What does the EU (Withdrawal) Bill mean for health law?

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Here (and here in longer form) is my take* on what the EU (Withdrawal) Bill means for health law and policy. The analysis is necessarily speculative: the Bill is just published, and hasn’t yet been through Commons or Lords. With the government’s narrow majority, it’s even more so.

The Withdrawal Bill repeals the European Communities Act 1972 and creates a new formal source of UK law: ‘retained EU law’ (an umbrella term in the Bill).

‘Retained EU law’ includes ‘domesticated EU law’ and EU-derived domestic law.

Domesticated EU law is EU law which is currently ‘directly applicable’ in UK law (applies without further ado once adopted at EU level). Health law examples include: Advanced Therapy Medicinal Products Regulation 1394/2007; the Data Protection Regulation 2016/679. One to look out for: the new EU Clinical Trials Regulation is yet to enter into effect. It would have to be operative immediately before Brexit day to be covered by the Bill’s terms. It will not be because the relevant database will not be operative in time.

EU-derived domestic law is UK law derived from EU law that is already incorporated into UK law. A health law example is UK compliance with Human Tissue and Cells Directive through the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2004, and the Human Fertilisation and Embryology Act 1990.

Retained EU law will be amended.

It will be amended through primary legislation: e.g. an Immigration Bill. This has been misleadingly portrayed as ensuring continuity for EU citizens in UK unless changes are approved by Parliament. In reality, everything will change and this has serious implications for health and social care staffing and recruitment to health research posts in UK. It also has implications for UK nationals in the EU-27. When the Immigration Bill emerges, health law and policy community should therefore pay careful attention.

It will also be amended through delegated legislation. The Withdrawal Bill confers a great deal of power on ministers to address ‘deficiencies’ in retained EU law.

A ‘deficiency’ is defined by implication by reference to the view of the relevant minister. It is not defined any more than this, but the Government’s Explanatory Notes preclude its interpretation as merely any EU law ‘a minister considers… was flawed prior to exit.’

If the executive power to address ‘deficiencies’ is as sweeping as it appears, every aspect of health law pertaining to the UK’s withdrawal agreement could be altered by executive powers. For example, a change to the rights of R-EU nationals to healthcare access in UK negotiated by the withdrawal agreement/due to no-deal Brexit could be implemented via delegated legislation. Functions of EU entities (like the European Medicines Agency) that must, following Brexit, be carried out by existing UK public authorities or newly-established bodies could be defined by ministers alone. Where EU law currently requires and facilitates information-sharing with EU institutions, such as sharing data on cancer outcomes or sharing information about adverse effects of pharmaceuticals, executive decisions could decide what UK law will require. What’s more – even though health is a devolved power – the Bill essentially gives power to Westminster/Whitehall, and effectively undermines the role of the devolved nations/regions completely.

All of this is particularly worrying if there is a ‘no deal’ Brexit. The Withdrawal Bill (if adopted as it stands) gives executive power to remove regulatory oversight. If there’s no deal, there will be no external source of regulatory standards as there is now. If the UK government pursues a low regulation economy, as it has at times threatened, there will be serious ramifications for health law.

The overall lack of parliamentary scrutiny of changes to health law is particularly problematic: Even where health law is notionally ‘technical’, the ‘technical’ choices made have significant normative implications, including for individuals’ lives, their dignity, and perhaps even their identities. Thus democratic processes are necessary to its fair implementation.

What should we be doing?

Anyone who is worried about these proposed changes to UK health law – health lawyers and health policy stakeholders – should be persuading Parliament to provide effective scrutiny of the Withdrawal Bill. We should also watch what is proposed in the UK withdrawal agreement, primary legislation, and delegated legislation, and be clear about what it means for health.

There may be some small opportunities in this landscape of chaos. We’d be healthier overall in the EU: that much is clear. Much of what we need to do now is to secure as healthy a Brexit as we can – it’s damage limitation. But we could make some small changes to UK health law for the better. For instance, some want to change working time rules for the NHS. We could review our position that NHS plasma for those under 21 comes from Austria. We could bring together rules on marketing pharmaceuticals with those on more complex medical devices.

There are huge dangers. We stand to lose a human-rights inspired approach to health regulation, which has implications for public health issues such as tobacco or alcohol regulation. A low taxation and regulation agenda would be not far short of a disaster for health and the NHS.

What we do have on our side is the political capital of the referendum to use to get a seat at the table when the implications of Brexit for health are discussed.

Brexit bus

*with huge thanks to Sarah McCloskey, Brexit Intern, and Sheffield Law School for funding the internship

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