed consent does little to support medical decision making in the context of teratogenic risk and a PPP.