Bil Arloesi Meddygol? Wales votes No

The Welsh Assembly votes unanimously against Saatchi Bill


Vote in the Senedd clear: National Assembly for Wales united against Saatchi Bill

“a solution in search of a problem and not a very sound solution at that”

Previous post on LCM here.

The National Assembly for Wales debated the Medical Innovation Bill in Plenary yesterday, February 3 2015.

The debate, informed by the report of the Committee released last week, revealed a cross-party clarity and cutting precision from the Senedd, despite Lord Saatchi’s best attempt and Lord Howe’s assertions in the Lords.

Legislative Consent

The Government of Wales Act 2006 permitted a referendum on devolving legislative competence to the Welsh Government. This occurred in 2011 since which Wales has had full legislative competence in the 20 areas set out in Schedule 7 of the 2006 Act, subject to any exceptions listed therein.  One of these areas, under Para 9, Pt 1 Schedule 7 is health and health service provision.  A Legislative Consent Motion must be passed by the Assembly to provide agreement for Westminster to legislate for Wales in an area of Welsh legislative competence. The Welsh government identified that the Bill clearly applied to an area that has been fully devolved, and so the Minister for Health and Social Services Mark Drakeford issued a legislative consent memorandum in December 2014.

Ignorance or arrogance?

Already clear, the 2014 SC judgment on Agricultural Sector (Wales) Bill  irrefutably delineated the matter of legislative competence as being a test of whether the provisions of a Bill relate to a devolved subject.  Indeed, the Bill “sits firmly” within the legislative competence of the National Assembly: the Westminster Parliament’s assertions that it does not apply are “plainly not the case”.

What were the UK govt, Bill team, DH thinking? To attempt to pass legislation in an area so clearly devolved to Wales is a fundamental breach of convention, but to add to that the Bill is widely considered unnecessary and harmful. Surely they knew this would be picked up? and if they aren’t aware, then what are they doing in their jobs?  Earl Howe was wrong in his assertions to Baroness Finlay which is somewhat remarkable for a Parliamentary Under-Secretary of State for Quality at the Department of Health, speaking for the UK government in the House of Lords.

“It is extremely concerning that there is still advice being given that clearly contradicts the position that’s been outlined very clearly by the Supreme Court, and the amount of time that appears to be wasted in Westminster now as a consequence of that lack of understanding and lack of attention to decisions relating to Welsh devolution should concern us all. It’s certainly my view that approaches should be made, either via the First Minister or via the Counsel General, to try and resolve that situation.” – Mick Antoniw

“is this Bill the appropriate vehicle, and does this lie within the competence of the National Assembly for Wales?”
“I have to say that I fully concur with the Welsh Government in terms of its view and the view of the Health and Social Care Committee in terms of the scope of this Bill falling absolutely within the competence of the Assembly. It is very clear that this is touching on issues that relate to the field of health in the Government of Wales Act 2006, and therefore it is entirely appropriate that we’re having this debate in the Senedd today.”
“We will be voting against the LCM on the basis that we do not feel that there is a need, frankly, for the provisions in this Bill in order to allow for appropriate medical innovation here in Wales. As the Minister has already said, and, as we received evidence to the health committee from a range of sources, there is innovation already taking place. Frankly, Wales and the rest of the United Kingdom are at the cutting edge, in many respects, of medical innovation, with new treatments coming online and upstream all of the time.     We ought not to undermine that by tinkering with our legislative arrangements in a way that would undermine the accountability that’s currently in the system, which allows for that innovation to take place. So, we do feel that the provisions in this Bill are unnecessary, that the current law, and the ethical guidance that sits alongside that law, are sufficient and adequate to be able to allow for responsible medical innovation where there is a patient interest that clearly is going to be pursued. For that reason, we’ll be supporting the Government’s position today and encouraging Members in this Chamber to vote against this LCM.”

An appropriate vehicle?

