Pushing boundaries: the Medical Innovation Bill and the constitution

Published 03/02/2015   |   Last Updated 27/05/2021   |   Reading Time minutes

The Assembly is due to vote today on whether or not to approve a Legislative Consent Motion (LCM) for Lord Saatchi’s Medical Innovation Bill. The LCM process is how the Assembly provides, or refuses to provide, agreement for the UK Parliament to pass laws in areas devolved to Wales. There’s been some debate recently about whether or not the Medical Innovation Bill touches on devolved matters, and whether an LCM is necessary. The UK Government says the Bill relates to modifying the law of tort, which isn’t a devolved matter, and so there’s no need for an LCM. The Welsh Government doesn’t agree and says the Bill relates to health, which is devolved. The Welsh Government has therefore put forward the LCM.

Adding to the debate further, the Welsh Government thinks the Bill is unnecessary and that it shouldn’t apply to Wales.

What does the Bill propose to do?

The Medical Innovation Bill is a Private Members Bill introduced in the House of Lords by Lord Saatchi. The purpose of the Bill is to encourage responsible innovation in medical treatment. In particular, it wouldn’t be negligent for a doctor to depart from accepted medical treatments for a condition if the decision to do so is taken responsibly. The Bill can only be used to further the best interests of the patient. The Bill can’t be used for other purposes, such as research. The Bill clarifies that common law relating to departure from acceptable medical treatments remains unchanged. The common law position is that departure from acceptable medical treatments will not amount to negligence provided the decision is supported by a responsible body of medical opinion. The Bill will receive its second reading in the House of Commons on 27 February.

What does the UK Government say?

The UK Government supports the Bill and says it relates to a non-devolved matter. Earl Howe, the Parliamentary Under-Secretary of State for Quality at the Department of Health has said that:

The operative provisions of the Bill relate entirely to modifying the law of tort, which is a reserved matter. The Bill can fairly and realistically be classified as relating to a non-devolved subject, and therefore not within the competence of the National Assembly for Wales.

What’s the view in Wales?

Mark Drakeford, the Health Minister, recently wrote to the Assembly’s Health and Social Care Committee to outline the Welsh Government’s position. The Minister says the Bill isn’t consistent with the ‘fundamental principles which we wish to drive improvements in NHS Wales’ and that there’s no evidence that innovative care is prevented by doctors’ fears of clinical negligence. He also says:

It appears to us, therefore, that the existing common law rule to the effect that departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion works well, and there is no need for the alternative route allowing a doctor to undertake ‘responsible innovation’ set out in the Bill.

The Health and Social Care Committee looked at the Legislative Consent Memorandum in January. In its report the Committee says it agrees with the Welsh Government that an LCM is required:

The Committee is of the opinion that the provisions in the Bill as currently drafted fall within the legislative competence of the Assembly. Therefore, it agrees with the Welsh Government that a legislative consent motion is required.

The Committee also highlighted that the majority of respondents to its consultation raised concerns, such as whether the Bill is required, and whether it could create unnecessary confusion and uncertainty. Others, while in favour of the aims of the Bill, question whether the Bill as drafted would achieve those aims. The Committee concludes:

It is important that patients are able to benefit from appropriate innovative treatments where it is in their best interests to do so, but on the basis of the evidence available to date, the Committee is not yet persuaded that this Bill would achieve its stated aim of encouraging such innovation. The Committee is therefore not yet persuaded that the Bill is an appropriate legislative vehicle to achieve its stated aims.

What happens if the Assembly votes against the LCM?

Although the Assembly has the power to legislate in 20 devolved areas, the UK Parliament retains the authority to legislate on any issue relating to Wales whether devolved or not. The convention that the UK Parliament requires the agreement of the Assembly to pass laws that relate to a devolved area – the LCM process - is set out in the Memorandum of Understanding and Supplementary Agreements (MoU). The MoU outlines the principles of co-operation underpinning the relationship between the UK Government and the devolved administrations The MoU says:

… the UK Government will proceed in accordance with the convention that the UK Parliament will not normally legislate with regard to devolved matters except with the agreement of the devolved legislature.

So the crucial question is, does the Medical Innovation Bill relate to a devolved matter, or not? The Assembly has withheld consent to provisions in UK legislation affecting devolved matters on four occasions. See the previous blog post: Memorandum on the Legislative Consent Process

Article by Elfyn Henderson, National Assembly for Wales Research Service.