Pregnant Women as a 'Vulnerable' Population in the New EU Clinical Trials Regulation: Does This Classification Adequately Consider the Harms Associated with the Exclusion of Pregnant Women from Clinical Research?

AuthorNiamh O'Leary McNeice
PositionBCL (Law and Irish), University College Cork; LLM, University of Edinburgh
(2021) 20 COLR 1
Niamh O'Leary McNeice*
On 2 April 2014, the European Parliament approved the new EU Clinical Trials Regulation.1
Though initially expected to enter into application during 2019, this has been repeatedly
postponed, and the timeframe for the application of the Regulation is, at present, unclear. The
Regulation classifies pregnant women as a ‘vulnerable population’ for the purposes of clinical
research and restricts the conduct of such research on this population unless certain conditions
are met.2
This article seeks to analyse the tension between the harms associated with the inclusion and
exclusion of pregnant women from clinical research, and to assess the extent to which this
classification strikes an appropriate balance between protecting against these harms. There is
now a widely acknowledged need for greater clinical research during pregnancy, so as to
produce evidence-based knowledge on medications for pregnant women and ensure high
quality care.3 This necessity has recently been brought into sharp focus by the COVID-19
pandemic, the response to which calls attention to the need to examine the regulatory approach
to the inclusion of this population in clinical research.4 This tension is founded on the question
of how to balance this need with the need to protect pregnant women and their foetuses from
possible harm during clinical research. It will ultimately be argued that while the harms on both
sides of this question are legitimate and deserving of consideration, the Regulation does not
* BCL (Law and Irish), University College Cork; LLM, University of Edinburgh. I am grateful to Ms Annie Sorby
of the Medical Law and Ethics faculty at Edinburgh Law School for her guidance in respect of this article, and in
relation to this subject area generally. Further thanks to Mairead, Conor, Jack, Aoife and the Editorial Board for
their helpful contributions.
1 Parliament and Council Regulation (EU) 536/2014 of 16 April 2014 on clinical trials on medicinal products for
human use, and repealing Directive 2001/20/EC [2014] OJ L158/1 (the Regulation).
2 ibid articles 10.3, 33.
3 Verina Wild and Nikola Biller-Andorno, ‘Pregnant Women’s Views about Participation in Clinical Research’
in Françoise Baylis and Angela Ballantyne (eds), Clinical Research Involving Pregnant Women (Springer 2016)
122; Indira van der Zande and others, ‘Vulnerability of Pregnant Women in Clinical Research’ (2017) 43(10)
Journal of Medical Ethics 657, 657.
4 Ruth Farrell, Marsha Michie and Rachel Pope, ‘Pregnant Women in Clinical Trials of COVID-19: A Critical
Time to Consider Ethical Frameworks of Inclusion in Clinical Trials’ (2020) 42(4) Ethics and Human Research
17, 19.
(2021) 20 COLR 2
strike an appropriate balance, because it focuses too much on what are arguably lesser harms
associated with the inclusion of pregnant women in clinical research.
To illustrate the inadequacy of the Regulation’s classification of pregnant women, the current
approach to the inclusion of this population in clinical research will be briefly outlined. Its
effect on the provision of medical treatment to this population will be assessed, and the position
of pregnant women in the context of the COVID-19 pandemic will be examined as an example
of this. The classification of pregnant women in the Regulation will be considered, as well as
the extent to which this is influenced by the current approach. In order to assess the possible
intended definition of ‘vulnerability’ for the purposes of the Regulation, a number of
conceptions of vulnerability and their application to pregnant women will then be examined.
The harms associated with the inclusion of pregnant women in clinical research will be
analysed, and their magnitude will be compared to that of the corresponding harms associated
with the exclusion of pregnant women from clinical research. Following this, the extent to
which the classification does not conform to the shift in the international regulatory framework
on clinical research, away from a narrative that perpetuates the exclusion of pregnant women,
will be discussed. The limitations of the practical influence of regulatory language on the
inclusion or exclusion of pregnant women in clinical research will then be assessed. Finally,
this analysis will be built on in order to propose some steps that could be adopted moving
forward, so as to move towards a regulatory classification that strikes a more appropriate
balance between these harms.
The aim of this article is not to suggest that pregnant women should be mandated for inclusion
in all clinical trials. There are undoubtedly situations in which clinical research involving
pregnant women is inappropriate. However, it is suggested that it would be possible for the
Regulation to classify pregnant women in a way that recognises the potential harms associated
with their inclusion in clinical research, without perpetuating an approach that results in their
blanket exclusion.
I Approach to Pregnant Women in Clinical Research and Medical Treatment
The Thalidomide and DES (diethylstilboestrol) Tragedies of the 20th century led to an
increased understanding of the physiological interconnectedness of pregnant women and

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