The Assembly debate had to consider whether to pass the LCM to agree to the Bill applying in Wales. In considering the Bill Wales took into account its consultation, which though brief received “clear and robust responses”, as did that run by the DH and Bill team . They concluded:

  • “against Lord Saatchi’s own test, the Bill is unnecessary as there is no evidence that innovative care is prevented by doctors’ fears of the current system of clinical negligence”  “there are many organisations and individuals who go beyond the belief that the Bill is unnecessary to argue that it is positively harmful“(Mark Drakeford)
  • “The Bill is ill thought out. It also offers fewer guarantees and protections than currently exist in common law and therefore the legislation is unnecessary and also undesirable.” (Mick Antoniw, Welsh Labour)
  • “there is a lack of research accountability inherent in the Bill ” (Elin Jones, Plaid Cymru)
  • “we do not feel that there is a need, frankly, for the provisions in this bill in order to allow for appropriate medical innovation” (Darren Millar)
  • “as outlined by many of the responses that the health committee received, or, indeed, responses to Lord Saatchi’s own consultation, there is a very genuine fear that patients could be harmed as a result of this legislation, and innovation stifled.” (Kirsty Williams, Welsh Liberal Democrats)
  • “Not only would the Bill risk real detriment to individual patients, but as the Academy of Medical Royal Colleges concludes, one of its unintended but adverse consequences could be to undermine the essential role of proper, scientifically rigorous clinical trials on which innovative treatments for the whole of our patient body are legitimately based.”    “Above all, it will leave patients without a remedy when injured by treatments that many doctors would consider unacceptable, and at the mercy of the judgments made by individual practitioners who have no professional support or oversight.”    “The Bill is unnecessary and should not proceed” (Mark Drakeford)

“There’s clearly an emerging consensus across the Chamber around three key issues. Firstly, it’s common ground in this Chamber that this is a Bill that trespasses into areas of devolved competence…. Secondly, we are all agreed here that responsible medical innovation is something we want to see and we strongly support, but, in the third point of consensus, our fear is that the Bill, far from adding to the capacity to do that, runs the risk of frustrating responsible innovation. I therefore ask Members to vote against the motion, confirming our view that the provisions within this Bill should not apply to Wales.” – Mark Drakeford


This Side of the Truth: Wales and the Medical Innovation Bill

Baroness Ilora Finlay, a crossbench peer in the Lords and a very experienced consultant in palliative medicine,  moved an amendment in the House of Lords Committee debate on 24th October:

39: Clause 2, page 2, line 11, at end insert “but shall only come into force in Wales following legislative consent from the Assembly”

She explained that ‘health and healthcare provision is completely devolved’ in Wales, and ‘the experience of patients under the Welsh NHS falls completely within the legislative competence of the Assembly.’  She acknowledged that the Bill amends the law of negligence, however related concern from Wales about the use of resources, and ‘the possibility of practitioners being answerable as regards legislation that covers England and Wales, when the provision of healthcare is something for which they are answerable to the National Assembly.’

‘Sadly, we have had experience of extremely strange medical practices sometimes being put forward in the past. The Assembly is particularly concerned that, with its move toward prudent healthcare, which is a whole policy direction for NHS Wales, the Bill should not inadvertently cut across the principles of prudent healthcare, the first of which is, of course, to do no harm. ‘

The effect of this amendment would have been that the Bill would apply in Wales only once a legislative consent Motion had been passed in the Assembly, but this was rejected by the government, per Earl Howe:

 ‘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.’

Now, on one side  Earl Howe raised some valid points. The Bill does fundamentally destroy change the law of negligence, and it certainly provides no new access rights to a treatment for any patients in Wales, nor any new powers for them to be funded.   This is no more the truth than declaring a huge bouncy castle to be a flat line after measuring an inch of tarpaulin (insert varying analogies and units of choice) and actually, it’s worse.    The government’s statement clearly ignores the Bill’s obvious stated purpose, its effect and implications, while riding roughshod over the concept of devolution. It would be laughable if it were not such a serious topic.

