'Governing Commercial Access to Health Data For Public Benefit: Charity Law Solutions' by Jessica L Bell in (2019)
Medical Law Review 1–23 comments
There is a growing body of evidence that supports the view that research participants
and the public are concerned about commercial access to health data. Evidence also
suggests that attitudes are ameliorated when charity organisations are involved and
where research promises to deliver ‘public benefit’. To a significant extent, therefore,
mechanisms that ensure the public benefit are key to sustaining public and participant
support for research access to health data. As a regime founded on the concept of public
benefit, charity law provides regulatory and governance mechanisms through which the
public benefit of a charity is protected and promoted. This article examines the merits
of charity law mechanisms and analyses their significance for governance of commercial
access to health data for public benefit, using UK Biobank Ltd, a charitable company
limited by guarantee, as an example. The article critically analyses three charity law
mechanisms that operate to ensure that an organization providing access to data meets
its public benefit requirements: charitable purposes; members’ and directors’ powers
and duties; and accountability via the oversight powers of the Charity Commission and
charity proceedings in court. The article concludes that there is potential for the charity
model to be the benchmark for governing commercial access to health data for public
benefit research, but notes the limitations of the model and recommends the appointment of independent data governance committees to further bolster the charity law
framework.
Bell argues
The past decade has seen substantial developments in the scale, scope, availability and
use of health data for direct healthcare and secondary purposes such as research. Both private and public organisations are collecting, storing, accessing, analysing and
releasing health data for profit and not-for-profit objectives. However, empirical studies indicate that the public are concerned about health data being shared with private
companies. The most recent studies that have explored different types of commercial
access have revealed that attitudes are ameliorated in the context of research uses of
health data, where an academic or charitable organisation is involved, and where research promises to deliver ‘public benefit’. To a significant extent, therefore, where commercial organisations are accessing
health data, the type of institution and its research objectives will be key to securing
public and participant support for the research. There has been considerable scholarly
and policy debate about the concerns raised by commercial access to health data, as
well as proposals for enhanced involvement of the public and data subjects in the governance of health data as a way of inspiring trust and confidence in health data access. Comparatively little has been written about how different legal structures give rise to
regulatory and governance mechanisms that can serve to protect and promote public
benefit uses of health data, including by commercial users, which will also be key to
maintaining support for research activity.
This article analyses the significance of charity law for governance of commercial
access to health data. Charity law is important for a number of reasons: first, there is
current evidence that indicates a high degree of public trust and confidence in charitable organisations in the health research context, which warrants further exploration,
investigation and protection; second, charity law is founded on the concept of public
benefit, with a corresponding regulatory framework and governance mechanisms that
operate to protect and promote the public benefit in charitable organisations.
Moreover, examples are available of charitable organisations in this context, which
allows for critical analysis of the charity law mechanisms and their application to concerns regarding commercial access to health data. This article will use UK Biobank
Ltd, which has been set up as a charitable company limited by guarantee, as an example of a successful research initiative that provides access (including commercial access) to health data for research purposes, to demonstrate the ways in which the
charity law framework for England and Wales protects and promotes public benefit
research.
The article is in three parts: first, background is provided on the empirical research
on public concerns regarding commercial access to health data and public confidence
in charity institutions. Secondly, the charity law mechanisms that may address these
concerns and ensure the public benefit are analysed, namely: charitable purposes;
powers and responsibilities of charity members and trustees; and accountability
via the Charity Commission for England and Wales and charity proceedings. Finally,
the article reflects on issues for further consideration, noting the potential shortcomings of the charitable model for addressing concerns regarding commercial access to
health data.
