Stop the Saatchi Bill

Driven by an extraordinary two-year PR campaign on social media and a supportive newspaper partner, this all started as Lord Saatchi’s Medical Innovation Bill, metamorphosed through several versions, and was resurrected under a new name by Chris Heaton-Harris, before finally clearing its last hurdle in the Lords this week to become the Access to Medical Treatments (Innovation) Act. Pretty much the only thing they share is the word 'Innovation' in the title.

One day, it may be possible for politicians to ask the people who actually work in the medical field: what are the problems you face, and how can we help you overcome them?

One day, politicians may actually listen to the answers they receive, and thus try to tackle genuine problems rather than imagined ones.

One day, politicians, medics, researchers, lawyers, patient groups, charities, and the public, may work together to overcome the barriers to the development and provision of new treatments.

But it is not this day.

Read more: Not this day

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

Re-blogged with permission from This Side of the Truth: Wales and the Medical Innovation Bill by Sofia

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. Aconsultation 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.