The Government of Wales Act 2006 extended its predecessor and the remit of the Assembly, with s103 establishing that the Welsh Assembly Government, known as the Welsh Government since 2011, may pass primary legislation in accordance with Part 4, Schedule 7 and s108 if such power were to be approved through a referendum. This referendum took place in March 2011, and the Assembly can now pass legislation without the consent of UK Parliament, within the 20 specified areas of legislative competence listed in Sch.7  GoWA 2006

One of these areas happens to be, as pointed out by Baroness Finlay, health and health care provision under para 9, Pt 1 Sch.7.   Indeed in Wales there are perceptible differences in priorities, agendas, governance, even legislation in relation to the Welsh health service.  The AWMSG can make commissioning decisions and is not bound by NICE, NHS England et al.  Wales approves and pays for drugs not approved by or faster than England where assessed as appropriate, and has its own policies and consultations regarding access to treatment and responsible approaches to orphan drugs. Its decisions are not undermined for political purposes by schemes such as a cancer drugs fund, but it has appropriate schemes in place which conduct evidence reviews and consider individual circumstances. Wales even decided to legislate for presumed consent in relation to organ donation  (rather than continuing the UK system or introducing any alternative such as my preferred one, mandated choice): agree or disagree, this was done.

It’s therefore somewhat specious to assert that the Medical Innovation Bill would have no bearing on an area which is devolved, for it relates to medical practice, commissioning, resources, budgets, treatment, policies, oversight structures and patient care that are all, subject to any exceptions provided, entirely within the legislative, executive and administrative competence of the Welsh Assembly.  A quick glance at the Department of Health’s consultation document from 2014  provides p30:

Who will be affected?

Potentially doctors and patients, both in the NHS and more widely, in England and Wales.

Where Westminster chooses to legislate on an area of devolved competence, or if a Bill includes any provision that falls within or modifies an area of the Assembly’s legislative competence, by convention Ministers must gain the consent of the National Assembly via a Legislative Consent Motion (LCM) as set out within the Standing Orders of the Fourth Assembly.  A Legislative Consent Memorandum must be issued for an LCM to be considered, debated and passed in the National Assembly. A motion may seek to include a relevant provision in the Bill, and if provided in the legislation Wales may subordinately adopt, amend or annul its application.

Such a Legislative Consent Memorandum was laid down under SO 29.2(ii) on 10 December 2014. A consultation ran from 16 Dec 2014 until 9 Jan 2015, albeit rather quietly. Saatchi‘s close to the wire response contained somewhat misleading and truth-contorting PR, although submissions from the MDU, Patients Association and other organisations provide a more accurate perspective.

It was referred to the Health and Social Care Committee which met 21st January, and their report shall inform the debate in Plenary on Tuesday 3rd February.

The Health and Social Care Committee Report– released today- states:

‘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.’

On the subject of legislative competence it confirms:

‘The Supreme Court in its judgment on  Agricultural Sector (Wales) Bill in July 2014, clarified that the test of whether the provisions of a Bill fall within the legislative competence of the Assembly is simply whether those provisions relate to a devolved subject.’

‘In the view of the Committee, the Bill relates to the devolved subject of health, specifically the treatment and alleviation of disease, illness, injury, disability and mental disorder; provision of health services; clinical governance and standards of health. Neither medical innovation nor the law of tort are exceptions under Schedule 7 to the Government of Wales Act 2006, and therefore no relevant exceptions apply.’

The Bill relates to and will serve to significantly impact on large areas within the Assembly’s legislative and administrative competence.  It will affect the provision of health services, clinical governance, standards of health care, authorisation and commissioning of services and resources, the treatment of any patient and patient safety with resultant un-quantified constraint on associated functions.    It would be an unacceptable violation of political, legal and constitutional obligations for the Welsh Assembly to be ignored by Westminster and the Department of Health, due to the far reach and influence of the noble Lord, on this extremely significant potential legislative change that certainly does pertain to areas within the Assembly’s competence.    It’s remarkable that the Bill team and DH were not in more appropriate dialogue with the Wales Office and Welsh Government in time to correctly consider Baroness Finlay’s concerns.

The overwhelming opposition across the UK has continued from all expert bodies and organisations: medical, legal, charitable, research and patient groups are united in opposing this very misguided, unnecessary, unscientific, botched, rushed and dangerous Bill and this opposition is maintained by all key organisations despite attempts to mislead, coerce and force through deeply illegitimate legislation with illusory amendments as political devices.   It would be unthinkably irresponsible for the Assembly to pass the LCM on the 3rd.   It is not in the interests of Wales at all for this rushed, unmandated and unnecessary Bill to go through, a point not lost on the Committee.

The National Assembly must now take heed of its consultation findings and the careful consideration and work of its Committee in Plenary next week and Ministers subsequently in the Commons.